Pre-dilatation balloon and balloon dilatation catheter assembly

Abstract

According to the pre-dilation balloon and the balloon dilation catheter assembly, the columnar balloon body is arranged in the middle of the pre-dilation balloon, the columnar balloon body is composed of the at least two balloon body units with the different outer diameters, the pre-dilation balloon can be arranged to be a reducing balloon, and therefore an anti-slipping step is formed in the middle of the pre-dilation balloon. In the pre-dilation process of the pre-dilation balloon, the anti-slip step is in contact with the calcified aortic valve, so that the friction force between the middle part of the pre-dilation balloon and the calcified aortic valve is increased, and the pre-dilation balloon is effectively prevented from shifting or slipping off from the calcified aortic valve in the pre-dilation process; the defect that the pre-expanded balloon is difficult to adapt to pre-expansion treatment of aortic valve calcification parts and lesion narrow parts due to the fact that the pre-expanded balloon is prone to displacement or slippage in the balloon pre-expansion link is overcome.

Description

Technical Field

[0001] This utility model belongs to the field of medical device technology, and in particular, relates to a pre-dilation balloon and a balloon dilation catheter assembly. Background Technology

[0002] Currently, in balloon angioplasty, aortic valve pre-dilation with a pre-dilation balloon is generally required to treat the lesion or to check the size and select a suitable balloon dilation catheter for the procedure. However, in actual balloon angioplasty, factors such as severe valve calcification can lead to hard, smooth, or uneven local tissues, making balloon displacement or slippage prone to occur during pre-dilation. This can result in the pre-dilation balloon having poor adaptability to aortic valve lesions and stenosis, often requiring multiple pre-dilation procedures, prolonging the operation time and increasing surgical risks. Utility Model Content

[0003] One of the objectives of this utility model is to provide a pre-dilation balloon to solve the technical problem in the prior art where the pre-dilation balloon is prone to displacement or slippage during the pre-dilation stage, making it difficult for the pre-dilation balloon to adapt to the pre-dilation treatment of calcified aortic valve sites and stenotic lesions.

[0004] To achieve the above objectives, the technical solution adopted by this utility model is: to provide a pre-expanded balloon, comprising:

[0005] The first conical sac is used to form the distal end of the pre-expanded balloon;

[0006] A second conical capsule is used to form the proximal end of the pre-inflated balloon; and

[0007] A columnar capsule is disposed between the first conical capsule and the second conical capsule to form the middle part of the pre-inflated balloon;

[0008] The columnar balloon is composed of at least two balloon units, with adjacent balloon units having different outer diameters, so as to form an anti-slip step at the connection of adjacent balloon units to prevent the pre-expanded balloon from shifting or slipping.

[0009] Furthermore, the distal end of the columnar cyst is connected to the larger outer diameter end of the first conical cyst, and the proximal end of the columnar cyst is connected to the larger outer diameter end of the second conical cyst, thereby forming a hollow tubular sac with the distal end converging to the distal end of the columnar cyst and the proximal end converging to the proximal end of the columnar cyst. The outer diameter of the cyst unit connected to the first conical cyst is larger than the outer diameter of the cyst unit connected to the second conical cyst.

[0010] Furthermore, the smaller end of the first conical balloon is connected to a guide tube for the guide wire to pass through the pre-inflated balloon, and the guide tube is connected to the hollow tubular balloon.

[0011] Furthermore, the smaller end of the second conical balloon is connected to a connecting sleeve, which communicates with the hollow tubular balloon.

[0012] Furthermore, the capsule unit connected to the second conical capsule is provided with an anti-slip structure.

[0013] Furthermore, the anti-slip structure includes a plurality of protrusions on the outer peripheral surface of the capsule unit, and the plurality of protrusions are distributed at intervals on the outer peripheral surface of the capsule unit.

[0014] Furthermore, the pre-expanded balloon is a foldable balloon supported by medical polymer materials.

[0015] The second objective of this utility model embodiment is to provide a balloon dilation catheter assembly having the pre-dilation balloon described in any of the above-mentioned solutions.

[0016] To achieve the above objectives, the technical solution adopted by this utility model is: to provide a balloon dilation catheter assembly, including the pre-dilation balloon in any of the above solutions.

[0017] Furthermore, the balloon dilation catheter assembly also includes an outer tube connected to the smaller end of the second conical balloon and an inner tube inserted in the outer tube. The first end of the inner tube extends into a guide tube on the first conical balloon, and a delivery channel for delivering fluid medium into the cylindrical balloon is formed between the outer tube and the inner tube.

[0018] Furthermore, the outer tube is provided with a three-way connector at the end away from the second conical bladder. The three-way connector includes a first pipe sleeved on the outer tube, a second pipe communicating with the second end of the inner tube, and a third pipe communicating with the delivery channel.

[0019] Compared with the prior art, one or more technical solutions in the embodiments of this utility model have at least one of the following beneficial effects:

[0020] The pre-dilation balloon and balloon dilation catheter assembly in this embodiment of the invention features a cylindrical balloon body in the middle of the pre-dilation balloon. This cylindrical balloon body is composed of at least two balloon units with different outer diameters, allowing the pre-dilation balloon to be configured as a variable-diameter balloon. This creates an anti-slip step in the middle of the pre-dilation balloon. During pre-dilation, the pre-dilation balloon can contact the calcified aortic valve through the anti-slip step, increasing the friction between the middle of the pre-dilation balloon and the calcified aortic valve. This effectively prevents the pre-dilation balloon from shifting or slipping off the calcified aortic valve during pre-dilation, overcoming the defect of pre-dilation balloons being prone to shifting or slipping during the pre-dilation stage, making them unsuitable for pre-dilation of calcified aortic valve sites and stenotic lesions. Attached Figure Description

[0021] To more clearly illustrate the technical solutions in the embodiments of this utility model, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0022] Figure 1 A three-dimensional structural schematic diagram of the pre-expanded balloon provided in an embodiment of this utility model;

[0023] Figure 2 A side view of the balloon dilation catheter assembly provided in an embodiment of this utility model;

[0024] Figure 3 for Figure 2 A cross-sectional view of the balloon dilation catheter assembly shown in the figure;

[0025] Figure 4 for Figure 3 A magnified schematic diagram of a portion of part A in the middle;

[0026] Figure 5 A three-dimensional structural schematic diagram of a pre-expanded balloon provided for another embodiment of the present invention;

[0027] Figure 6 A side view of a balloon dilation catheter assembly provided in another embodiment of the present invention;

[0028] Figure 7 A three-dimensional structural diagram of a tee connector provided in an embodiment of this utility model.

[0029] The following are the labeling elements in the figure:

[0030] 1-First conical cyst; 2-Columnar cyst; 21-Cyclocyst unit; 22-Anti-slip step;

[0031] 3-Second cone-shaped bladder; 4-Anti-slip structure; 41-Protruding structure;

[0032] 5-Guide tube; 6-Connecting sleeve; 7-Inner tube; 8-Outer tube;

[0033] 9-Tee connector; 91-First pipe; 92-Second pipe; 93-Third pipe; 94-Inlet; 95-Inlet;

[0034] 10-Hollow tubular balloon; 20-Convex ring structure; 30-Delivery channel; 40-Inflation chamber;

[0035] 100 - Pre-dilation balloon; 200 - Balloon dilation catheter assembly. Detailed Implementation

[0036] To make the technical problems, technical solutions, and beneficial effects of this utility model clearer, the present utility model will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the present utility model and are not intended to limit the present utility model.

[0037] It should be noted that when a component is referred to as "connected to" or "set on" another component, it can be directly on or indirectly on that other component. When a component is referred to as "connected to" another component, it can be directly connected to or indirectly connected to that other component.

[0038] In the description of this utility model, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "joining" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model according to the specific circumstances.

[0039] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this application, "multiple" means two or more, unless otherwise expressly specified. "Several" means one or more, unless otherwise expressly specified.

[0040] Throughout this specification, references to "an embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic described in connection with an embodiment is included in at least one embodiment of this application. Therefore, the phrases "in one embodiment" or "in some embodiments" appear in various places throughout the specification, and not all refer to the same embodiment. Furthermore, in one or more embodiments, particular features, structures, or characteristics may be combined in any suitable manner.

[0041] Please refer to this as well. Figures 1 to 7 The pre-dilation balloon 100 provided in this embodiment of the present invention will now be described. The pre-dilation balloon 100 provided in this embodiment of the present invention can be applied to balloon catheter assemblies for pre-dilation and / or post-dilation of the aortic valve in patients. The pre-dilation balloon 100 provided in this embodiment of the present invention includes a first conical balloon 1, a cylindrical balloon 2, and a second conical balloon 3. The first conical balloon 1 constitutes the distal end of the pre-dilation balloon 100, the second conical balloon 3 constitutes the proximal end of the pre-dilation balloon 100, and the cylindrical balloon 2 is disposed between the first conical balloon 1 and the second conical balloon 3, such that the cylindrical balloon 2 constitutes the middle part of the pre-dilation balloon 100. It should be noted that in some embodiments, the first conical balloon 1, the cylindrical balloon 2, and the second conical balloon 3 are integrally formed, allowing the pre-dilation balloon 100 to be folded after depressurization. In actual balloon dilation surgery, factors such as severe valve calcification can lead to hardened, smooth, or uneven local tissues, making the balloon prone to displacement or slippage during pre-dilation. This can result in the pre-dilation balloon 100 having poor adaptability to aortic valve lesions and stenosis. To prevent balloon displacement or slippage during pre-dilation, the columnar balloon 2 is composed of at least two balloon units 21 with different outer diameters, forming an anti-slip step 22 at the connection between adjacent balloon units 21. Because the columnar balloon 2 of the pre-dilation balloon 100 is composed of at least two balloon units 21 with different outer diameters, by setting the pre-dilation balloon 100 as a variable-diameter balloon, an anti-slip step 22 is formed in the middle of the pre-dilation balloon 100, effectively preventing the pre-dilation balloon 100 from displacing or slipping from the calcified aortic valve during pre-dilation.

[0042] Compared with the prior art, the pre-dilation balloon 100 provided in this embodiment of the utility model has a columnar balloon body 2 in the middle part of the pre-dilation balloon 100. The columnar balloon body 2 is composed of at least two balloon body units 21 with different outer diameters, so that the pre-dilation balloon 100 can be set as a variable diameter balloon, thereby forming an anti-slip step 22 in the middle part of the pre-dilation balloon 100. During the pre-dilation process, the pre-dilation balloon 100 can contact the calcified aortic valve through the anti-slip step 22, increasing the friction between the middle part of the pre-dilation balloon 100 and the calcified aortic valve, effectively preventing the pre-dilation balloon 100 from shifting or slipping off the calcified aortic valve during the pre-dilation process. This overcomes the defect that the pre-dilation balloon 100 is prone to balloon shifting or slipping during the pre-dilation stage, making it difficult for the pre-dilation balloon 100 to adapt to the pre-dilation treatment of calcified aortic valve sites and stenotic lesions.

[0043] Please refer to the following: Figure 1 , Figure 2 and Figure 3 In some embodiments, the distal end of the columnar balloon 2 is sealed to the larger outer diameter end of the first conical balloon 1, and the proximal end of the columnar balloon 2 is sealed to the larger outer diameter end of the second conical balloon 3, forming a hollow tubular balloon 10 with its distal end converging to the distal end of the columnar balloon 2 and its proximal end converging to the proximal end of the columnar balloon 2. The outer diameter of the balloon unit 21 connected to the first conical balloon 1 is larger than the outer diameter of the balloon unit 21 connected to the second conical balloon 3, so that an anti-slip step 22 is formed at the connection of the two balloon units 21, increasing the friction between the middle part of the pre-dilation balloon 100 and the calcified aortic valve, effectively preventing the pre-dilation balloon 100 from shifting or slipping from the calcified aortic valve during pre-dilation.

[0044] Please refer to the following: Figure 1 , Figure 2 and Figure 3 In some embodiments, the smaller outer diameter end of the first conical balloon 1 is connected to a guide tube 5 for the guide wire to pass through the pre-expanded balloon 100, and the guide tube 5 is connected to the hollow tubular balloon 10. Specifically, the guide tube 5 is sealed to the smaller outer diameter end of the first conical balloon 1, and the first end of the inner tube 7 passes through the hollow tubular balloon 10 of the pre-expanded balloon 100 and extends into the guide tube 5, and the first end of the inner tube 7 is sealed to the guide tube 5, so the guide wire can be guided through the inner tube 7 to the guide tube 5, and the guide wire can finally pass through the guide tube 5 to exit the pre-expanded balloon 100.

[0045] Please refer to the following: Figure 1 , Figure 2 and Figure 3In some embodiments, the smaller end of the second conical balloon 3 is connected to a connecting sleeve 6, which communicates with the hollow tubular balloon 10. One end of the outer tube 8 is inserted into the connecting sleeve 6, and the outer tube 8 and the connecting sleeve 6 are sealed together. The inner tube 7 is inserted into the outer tube 8, and a delivery channel 30 for delivering fluid media to the cylindrical balloon 2 is formed between the outer tube 8 and the inner tube 7. The delivery channel 30 is connected to the hollow tubular balloon 10 of the pre-dilation balloon 100. In this way, gas or saline solution can be injected into the hollow tubular balloon 10 of the pre-dilation balloon 100 through the delivery channel 30 between the outer tube 8 and the inner tube 7, causing the pre-dilation balloon 100 to inflate and perform pre-dilation and / or post-dilation treatment on the patient's aortic valve.

[0046] Please refer to the following: Figure 5 and Figure 6 In some embodiments, the sac unit 21 connected to the second conical sac 3 is provided with an anti-slip structure 4 to further prevent the pre-dilation balloon 100 from shifting or slipping off from the calcified aortic valve during the pre-dilation process.

[0047] Please refer to the following: Figure 5 and Figure 6 In some embodiments, the anti-slip structure 4 includes multiple protrusions 41 on the outer peripheral surface of the balloon unit 21, with the multiple protrusions 41 distributed at intervals on the outer peripheral surface of the balloon unit 21. It should be noted that the protrusions 41 can be, but are not limited to, protrusions or bumps of different shapes such as circular, rhomboid, elliptical, V-shaped, or elongated. By providing multiple protrusions 41 on the outer peripheral surface of the columnar balloon 2, the friction between the middle part of the pre-dilation balloon 100 and the calcified aortic valve is increased, preventing the pre-dilation balloon 100 from shifting or slipping from the calcified aortic valve during pre-dilation, so that the pre-dilation balloon 100 can better adapt to the pre-dilation treatment of calcified aortic valve sites and stenotic lesions.

[0048] Please refer to the following: Figure 5In some embodiments, the pre-dilation balloon 100 is a foldable balloon made of medical polymer material, and the protruding structure 41 is a dot-shaped or block-shaped balloon integrally formed with the columnar balloon 2. When the pre-dilation balloon 100 is inflated, the dot-shaped or block-shaped balloon protrudes from the outer peripheral surface of the columnar balloon 2, allowing it to contact the aortic valve surface. Inflation to bring the dot-shaped or block-shaped balloon protruding from the outer peripheral surface of the columnar balloon 2 into contact with the aortic valve surface increases the friction between the middle portion of the pre-dilation balloon 100 and the calcified aortic valve, preventing displacement or slippage of the pre-dilation balloon 100 during pre-dilation. It also enhances the pressure tolerance of the pre-dilation balloon 100 during pre-dilation and ensures a tight fit between the pre-dilation balloon 100 and the aortic valve, guaranteeing the safety and stability of the procedure.

[0049] Please refer to the following: Figure 2 , Figure 3 and Figure 6 This utility model also provides a balloon dilation catheter assembly 200, including the pre-dilation balloon 100 provided in any of the above embodiments. Since the balloon dilation catheter assembly 200 has all the technical features of the pre-dilation balloon 100 provided in any of the above embodiments, the balloon dilation catheter assembly 200 has the same technical effect as the pre-dilation balloon 100 provided in any of the above embodiments, and will not be described in detail here.

[0050] Please refer to the following: Figure 3 and Figure 4 In some embodiments, the balloon dilation catheter assembly 200 further includes an outer tube 8 connected to the smaller end of the second conical balloon 3 and an inner tube 7 inserted in the outer tube 8. The first end of the inner tube 7 extends into a guide tube 5 on the first conical balloon 1. A delivery channel 30 for delivering fluid media into the cylindrical balloon 2 is formed between the outer tube 8 and the inner tube 7. The portion of the hollow tubular balloon 10 of the pre-dilation balloon 10 outside the inner tube 7 defines a sealed inflation chamber 40, and the delivery channel 30 communicates with the inflation chamber 40. Thus, a fluid medium such as gas or saline can be injected into the inflation chamber 40 through the delivery channel 30 between the outer tube 8 and the inner tube 7, causing the pre-dilation balloon 100 to inflate and perform pre-dilation and / or post-dilation treatment on the patient's aortic valve.

[0051] Please refer to the following: Figure 2 , Figure 3 and Figure 7In some embodiments, the outer tube 8 is provided with a tee connector 9 at the end away from the second conical capsule 3. The tee connector 9 includes a first pipe 91 sleeved on the outer tube 8, a second pipe 92 communicating with the second end of the inner tube 7, and a third pipe 93 communicating with the delivery channel 30. The tee connector 9 may be, but is not limited to, a Y-type connector. The second pipe 92 is provided with an inlet 94 for inserting a guide wire into the inner tube 7, and the third pipe 93 is provided with an inlet 95 for inputting fluid media such as gas or saline into the delivery channel 30.

[0052] Please refer to the following: Figure 5 and Figure 6 The pre-dilation balloon 100 provided in another embodiment of the present invention will now be described. The pre-dilation balloon 100 provided in this embodiment can be applied to balloon catheter assemblies for pre-dilation and / or post-dilation of the aortic valve in patients. The pre-dilation balloon 100 provided in this embodiment includes a first conical balloon 1, a cylindrical balloon 2, and a second conical balloon 3. The first conical balloon 1 constitutes the distal end of the pre-dilation balloon 100, and the second conical balloon 3 constitutes the proximal end of the pre-dilation balloon 100. The cylindrical balloon 2 is disposed between the first conical balloon 1 and the second conical balloon 3, such that the cylindrical balloon 2 constitutes the middle part of the pre-dilation balloon 100. The distal end of the cylindrical balloon 2 is sealed to the end with the larger outer diameter of the first conical balloon 1, and the proximal end of the cylindrical balloon 2 is sealed to the end with the larger outer diameter of the second conical balloon 3, forming a hollow tubular balloon 10 whose distal end converges to the distal end of the cylindrical balloon 2 and whose proximal end converges to the proximal end of the cylindrical balloon 2. In actual balloon dilation surgery, factors such as severe valve calcification can lead to hardened, smooth, or uneven local tissues, making the balloon prone to displacement or slippage during pre-dilation. This can result in the pre-dilation balloon 100 having poor adaptability to aortic valve lesions and stenosis. To prevent balloon displacement or slippage during pre-dilation, an anti-slip structure 4 is provided in the middle of the pre-dilation balloon 100. Specifically, the anti-slip structure 4 is located on the outer peripheral surface of the columnar balloon body 2, that is, on the outer peripheral surface of at least one balloon unit 21, effectively preventing the pre-dilation balloon 100 from displacing or slipping from the calcified aortic valve during pre-dilation.

[0053] Another embodiment of the present invention provides a pre-dilation balloon 100, which, compared with the prior art, has an anti-slip structure 4 in the middle part of the pre-dilation balloon 100. During the pre-dilation process, the pre-dilation balloon 100 maintains close contact with the calcified aortic valve through the anti-slip structure 4, effectively preventing displacement or slippage of the pre-dilation balloon 100 with the calcified aortic valve. This overcomes the defect that the pre-dilation balloon 100 is prone to displacement or slippage during the pre-dilation stage, making it difficult to adapt to the pre-dilation treatment of calcified aortic valve sites and stenotic lesions. Furthermore, the anti-slip structure 4 on the outer peripheral surface of the columnar balloon 2 located in the middle part of the pre-dilation balloon 100 helps to enhance the pressure resistance of the pre-dilation balloon 100 during the pre-dilation process. Meanwhile, the middle part of the pre-dilation balloon 100 is in close contact with the calcified aortic valve through the anti-slip structure 4. The middle part of the pre-dilation balloon 100 has a relatively small degree of expansion in the initial stage, while the distal and proximal ends of the pre-dilation balloon 100 have a relatively large degree of expansion in the initial stage. This allows the pre-dilation balloon 100 to form a dumbbell shape that is thick at both ends and thin in the middle, which helps to prevent the pre-dilation balloon 100 from shifting or slipping during the pre-dilation process.

[0054] Please refer to the following: Figure 5 and Figure 6 In some embodiments, the anti-slip structure 4 includes multiple protrusions 41 on the outer peripheral surface of the columnar balloon 2, with the multiple protrusions 41 distributed at intervals on the outer peripheral surface of the columnar balloon 2. It should be noted that the protrusions 41 can be, but are not limited to, protrusions or bumps of different shapes such as circular, rhomboid, elliptical, V-shaped, or elongated. By providing multiple protrusions 41 on the outer peripheral surface of the columnar balloon 2, the friction between the middle part of the pre-dilation balloon 100 and the calcified aortic valve is increased, preventing the pre-dilation balloon 100 from shifting or slipping from the calcified aortic valve during pre-dilation, so that the pre-dilation balloon 100 can better adapt to the pre-dilation treatment of calcified aortic valve sites and stenotic lesions.

[0055] Please refer to further details. Figure 5 and Figure 6 In some specific application scenarios, the protrusion structure 41 is a spherical protrusion or an elliptical protrusion. The spherical or elliptical protrusion makes close contact with the calcified aortic valve, which helps to increase the friction between the middle part of the pre-dilation balloon 100 and the calcified aortic valve, and prevents the pre-dilation balloon 100 from shifting or slipping off from the calcified aortic valve during the pre-dilation process.

[0056] Understandably, in some other specific application scenarios, the protrusion structure 41 is a rhomboid protrusion. The rhomboid protrusion makes close contact with the calcified aortic valve, which helps to increase the friction between the middle part of the pre-dilation balloon 100 and the calcified aortic valve, and prevents the pre-dilation balloon 100 from shifting or slipping off from the calcified aortic valve during the pre-dilation process.

[0057] Understandably, in some other specific application scenarios, the protruding structure 41 is a V-shaped protrusion, with the tip of the V-shaped protrusion pointing towards the first conical balloon 1. The V-shaped protrusion makes close contact with the calcified aortic valve, which helps to increase the friction between the middle part of the pre-dilation balloon 100 and the calcified aortic valve, and prevents the pre-dilation balloon 100 from shifting or slipping off from the calcified aortic valve during the pre-dilation process.

[0058] Understandably, in some other specific application scenarios, the protrusion structure 41 is a long strip protrusion. The length of the long strip protrusion extends along the circumference of the columnar balloon 2. It makes close contact with the calcified aortic valve through the V-shaped protrusion, which helps to increase the friction between the middle part of the pre-dilation balloon 100 and the calcified aortic valve and prevent the pre-dilation balloon 100 from shifting or slipping off from the calcified aortic valve during the pre-dilation process.

[0059] Please refer to the following: Figure 5 and Figure 6 In some embodiments, the anti-slip structure 4 includes multiple protrusions 41, which are spaced apart circumferentially along the columnar balloon 2 to form multiple discontinuous convex ring structures 2 on the outer peripheral surface of the columnar balloon 2. The multiple discontinuous convex ring structures 2 are arranged axially spaced along the columnar balloon 2, with the protrusions 41 on adjacent ring structures 2 staggered. This allows the protrusions 41 to be more concentrated and evenly distributed in the central position on the outer peripheral surface of the columnar balloon 2, facilitating more thorough and tight contact between the protrusions 41 and the calcified aortic valve. This effectively improves the anti-slip performance of the pre-dilation balloon 100, enabling it to better adapt to pre-dilation treatment of calcified aortic valve sites and stenotic lesions.

[0060] Please refer to the following: Figure 5 and Figure 6 In some embodiments, the spacing between two adjacent protrusions 41 on the same convex ring structure 2 is equal, so that the protrusions 41 can be more evenly distributed on the outer peripheral surface of the columnar balloon 2. This is beneficial for the protrusions 41 to make more full and tight contact with the calcified aortic valve, thereby effectively improving the anti-slip performance of the pre-dilation balloon 100 and enabling the pre-dilation balloon 100 to better adapt to the pre-dilation treatment of calcified aortic valve sites and stenotic lesions.

[0061] Please refer to the following: Figure 5 and Figure 6 In some embodiments, multiple discontinuous convex ring structures 2 are evenly distributed along the axial direction of the columnar balloon 2, so that the convex structures 41 can be more evenly distributed on the outer peripheral surface of the columnar balloon 2. This facilitates the convex structures 41 to make more full and tight contact with the calcified aortic valve, thereby effectively improving the anti-slip performance of the pre-dilation balloon 100 and enabling the pre-dilation balloon 100 to better adapt to the pre-dilation treatment of calcified aortic valve sites and stenotic lesions.

[0062] Please refer to the following: Figure 5 and Figure 6 In some embodiments, the protruding structure 41 is a dot-shaped or block-shaped balloon integrally formed with the columnar balloon 2. During inflation of the pre-dilation balloon 100, the dot-shaped or block-shaped balloon protrudes from the outer peripheral surface of the columnar balloon 2, allowing it to contact the aortic valve surface. Inflation to bring the dot-shaped or block-shaped balloon protruding from the outer peripheral surface of the columnar balloon 2 into contact with the aortic valve surface increases the friction between the middle portion of the pre-dilation balloon 100 and the calcified aortic valve, preventing displacement or slippage of the pre-dilation balloon 100 during pre-dilation. It also enhances the pressure tolerance of the pre-dilation balloon 100 during pre-dilation and ensures a tight fit between the pre-dilation balloon 100 and the aortic valve, guaranteeing the safety and stability of the procedure.

[0063] Please refer to the following: Figure 1 In some embodiments, the first conical balloon 1, the cylindrical balloon 2, and the second conical balloon 3 are integrally formed, allowing the pre-expansion balloon 100 to be folded after depressurization. It is understood that in some embodiments, the pre-expansion balloon 100 may be, but is not limited to, a foldable balloon made of medical polymer materials.

[0064] The above description is only a preferred embodiment of the present utility model and is not intended to limit the present utility model. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present utility model should be included within the protection scope of the present utility model.

Claims

1. A pre-dilation balloon, characterized in that, The pre-dilation balloon comprises: a first conical balloon body for forming a distal end of the pre-dilation balloon; a second conical balloon body for forming a proximal end of the pre-dilation balloon; and a cylindrical balloon body arranged between the first conical balloon body and the second conical balloon body to form a middle part of the pre-dilation balloon; wherein the cylindrical balloon body is formed by at least two balloon units, and the outer diameters of adjacent two balloon units are different to form an anti-slippage step at the connection between the adjacent two balloon units for preventing the pre-dilation balloon from slipping or dislocating. The distal end of the cylindrical balloon body is connected to the end of the first conical balloon body with a larger outer diameter, and the proximal end of the cylindrical balloon body is connected to the end of the second conical balloon body with a larger outer diameter, so as to form a hollow tubular balloon with the distal end converging to the distal end of the cylindrical balloon body and the proximal end converging to the proximal end of the cylindrical balloon body, and the outer diameter of the balloon unit connected to the first conical balloon body is larger than the outer diameter of the balloon unit connected to the second conical balloon body.

2. The pre-dilated balloon of claim 1, wherein, The end of the first conical balloon body with a smaller outer diameter is connected to a guide tube for guiding a guide wire to pass out of the pre-dilation balloon, and the guide tube is connected to the hollow tubular balloon.

3. The pre-dilation balloon of claim 2, wherein, The end of the second conical balloon body with a smaller outer diameter is connected to a connecting sleeve, and the connecting sleeve is in communication with the hollow tubular balloon.

4. The pre-dilated balloon of claim 2, wherein, The balloon unit connected to the second conical balloon body is provided with an anti-slippage structure.

5. The pre-dilation balloon of any one of claims 1 to 4, wherein, The anti-slippage structure comprises a plurality of protruding structures protruding from the outer circumferential surface of the balloon unit, and the plurality of protruding structures are distributed on the outer circumferential surface of the balloon unit at intervals.

6. The pre-dilation balloon of claim 5, wherein, The pre-dilation balloon is a foldable balloon body supported by a medical polymer material.

7. The pre-dilation balloon of claim 5, wherein, The pre-dilation balloon according to any one of claims 1 to 7.

8. A balloon dilatation catheter assembly characterized by, The balloon dilation catheter assembly further comprises an outer tube connected to the end of the second conical balloon body with a smaller outer diameter, and an inner tube inserted into the outer tube, wherein the first end of the inner tube extends into the guide tube on the first conical balloon body, and a delivery channel for delivering fluid medium into the cylindrical balloon body is formed between the outer tube and the inner tube.

9. The balloon dilation catheter assembly of claim 8, wherein, The end of the outer tube away from the second conical balloon body is provided with a three-way joint, and the three-way joint comprises a first pipe arranged on the outer tube, a second pipe in communication with the second end of the inner tube, and a third pipe in communication with the delivery channel.

10. The balloon dilation catheter assembly of claim 9, wherein, ​

Images