Balloon catheter

Abstract

The balloon catheter comprises an inner tube, an outer tube, a balloon, a limiting piece and a limiting umbrella, the inner tube is sleeved with the outer tube, the far end of the inner tube is exposed out of the far end of the outer tube, the limiting umbrella comprises a main body part, a connecting rod and a clamping part, the main body part is connected with the outer tube, the inner tube is sleeved with the clamping part, and the far end of the connecting rod is connected with the clamping part; the near end of the connecting rod is connected with the main body part, the limiting piece is fixedly arranged on the inner tube in a sleeving mode and is close to the clamping part, the far end of the balloon is fixed to the far end of the inner tube, and the near end of the balloon is fixed to the far end of the outer tube. According to the balloon catheter, the clamping part abuts against the limiting piece, the opposite movement between the inner tube and the outer tube is limited, namely, the movement of the inner tube towards the near end and / or the movement of the outer tube towards the far end are limited, then the balloon cannot be shortened, the specification size of the balloon is ensured, and it is ensured that the inner tube cannot be bent due to shortening of the balloon. The main body part can also provide support for the outer tube, and the situation that the outer tube collapses when the balloon is welded is avoided.

Description

Technical Field

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

[0002] Peripheral vascular diseases include diseases of the arterial and venous systems. Arterial diseases are usually caused by deposits (plaques) containing fat and cholesterol attached to the arterial vessel wall, and this process is called atherosclerosis. Atherosclerosis can cause arterial stenosis, thereby reducing the blood flow through the artery. Atherosclerosis can affect the arterial blood vessels throughout the body. If the arteries supplying blood to the limbs are affected by atherosclerosis, 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), which cannot meet the body's needs, and this may cause symptoms such as pain in the upper limbs, pain in the leg muscles 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, the plaque accumulation in the artery may also affect the blood vessels in the heart and brain, thereby triggering strokes and heart attacks. Venous diseases usually include venous compression syndrome, deep vein thrombosis, and so on.

[0003] Treatment of atherosclerosis usually requires the use of a balloon catheter. By inflating the balloon, the atherosclerotic plaque and the diseased blood vessel are expanded, and the smooth flow of blood through the blood vessel is restored. Existing balloon catheters are mostly made of polymer materials, and the balloon body is formed by the process of stretch blow molding. However, shrinkage is an inevitable problem of the balloon body. After the balloon body is stored for a period of time, the shrinkage is obvious. The inner tube of the balloon does not shrink, and when the balloon parts shrink while the length of the inner tube of the balloon remains unchanged, it will cause the balloon catheter to bend. Summary of the Invention

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

[0005] The solution of the present invention to solve the technical problem is to provide a balloon catheter, which includes an inner tube, an outer tube, a balloon, a limiting member, and a limiting umbrella. The outer tube is sleeved on the inner tube, the distal end of the inner tube is exposed outside the distal end of the outer tube. The limiting umbrella includes a main body portion, a connecting rod, and a clamping portion. The main body portion is connected to the outer tube, the clamping portion is sleeved on the inner tube, the distal end of the connecting rod is connected to the clamping portion, and the proximal end of the connecting rod is connected to the main body portion. The limiting member is fixedly sleeved on the inner tube and is arranged close to the clamping portion. The distal end of the balloon is fixed on the distal end of the inner tube, and the proximal end of the balloon is fixed on the distal end of the outer tube.

[0006] In some embodiments of the present invention, the main body portion is fixedly sleeved on the outer surface of the outer tube, and the proximal end of the balloon is fixed on the main body portion; or the main body portion is fixed on the inner wall of the distal end of the outer tube, and the proximal end of the balloon is fixed at a position corresponding to the main body portion at the distal end of the outer tube.

[0007] In some embodiments of the present invention, the number of the connecting rods is multiple, the proximal ends of the multiple connecting rods are uniformly arranged in the circumferential direction of the main body portion, and the distal ends of the multiple connecting rods are uniformly arranged in the circumferential direction of the clamping portion.

[0008] In some embodiments of the present invention, the limiting member is close to the distal side of the clamping portion; the clamping portion and the limiting member are arranged on the part of the inner tube exposed outside the outer tube.

[0009] In some embodiments of the present invention, the inner tube can move relative to the outer tube, a locking member extends outward from the outer wall of the clamping portion, and the clamping portion is movably sleeved on the inner tube. The limiting member includes a fixing portion and a matching portion. The fixing portion is fixedly connected to the inner tube, the matching portion is arranged close to the clamping portion, the matching portion includes a hollow cavity, the movement of the inner tube can drive the limiting member to move, the clamping portion and the locking member can enter the cavity, and the locking member can pass through the matching portion and be exposed outside the matching portion.

[0010] In some embodiments of the present invention, a through hole penetrating the inner and outer surfaces of the matching portion is provided on the matching portion. When the matching portion moves towards the clamping portion, the locking member can enter the cavity, and the free end of the locking member can pass through the through hole and cooperate with the through hole.

[0011] In some embodiments of the present invention, one end of the matching portion facing the clamping portion extends outward to form a flared structure; a sliding groove passing through the through hole is provided on the inner wall of the matching portion. When the locking member enters the cavity through the flared structure, the locking member can move along the sliding groove and then cooperate with the through hole.

[0012] In some embodiments of the present invention, the number of the locking members is two or more, two or more of the locking members are arranged at intervals along the axial direction of the clamping portion and / or are uniformly distributed along the circumferential direction of the rod body, the number of the through holes is two or more, two or more of the through holes are arranged at intervals along the axial direction of the matching portion and / or are uniformly distributed along the circumferential direction of the matching portion, and two or more of the locking members can respectively cooperate with two or more of the through holes in a one-to-one correspondence.

[0013] In some embodiments of the present invention, the balloon catheter further includes a restraint structure. The restraint structure includes a tubular structure woven from metal wires. The restraint structure is sleeved on the outer surface of the balloon, and the proximal end of the restraint structure extends towards the outer tube and is fixed to the distal end of the outer tube. The distal end of the restraint structure extends towards the distal end of the inner tube and is fixed to the distal end of the inner tube.

[0014] In some embodiments of the present invention, the balloon catheter further includes a connecting ring. The connecting ring is fixed to the inner wall of the distal end of the outer tube, and the proximal end of the restraint structure is fixed at the position of the outer tube where the connecting ring is provided.

[0015] Compared with the prior art, a balloon catheter of the present invention has the following advantages: By the clamping portion abutting against the limiting member of the present invention, the relative movement between the inner tube and the outer tube is restricted, that is, the movement of the inner tube towards the proximal end and / or the movement of the outer tube towards the distal end is restricted, thereby preventing the balloon from being shortened, ensuring the specification size of the balloon, and ensuring that the inner tube will not be bent due to the shortening of the balloon. The main body portion can also provide support for the outer tube to prevent the outer tube from collapsing when the balloon is welded to the outer tube. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0017] Figure 2 is Figure 1 an enlarged view of part A in

[0018] Figure 3 is a schematic front view structure diagram of the limiting umbrella of the balloon catheter provided by an embodiment of the present invention.

[0019] Figure 4 is a schematic three-dimensional structure diagram of the limiting umbrella of the balloon catheter provided by an embodiment of the present invention.

[0020] Figure 5 is a schematic front view structure diagram of the limiting umbrella of another embodiment of the balloon catheter provided by an embodiment of the present invention.

[0021] Figure 6 is a schematic three-dimensional structure diagram of the limiting umbrella of another embodiment of the balloon catheter provided by an embodiment of the present invention.

[0022] Figure 7 is a schematic structure diagram of the limiting member and the limiting umbrella of the balloon catheter provided by an embodiment of the present invention.

[0023] Figure 8 is a schematic diagram of the cooperation process between the limiting member and the clamping portion of the balloon catheter provided by an embodiment of the present invention.

[0024] Figure 9 It is a schematic diagram of the cooperation state between the limiting member and the clamping portion of the balloon catheter provided by the embodiment of the present invention.

[0025] Figure 10 It is a schematic diagram of the initial state structure of the balloon of the balloon catheter provided by the embodiment of the present invention.

[0026] Figure 11 It is a schematic diagram of the structural change state of the balloon of the balloon catheter provided by the embodiment of the present invention.

[0027] Figure 12 It is a schematic diagram of another cooperation process between the limiting member and the clamping portion of the balloon catheter provided by the embodiment of the present invention.

[0028] Figure 13 It is a front view schematic diagram of another cooperation process between the limiting member and the clamping portion of the balloon catheter provided by the embodiment of the present invention.

[0029] Figure 14 It is a schematic diagram of another cooperation state between the limiting member and the clamping portion of the balloon catheter provided by the embodiment of the present invention.

[0030] Figure 15 It is a three-dimensional structure schematic diagram of the limiting member of the balloon catheter provided by the embodiment of the present invention.

[0031] Figure 16 It is a front view schematic diagram of another cooperation process between the limiting member and the clamping portion of the balloon catheter provided by the embodiment of the present invention.

[0032] Explanation of the reference numerals in the drawings: 100, balloon catheter; 11, inner tube; 12, outer tube; 13, balloon; 14, limiting member; 15, limiting umbrella; 151, clamping portion; 152, connecting rod; 153, main body portion; 1511, locking member; 141, fixing portion; 142, cooperating portion; 1421, cavity; 1422, through hole; 1423, flared portion; 1424, sliding groove; 16, restraint structure; 17, connecting ring. Detailed implementation manners

[0033] Hereinafter, the exemplary embodiments of the present invention will be described in more detail with reference to the drawings. Although the exemplary embodiments of the present invention are shown in the drawings, it should be understood that the present invention can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided so that the present invention can be more thoroughly understood and the scope of the present invention can be completely conveyed to those skilled in the art.

[0034] It should be understood that the terms used herein are for the purpose of describing particular example embodiments only and are not intended to be limiting. Unless the context clearly dictates otherwise, the singular forms "a", "an", and "the" as used herein may also include the plural forms. The terms "comprising", "including", "containing", and "having" are inclusive and thus specify the presence of the stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order described or illustrated, unless explicitly stated as an order of performance. It should also be understood that additional or alternative steps may be used.

[0035] Although the terms first, second, third, etc. may be used herein 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 may be used only to distinguish one element, component, region, layer, or section from another. Unless the context clearly indicates otherwise, terms such as "first" and "second" and other numerical terms when used herein do not imply an order or sequence. Thus, a first element, component, region, layer, or section discussed below may be referred to as a second element, component, region, layer, or section without departing from the teachings of the example embodiments.

[0036] For ease of description, spatial relative relationship terms may be used herein to describe the relationship of one element or feature shown in the figures to another element or feature, such as "inner", "outer", "inside", "outside", "below", "beneath", "above", "over", etc. Such spatial relative relationship terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is flipped, an element described as "below" or "beneath" another element or feature will then be oriented "above" or "over" the other element or feature. Thus, the example term "below" can include both an orientation above and below. The device may be otherwise oriented (rotated 90 degrees or in other directions) and the spatial relative relationship descriptors used herein are to be interpreted accordingly.

[0037] For a clearer description of the structure of the present application, the terms "proximal" and "distal" are defined herein as conventional terms in the field of interventional medicine. Specifically, "distal" refers to the end away from the operator during a surgical operation, "proximal" refers to the end close to the operator during a surgical operation, "axial" refers to its length direction, and "radial" refers to the direction perpendicular to the "axial" direction.

[0038] Please refer to Figure 1 and Figure 2 In an embodiment of the present invention, a balloon catheter 100 is provided, which includes an inner tube 11, an outer tube 12, a balloon 13, a limiting member 14, and a limiting umbrella 15. The outer tube 12 is sleeved on the inner tube 11, and the distal end of the inner tube 11 is exposed outside the distal end of the outer tube 12. The limiting umbrella 15 includes a main body portion 153, a connecting rod 152, and a clamping portion 151. The main body portion 153 is connected to the outer tube 12, the clamping portion 151 is sleeved on the inner tube 11, the distal end of the connecting rod 152 is connected to the clamping portion 151, and the proximal end of the connecting rod 152 is connected to the main body portion 153. The limiting member 14 is sleeved and fixed on the inner tube 11, and the limiting member 14 is arranged close to the clamping portion 151. The distal end of the balloon 13 is fixed on the distal end of the inner tube 11, and the proximal end of the balloon 13 is fixed on the distal end of the outer tube 12.

[0039] Specifically, there is a gap between the inner tube 11 and the outer tube 12, and this gap is the filling cavity. The filling cavity is used for the filling liquid to pass through, so that the filling liquid enters the inside of the balloon 13 and fills the balloon 13. It should be noted that after the balloon 13 is placed for a long time, the length of the balloon 13 in the axial direction will be shortened, which will lead to the shortening of the balloon 13, affecting the specification size and quality of the balloon 13. Since the inner tube 11 will not be shortened, the shortening of the balloon 13 will cause a relative displacement between the inner tube 11 and the outer tube 12, which will further affect the specification size of the balloon 13 and will also cause the inner tube 11 to bend, affecting the quality of the balloon 13. Therefore, in a specific embodiment of the present invention, when the balloon 13 is shortened, the clamping portion 151 will abut against the limiting member 14. Since the main body portion 153 is connected to the outer tube 12, the connecting rod 152 extends towards the inner tube 11 and is connected to the clamping portion 151 sleeved on the inner tube 11, and the clamping portion 151 is arranged close to the limiting member 14 fixed on the inner tube 11. Therefore, when the clamping portion 151 abuts against the limiting member 14, the relative movement between the inner tube 11 and the outer tube 12 is restricted, that is, the movement of the inner tube 11 towards the proximal end and / or the movement of the outer tube 12 towards the distal end is restricted, so that the balloon 13 cannot be shortened, thereby ensuring the specification size of the balloon 13 and ensuring that the inner tube 11 will not bend due to the shortening of the balloon 13.

[0040] It should be noted that to ensure the anti-shortening effect of the balloon 13, the positioning part 151 and the limiting member 14 can be arranged close to each other in contact at the initial stage. The main body part 153 can be sleeved and then fixed on the outer surface of the outer tube 12 by means of hot melt welding, laser welding, ultrasonic welding, etc. The proximal end of the balloon 13 is fixed on the main body part 153 by means of hot melt welding, laser welding, ultrasonic welding, etc. The main body part 153 can also be fixed on the inner wall of the distal end of the outer tube 12 by means of hot melt welding, laser welding, ultrasonic welding, etc. The proximal end of the balloon 13 can be fixed at the position corresponding to the main body part 153 on the distal end of the outer tube 12. Fixing the main body part 153 on the inner surface of the outer tube 12 and then fixing the balloon at the position corresponding to the main body part 153 on the distal end of the outer tube 12 enables the main body part 153 to provide support for the outer tube 12, avoiding the situation that the outer tube 12 collapses when the balloon 13 is welded to the outer tube 12.

[0041] Please refer to Figure 1 and Figure 2, to further ensure the anti-shortening effect of the balloon 13, in a specific embodiment of the present invention, the clamping portion 151 and the limiting member 14 are provided on the portion of the inner tube 11 exposed outside the outer tube 12, that is, the clamping portion 151 and the limiting member 14 are both provided on the inner tube 11 inside the balloon 13. The limiting member 14 is provided near the distal side of the clamping portion 151, that is, the limiting member 14 is closer to the distal side than the clamping portion 151. Specifically, when installing the limiting member 14 and the limiting umbrella 15 on the inner tube 11 and the outer tube 12, the limiting umbrella 15 can be first sleeved from the distal end of the inner tube 11, and then the limiting umbrella 15 is moved towards the distal end of the outer tube 12, and the main body portion 153 of the limiting umbrella 15 is sleeved on the distal end of the outer tube 12. At this time, the position of the clamping portion 151 is determined. Then the limiting member 14 is sleeved from the distal end of the inner tube 11, and the limiting member 14 is moved to the clamping portion 151, so that the proximal end of the limiting member 14 abuts against the distal end of the clamping portion 151. Since the distal end of the balloon 13 is fixed to the distal end of the inner tube 11 and the proximal end of the balloon 13 is fixed to the distal end of the outer tube 12, if the balloon 13 is shortened, the balloon 13 will drive the distal end of the inner tube 11 to move proximally, and at the same time drive the distal end of the outer tube 12 to move towards the distal end of the inner tube 11. At this time, the bent portion of the inner tube 11 is mainly on the inner tube 11 inside the balloon 13. Therefore, by providing the clamping portion 151 and the limiting member 14 on the inner tube 11 inside the balloon 13 and the limiting member 14 is provided near the distal side of the clamping portion 151, it can be ensured that if the balloon 13 is shortened, the proximal end of the limiting member 14 abuts against the distal end of the clamping portion 151, restricting the distal end of the inner tube 11 from moving proximally and the distal end of the outer tube 12 from moving towards the distal end of the inner tube 11, thereby ensuring that there is no relative movement between the inner tube 11 and the outer tube 12 inside the balloon 13, preventing the inner tube 11 from bending, and at the same time preventing the balloon 13 from shortening.

[0042] Please refer to Figure 3 and Figure 4, the number of the connecting rods 152 is multiple, the proximal ends of the multiple connecting rods 152 are evenly arranged in the circumferential direction of the main body portion 153, and the distal ends of the multiple connecting rods 152 are evenly arranged in the circumferential direction of the clamping portion 151. To ensure the structural stability of the overall limiting umbrella 15, the number of the connecting rods 152 is at least three. In a specific embodiment of the present invention, the number of the connecting rods 152 is six. By evenly arranging the six connecting rods 152 in the circumferential directions of the main body portion 153 and the clamping portion 151, it can be ensured that the radial dimension of the connecting rods 152 is smaller and it is also better compressed. When the balloon 13 is compressed, the proximal end of the balloon 13 may contact the connecting rods 152 during contraction. By arranging the connecting rods 152 in the above manner, when the connecting rods 152 are subjected to the contraction of the proximal end of the balloon 13, the connecting rods 152 can generate slight and uniform deformation to adapt to the compression of the balloon 13, ensuring that the balloon 13 will not be interfered by the limiting umbrella 15 during compression, and further ensuring that the volume of the balloon 13 after compression is small. The six connecting rods 152 can also ensure the overall stability and support of the limiting umbrella 15, preventing the connecting rods 152 from being deformed when the proximal end of the balloon 13 contracts. In other specific embodiments of the present invention, the number of the connecting rods 152 is six. The proximal ends of the connecting rods 152 are evenly arranged in the circumferential direction of the main body portion 153, and the distal ends of every two connecting rods 152 are close to each other and arranged at a point on the clamping portion 151, as shown in Figure 5 and Figure 6 shown. By arranging the connecting rods 152 in the above manner, the overall support and stability of the limiting umbrella 15 can be increased, preventing the connecting rods 152 from being twisted and deformed in the circumferential direction. Further, to ensure that the limiting umbrella 15 does not interfere with the contraction and compression of the balloon 13, the overall length range of the connecting rods 152 and the clamping portion 151 is from 1 millimeter to 3 millimeters, and the included angle range between the connecting rods 152 and the central axis of the inner tube is from 15 degrees to 90 degrees.

[0043] It should be noted that the limiting umbrella 15 can be made of metal materials such as stainless steel and nitinol. The limiting umbrella 15 made of metal materials is not easy to deform and has good strength, thus ensuring the limiting effect between the limiting umbrella 15 and the limiting member 14. The limiting umbrella 15 can also be made of polymer materials such as nylon, polyethylene, and polypropylene. The limiting umbrella 15 made of polymer materials has good flexibility, thus ensuring the overall flexibility of the balloon catheter 100. The limiting umbrella 15 and the limiting member 14 can also be integrally formed and supported. The proximal end of the limiting umbrella 15 is fixedly connected to the outer tube 12, the distal end of the limiting umbrella 15 is fixedly connected to the limiting member 14, and the distal end of the limiting umbrella 15 and the limiting member 14 are fixedly connected to the inner tube 11.

[0044] Please refer to Figure 7 In another specific embodiment of the present invention, the inner tube 11 can move relative to the outer tube 12. A locking member 1511 with a free end extends outwardly from the outer wall of the clamping portion 151, and the clamping portion 151 is movably sleeved on the inner tube 11. In the natural state, the free end of the locking member 1511 extends towards the distal end. The limiting member 14 includes a fixing portion 141 and a cooperating portion 142. The fixing portion 141 is fixedly connected to the inner tube 11, and the function of the fixing portion 141 is to fixedly arrange the limiting member 14 on the inner tube 11. The cooperating portion 142 is disposed close to the clamping portion 151. The cooperating portion 142 includes a hollow cavity 1421. When the inner tube 11 moves proximally, it drives the limiting member 14 towards the clamping portion 151. Since the clamping portion 151 is movably sleeved on the inner tube 11, the clamping portion 151 does not move with the movement of the inner tube 11. Therefore, the clamping portion 151 and the locking member 1511 can enter the cavity 1421, and the locking member 1511 can pass through the cooperating portion 142 and be exposed outside the cooperating portion 142. Specifically, a through hole 1422 penetrating the inner and outer surfaces of the cooperating portion 142 is provided on the cooperating portion 142. The free end of the locking member 1511 extends with a circular arc transition towards the distal end to form a hook-like structure in a circular arc shape. The size of the through hole 1422 is slightly larger than the size of the locking member 1511, and the outer diameter of the clamping portion 151 is smaller than the diameter of the cavity 1421 so that the clamping portion 151 can enter the cavity 1421. When the clamping portion 151 enters the cavity 1421, since the length of the locking member 1511 in the radial direction exceeds the radius of the cavity 1421, the locking member 1511 will be resisted by the inner wall of the cavity 1421 and thus deformed. The locking member 1511 will deform towards the proximal direction, so the locking member 1511 has elastic potential energy to restore its original shape at this time, as Figure 8 shown. And the locking member 1511 is a hook-like structure in a circular arc shape, enabling it to smoothly deform and enter the cavity 1421. When the end of the locking member 1511 in contact with the cavity 1421 reaches the position of the through hole 1422, the elastic potential energy of the locking member 1511 causes the locking member 1511 to restore its original shape towards the distal direction, and thus the end of the locking member 1511 in contact with the cavity 1421 passes through the through hole 1422 and is exposed outside the cooperating portion 142, as Figure 9As shown. Therefore, after the locking member 1511 passes through the through hole 1422, the movement of the limiting member 14 and the limiting umbrella 15 can be restricted, and further the movement of the inner tube 11 and the outer tube 12 can be restricted, so that the inner tube 11 and the outer tube 12 are relatively fixed. When the inner tube 11 and the outer tube 12 move, the balloon 13 will be axially compressed, so that the radial dimension of the balloon 13 increases, that is, the balloon 13 changes from Figure 10 the shape to Figure 11 the shape changes. After the inner tube 11 and the outer tube 12 are relatively fixed, the shape of the balloon 13 remains unchanged after being compressed, and thus the overall shape of the balloon 13 is changed, that is, at this time the balloon 13 can act on thicker and larger blood vessels. Therefore, the balloon 13 can meet the requirements of different parts and different sizes, increase the adaptability of the balloon 13. Doctors do not need to replace the specifications of the balloon 13 for treatment, nor do they need to manufacture various specifications of balloons to match the size of the lesion location, reducing the surgical steps and time, reducing the risk of surgery, and also reducing the manufacturing cost of the balloon catheter 100.

[0045] It should be noted that the balloon 13 can be a compliant balloon, such as a balloon made of materials such as silicone, latex, and TPU. Such balloons have large elasticity and can produce large deformations to meet the requirements of balloons of different specifications.

[0046] Further, after the locking member 1511 is engaged with the through hole 1422, the through hole 1422 can also restrict the circumferential rotation of the locking member 1511, and further restrict the relative rotation between the inner tube 11 and the outer tube 12, avoiding relative rotation between the inner tube 11 and the outer tube 12 and affecting the medical effect. If it is necessary to release the cooperation between the locking member 1511 and the through hole 1422 and then adjust the shape of the balloon 13. The inner tube 11 can be moved further in the proximal direction. The locking member 1511 is deformed in the direction of the clamping portion 151 under the abutment of the inner wall of the cavity 1421, and then a part of the locking member 1511 exposed outside the cavity 1421 gradually enters the cavity 1421 until the locking member 1511 is completely received in the cavity 1421, as Figure 12 shown. At this time, the inner tube 11 is slightly rotated so that the movement path of the locking member 1511 does not pass through the through hole 1422, as Figure 13 shown. Then the inner tube 11 is moved distally so that the locking member 1511 disengages from the cavity 1421. At this time, the inner tube 11 is released to restore its original shape, and the balloon 13 can then return to its original shape.

[0047] It should be noted that in the initial state, since the radial dimension of the locking member 1511 is greater than the dimension of the mating portion 142, when the balloon 13 is shortened, the locking member 1511 can abut against the mating portion 142, thereby restricting the movement of the inner tube 11 and the outer tube 12, achieving the effect of preventing shortening. Therefore, the balloon catheter 100 of the present invention not only increases the applicability of the balloon 13, but also can prevent the balloon from shortening.

[0048] Please refer to Figure 14 and Figure 15 , a flared portion 1423 is formed by extending the distal end of the mating portion 142 outwardly of the mating portion 142. The flared portion 1423 can play a guiding role, enabling the locking member 1511 to enter the mating portion 142 more easily and accurately, facilitating the cooperation between the locking member 1511 and the mating portion 142. Further, to facilitate the accurate cooperation of the locking member 1511 with the through hole 1422, a sliding groove 1424 passing through the through hole 1422 is provided on the inner wall of the mating portion 142. The dimension of the sliding groove 1424 in the circumferential direction gradually increases from the distal end to the proximal end, and the dimension of the sliding groove 1424 in the circumferential direction at the portion close to the through hole 1422 is similar to the dimension of the through hole 1422. Specifically, the sliding groove 1424 has a funnel-shaped structure. The sliding groove 1424 can play a guiding role. The dimension of the sliding groove 1424 in the circumferential direction gradually decreases from the proximal end to the distal end until it decreases to be similar to the dimension of the through hole 1422. At this time, when the locking member 1511 enters the mating portion 142, since the dimension of the sliding groove 1424 at the distal end is larger, the locking member 1511 can easily enter the sliding groove 1424. At this time, the locking member 1511 can move along the sliding groove 1424. Since the dimension of the sliding groove 1424 in the circumferential direction gradually decreases from the proximal end to the distal end to be similar to the dimension of the through hole 1422, and the through hole 1422 is provided at the portion where the dimension of the sliding groove 1424 in the circumferential direction is similar to the dimension of the through hole 1422. Therefore, the locking member 1511 will gradually move along the sliding groove 1424 to the portion where the dimension of the sliding groove 1424 is similar to the dimension of the through hole 1422. At this time, since the dimension of the sliding groove 1424 in the circumferential direction is similar to the dimension of the through hole 1422, the locking member 1511 can easily align with the through hole 1422 in the sliding groove 1424 and then easily pass through the through hole 1422. Therefore, the sliding groove 1424 enables the cooperation between the locking member 1511 and the through hole 1422 to be more easily and conveniently achieved. The sliding groove 1424 then passes through the through hole 1422. When the locking member 1511 enters the

[0049] Further, to ensure the smoothness of the movement of the locking member 1511 within the sliding groove 1424, a layer of drag-reducing film (not shown in the figure) may be provided on the surfaces of the sliding groove 1424 and the locking member 1511. Since both the sliding groove 1424 and the locking member 1511 are within the balloon 13, the drag-reducing film may be a hydrophilic coating.

[0050] Please refer to Figure 14 and Figure 16 In a specific embodiment of the present invention, the number of the locking members 1511 is four. The four locking members 1511 are axially spaced apart on the positioning portion 151, and the locking members 1511 are evenly distributed in the circumferential direction of the positioning portion 151, that is, the angle between two adjacent locking members 1511 is 90 degrees. The number of the through holes 1422 also corresponds to four. The positions of the four through holes 1422 are set corresponding to the positions of the locking members 1511. The four locking members 1511 are respectively in one-to-one correspondence and cooperation with the four through holes 1422. By axially spacing the four locking members 1511, the four locking members 1511 will not interfere with each other when stressed, and it also avoids interference when the four locking members 1511 are deformed. The four locking members 1511 and the through holes 1422 are axially spaced apart, so that the locking members 1511 can select the number of through holes 1422 to cooperate with according to the thickness of the blood vessel at the lesion position of the patient. For example, when the blood vessel at the lesion position of the patient is thinner, only the locking member 1511 at the farthest end may be cooperated with the through hole 1422 at the nearest end. When the blood vessel at the lesion position of the patient is thicker, the four locking members 1511 may be in one-to-one correspondence and cooperation with the four through holes 1422. At the same time, the stress points of the four locking members 1511 are not on the same plane, making the restriction of the displacement between the inner tube 11 and the outer tube 12 more firm. By circumferentially and evenly arranging the four locking members 1511, the force received by the through holes 1422 from the locking members 1511 is more uniform, and the cooperation between the locking members 1511 and the through holes 1422 is more stable, avoiding the through holes 1422 from tilting due to uneven force received, and further causing the balloon 13 to deform and present an irregular appearance.

[0051] In other specific embodiments of the present invention, the number and positions of the locking members 1511 may be set corresponding to actual requirements. For example, the number of the locking members 1511 may be two, and the two locking members 1511 are arranged on the same horizontal plane and on opposite sides of the positioning portion 151.

[0052] Please continue to refer to Figures 1 to 2, the balloon catheter 100 further includes a binding structure 16. The binding structure 16 is a tubular structure woven from metal wires. The binding structure 16 is sleeved on the outer surface of the balloon 13. The proximal end of the binding structure 16 extends towards the distal end of the outer tube 12 and is fixed to the distal end of the outer tube 12. The distal end of the binding structure 16 extends towards the distal end of the inner tube 11 and is fixed to the distal end of the inner tube 11. Further, the balloon catheter 100 further includes a connection ring 17. The connection ring 17 is fixed to the inner wall of the distal end of the outer tube 12. The proximal end of the binding structure 16 is fixed at the position of the outer tube 12 where the connection ring 17 is provided.

[0053] It should be noted that when the proximal end of the existing binding structure is welded to the distal end of the outer tube, it is necessary to first weld the proximal end of the balloon to the distal end of the outer tube, weld the distal end of the balloon to the distal end of the inner tube, and then cut off the whole balloon together with the distal end of the outer tube and the inner tube. Then, the distal end of the connecting tube is sleeved on the cut-off outer tube, and the proximal end of the connecting tube is sleeved on the distal end of the uncut outer tube, that is, the cut-off balloon, outer tube and inner tube are reconnected through the connecting tube. Then, the proximal end of the binding structure is welded to the connecting tube, thereby avoiding the collapse of the outer tube caused by directly welding the binding structure to the outer tube and affecting the balloon inflation. In the present invention, a connection ring 17 is fixed to the inner wall of the distal end of the outer tube 12. The connection ring 17 has the effect of supporting the distal end of the outer tube 12. The binding structure 16 can be directly welded to the position of the outer tube 12 where the connection ring 17 is provided. At this time, due to the setting of the connection ring 17, the distal end of the outer tube 12 will not collapse due to the welding of the binding structure 16. Therefore, through the setting of the connection ring 17, the manufacturing process of the balloon catheter 100 can be simplified, making the balloon catheter 100 simpler in manufacturing, reducing the manufacturing cost of the balloon catheter 100, and preventing the problem of collapse when the binding structure 16 is welded to the outer tube 12.

[0054] Further, the main body portion 153 of the limiting umbrella 15 and the connection ring 17 can be arranged at positions corresponding to the distal end of the outer tube 12. For example, when the main body portion 153 is arranged on the inner wall of the distal end of the outer tube 12, the connection ring 17 is sleeved on the outer tube 12 at the position corresponding to the main body portion 153, thereby further avoiding the collapse of the distal end of the outer tube 12 during welding. The main body portion 153 and the connection ring 17 can also be arranged in a staggered manner, thereby ensuring that the overall size of the outer tube 12 is smaller.

[0055] Compared with the prior art, a balloon catheter of the present invention has the following advantages: By means of the clamping portion abutting against the limiting member, the relative movement between the inner tube and the outer tube is restricted, that is, the movement of the inner tube towards the proximal end and / or the movement of the outer tube towards the distal end is restricted, thereby preventing the balloon from being shortened, ensuring the size specification of the balloon, and ensuring that the inner tube will not be bent due to the shortening of the balloon. The main body portion can also provide support for the outer tube to prevent the outer tube from collapsing when the balloon is welded to the outer tube.

[0056] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, and improvements made within the principles of the present invention shall be included within the protection scope of the present invention.

Claims

1. A balloon catheter, characterized in that: The balloon catheter includes an inner tube, an outer tube, a balloon, a limiting member, and a limiting umbrella. The outer tube is sleeved on the inner tube. The distal end of the inner tube is exposed outside the distal end of the outer tube. The limiting umbrella includes a main body portion, a connecting rod, and a clamping portion. The main body portion is connected to the outer tube. The clamping portion is sleeved on the inner tube. The distal end of the connecting rod is connected to the clamping portion, and the proximal end of the connecting rod is connected to the main body portion. The limiting member is fixedly sleeved on the inner tube and is disposed close to the clamping portion. The distal end of the balloon is fixed to the distal end of the inner tube, and the proximal end of the balloon is fixed to the distal end of the outer tube.

2. The balloon catheter according to claim 1, wherein: The main body portion is fixedly sleeved on the outer surface of the outer tube, and the proximal end of the balloon is fixed to the main body portion; or the main body portion is fixed to the inner wall of the distal end of the outer tube, and the proximal end of the balloon is fixed to the position corresponding to the main body portion at the distal end of the outer tube.

3. The balloon catheter according to claim 1, wherein: The number of the connecting rods is multiple. The proximal ends of the multiple connecting rods are evenly arranged in the circumferential direction of the main body portion, and the distal ends of the multiple connecting rods are evenly arranged in the circumferential direction of the clamping portion.

4. The balloon catheter according to claim 1, characterized in that: The limiting member is close to the distal side of the clamping portion; the clamping portion and the limiting member are disposed on the part of the inner tube exposed outside the outer tube.

5. The balloon catheter according to claim 1, wherein: The inner tube can move relative to the outer tube. A locking member extends outward from the outer wall of the clamping portion, and the clamping portion is movably sleeved on the inner tube. The limiting member includes a fixing portion and a cooperating portion. The fixing portion is fixedly connected to the inner tube. The cooperating portion is disposed close to the clamping portion. The cooperating portion includes a hollow cavity. The movement of the inner tube can drive the limiting member to move. The clamping portion and the locking member can enter the cavity, and the locking member can pass through the cooperating portion and be exposed outside the cooperating portion.

6. The balloon catheter according to claim 5, wherein: A through hole penetrating the inner and outer surfaces of the cooperating portion is provided on the cooperating portion. When the cooperating portion moves toward the clamping portion, the locking member can enter the cavity, and the free end of the locking member can pass through the through hole and cooperate with the through hole.

7. The balloon catheter according to claim 6, wherein: One end of the cooperating portion facing the clamping portion extends outward to form a flared structure; a sliding groove passing through the through hole is provided on the inner wall of the cooperating portion. When the locking member enters the cavity through the flared structure, the locking member can move along the sliding groove and then cooperate with the through hole.

8. The balloon catheter according to claim 6, wherein: The number of the locking members is two or more. The two or more locking members are spaced along the axial direction of the clamping portion and / or are evenly distributed along the circumferential direction of the rod body. The number of the through holes is two or more. The two or more through holes are spaced along the axial direction of the cooperating portion and / or are evenly distributed along the circumferential direction of the cooperating portion. The two or more locking members can respectively cooperate with the two or more through holes in a one-to-one correspondence.

9. The balloon catheter according to claim 1, characterized in that: The balloon catheter further includes a binding structure. The binding structure includes a tubular structure woven by metal wires. The binding structure is sleeved on the outer surface of the balloon. The proximal end of the binding structure extends toward the outer tube and is fixed to the distal end of the outer tube. The distal end of the binding structure extends toward the distal end of the inner tube and is fixed to the distal end of the inner tube.

10. The balloon catheter according to claim 9, characterized in that: The balloon catheter further includes a connecting ring, the connecting ring is fixed on the inner wall of the distal end of the outer tube, and the proximal end of the restraint structure is fixed at the position of the outer tube where the connecting ring is provided.

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