Balloon dilation catheter

Abstract

The present invention provides a balloon dilatation catheter comprising 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. An outer wall of one side of the second tube body is connected to an inner wall of one side of the first tube body, and a blood flow cavity is formed between an outer wall of the other side of the second tube body and an inner wall of the other side of the first tube body. The balloon sleeves an outer wall of the first tube body, 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 tube body, and a first medium cavity is formed between the far end of the catheter body and the second tube body. A through part for communication between the first medium cavity and the filling cavity is arranged at a connection between the first tube body and the second tube body. The present invention can solve the blood flow supply problem of distal blood vessels during balloon dilatation.

Description

Balloon dilatation catheter Technical Field

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

[0002] Atherosclerosis refers to the thickening of the arterial walls and narrowing of the lumen of arteries supplying various organs, including the heart, brain, and kidneys. It is a leading cause of heart attacks and strokes, and the leading cause of death worldwide. Currently, balloon products are widely used for the interventional treatment of atherosclerosis through percutaneous transluminal angioplasty. These balloon products can be categorized by function into pre-expansion balloons, post-expansion balloons, and drug-coated balloons.

[0003] Pre-dilation balloons are typically used for vascular calcification, severe stenosis, chronic total occlusion, and specialized treatments. Pre-dilation of the lesion with a pre-dilation balloon can assess the nature of the lesion, estimate the difficulty of lesion management, and guide subsequent strategy development. Furthermore, pre-dilation can partially relieve stenosis, increase the success rate of subsequent stent placement through the lesion, and reduce damage to the stent coating.

[0004] Post-dilatation balloon angioplasty is generally used for complex lesions, ostial lesions, and in-stent lesions. Through post-implantation treatment, it ensures full stent expansion and adherence to the wall, reduces intra-stent thrombosis, and lowers the incidence of restenosis and revascularization rates after stent implantation.

[0005] As a new "implant-free" interventional therapy device, the drug-coated balloon (DCB) is a device that coats the balloon with a drug. After inflation, the drug coating separates from the balloon and adheres to the vessel wall to treat the lesion. This approach offers significant advantages, allowing for the treatment of severe coronary artery disease without leaving a permanent implant in the vessel. This avoids the problems associated with stent placement and opens the door to retreatment of diseased vessels, offering significant advantages.

[0006] During the expansion of the above-mentioned conventional balloon, 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 expanded for a sufficient time. For pre-expansion balloons and post-expansion 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 invention is only intended to deepen the understanding of the general background technology of the invention, and should not be regarded as an admission or any form of implication that the information constitutes prior art already known to those skilled in the art.

[0008] Summary of the Invention

[0009] The object of the present invention is to provide a balloon dilatation catheter which can solve the problem of blood flow supply to distal blood vessels during balloon dilatation.

[0010] To achieve the above object, the present invention provides a balloon dilatation catheter, comprising 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;

[0011] The blood flow tube includes a first tube body and a second tube body, the second tube body is located in the first tube body, the outer wall of the first side of the second tube body is connected to the inner wall of the first side of the first tube body, and a blood flow cavity for blood flow is formed between the outer wall of the second side of the second tube body and the inner wall of the second side of the first tube body;

[0012] The balloon is sleeved on the outer wall of the first tube, and a filling cavity for accommodating a filling medium is defined between the balloon and the first tube;

[0013] 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 defined between the distal end of the catheter body and the second tube body;

[0014] 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.

[0015] Optionally, the outer wall of the first side of the second tube body is welded to the inner wall of the first side of the first tube body, and the welding length between the second tube body and the first tube body is 2mm to 6mm, and the through portion includes at least one through hole provided at the welding point between the first tube body and the second tube body.

[0016] Optionally, the second tube body and the first tube body are an integral structure, and the through portion includes an open seam provided at the connection between the first tube body and the second tube body.

[0017] 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.

[0018] 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, and the distal end of the inner tube is located inside the second tube body. There is a first medium cavity between the inner tube and the second tube body, and there is a second medium cavity 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.

[0019] Optionally, the inner tube has a guidewire cavity extending along its axial direction, and one side of the outer tube has a guidewire port for allowing a guidewire to extend into the guidewire cavity.

[0020] 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.

[0021] 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.

[0022] 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.

[0023] 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.

[0024] Optionally, the cross-section of the blood flow cavity is crescent-shaped.

[0025] Optionally, the diameter of the balloon is 2 mm to 4 mm.

[0026] Optionally, the length of the balloon is 10 mm to 40 mm.

[0027] Optionally, the outer diameter of the first tube is 0.7 mm to 1.5 mm.

[0028] Optionally, the wall thickness of the first tube body is 0.15 mm to 0.25 mm.

[0029] Optionally, the length of the first tube is 20 mm to 50 mm.

[0030] Optionally, the outer diameter of the second tube is 0.6 mm to 1 mm.

[0031] Optionally, the length of the second tube is 25 mm to 55 mm.

[0032] Optionally, the outer surface of the balloon has a drug coating.

[0033] Optionally, the material of the balloon is nylon, a block copolymer of polyamide and polyether, or thermoplastic polyurethane.

[0034] Compared with the prior art, the balloon dilatation catheter provided by the present invention has the following beneficial effects:

[0035] The balloon dilatation catheter provided by the present invention includes a catheter body, a blood flow tube and a balloon, and the blood flow tube runs through the proximal end and distal end of the balloon; the blood flow tube includes a first tube body and a second tube body, the second tube body is located in the first tube body, one side outer wall of the second tube body is connected to one side inner wall of the first tube body, and a blood flow cavity for blood flow is formed between the other side outer wall of the second tube body and the other side inner wall 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; 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. Thus, by disposing a blood flow tube penetrating the balloon and having a blood flow lumen at the distal end of the balloon dilatation catheter, the present invention ensures that proximal blood can flow to distal tissues both before and after balloon dilatation, thus preventing distal ischemia caused by balloon dilatation. This solves the problem that conventional balloons, during pre-dilatation, post-dilatation, and drug delivery, completely block blood vessels for a period of time, thereby reducing the therapeutic effect for some patients with poor tolerance to distal vascular ischemia. Furthermore, by nesting multiple tubing materials to form multiple independent chambers, the present invention minimizes the traversable diameter of the balloon dilatation catheter while ensuring that each chamber functions properly. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] FIG1 is a schematic diagram of the overall structure of a balloon dilatation catheter provided by one embodiment of the present invention;

[0037] FIG2 is a schematic structural diagram of the proximal portion of a balloon dilatation catheter provided in one embodiment of the present invention;

[0038] FIG3 is a schematic plan view of the distal end portion of a balloon dilatation catheter provided in one embodiment of the present invention;

[0039] FIG4 is a schematic diagram of the three-dimensional structure of the distal end portion of a balloon dilatation catheter provided by one embodiment of the present invention;

[0040] FIG5 is a cross-sectional view of the distal end portion of a balloon dilatation catheter in an expanded state provided by one embodiment of the present invention;

[0041] FIG6 is a cross-sectional view of the proximal end portion of the balloon dilatation catheter in a folded state provided by one embodiment of the present invention;

[0042] FIG7 is a blood flow diagram during the filling period of a conventional balloon dilatation catheter;

[0043] FIG8 is a blood flow diagram during the filling period of a balloon dilatation catheter according to an embodiment of the present invention;

[0044] FIG9 is a schematic structural diagram of a blood flow tube in a balloon dilatation catheter provided by another embodiment of the present invention.

[0045] In which, the reference numerals are explained as follows: catheter body - 100; outer tube - 110; guidewire port - 111; proximal outer tube - 112; distal outer tube - 113; inner tube - 120; guidewire cavity - 121; development mark - 140; catheter identification band - 150; blood flow tube - 200; first tube body - 210; first sloped port - 211; second sloped port - 212; second tube body - 220; blood flow cavity - 230; through portion - 240; balloon - 300; filling cavity - 410; first medium cavity - 420; connector - 510; diffusion stress tube - 520; head structure - 530. DETAILED DESCRIPTION

[0046] The following is a detailed description of the balloon dilatation catheter of the present invention, in conjunction with the accompanying drawings and specific embodiments. The advantages and features of the present invention will become more apparent from the following description. It should be noted that the drawings are simplified and not to exact scale, and are intended solely to facilitate and clearly illustrate the purpose of the embodiments of the present invention. To make the purposes, features, and advantages of the present invention more readily apparent, please refer to the accompanying drawings. It should be noted that the structures, proportions, and sizes illustrated in the drawings are intended solely to facilitate understanding and reading by those skilled in the art, and are not intended to limit the implementation of the present invention. Any structural modifications, changes in proportions, or adjustments in size, provided they produce the same or similar effects and achieve the same objectives, will still fall within the scope of the technical content disclosed herein. The specific design features of the present invention disclosed herein, including, for example, specific dimensions, orientations, positions, and shapes, will be determined in part by the specific application and environment in which they are intended. Furthermore, in the embodiments described below, the same reference numerals may be used across different drawings to denote the same parts or parts having the same functions, and their repeated descriptions may be omitted. In this specification, similar reference numerals and letters are used to refer to similar items, so once an item is defined in one figure, it need not be further discussed in subsequent figures. In addition, if the method described in this application includes a series of steps, the order in which these steps are presented in this application 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 in this application may be added to the method.

[0047] It should be noted that, in this application, 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 actual relationship or order between these entities or operations, nor can they be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Moreover, the terms "comprises", "includes" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device comprising 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, an element defined by the sentence "comprises a..." does not exclude the presence of other identical elements in the process, method, article or device comprising the element. 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 "multiple" is generally used in a sense including "at least two".

[0048] In the description of the present invention, 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, indicating positions or positional relationships, are based on the positions or positional relationships shown in the accompanying drawings and are only for the convenience of describing the present invention and simplifying the description. They do not indicate or imply that the devices or components referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore should not be understood as limiting the present invention. In the description of the present invention, unless otherwise expressly specified or limited, the terms "installed", "connected", "connected", and "fixed" should be understood in a broad sense. For example, they can be fixedly connected, detachably connected, or integrated; they can be mechanically connected or electrically connected; they can be directly connected or indirectly connected through an intermediate medium; they can be internal communication between two components or an interaction relationship between two components. For those skilled in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances. In addition, in the present invention, unless otherwise expressly specified or limited, a first feature being "above" or "below" a second feature may include the first and second features being in direct contact, or may include the first and second features being in contact not directly but through another feature between them. Moreover, a first feature being "above," "above," and "above" a 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. A first feature being "below," "below," and "below" a 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.

[0049] The core idea of ​​the present invention is to provide a balloon dilatation catheter to solve the problem of blood flow supply to distal blood vessels during balloon dilatation.

[0050] Please refer to Figures 1 to 6, wherein Figure 1 is a schematic diagram of the overall structure of a balloon dilatation catheter provided in one embodiment of the present invention; Figure 2 is a schematic diagram of the structure of the proximal portion of a balloon dilatation catheter provided in one embodiment of the present invention; Figure 3 is a schematic diagram of the planar structure of the distal portion of a balloon dilatation catheter provided in one embodiment of the present invention; Figure 4 is a schematic diagram of the three-dimensional structure of the distal portion of a balloon dilatation catheter provided in one embodiment of the present invention; Figure 5 is a cross-sectional view of the distal portion of the balloon dilatation catheter provided in an expanded state in one embodiment of the present invention; and Figure 6 is a cross-sectional view of the proximal portion of the balloon dilatation catheter provided in a folded state in one embodiment of the present invention. As shown in Figures 1 to 6, the balloon dilatation catheter provided by the present invention includes a catheter body 100, a blood flow tube 200 and a balloon 300, wherein the blood flow tube 200 passes 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 within 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 vessel for blood flow 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. flow cavity 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 is provided at the connection between the first tube body 210 and the second tube body 220 for connecting the first medium cavity 420 and the filling cavity 410. Thus, the present invention, by setting a blood flow tube 200 having a blood flow cavity 230 and a penetrating balloon 300 at the distal end of the balloon dilatation catheter, can ensure that blood flow from the proximal end can reach the distal tissue before and after the balloon 300 is expanded (i.e., before and after filling), thereby avoiding distal ischemia caused by the expansion of the balloon 300, thereby solving the problem that the existing conventional balloon 300 completely blocks the blood vessels for a period of time during pre-expansion, post-expansion, and drug delivery, thereby reducing the therapeutic effect for some patients with poor tolerance to distal vascular ischemia. In addition, the present invention forms multiple independent chambers by nesting multiple tubing materials, 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) functions, 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.

[0051] 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, causing the balloon 300 to expand or inflate, the balloon dilatation catheter is in the expanded state, as shown in Figure 5. Before the balloon 300 is expanded or inflated, the balloon dilatation catheter is in the folded state, as shown in Figure 6. Furthermore, during the folding and pressing process, the balloon 300 does not compress or deform the blood flow tube 200, thereby ensuring that blood flow from the proximal end to the distal tissue can flow before and after the balloon 300 is expanded (i.e., before and after filling).

[0052] Please continue to refer to Figures 7 and 8, wherein Figure 7 is a blood flow diagram during the filling period of a conventional balloon dilatation catheter; and Figure 8 is a blood flow diagram during the filling period of a balloon dilatation catheter provided by an embodiment of the present invention. As shown in Figure 7, for a conventional balloon dilatation catheter, after the proximal blood flow reaches the filling point 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. As shown in Figure 8, 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, which allows the proximal blood flow to further reach the distal tissue. It should be noted that, as can be understood by those skilled in the art, the dotted arrows in Figures 7 and 8 represent the direction of blood flow.

[0053] Continuing with reference to Figures 5 and 6 , as shown in these figures, in some exemplary embodiments, the cross-section (a cross-section perpendicular to the axial direction) of the blood flow lumen 230 is crescent-shaped. Thus, the crescent-shaped blood flow lumen 230 allows blood to flow into the blood flow lumen 230 at a greater angle along the circumference of the catheter, maximizing the blood flow through the blood flow lumen 230 while preventing distal blood flow obstruction.

[0054] Continuing with reference to FIG. 4 , as shown in FIG. 4 , in some exemplary embodiments, the proximal end of the first tube body 210 has a first beveled opening 211 inclined toward the proximal end, and the distal end of the first tube body 210 has a second beveled opening 212 inclined toward the distal end. Thus, by providing the first beveled opening 211 at the proximal end of the first tube body 210 and the second beveled opening 212 at the distal end of the first tube body 210, not only can the blood flow inlet area be increased, allowing some blood to enter the blood flow cavity 230 in a turbulent manner, thereby facilitating increased blood flow, but also can help reduce the pushing resistance of the balloon dilatation catheter, thereby facilitating delivery of the balloon dilatation catheter provided by the present invention to the location of the lesion within the blood vessel. It should be noted that, as will be understood by those skilled in the art, in other embodiments, the second beveled opening 212 may be provided only at the distal end of the first tube body 210 to reduce the pushing resistance of the balloon dilatation catheter, or the first beveled opening 211 may be provided only at the proximal end of the first tube body 210 to improve blood flow.

[0055] 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 will appreciate, the first bevel opening 211 and the second bevel opening 212 can also be formed by other means, and the present invention is not limited thereto.

[0056] Furthermore, the first bevel opening 211 can have an inclination angle of 45° to 60°, and the second bevel opening 212 can have an inclination angle of 45° to 60°. Thus, this angle setting not only prevents the sidewalls of the first bevel opening 211 and the second bevel opening 212 from scratching blood vessels, but also increases the blood flow entrance area, further helping to increase blood flow.

[0057] In some exemplary embodiments, the balloon 300 is made of 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 form the balloon 300, the balloon dilatation catheter provided by the present invention can be used in various scenarios, such as pre-dilatation, post-dilatation, and drug delivery.

[0058] 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 sizing further enables the balloon dilatation catheter provided by the present invention to cope with different usage scenarios such as pre-dilatation, post-dilatation, and drug delivery.

[0059] 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. This sizing not only prevents compression or deformation of the first tube 210 during the folding and crimping process of the balloon 300, thereby ensuring blood flow from the proximal end to the distal tissue before and after the balloon 300 is expanded (i.e., before and after filling), but also ensures that the first tube 210 will not collapse or deform within the operating pressure range of the balloon 300, ensuring normal blood flow.

[0060] Furthermore, the first tube 210 is made of nylon or a block copolymer of polyamide and polyether. Thus, by using nylon or a block copolymer of polyamide and polyether (Pebax) to make the first tube 210, it is possible to ensure that the first tube 210 has sufficient strength to further ensure that the first tube 210 is not compressed or deformed during the folding and gripping process of the balloon 300, thereby ensuring that blood flow from the proximal end to the distal tissue can be achieved before and after the balloon 300 is expanded (i.e., before and after filling).

[0061] 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. This dimensioning ensures that a crescent-shaped blood flow lumen 230 is formed between the first tube 210 and the second tube 220, thereby allowing blood to flow into the blood flow lumen 230 at a wider angle along the circumference of the catheter.

[0062] Furthermore, the second tube 220 is made of nylon or a block copolymer of polyamide and polyether. Using nylon or a block copolymer of polyamide and polyether (Pebax) to form the second tube 220 ensures sufficient strength to further ensure that the blood flow tube 200 is not compressed or deformed during the folding and gripping of the balloon 300. This ensures that blood flow from the proximal end to the distal tissue can be maintained before and after the balloon 300 is expanded (i.e., before and after filling).

[0063] In some exemplary embodiments, the outer surface of the balloon 300 is coated with a drug. Thus, the drug coating 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 vascular elastic retraction.

[0064] Specifically, the drug can be applied to the outer surface of the balloon 300 by electrostatic spraying, ultrasonic spraying, or crystal self-growth, thereby forming a drug coating on the outer surface of the balloon 300. Furthermore, the drug coating can be a coating containing only the drug or a mixture of the drug and a carrier matrix. Furthermore, the drug can be one or more of rapamycin, a rapamycin derivative, paclitaxel, or a paclitaxel derivative. The carrier matrix can be one or more of iopromide, urea, polyethylene oxide, polylactic acid, and the like.

[0065] In some exemplary embodiments, the outer wall of the second tube body 220 is welded to the inner wall of the first tube body 210, and the weld length between the second tube body 220 and the first tube body 210 is 2 mm to 6 mm. The through-hole 240 includes at least one through-hole located at the weld between the first and second tube bodies 210 and 220. Thus, by configuring the first and second tube bodies 210 as separate structures and welding the outer wall of the second tube body 220 to the inner wall of the first tube body 210 to form a blood flow tube 200 with a crescent-shaped lumen, the production cost of the balloon dilatation catheter provided by the present invention can be reduced. Furthermore, by setting the weld length between the second tube body 220 and the first tube body 210 to 2 mm to 6 mm, the push compliance of the balloon dilatation catheter provided by the present invention within the blood flow tube 200 can be prevented from being affected by an excessively long weld length. In addition, at least one through hole is provided 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 , thereby effectively preventing air leakage.

[0066] It should be noted that, as those skilled in the art will appreciate, 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 here one by one.

[0067] Furthermore, a fine needle can be used to puncture the weld between the first tube body 210 and the second tube body 220 to form one or more through-holes. Preferably, the through-hole 240 includes a single through-hole to reduce process risk. It should be noted that, as will be understood by those skilled in the art, the perforated area (i.e., the through-hole 240) should not extend beyond the edge of the weld to prevent air leakage.

[0068] Please continue to refer to Figure 1. As shown in Figure 1, 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. A first medium cavity 420 is provided between the inner tube 120 and the second tube body 220, and a second medium cavity for passing a filling medium 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 configuring the catheter body 100 as a double-layer structure comprising an outer tube 110 and an inner tube 120, not only can the balloon dilatation catheter provided by the present invention have good pushing performance, but 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, thereby filling the entire balloon 300. It should be noted that, as will be understood by those skilled in the art, the blood flow cavity 230 is separated from the second medium cavity, that is, the blood flow cavity 230 and the second medium cavity are not connected to each other.

[0069] Please continue to refer to Figures 1, 2 and 5. As shown in Figures 1, 2 and 5, 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 a guidewire to extend into the guidewire cavity 121. Thus, the guidewire port 111 and the guidewire cavity 121 can be used to pass through the guidewire, so that the balloon dilatation catheter can be moved 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, a 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 and close to the target blood vessel wall. During the filling and pressure maintenance period of the balloon 300, the proximal blood flow can still flow to the distal tissue through the reserved blood flow cavity 230.

[0070] Please continue to refer to Figure 1. As shown in Figure 1, in some exemplary embodiments, the proximal end of the inner tube 120 extends out of the guide wire port 111. Therefore, this arrangement can make it easier to insert the guide wire.

[0071] Continuing with reference to FIG. 3 and FIG. 4 , as shown in FIG. 3 and FIG. 4 , in some exemplary embodiments, the region of the inner tube 120 located within the balloon 300 is provided with a radiographic marker 140. Thus, by providing the radiographic marker 140 in the region of the inner tube 120 located within the balloon 300, imaging and positioning of the balloon 300 can be performed. Specifically, the radiographic marker 140 can be integrally formed with the inner tube 120, i.e., a portion of the inner tube 120 is made of radiographic material. Alternatively, the radiographic marker 140 can be formed separately from the inner tube 120, such as by separately forming a radiographic ring that is then nested within the inner tube 120.

[0072] 3 and 4 , there are two imaging marks 140, one of which corresponds to the proximal end of the balloon 300, and the other corresponds to the distal end of the balloon 300. Thus, by providing two imaging marks 140, it is possible to better locate the position of the balloon 300 through imaging.

[0073] 1 and 2 , as shown in FIG1 and 2 , in some exemplary embodiments, the proximal end of the outer tube 110 has a catheter marking band 150. Thus, by providing the catheter marking band 150 at the proximal end of the outer tube 110, the length of the balloon dilatation catheter that has entered the patient's body can be marked.

[0074] Please continue to refer to Figures 1 and 2. As shown in Figures 1 and 2, 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. Therefore, by configuring the outer tube 110 to include a proximal outer tube 112 and a distal outer tube 113, the balloon dilatation catheter provided by the present invention 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 performance, 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 present invention.

[0075] Please continue to refer to Figures 1 and 2. As shown in Figures 1 and 2, 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). Therefore, 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 present invention from breaking during use.

[0076] Continuing to refer to FIG. 1 and FIG. 3 , as shown in FIG. 1 and FIG. 3 , in some exemplary embodiments, the balloon dilatation catheter further includes a head structure 530. The distal end surface of the catheter body 100 and the distal end surface of the second tube 220 are both connected to the proximal end of the head structure 530. Thus, by providing the head structure 530 at the distal end of the balloon dilatation catheter, the catheter can be used to pass through diseased tissue.

[0077] Furthermore, as shown in Figures 1 and 3, in some exemplary embodiments, the diameter of the head structure 530 gradually decreases from the proximal end to the distal end. Thus, this configuration can make it easier for the head structure 530 to pass through the diseased tissue.

[0078] The specific manufacturing process of the balloon dilatation catheter provided in this embodiment is described below.

[0079] 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.

[0080] Then, the inner wall of the first tube 210 is welded to the outer wall of the second tube 220 , with a welding length of 2 mm to 6 mm, for example, 4 mm. This step forms a nesting, thereby forming the blood flow cavity 230 .

[0081] Then, a fine needle is used to pierce the welding point between the first tube body 210 and the second tube body 220 to obtain one or more through holes to form the through portion 240 .

[0082] Then, a balloon 300 is welded to both ends of the outer wall of the first tube 210. The balloon 300 is made of Pebax (a block copolymer of polyamide and polyether) or other materials, has an outer diameter of 2 mm to 4 mm, for example, 3 mm, and a length of 10 mm to 40 mm, for example, 20 mm. This step forms a secondary nesting, thereby forming a filling cavity 410.

[0083] The proximal end of the second tube body 220 is then connected to the distal outer tube 113, and the distal end of the second tube body 220 is fixedly connected to the inner tube 120 via the head structure 530. The proximal end of the inner tube 120 serves as the entrance to the guidewire port 111. This step forms a three-step nesting process, with the inner tube 120 containing the guidewire lumen 121. A first dielectric lumen 420 is formed between the inner tube 120 and the second tube body 220, and a second dielectric lumen is formed between the inner tube 120 and the outer tube 110 (including the proximal outer tube 112 and the distal outer tube 113). The first dielectric lumen 420 and the second dielectric lumen are interconnected front to back.

[0084] Please continue to refer to Figure 9, which is a schematic diagram of the structure of the blood flow tube 200 in the balloon dilatation catheter provided in another embodiment of the present invention. As shown in Figure 9, 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-hole 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-hole 240, a larger through-hole 240 can be provided, so that the balloon 300 can be quickly inflated and depressurized.

[0085] It should be noted that although FIG9 does not show the first bevel opening 211 and the second bevel opening 212 of the first tube body 210, as those skilled in the art will appreciate, 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 body 210. Of course, as those skilled in the art will appreciate, the first bevel opening 211 and the second bevel opening 212 can also be formed by other means, and the present invention is not limited thereto.

[0086] The specific manufacturing process of the balloon dilatation catheter provided in this embodiment is described below.

[0087] 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 lumen of the second tube body 220 (that is, the circular chamber of the double-lumen tube) and the inner tube 120 subsequently passing through it form a first medium chamber 420.

[0088] Then, a slit is laser-etched 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) 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.

[0089] 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 (a 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 the filling cavity 410.

[0090] 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). The first medium cavity 420 and the second medium cavity are connected front to back.

[0091] Finally, the surface of the balloon 300 is coated with an everolimus drug coating by ultrasonic spraying, and then the balloon 300 segments are folded and pressed to obtain a balloon dilatation catheter.

[0092] In summary, compared with the prior art, the balloon dilatation catheter provided by the present invention has the following beneficial effects:

[0093] (1) The present invention provides a blood flow tube 200 having a blood flow cavity 230 and a penetrating balloon 300 at the distal end of the balloon dilation catheter, thereby ensuring that blood flow from the proximal end can reach 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 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.

[0094] (2) The present invention forms multiple independent chambers by nesting multiple tubes, thereby ensuring that each chamber functions while minimizing the diameter that the balloon dilatation catheter can penetrate.

[0095] (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.

[0096] 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" 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 present invention. 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 different embodiments or examples described in this specification and the features of different embodiments or examples, unless they are contradictory.

[0097] It should also be noted that the above description is merely a description of preferred embodiments of the present invention and does not limit the scope of the present invention. Any changes or modifications made by a person skilled in the art based on the above disclosure are within the scope of protection of the present invention. Obviously, various changes and modifications may be made by a person skilled in the art without departing from the spirit and scope of the present invention. Thus, if such modifications and variations fall within the scope of the present invention and its equivalents, the present invention is intended to include such 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, the second tube body is located in the first tube body, the outer wall of the first side of the second tube body is connected to the inner wall of the first side of the first tube body, and a blood flow cavity for blood flow to pass through is formed between the outer wall of the second side of the second tube body and the inner wall of the second 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: The outer wall of the first side of the second tube body is welded to the inner wall of the first side of the first tube body, and the welding length between the second tube body and the first tube body is 2mm to 6mm. The through portion includes at least one through hole arranged at the 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 crescent-shaped; 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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