Balloon catheter

Abstract

The balloon catheter is characterized in that the balloon catheter comprises a balloon, a catheter body, a tail end tube, a developing ring, a catheter base, a stress tube and a catheter sleeve, the catheter body comprises an inner tube and an outer tube, the outer tube is arranged outside the inner tube in a sleeving mode, the far end of the inner tube is connected with the near end of the tail end tube, and the developing ring is arranged at the tail end of the tail end tube. The far end of the balloon is fixed to the outer surface of the tail end tube and / or the outer surface of the inner tube, the near end of the balloon is fixed to the outer surface of the far end of the outer tube, the developing ring is arranged on the inner tube in the balloon, the stress tube is fixed to the far end of the catheter base, and the developing ring is arranged on the inner tube in the balloon. The near end of the inner tube penetrates through the stress tube and the catheter seat and is fixed in the near end of the catheter seat, the near end of the outer tube penetrates through the stress tube and the catheter seat and is fixed in the far end of the catheter seat, and the balloon is sleeved with the catheter sleeve. The balloon catheter can effectively solve the problem of treatment of lesions such as artery or vein stenosis and the like.

Description

Technical Field

[0001] The invention relates to the field of interventional medicine, and in particular to a balloon catheter. Background Art

[0002] Peripheral vascular disease includes diseases of the arterial and venous systems. Arterial disease is usually caused by deposits (plaques) containing fat and cholesterol attached to the walls of arterial blood vessels. This process is called atherosclerosis. Atherosclerosis can cause arterial narrowing, resulting in reduced blood flow through the arteries. Atherosclerosis can affect arterial vessels throughout the body. If atherosclerosis occurs in the arteries that supply blood to the limbs, it will cause peripheral arterial disease. Patients with peripheral arterial disease (PAD) have insufficient blood supply to the upper and lower limbs (commonly in the lower limbs) to meet the body's needs, which may cause symptoms such as upper limb pain, leg muscle pain when walking, leg cramps, and difficulty walking. If peripheral arterial disease worsens, pain may also occur when resting or lying down, and the pain may interrupt sleep. At the same time, plaque accumulation in the arteries may also affect blood vessels in the heart and brain, causing strokes and heart attacks. Venous disease usually includes venous compression syndrome, deep vein thrombosis, etc.

[0003] Therefore, there is a great need for medical devices suitable for percutaneous transluminal angioplasty of the peripheral vasculature, including the iliac arteries and iliofemoral veins, and for the treatment of obstructive lesions of native or artificial arteriovenous dialysis fistulas. Summary of the invention

[0004] In order to overcome the problems existing in the prior art, the present invention provides a balloon catheter.

[0005] In some embodiments of the present invention, the balloon catheter includes a balloon, a catheter, a terminal tube, a catheter seat and a stress tube. The catheter includes an inner tube and an outer tube. The outer tube is sleeved outside the inner tube. The distal end of the inner tube is connected to the proximal end of the terminal tube. The distal end of the balloon is fixed on the outer surface of the terminal tube and / or the inner tube, and the proximal end of the balloon is fixed on the outer surface of the distal end of the outer tube. The stress tube is arranged at the distal end of the catheter seat. The proximal end of the inner tube passes through the stress tube and the catheter seat and is fixed inside the proximal end of the catheter seat. The proximal end of the outer tube passes through the stress tube and the catheter seat and is fixed inside the distal end of the catheter seat.

[0006] In some embodiments of the present invention, the outer diameter of the stress tube gradually decreases from the proximal end to the distal end, and the outer surface of the stress tube is provided with a plurality of alternating continuous recessed portions and discontinuous recessed portions, wherein the continuous recessed portion includes an annular recessed portion arranged around the circumference of the stress tube, and the discontinuous recessed portion includes at least one circumferential recessed segment arranged along the circumference of the stress tube.

[0007] In some embodiments of the present invention, the balloon includes a first layer and a second layer, the second layer is arranged close to the inner tube, the first layer is arranged on a side of the second layer away from the inner tube, the material of the first layer is nylon 12, the material of the second layer is pebax, and the mass ratio of the first layer to the second layer ranges from 6 / 4 to 8 / 2.

[0008] In some embodiments of the present invention, the balloon includes a first straight segment, a first transition segment, a second straight segment, a second transition segment and an expansion main body, the first straight segment is fixed on the outer surface of the terminal tube and / or the inner tube, the proximal end of the first straight segment is connected to the distal end of the first transition segment, the proximal end of the first transition segment is connected to the distal end of the expansion main body, the second straight segment is fixed on the outer surface of the outer tube, the distal end of the second straight segment is connected to the proximal end of the second transition part, and the distal end of the second transition part is connected to the proximal end of the expansion main body.

[0009] In some embodiments of the present invention, the diameter of the first transition section gradually increases from the distal end to the proximal end, and the diameter of the second transition section gradually increases from the proximal end to the distal end. The balloon catheter also includes two developing rings, one of which is arranged at a position on the inner tube corresponding to the connection between the first transition section and the expansion main body, and the other of which is arranged at a position on the inner tube corresponding to the connection between the second transition section and the expansion main body.

[0010] In some embodiments of the present invention, the inner surface of the outer tube and the outer surface of the inner tube jointly define an annular cavity, the inner cavity of the balloon is connected to the annular cavity, and a guide wire port and a filling port are provided at the proximal end of the catheter seat, the guide wire port is connected to the cavity of the inner tube, and the filling port is connected to the annular cavity.

[0011] In some embodiments of the present invention, the ratio of the gap between the inner tube and the outer tube to the opening size of the filling port at one end close to the catheter is 1:8.8-1:3.6, and the ratio of the opening size of the filling port at one end close to the catheter to the opening size of the filling port at one end away from the catheter is 1:2.5-1:1.81.

[0012] In some embodiments of the present invention, the distal end of the catheter seat protrudes toward the distal end to form a step structure, and a first glue spot hole and a second glue spot hole are provided on the catheter seat. The first glue spot hole is provided on the step structure, and the first glue spot hole passes through the outer surface of the outer tube. The second glue spot hole is provided on the catheter seat, and the second glue spot hole passes through the outer surface of the inner tube. The second glue spot hole is located between one end of the filling port close to the catheter and one end of the guide wire port close to the catheter.

[0013] In some embodiments of the present invention, the ratio of the distance between the first glue spot hole and the distal end face of the step structure to the length of the step structure in the axial direction is 2 / 5-3 / 5, and the ratio of the distance between the second glue spot hole and the distal end face of the step structure to the length of the catheter seat in the axial direction is 2 / 5-3 / 5.

[0014] In some embodiments of the present invention, the hardness of the terminal tube is smaller than that of the inner tube and the outer tube, and the ratio of the hardness of the terminal tube to the hardness of the inner tube or the outer tube is in the range of 1:1.1-1:1.6.

[0015] The solution to the technical problem of the present invention is to provide a balloon catheter of the present invention having the following advantages compared with the prior art: the balloon catheter of the present invention can effectively treat diseases of the peripheral vascular system, including percutaneous transluminal angioplasty of the iliac artery and iliofemoral vein, and obstructive lesions of autologous or artificial arteriovenous dialysis fistula, etc. The balloon has the characteristics of high burst pressure and good retraction performance. The diameter of the balloon after the folded wings are compressed is small, which can reduce damage to blood vessels and harm to the human body. The setting of the dispensing hole position can also cleverly avoid the situation where the guide wire port, filling port or annular cavity is blocked. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 It is a schematic diagram of the three-dimensional structure of a balloon catheter provided by an embodiment of the present invention.

[0017] Figure 2 It is a perspective structural diagram of a balloon catheter provided by an embodiment of the present invention.

[0018] Figure 3 It is a schematic diagram of the three-dimensional structure of the stress tube of the balloon catheter provided by an embodiment of the present invention.

[0019] Figure 4 It is a schematic diagram of the cross-sectional structure of the balloon of the balloon catheter provided by an embodiment of the present invention in the circumferential direction.

[0020] Figure 5 It is a schematic diagram of the balloon structure of the balloon catheter provided in an embodiment of the present invention.

[0021] Figure 6 It is a schematic diagram of the structure of a catheter seat of a balloon catheter provided in an embodiment of the present invention.

[0022] Figure 7 It is a schematic diagram of the cross-sectional structure of a balloon catheter provided by an embodiment of the present invention.

[0023] Explanation of the accompanying drawings: 100, balloon catheter; 1, balloon; 2, catheter; 3, terminal tube; 4, developing ring; 5, catheter seat; 6, stress tube; 7, catheter sleeve; 21, inner tube; 22, outer tube; 11, first layer; 12, second layer; 13, first straight segment; 14, first transition segment; 15, second straight segment; 16, second transition segment; 17, expansion main body; 131, first matching part; 151, second matching part; 211, annular cavity; 18, inner cavity; 51, guide wire port; 52, filling port; 53, step structure; 531, locking part; 54, first glue dispensing hole; 55, second glue dispensing hole; 61, continuous recessed part; 62, intermittent recessed part; 611, annular recess; 621, circumferential recessed section. DETAILED DESCRIPTION

[0024] The exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present invention are shown in the accompanying drawings, it should be understood that the present invention can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided in order to enable a more thorough understanding of the present invention and to fully convey the scope of the present invention to those skilled in the art.

[0025] It should be understood that the terms used herein are only for the purpose of describing specific example embodiments and are not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms "one", "an" and "said" as used herein may also be meant to include plural forms. The terms "include", "comprise", "contain", and "have" are inclusive, and therefore specify the existence of stated features, steps, operations, elements and / or parts, but do not exclude the existence or addition of one or more other features, steps, operations, elements, parts, and / or combinations thereof. The method steps, processes, and operations described herein are not interpreted as necessarily requiring them to be performed in the specific order described or illustrated, unless the execution order is clearly indicated. It should also be understood that additional or alternative steps may be used.

[0026] Although the terms first, second, third, etc. can be used in the text to describe multiple elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms can only be used to distinguish an element, component, region, layer or section from another region, layer or section. Unless the context clearly indicates, terms such as "first", "second" and other numerical terms do not imply order or sequence when used in the text. Therefore, the first element, component, region, layer or section discussed below can be referred to as the second element, component, region, layer or section without departing from the teaching of the example embodiments.

[0027] For ease of description, spatial relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figure, such as "inside", "outside", "inner side", "outer side", "below", "below", "above", "above", etc. Such spatial relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figure. For example, if the device in the figure is turned over, then the elements described as "below other elements or features" or "below other elements or features" will subsequently be oriented as "above other elements or features" or "above other elements or features". Therefore, the example term "below..." can include both upper and lower orientations. The device can be oriented otherwise (rotated 90 degrees or in other directions) and the spatial relative descriptors used in the text are interpreted accordingly.

[0028] In order to more clearly describe the structure of the present application, the terms "proximal end" and "distal end" are defined herein as commonly used terms in the field of interventional medicine. Specifically, "distal end" refers to the end away from the operator during the surgical operation, "proximal end" refers to the end close to the operator during the surgical operation, "axial" refers to its length direction, and "radial" refers to the direction perpendicular to the "axial" direction.

[0029] See also Figure 1 and Figure 2The present invention provides a balloon catheter 100, which is particularly suitable for the peripheral vascular system, including percutaneous transluminal angioplasty of the iliac artery and iliofemoral vein, and for the treatment of obstructive lesions of autologous or artificial arteriovenous dialysis fistulas, and is also suitable for post-dilation of stents and covered stents in peripheral blood vessels. The balloon catheter 100 includes a balloon 1, a catheter 2, a terminal tube 3, a developing ring 4, a catheter seat 5, a stress tube 6 and a catheter sleeve 7. The catheter 2 includes an inner tube 21 and an outer tube 22. The outer tube 22 is sleeved outside the inner tube 21, and the inner tube 21 is coaxially arranged with the outer tube 22. The distal end of the inner tube 21 is connected to the proximal end of the terminal tube 3, the terminal tube 3 is coaxially arranged with the inner tube 21, and the terminal tube 3 is connected to the cavity of the inner tube 21. The distal end of the balloon 1 is fixed on the outer surface of the terminal tube 3 and / or the inner tube 21. In a specific embodiment of the present invention, part of the distal end of the balloon 1 is fixed on the outer surface of the terminal tube 3, part of the distal end is fixed on the outer surface of the inner tube 21, and the proximal end of the balloon 1 is fixed on the outer surface of the distal end of the outer tube 22. The developing ring 4 is arranged on the inner tube 21 in the balloon 1, the stress tube 6 is fixed on the distal end of the catheter seat 5, the proximal end of the inner tube 21 passes through the stress tube 6 and the catheter seat 5 is fixed inside the proximal end of the catheter seat 5. The proximal end of the outer tube 22 passes through the stress tube 6 and the catheter seat 5 is fixed inside the distal end of the catheter seat 5, and the catheter sleeve 7 is sleeved outside the balloon 1.

[0030] It can be understood that part of the distal end of the balloon 1 is fixed on the outer surface of the terminal tube 3, and part of it is fixed on the outer surface of the inner tube 21, which can make the connection between the inner tube 21 and the terminal tube 3 more secure, and avoid the terminal tube 3 and the inner tube 21 from being disconnected. At the same time, in a specific embodiment of the present invention, the connection between the inner tube 21 and the terminal tube 3 is hot air welding, and part of the distal end of the balloon 1 is fixed on the outer surface of the terminal tube 3, and part of it is fixed on the outer surface of the inner tube 21, which can also cover the welding marks between the inner tube 21 and the terminal tube 3, and ensure the overall beauty of the balloon catheter 100. The developing ring 4 is fixed on the inner tube 21 in the balloon 1, so as to facilitate the observation and positioning of the position of the balloon 1 in the body. The stress tube 6 is a truncated cone structure, and the outer diameter of the stress tube 6 gradually decreases from the proximal end to the distal end. The portion of the catheter 2 close to the catheter seat 5 is prone to bending, which may cause damage to the catheter 2. The stress tube 6 can play a certain fixing role on the portion of the catheter 2 close to the catheter seat 5 to prevent it from bending at a large angle, thereby preventing the catheter 2 from being damaged after bending. Furthermore, the balloon 1 is provided with folding wings (not shown in the figure), which are prior art and will not be described here. The catheter sleeve 7 is sleeved on the balloon 1 when the balloon catheter 100 is not in use. When the balloon catheter 100 needs to be used, the catheter sleeve 7 needs to be removed from the balloon 1. The catheter sleeve 7 can protect the balloon 1, and at the same time, when the balloon catheter 100 is not in use, the shape of the folding wings can be maintained to prevent the folding wings from tilting. A hydrophilic coating is provided on the outer surface of the terminal tube 3 , the outer surface of the balloon 1 , and the outer surface of the outer tube to ensure smooth passage of the balloon catheter 100 in the body.

[0031] Furthermore, the working principle of the balloon catheter 100 is to confirm the information such as the stenosis position, diameter and length through angiography, and then select the balloon catheter 100 of the corresponding specifications. Then, the sheath is inserted to establish a channel, and the guide wire is inserted to establish a track. Then, the balloon catheter 100 moves forward along this channel and track from outside the body until the distal end of the balloon catheter 100 passes through the stenosis segment (so that the balloon 1 is aligned with the stenosis segment). Then, a pressure expansion device is used to apply pressure to the balloon catheter 100 to expand the balloon 1. After the balloon 1 is expanded, the stenosis segment is squeezed, so that the atherosclerotic material, arterial plaque, etc. in the stenosis segment are squeezed and deformed and attached to the inner wall of the blood vessel. The balloon 1 is further expanded to tear the smooth muscle of the blood vessel wall appropriately, and the blood vessel and its inner cavity are further expanded. After a period of time (about tens of seconds to several minutes), the pressure of the balloon 1 is removed and withdrawn along the guide wire and the channel. At this time, the lumen of the stenotic segment of the blood vessel is expanded, and good blood supply function is restored.

[0032] See also Figure 3The outer surface of the stress tube 6 is provided with a plurality of alternately arranged continuous recessed portions 61 and discontinuous recessed portions 62, wherein the continuous recessed portion 61 includes an annular recessed portion 611 arranged around the circumference of the stress tube, and the discontinuous recessed portion 62 includes at least one circumferential recessed portion 621 arranged along the circumference of the stress tube 6. Specifically, the annular recessed portion 611 is a closed annular recessed portion formed by inwardly recessing the outer surface of the stress tube 6, and the circumferential recessed portion 621 is a small section of recessed portion formed by inwardly recessing the outer surface of the stress tube 6. The alternating arrangement of the continuous recessed portion 61 and the discontinuous recessed portion 62 can be understood as one of the continuous recessed portions 61 is connected to one of the discontinuous recessed portions 62, the discontinuous recessed portion 62 is connected to another continuous recessed portion 61, the other continuous recessed portion 61 is connected to another discontinuous recessed portion 62, and so on, the continuous recessed portions 61 and the discontinuous recessed portions 62 are alternately arranged. Alternating the continuous recessed portion 61 and the discontinuous recessed portion 62 can make the stress tube 6 as a whole have good support and strength, make the stress tube 6 more evenly stressed, avoid cracking of the stress tube 6, and improve the fatigue performance of the stress tube 6. At the same time, the stress tube 6 can also have good flexibility to adapt to the deformation of the catheter 2. That is, the support and flexibility of the stress tube 6 can be balanced, the stress tube 6 will not be too hard or too soft, and the flexibility and stress relief effect of the stress tube 6 can be guaranteed, but the wall of the stress tube 6 will not be too thin and the casing will not be damaged. Further, in a specific embodiment of the invention, each of the discontinuous recessed portions 62 includes two circumferential recessed sections 621, the two circumferential recessed sections 621 are symmetrically arranged, and the circumferential recessed sections 621 between two adjacent discontinuous recessed portions 62 are staggered.

[0033] Please continue reading Figure 3 , the width d1 of each annular recess 611 is consistent with the width d2 of each circumferential recess section 621, so that the overall size of the stress tube 6 is more uniform, the stress of the stress tube 6 is more uniform, the bending of the stress tube 6 is smoother, and the stress of the stress tube 6 is prevented from being concentrated on a certain point when bending. At the same time, in order to further ensure the flexibility and smoothness of the bending of the stress tube 6, the ratio of the axial length of the stress tube 6 to the width d1 or d2 is in the range of 24:1-28:1. In a specific embodiment of the present invention, the ratio of the axial length of the stress tube 6 to the width d1 or d2 is specifically 26:1.

[0034] See also Figure 4, the balloon 1 includes a first layer 11 and a second layer 12, the second layer 12 is arranged close to the inner tube 21, and the first layer 11 is arranged on the side of the second layer 12 away from the inner tube 21. In order to ensure that the balloon 1 can meet the standard of high burst pressure, the material of the first layer 11 is nylon 12, the material of the second layer 12 is pebax, and the mass ratio of the first layer 11 to the second layer 12 is 6 / 4-8 / 2. In a specific embodiment of the present invention, the mass ratio of the first layer 11 to the second layer 12 is specifically 7 / 3. The double-layer setting of the balloon 1 and the setting of the mass ratio of the first layer 11 to the second layer 12 to 7 / 3 enable the balloon 1 to have a higher burst pressure, thereby ensuring the safety of the balloon 1. At the same time, the withdrawal performance of the balloon 1 can be guaranteed, so that the balloon 1 has a lower sense of obstruction during the withdrawal out of the body and the withdrawal is smoother.

[0035] In other specific embodiments of the present invention, the balloon 1 may also be a single-layer structure, and the balloon 1 is formed by extruding nylon 12 and pebax in a mass ratio of 7 / 3. The mass ratio of nylon 12 to pebax can be set according to the actual burst pressure requirements and the requirements of the withdrawal performance, such as the mass ratio of nylon 12 to pebax can be 8 / 2 or 6 / 4.

[0036] See also Figure 2 and Figure 5 When the balloon 1 is not inflated, the balloon 1 comprises a first straight segment 13, a first transition segment 14, a second straight segment 15, a second transition segment 16 and an expansion main body 17. The first straight segment 13 is fixed on the outer surface of the terminal tube 3 and / or the inner tube 21, and the first straight segment 13 acts as a connecting portion and is connected to the outer surface of the terminal tube 3 and / or the inner tube 21. In a specific embodiment of the present invention, part of the first straight segment 13 is connected to the outer surface of the terminal tube 3, and the rest of the first straight segment 13 is connected to the outer surface of the inner tube 21. The proximal end of the first straight segment 13 is connected to the distal end of the first transition segment 14, and the proximal end of the first transition segment 14 is connected to the distal end of the expansion main body 17. The second straight segment 15 is fixed on the outer surface of the outer tube 22, and the second straight segment 15 acts as a connecting portion and is connected to the outer surface of the outer tube 22. The distal end of the second straight segment 15 is connected to the proximal end of the second transition segment 16, and the distal end of the second transition segment 16 is connected to the proximal end of the expansion main body 17. The diameter of the first transition section 14 gradually increases from the distal end to the proximal end, and the diameter of the second transition section 16 gradually increases from the proximal end to the distal end.

[0037] It can be understood that in a specific embodiment of the present invention, the first straight segment 13, the first transition segment 14, the second straight segment 15, the second transition segment 16 and the expansion main body 17 are integrally formed. The length of the expansion main body 17 is the effective length of the balloon 1, that is, when the balloon 1 is filled, the expansion main body 17 is the main filling part, and the remaining part will not be filled or only a small part of the filling will be generated. The length of the expansion main body 17 is 20mm-120mm. The expansion main body 17 refers to the part whose diameter after filling is 5 times to 7 times that of the part when it is not filled in the natural state. For example, when the balloon catheter 100 is adapted to a 7F delivery sheath, the diameter of the balloon 1 when it is not filled is 2.31mm, and the diameter of the balloon 1 after filling reaches 12mm. There are two developing rings 4, one of which is arranged at the position of the inner tube 21 corresponding to the connection between the first transition section 14 and the expansion main body 17, and the other developing ring 4 is arranged at the position of the inner tube 21 corresponding to the connection between the second transition section 16 and the expansion main body 17. The developing ring 4 can be used to determine the position of the balloon 1 in the body, and at the same time, the developing ring 4 can determine the position of the expansion main body 17, thereby confirming the position of the effective length of the balloon 1 in the body, thereby making the effective length of the balloon 1 act more accurately on the lesion position. In other specific embodiments of the present invention, the first straight segment 13, the first transition segment 14, the second straight segment 15, the second transition segment 16 and the expansion main body 17 can also be made separately.

[0038] For further information, please refer to Figure 2 and Figure 5In a specific embodiment of the present invention, since the size of the first straight segment 13 and the second straight segment 15 is larger than the terminal tube 3, the inner tube 21 and the outer tube 22, if the first straight segment 13 is directly connected to the terminal tube 3 and the inner tube 21, or the second straight segment 15 is directly connected to the outer tube 22, the first straight segment 13 and the second straight segment 15 will have redundant parts that cannot be directly connected to the terminal tube 3, the inner tube 21 and the outer tube 22. The redundant parts of the first straight segment 13 and the second straight segment 15 will be accumulated on the terminal tube 3, the inner tube 21 and the outer tube 22 and then heat-melted and welded, thereby increasing the outer diameter of the two ends of the balloon 1. The minimum size of the balloon 1 after the folded wings are compressed depends on the size of the two ends of the balloon 1. If the size of the two ends of the balloon 1 is larger, the size of the balloon 1 after the folded wings are compressed will also be larger. Therefore, in order to reduce the size of the two end portions of the balloon 1 and make the size of the balloon 1 after the folded wings are compressed smaller, thereby reducing damage to blood vessels and harm to the human body, the first straight line segment 13 and the second straight line segment 15 are cut and then directly connected to the terminal tube 3 and the inner tube 21, so as to avoid the first straight line segment 13 and the second straight line segment 15 having redundant parts that cannot be directly connected to the terminal tube 3, the inner tube 21 and the outer tube 22, thereby minimizing the size of the balloon 1 after the folded wings are compressed.

[0039] Specifically, the distal end of the first straight segment 13 and the proximal end of the second straight segment 15 are uniformly cut, so that the distal end of the first straight segment 13 includes at least two first matching portions 131 cut out and arranged at intervals, and the proximal end of the second straight segment 15 includes at least two second matching portions 151 cut out and arranged at intervals, and each of the first matching portions 131 has the same size, and each of the second matching portions 151 has the same size. It can be understood that in a specific embodiment of the present invention, the first straight segment 13 and the second straight segment 15 are cut in the horizontal and vertical directions, and four first matching portions 131 and four second matching portions 151 are obtained after cutting. The four first matching parts 131 are connected to the terminal tube 3 and the inner tube 21, and the four second matching parts 151 are connected to the outer tube 22, so as to reduce the contact area between the first straight section 13 and the second straight section 15 and the terminal tube 3, the inner tube 21, and the outer tube 22, thereby ensuring that the first matching parts 131 can all be connected to the terminal tube 3 and the inner tube 21, and the second matching parts 151 can all be connected to the outer tube 22, thereby avoiding redundant parts in the first straight section 13 and the second straight section 15. At the same time, the distal end of the first straight section 13 and the proximal end of the second straight section 15 are uniformly cut, so as to ensure that the size of each first matching part 131 is the same, and the size of each second matching part 151 is the same, thereby avoiding redundant parts caused by a single large size of a first matching part 131 or a second matching part 151.

[0040] See also Figure 2 The inner surface of the outer tube 22 and the outer surface of the inner tube 21 jointly define an annular cavity 211, and the inner cavity 18 of the balloon 1 is connected to the annular cavity 211. The proximal end of the catheter seat 5 is provided with a guidewire port 51 and a filling port 52, the guidewire port 51 is connected to the cavity of the inner tube 21, and the filling port 52 is connected to the annular cavity 211. Specifically, the guidewire port 51 is used to pass a guidewire, which passes through the guidewire port 51 and then enters the cavity of the inner tube 21. After passing through the inner tube 21, the guidewire enters the cavity of the terminal tube 3 and finally passes out from the distal end of the terminal tube 3. The filling port 52 is used to allow filling liquid to enter the annular cavity 211. After passing through the annular cavity 211, the filling liquid enters the inner cavity 18 of the balloon 1 and fills and expands the balloon 1.

[0041] For further information, see Figure 1 , Figure 2 , Figure 6 and Figure 7The distal end of the catheter seat 5 protrudes toward the distal end to form a step structure 53, and a clamping portion 531 is protruded on the outer surface of the step structure 53. The proximal end of the stress tube 6 is sleeved on the step structure 53 and fixed on the step structure 53 through the clamping portion 531. The catheter seat 5 is provided with a first glue spot hole 54 and a second glue spot hole 55. The first glue spot hole 54 is provided on the step structure 53. The ratio of the distance S1 of the first glue spot hole 54 from the distal end face of the step structure 53 to the length of the step structure 53 in the axial direction is 2 / 5-3 / 5, and the first glue spot hole 54 passes through the outer surface of the outer tube 22. The second glue spot hole 55 is provided on the catheter seat 5. The ratio of the distance S2 of the second glue spot hole 55 from the distal end face of the step structure 53 to the length of the catheter seat in the axial direction is 2 / 5-3 / 5, and the second glue spot hole 55 passes through the outer surface of the inner tube 21.

[0042] It can be understood that glue can be dripped into the first glue-dispensing hole 54 to fix the outer tube 22 relative to the catheter seat 5. Glue can be dripped into the second glue-dispensing hole 55 to fix the inner tube 21 relative to the catheter seat 5. At the same time, the position of the first glue-dispensing hole 54 is set at a distance S1 from the distal end face of the step structure 53, so that the first glue-dispensing hole 54 has a certain distance from the distal end of the step structure 53, and also has a certain distance from the proximal end of the outer tube 22 and the filling port 52, thereby preventing glue from penetrating into the annular cavity 211 and blocking the annular cavity 211, preventing glue from penetrating into the filling port 52, preventing glue from blocking the filling port 52, and preventing glue from overflowing from the distal end of the catheter seat 5. The position of the second glue spot hole 55 is set at a distance S2 from the distal end face of the step structure 53, and the second glue spot hole 55 is located between the end D1 of the filling port 52 close to the catheter 2 and the end D2 of the guide wire port 51 close to the catheter 2, so that the second glue spot hole 55 has a certain distance from the proximal end of the outer tube 22, and at the same time has a certain distance from the guide wire port 51 and the filling port 52, thereby preventing glue from penetrating into the guide wire port 51, the filling port 52 and the annular cavity 211, thereby preventing glue from blocking the guide wire port 51, the filling port 52 or the annular cavity 211.

[0043] Please continue reading Figure 1 , Figure 2 and Figure 7, the balloon 1 provided by the present invention has the characteristic of fast pressure relief. Specifically, the ratio of the gap between the inner tube 21 and the outer tube 22 to the opening size L1 of the filling port 52 close to the end of the catheter 2 is 1:8.8-1:3.6, and the ratio of the opening size L1 of the filling port 52 close to the end of the catheter 2 to the opening size L2 of the filling port 52 away from the end of the catheter is 1:2.5-1:1.81. In a specific embodiment of the present invention, the gap between the inner tube 21 and the outer tube 22 is set at 0.25mm-0.5mm, the opening size L1 of the filling port 52 close to the end of the catheter 2 is 1.8mm-2.2mm, and the opening size L2 of the filling port 52 away from the end of the catheter is 4mm-4.5mm. By setting the above size, the flow rate of the liquid filled in the balloon 1 is faster, thereby reducing the pressure relief time of the balloon 1. For example, when the effective length of the balloon 1 is 60 mm, the diameter of the balloon 1 after inflation is 18 mm, the gap between the inner tube 21 and the outer tube 22 is set at 0.42 mm, the opening size L1 of the filling port 52 close to the end of the catheter 2 is 2.06 mm, and the opening size L2 of the filling port 52 away from the end of the catheter is 4.29 mm, the pressure relief time of the balloon 1 is 20 seconds.

[0044] Please continue reading Figure 2 , the hardness of the terminal tube 3 is less than that of the inner tube 21 and the outer tube 22, and the ratio of the hardness of the terminal tube to the hardness of the inner tube or the outer tube is in the range of 1:1.1-1:1.6. Specifically, the hardness of the terminal tube 3 is 50D-60D, and the hardness of the inner tube 21 and the outer tube 22 is 67D-77D. In a specific embodiment of the present invention, the hardness of the terminal tube 3 is 55D, and the hardness of the inner tube 21 and the outer tube 22 is 72D. This is because the hardness of the distal end of the balloon catheter 100 is reduced, thereby improving the smoothness of the balloon catheter 100 when entering the human body, and avoiding the balloon catheter 100 from causing damage to human tissues, blood vessels, etc. when entering the human body. The hardness of the outer tube 22 and the inner tube 21 is relatively high. This is because when the balloon 1 is filled, the filled liquid will exert pressure on the inner tube 21 and the outer tube 22. To prevent the inner tube 21 and the outer tube 22 from deforming, the hardness of the inner tube 21 and the outer tube 22 is relatively high.

[0045] Compared with the prior art, the balloon catheter of the present invention has the following advantages: The balloon catheter of the present invention can effectively treat diseases of the peripheral vascular system, including percutaneous transluminal angioplasty of the iliac artery and iliofemoral vein, and obstructive lesions of autologous or artificial arteriovenous dialysis fistula, etc. The balloon has the characteristics of high burst pressure and good retraction performance. The diameter of the balloon after the folded wings are compressed is small, which can reduce damage to blood vessels and harm to the human body. The setting of the dispensing hole position can also cleverly avoid the situation where the guide wire port, filling port or annular cavity is blocked.

[0046] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A balloon catheter, characterized in that: The balloon catheter includes a balloon, a catheter, a terminal tube, a catheter seat and a stress tube. The catheter includes an inner tube and an outer tube. The outer tube is sleeved outside the inner tube. The distal end of the inner tube is connected to the proximal end of the terminal tube. The distal end of the balloon is fixed on the outer surface of the terminal tube and / or the inner tube, and the proximal end of the balloon is fixed on the outer surface of the distal end of the outer tube. The stress tube is arranged at the distal end of the catheter seat. The proximal end of the inner tube passes through the stress tube and the catheter seat and is fixed inside the proximal end of the catheter seat. The proximal end of the outer tube passes through the stress tube and the catheter seat and is fixed inside the distal end of the catheter seat.

2. The balloon catheter according to claim 1, characterized in that: The outer diameter of the stress tube gradually decreases from the proximal end to the distal end. The outer surface of the stress tube is provided with a plurality of alternating continuous recessed portions and discontinuous recessed portions. The continuous recessed portion includes an annular recessed portion arranged around the circumference of the stress tube, and the discontinuous recessed portion includes at least one circumferential recessed segment arranged along the circumference of the stress tube.

3. The balloon catheter according to claim 1, characterized in that: The balloon includes a first layer and a second layer, the second layer is arranged close to the inner tube, the first layer is arranged on a surface of the second layer away from the inner tube, the first layer is made of nylon 12, the second layer is made of pebax, and the mass ratio of the first layer to the second layer is in the range of 6 / 4-8 / 2.

4. The balloon catheter according to claim 1, characterized in that: The balloon includes a first straight segment, a first transition segment, a second straight segment, a second transition segment and an expansion main body. The first straight segment is fixed on the outer surface of the terminal tube and / or the inner tube, the proximal end of the first straight segment is connected to the distal end of the first transition segment, the proximal end of the first transition segment is connected to the distal end of the expansion main body, the second straight segment is fixed on the outer surface of the outer tube, the distal end of the second straight segment is connected to the proximal end of the second transition portion, and the distal end of the second transition portion is connected to the proximal end of the expansion main body.

5. The balloon catheter according to claim 4, characterized in that: The diameter of the first transition section gradually increases from the distal end to the proximal end, and the diameter of the second transition section gradually increases from the proximal end to the distal end. The balloon catheter also includes two developing rings, one of which is arranged at a position on the inner tube corresponding to the connection between the first transition section and the expansion main body, and the other of which is arranged at a position on the inner tube corresponding to the connection between the second transition section and the expansion main body.

6. The balloon catheter according to claim 1, characterized in that: The inner surface of the outer tube and the outer surface of the inner tube jointly define an annular cavity, the inner cavity of the balloon is connected to the annular cavity, and a guide wire port and a filling port are provided at the proximal end of the catheter seat, the guide wire port is connected to the cavity of the inner tube, and the filling port is connected to the annular cavity.

7. The balloon catheter according to claim 6, characterized in that: The ratio of the gap between the inner tube and the outer tube to the opening size of the filling port close to the end of the catheter is 1:8.8-1:3.6, and the ratio of the opening size of the filling port close to the end of the catheter to the opening size of the filling port away from the catheter is 1:2.5-1:1.

81.

8. The balloon catheter according to claim 7, characterized in that: The distal end of the catheter seat protrudes toward the distal end to form a step structure, and a first glue spot hole and a second glue spot hole are provided on the catheter seat. The first glue spot hole is provided on the step structure, and the first glue spot hole passes through the outer surface of the outer tube. The second glue spot hole is provided on the catheter seat, and the second glue spot hole passes through the outer surface of the inner tube. The second glue spot hole is located between one end of the filling port close to the catheter and one end of the guide wire port close to the catheter.

9. The balloon catheter according to claim 8, characterized in that: The ratio of the distance between the first glue spot hole and the distal end face of the step structure to the axial length of the step structure is 2 / 5-3 / 5, and the ratio of the distance between the second glue spot hole and the distal end face of the step structure to the axial length of the catheter seat is 2 / 5-3 / 5.

10. The balloon catheter according to claim 1, characterized in that: The hardness of the terminal tube is smaller than that of the inner tube and the outer tube, and the ratio of the hardness of the terminal tube to the hardness of the inner tube or the outer tube is in the range of 1:1.1-1:1.6.

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