Balloon-constrained stents and balloon catheters

Abstract

This invention belongs to the technical field of medical devices and discloses a balloon restraint stent and a balloon catheter. The balloon restraint stent includes a first fixing segment, a second fixing segment, and a main body segment. The first fixing segment is used to connect to a first end of the balloon; the second fixing segment is used to connect to a second end of the balloon; the main body segment is sleeved on the middle of the balloon to restrain its expansion. Connecting segments are provided on both sides of the main body segment, and the sides of the two connecting segments away from the main body segment are respectively connected to the first fixing segment and the second fixing segment to restrain the expansion of the balloon on both sides of the main body segment. The balloon restraint stent ensures that after balloon expansion, the main body segment can restrain the middle part of the balloon, while the connecting segments can effectively restrain the balloon on both sides of the main body segment. This allows the outer surface of the balloon to maintain a cylindrical shape after expansion, effectively reducing the possibility of the "dog bone effect," thereby reducing the possibility of damage to the blood vessel wall and improving the precision and success rate of the surgery.

Description

Technical Field

[0001] This invention relates to the technical field of medical devices, and more particularly to a balloon restraint stent and a balloon catheter. Background Technology

[0002] Angioplasty, also known as balloon angioplasty, is a procedure used to restore narrowed blood vessels to their original shape. It is a minimally invasive surgery that primarily uses the physical expansion of a balloon to remove obstructions from narrowed or blocked arteries, thereby clearing plaque.

[0003] In the prior art, a restraint balloon catheter includes a balloon, a catheter, and a stent disposed on the outside of the balloon. The stent is attached to the outer surface of the balloon and can expand as the balloon expands to restrain the overall expansion of the balloon.

[0004] However, balloons are generally elongated with a large length-to-diameter ratio, and the materials used are mostly compliant or semi-compliant. In existing technologies, the stent mainly constrains the balloon in the middle, with less constraint on the ends. This can lead to a "dog bone effect" after balloon expansion, where the diameters of the balloon ends are larger than the stent ends, which can easily damage blood vessels. Summary of the Invention

[0005] The purpose of this invention is to provide a balloon-constrained stent and balloon catheter, which solves the problem of "dog bone effect" that occurs when the balloon catheter is expanded due to the small constraint force at both ends of the balloon, causing damage to blood vessels.

[0006] To achieve this objective, the present invention adopts the following technical solution:

[0007] A balloon restraint stent includes a first fixing segment, a second fixing segment, and a main body segment. The first fixing segment is used to connect to a first end of a balloon; the second fixing segment is used to connect to a second end of the balloon; the main body segment is sleeved on the middle of the balloon to restrain the expansion of the balloon, and connecting segments are provided on both sides of the main body segment. The sides of the two connecting segments away from the main body segment are respectively connected to the first fixing segment and the second fixing segment to restrain the expansion of the balloon on both sides of the main body segment.

[0008] Optionally, multiple connecting segments are provided, and the multiple connecting segments are sequentially connected and distributed along the axial direction of the balloon.

[0009] The above technical solution allows for the setting of multiple connecting segments based on the actual size of the balloon, thereby increasing the constraint on the balloons on both sides of the main body and further reducing the possibility of the "dog bone effect".

[0010] Optionally, the connecting segment includes: multiple connecting frames, which are sequentially connected and arranged around the circumference of the balloon, and the internal space of the connecting frames can expand as the balloon expands, and the total expansion of the multiple connecting frames is consistent with the expansion of the main body segment.

[0011] With the above technical solution, as the balloon expands, the space within the multiple connecting frames also expands. The overall expansion range of the connecting segments is consistent with the expansion range of the main body segment, so that the balloon presents a cylindrical shape after overall expansion, thereby effectively reducing the possibility of the "dog bone effect".

[0012] Optionally, the connecting frame has a rhomboid structure.

[0013] Through the above technical solution, the rhomboid structure has good radial strength, which can effectively constrain the expansion range of the balloon, and it is also easy to retract, so that the balloon has good delivery performance in the body.

[0014] Optionally, an extension ring is provided between the protruding ends of each two adjacent connecting frames, and the side of the extension ring away from the connecting frame is connected to the main body segment.

[0015] By adding an extension ring, the connection strength between the connecting segment and the main body segment is strengthened with fewer additional structures, thereby improving the synchronicity of the expansion of the main body segment and the connecting segment.

[0016] Optionally, the connecting frame is provided with connecting rods, two adjacent connecting rods intersect at the ends away from the connecting frame, and the intersecting ends of the two connecting rods are provided with extension rods, which are connected to the main body segment.

[0017] Through the above technical solution, the connecting rod and the extension rod work together to further improve the connection strength between the main body segment and the connecting segment. At the same time, the intersection of the connecting rod and the setting of the extension rod make the independent area between the connecting segment and the main body segment more uniform, so as to improve the overall expansion constraint of the balloon.

[0018] Optionally, the main body segment includes: a plurality of constraint rods fixed to the outer surface of the balloon and spaced apart circumferentially along the balloon, the constraint rods extending along the axial direction of the balloon; wherein, a plurality of connecting rods are provided between adjacent constraint rods, the plurality of connecting rods are spaced apart along the axial direction of the constraint rods, and the plurality of connecting rods and the plurality of constraint rods enclose a plurality of evenly distributed independent spaces for the balloon to enter.

[0019] With the above technical solution, as the balloon expands, the restraint rod and connecting rod gradually expand synchronously, and the independent space gradually increases. After the balloon expands to the nominal pressure, the surface of the balloon will extend into the independent space, thereby achieving restraint on the balloon expansion and reducing the possibility of damage to blood vessels.

[0020] Optionally, the connecting rod is a retractable wave rod.

[0021] Through the above technical solution, the wave bar can generate corresponding deformation when it expands, so as to gradually generate a corresponding expansion trend with the expansion of the balloon until the wave bar straightens. Then, it contracts and returns to its original position as the balloon retracts, thereby improving the degree of constraint on the balloon and also improving the mobility of the balloon in the body.

[0022] Optionally, the constraint rod has an annular protrusion adapted to the balloon; and / or the constraint rod has a retractable wavy protrusion.

[0023] Through the above technical solution, the annular protrusions allow the restraint rod to better constrain the balloon, thus limiting the torsion generated during balloon expansion and further reducing the possibility of damage to the blood vessel wall. The wavy protrusions, on the other hand, allow the restraint rod to expand and contract with the balloon expansion, offsetting the expansion and contraction caused by the expansion of the main segment.

[0024] The present invention also provides a balloon catheter comprising: a balloon restraint stent as described in any of the preceding claims; and a balloon disposed within the balloon restraint stent.

[0025] The beneficial effects of this invention are:

[0026] When constraining balloon expansion, the main constraint structure is divided into three segments: the main segment and connecting segments at both ends of the main segment. The connecting segments not only securely connect the main segment to the first and second fixation segments, thus fixing the main segment to the balloon, but also enhance the radial strength at both ends of the main segment, increasing the pressure at both ends. This allows the main segment to constrain the middle portion of the balloon after expansion, while the connecting segments effectively constrain the balloon's sides. Consequently, after expansion, the balloon's outer surface maintains a cylindrical shape, effectively reducing the likelihood of the "dog bone effect" and thus minimizing damage to the blood vessel wall, improving surgical precision and success rate. Attached Figure Description

[0027] Figure 1 The diagram shown is a schematic diagram of the deployment structure of the balloon-constrained stent in some embodiments of the present invention.

[0028] Figure 2 The diagram shown is a schematic diagram of the balloon-constrained catheter after expansion in some embodiments of the present invention.

[0029] Figure 3 The diagram shown is a structural schematic of the extension ring of the balloon-constrained stent in some embodiments of the present invention.

[0030] Figure 4 The diagram shown is a structural schematic of the connecting rod and extension rod of the balloon restraint stent in some embodiments of the present invention.

[0031] Figure 5 The diagram shown is a structural schematic of the constraint rod of the balloon-constrained stent in some embodiments of the present invention.

[0032] Figure 6 The image shown is a cross-sectional view of the balloon in a balloon-constrained stent according to some embodiments of the present invention.

[0033] Figure 7 The diagram shown is a schematic diagram of the balloon catheter structure according to some embodiments of the present invention.

[0034] In the picture:

[0035] 100, First fixed section; 200, Second fixed section; 300, Main body section; 310, Independent space; 320, Extension ring; 330, Connecting rod; 340, Extension rod; 350, Constraint rod; 351, Annular protrusion; 360, Connecting rod; 400, Connecting section; 410, Connecting frame; 500, Balloon. Detailed Implementation

[0036] The present invention will now be described in further detail with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and not intended to limit it. Furthermore, it should be noted that, for ease of description, the accompanying drawings show only the parts relevant to the present invention, and not all of the structures.

[0037] In the description of this invention, unless otherwise explicitly specified and limited, the terms "connected," "linked," and "fixed" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0038] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0039] In the description of this embodiment, the terms "upper," "lower," "right," etc., refer to the orientation or positional relationship shown in the accompanying drawings. They are used only for ease of description and simplification of operation, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the present invention. In addition, the terms "first" and "second" are used only for distinction in description and have no special meaning.

[0040] For cardiovascular diseases, balloon angioplasty is one of the most commonly used treatments. Traditional balloon catheters are made with balloons of different diameters and lengths depending on the size of the patient's blood vessels and the length of the lesion. After inflation, the balloon becomes cylindrical to support the blood vessel wall. Its working principle is as follows: using a delivery system, a balloon-dilatation catheter is placed at the lesion site. After inflation, the balloon expands and compresses the blood vessel wall, causing the blood vessel to return to its original shape, thus widening the lumen.

[0041] Traditional balloon angioplasty is often accompanied by vascular damage. For example, during balloon inflation, the proximal and distal diameters of the balloon are larger than the central diameter (the "dog bone effect"), leading to excessive expansion of the vessel walls at both ends. This causes damage to the vessel walls and accelerates longitudinal elongation of the balloon, potentially resulting in vascular dissection. It can also trigger acute vascular occlusion at the lesion site and postoperative restenosis. Vascular dissection, acute vascular occlusion, and vessel wall damage are all serious vascular traumas, and their formation is closely related to the mechanism of action of traditional balloon angioplasty.

[0042] Traditional balloon angioplasty has many causes of vascular damage, and therefore is often used as an initial treatment for cardiovascular diseases, followed by the implantation of bare-metal stents or drug-eluting stents. Although bare-metal stents and drug-eluting stents have been proven to have better patency rates than balloon angioplasty, there are still adverse clinical outcomes with long-term implantation and late-stage restenosis, especially in the lower limb arteries where the dynamic stress on the stent may lead to stent fracture or in-stent restenosis.

[0043] The mechanism of action of traditional balloon catheters involves the shear force exerted on the blood vessel wall by the twisting of the folded balloon during inflation. Due to the limitations of structure and materials of traditional balloons, as well as the morphological differences and anisotropy of vascular lesion sites, "dog bone effect" can easily occur during use, causing further trauma to the blood vessel and damage to blood vessels in non-lesion areas.

[0044] The balloon-constrained stent and balloon catheter provided by this invention divide the main constraining part of the stent into three segments: the main body segment and two connecting segments respectively located at both ends of the main body segment. The connecting segments are fixedly connected to the main body segment stent. By setting the connecting segments, the radial strength at both ends of the main body segment is increased, which in turn increases the pressure at both ends of the main body segment, thereby preventing the balloon ends from having an excessively large diameter during expansion and effectively preventing the "dog bone effect". Moreover, the connecting segments are constructed of rhomboid blocks, which have better retraction performance and facilitate the decompression and retraction of the balloon catheter, improving the mobility of the balloon catheter in the body. The connecting segments are also connected to the main body segment through rhomboid structures, single rods, or double rods, which not only improves the connection strength between the connecting segments and the main body segment, but also divides the overall constrained area into multiple small blocks of uniform area, improving the degree of constraint on the balloon. Appropriate protrusions can also be set on the main body segment according to the shape of the balloon to constrain the torsion generated by the balloon during expansion, further reducing the possibility of the balloon causing damage to blood vessels. When performing angioplasty using this balloon catheter, the possibility of the "dog bone effect" can be effectively reduced. It is also easy to move within the body to facilitate the insertion or withdrawal of the balloon catheter. At the same time, by restricting the direction of balloon expansion, the possibility of balloon damage to blood vessels can be reduced, thereby effectively improving the precision and success rate of the surgery.

[0045] After briefly introducing the implementation principle of the present invention, the various embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

[0046] Figure 1 The diagram shown is a schematic representation of the deployment structure of the balloon-constrained stent in some embodiments of the present invention. (Refer to...) Figure 1 As shown, the balloon restraint stent specifically includes: a first fixing segment 100, a second fixing segment 200, and a main body segment 300. The first fixing segment 100 is used for fixed connection to a first end of the balloon. The second fixing segment 200 is used for fixed connection to a second end of the balloon. The main body segment 300 is located between the first fixing segment 100 and the second fixing segment 200 and is sleeved in the middle of the balloon. Connecting segments 400 are provided on both sides of the main body segment 300 along the balloon's axial direction. The two connecting segments 400 are located near both ends of the balloon and are fixedly connected to the first fixing segment 100 and the second fixing segment 200, respectively. The connecting segments 400 are used to restrain the expansion of the balloon on both sides of the main body segment 300.

[0047] Specifically, the stent is a ring-shaped device fitted around the outer surface of the balloon. Its first fixing section 100 includes multiple wave-shaped fixing rods extending along the balloon's axis. The end of each fixing rod near the main body section 300 is fixedly connected to the connecting section 400. Each fixing rod can be constructed by sequentially connecting multiple arc-shaped rods to form peaks and troughs on each rod, with the peaks of adjacent fixing rods connecting together. Each fixing rod can have one peak or two symmetrical peaks. The specific shape of the fixing rod can be designed according to the actual application scenario, and this invention does not limit this. The fixing rods are fixed to the balloon by adhesive application, requiring only a small amount of glue for fixation, resulting in minimal glue adhesion and minimal space occupation, thus not affecting the overall mobility of the balloon catheter. The second fixing section 200 has the same structure as the first fixing section 100 and will not be described further here.

[0048] Reference Figure 1 As shown, the main body segment 300 can have a mesh-like structure, with multiple uniformly sized independent spaces 310 formed on its surface. These independent spaces 310 can be square, rectangular, rhomboid, or other shapes. The connecting segment 400 also has multiple corresponding independent spaces 310 inside, which are inserted into the outer surface of the balloon after inflation. The connecting segment 400 is annularly fitted onto the outer surface of the balloon, positioned near both ends. The connecting segment 400 and the main body segment 300 can be fixedly connected by multiple rods. The connecting segment 400 can have only one row or multiple rows; the specific number of rows can be designed according to the actual balloon size, and this invention does not limit this. The main body segment 300 and the connecting segment 400 are located between the radiopaque markings of the balloon.

[0049] By setting up the aforementioned stent, during balloon dilation, the main body segment 300 can constrain the middle part of the balloon, while the two connecting segments 400 can increase the radial strength on both sides of the main body segment 300, thereby increasing the pressure at both ends of the main body segment 300 to constrain both ends of the balloon. As a result, after balloon dilation is completed, the balloon as a whole can maintain its cylindrical shape, reducing the possibility of dog bone effect, lowering the possibility of damage to the blood vessel wall, and improving the precision and success rate of the surgery.

[0050] Figure 2 The diagram shown is a schematic representation of the balloon-constrained catheter after expansion in some embodiments of the present invention. (Refer to...) Figure 2 As shown, in some embodiments of the present invention, multiple connecting segments 400 are provided, and the multiple connecting segments 400 are sequentially connected and distributed along the axial direction of the balloon.

[0051] Specifically, the connecting segment 400 is disposed between the main body segment 300 and the first fixed segment 100 or the main body segment 300 and the second fixed segment 200. The specific number of connecting segments 400 can be designed according to the actual size and shape of the balloon. For example, two connecting segments 400 can be disposed on each side of the main body segment 300, or one on each side, or one connecting segment 400 can be disposed on one side and two connecting segments 400 on the other side. The number of connecting segments 400 can be from 1 to 3, and the specific number can be designed according to the pressure required on both sides of the main body segment 300. In this embodiment of the invention, one connecting segment 400 is disposed between the first fixed segment 100 and the main body segment 300, and two connecting segments 400 are disposed between the second fixed segment 200 and the main body segment 300. By setting different numbers of connecting segments 400, the pressure on both sides of the main body segment 300 is different, so as to adapt to balloons of different sizes and models, so that the balloon maintains a cylindrical shape after expansion.

[0052] Reference Figure 1 and Figure 2 As shown, in some embodiments of the present invention, the connecting segment 400 includes a plurality of connecting frames 410, which are sequentially connected and arranged around the circumference of the balloon. The space inside the connecting frame 410 can expand as the balloon expands, and the total expansion amplitude of the plurality of connecting frames 410 is consistent with the expansion amplitude of the main body segment 300.

[0053] Specifically, the connecting frame 410 can be polygonal, such as a quadrilateral or hexagon. The top and bottom vertices of the connecting frame 410 are used to connect end-to-end with adjacent connecting frames 410, while the left and right vertices of the connecting frame 410 are used to connect with the main body segment 300 and the first fixed segment 100 or the second fixed segment 200. When there are two or more connecting segments 400, the left and right vertices of the connecting frame 410 can connect with the left and right vertices of adjacent connecting frames 410. The distance between the top and bottom vertices and the left and right vertices of the connecting frame 410 can change as the balloon expands. For example, when the balloon expands, the top and bottom vertices of the connecting frame 410 will separate from each other, while the left and right vertices of the connecting frame 410 will move closer to each other. The overall expansion range of the multiple connecting frames 410 is consistent with the expansion range of the main body segment 300, that is, the sum of the distances between the top and bottom vertices of all the expanding connecting frames 410 is the same as the distance between the top and bottom sides of the expanding main body segment 300. The number of connecting frames 410 included in each connecting segment 400 can be designed according to the size and model of the balloon, and can be three, four, or five, etc., and the present invention does not make a specific limitation. In an embodiment of the present invention, the connecting segment 400 includes four connecting frames 410.

[0054] During balloon inflation, the balloon compresses multiple connecting frames 410, which expand simultaneously with the main body segment 300. The expansion amplitude of the connecting frame 400 is always the same as that of the main body segment 300, thereby constraining both ends of the balloon and effectively reducing the occurrence of the dog bone effect.

[0055] In some embodiments of the present invention, the connecting frame 410 has a rhomboid structure. Specifically, the connecting frame 410 is formed by four rods connected end to end to enclose a rhomboid structure. The top and bottom vertices of this rhomboid structure are located on the same vertical line, while the left and right vertices are located on the same horizontal line. When the balloon is in the contracted state, the rhomboid structure is elongated, meaning the distance between the top and bottom vertices is the smallest, and the distance between the left and right vertices is the largest. When the balloon expands, the rhomboid structure becomes square, and the four rods are perpendicular to each other, thus providing sufficient constraint on both ends of the balloon and avoiding the "dog bone effect." When the balloon contracts, the connecting frame 410 also contracts, reducing the overall space it occupies, thereby enabling the balloon to have better delivery performance.

[0056] Figure 3 The diagram shown is a structural schematic of the extension ring of the balloon-constrained stent in some embodiments of the present invention. (Refer to...) Figure 3 As shown, in some embodiments of the present invention, an extension ring 320 is provided between the extended ends of two adjacent connecting frames 410, and the side of the extension ring 320 away from the connecting frame 410 is connected to the main body segment 300.

[0057] When the upper and lower sides of the connecting segment 400 are connected to the upper and lower sides of the main body segment 300, the connection between the middle part of the connecting segment 400 and the main body segment 300 is relatively weak. The extension ring 320 is located between the two connection points of the connecting segment 400 and the main body segment 300. In this embodiment of the invention, four connecting frames 410 are provided. The middle part of the connecting segment 400 near the second fixed segment 200 is also connected to the main body segment 300, so there are three connection points between the connecting segment 400 and the main body segment 300. An extension ring 320 is provided between two adjacent connection points.

[0058] Specifically, the extension ring 320 can be semi-circular, such as half a rhombus. Both ends of the extension ring 320 can be fixedly connected to the protruding ends of two adjacent connecting frames 410, with the protruding ends of the connecting frames 410 referring to the apex of the rhombus structure near the main body segment 300. Both ends of the extension ring 320 are bent, while the other end is arc-shaped and fixedly connected to the crest of the main body segment 300. Thus, as the balloon expands, the extension ring 320 can also undergo corresponding expansion deformation. It should be understood that the extension ring 320 can also be other shapes, such as elliptical, etc. This invention does not limit the specific shape of the extension ring 320. By setting the extension ring 320, the connection strength between the connecting frame 410 and the main body segment 300 can be improved, thereby increasing the overall connection strength between the connecting segment 400 and the main body segment 300, thus improving the constraint force on the balloon and further reducing the possibility of the "dog bone effect."

[0059] Figure 4 The diagram shown is a structural schematic of the connecting rod and extension rod of the balloon restraint stent in some embodiments of the present invention. (Refer to...) Figure 4 As shown, in some embodiments of the present invention, the connecting frame 410 is provided with a connecting rod 330 at one end near the main body segment 300, and the ends of two adjacent connecting rods 330 away from the connecting frame 410 can intersect each other. The intersecting ends of the two connecting rods 330 are provided with an extension rod 340, and the extension rod 340 is connected to the main body segment 300.

[0060] When the connection between the connecting segment 400 and the main body segment 300 is located in the middle of the connecting segment 400, two connection points can be provided in the connecting segment 400 to connect with the main body segment 300. The connecting rod 330 and the extension rod 340 are provided between the two connection points. In this embodiment of the invention, in the connecting segment 400 near the first fixed segment 100, four connecting frames 410 are provided and connected in a ring. There are four connection points between the four connecting frames 410. Therefore, the two connection points are distributed with one connection point between them. That is, there are two connecting frames 410 between the two connection points, and the two connecting rods 330 are provided on the two connecting frames 410.

[0061] Specifically, the ends of the two connecting rods 330 furthest from the connecting frame 410 are brought close to each other. For example, both connecting rods 330 can be straight rods, with one end intersecting by tilting them. Alternatively, the two connecting rods 330 can be wavy rods, with their ends furthest from the connecting frame 410 gradually approaching each other to create corresponding expansion deformation during balloon expansion. The shape of the connecting rods 330 can be designed according to the actual application scenario, and this invention does not limit it. The intersection of the two connecting rods 330 can be arc-shaped, and the extension rod 340 is set on the curved side of the arc and extends along the axis of the balloon. The other end of the extension rod 340 can connect to the trough of the main body segment 300.

[0062] The connection strength between the connecting section 400 and the main body section 300 is improved by the connecting rod 330 and the extension rod 340, thereby increasing the radial pressure on both sides of the main body section 300 and better constraining both ends of the balloon. Simultaneously, the connecting rod 330 and the extension rod 340 also create uniformly sized independent spaces 310, allowing the balloon's surface to extend into these spaces during inflation, further constraining the balloon.

[0063] Reference Figure 2 As shown, in some embodiments of the present invention, the main body segment 300 includes a plurality of constraint rods 350 and a plurality of connecting rods 360. The constraint rods 350 extend along the axial direction of the balloon and are fixed to the outer surface of the balloon, with the plurality of constraint rods 350 spaced apart circumferentially along the balloon. A plurality of connecting rods 360 are disposed between adjacent constraint rods 350, with the plurality of connecting rods 360 spaced apart along the axial direction of the constraint rods 350. The plurality of connecting rods 360 and the plurality of constraint rods 350 enclose a plurality of evenly distributed independent spaces 310, which the balloon can enter after expansion.

[0064] Specifically, the constraint rods 350 and connecting rods 360 are generally arranged in a crisscross pattern. When the balloon contracts, the connecting rods 360 are tilted, at which point the independent space 310 is parallelogram-shaped. When the balloon expands, the connecting rods 360 are vertical, and the independent space 310 is square-shaped. The tilt directions of two adjacent sets of connecting rods 360 distributed circumferentially can be opposite, and corresponding connecting rods 360 are connected together to create troughs and crests, facilitating expansion as the balloon expands.

[0065] The specific number of constraint rods 350 and connecting rods 360 can be set according to the size and model of the balloon, and this invention does not impose a specific limitation. It should be understood that the degree and direction of inclination of the connecting rods 360 can be designed according to the actual application scenario, and this invention does not impose a specific limitation. In this embodiment of the invention, five constraint rods 350 are provided. When the five constraint rods 350 are deployed, they form four rows of space for the installation of the connecting rods 360. Adjacent rows of connecting rods 360 can be in a "<" shape or a ">" shape. In this way, each column of connecting rods 330 will form corresponding peaks and troughs, and the constraint rods 350 can extend from the peaks or troughs to connect with the corresponding connecting segments 400.

[0066] When the balloon is constrained, as the balloon expands, the distance between the constraint rods 350 increases, the connecting rod 360 changes from an inclined state to a vertical state, the independent space 310 becomes square, and the connecting rod 360 can tighten the constraint rods 350 to compress the surface of the balloon, thereby constraining the expansion range of the balloon. The surface of the balloon will then protrude into the independent space 310, thus successfully constraining the expansion of the balloon.

[0067] In some embodiments of the present invention, the connecting rod 360 is a retractable wave-shaped rod. Specifically, the connecting rod 360 is generally wave-shaped; for example, curved portions can be provided at both ends of the connecting rod 360, or a wave shape can be formed in the middle of the connecting rod 360. In this way, when the balloon contracts, the connecting rod 360 maintains a wave shape, while when the balloon expands, the connecting rod 360 gradually stretches into a straight rod, thereby increasing the radial expansion range of the main body segment 300 to better meet surgical needs.

[0068] In some embodiments of the present invention, the constraint rod 350 has retractable wavy protrusions. Specifically, the constraint rod 350 is partially bent at intervals to form protrusions, and the multiple protrusions are distributed at intervals along the axial direction to form wavy protrusions. During balloon inflation, the constraint rod 350 can flatten the wavy protrusions, thereby counteracting the expansion and contraction during inflation and ensuring effective constraint on the balloon.

[0069] Figure 5 The diagram shown is a structural schematic of the constraint rod of the balloon-constrained stent in some embodiments of the present invention. Figure 6 The image shown is a cross-sectional view of the balloon in a balloon-constrained stent according to some embodiments of the present invention. (Refer to...) Figure 5 and Figure 6 As shown, in some embodiments of the present invention, the constraint rod 350 has an annular protrusion 351 adapted to the balloon 500. Specifically, the balloon 500 is folded during installation, so the balloon 500 expands and twists in a clockwise or counterclockwise direction during expansion. The orientation of the annular protrusion 351 is designed according to the expansion direction of the balloon 500, so that the balloon 500 is constrained by the annular protrusion during twisting, thereby reducing the torsional force generated by the balloon 500 during twisting and thus reducing damage to the blood vessel wall. For example, if the balloon 500 is folded clockwise, the annular protrusion 351 is arranged in an upwardly concave form; if the balloon 500 is folded counterclockwise, the annular protrusion 351 is arranged in a downwardly concave form.

[0070] It should be understood that the annular protrusion 351 and the wavy protrusion can be the same protrusion, that is, the wavy protrusion is also the annular protrusion 351. The annular protrusion 351 and the wavy protrusion can be different protrusions, that is, the two protrusions can be set separately. The specific design can be based on the actual application scenario, and the present invention does not limit it.

[0071] Figure 7 The diagram shown is a schematic representation of the balloon catheter according to some embodiments of the present invention. (Refer to...) Figure 7 As shown, this embodiment of the invention also discloses a balloon catheter. It includes a balloon restraint stent as described in any of the above embodiments and a balloon 500. The balloon 500 is disposed within the balloon restraint stent.

[0072] When performing angioplasty using this balloon catheter, the balloon-constrained stent effectively avoids the "dog bone effect" of the balloon, and the stent also has good retraction properties, allowing the balloon catheter to smoothly deflate and retract. This enables the angioplasty to be completed quickly and accurately, improving both surgical efficiency and success rate.

[0073] The balloon catheter described above has all the technical features of the balloon-constrained stent described above, and therefore the balloon catheter has all the technical effects of the balloon stent described above, which will not be repeated here.

[0074] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the implementation of the present invention. Those skilled in the art will be able to make various obvious changes, readjustments, and substitutions without departing from the scope of protection of the present invention. It is neither necessary nor possible to exhaustively describe all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the claims of the present invention.

Claims

1. A balloon-restrained stent, characterized in that, The balloon-constrained stent includes: The first fixed section (100) is used to connect to the first end of the balloon; The second fixed section (200) is used to connect to the second end of the balloon; The main body segment (300) is fitted onto the middle of the balloon to constrain the expansion of the balloon. Connecting segments (400) are provided on both sides of the main body segment (300). The side of each connecting segment (400) away from the main body segment (300) is connected to the first fixing segment (100) and the second fixing segment (200) respectively to constrain the expansion of the balloon on both sides of the main body segment (300). The connecting segment (400) includes: Multiple connecting frames (410) are sequentially connected and arranged around the circumference of the balloon. The internal space of each connecting frame (410) can expand as the balloon expands. The total expansion of the multiple connecting frames (410) is consistent with the expansion of the main body segment (300). Each connecting frame (410) has a rhomboid structure, which is formed by four rods connected end to end. The main body segment (300) includes: Multiple constraint rods (350) are fixed to the outer surface of the balloon and are spaced apart circumferentially along the balloon, the constraint rods (350) extending along the axial direction of the balloon; Among them, multiple connecting rods (360) are provided between adjacent constraint rods (350), and the multiple connecting rods (360) are distributed at intervals along the axial direction of the constraint rods (350). The multiple connecting rods (360) and the multiple constraint rods (350) enclose multiple evenly distributed independent spaces (310) for balloon insertion.

2. The balloon-constrained stent according to claim 1, characterized in that, Multiple connecting segments (400) are provided, and the multiple connecting segments (400) are sequentially connected and distributed along the axial direction of the balloon.

3. The balloon-constrained stent according to claim 1, characterized in that, An extension ring (320) is provided between the protruding ends of each two adjacent connecting frames (410), and the side of the extension ring (320) away from the connecting frame (410) is connected to the main body segment (300).

4. The balloon-constrained stent according to claim 1, characterized in that, The connecting frame (410) is provided with connecting rods (330), and the ends of two adjacent connecting rods (330) that are away from the connecting frame (410) intersect. The intersecting ends of the two connecting rods (330) are provided with extension rods (340), and the extension rods (340) are connected to the main body section (300).

5. The balloon-restrained stent according to claim 1, characterized in that, The connecting rod (360) is a retractable wave rod.

6. The balloon-restrained stent according to claim 1, characterized in that, The constraint rod (350) has an annular protrusion (351) adapted to the balloon; and / or The constraint rod (350) has a retractable wavy protrusion.

7. A balloon catheter, characterized in that, The balloon catheter includes: The balloon-stent as described in any one of claims 1 to 6; and A balloon is disposed within the balloon restraint stent.

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