Balloon dilatation catheter

Abstract

The application provides a balloon dilatation catheter, which 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, one side outer wall of the second tube body is connected with one side inner wall of the first tube body, and the other side outer wall of the second tube body and the other side inner wall of the first tube body form a blood flow cavity; the balloon is sleeved on the outer wall of the first tube body, and the balloon and the first tube body have a filling cavity; the distal end of the catheter body is inserted into the second tube body, and the distal end of the catheter body and the second tube body have a first medium cavity; the connecting part of the first tube body and the second tube body has a through part for connecting the first medium cavity and the filling cavity. The application can solve the blood flow supply problem of the distal end blood vessel during balloon dilatation.

Description

Technical Field

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

[0002] Atherosclerosis refers to the thickening of the walls and narrowing of the lumen of the arteries supplying blood to various organs such as the heart, brain, and kidneys. It is a major cause of heart attacks and strokes, and a leading cause of death worldwide. Currently, balloon products are widely used in the interventional treatment of atherosclerosis through percutaneous endovascular angioplasty. These balloon products, classified by function, can include pre-dilatation balloons, post-dilatation balloons, and drug-coated balloons.

[0003] Pre-dilatation balloons are generally used for vascular calcification, severe stenosis, chronic total occlusion lesions, and special treatments. By pre-dilatating the lesion site with a pre-dilatation balloon, the nature of the lesion can be assessed, the difficulty of treatment estimated, and subsequent strategy development guided. Furthermore, pre-dilatation can partially relieve stenosis, increase the success rate of subsequent stent passage, and reduce damage to the stent coating.

[0004] Post-dilatation balloons are generally used for complex lesions, ostial lesions, and in-stent lesions. By performing post-stent placement procedures, sufficient stent expansion and apposition to the stent wall are ensured, reducing in-stent thrombosis, and lowering the incidence of restenosis and revascularization rate after stent placement.

[0005] Drug-coated balloons, as a novel "implant-free" interventional treatment device, work by coating the surface of a balloon with medication. After inflation, the drug coating separates from the balloon and adheres to the vessel wall to treat the lesion. This achieves the treatment of severe coronary artery lesions without leaving a permanent implant in the blood vessel, avoiding a series of problems caused by stent placement, and also providing the possibility of retreatment of diseased vessels, offering significant and unique advantages.

[0006] During conventional balloon dilation, the vessel is completely blocked to improve apposition and enhance the expected therapeutic effect or drug delivery efficiency. However, in some patients, distal vessels cannot tolerate prolonged ischemia and cannot be dilated for an adequate period. This can lead to poor treatment outcomes with pre-dilation and post-dilation balloons. With drug-coated balloons, the drug coating cannot be maximized and firmly transferred to the vessel wall, reducing drug concentration in the lesion area and potentially causing distal vascular embolism. In summary, current conventional balloons still have limitations in treating various lesions.

[0007] It should be noted that the information disclosed in the background section of this invention is intended only to enhance the understanding of the general background of this invention, and should not be construed as an admission or in any way implying that the information constitutes prior art known to those skilled in the art. Summary of the Invention

[0008] The purpose of this invention is to provide a balloon dilation catheter that can solve the problem of blood supply to distal vessels during balloon dilation.

[0009] To achieve the above objectives, the present invention provides a balloon dilation catheter, comprising a catheter body, a blood flow tube, and a balloon, wherein the blood flow tube extends through the proximal and distal ends of the balloon;

[0010] The blood flow tube includes a first tube body and a second tube body. The second tube body is located inside the first tube body. One side of the outer wall of the second tube body is connected to one side of the inner wall of the first tube body, and a blood flow cavity for blood flow is formed between the other side of the outer wall of the second tube body and the other side of the inner wall of the first tube body.

[0011] The balloon is fitted onto the outer wall of the first tube, and there is an inflation cavity between the balloon and the first tube for containing the inflation medium.

[0012] The distal end of the catheter body is inserted into the second tube body, and there is a first medium cavity between the distal end of the catheter body and the second tube body for the passage of filling medium.

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

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

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

[0016] Optionally, the proximal end of the first tube has a first bevel inclined toward the proximal end, and / or the distal end of the first tube has a second bevel 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. A first medium cavity is provided between the inner tube and the second tube body. A second medium cavity for the passage of filling medium is provided between the inner tube and the outer tube. 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 guiding the guide wire into the guide wire cavity.

[0019] Optionally, the region of the inner tube located within the balloon has a radiopaque marker, 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 dilation catheter further includes a connector and a diffusion stress tube, the proximal end of the diffusion stress tube being connected to the distal end of the connector, and the distal end of the diffusion stress tube being connected to the proximal end of the catheter body.

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

[0023] Optionally, the blood flow cavity has a crescent-shaped cross-section.

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

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

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

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

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

[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 25mm to 55mm.

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

[0032] Optionally, the balloon may be made of nylon, a block copolymer of polyamide and polyether, or thermoplastic polyurethane.

[0033] Compared with the prior art, the balloon dilation catheter provided by the present invention has the following beneficial effects:

[0034] The balloon dilation catheter provided by the present invention includes a catheter body, a blood flow tube, and a balloon. The blood flow tube penetrates the proximal and distal ends of the balloon. The blood flow tube includes a first tube body and a second tube body. The second tube body is located inside the first tube body. One outer wall of the second tube body is connected to one inner wall of the first tube body, and a blood flow cavity for blood flow is formed between the other outer wall of the second tube body and the other inner wall of the first tube body. The balloon is fitted onto the outer wall of the first tube body, and an filling cavity for accommodating 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 communicating the first medium cavity and the filling cavity. Therefore, this invention, by incorporating a blood flow tube with a blood flow cavity penetrating the balloon at the distal end of the balloon dilation catheter, ensures proximal blood flow to distal tissues both before and after balloon dilation, preventing distal ischemia during balloon dilation. This addresses the problem of conventional balloons completely occluding blood vessels for a period during pre-dilation, post-dilation, and drug delivery, thus reducing treatment effectiveness for patients with poor tolerance to distal vascular ischemia. Furthermore, this invention utilizes nested tubing to form multiple independent chambers, ensuring each chamber functions effectively while minimizing the permeable diameter of the balloon dilation catheter. Attached Figure Description

[0035] Figure 1 This is a schematic diagram of the overall structure of a balloon dilation catheter provided in an embodiment of the present invention;

[0036] Figure 2 This is a schematic diagram of the proximal portion of a balloon dilation catheter provided in an embodiment of the present invention;

[0037] Figure 3 A schematic diagram of the planar structure of the distal portion of a balloon dilation catheter provided in an embodiment of the present invention;

[0038] Figure 4 A three-dimensional structural schematic diagram of the distal portion of a balloon dilation catheter provided in an embodiment of the present invention;

[0039] Figure 5 A cross-sectional view of the distal portion of a balloon dilation catheter in an dilated state, according to an embodiment of the present invention;

[0040] Figure 6 A cross-sectional view of the proximal portion of a balloon dilation catheter in a folded state, according to an embodiment of the present invention;

[0041] Figure 7 Blood flow diagram during the inflation of a standard balloon dilation catheter;

[0042] Figure 8 This is a blood flow diagram during the inflation of a balloon dilation catheter according to an embodiment of the present invention;

[0043] Figure 9 This is a schematic diagram of the blood flow tube in a balloon dilation catheter provided in another embodiment of the present invention.

[0044] The reference numerals in the attached figures are explained as follows:

[0045] Catheter body - 100; outer cannula - 110; guidewire orifice - 111; proximal outer cannula - 112; distal outer cannula - 113; inner cannula - 120; guidewire lumen - 121; contrast marker - 140; catheter identification band - 150;

[0046] Blood flow tube - 200; First tube body - 210; First bevel - 211; Second bevel - 212; Second tube body - 220; Blood flow cavity - 230; Through section - 240;

[0047] Balloon-300;

[0048] Filling cavity - 410; First dielectric cavity - 420;

[0049] Connector-510; Stress diffuser-520; Head structure-530. Detailed Implementation

[0050] The balloon dilation catheter proposed in this invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. The advantages and features of this invention will become clearer from the following description. It should be noted that the drawings are in a very simplified form and use non-precise proportions, used only to facilitate and clarify the illustration of the embodiments of this invention. Please refer to the drawings to make the objectives, features, and advantages of this invention more apparent and understandable. It should be understood that the structures, proportions, sizes, etc., depicted in the accompanying drawings are only for the purpose of assisting those skilled in the art in understanding and reading the content disclosed in the specification, and are not intended to limit the implementation conditions of this invention. Any modifications to the structure, changes in proportions, or adjustments to the size, provided that the effects and objectives achieved by this invention are the same or similar, should still fall within the scope of the technical content disclosed in this invention. Specific design features of the invention disclosed herein, including, for example, specific dimensions, orientations, positions, and shapes, will be determined in part by the specific application and usage environment. Furthermore, in the embodiments described below, the same reference numerals are sometimes used across different drawings to denote the same parts or parts having the same function, and repeated descriptions are omitted. In this specification, similar reference numerals and letters are used to denote similar items; therefore, once an item is defined in one figure, it need not be discussed further in subsequent figures. Furthermore, if the methods described herein involve a series of steps, and the order of these steps presented herein is not necessarily the only possible order in which they can be performed, some of the described steps may be omitted and / or other steps not described herein may be added to the method.

[0051] It should be noted that, in this document, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations, nor should they be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element. The singular forms “a,” “one,” and “the” include plural objects. The term “or” is generally used to mean “and / or.” The term “several” is generally used to mean “at least one.” The term “at least two” is generally used to mean “two or more.” The term “multiple” is generally used to mean “at least two.”

[0052] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "axial," "radial," and "circumferential," etc., indicating orientation or positional relationships, are based on the orientation or positional relationships shown in the accompanying drawings and are only for the convenience of describing the invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the invention. In the description of this invention, unless otherwise expressly specified and limited, the terms "installed," "connected," "joined," and "fixed" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances. Furthermore, in this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Moreover, "above," "over," and "on top" of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0053] The core idea of ​​this invention lies in providing a balloon dilation catheter that can solve the problem of blood supply to distal vessels during balloon dilation. It should be noted that, as those skilled in the art will understand, this...

[0054] Please refer to Figures 1 to 6 ,in, Figure 1 This is a schematic diagram of the overall structure of a balloon dilation catheter provided in an embodiment of the present invention; Figure 2 This is a schematic diagram of the proximal portion of a balloon dilation catheter provided in an embodiment of the present invention; Figure 3 A schematic diagram of the planar structure of the distal portion of a balloon dilation catheter provided in an embodiment of the present invention; Figure 4 A three-dimensional structural schematic diagram of the distal portion of a balloon dilation catheter provided in an embodiment of the present invention; Figure 5 A cross-sectional view of the distal portion of a balloon dilation catheter in an dilated state, according to an embodiment of the present invention; Figure 6This is a cross-sectional view of the proximal portion of a balloon dilation catheter in a folded state, according to an embodiment of the present invention. Figures 1 to 6 As shown, the balloon dilation catheter provided by the present invention includes a catheter body 100, a blood flow tube 200, and a balloon 300. The blood flow tube 200 penetrates the proximal and distal ends of the balloon 300. The blood flow tube 200 includes a first tube body 210 and a second tube body 220. The second tube body 220 is located inside the first tube body 210. One outer wall of the second tube body 220 is connected to one inner wall of the first tube body 210, and a blood flow cavity 2 for blood flow is formed between the other outer wall of the second tube body 220 and the other inner wall of the first tube body 210. 30; The balloon 300 is sleeved on the outer wall of the first tube 210, and there is an filling cavity 410 between the balloon 300 and the first tube 210 for containing filling medium; The distal end of the catheter body 100 is inserted into the second tube 220, and there is a first medium cavity 420 between the distal end of the catheter body 100 and the second tube 220 for the filling medium to pass through; The connection between the first tube 210 and the second tube 220 has a through portion 240 for communicating the first medium cavity 420 and the filling cavity 410. Therefore, by providing a blood flow tube 200 with a blood flow cavity 230 penetrating the balloon 300 at the distal end of the balloon dilation catheter, this invention ensures proximal blood flow to distal tissues both before and after balloon dilation (i.e., before and after inflation), preventing distal ischemia during balloon dilation. This solves the problem that conventional balloons 300 completely occlude blood vessels for a period of time during pre-dilation, post-dilation, and drug delivery, thus reducing treatment efficacy for patients with poor tolerance to distal vascular ischemia. Furthermore, by employing multiple nested tubing to form multiple independent chambers, this invention ensures the proper functioning of each chamber (including the first media chamber 420, the inflation chamber 410, the blood flow cavity 230, and the second media chamber mentioned below) while minimizing the permeable diameter of the balloon dilation catheter. It should be noted that, as those skilled in the art will understand, the blood flow cavity 230 is separated from the first medium cavity 420 and the filling cavity 410, that is, the blood flow cavity 230 is neither connected to the first medium cavity 420 nor to the filling cavity 410.

[0055] Specifically, the balloon dilation catheter has a folded state and an expanded state (i.e., an inflated 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 dilation catheter is in the expanded state, such as... Figure 5 As shown. Before the balloon 300 inflates or expands, the balloon dilation catheter is in a folded state, as... Figure 6As shown. Furthermore, during the folding and gripping process, the balloon 300 will not compress the blood flow vessel 200 or cause it to deform, thus ensuring that there is proximal blood flow to distal tissues before and after the balloon 300 is expanded (i.e. before and after inflation).

[0056] Please continue to refer to this. Figure 7 and Figure 8 ,in, Figure 7 Blood flow diagram during the inflation of a standard balloon dilation catheter; Figure 8 This is a blood flow diagram during the inflation of a balloon dilation catheter provided in an embodiment of the present invention. Figure 7 As shown, with a conventional balloon dilation catheter, after the proximal blood flow reaches the inflation point of the balloon 300, due to the good adhesion between the balloon 300 and the vessel wall, the proximal blood flow cannot further reach the distal tissues. For example... Figure 8 As shown, during inflation, the blood flow cavity 230 formed between the first tube body 210 and the second tube body 220 in the balloon dilation catheter provided by this invention provides a channel for blood flow, allowing proximal blood flow to further reach distal tissues. It should be noted that, as those skilled in the art will understand, Figure 7 and Figure 8 The dashed arrows in the diagram indicate the direction of blood flow.

[0057] Please continue to refer to this. Figure 5 and Figure 6 ,like Figure 5 and Figure 6 As shown, in some exemplary embodiments, the cross-section (the section perpendicular to the axial direction) of the blood flow cavity 230 is crescent-shaped. Therefore, the crescent-shaped blood flow cavity 230 allows blood to flow at a greater angle along the circumference of the catheter into the blood flow cavity 230, maximizing the blood flow through the blood flow cavity 230 and preventing distal blood flow blockage.

[0058] Please continue to refer to this. Figure 4 ,like Figure 4As shown, in some exemplary embodiments, the proximal end of the first tube 210 has a first bevel 211 inclined towards the proximal end, and the distal end of the first tube 210 has a second bevel 212 inclined towards the distal end. Therefore, by providing the first bevel 211 at the proximal end of the first tube 210 and the second bevel 212 at the distal end, not only can the blood flow inlet area be increased, allowing some blood flow to enter the blood flow cavity 230 in a turbulent manner to improve blood flow, but it can also help reduce the pushing resistance of the balloon dilation catheter, facilitating the insertion of the balloon dilation catheter provided by the present invention into the vascular lesion site. It should be noted that, as those skilled in the art will understand, in other embodiments, the second bevel 212 may only be provided at the distal end of the first tube 210 to reduce the pushing resistance of the balloon dilation catheter; or the first bevel 211 may only be provided at the proximal end of the first tube 210 to improve blood flow.

[0059] Specifically, the first bevel 211 and the second bevel 212 can be formed by chamfering the proximal and distal ends of the first tube body 210. Of course, as those skilled in the art will understand, the first bevel 211 and the second bevel 212 can also be formed in other ways, and the present invention does not limit them.

[0060] Furthermore, the inclination angle of the first inclined bevel 211 can be 45° to 60°, and the inclination angle of the second inclined bevel 212 can be 45° to 60°. Therefore, this angle setting not only prevents the sidewalls of the first inclined bevel 211 and the second inclined bevel 212 from scratching blood vessels, but also allows for a larger blood flow inlet area, further contributing to increased blood flow.

[0061] 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, polyamide, and polyether (Pebax) or thermoplastic polyurethane (TPU) to manufacture the balloon 300, the balloon dilation catheter provided by this invention can address different usage scenarios such as pre-dilation, post-dilation, and drug delivery.

[0062] In some exemplary embodiments, the balloon 300 has a diameter of 2 mm to 4 mm and a length of 10 mm to 40 mm. This size configuration allows the balloon dilation catheter provided by the present invention to address different usage scenarios such as pre-dilation, post-dilation, 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 is 0.15 mm to 0.25 mm, and the length is 20 mm to 50 mm. This dimensional configuration ensures that the balloon 300 will not compress or deform the first tube 210 during folding and compression, thus guaranteeing proximal blood flow to distal tissues both before and after balloon 300 inflation. Furthermore, it ensures that the first tube 210 will not collapse or deform within the balloon 300's operating pressure range, guaranteeing normal blood flow.

[0064] Furthermore, the first tube 210 is made of 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 210, sufficient strength can be ensured to prevent the balloon 300 from compressing or deforming the first tube 210 during folding and gripping. This ensures that blood flow from the proximal end to the distal tissue is maintained both before and after balloon 300 inflation (i.e., before and after inflation).

[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. This dimensional arrangement ensures that a crescent-shaped blood flow cavity 230 can be formed between the first tube 210 and the second tube 220, allowing blood to flow at a greater angle along the circumference of the catheter into the blood flow cavity 230.

[0066] Furthermore, the first tube 210 is made of 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 220, sufficient strength can be ensured to further guarantee that the balloon 300 will not compress the blood flow tube 200 or cause deformation during folding and gripping, thus ensuring proximal blood flow to distal tissues before and after balloon 300 expansion (i.e., before and after inflation).

[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 likelihood of intimal hyperplasia and minimizing vascular elastic recoil.

[0068] Specifically, the drug can be coated onto the outer surface of the balloon 300 by methods such as electrostatic spraying, ultrasonic spraying, or crystal self-growth to form a drug coating on the outer surface of the balloon 300. Further, the drug coating can be a drug-only coating or a mixture of drug and 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, polyoxyethylene, and polylactic acid.

[0069] In some exemplary embodiments, one outer wall of the second tube 220 is welded to one inner wall of the first tube 210, and the weld length between the second tube 220 and the first tube 210 is 2mm to 6mm. The through portion 240 includes at least one through hole at the weld between the first tube 210 and the second tube 220. Thus, by configuring the first tube 210 and the second tube 220 as separate structures and using a welding method to connect one outer wall of the second tube 220 to one inner wall of the first tube 210 to form a blood flow tube 200 with a crescent-shaped vascular lumen, the production cost of the balloon dilation catheter provided by the present invention can be reduced. Furthermore, by setting the weld length between the second tube 220 and the first tube 210 to 2mm to 6mm, the flexibility of the balloon dilation catheter provided by the present invention in pushing the blood flow tube 200 segment can be prevented from being affected due to excessively long weld lengths. In addition, by opening at least one through hole at the weld between the first tube 210 and the second tube 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 those skilled in the art will understand, in some other embodiments, adhesive or other connection methods can be used to connect one side of the outer wall of the second tube 220 to one side of the inner wall of the first tube 210. For details, please refer to the relevant technologies known to those skilled in the art, which will not be listed here.

[0071] Furthermore, a fine needle can be used to puncture the weld 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 those skilled in the art will understand, the puncturing area (i.e., the through portion 240) should not extend beyond the edge of the weld seam to prevent air leakage.

[0072] Please continue to refer to this. 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. A first medium cavity 420 is provided between the inner tube 120 and the second tube body 220. A second medium cavity for the passage of filling medium is provided between the inner tube 120 and the outer tube 110. The second medium cavity is connected to the first medium cavity 420. Therefore, by configuring the catheter body 100 as a double-layer structure including an outer tube 110 and an inner tube 120, not only can the balloon dilation catheter provided by the present invention have good pushing performance, but also external gas or liquid can be delivered 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 delivered to the filling cavity 410 through the through-hole 240, so that the balloon 300 is fully inflated. It should be noted that, as those skilled in the art will understand, the blood flow cavity 230 is also separated from the second medium cavity, that is, the blood flow cavity 230 is not connected to the second medium cavity.

[0073] Please continue to refer to this. 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 lumen 121 extending axially therein, and one side of the outer tube 110 has a guidewire port 111 for the guidewire to be inserted into the guidewire lumen 121. Thus, the guidewire can be inserted through the guidewire port 111 and the guidewire lumen 121, allowing the balloon dilation catheter to move along the guidewire to the lesion area. Specifically, the balloon 300, in a folded state, enters the lesion area along the guidewire. Subsequently, a filling medium such as contrast fluid or gas sequentially passes through the second medium cavity, the first medium cavity 420, and the through portion 240 to reach the filling cavity 410, so that the balloon 300 is fully inflated and closely adheres to the target vessel wall. During the inflation and pressure maintenance of the balloon 300, proximal blood flow can still flow to distal tissues through the reserved blood flow cavity 230.

[0074] Please continue to refer to this. Figure 1 ,like Figure 1 As shown, in some exemplary embodiments, the proximal end of the inner tube 120 extends outside the guidewire opening 111. This arrangement facilitates the insertion of the guidewire.

[0075] Please continue to refer to this. 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 within the balloon 300 has a radiopaque marker 140. Thus, by providing the radiopaque marker 140 in the region of the inner tube 120 located within the balloon 300, the position of the balloon 300 can be determined using imaging. Specifically, the radiopaque marker 140 can be integrally formed with the inner tube 120, that is, a portion of the inner tube 120 can be made of a radiopaque material; alternatively, the radiopaque marker 140 can be separately formed from the inner tube 120, such as by separately forming a radiopaque ring and then nesting the radiopaque ring onto the inner tube 120.

[0076] Furthermore, such as Figure 3 and Figure 4 As shown, there are two imaging markers 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. Therefore, by providing two imaging markers 140, the position of the balloon 300 can be more easily located through imaging.

[0077] Please continue to refer to this. 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 dilation catheter inserted into the patient's body.

[0078] Please continue to refer to this. 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 configuring the outer tube 110 with a structure including the proximal outer tube 112 and the distal outer tube 113, the balloon dilation catheter provided by the present invention can have good overall pushing performance, good torsional resistance, smooth passage through tortuous and thin tubes, and good retraction properties, which is beneficial for multiple dilations and shortens the operation time. Furthermore, the rigidity of the proximal outer tube 112 is higher than that of the distal outer tube 113 to further improve the pushing performance of the balloon dilation catheter provided by the present invention.

[0079] Please continue to refer to this. Figure 1 and Figure 2 ,like Figure 1 and Figure 2As shown, in some exemplary embodiments, the balloon dilation 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 this invention from breaking during use.

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

[0081] Furthermore, such as 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. This arrangement facilitates the head structure 530's passage through diseased tissue.

[0082] The specific manufacturing process of the balloon dilation 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 0.6 mm to 1 mm, for example 0.7 mm, and a length of 25 mm to 55 mm, for example 35 mm, is used as the second tube body 220; then, a 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, a length of 20 mm to 50 mm, for example 30 mm, and a wall thickness of 0.15 mm to 0.25 mm, for example 0.2 mm, is used as the first tube body 210.

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

[0085] Then, a fine needle is used to make holes at the weld between the first tube body 210 and the second tube body 220 to obtain one or more through holes, so as to form a through part 240.

[0086] Then, balloons 300 are welded to both ends of the outer wall of the first tube 210. The balloons 300 are made of Pebax (a block copolymer of polyamide and polyether) or other materials, with 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 an inflatable cavity 410.

[0087] Next, the proximal end of the second tube 220 is connected to the distal outer tube 113, and the distal end of the second tube 220 is connected and fixed to the inner tube 120 through the head structure 530. The proximal end of the inner tube 120 is the guide wire inlet 111. This step forms a three-fold nesting. The inside of the inner tube 120 is the guide wire cavity 121. A first medium cavity 420 is formed between the inner tube 120 and the second tube 220. 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 end to end.

[0088] Please continue to refer to this. Figure 9 This is a schematic diagram of the blood flow tube 200 in a balloon dilation catheter provided in another embodiment of the present invention. Figure 9 As shown, the difference between the balloon dilation catheter provided in this embodiment and the balloon dilation catheter provided in the previous embodiment is that, in this embodiment, the second tube body 220 and the first tube body 210 are an integral structure, and the through portion 240 includes an opening slit at the connection between the first tube body 210 and the second tube body 220. Therefore, by making the second tube body 220 and the first tube body 210 an integral structure, the problems of reduced catheter flexibility and process instability caused by multiple weldings can be reduced. By providing an opening slit 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, allowing the balloon 300 to be rapidly inflated and depressurized.

[0089] It should be noted that, although Figure 9 The first bevel 211 and the second bevel 212 of the first tube 210 are not shown, but as those skilled in the art will understand, the first bevel 211 and the second bevel 212 can be formed by chamfering the proximal and distal ends of the first tube 210. Of course, as those skilled in the art will understand, the first bevel 211 and the second bevel 212 can also be formed in other ways, and the present invention does not limit them.

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

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

[0092] 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 form an opening slit, thereby forming a through part 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] Next, balloons 300 are welded to both ends of the outer wall of the double-lumen tube. The balloons 300 are made of Pebax (a block copolymer of polyamide and polyether) or other materials, with an outer diameter of 2mm to 4mm, for example 3mm, and a length of 10mm to 40mm, for example 20mm. This step forms the 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 guide wire inlet 111, and the inside 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. The inner tube 120 and the outer tube 110 (including the proximal outer tube 112 and the distal outer tube 113) form a second medium cavity. The first medium cavity 420 and the second medium cavity are connected from front to back.

[0095] Finally, the surface of balloon 300 is coated with an everolimus drug coating using ultrasonic spraying, and then the balloon 300 segment is folded and squeezed to obtain a balloon dilation catheter.

[0096] In summary, compared with the prior art, the balloon dilation catheter provided by the present invention has the following beneficial effects:

[0097] (1) By setting a blood flow tube 200 through the balloon 300 and having a blood flow cavity 230 at the distal end of the balloon dilation catheter, the present invention can ensure that there is blood flow to the distal tissue before and after balloon dilation, thus avoiding distal ischemia caused by balloon dilation. This solves the problem that conventional balloons 300 completely block blood vessels for a period of time during pre-dilation, post-dilation and drug delivery, thereby reducing the treatment effect for some patients with poor tolerance to distal vascular ischemia.

[0098] (2) By using multiple nested tubing to form multiple independent chambers, this invention ensures that each chamber functions while minimizing the permissible diameter of the balloon dilation catheter.

[0099] (3) The crescent-shaped blood flow chamber 230 allows blood to flow at a greater angle along the circumference of the catheter into the blood flow chamber 230, which maximizes the blood flow through the blood flow chamber 230 and avoids the blockage of distal blood flow.

[0100] It should be noted that, in the description of this specification, the reference to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., means that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described can be combined in a suitable manner in any one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0101] It should also be noted that the above description is merely a description of preferred embodiments of the present invention and is not intended to limit the scope of the present invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure are within the protection scope of the present invention. Obviously, those skilled in the art can make various modifications and variations to the invention without departing from the spirit and scope of the invention. Therefore, if these modifications and variations fall within the scope of the present invention and its equivalents, the present invention also intends to include these modifications and variations.

Claims

1. A balloon dilatation catheter characterized by, The balloon dilatation catheter comprises a catheter body, a blood flow tube and a balloon, the blood flow tube penetrates through the proximal end and the distal end of the balloon; The blood flow tube comprises a first tube and a second tube, the second tube is located in the first tube, one side of the outer wall of the second tube is connected with one side of the inner wall of the first tube, and the other side of the outer wall of the second tube and the other side of the inner wall of the first tube form a blood flow cavity for blood flow; The balloon is sleeved on the outer wall of the first tube, and the balloon and the first tube have a filling cavity for accommodating the filling medium; The distal end of the catheter body is inserted into the second tube, and the distal end of the catheter body and the second tube have a first medium cavity for the filling medium; The connection part of the first tube and the second tube has a through part for connecting the first medium cavity and the filling cavity; The proximal end of the first tube has a first inclined port which is inclined towards the proximal end, and the distal end of the first tube has a second inclined port which is inclined towards the distal end; The catheter body comprises an outer tube and an inner tube, the distal end of the outer tube is connected with the proximal end of the second tube, the proximal end of the inner tube is located in the distal end of the outer tube, the distal end of the inner tube is located in the second tube, the inner tube and the second tube have the first medium cavity, the inner tube and the outer tube have a second medium cavity for the filling medium, and the second medium cavity is connected with the first medium cavity; The inner tube has a guide wire cavity which extends along the axial direction of the inner tube, and one side of the outer tube has a guide wire port for the guide wire to extend into the guide wire cavity.

2. The balloon dilation catheter of claim 1, wherein, One side of the outer wall of the second tube is welded with one side of the inner wall of the first tube, and the welding length between the second tube and the first tube is 2mm-6mm, and the through part comprises at least one through hole which is arranged at the welding part of the first tube and the second tube.

3. The balloon dilation catheter of claim 1, wherein, The second tube and the first tube are integrated, and the through part comprises an open seam which is arranged at the connection part of the first tube and the second tube.

4. The balloon dilation catheter of claim 1, wherein, The area of the inner tube which is located in the balloon has a developing mark, and / or the proximal end of the outer tube has a catheter identification band.

5. The balloon dilation catheter of claim 1, wherein, The outer tube comprises a proximal outer tube and a distal outer tube, the proximal end of the distal outer tube is connected with the distal end of the proximal outer tube, and the distal end of the distal outer tube is connected with the proximal end of the second tube.

6. The balloon dilation catheter of claim 1, wherein, The balloon dilatation catheter further comprises a head structure, and the distal end face of the catheter body and the distal end face of the second tube are connected with the proximal end of the head structure.

7. The balloon dilation catheter of claim 1, wherein, The balloon dilatation catheter further 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 2mm-4mm; The length of the balloon is 10mm-40mm; The outer diameter of the first tube is 0.7mm-1.5mm; The wall thickness of the first tube is 0.15mm-0.25mm; The length of the first tube is 20mm-50mm; The outer diameter of the second tube is 0.6mm-1mm; The length of the second tube is 25mm-55mm; 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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