Nicking balloon catheter

Abstract

The nick balloon catheter comprises a catheter body, a balloon and a catheter seat, the catheter body comprises an inner tube and an outer tube, the outer tube is arranged on the outer side of the inner tube in a sleeving mode, the far end of the outer tube is connected with the near end of the balloon, and the near end of the outer tube is connected with the catheter seat; the far end of the inner tube penetrates out of the far end of the balloon, a first nicking piece and a guide wire are arranged in an inner cavity of the inner tube in a penetrating mode, and the first nicking piece comprises a first developing piece capable of developing under X rays; the inner tube comprises a nicking piece cavity and a guide wire cavity, the nicking piece cavity and the guide wire cavity extend in the length direction of the inner tube in a penetrating mode, the nicking piece cavity and the guide wire cavity are arranged in parallel, and the first nicking piece penetrates out of the far end of the inner tube through the nicking piece cavity. According to the nicking balloon catheter, the first nicking piece is arranged to cut the seriously narrow lesion position, the problem that the balloon cannot reach the seriously narrow lesion position is solved, and the application range of the nicking balloon catheter is wider.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a notched balloon catheter. Background Art

[0002] A notched balloon catheter is a device used in nerve and cardiovascular surgeries, mainly for dilating stenosed blood vessels or ducts to restore normal blood flow or unobstructed passage. The notched balloon catheter includes a catheter, a notched balloon, and a catheter hub. The notched balloon is a special type of balloon that combines micro-notching technology and balloon dilation. The notching member is disposed on the outer surface of the balloon, so that the notching member is combined with the dilation structure of a common balloon, and the notching member can be fully dilated at a relatively low pressure to cut the diseased area.

[0003] Notched balloon catheters are currently widely used in vascular surgeries. When the blood vessel is calcified and stenosed, a notched balloon is usually selected to dilate the stenosis. However, when the blood vessel is severely blocked and only a very small gap remains, due to the relatively large size of the balloon, it cannot enter the stenosis, so the diseased area cannot be dilated, which limits the use of the balloon. Summary of the Invention

[0004] In view of this, the present invention provides a notched balloon catheter, which solves the problem that the balloon cannot reach the severely stenosed diseased position by providing a first notching member to cut the severely stenosed diseased position, and makes the applicable range of the notched balloon catheter wider.

[0005] To achieve the above object, the present invention provides the following technical solutions: A notched balloon catheter includes a catheter body, a balloon, and a catheter hub. The catheter body includes an inner tube and an outer tube. The outer tube is sleeved outside the inner tube. The distal end of the outer tube is connected to the proximal end of the balloon, and the proximal end is connected to the catheter hub. The distal end of the inner tube passes through the distal end of the balloon. A first notching member and a guide wire are disposed in the inner cavity of the inner tube. The first notching member includes a first imaging member that can be imaged under X-rays. The inner tube includes a notching member cavity and a guide wire cavity. The notching member cavity and the guide wire cavity extend through the inner tube along the length direction of the inner tube. The notching member cavity is parallel to the guide wire cavity. The first notching member passes through the distal end of the inner tube through the notching member cavity.

[0006] Optionally, a second notching member is disposed on the outer surface of the balloon. The second notching member is parallel to the axial direction of the balloon. The second notching member is disposed along the length direction of the balloon. The second notching member includes a second imaging member that can be imaged under X-rays.

[0007] Optionally, a first guide tube and a second guide tube are arranged inside the inner tube. The lumen of the first guide tube is the notch member cavity, and the lumen of the second guide tube is the guide wire cavity.

[0008] Optionally, the inner tube is a double-lumen tube, and the lumen of the inner tube is separated into the notch member cavity and the guide wire cavity by a partition wall.

[0009] Optionally, the first notch member and the second notch member are hollow structural members formed by helically winding structural wires.

[0010] Optionally, both the first developer and the second developer are developer cores; The structural wire includes a developer core and a structural layer. The structural layer is sleeved on the outer surface of the developer core, and the developer core extends along the center line of the structural wire.

[0011] Optionally, at least one developer core is arranged in each structural wire; Two developer cores are arranged in the structural wire, and the two developer cores are symmetrically arranged about the central position of the structural wire; The material of the structural layer is medical stainless steel, cobalt-chromium alloy or nickel-titanium alloy.

[0012] Optionally, both the first developer and the second developer are developer wires; The structural wire includes a developer wire and a support wire arranged in parallel; Each structural wire includes at least one developer wire and at least one support wire. The developer wire and the support wire are wound side by side in parallel, and the height of the support wire is higher than that of the developer wire; The material of the support wire is medical stainless steel, cobalt-chromium alloy or nickel-titanium alloy.

[0013] Optionally, the cross-section of the hollow structural member is a hollow circle or a hollow polygon; The hollow polygon includes a hollow triangle and a hollow quadrilateral; The volume percentage of the first developer and / or the second developer in the structural wire is 10%-50%.

[0014] Optionally, the balloon includes a working section and a guiding section, and the second notch member is bonded to the working section; The second notch member is bonded to the balloon by a medical adhesive; The medical adhesive is an instant adhesive or an ultraviolet light-curing adhesive.

[0015] As can be seen from the above technical solutions, the notched balloon catheter provided by the present invention is provided with a first notching member disposed inside the inner tube. The first notching member is separated from the balloon. The first notching member can extend to the distal end of the balloon and extend out of the inner tube. The first notching member can first cut the severely stenotic lesion site, and then the balloon expands by filling with fluid at the lesion site, solving the problem that the balloon cannot reach the severely stenotic lesion site, and making the applicable range of the notched balloon catheter wider. At the same time, a first imaging member is provided on the first notching member to make the first notching member visible under X-ray, realizing precise control of the surgical process. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings.

[0017] Figure 1 Structural schematic diagram of a notched balloon catheter provided by an embodiment of the present invention; Figure 2 For Figure 1 Partial enlarged structural schematic diagram of part A in; Figure 3 Provided by an embodiment of the present invention Figure 1 Cross-sectional structural schematic diagram at the B-B position in; Figure 4 Provided by another embodiment of the present invention Figure 1 Cross-sectional structural schematic diagram at the B-B position in; Figure 5 Provided by yet another embodiment of the present invention Figure 1 Cross-sectional structural schematic diagram at the B-B position in; Figure 6 Structural schematic diagram of a notched balloon catheter provided by another embodiment of the present invention; Figure 7 For Figure 6 Partial enlarged structural schematic diagram of part C in; Figure 8 Provided by an embodiment of the present invention Figure 6 Cross-sectional structural schematic diagram at the D-D position in; Figure 9 Provided by another embodiment of the present invention Figure 6 Cross-sectional structural schematic diagram at the D-D position in; Figure 10 Structural schematic diagram of the balloon of the notched balloon catheter provided by the embodiment of the present invention; Figure 11Schematic cross-sectional structure diagram of the structural wire provided by an embodiment of the present invention; Figure 12 Schematic cross-sectional structure diagram of the structural wire provided by another embodiment of the present invention; Figure 13 Schematic cross-sectional structure diagram of the structural wire provided by yet another embodiment of the present invention; Figure 14 Schematic cross-sectional structure diagram of the structural wire provided by the fourth embodiment of the present invention; Figure 15 Schematic cross-sectional structure diagram of the structural wire provided by the fifth embodiment of the present invention; Figure 16 Schematic diagram of the imaging structure of different balloons under X-rays; Figure 17 Schematic diagram of the structure of the scoring member wound by the imaging wire and the support wire at an angle provided by an embodiment of the present invention; Figure 18 Schematic diagram of the structure of the scoring member wound by the imaging wire and the support wire at another angle provided by an embodiment of the present invention; Figure 19 is Figure 17 Schematic cross-sectional structure diagram along the axial direction.

[0018] Wherein: 1. Catheter seat, 101. Inflation / deflation port, 102. Guide wire inlet, 2. Catheter body, 201. Outer tube, 202. Inner tube, 2021. Scoring member cavity, 2022. Guide wire cavity, 203. First guide tube, 204. Second guide tube, 205. Fluid communication cavity, 206. Partition wall, 3. Balloon, 4. First scoring member, 5. Guide wire, 6. Second scoring member, 7. Structural wire, 701. Structural layer, 702. Imaging core, 703. Imaging wire, 704. Support wire. Detailed implementation manners

[0019] The present invention discloses a scoring balloon catheter. By providing a first scoring member to cut the severely stenotic lesion site, the problem that the balloon cannot reach the severely stenotic lesion site is solved, making the applicable range of the scoring balloon catheter wider.

[0020] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0021] Referring to Figures 1 to 19 , the notched balloon catheter of the present invention includes a catheter body 2, a balloon 3, and a catheter hub 1. The catheter body 2 includes an inner tube 202 and an outer tube 201. The outer tube 201 is sleeved outside the inner tube 202, and the inner diameter of the outer tube 201 is greater than the outer diameter of the inner tube 202 to form a fluid passage cavity 205 for filling the balloon 3 with fluid between the outer tube 201 and the inner tube 202. The distal end of the outer tube 201 is connected to the proximal end of the balloon 3, and the proximal end of the outer tube 201 is connected to the catheter hub 1. The distal end of the inner tube 202 passes through the distal end of the balloon 3, and a first notching member 4 and a guide wire 5 are disposed through the inner cavity of the inner tube 202. The first notching member 4 includes a first imaging member that is visible under X-rays. By providing the first imaging member, it is convenient to monitor the precise position of the first notching member 4.

[0022] Among them, the catheter hub 1 is a hollow structure, and a filling / discharging port 101 and a guide wire inlet 102 are provided on the catheter hub 1. The first notching member 4 and the guide wire 5 are inserted into the inner tube 202 through the guide wire inlet 102. The filling / discharging port 101 is communicated with the inner cavity of the balloon 3 through the fluid passage cavity 205 for filling or discharging fluid to the balloon 3, so that the balloon 3 can be switched between two states of expansion and contraction. To prevent interference between the first notching member 4 and the guide wire 5 disposed in the inner tube 202, the inner tube 202 is provided with a notching member cavity 2021 and a guide wire cavity 2022. The notching member cavity 2021 and the guide wire cavity 2022 extend through along the length direction of the inner tube 202, and the notching member cavity 2021 and the guide wire cavity 2022 are arranged in parallel. The first notching member 4 passes through the notching member cavity 2021 and exits the distal end of the inner tube 202, so that the part of the balloon 3 with a larger radial dimension can reach the lesion position first.

[0023] In the notched balloon catheter of the present invention, by providing the first notching member 4 disposed in the inner tube 202, the first notching member 4 is separated from the balloon 3. The first notching member 4 can extend to the distal end of the balloon 3 and protrude from the inner tube 202. The first notching member 4 can first cut the severely stenotic lesion position, and then the balloon 3 expands by filling fluid at the lesion position, solving the problem that the balloon 3 cannot reach the severely stenotic lesion position, and making the applicable range of the notched balloon catheter wider. At the same time, a first imaging member is provided on the first notching member 4, so that the first notching member 4 can be imaged under X-rays to achieve precise control of the surgical process.

[0024] To achieve precise positioning of the balloon 3 and further precise cutting of the lesion, a second scoring member 6 is provided on the outer surface of the balloon 3, as Figure 6 and Figure 7 shown. The second scoring member 6 is arranged parallel to the axial direction of the balloon 3 and along the length direction of the balloon 3. The second scoring member 6 includes a second imaging member that can be imaged under X-rays. The second scoring member 6 is arranged along the length direction of the balloon 3, which can not only show the position of the balloon 3 but also improve the cutting efficiency of the lesion position.

[0025] Specifically, as Figure 3 and Figure 4 shown, the scoring member cavity 2021 and the guide wire cavity 2022 are arranged parallel to each other in the vertical direction, that is, the central connection line of the scoring member cavity 2021 and the guide wire cavity 2022 is arranged along the vertical direction. In other embodiments, the scoring member cavity 2021 and the guide wire cavity 2022 may also be arranged parallel to each other in other directions. For example, the central connection line of the scoring member cavity 2021 and the guide wire cavity 2022 is arranged along the horizontal direction, as Figure 5 shown; or the included angle between the central connection line of the scoring member cavity 2021 and the guide wire cavity 2022 and the horizontal line is a set acute angle. The arrangement positions of the scoring member cavity 2021 and the guide wire cavity 2022 are set according to actual needs. When the scoring member cavity 2021 and the guide wire cavity 2022 are arranged vertically, the scoring member cavity 2021 can be arranged above or below the guide wire cavity 2022, and no limitation is made here.

[0026] In one embodiment, to form an independently arranged scoring member cavity 2021 and guide wire cavity 2022, a first guide tube 203 and a second guide tube 204 are arranged in the inner tube 202. The lumen of the first guide tube 203 is the scoring member cavity 2021, and the lumen of the second guide tube 204 is the guide wire cavity 2022, as Figure 3 shown.

[0027] In another embodiment, the inner tube 202 is a double-lumen tube. Specifically, the inner tube 202 is divided into two chambers independently arranged along the length direction of the tube body. The two chambers are the scoring member cavity 2021 and the guide wire cavity 2022 respectively, as Figure 4 shown, and the scoring member cavity 2021 and the guide wire cavity 2022 are separated by a partition wall 206.

[0028] Among them, both the first scoring member 4 and the second scoring member 6 are hollow structural members formed by helically winding a structural wire 7. As Figure 8 or Figure 9As shown, it is a cross-sectional view of the second notching member 6 in two different embodiments. By setting the first notching member 4 and the second notching member 6 as hollow structural members formed by helically winding the structural wire 7, that is, setting them into a helical spring-like structure, the bending performance of the first notching member 4 and the second notching member 6 is improved, so that the balloon 3 has good flexibility, can smoothly pass through complex and tortuous blood vessels, and improves the bending performance of the notched balloon.

[0029] Specifically, referring to Figure 10 , the balloon 3 is a structural body with a cylindrical structure in the middle and conical structures at both ends. The middle cylindrical structure is the working section, and the conical structures at both ends are non-working sections. The conical structures at both ends are used for guiding, making the process of the balloon 3 moving bidirectionally in the blood vessel smoother and not easily scratching the blood vessel.

[0030] Furthermore, in order to achieve reliable imaging at different angles, a plurality of second notching members 6 are provided. The plurality of second notching members 6 are evenly arranged circumferentially on the outer surface of the balloon 3. Here, the plurality means greater than or equal to two. By providing a plurality of second notching members 6, the lesion site can be cut from multiple angles within the blood vessel. In a specific embodiment, three second notching members 6 are provided, and the three second notching members 6 are evenly distributed around the axis of the balloon 3, that is, the included angle between two adjacent second notching members 6 is 120°.

[0031] In order to facilitate connecting the second notching member 6 to the balloon 3, the second notching member 6 is pasted on the working section of the outer surface of the balloon 3 through medical glue. Preferably, the length of the second notching member 6 is the same as the length of the working section of the balloon 3. The medical glue is instant glue or ultraviolet light-curable glue.

[0032] In one embodiment, referring to Figures 11 to 15 , the first imaging member and the second imaging member are imaging cores 702, and the structural wire 7 includes the imaging cores 702. The structural wire 7 further includes a structural layer 701, and the structural layer 701 is wrapped outside the imaging core 702. The imaging core 702 extends along the axial direction of the structural wire 7, and the structural layer 701 covers the entire outer surface of the imaging core 702. The material of the structural layer 701 is medical stainless steel, cobalt-chromium alloy or nickel-titanium alloy, and other metals or alloys with good biocompatibility can also be selected, or it can be a polymer material with good biocompatibility, which is not limited here. Preferably, the material of the structural layer 701 is nickel-titanium alloy. Selecting nickel-titanium alloy material can further improve the flexibility of the notched balloon, and it has good shape memory performance. The material of the imaging core 702 is one of platinum, tungsten, barium sulfate, bismuth subcarbonate, bismuth oxychloride or bismuth trioxide.

[0033] In this embodiment, the cross-section of the structural wire 7 can be rectangular, square or circular, or other polygons, which is not limited here. As Figures 11 to 13As shown, the cross-section of the structural wire 7 is rectangular, and the corners of the rectangle are rounded. As Figure 14 shown, the cross-section of the structural wire 7 is circular. As Figure 15 shown, the cross-section of the structural wire 7 is square, and the corners of the square are chamfered. The cross-section of the developing core 702 is circular, rectangular or square, or it can be other shapes, which are not limited here. As Figure 11 shown, the cross-section of the developing core 702 is circular. As Figure 12 shown, the cross-section of the developing core 702 is rectangular.

[0034] Furthermore, at least one developing core 702 is arranged in each structural wire 7. Refer to Figure 11 , Figure 12 , Figure 14 and Figure 15 , one developing core 702 is arranged in each structural wire 7. Refer to Figure 13 shown, two developing cores 702 are arranged in each structural wire 7. The two developing cores 702 can be symmetrically arranged about the center of the structural wire 7, or can be asymmetrically arranged. In other embodiments, more than two parallel developing cores 702 are arranged in each structural wire 7, and multiple developing cores 702 can be evenly distributed in the cross-section of the structural wire 7.

[0035] In the above embodiments, the structural wire 7 of the present invention adopts a structure in which the developing core 702 containing a developable material is enclosed in the structural layer 701. In this embodiment, the structural layer 701 is preferably a nickel-titanium alloy flat wire. The height of the second scoring member 6 is 0.2 - 0.5 mm. The height of the second scoring member 6 is the distance between the position of the second scoring member 6 away from the balloon 3 and the surface of the balloon 3. The cross-sectional size of the nickel-titanium alloy flat wire is preferably 0.038 * 0.076 mm. The volume percentage of the developing core 702 in the structural wire 7 is 10% - 50%. The higher the proportion of the developing core 702, the better the developing effect of the first scoring member 4 and the second scoring member 6. The higher the proportion of the developing core 702, the lower the strength of the first scoring member 4 and the second scoring member 6, affecting the cutting efficiency.

[0036] Example 1

[0037] The structural layer 701 in the structural wire 7 is nickel-titanium alloy, and the developing core 702 is platinum. When the volume proportion of platinum is 10%, the strength of the structural wire 7 is 95% of that of pure nickel-titanium alloy; when the volume proportion of platinum is 30%, the strength of the structural wire 7 is 80% of that of pure nickel-titanium alloy; when the volume proportion of platinum is 50%, the strength of the structural wire 7 is 65% of that of pure nickel-titanium alloy.

[0038] Example 2

[0039] The structural layer 701 in the structural wire 7 is made of nitinol alloy, and the developing core 702 is barium sulfate. When the volume ratio of barium sulfate is 10%, the strength of the structural wire 7 is 85% of that of pure nitinol alloy; when the volume ratio of barium sulfate is 30%, the strength of the structural wire 7 is 70% of that of pure nitinol alloy; when the volume ratio of barium sulfate is 50%, the strength of the structural wire 7 is 55% of that of pure nitinol alloy.

[0040] From the experimental data in the above two embodiments, it can be seen that the higher the addition ratio of the developable material, the lower the strength of the structural wire 7, and thus the lower the strength of the first scoring member 4 and the second scoring member 6. At the same time, it can be known that when the same proportion of platinum and barium sulfate is added to the structural wire 7, compared with adding barium sulfate, adding platinum results in a smaller change in the strength of the first scoring member 4 and the second scoring member 6.

[0041] By adding the developing core 702 of the developable material to the first scoring member 4 and the second scoring member 6, the developing effect of the first scoring member 4 and the second scoring member 6 is significantly enhanced. For details, please refer to Figure 16 the pictures in Figure 16 which are the comparison diagrams of the developing effects of different scoring balloons on the second scoring member 6 under X-rays. In the figure, line A represents the state where the second scoring member 6 is made of nitinol alloy and 30% platinum (developable material) and the scoring balloon is not expanded. Line C represents the state where the second scoring member 6 is made of nitinol alloy and 30% platinum (developable material) and the scoring balloon is in the expanded state. Line B represents the scoring balloon where no developable material is added to the second scoring member 6. The two small dots at both ends of line A, line B, and line C are the two developing rings inside the balloon. From Figure 16 it can be seen that under X-rays, the second scoring member 6 can be clearly seen in line A and line C, which is the black line between the two small dots, while the second scoring member 6 can hardly be seen in line B. It can be seen that adding the developable material to the nitinol alloy can make the second scoring member 6 develop under X-rays.

[0042] In another embodiment, referring to Figures 17 to 19 , the first developing member and the second developing member are developing wires 703. In this embodiment, the structural wire 7 includes parallel developing wires 703 and supporting wires 704. Each structural wire 7 includes at least one developing wire 703 and at least one supporting wire 704. The developing wires 703 and the supporting wires 704 are wound side by side in parallel, and the winding joints of the developing wires 703 and the supporting wires 704 are welded. The height of the supporting wire 704 is higher than that of the developing wire 703 to facilitate the high-strength supporting wire 704 to cut the diseased part. As shown in Figure 18 and Figure 19As shown, the structural wire 7 includes a developing wire 703 and a support wire 704 arranged in parallel. The two are wound in parallel to form a hollow-structured second scoring member 6 or a first scoring member 4, and the adjacent developing wire 703 and support wire 704 are welded. The material of the developing wire 703 is one of platinum, tungsten, barium sulfate, bismuth subcarbonate, bismuth hydroxide chloride, or bismuth trioxide. The material of the support wire 704 is medical stainless steel, cobalt-chromium alloy, or nickel-titanium alloy. Other metals or alloys with good biocompatibility can also be selected, or it can be a polymer material with good biocompatibility, which is not limited here. Preferably, the material of the support wire 704 is nickel-titanium alloy. Selecting nickel-titanium alloy material can further improve the flexibility of the scoring balloon, and it has good shape memory performance.

[0043] Further, the cross-sections of the developing wire 703 and the support wire 704 can be rectangular, square, or circular. As Figure 19 shown, in this embodiment, the cross-sections of the developing wire 703 and the support wire 704 are rectangular. To improve the cutting efficiency, the hardness of the support wire 704 is greater than that of the developing wire 703, and the distance from the outer surface of the developing wire 703 to the axis of the structural wire 7 is less than the distance from the outer surface of the support wire 704 to the axis of the structural wire 7, that is, the outer diameter of the structural wire 7 at the position of the developing wire 703 is less than the outer diameter at the position of the support wire 704, so as to facilitate the support wire 704 to cut the lesion. In other embodiments, the distance from the outer surface of the developing wire 703 to the axis of the structural wire 7 can also be equal to the distance from the outer surface of the support wire 704 to the axis of the structural wire 7.

[0044] Among them, the cross-section of the hollow structure member formed by winding the structural wire 7 can be a hollow circle or a hollow polygon. Specifically, as Figure 9 and Figure 18 shown, the hollow polygon is a hollow triangle, that is, the hollow structure member is a hollow triangular prism structure formed by winding the structural wire.

[0045] For the scoring balloon catheter of the present invention, the balloon 3 is a compliant balloon, a semi-compliant balloon, or a non-compliant balloon, and the selected material is one or more of polyvinyl chloride, polyethylene, polyurethane, polyamide, polyether block polyamide, polyethylene terephthalate, or other polymer materials with good biocompatibility.

[0046] For the scoring balloon catheter of the present invention, the first scoring member 4 and the second scoring member 6 are visible under X-ray, which can achieve precise positioning of the first scoring member 4 and the second scoring member 6 and precise cutting of the lesion. The first scoring member 4 can be inserted from the guide wire inlet 102, passed through the scoring member cavity 2021, and extended to the distal end of the catheter. The first scoring member 4 can first enter the severely stenosed part of the blood vessel, perform scoring and cutting on this part, and then move the balloon 3 to the lesion, and the second scoring member 6 on the balloon 3 performs further dilation treatment on the lesion.

[0047] In the description of this solution, it should be understood that the orientation or positional relationship indicated by terms such as "upper", "lower", "vertical", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings. This is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation to this solution.

[0048] In addition, the terms "first" and "second" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include one or more of such features. In the description of this solution, the meaning of "a plurality" is two or more, unless otherwise specifically defined.

[0049] The various embodiments in this specification are described in a progressive manner. Each embodiment focuses on the differences from other embodiments. For the same or similar parts among the various embodiments, reference can be made to each other.

[0050] The above description of the disclosed embodiments enables those skilled in the art to implement or use the present invention. Various modifications to these embodiments will be obvious to those skilled in the art. The general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to these embodiments shown herein, but rather will be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A notched balloon catheter, characterized in that, It includes a catheter body, a balloon and a catheter hub. The catheter body includes an inner tube and an outer tube. The outer tube is sleeved outside the inner tube. The distal end of the outer tube is connected to the proximal end of the balloon, and the proximal end is connected to the catheter hub. The distal end of the inner tube extends out of the distal end of the balloon. A first scoring member and a guide wire are disposed through the inner cavity of the inner tube. The first scoring member includes a first imaging member that can be imaged under X-rays. The inner tube includes a scoring member cavity and a guide wire cavity. The scoring member cavity and the guide wire cavity extend through along the length direction of the inner tube. The scoring member cavity is arranged parallel to the guide wire cavity. The first scoring member passes through the scoring member cavity and extends out of the distal end of the inner tube.

2. The notched balloon catheter according to claim 1, wherein A second scoring member is disposed on the outer surface of the balloon. The second scoring member is arranged parallel to the axial direction of the balloon. The second scoring member is arranged along the length direction of the balloon. The second scoring member includes a second imaging member that can be imaged under X-rays.

3. The notched balloon catheter according to claim 1, characterized in that, A first guide tube and a second guide tube are disposed in the inner tube. The lumen of the first guide tube is the scoring member cavity, and the lumen of the second guide tube is the guide wire cavity.

4. The notched balloon catheter according to claim 1, wherein The inner tube is a double lumen tube. The lumen of the inner tube is separated into the scoring member cavity and the guide wire cavity by a partition wall.

5. The scored balloon catheter according to claim 2, wherein The first scoring member and the second scoring member are hollow structural members formed by helically winding structural wires.

6. The notched balloon catheter according to claim 5, wherein Both the first imaging member and the second imaging member are imaging cores. The structural wire includes an imaging core and a structural layer. The structural layer is sleeved on the outer surface of the imaging core. The imaging core extends along the center line of the structural wire.

7. The notched balloon catheter according to claim 6, characterized in that, At least one imaging core is disposed in each structural wire. Two imaging cores are disposed in the structural wire. The two imaging cores are symmetrically arranged about the central position of the structural wire. The material of the structural layer is medical stainless steel, cobalt-chromium alloy or nitinol alloy.

8. The notched balloon catheter according to claim 5, wherein, Both the first imaging member and the second imaging member are imaging wires. The structural wire includes imaging wires and support wires arranged in parallel. Each structural wire includes at least one imaging wire and at least one support wire. The imaging wire and the support wire are wound side by side in parallel. The height of the support wire is higher than the height of the imaging wire. The material of the support wire is medical stainless steel, cobalt-chromium alloy or nitinol alloy.

9. The notched balloon catheter according to claim 5, wherein The cross-section of the hollow structural member is a hollow circle or a hollow polygon. The hollow polygon includes a hollow triangle and a hollow quadrilateral. The volume percentage of the first imaging member and / or the second imaging member in the structural wire is 10% - 50%.

10. The scored balloon catheter according to claim 2, wherein, The balloon includes a working section and a guiding section. The second scoring member is bonded to the working section. The second scoring member is bonded to the balloon by a medical adhesive. The medical adhesive is an instant adhesive or an ultraviolet curable adhesive.

Images