Blade, cutting balloon and balloon catheter system

Abstract

The utility model provides a blade, a cutting balloon and a balloon catheter system. The blade comprises a cutting edge part and a cutter body part connected with the bottom of the cutting edge part. The blade part comprises a plurality of three-dimensional tooth block structures which are continuously arranged; the cutter body part comprises two fixed ends located at the two ends respectively and a middle part between the two fixed ends. The blade is high in cutting capacity for a diseased region, and the blade can be reliably fixed on the main body. The sacculus body of the cutting sacculus provided with the blade is provided with the groove, the blade is provided with the continuous cutting edge portion of the three-dimensional tooth block structure, the flexibility and cutting force of the cutting sacculus are enhanced, the turning performance of the cutting sacculus in a blood vessel and the cutting performance of the sacculus on lesion are improved, the blade is fixed to the groove through the blade body portion, and the cutting sacculus is fixed to the blade body portion. And the probability that the cutting balloon slips and is nested in plaques during cutting is greatly reduced.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, and particularly to a blade, a cutting balloon and a balloon catheter system. Background Art

[0002] In the traditional technology of interventional minimally invasive treatment for vascular calcification, generally a scoring balloon or a common cutting balloon is used to destroy plaques, so as to expand the cross-section that can pass through the blood vessel to achieve the treatment effect of keeping the blood vessel unobstructed. The structure of the scoring wire on the scoring balloon uses a helical unwinding motion for expansion and deformation. When the length of the balloon is relatively long, it is very difficult for the helical unwinding motion to proceed regularly, and it is quite difficult to recover in a complex helix. When the expansion multiple is relatively large, the number of turns of the helical unwinding motion is relatively large, and the risk of irregular expansion increases, and there is a high risk of cutting off the intima to cause thrombosis. When the length of the balloon increases, the passing performance of the balloon will be relatively low. The existing scoring balloons are very likely to have the scoring wire cut and slide, resulting in dissection. The structure of the blade of the traditional cutting balloon has an unclear cutting effect on fibrotic lesions, and at the same time, the structure of the blade will reduce the passing performance and bending performance of the balloon in the blood vessel. Therefore, it is urgent to develop a cutting balloon that can effectively destroy calcified tissues in blood vessels. Summary of the Utility Model

[0003] Aiming at the problems in the prior art, the purpose of the utility model is to provide a blade, a cutting balloon and a balloon catheter system. The blade of the cutting balloon has a blade part with a continuous three-dimensional tooth block structure, which enhances the flexibility and cutting force of the cutting balloon, improves its bending performance in blood vessels and the cutting performance of the balloon on lesions. The method of setting grooves on the balloon body to fix the blade greatly reduces the passing outer diameter after the balloon is folded, which is beneficial to improving the passing performance of the product in blood vessels, can avoid scratching healthy blood vessels during the process of introducing the lesion, and the special blade fixing method is also beneficial to increasing the flexibility of the cutting balloon, and can effectively improve the bending and recovery performance of the cutting balloon; at the same time, the cutting balloon design provided by the utility model can also reduce the height of the blade relative to the balloon surface, and the special blade design can maintain a good or even better cutting effect. At the same time, the blade part with a saw-like three-dimensional tooth block structure greatly reduces the probability of the cutting balloon slipping and nesting in plaques during cutting.

[0004] The first aspect of the utility model provides a blade, which comprises a blade part and a tool body part connected to the bottom of the blade part;

[0005] The blade part comprises a plurality of continuously arranged three-dimensional tooth block structures;

[0006] The tool body part comprises two fixed ends respectively located at both ends and an intermediate part between the two fixed ends.

[0007] According to the first aspect of the present utility model, the middle part includes a plurality of pores arranged at intervals.

[0008] According to the first aspect of the present utility model, the middle part is provided with a plurality of inverted T-shaped support parts. The support part includes a support rod and a support base. Two ends of the support rod are respectively connected to the bottom of the blade part and the support base; and / or,

[0009] The longitudinal section at the connection between the bottom of the blade part and the support rod is arc-shaped; and / or,

[0010] Both ends of the support base are respectively provided with convex structures pointing to the blade part.

[0011] According to the first aspect of the present utility model, the angle between the side surface of at least one end of the three-dimensional tooth block structure of the blade part close to the adjacent fixed end and the plane where the support base is located is greater than or equal to 145°; and / or,

[0012] The side surface of at least one end of the three-dimensional tooth block structure of the blade part far from the adjacent fixed end is perpendicular to the plane where the support base is located.

[0013] According to the first aspect of the present utility model, the heights of the plurality of three-dimensional tooth block structures of the blade part are different.

[0014] The second aspect of the present utility model provides a cutting balloon, which includes a balloon body and at least one of the blades;

[0015] At least one groove is provided on the outer surface of the balloon body;

[0016] The blade is mounted in the groove through the blade body part.

[0017] According to the second aspect of the present utility model, the central axis of the blade body part is parallel to the central axis of the balloon body; and / or,

[0018] The central axis of the blade part is parallel to the central axis of the blade body part.

[0019] According to the second aspect of the present utility model, covering structures covering the fixed ends are respectively provided at both ends of the groove, and the blade body part of the blade is clamped in the groove.

[0020] According to the second aspect of the present utility model, at least two of the grooves are evenly distributed along the circumferential direction of the balloon body; or

[0021] At least two of the grooves are arranged in an array along the circumferential direction of the balloon body.

[0022] According to the second aspect of the present utility model, the fixed end includes a sheet-like structure extending along the plane where the support base is located, and the width of the sheet-like structure gradually increases from near the middle part to away from the middle part.

[0023] A third aspect of the present utility model provides a balloon catheter system, including a distal catheter, the cutting balloon, and a proximal catheter connected in sequence.

[0024] According to the third aspect of the present utility model, the balloon catheter system further includes a delivery unit, the delivery unit includes an inner lumen tube, and a delivery seat, a push rod, a proximal outer tube, and a distal outer tube connected in sequence, and the inner lumen tube penetrates through the balloon body;

[0025] The proximal catheter is connected to the distal end of the distal outer tube;

[0026] At least one reinforcing wire is provided at the distal end of the push rod, and the reinforcing wire extends from the proximal outer tube to the distal outer tube.

[0027] According to the third aspect of the present utility model, the reinforcing wire includes a first part connected to the distal outer tube and a second part connected to the proximal outer tube, and the radial dimension of the reinforcing wire gradually increases along the direction from the first part to the second part.

[0028] According to the third aspect of the present utility model, a spiral groove is provided on the surface of the second part.

[0029] According to the third aspect of the present utility model, the first part is an arc cone structure.

[0030] The blade body part of the blade of the present utility model has two fixed ends, which can conveniently realize the fixation with the main body and improve the fixation stability; the blade also includes a blade edge part provided with a continuous three-dimensional tooth block structure, which improves the cutting ability of the blade on the lesion site and can also reduce the possibility of the blade nesting with the lesion site. The balloon body of the cutting balloon of the present utility model is provided with a groove, and the blade is fixed to the groove through the blade body part, which enhances the flexibility and cutting force of the cutting balloon, improves the bending performance of the cutting balloon in the blood vessel and the cutting performance of the balloon on the lesion, and greatly reduces the probability of the cutting balloon slipping and nesting in the plaque during cutting. The balloon catheter system of the present utility model has good cutting performance and a low failure probability. Description of the Drawings

[0031] The accompanying drawings here are incorporated into the specification and form a part of this specification, showing embodiments consistent with this application, and are used together with the specification to explain the concept of this application. By reading the detailed description of the non-limiting embodiments with reference to the following drawings, other features, objectives, and advantages of the present utility model will become more apparent. Obviously, the drawings in the following description are only some embodiments of the present utility model. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts. In addition, the drawings are only schematic diagrams of the present disclosure and are not necessarily drawn to scale. The same reference numerals in the drawings represent the same or similar parts, and thus repeated descriptions thereof will be omitted. Some of the block diagrams shown in the drawings are functional entities and do not necessarily correspond to physically or logically independent entities.

[0032] Figure 1 Schematic perspective view of a blade according to an embodiment of the present utility model;

[0033] Figure 2 is Figure 1 Cross-sectional view of the blade of the embodiment;

[0034] Figure 3 is Figure 1 Top view of the blade of the embodiment;

[0035] Figure 4 is Figure 1 Side view of the blade of the embodiment;

[0036] Figure 5 and Figure 6 Schematic perspective view and cross-sectional view of a blade according to another embodiment of the present utility model respectively;

[0037] Figure 7 Schematic diagram of the structure of a cutting balloon according to an embodiment of the present utility model;

[0038] Figure 8 and Figure 9 Schematic diagram of the structure and side view of a cutting balloon in a contracted state according to an embodiment of the present utility model respectively;

[0039] Figure 10 Schematic diagram of the structure of a cutting balloon system according to an embodiment of the present utility model; and

[0040] Figure 11 and Figure 12 Schematic diagrams of the reinforcing wire from different perspectives according to an embodiment of the present utility model respectively. Detailed implementation manners

[0041] Example embodiments will now be described more fully with reference to the accompanying drawings. However, the example embodiments can be implemented in various forms and should not be construed as limited to the examples set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the concept of example embodiments to those skilled in the art. The features, structures, or characteristics described may be combined in any suitable manner in one or more embodiments.

[0042] In the descriptions given herein, the representation of reference terms such as "one embodiment", "some embodiments", "example", "specific example", or "some examples", etc. means that the specific features, structures, materials, or characteristics represented in connection with the embodiment or example are included in at least one embodiment or example of this specification. Moreover, the specific features, structures, materials, or characteristics represented may be combined in any suitable manner in any one or more embodiments or examples. In addition, without contradiction, those skilled in the art can combine and combine the different embodiments or examples represented in this specification and the features of different embodiments or examples.

[0043] Although in some instances the terms first, second, etc. are used herein to denote different solutions, these solutions should not be limited by these terms. These terms are only used to distinguish one solution from another. For example, the first solution and the second solution, etc. are indicated. Furthermore, as used herein, the singular forms "a", "an", and "the" are also intended to include the plural forms unless the context indicates otherwise. It should be further understood that the terms "comprising", "including" indicate the presence of the stated features, steps, operations, elements, components, items, kinds, and / or groups, but do not exclude the presence, occurrence, or addition of one or more other features, steps, operations, elements, components, items, kinds, and / or groups. The terms "or" and "and / or" used herein are interpreted as inclusive, or meaning any one or any combination. Thus, "A, B, or C" or "A, B, and / or C" means "any one of the following: A; B; C; A and B; A and C; B and C; A, B, and C". An exception to this definition only occurs when the combination of elements, functions, steps, or operations is inherently mutually exclusive in some way.

[0044] Although not fully defined, including the technical terms and scientific terms used herein, all terms have the same meaning as generally understood by those skilled in the art to which this specification pertains. Terms defined in commonly used dictionaries are additionally interpreted to have a meaning consistent with the relevant technical literature and the content presented herein. As long as they are not defined, they should not be over-interpreted as ideal or overly formulaic meanings.

[0045] In traditional techniques, in order to treat vascular calcification, interventional minimally invasive treatment is adopted. Special balloons such as scoring balloons or cutting balloons are used to break plaques and dilate blood vessels to achieve the treatment effect of keeping blood vessels unobstructed. The cutting balloon installs a micro blade on the balloon and uses balloon dilation to prompt the blade to complete the cutting action of the plaque. The scoring balloon installs a deformable metal mesh on the balloon surface and uses balloon dilation to expand the metal mesh, thereby forcing the metal mesh to squeeze and damage the blood vessel plaque. The structure of the blade of the traditional cutting balloon has an insignificant cutting effect on fibrotic lesions, and at the same time, the structure of the blade will reduce the passing performance and bending performance of the balloon in the blood vessel. The structure of the scoring wire on the existing scoring balloon uses a de-spiraling motion for expansion and deformation. When the balloon length is relatively long, it is difficult for the de-spiraling motion to proceed regularly, and it is more difficult to recover in a complex spiral manner. When the deformation expansion multiple is relatively large, the number of de-spiraling motion turns is relatively large, and the risk of irregular expansion will increase, and there is a high risk of cutting off the intima to cause thrombosis. When the balloon length increases, the passing performance of the balloon will be relatively low. The existing scoring balloon is prone to scoring wire cutting and sliding, resulting in dissection.

[0046] The traditional cutting balloon (the blade edge of which is macroscopically linearly continuous) and the serrated balloon (the blade edge of which is macroscopically discontinuous) also have the following problems: 1. The blade and the balloon are connected through a base. This connection method results in a relatively high height of the blade relative to the balloon surface, which is likely to scratch the blood vessel during the process of introducing the lesion, and the diameter of the balloon in the contracted state is usually relatively large; 2. Compared with the point contact between the blade edge of the serrated balloon and the plaque in the blood vessel, the blade edge of the cutting balloon is extremely prone to the risk of being stuck in the plaque and unable to be withdrawn (the top of the blade edge is in continuous line or surface contact with the plaque tissue); 3. Compared with the ordinary blade, the proportion of the blade edge height in the serrated blade is larger, and the same level of cutting effect on the plaque in the blood vessel can be achieved with a lower blade height; 4. The width of the contact surface between the blade and the balloon is the same. This kind of blade has relatively poor passing performance in the blood vessel, specifically manifested as relatively poor bending and recovery performance.

[0047] In view of the existing technical problems, the present utility model provides a blade, a cutting balloon and a balloon catheter system. The blade includes a blade edge part and a blade body part connected to the bottom of the blade edge part; the blade edge part includes a plurality of continuously arranged three-dimensional tooth block structures; the blade body part includes two fixed ends located at both ends and an intermediate part between the two fixed ends. For the cutting balloon provided with the blade of the present utility model, its balloon body is provided with a groove, and the blade edge part of the blade is provided with a continuous three-dimensional tooth block structure, which enhances the flexibility and cutting force of the cutting balloon, improves the bending performance of the cutting balloon in the blood vessel and the cutting performance of the balloon on the lesion. The blade is fixed to the groove through the blade body part, greatly reducing the probability of the cutting balloon slipping and being nested in the plaque during cutting.

[0048] The following further elaborates on the structures of the blade, cutting balloon, and balloon catheter system of the present utility model in conjunction with the accompanying drawings and specific embodiments. It can be understood that each specific embodiment does not limit the protection scope of the present utility model.

[0049] Figures 1 to 4 They are respectively structural schematic diagrams of the blade of an embodiment of the present utility model from different perspectives. Figure 1 The three-dimensional structure diagram shows that the blade 2 is strip-shaped. The blade 2 includes a cutting edge portion 21 and a blade body portion connected to the bottom of the cutting edge portion 21. The cutting edge portion 21 includes a plurality of continuous three-dimensional tooth block structures. Since the three-dimensional tooth block structures at both ends are slightly different from the three-dimensional tooth block structures between the two ends, the three-dimensional tooth block structures 212 at both ends and the three-dimensional tooth block structures 211 between the two ends are respectively marked here. The blade body portion of this blade has two fixed ends, which can conveniently realize the fixation with the main body and improve the stability of the fixation. The blade also includes a cutting edge portion provided with continuous three-dimensional tooth block structures, which improves the cutting ability of the blade for the lesion site and at the same time reduces the possibility of nesting with the lesion site. As Figure 1 shown, a single three-dimensional tooth block structure 211 is a pentahedron similar to a pyramid structure. A plurality of three-dimensional tooth block structures 211 are arranged. The continuity means that the bottoms of the plurality of three-dimensional tooth block structures 211 are connected and form a continuous structure. In this embodiment, the heights of the plurality of three-dimensional tooth block structures 211 are the same, as shown in Figure 2 . The surface C at the end is the actual working surface of the cutting edge. The surface C at the end can be designed as an arc-shaped cutting edge, as shown in Figure 2 . From Figure 3 the top view of this blade, it can be seen that the surfaces C at the ends of the plurality of three-dimensional tooth block structures are arranged along the dotted line. In the Figure 4 side view, it is shown as the vertices at the ends. That is, the cutting edges of the blade of the present utility model are discontinuous. The connection at the bottom between two adjacent three-dimensional tooth block structures 211 can be designed as an arc chamfer R. The cutting edge portion with the above structure ensures that the whole blade can be easily bent, thus ensuring the bending performance of the whole product.

[0050] The blade body part includes two fixed ends 22 located at both ends respectively and an intermediate part 23 between the two fixed ends 22. Preferably, the blade 2 is made of a metal material with memory function and superelasticity, and other metals or non-metallic materials can also be used. After the above balloon body is assembled with multiple blades, the cutting pressure of the cutting balloon is ensured, and at the same time, the risk of the blade embedding into the diseased tissue is reduced. During the use of the cutting balloon, the three-dimensional tooth block structure embedding in the disease can prevent the balloon body from sliding. The arc-shaped blade edge ensures that the contact area between the blade and the disease is smaller, and a greater cutting pressure can be generated under the same balloon inflation pressure, so as to have a better cutting effect, effectively reducing the working pressure when opening the disease and reducing the risk of accidental injury to the human body and the balloon body during the use process. Arc chamfers are designed in the grooves between the three-dimensional tooth block structures to ensure the structural strength of a single three-dimensional tooth block structure.

[0051] In order to further improve the bending performance of the overall blade, the intermediate part 23 of the blade body part includes a plurality of spaced pores, that is, the intermediate part 23 can be designed to be discontinuous. This pore design does not affect the combination of the blade and the surface of the balloon body, and is beneficial to reducing the resistance during the blade bending process, increasing the bendability and flexibility of the overall blade, and thus improving the passing performance of the cutting balloon in the blood vessel. As Figures 1 to 4 In the embodiment of, the intermediate part 23 can be provided with a plurality of inverted T-shaped support parts 231. The support part 231 includes a support rod and a support base. The two ends of the support rod are respectively connected to the bottom of the blade edge part and the support base; the bottoms of the support bases of the plurality of support parts 231 are on the same plane, which is convenient for this part to fit with the groove on the balloon body. The longitudinal section at the connection of the bottom of the blade edge part and the support rod is arc-shaped. Here, the longitudinal section is a plane parallel to the central axis of the blade, rather than a plane perpendicular to the central axis of the blade or along the central axis direction of the blade. The support base and the bottom of the blade edge part are U-shaped; convex structures 2311 pointing to the blade edge part are respectively arranged at both ends of the support base. The support base provided with the convex structures 2311 is similar to a claw-type structure, which ensures the firmness after the blade and the balloon body are assembled.

[0052] In some embodiments, the structures of the three-dimensional tooth block structures 212 at both ends of the blade edge part 21 are slightly different from those of the three-dimensional tooth block structures 211 in the middle part, such as Figure 2As shown, the angle θ between one side surface of the three-dimensional tooth block structure 212 at at least one end of the blade portion 21, which is close to the adjacent fixed end 22, and the plane where the support base is located is greater than or equal to 145°. The plane where the support base is located is the tangent plane at the outer surface where the support base is connected to the balloon body. One side surface of the three-dimensional tooth block structure 212 at at least one end of the blade portion 21, which is far from the adjacent fixed end 22, is perpendicular to the plane where the support base is located, that is, β is ~90°. The angle θ being greater than or equal to 145° makes the slopes of the inclined surfaces on both sides where the three-dimensional tooth block structures at both ends are close to relatively gentle, and the above-mentioned relatively gentle inclined surface slopes extend and connect to the fixed end 22 of the blade body portion connection section. The special design of the three-dimensional tooth block structures at both ends of the blade portion can reduce the risk of jamming during the use of the blade.

[0053] Figure 5 and Figure 6 are respectively the three-dimensional structure schematic diagram and cross-sectional view of the blade 2' of another embodiment of the present utility model. In this embodiment, the three-dimensional tooth block structures 212' at both ends of the blade portion and the three-dimensional tooth block structure between the two ends Figure 1 are slightly different from the structure in the embodiment. The three-dimensional tooth block structure between the two ends includes three-dimensional tooth block structures 211a' and three-dimensional tooth block structures 211b' with different heights. The height here is the maximum distance between the tip of the three-dimensional tooth block structure and the plane where the support base is located. The angle θ' between one side surface of the three-dimensional tooth block structure 212' at the end of the blade portion 21, which is close to the fixed end 22', and the plane where the support base is located is greater than or equal to 145°. The angle between one side surface of the three-dimensional tooth block structure 212' at the end of the blade portion 21', which is far from the fixed end 22', and the plane where the support base is located is β'. In this embodiment, the angle β' is greater than 90°. In this embodiment, the middle portion 23' can also be provided with a plurality of inverted T-shaped support portions 231'. The support portion includes a support rod connected to the blade portion and a support base; the cross-section of the connection between the bottom of the blade portion and the support rod is arc-shaped, and the support base and the bottom of the blade portion are U-shaped.

[0054] Figure 7Structural schematic diagram of a cutting balloon according to an embodiment of the present utility model (the blade is not shown in the figure). The cutting balloon includes a balloon body 1. The balloon body 1 has two states, namely a contracted state and an expanded state. At least one strip-shaped groove 11 is provided on the outer surface of the balloon body 1, and the groove 11 is used to accommodate or install the blade. The blade 2 can be installed in the groove 11 through the blade body part. Correspondingly, the structure of the groove 11 is adapted to the structure of the blade 2. It can be understood that the installation here refers to achieving the contact, assembly or fixation between the blade body part and the groove in a certain manner. In the present utility model, the assembly method of the balloon body and the blade is not limited. The blade can be installed by mechanical means (such as covering, bayonet and flange, etc.), can also be connected by chemical adhesives, and can also be installed, assembled or fixed on the balloon body by a variety of combined methods of mechanical, chemical adhesives and others (such as magnetic attraction, etc.). The cutting balloon includes at least one blade. In the present utility model, the number of blades is not limited and can be one or more blades. In the present utility model, the corresponding manner between the blade and the groove is also not limited. For example, a plurality of blades can be accommodated in one groove of the balloon body.

[0055] Taking Figure 1 the blade of the embodiment as an example, the fixed end of the blade body part is connected to the bottom of the blade edge part to ensure the overall stability of the blade with a plurality of body tooth block structures. Further, the fixed end 22 includes a sheet-like structure extending along the plane where the support base is located. In some embodiments, the width of the sheet-like structure gradually increases from the vicinity of the middle part to the part far from the middle part. Covering structures 111 covering the fixed end 22 are respectively provided at both ends of the groove 11. The balloon body 1 can be made of materials such as nylon (PA) or polyether block amide (PEBAX). The groove 11 and the covering structures 111 at both ends can be prepared during the hot blow molding process of the balloon body 1. The blade body part of the blade can be snapped or engaged into the groove 11. The fixed end 22 can ensure the firmness of the combination between the blade and the balloon body and the standing stability of the blade edge part.

[0056] The blade and the groove in the present utility model are strip-shaped, and a plurality of grooves 11 can be evenly distributed along the circumferential direction of the balloon body 1, that is, a row of a plurality of grooves are assembled on the balloon body. In some other embodiments, a plurality of grooves 11 can be arranged in an array along the circumferential direction of the balloon body 1, that is, multiple rows of a plurality of grooves are assembled on the balloon body, as shown in Figure 10 below, where the balloon body is provided with four rows of grooves, and each row has a plurality of grooves. The regularly distributed grooves ensure the precise installation and positioning of the blade, and at the same time ensure the firmness of the combination between the blade and the balloon body. In actual use, the number of grooves or the number of blades can also be determined according to the structure of the balloon body in the cutting balloon.

[0057] To improve the cutting performance of the cutting balloon, the direction of the cutting edge at the end of the three-dimensional tooth-like structure of the installed blade can be set. Generally, the cutting edge at the end of the three-dimensional tooth-like structure, or rather, the central axis of the cutting edge part is parallel to the central axis of the strip-shaped blade part. Therefore, the direction of the surface at the end of the three-dimensional tooth-like structure can be determined by determining the angle between the central axis of the blade part and the central axis of the balloon body. Preferably, both the central axis of the blade part and the cutting edge of the cutting edge part are parallel to the central axis of the balloon body, that is, the cutting edge at the end of the three-dimensional tooth-like structure extends along the central axis of the balloon body.

[0058] Figure 8 and Figure 9 Figures and

[0058] are respectively the structural schematic diagram and side view of the cutting balloon in the contracted state according to an embodiment of the present invention. When the cutting balloon is in the contracted state, the balloon body is in a folded state. The cutting balloon of the present invention can adopt the following folding method, which includes the first step of lobing and the second step of winding. When lobing, the balloon body needs to be pressurized and placed in a special tooling. The special tooling is used to limit the balloon body to ensure the uniformity of the lobing of each balloon body. After the balloon body is placed in the special tooling, the tooling rotates to compress the balloon body. The balloon body is slowly depressurized during the above process. Finally, the balloon body will be folded along the blade to form lobes of corresponding length; then the balloon body is placed in the special tooling for winding. The special tooling slowly rotates and winds the lobes by means of rotational compression until they are attached to the side wall of the blade and then further compressed and shaped. The side view of the balloon body in the contracted state after shaping shows protrusions. Among them, the lobes of the balloon body and the blade are at the same height, and the overall diameter of the balloon body is uniform. The balloon body in the contracted state has a smaller passing outer diameter, improving the passing performance of the cutting balloon in blood vessels. Compared with the prior art method of setting a base on the surface of the balloon body, the groove design on the surface of the balloon body of the present invention makes it possible for the lobes of the balloon body to contact and be flush with the blade, reducing the height of the blade to a certain extent, reducing the folded outer diameter of the balloon body, and reducing the risk of accidental damage to blood vessels caused by the blade protruding significantly above the lobes.

[0059] The present invention also provides a balloon catheter system, which includes a distal catheter 31, a cutting balloon, and a proximal catheter 32 connected in sequence, that is, the distal end and the proximal end of the balloon body 1 are respectively connected to the distal catheter 31 and the proximal catheter 32, that is, the balloon catheter of the balloon catheter system. The balloon catheter system of the present invention has good cutting performance and a low failure probability. It should be noted that the proximal and distal ends of the present invention are relative to the operator. The end closer to the operator is the proximal end, and the end farther from the operator is the distal end.

[0060] Figure 10The structural schematic diagram of a cutting balloon system according to an embodiment of the present utility model. More specifically, the balloon catheter system includes a balloon catheter and a delivery unit. The delivery unit includes an inner lumen tube 4, and a delivery seat 8, a push rod 7, a proximal outer tube 6, and a distal outer tube 5 that are sequentially connected. The inner lumen tube 4 penetrates through the balloon body 1, and the proximal catheter 32 is connected to the distal end of the distal outer tube 5. The inner lumen tube 4 penetrates through the balloon body 1, and the distal end of the inner lumen tube 4 can be connected to the distal end of the balloon body 1 or the distal catheter 31, and it can be exposed outside the distal catheter 31. Through the delivery unit, liquid or gas can be delivered into the balloon body 1, and the balloon body 1 is expanded and deformed by using pressure.

[0061] In the existing balloon catheter system, the distal outer tube of the delivery unit is relatively soft, so the pushing performance is poor and the pushing force cannot be effectively transmitted. Figure 10 In the embodiment of, at least one reinforcing wire 9 is provided at the distal end of the push rod 7. The reinforcing wire 9 extends from the proximal outer tube 6 to the distal outer tube 5, and the reinforcing wire can be made of stainless steel or nitinol. The reinforcing wire can enhance the pushing performance of the balloon catheter system. Figure 11 and Figure 12 Figures and respectively show the structural schematic diagrams of the reinforcing wire from different perspectives according to an embodiment of the present utility model. The reinforcing wire 9 includes a first part 91 connected to the distal outer tube and a second part 92 connected to the proximal outer tube. The radial dimension of the reinforcing wire 9 gradually increases from the first part 91 to the second part 92, that is, the structural stiffness of the reinforcing wire gradually decreases in the direction from the proximal outer tube to the distal outer tube. The cross-section of the reinforcing wire 9 can be circular or elliptical. Herein, the "radial dimension" refers to the distance between the two farthest points on the cross-section of the reinforcing wire. Taking the cross-section of the reinforcing wire as a circle as an example, the radial dimension of the reinforcing wire is the diameter of the reinforcing wire; if the cross-section of the reinforcing wire is elliptical, it is considered that the radial dimension of the reinforcing wire is the major axis of the reinforcing wire; if the cross-section of the reinforcing wire is a circular arc with thickness, a semi-lunar shape or a lunar shape, it is considered that the radial dimension of the reinforcing wire is the length of the line segment between the two points where the straight line passing through the center of the outer arc of the cross-section (the circular arc with thickness, the semi-lunar shape or the lunar shape) intersects the outer arc.

[0062] The reinforcing wire can be a composite structure, that is, the structure of the first part 91 and the structure of the second part 92 can be different. Figure 11 In the embodiment of, a spiral groove is provided on the surface of the second part 92. The first part 91 is an arc cone structure formed by longitudinal cutting. The radial dimension gradually decreases from the proximal end to the distal end and can be regarded as a conical (cone or frustum) structure. Cut along the diameter or chord of the bottom surface of the conical structure and the vertex (or the diameter or chord of the top surface) (for example, cut along the arc) to obtain as Figure 11 and Figure 12The arc cone structure of the first part 91 is used to adapt to the narrow space structure in the distal outer tube. Here, the arc cone refers to a cross-section obtained by cutting along the axial direction perpendicular to the first part of the reinforcing wire, which is an arc with a thickness, and its shape can also be called a quasi-crescent shape or a crescent shape. When it is a crescent shape, the cross-sectional shape has an inner chord and an outer chord. When it is a quasi-crescent shape, the connection between the inner chord and the outer chord of the cross-sectional shape can be an arc rather than a point.

[0063] Compared with the existing balloon catheter system, the balloon catheter system of the present utility model has a small outer diameter in the contracted state of the cutting balloon, good passing performance in blood vessels, good blade flexibility, good bending performance in blood vessels, good cutting performance for lesions, and can be used in calcified lesions and fibrotic lesions, greatly reducing the risk of balloon cutting slipping and nesting in plaques. With multiple reinforcing wires at the outer tube, the balloon catheter system of the present utility model has good overall pushing performance and is applicable to more medical occasions. The above content is a further detailed description of the present utility model in combination with specific preferred embodiments, and it cannot be determined that the specific implementation of the present utility model is only limited to these descriptions. For those skilled in the art, it is obvious that this application is not limited to the details of the above exemplary embodiments, and without departing from the spirit or basic characteristics of this application, this application can be implemented in other specific forms. Therefore, from any point of view, the embodiments should be regarded as exemplary and non-limiting. The scope of this application is defined by the appended claims rather than the above description. Therefore, all changes falling within the meaning and scope of the equivalent elements of the claims are intended to be included in this application. Any reference signs in the claims should not be regarded as limiting the claimed rights.

Claims

1. A blade, characterized in that: The blade comprises a blade portion and a blade body portion connected to the bottom of the blade portion; The blade portion includes a plurality of three-dimensional tooth block structures arranged in series; The blade body portion includes two fixed ends respectively located at two ends and a middle portion between the two fixed ends, and the two fixed ends are configured to fix the blade to the surface of the main body.

2. The blade according to claim 1, characterized in that The intermediate portion includes a plurality of spaced-apart apertures.

3. The blade according to claim 1, characterized in that The middle part is provided with a plurality of inverted T-shaped support parts, the support parts include a support rod and a support base, and the two ends of the support rod are respectively connected to the bottom of the blade part and the support base; and / or, The longitudinal section of the connection between the bottom of the blade portion and the support rod is arc-shaped; and / or, Both ends of the support base are respectively provided with a protruding structure pointing to the blade portion.

4. The blade according to claim 3, characterized in that The angle between a side surface of the three-dimensional tooth block structure at at least one end of the blade portion close to the adjacent fixed end and the plane where the support base is located is greater than or equal to 145°; and / or, A side surface of the three-dimensional tooth block structure at at least one end of the blade portion away from the adjacent fixed end is perpendicular to the plane where the support base is located.

5. The blade according to claim 1, characterized in that The plurality of three-dimensional tooth block structures of the blade portion have different heights.

6. A cutting balloon, characterized in that: comprising a balloon body and at least one blade according to any one of claims 1 to 5; The outer surface of the balloon body is provided with at least one groove; The blade is mounted in the groove through the blade body.

7. The cutting balloon according to claim 6, characterized in that: The central axis of the blade body is parallel to the central axis of the balloon body; and / or, The central axis of the blade portion is parallel to the central axis of the blade body portion.

8. The cutting balloon according to claim 6, characterized in that: Covering structures covering the fixed ends are respectively arranged at both ends of the groove, and the blade body of the blade is clamped in the groove.

9. The cutting balloon according to claim 6, characterized in that: At least two of the grooves are evenly distributed along the circumference of the balloon body; or At least two of the grooves are distributed along a circumferential array of the balloon body.

10. The cutting balloon according to claim 6, characterized in that: The fixed end comprises a sheet-like structure extending along the plane where the support base is located, and the width of the sheet-like structure gradually increases from close to the middle part to far away from the middle part.

11. A balloon catheter system, characterized in that: It comprises a distal catheter, a cutting balloon according to any one of claims 6 to 10, and a proximal catheter which are connected in sequence.

12. The balloon catheter system according to claim 11, characterized in that: The balloon catheter system further comprises a delivery unit, which comprises an inner lumen tube, and a delivery seat, a push rod, a proximal outer tube and a distal outer tube connected in sequence, wherein the inner lumen tube passes through the balloon body; The proximal catheter is connected to the distal end of the distal outer tube; The distal end of the push rod is provided with at least one reinforcing wire, and the reinforcing wire extends from the proximal outer tube to the distal outer tube.

13. The balloon catheter system according to claim 12, characterized in that: The reinforcing wire comprises a first portion connected to the distal outer tube and a second portion connected to the proximal outer tube, and the radial dimension of the reinforcing wire gradually increases from the first portion to the second portion.

14. The balloon catheter system according to claim 13, characterized in that: The surface of the second portion is provided with spiral grooves.

15. The balloon catheter system according to claim 13, characterized in that: The first part is an arc cone structure.

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