Blade, cutting balloon and balloon catheter system

Abstract

The invention 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 balloon body of the cutting balloon 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 balloon are enhanced, the turning performance of the cutting balloon in a blood vessel and the cutting performance of the balloon on lesions are improved, the blade is fixed to the groove through the blade body portion, and the cutting balloon is fixed to the blade body portion through 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] This invention relates to the field of medical device technology, and more specifically, to a blade, a cutting balloon, and a balloon catheter system. Background Technology

[0002] Traditional interventional minimally invasive treatments for vascular calcification typically use scoring balloons or conventional cutting balloons to break down plaques, thereby expanding the blood vessel's cross-section to maintain vascular patency. The scoring wires on scoring balloons expand and deform using a spiral motion. When the balloon is long, this spiral motion becomes difficult to maintain regularly, and retraction is challenging. With greater expansion, the number of spiral rotations increases, raising the risk of irregular expansion and potentially causing intimal shearing and thrombosis. As the balloon length increases, its permeability decreases. Existing scoring balloons are prone to scoring wire slippage, leading to dissection. The blade structure of traditional cutting balloons is not effective at cutting fibrotic lesions, and it also reduces the balloon's permeability and bending performance within the blood vessel. Therefore, there is an urgent need to develop a cutting balloon that can effectively destroy calcified tissue within the blood vessel. Summary of the Invention

[0003] To address the problems in existing technologies, the present invention aims to provide a blade, a cutting balloon, and a balloon catheter system. The blade of the cutting balloon has a continuous three-dimensional toothed structure, enhancing the flexibility and cutting force of the cutting balloon, improving its bending performance in blood vessels, and enhancing its cutting performance on lesions. The method of fixing the blade with grooves on the balloon body significantly reduces the outer diameter of the balloon after folding, which is beneficial for improving the product's passage performance in blood vessels and avoiding scratches to healthy blood vessels during lesion placement. Furthermore, the special blade fixing method also increases the flexibility of the cutting balloon, effectively improving its bending and recovery performance. Simultaneously, the cutting balloon design provided in this invention can reduce the height of the blade relative to the balloon surface, while the special blade design maintains or even achieves better cutting results. At the same time, the three-dimensional toothed structure of the blade greatly reduces the probability of slippage and embedding within plaques during cutting.

[0004] A first aspect of the present invention provides a blade comprising a cutting edge portion and a blade body portion connected to the bottom of the cutting edge portion;

[0005] The cutting edge includes multiple three-dimensional tooth block structures arranged continuously;

[0006] The blade body includes two fixed ends located at both ends and a middle section between the two fixed ends.

[0007] According to a first aspect of the invention, the intermediate portion includes a plurality of spaced-apart pores.

[0008] According to a first aspect of the invention, the middle portion is provided with a plurality of inverted T-shaped support portions, each support portion including a support rod and a support base, the two ends of the support rod being respectively connected to the bottom of the blade portion and the support base; and / or,

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

[0010] The support base has protrusions pointing towards the blade at both ends.

[0011] According to a first aspect of the invention, the angle between a side of the three-dimensional toothed structure at at least one end of the blade portion near the adjacent fixed end and the plane containing the support base is greater than or equal to 145°; and / or,

[0012] The side of the three-dimensional toothed block structure at at least one end of the blade portion, away from the adjacent fixed end, is perpendicular to the plane of the support base.

[0013] According to a first aspect of the invention, the heights of the plurality of three-dimensional toothed structures in the cutting edge portion are different.

[0014] A second aspect of the invention provides a cutting balloon, comprising a balloon body and at least one of the blades described above;

[0015] The outer surface of the balloon is provided with at least one groove;

[0016] The blade is mounted in the groove via the blade body portion.

[0017] According to a second aspect of the invention, the central axis of the blade portion is parallel to the central axis of the sac; and / or,

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

[0019] According to a second aspect of the invention, each end of the groove is provided with a covering structure covering the fixed end, and the blade body portion of the blade is engaged with the groove.

[0020] According to a second aspect of the invention, at least two of the grooves are uniformly distributed circumferentially along the balloon body; or

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

[0022] According to a second aspect of the invention, the fixed end includes a sheet-like structure extending along the plane of the support base, the width of the sheet-like structure gradually increasing from near the middle portion to away from the middle portion.

[0023] A third party to this invention provides a balloon catheter system comprising a distal catheter, the cutting balloon, and a proximal catheter connected in sequence.

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

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

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

[0027] According to a third aspect of the invention, the reinforcing wire includes a first portion connected to the distal outer tube and a second portion connected to the proximal outer tube, the reinforcing wire having a gradually increasing radial dimension from the first portion to the second portion.

[0028] According to a third aspect of the invention, the surface of the second portion is provided with a spiral groove.

[0029] According to a third aspect of the invention, the first part is a circular arc cone structure.

[0030] The blade of this invention has two fixed ends, which facilitates fixation to the main body and improves the stability of fixation. The blade also includes a cutting edge with a continuous three-dimensional toothed structure, which improves the cutting ability of the blade on lesions and reduces the possibility of the blade embedding into the lesion. The cutting balloon of this invention has a groove in its balloon body, and the blade is fixed to the groove by the blade body, enhancing the flexibility and cutting force of the cutting balloon, improving its bending performance in blood vessels and its cutting performance on lesions, and greatly reducing the probability of slippage and embedding within plaques during cutting. The balloon catheter system of this invention has good cutting performance and a low failure rate. Attached Figure Description

[0031] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with this application and, together with the description, serve to explain the scope of this application. Other features, objects, and advantages of the invention will become more apparent from the following detailed description of non-limiting embodiments with reference to the accompanying drawings. It is obvious that the drawings described below are merely some embodiments of the invention, and other drawings can be obtained by those skilled in the art based on these drawings without inventive effort. Furthermore, the drawings are merely illustrative diagrams of this disclosure and are not necessarily drawn to scale. The same reference numerals in the drawings denote the same or similar parts, and therefore repeated descriptions of them will be omitted. Some block diagrams shown in the drawings are functional entities and do not necessarily correspond to physically or logically independent entities.

[0032] Figure 1 This is a three-dimensional structural diagram of a blade according to an embodiment of the present invention;

[0033] Figure 2 for Figure 1 A cross-sectional view of the blade in the embodiment;

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

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

[0036] Figure 5 and Figure 6 These are a three-dimensional structural schematic diagram and a cross-sectional view of the blade according to another embodiment of the present invention;

[0037] Figure 7 This is a schematic diagram of the structure of a cutting balloon according to an embodiment of the present invention;

[0038] Figure 8 and Figure 9 These are a schematic diagram and a side view of a scissor balloon in a contracted state according to an embodiment of the present invention;

[0039] Figure 10 This is a schematic diagram of the structure of a cutting balloon system according to an embodiment of the present invention; and

[0040] Figure 11 and Figure 12 These are schematic diagrams of the reinforcing wire from different perspectives, representing an embodiment of the present invention. Detailed Implementation

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

[0042] In this specification, the terms "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., refer to specific features, structures, materials, or characteristics represented in connection with that embodiment or example, which are included in at least one embodiment or example of this specification. Furthermore, the specific features, structures, materials, or characteristics represented may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples represented in this specification, as well as the features of different embodiments or examples.

[0043] Although the terms first, second, etc., are used in some instances herein to refer to different solutions, these solutions should not be limited by these terms. These terms are used only to distinguish one solution from another. For example, first solution and second solution, etc., are used. Furthermore, as used herein, the singular forms “a,” “an,” and “the” are intended to also 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 feature, step, operation, element, component, item, type, and / or group, but do not exclude the presence, occurrence, or addition of one or more other features, steps, operations, elements, components, items, types, and / or groups. The terms “or” and “and / or” as used herein are interpreted as inclusive, or mean any one or any combination thereof. Thus, “A, B, or C” or “A, B, and / or C” means “any one of: A; B; C; A and B; A and C; B and C; A, B, and C.” Exceptions to this definition will only occur if the combination of elements, functions, steps, or operations is inherently mutually exclusive in some way.

[0044] Although not fully defined, all terms, including technical and scientific terms used herein, shall have the same meaning as commonly understood by one of ordinary skill in the art to which this specification pertains. Terms defined in commonly used dictionaries shall be further interpreted as having a meaning consistent with the relevant technical literature and the content of this present instruction, and shall not be over-interpreted as having an ideal or overly formulaic meaning unless otherwise defined.

[0045] Traditional techniques for treating vascular calcification employ minimally invasive interventional therapy, using specialized balloons such as scoring balloons or cutting balloons to break down plaques and dilate blood vessels, thus maintaining vascular patency. Cutting balloons utilize micro-blades mounted on the balloon, which are then expanded to force the blades to cut the plaque. Scoring balloons, on the other hand, have deformable metal mesh attached to their surface; balloon expansion forces the mesh to compress and destroy the vascular plaque. However, the blade structure of traditional cutting balloons is not very effective at cutting fibrotic lesions, and it also reduces the balloon's passage and bending performance within the vessel. Current scoring balloons utilize a spiraling expansion mechanism, which becomes difficult to maintain with longer balloons, and recovery from spiraling is challenging. Larger expansion ratios result in more spiral rotations, increasing the risk of irregular expansion and potentially causing intimal shearing and thrombosis. Furthermore, increased balloon length further reduces its passage capacity. Existing scoring balloons are prone to scoring wire slippage, which can lead to delamination.

[0046] Traditional cutting balloons (with a macroscopically continuous linear blade) and serrated balloons (with a macroscopically discontinuous blade) have the following problems: 1. The blade and balloon are connected via a base, which results in a relatively high blade height relative to the balloon surface, making it easy to scratch blood vessels during lesion delivery, and the balloon diameter is usually large when contracted; 2. Compared to the point contact between the blade and plaque in a serrated balloon, the blade of a cutting balloon is more prone to getting stuck in the plaque and unable to retract (the tip of the blade makes continuous linear or surface contact with the plaque tissue); 3. The serrated blade has a larger blade height as a percentage of the blade's length compared to a regular blade, allowing for the same level of plaque cutting effect with a lower blade height; 4. The blade and balloon contact surface has the same width, resulting in poor passage through blood vessels, specifically poor bending and recovery performance.

[0047] To address the existing technical problems, this invention provides a blade, a cutting balloon, and a balloon catheter system. The blade includes a cutting edge and a blade body connected to the bottom of the cutting edge. The cutting edge includes a plurality of continuously arranged three-dimensional toothed blocks. The blade body includes two fixed ends located at both ends and an intermediate portion between the two fixed ends. The cutting balloon equipped with the blade of this invention has a groove in its balloon body, and the blade with the continuous three-dimensional toothed block structure enhances the flexibility and cutting force of the cutting balloon, improves its bending performance in blood vessels, and enhances its cutting performance on lesions. The blade is fixed to the groove by the blade body, greatly reducing the probability of slippage and embedding within plaques during cutting.

[0048] The structure of the blade, cutting balloon, and balloon catheter system of the present invention will be further described below with reference to the accompanying drawings and specific embodiments. It should be understood that the specific embodiments are not intended to limit the scope of protection of the present invention.

[0049] Figures 1 to 4 These are schematic diagrams of the blade from different perspectives according to an embodiment of the present invention. Figure 1 The three-dimensional structural diagram shows that the blade 2 is strip-shaped, including a cutting edge 21 and a blade body connected to the bottom of the cutting edge 21. The cutting edge 21 includes multiple continuously arranged three-dimensional toothed block structures. Since the three-dimensional toothed block structures at both ends are slightly different from those between the two ends, the three-dimensional toothed block structures at both ends and between the two ends are labeled 212 and 211 respectively. The blade body has two fixed ends, which can easily achieve fixation with the main body and improve the stability of fixation. The blade also includes a cutting edge with continuous three-dimensional toothed block structures, which improves the cutting ability of the blade to cut lesions and reduces the possibility of nesting with lesions. Figure 1 As shown, a single three-dimensional tooth block structure 211 is a pentahedral pyramid-like structure. Multiple three-dimensional tooth block structures 211 are arranged in a continuous manner, meaning their bases are connected, forming a continuous structure. In this embodiment, the multiple three-dimensional tooth block structures 211 have the same height. Figure 2 The end face C is the actual working surface of the cutting edge. The end face C can be designed as an arc-shaped cutting edge, see... Figure 2 .from Figure 3 The top view of the blade shows that the end faces C of the multiple three-dimensional toothed structures are arranged along the dotted lines. Figure 4 The side view shows the apex of the end. That is, the cutting edge of the blade of this invention is discontinuous. The bottom connection between two adjacent three-dimensional tooth block structures 211 can be designed as a rounded chamfer R. The cutting edge of the above structure ensures that the entire blade can be easily bent, thereby ensuring the overall bending performance of the product.

[0050] The blade body includes two fixed ends 22 located at both ends and a middle section 23 between the two fixed ends 22. Preferably, the blade 2 is made of a metal material with memory function and super elasticity, but other metals or non-metallic materials can also be used. The balloon body equipped with multiple blades ensures the cutting pressure of the cutting balloon while reducing the risk of blades embedding into the lesion tissue. During balloon cutting, the three-dimensional toothed structure embedded in the lesion prevents the balloon body from sliding, and the arc-shaped blade ensures a smaller contact area between the blade and the lesion, generating greater cutting pressure under the same balloon inflation pressure, resulting in better cutting effect. This effectively reduces the working pressure when opening the lesion and minimizes the risk of accidental damage to the human body and the balloon body during use. The grooves between the three-dimensional toothed structures are all designed with rounded chamfers to ensure the structural strength of each individual three-dimensional toothed structure.

[0051] To further improve the overall bending performance of the blade, the middle portion 23 of the blade body includes multiple spaced-apart holes. That is, the middle portion 23 can be designed to be discontinuous. This hole design does not affect the bonding between the blade and the balloon surface while reducing resistance during bending, increasing the overall bending performance and flexibility of the blade, thereby improving the passage performance of the cutting balloon through blood vessels. Figures 1 to 4 In this embodiment, the middle portion 23 may be provided with multiple inverted T-shaped support portions 231. Each support portion 231 includes a support rod and a support base. The two ends of the support rod are connected to the bottom of the blade portion and the support base, respectively. The bottoms of the support bases of the multiple support portions 231 are on the same plane, which facilitates the fitting of this part with the groove on the balloon body. The longitudinal section at the connection between the bottom of the blade portion and the support rod is arc-shaped. This longitudinal section is on a plane parallel to the central axis of the blade, rather than a plane perpendicular to or along the direction of the central axis of the blade. The support base and the bottom of the blade portion are U-shaped. The two ends of the support base are respectively provided with protruding structures 2311 pointing towards the blade portion. The support base with protruding structures 2311 has a claw-like structure, which ensures the firmness of the blade and the balloon body after assembly.

[0052] In some embodiments, the structure of the three-dimensional tooth block structure 212 at both ends of the blade portion 21 is slightly different from the three-dimensional tooth block structure 211 in the middle portion, such as... Figure 2As shown, the angle θ between the side of the three-dimensional toothed block structure 212 at at least one end of the blade portion 21 near the adjacent fixed end 22 and the plane containing the support base is greater than or equal to 145°. The plane containing the support base is the tangential plane at the outer surface where the support base connects to the sac body. The side of the three-dimensional toothed block structure 212 at at least one end of the blade portion 21 away from the adjacent fixed end 22 is perpendicular to the plane containing the support base, i.e., β is ~90°. The angle θ being greater than or equal to 145° results in a gentler slope on the inclined surfaces near the sides of the three-dimensional toothed block structure at both ends, and this gentler slope extends to the fixed end 22 of the blade body segment. The special design of the three-dimensional toothed block structure at both ends of the blade portion can reduce the risk of jamming during blade use.

[0053] Figure 5 and Figure 6 These are a three-dimensional structural schematic diagram and a cross-sectional view of a blade 2' according to another embodiment of the present invention. 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 are... Figure 1 The structure in this embodiment is slightly different. The three-dimensional toothed block structure between the two ends includes three-dimensional toothed block structures 211a' and 211b' with different heights. The height here is the maximum distance between the tip of the three-dimensional toothed block structure and the plane where the support base is located. The angle θ' between the side of the three-dimensional toothed block structure 212' at the end of the blade 21 near the fixed end 22' and the plane where the support base is located is greater than or equal to 145°. The angle β' between the side of the three-dimensional toothed block structure 212' at the end of the blade 21' away 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 part 23' can also be provided with multiple inverted T-shaped support parts 231'. The support part includes a support rod connected to the blade and a support base; the cross-section at the bottom of the blade where it connects to the support rod is arc-shaped, and the support base and the bottom of the blade are U-shaped.

[0054] Figure 7This is a schematic diagram of the structure of a cutting balloon according to an embodiment of the present invention (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 inflated state. At least one strip-shaped groove 11 is provided on the outer surface of the balloon body 1, the groove 11 being used to accommodate or install a blade. The blade 2 can be installed in the groove 11 via its blade body portion; correspondingly, the structure of the groove 11 is adapted to the structure of the blade 2. It is understood that installation here refers to achieving contact, assembly, or fixation between the blade body portion and the groove in a certain way. The assembly method of the balloon body and the blade is not limited in the present invention. The blade can be installed using mechanical means (e.g., covering, clamping, and flanges), or connected using chemical adhesives, or installed, assembled, or fixed on the balloon body using a combination of mechanical, chemical adhesives, and other methods (e.g., magnetic attraction). The cutting balloon includes at least one blade; the number of blades is not limited in the present invention, and there can be one or more blades. The correspondence between the blade and the groove is also not limited in the present invention; for example, multiple blades can be accommodated in one groove of the balloon body.

[0055] by Figure 1 Taking the blade of the embodiment as an example, the fixed end of its blade body is connected to the bottom of the blade edge to ensure the overall stability of the blade with multiple body tooth block structures. Further, the fixed end 22 includes a sheet-like structure extending along the plane of the support base. In some embodiments, the width of the sheet-like structure gradually increases from near the middle to away from the middle. 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 thermoforming process of the balloon body 1. The blade body can be snapped into or engaged with the groove 11. The fixed end 22 ensures the firmness of the connection between the blade and the balloon body, as well as the standing stability of the blade edge.

[0056] In this invention, the blade and groove are strip-shaped, and multiple grooves 11 can be evenly distributed along the circumference of the balloon body 1, that is, the balloon body is equipped with a row of multiple grooves. In some other embodiments, multiple grooves 11 can be distributed in an array along the circumference of the balloon body 1, that is, the balloon body is equipped with multiple rows of multiple grooves, as described below. Figure 10 As shown, the balloon body has four rows of grooves, with multiple grooves in each row. The regularly distributed grooves ensure precise installation and positioning of the blade, while also guaranteeing a strong bond between the blade and the balloon body. In practical use, the number of grooves, or blades, can be determined based on the structure of the balloon body within the cutting balloon.

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

[0058] Figure 8 and Figure 9 The images show a schematic diagram and a side view of the cutter balloon in its contracted state, according to an embodiment of the present invention. In the contracted state, the balloon body is folded. The cutter balloon of the present invention can be folded using the following method, which includes a first step of segmentation and a second step of winding. During segmentation, the balloon body needs to be inflated and placed into a special fixture. The special fixture is used to limit the balloon body and ensure the uniformity of the segmentation of each segment. After the balloon body is placed into the special fixture, the fixture rotates and compresses the balloon body. During this process, the balloon body is slowly depressurized, and finally, the balloon body is folded along the blade to form lobes of corresponding length. Then, the balloon body is placed into the special fixture for winding. The special fixture slowly rotates and winds the lobes by rotational compression until they adhere to the side wall of the blade and are further compressed and shaped. The side view of the shaped, contracted balloon body shows a protrusion, wherein the lobes of the balloon body are at the same height as the blade, and the overall diameter of the balloon body is uniform. The balloon body in its contracted state has a smaller outer diameter, which improves the passage performance of the cutting balloon in blood vessels. Compared with the existing technology of setting a base on the surface of the balloon body, the groove design on the surface of the balloon body in this invention makes it possible for the flaps of the balloon body to contact and be flush with the blade, which reduces the height of the blade to a certain extent, reduces the folded outer diameter of the balloon body, and reduces the risk of the blade protruding significantly above the flaps and accidentally damaging blood vessels.

[0059] This invention also provides a balloon catheter system, comprising a distal catheter 31, a cutting balloon, and a proximal catheter 32 connected in sequence. Specifically, the distal and proximal ends of the balloon body 1 are connected to the distal catheter 31 and the proximal catheter 32, respectively, forming the balloon catheters of the balloon catheter system. The balloon catheter system of this invention has good cutting performance and a low failure rate. It should be noted that the terms "proximal" and "distal" in this 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 10This is a schematic diagram of the structure of a cutting balloon system according to an embodiment of the present invention. More specifically, the balloon catheter system includes a balloon catheter and a delivery unit. The delivery unit includes an inner lumen 4, and a delivery seat 8, a push rod 7, a proximal outer tube 6, and a distal outer tube 5 connected in sequence. The inner lumen 4 penetrates the balloon body 1, and the proximal catheter 32 is connected to the distal end of the distal outer tube 5. The distal end of the inner lumen 4 can be connected to the distal end of the balloon body 1 or the distal catheter 31, and can protrude 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 can be expanded and deformed by pressure.

[0061] The distal outer tube of the delivery unit in existing balloon catheter systems is relatively soft, resulting in poor delivery performance and ineffective transmission of delivery force. Figure 10 In this embodiment, the distal end of the push rod 7 is provided with at least one reinforcing wire 9, which extends from the proximal outer tube 6 to the distal outer tube 5. The reinforcing wire can be made of stainless steel or nickel-titanium alloy. The reinforcing wire can enhance the pushing performance of the balloon catheter system. Figure 11 and Figure 12 These are schematic diagrams of the reinforcing wire from different perspectives according to an embodiment of the present invention. 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 reinforcing wire exhibits a decreasing structural stiffness gradient along 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. Here, "radial dimension" refers to the distance between the two farthest points on the cross-section of the reinforcing wire. Taking a circular cross-section 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, the radial dimension is considered to be the major axis of the reinforcing wire; if the cross-section of the reinforcing wire is a thick arc, crescent-shaped, or crescent-shaped cross-section, the radial dimension is considered to be the length of the line segment between the two points where the straight line passing through the center of the outer arc of the (thick arc, crescent-shaped, or crescent-shaped) cross-section intersects the outer arc.

[0062] The reinforcing wire can be a composite structure, meaning the structure of the first part 91 and the structure of the second part 92 can be different. Figure 11 In one embodiment, the surface of the second portion 92 is provided with a spiral groove. The first portion 91 is a longitudinally cut arc-shaped cone structure, and its radial dimension gradually decreases from the near end to the far end, which can be regarded as a conical (cone or frustum) structure. Cutting along the diameter or chord of the base of the cone structure and the apex (or the diameter or chord of the top surface) (e.g., cutting along an arc) yields... Figure 11 and Figure 12The first part, 91, features a conical arc structure designed to accommodate the confined space within the distal outer tube. Here, the conical arc refers to a thick arc-shaped section obtained by cutting along the axial direction perpendicular to the reinforcing wire of the first part; its shape can also be described as crescent-shaped or crescent-like. When crescent-shaped, the cross-sectional shape has an inner chord and an outer chord. When crescent-shaped, the connection between the inner and outer chords of the cross-sectional shape can be an arc rather than a point.

[0063] Compared to existing balloon catheter systems, the balloon catheter system of this invention has a smaller outer diameter of the cutting balloon in its contracted state, resulting in better passage performance in blood vessels. It also features a flexible blade, good bending performance in blood vessels, and excellent cutting performance for lesions. It can be used in calcified and fibrotic lesions, significantly reducing the risk of balloon slippage and embedding within plaques. Combined with multiple reinforcing wires at the outer tube, the balloon catheter system of this invention has good overall delivery performance and is suitable for a wider range of medical applications. The above description, in conjunction with specific preferred embodiments, provides a further detailed explanation of the invention and should not be construed as limiting the specific implementation of the invention to these descriptions. It will be apparent to those skilled in the art that this application is not limited to the details of the above exemplary embodiments, and that this application can be implemented in other specific forms without departing from the spirit or essential characteristics of this application. Therefore, the embodiments should be considered exemplary and non-limiting in all respects, and the scope of this application is defined by the appended claims rather than the foregoing description. Therefore, all changes falling within the meaning and scope of equivalents of the claims are intended to be embraced within this application. No reference numerals in the claims should be construed as limiting the scope of the claims.

Claims

1. A blade, characterized in that, The blade includes a cutting edge portion and a blade body portion connected to the bottom of the cutting edge portion; The cutting edge includes multiple three-dimensional tooth block structures arranged continuously; The blade body includes two fixed ends located at both ends and a middle section between the two fixed ends.

2. The blade according to claim 1, characterized in that, The middle section includes multiple spaced-apart pores.

3. The blade according to claim 1, characterized in that, The middle part is provided with multiple inverted T-shaped support parts, each support part including a support rod and a support base, with the two ends of the support rod connected to the bottom of the blade part and the support base respectively; And / or, The longitudinal section at the connection point between the bottom of the blade and the support rod is arc-shaped; and / or... The support base has protrusions pointing towards the blade at both ends.

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

5. The blade according to claim 1, characterized in that, The heights of the multiple three-dimensional toothed blocks on the blade portion are different.

6. A cutting balloon, characterized in that, Includes a balloon body and at least one blade as described in any one of claims 1 to 5; The outer surface of the balloon is provided with at least one groove; The blade is mounted in the groove via the blade body portion.

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, The groove has a covering structure at each end that covers the fixed end, and the blade body is engaged with 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 arranged in a circumferential array along the spherical body of the balloon.

10. The cutting balloon according to claim 6, characterized in that, The fixed end includes a sheet-like structure extending along the plane of the support base, the width of which gradually increases from near the middle portion to away from the middle portion.

11. A balloon catheter system, characterized in that, It includes a distal catheter, a cutting balloon as described in any one of claims 6 to 10, and a proximal catheter connected in sequence.

12. The balloon catheter system according to claim 11, characterized in that, The balloon catheter system also includes a delivery unit, which includes 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 extends 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, which 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 includes a first portion connected to the distal outer tube and a second portion connected to the proximal outer tube, wherein 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 part is provided with spiral grooves.

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

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