Nicking balloon catheter assembly and using method thereof

Abstract

The invention provides a nicked balloon catheter assembly and a method of using the same. The nicking balloon catheter assembly comprises a nicking balloon catheter, a guide tube and a nicking piece. Wherein the nick balloon catheter comprises a catheter seat, a catheter and a balloon, the guide tube is arranged on the outer surface of the balloon and extends along the axial direction of the catheter, and at least part of the guide tube is fixed on the nick balloon catheter; the guide tube can be compressed along with the folding of the balloon, so that the outer diameter of the nick balloon catheter can be prevented from being increased, and the trafficability of the nick balloon catheter is improved; besides, the nicking piece can be transmitted to the far end of the guide tube along the inner cavity channel of the guide tube, stress concentration is generated along with expansion of the balloon, the inner cavity channel of the guide tube provides a directional channel for movement of the nicking piece, and the navigation advancing capacity of the nicking piece on the nicking balloon catheter is enhanced.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular, to a scored balloon catheter assembly and a method of using the same. Background Art

[0002] The Scoring Balloon is an improved balloon catheter designed with a specifically designed scoring structure on the balloon surface, enhancing its ability to cut and expand vascular lesions (particularly calcified or fibrotic stenoses) during balloon expansion. The core principle is that when the balloon is inflated, the scoring structure concentrates stress, creating a controllable, localized high-pressure zone. This more effectively tears calcified plaques, reduces the risk of vascular recoil, and minimizes excessive damage to the healthy vessel wall.

[0003] To enhance the scoring effect, currently available scored balloons often use metal as the scoring elements on their surfaces, and most of these elements are fixed to the balloon surface or at the ends of the balloon tube. Because the metal material of the scoring elements differs from the properties of the polymer material used for the balloon, when the scoring elements are subjected to significant stretching and elongation during balloon expansion, the metal scoring elements are more rigid and prone to falling off the balloon catheter, or bending after the balloon is inflated, thereby reducing the permeability of the scored balloon. Furthermore, the addition of metal scoring elements to the balloon surface significantly increases the outer diameter and flexibility of the balloon, affecting its permeability. Summary of the Invention

[0004] The purpose of the present application is to provide a scored balloon catheter assembly and a method of using the same, so as to improve the passability of the scored balloon catheter assembly.

[0005] The embodiment of the present application is implemented as follows:

[0006] In a first aspect, embodiments of the present application provide a scoring balloon catheter assembly, comprising a scoring balloon catheter, a guide tube, and a scoring member. The scoring balloon catheter comprises a catheter seat, a catheter, and a balloon, wherein the catheter seat is fixed to the proximal end of the catheter, and the balloon is covered on the distal end of the catheter; the guide tube is disposed on the outer surface of the balloon and extends in the axial direction of the catheter, with at least a portion of the guide tube fixed to the scoring balloon catheter; the guide tube can be compressed as the balloon folds; the scoring member can be transmitted along the inner lumen of the guide tube to the distal end of the guide tube, and generates stress concentration as the balloon expands.

[0007] In the above technical solution, the guide tube is arranged on the outer surface of the balloon and is at least partially fixed to the scored balloon catheter, so that the guide tube can move together with the scored balloon catheter. Since the guide tube can be compressed as the balloon is folded, it is possible to avoid increasing the outer diameter size at the position of the balloon, reducing the impact on the passability of the balloon, thereby making the scored balloon catheter provided with the guide tube still have good passability. In the above technical solution, the scoring member can be transmitted to the distal end of the guide tube along the inner cavity channel of the guide tube, that is, the scoring member is not directly fixed to the scored balloon catheter or to the guide tube. The present application utilizes the inner cavity channel of the guide tube to provide a directional channel for the movement of the scoring member, thereby enhancing the navigation and forward movement capability of the scoring member on the scored balloon catheter.

[0008] In a second aspect, an embodiment of the present application provides a method for using a scored balloon catheter assembly, wherein the scored balloon catheter assembly is the scored balloon catheter assembly provided in the first aspect, comprising the steps of:

[0009] S1: The balloon in the scoring balloon catheter assembly is folded, and the guide tube is wrapped in the folds of the balloon and transported to the marked position along with the scoring balloon catheter;

[0010] S2: the distal end of the scoring member enters the inner cavity channel of the guide tube from the proximal end of the guide tube and is transmitted to the distal end of the guide tube;

[0011] S3: filling a medium into the balloon to expand the balloon, so that the scoring member generates stress concentration as the balloon expands;

[0012] S4: discharging the medium in the balloon to shrink the balloon; slowly withdrawing the scoring member from the inner cavity of the guide tube;

[0013] S5: Pulling out the scored balloon catheter from the sheath.

[0014] In the above technical solution, since the scoring balloon catheter and the guide tube are sent to the marking position one after another, the scoring balloon catheter is first transferred to the marking position to avoid the problem of increased outer diameter caused by carrying the scoring part, thereby ensuring the passability of the catheter; then, in the process of sending the scoring part from the guide tube to the marking position, the inner cavity channel of the guide tube is used to provide a directional channel for the movement of the scoring part, thereby enhancing the navigation forward ability of the scoring part on the scoring balloon catheter, so that the scoring part can reach the marking position quickly and effectively, and the guide tube on the balloon can play a navigation and protection role. Sending the scoring balloon catheter and the scoring part to the marking position separately is easier than sending them to the marking position at the same time. On the one hand, it avoids the problem of the scoring part restraining the balloon during synchronous entry, which leads to a decrease in the flexibility of the scoring balloon catheter. On the other hand, it avoids the problem of an increase in the friction points between the scoring balloon catheter and the inner wall of the blood vessel during synchronous entry, so that the scoring balloon catheter assembly provided by the above technical solution has better passability. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following is a brief introduction to the drawings required for use in the embodiments. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without creative work.

[0016] Figure 1 Schematic diagram of the connection between the scored balloon catheter and the guide tube;

[0017] Figure 2 for Figure 1 a cross-sectional view of the structure shown;

[0018] Figure 3 A schematic diagram of the cross-sectional profile of the scored wire provided in an embodiment of the present application;

[0019] Figure 4 A schematic diagram of an opening provided on a guide tube according to an embodiment of the present application;

[0020] Figure 5 A schematic diagram of a guide tube in a compressed state provided by an embodiment of the present application;

[0021] Figure 6 for Figure 5 Schematic diagram of feeding the scoring member into the guide tube in the state;

[0022] Figure 7 A schematic diagram of a scored balloon catheter assembly provided in an embodiment of the present application in an expanded balloon state;

[0023] Figure 8This is a schematic diagram of the scored balloon catheter assembly provided in an embodiment of the present application after the medium in the balloon is discharged;

[0024] Figure 9 Schematic diagram of withdrawing the scored balloon catheter from the sheath.

[0025] Icons: 200- notched balloon catheter assembly; 100- notched balloon catheter; 105- notched member; 101- balloon; 102- guide tube; 1021- first guide segment; 1022- second guide segment; 1023- third guide segment; 103- catheter; 1031- body segment; 1032- tip segment; 104- catheter hub; 106- inlet; 107- outlet; 108- guidewire cavity; 109- hollow structure; 110- opening; 120- end cap; 300- sheath. DETAILED DESCRIPTION

[0026] To make the objectives, technical solutions, and advantages of the embodiments of the present application more clear, the technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the accompanying drawings of the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Generally, the components of the embodiments of the present application described and shown in the drawings herein can be arranged and designed in various different configurations.

[0027] Therefore, the following detailed description of the embodiments of the present application provided in the accompanying drawings is not intended to limit the scope of the present application for protection, but merely represents selected embodiments of the present application. All other embodiments obtained by persons of ordinary skill in the art based on the embodiments in the present application without making any creative efforts shall fall within the scope of protection of the present application.

[0028] The present application provides a scoring balloon catheter assembly 200, such as Figures 1 to 9 As shown, the scored balloon catheter 100 includes a scoring balloon catheter 100, a guide tube 102, and a scoring member 105. The scored balloon catheter 100 includes a balloon 101, a catheter 103, and a catheter hub 104. The catheter hub 104 is fixed to the proximal end of the catheter 103, and the balloon 101 is covered on the distal end of the catheter 103. In the field of interventional medical devices, the end of a medical device implanted in a human or animal body that is closer to the operator is generally referred to as the "proximal end," and the end farther from the operator is referred to as the "distal end." This application defines the "proximal end" and "distal end" of any component of a medical device based on this principle.

[0029] In the present application, the guide tube 102 is arranged on the outer surface of the balloon 101. It can be understood that in the radial direction of the scored balloon catheter 100, at least part of the guide tube 102 and the balloon 101 overlap, and the guide tube 102 is arranged directly above one side of the outer wall of the balloon 101; this ensures that the guide tube 102 can be squeezed when the balloon 101 is in an expanded state.

[0030] In the present application, the guide tube 102 extends along the axial direction of the catheter 103, and at least a portion of the guide tube 102 is fixed to the scoring balloon catheter 100. "Axial" generally refers to the length direction of the medical device when being transported, and "radial" generally refers to the direction of the medical device perpendicular to its "axial direction." This application defines the "axial" and "radial" of any component of the medical device based on this principle. Since at least a portion of the guide tube 102 is fixed to the scoring balloon catheter 100, it is convenient for the guide tube 102 to move with the scoring balloon catheter 100 and can also be sent to the marking position. The guide tube 102 extends along the axial direction of the catheter 103. Therefore, the transmission direction of the scoring member 105 in the inner cavity channel of the guide tube 102 is consistent with the direction in which the catheter 103 sends the balloon 101 to the marking position, making it convenient to send the scoring member 105 to the marking position.

[0031] Wherein, at least part of the guide tube 102 is fixed to the scored balloon catheter 100, including only a part of the guide tube 102 being fixedly connected to the scored balloon catheter 100, and also including the entire guide tube 102 being fixed to the scored balloon catheter 100. In some embodiments, the portion of the guide tube 102 corresponding to the balloon 101 can be fixedly connected to the outer surface of the balloon 101, or can be in contact and adjacent to each other so as to be separable from each other. In the present application, the guide tube 102 can be compressed as the balloon 101 is folded, such as Figure 5 As shown, since the guide tube 102 can be compressed as the balloon 101 is folded, the outer diameter profile size at the position of the balloon 101 can be reduced, reducing the influence of the guide tube 102 on the passability of the balloon 101, thereby ensuring that the scored balloon catheter 100 provided with the guide tube 102 still has good passability.

[0032] In the present application, the scoring member 105 can be delivered along the inner lumen of the guide tube 102 to the distal end of the guide tube 102, reaching the marked position of the balloon 101. As the balloon 101 expands, the scoring member 105 exerts a stress concentration effect on the marked position along with the guide tube 102 outside the balloon 101. In the present application, the guide tube 102 is disposed on the outer surface of the balloon 101. The guide tube 102 is located outside the balloon 101 and can contact the balloon 101, so that after the balloon 101 is expanded, the scoring member 105 can exert a stress concentration effect on the marked position.

[0033] In the present application, the guide tube 102 can be compressed along with the balloon 101 being folded; the score member 105 can be transmitted along the inner cavity channel of the guide tube 102 to the distal end of the guide tube 102, and stress concentration is generated along with the expansion of the balloon 101. After the balloon 101 reaches the marked position, the score member 105 can be sent to the distal end of the guide tube 102 in the direction shown by the arrow X, at this time, the balloon 101 and the guide tube 102 are still in the folded state as shown in Figure 6 ; when the balloon 101 is filled with medium, the balloon 101 is expanded to the expanded state as shown in Figure 7 , and stress concentration is generated along with the expansion of the balloon 101.

[0034] In the present application, the guide tube 102 is arranged to be fixed on the scored balloon catheter 100, the guide tube 102 can be compressed along with the balloon 101 being folded, which can avoid increasing the outer diameter size at the position of the balloon 101, reduce the influence on the passability of the balloon 101, and further make the scored balloon catheter 100 provided with the guide tube 102 still have good passability. In the present application, the score member 105 can be transmitted along the inner cavity channel of the guide tube 102 to the distal end of the guide tube 102, that is, the score member 105 is not directly fixed with the scored balloon catheter 100 or the guide tube 102, which not only avoids the influence of the score member 105 on the flexibility and passability of the scored balloon catheter 100 in the process of passing, but also utilizes the inner cavity channel of the guide tube 102 to provide a directional channel for the movement of the score member 105, and enhances the navigation ability of the score member 105 on the scored balloon catheter 100.

[0035] In some embodiments, as shown in Figure 1 , Figure 2 and Figure 7 , the guide tube 102 includes an inlet 106 close to the proximal end side and an outlet 107 close to the distal end side, and the inlet 106 and the outlet 107 are both in communication with the outside. That is, the inner cavity channel of the guide tube 102 is not closed, which can facilitate the compression of the guide tube 103 along with the folding of the balloon 101, so that the scored balloon catheter assembly 200 has good passability. In the process of using the scored balloon catheter assembly 200 provided by the present embodiment, the score member 105 can enter the inner cavity channel of the guide tube 102 through the inlet 106 and pass through the position where the balloon 101 is located; and the score member 105 can also extend out of the inner cavity channel of the guide tube 102 through the outlet 107; the user can send the score member 105 to the appropriate position according to the use needs. Since the distal end of the guide tube 102 is not closed, the score member 105 can move back and forth, which avoids the score member 105 being restricted and affecting the expansion of the balloon 101.

[0036] In some embodiments, as shown in Figure 1 and Figure 2As shown, the catheter 103 includes a tube segment 1031 arranged at the proximal end of the balloon 101, and a tip segment 1032 arranged at the distal end of the balloon 101. In this embodiment, the tip segment 1032 is small in size, and the balloon 101 is still wrapped at the distal end of the catheter 103. The guide tube 102 includes a first guide segment 1021 arranged at the tip segment 1032, a second guide segment 1022 arranged on the outer surface of the balloon 101, and a third guide segment 1023 arranged at the tube segment 1031, which are sequentially communicated. The first guide segment 1021 is arranged at the tip segment 1032 of the catheter 103, the second guide segment 1022 is arranged on the outer surface of the balloon 101, and the third guide segment 1023 is arranged at the tube segment 1031, which can facilitate the compression of the second guide segment 1022 of the guide tube 102 with the folding of the balloon 101; and by arranging the first guide segment 1021 of the guide tube 102 at the tip segment 1032 of the catheter 103, it can facilitate the movement of the guide tube 102 together with the scored balloon catheter 100, which on one hand helps to fix the end of the guide tube 102 by the tip segment 1032, and on the other hand, the guide tube 102 is arranged to have a length exceeding the area of the balloon 101, which fully provides a navigation channel for the scoring member 105, and ensures that the distal end of the scoring member 105 can fully reach the distal end of the balloon 101, and fully plays the stress concentration effect of the balloon 101 on the scoring member 105 after expansion.

[0037] Further, the cross-sectional shape of the first guide segment 1021 and the third guide segment 1023 is circular, which can ensure that the scoring member 105 can effectively pass through the first guide segment 1021 and the third guide segment 1023; the second guide segment 1022 arranged on the balloon 101 will be compressed with the folding of the balloon 101 during the delivery of the balloon 101, will be extruded and deformed after the expansion of the balloon 101, and will still maintain the compressed state after the folding of the balloon 101 to avoid the expansion of the outer diameter size affecting the passability.

[0038] In some embodiments, the first guide segment 1021 is fixed to the inner or outer wall of the tip segment 1032, and the third guide segment 1023 is fixed to the inner or outer wall of the body segment 1031. The tip segment 1032 and the body segment 1031 are both part of the catheter 103, which includes a guidewire lumen 108 and a filling lumen. The guidewire lumen 108 allows the scoring balloon catheter assembly 200 provided in this application to be threaded onto a guidewire and moved along the guidewire until the balloon 101 moves to the marked position; the filling lumen is connected to the interior of the balloon 101, so that a medium can be filled into the balloon 101 to expand the balloon 101. Optionally, the first guide segment 1021 and the third guide segment 1023 can be independently fixed to the outer wall of the catheter 103 at both ends of the balloon 101 by welding or bonding; in another optional embodiment, the first guide segment 1021 and the third guide segment 1023 can be independently arranged in the internal space of the catheter 103 at both ends of the balloon 101, so as to avoid increasing the outer contour of the cross section of the scoring balloon catheter assembly 200 at the tip segment 1032 or at the position of the tube segment 1031, and do not affect the passability of the scoring balloon catheter assembly 200, so that it can be more easily delivered to the marking position; wherein, the cross section is a cross section perpendicular to the axial direction of the catheter 103. In an optional embodiment, as Figure 2 As shown, the first guide segment 1021 is arranged in the inner space of the tip segment 1032 of the catheter 103 , and the third guide segment 1023 is arranged on the outer wall of the tube segment 1031 of the catheter 103 .

[0039] It can be understood that when the first guide segment 1021 and the third guide segment 1023 are arranged in the internal space of the catheter 103, before being bonded to the catheter 103, the first guide segment 1021 and the third guide segment 1023 are supported in the inner cavity of the catheter 103 by a bracket, and the supporting bracket is removed after bonding, thereby ensuring the inner cavity space of the first guide segment 1021 and the third guide segment 1023.

[0040] In some embodiments, an end cap 120 is further provided at the end of the tip section 1032 facing away from the balloon 101, and the distal end of the guide tube 102 is fixed to the end cap 120. Figure 1 and Figure 2 As shown, the outlet 107 of the guide tube 102 may pass through the end cap 120 .

[0041] Furthermore, the second guide segment 1022 is welded or adhesively connected to the outer wall of the balloon 101; alternatively, the second guide segment 1022 and the outer wall of the balloon 101 are not fixedly connected; that is, the guide tube 102 and the outer surface of the balloon 101 can be fixedly connected or in a contact connection that can be separated from each other. When the balloon 101 expands or contracts, the first guide segment 1021 and the second guide segment 1022 remain connected to the catheter 103, and the second guide segment 1022 moves in the direction of expansion of the balloon 101. By fixing the first guide segment 1021 and the third guide segment 1023, the second guide segment 1022 is closely attached to the outer surface of the balloon 101, which can avoid the problem of uneven expansion of the balloon 101 caused by using welding agents or adhesives on the surface of the balloon 101.

[0042] In some embodiments, as Figure 4 As shown, a hollow structure 109 is provided on the side of the second guide section 1022 away from the balloon 101. The hollow structure 109 includes at least one opening 110 arranged along the extension direction of the catheter 103. The opening 110 extends along the length direction of the guide tube 102. Specifically, the number of openings 110 can be one, two, or three. Since the opening 110 is provided on the side of the second guide section 1022 away from the balloon 101, the notching member 105 can be exposed from the position of the opening 110, so that the notching member 105 can directly act on the marking position to apply a force to the marking position. Furthermore, the shape of the opening 110 can be rectangular, elliptical, or other shapes.

[0043] Furthermore, the opening 110 has a length dimension L1 and a width dimension L2, with L2 < L1 ≤ 5L2. The length dimension is the dimension parallel to the axial direction of the guide tube 102, and the width dimension is the dimension perpendicular to the axial direction of the guide tube 102. When these dimensional relationships are met, the opening 110 is appropriately sized, allowing for easy exposure of the scoring element 105 while minimizing the size of the opening 110, preventing the scoring element 105 from being ejected during insertion. In some embodiments, L1 ranges from 2 to 100 nm, and L2 ranges from 1 to 30 nm.

[0044] In some embodiments, the guide tube 102, the catheter 103, and the balloon 101 are all made of polymer materials, such as one or more of rubber, polyurethane, polyamide, polyimide, and polytetrafluoroethylene, or other types of polymer materials. The material of the guide tube 102 and the material of the catheter 103 can be the same or different.

[0045] Furthermore, in some embodiments, the guide tube 102 is a single-layer structure. In this embodiment, the material of the guide tube 102 includes at least one of rubber, polyurethane, polyamide, polyimide, and polytetrafluoroethylene. The high elasticity of rubber and polyurethane facilitates the compression of the guide tube 102 as the balloon 101 folds, minimizing the impact on the passability of the balloon 101. The low surface roughness of polyamide, polyimide, and polytetrafluoroethylene facilitates the passage of the scoring member 105 within the guide tube 102.

[0046] In other embodiments, the guide tube 102 may also be a double-layer structure, specifically including an inner layer and an outer layer, and the friction coefficient of the material used for the inner layer is smaller than the friction coefficient of the material used for the outer layer, and the elastic modulus of the material used for the inner layer is higher than the elastic modulus of the material used for the outer layer; that is, the inner layer material is smoother, and the outer layer material has better elasticity, and under a unit force, the outer layer can have a greater deformation. Optionally, the inner layer material includes at least one of polyamide, polyimide, and polytetrafluoroethylene, and the outer layer material includes at least one of rubber and polyurethane. The guide tube 102 provided in this embodiment has a double-layer structure, which can facilitate the compression of the guide tube 102 as the balloon 101 is folded, and also facilitate the passage of the scoring member 105 inside the guide tube 102.

[0047] In some embodiments provided herein, the scoring member 105 includes a scoring wire, which can penetrate the guide tube 102 and reach the location of the balloon 101 , and apply force to the marked location during the expansion of the balloon 101 .

[0048] In some embodiments, as Figure 3 As shown, the cross-sectional profile of the scored wire includes a sector. In this application, a sector refers to a closed figure enclosed by an arc segment and two line segments of equal length. The two line segments connected by the arc segment may be the radius of the circle in which the arc segment is located, or they may not be. Figure 3 In the embodiment shown, the straight line segment is not the radius of the circle in which the arc segment is located; Figure 3 In the example, the angle corresponding to the arc segment (that is, the central angle) is 180°, and the length of the two straight line segments is greater than the radius of the circle in which the arc segment is located, so that the angle between the two straight line segments is smaller than the central angle of the arc segment. That is, in Figure 3 In the embodiment shown, the cross section of the scoring wire consists of a semicircle at the bottom and a triangle at the top. The semicircle at the bottom of the cross section allows the scoring member 105 to move more easily in the guide tube 102, while the triangle at the top of the cross section can reduce the contact area between the scoring wire and the guide tube 102 and the contact area with the marking position, thereby concentrating the force applied by the scoring wire. Figure 3In the embodiment shown, the center of gravity of the scoring member 105 is concentrated in the lower half of the semicircle, so that the scoring member 105 is not easy to flip over when navigating the guide channel, thereby enhancing its stability, so that the side of the scoring wire with a triangular cross-section can stably face the side away from the balloon 101, thereby better applying force to the marking position.

[0049] In some embodiments, the single-side gap between guide tube 102 and scoring element 105 should be no greater than 0.05 mm. This allows the outer diameter of guide tube 102 to be as small as possible while still ensuring that scoring element 105 can pass through the guide tube 102. The wall thickness of guide tube 102 affects its outer diameter and flexibility and should be as thin as possible. In some embodiments, the wall thickness (OD) of guide tube 102 satisfies the following conditions: 0.01 ≤ OD ≤ 0.06 mm. The wall thickness (OD) can be 0.01 mm, 0.02 mm, 0.03 mm, 0.04 mm, 0.05 mm, or 0.06 mm. Preferably, the wall thickness (OD) satisfies the following conditions: 0.01 ≤ OD ≤ 0.02 mm.

[0050] Furthermore, the scoring member 105 is made of metal or alloy material, that is, the scoring wire is made of metal or alloy material, so it can better generate stress concentration with the expansion of the balloon 101. For example, the scoring member 105 can be made of nickel, titanium, stainless steel and other materials.

[0051] The method for using the scored balloon catheter assembly 200 provided in this application comprises the following steps:

[0052] S1: The balloon 101 in the scoring balloon catheter assembly 200 is folded, and the guide tube 102 is wrapped in the folds of the balloon 101 and transported to the marking position along with the scoring balloon catheter 100, i.e. Figure 5 The status shown;

[0053] S2: The distal end of the scoring member 105 enters the inner cavity of the guide tube 102 from the proximal end of the guide tube 102 and is transferred to the distal end of the guide tube 102. At this time, the guide tube 102 and the balloon 101 are still in the folded state. Figure 6 As shown;

[0054] S3: Fill the balloon 101 with a medium to expand the balloon 101, so that the scoring member 105 generates stress concentration as the balloon 101 expands. At this time, the state diagram of the guide tube 102 and the balloon 101 is as shown in FIG. Figure 7 As shown;

[0055] S4: The medium in the balloon 101 is discharged to shrink the balloon 101, and the scoring member 105 is slowly withdrawn from the inner cavity of the guide tube 102. Figure 8 Pull out in the direction indicated by arrow Y;

[0056] S5: If Figure 9 As shown, the scoring balloon catheter 100 is withdrawn from the sheath 300 .

[0057] It should be noted that the marked positions in the present application include the positions of calcified lesion tissue in the simulated blood vessels and the positions of calcified lesion tissue in the guide catheter 103 .

[0058] The method for using the notched balloon catheter assembly 200 provided in the present application is that, since the notched balloon catheter 100 and the guide tube 102 are sent to the marking position successively, the notched balloon catheter 100 is first transferred to the marking position to avoid the problem of increased outer diameter caused by carrying the notched part 105, thereby ensuring the passability of the catheter 103; then, in the process of sending the notched part 105 from the guide tube 102 to the marking position, the inner cavity channel of the guide tube 102 is utilized to provide a directional channel for the movement of the notched part 105, thereby enhancing the navigation forward capability of the notched balloon catheter 105 on the notched balloon catheter 100, so that the notched part 105 can reach the marking position quickly and effectively, and the guide tube 102 on the balloon 101 can play a navigation and protection role. Delivering the scoring balloon catheter 100 and the scoring element 105 to the marking position separately is easier than delivering them simultaneously. This avoids the problem of the scoring element 105 restraining the balloon 101 during simultaneous delivery, which reduces the compliance of the scoring balloon catheter 100. It also avoids the problem of increased friction points between the scoring balloon catheter 100 and the blood vessels during simultaneous delivery, resulting in better passability of the scoring balloon catheter assembly 200 provided by the above technical solution. Furthermore, when removing the scoring balloon catheter assembly 200, the scoring element 105 can be first withdrawn from the guide tube 102, followed by the withdrawal of the balloon 101, making it even easier to remove the scoring balloon catheter assembly 200.

[0059] The above description is merely a preferred embodiment of the present application and is not intended to limit the present application. Various modifications and variations are possible for those skilled in the art. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present application shall be included within the scope of protection of the present application.

Claims

1. A scored balloon catheter assembly, characterized in that: It includes a scoring balloon catheter, a guide tube and a scoring piece; wherein, The scored balloon catheter comprises a catheter seat, a catheter and a balloon, wherein the catheter seat is fixed at the proximal end of the catheter and the balloon is covered at the distal end of the catheter; The guide tube is arranged on the outer surface of the balloon and extends along the axial direction of the catheter, and at least a portion of the guide tube is fixed to the scored balloon catheter; The guide tube can be compressed as the balloon is folded; the scoring member can be transmitted along the inner cavity channel of the guide tube to the distal end of the guide tube and generate stress concentration as the balloon is expanded.

2. The scored balloon catheter assembly according to claim 1, wherein: The guide tube includes an inlet near the proximal end and an outlet near the distal end, and both the inlet and the outlet are connected to the outside; The scoring member can enter the inner cavity channel of the guide tube through the inlet and extend from the inner cavity channel of the guide tube through the outlet.

3. The scored balloon catheter assembly according to claim 1, wherein: The catheter comprises a tube section arranged at the proximal end of the balloon and a tip section arranged at the distal end of the balloon. The guide tube includes a first guide segment arranged on the tip segment, a second guide segment arranged on the outer surface of the balloon, and a third guide segment arranged on the tube segment. The first guide segment, the second guide segment and the third guide segment are connected in sequence.

4. The scored balloon catheter assembly according to claim 3, wherein: The first guide section is fixed to the inner or outer wall of the tip section, and the third guide section is fixed to the inner or outer wall of the tube section; The second guide segment is connected to the outer wall of the balloon by welding or bonding; or the second guide segment and the outer wall of the balloon are not connected and fixed.

5. The scored balloon catheter assembly according to claim 3, characterized in that: A hollow structure is provided on a side of the second guide section away from the balloon. The hollow structure includes at least one opening arranged along the extension direction of the catheter, and the opening extends along the length direction of the guide tube.

6. The scored balloon catheter assembly according to claim 5, characterized in that The length dimension of the opening is L1, and the width dimension is L2, L2<L1≤5L2; wherein the length dimension is the dimension in the axial direction parallel to the guide tube, and the width dimension is the dimension in the axial direction perpendicular to the guide tube.

7. The scored balloon catheter assembly according to claim 1, wherein: The guide tube is a single-layer structural member; the material of the single-layer structural member includes at least one of rubber, polyurethane, polyamide, polyimide, and polytetrafluoroethylene; or, The guide tube is a double-layer structure, including an inner layer and an outer layer. The friction coefficient of the inner layer material is smaller than the friction coefficient of the outer layer material, and the elastic modulus of the inner layer material is higher than the elastic modulus of the outer layer material. Optionally, the inner layer material includes at least one of polyamide, polyimide, and polytetrafluoroethylene, and the outer layer material includes at least one of rubber and polyurethane.

8. The scored balloon catheter assembly according to claim 1, wherein: The scoring member includes a scoring wire, and the cross-sectional shape of the scoring wire includes a fan shape, wherein, The sector includes a closed figure enclosed by an arc segment and two line segments of equal length; Optionally, the angle corresponding to the arc segment is 180°.

9. The scored balloon catheter assembly according to claim 1, wherein: The scoring member is made of metal or alloy material.

10. A method for using a scored balloon catheter assembly, characterized in that: The scored balloon catheter assembly is the scored balloon catheter assembly according to any one of claims 1 to 9, comprising the steps of: S1: The balloon in the scoring balloon catheter assembly is folded, and the guide tube is wrapped in the folds of the balloon and transported to the marked position along with the scoring balloon catheter; S2: the distal end of the scoring member enters the inner cavity channel of the guide tube from the proximal end of the guide tube and is transmitted to the distal end of the guide tube; S3: filling a medium into the balloon to expand the balloon, so that the scoring member generates stress concentration as the balloon expands; S4: discharging the medium in the balloon to shrink the balloon; slowly withdrawing the scoring member from the inner cavity of the guide tube; S5: Pulling out the scored balloon catheter from the sheath.

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