Nicking shock wave balloon catheter

Abstract

The utility model is suitable for the technical field of interventional medical instruments, and provides a nick shock wave balloon catheter which comprises a balloon. The far end of the catheter assembly is arranged in the balloon in a penetrating mode and connected with the far end of the balloon in a sealed mode, and the near end of the balloon is connected between the far end and the near end of the catheter assembly in a sealed mode; the catheter assembly is provided with a first channel which is communicated with an inner cavity of the balloon and is at least used for inputting a filling medium into the balloon; the electrode assembly is arranged on the portion, located in the balloon, of the catheter assembly, and the electrode assembly is provided with an electrode hole used for generating shock waves; the nicking assembly comprises a nicking wire arranged on the outer surface of the balloon, and the nicking wire is used for transmitting shock waves to a calcified part of a blood vessel; wherein the axes of the electrode holes intersect on the indentation wires. In the utility model, the stress generated by the nick shock wave balloon catheter is concentrated, and the calcification is easier to generate regular cracks which are through along the axial direction due to the stress concentration, so that the crushing efficiency of the calcification and the success rate of an operation are improved.

Description

Technical Field

[0001] The utility model belongs to the technical field of interventional medical devices, and particularly relates to a notched shock wave balloon catheter. Background Art

[0002] The application of shock wave balloons in the recanalization of severely calcified blood vessels has significant clinical significance. In related technologies, the internal electrodes of shock wave balloons all adopt a perforated hollow tube structure, and multiple hollow tubes are evenly fixed on the inner tube inside the balloon to form multiple shock wave sources. However, there are only two electrode holes in each hollow tube electrode that are symmetrically distributed at 180°. This design has uneven circumferential energy distribution at the electrode, which may cause the circumferential calcification to not be shattered. Or, multiple hollow tube electrodes are evenly distributed on the inner tube inside the balloon, and the energy emitted by each hollow tube electrode is weakened due to superposition interference, which may cause the calcification between the hollow tube electrodes not to be shattered axially. In addition, the propagation of shock waves is divergent, and irregular cracks are likely to appear when shattering calcification, which affects the dilation after the operation. These reasons will all reduce the efficiency of calcification shattering and affect the success rate of the operation. Summary of the Utility Model

[0003] In view of this, the utility model provides a notched shock wave balloon catheter to solve the problems of low efficiency of calcification shattering and affecting the success rate of the operation.

[0004] To solve the above problems, the technical solution of the utility model is realized as follows:

[0005] A notched shock wave balloon catheter includes: a balloon; a catheter assembly, the distal end of the catheter assembly is inserted into the balloon and is hermetically connected to the distal end of the balloon, and the proximal end of the balloon is hermetically connected between the distal end and the proximal end of the catheter assembly; the catheter assembly has a first channel that communicates with the inner cavity of the balloon and is at least used to input a filling medium into the balloon; an electrode assembly, which is arranged on the catheter assembly located inside the balloon, and the electrode assembly has electrode holes for generating shock waves; a notching assembly, including notching wires arranged on the outer surface of the balloon, and the notching wires are used to conduct the shock waves to the calcified part of the blood vessel; wherein, the axes of the electrode holes intersect on the notching wires.

[0006] In some embodiments, N electrode holes are provided, M notching wires are provided, and the axis of at least one electrode hole intersects with one notching wire; wherein, N≥1, M≥1.

[0007] In some embodiments, three electrode holes are provided, at least three notching wires are provided, the axis of each electrode hole intersects with at least one notching wire, and the notching wires intersected by the axis of each electrode hole are different.

[0008] In some embodiments, the scoring wire includes a bottom portion and a tip portion. The bottom portion is connected to the outer surface of the balloon, and the tip portion is connected to the bottom portion with the tip facing away from the balloon. Wherein, the cross-section perpendicular to the length direction of the scoring wire is in the shape of a "triangle".

[0009] In some embodiments, the scoring wire has at least one of the following characteristics: (1) The total height of the scoring wire is 0.2 mm to 0.35 mm; (2) The height of the bottom portion is 0.08 mm to 0.17 mm; (3) The included angle of the tip portion is 20° to 60°; (4) The chamfer of the tip on the tip portion is 0.01 mm to 0.03 mm; (5) The chamfers on both sides in the length direction of the bottom portion are 0.02 mm to 0.04 mm.

[0010] In some embodiments, the scoring wire extends along the length direction of the balloon, the distal end of the scoring wire extends to the distal end of the balloon, and the proximal end of the scoring wire extends to the proximal end of the balloon.

[0011] In some embodiments, the scoring assembly further includes a distal fixing tube and a proximal telescopic tube. The distal fixing tube is sleeved on and connected to the distal end of the balloon, one end of the proximal telescopic tube is connected to the proximal end of the scoring wire, and the other end of the proximal telescopic tube is connected to the catheter assembly.

[0012] In some embodiments, the electrode assembly includes: an outer electrode, on which the electrode holes are formed and penetrate through the thickness of the outer electrode; an inner electrode, sleeved inside the outer electrode; and an insulating tube, disposed between the outer electrode and the inner electrode. The insulating tube is provided with insulating holes, and the insulating holes correspond to the electrode holes one by one and are coaxially arranged.

[0013] In some embodiments, two sets of the electrode assemblies are spaced apart on the catheter assembly located inside the balloon. The outer electrode near the distal end of the balloon is connected to an external power source through a first wire, the inner electrode near the distal end of the balloon is connected to the inner electrode near the proximal end of the balloon through a second wire, and the outer electrode near the proximal end of the balloon is connected to the external power source through a third wire.

[0014] In some embodiments, the length of the inner electrode is greater than the length of the outer electrode, and the length of the insulating tube is greater than the length of the inner electrode.

[0015] In some embodiments, notches are provided at both ends of the inner electrode.

[0016] In some embodiments, the catheter assembly includes a first catheter and a second catheter. The distal end of the first catheter is sealingly connected to the proximal end of the balloon, and a first channel is formed within the first catheter. The distal end of the second catheter passes through the first channel and is inserted into the balloon to be sealingly connected to the distal end of the balloon. The electrode assembly is connected to the distal end of the second catheter, a second channel is formed within the second catheter, and a guiding head is connected to the distal end of the second catheter.

[0017] A notch shock wave balloon catheter provided by an embodiment of the present utility model includes a balloon, a catheter assembly, an electrode assembly, and a notching assembly. The distal end of the catheter assembly is inserted into the balloon, the proximal end of the balloon is sealingly connected between the distal end and the proximal end of the catheter assembly, the electrode assembly is disposed on the catheter assembly located within the balloon, the electrode assembly has electrode holes for generating shock waves, the notching assembly includes notching wires disposed on the outer surface of the balloon, and the axes of the electrode holes intersect on the notching wires. In the embodiment of the present utility model, by making the axes of the electrode holes intersect on the notching wires, in this way, the notching wires are directly above the electrode holes. When the shock wave reaches the top of the notching wires, the calcification in contact with the top of the notching wires is more likely to generate regular and axially penetrating cracks due to stress concentration, further improving the fragmentation efficiency. Moreover, the generated regular cracks are also beneficial for subsequent treatment, improving the surgical success rate and reducing the complications of patients, and having good design ingenuity. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 is an overall structural schematic diagram of the notch shock wave balloon catheter provided by an embodiment of the present utility model;

[0019] Figure 2 is Figure 1 a schematic cross-sectional view taken along line A-A in

[0020] Figure 3 is a schematic cross-sectional view of the notching wire provided by an embodiment of the present utility model;

[0021] Figure 4 is a structural schematic diagram of the electrode assembly provided by an embodiment of the present utility model;

[0022] Figure 5 is an exploded schematic diagram of the outer electrode, the insulating tube, and the inner electrode provided by an embodiment of the present utility model;

[0023] Figure 6 is another structural schematic diagram of the inner electrode provided by an embodiment of the present utility model.

[0024] Description of the reference numerals:

[0025] 1. Notch shock wave balloon catheter; 11. Balloon; 111. Inner cavity; 12. Catheter assembly; 120. First channel; 121. First catheter; 122. Second catheter; 123. Second channel; 124. Guide head; 13. Electrode assembly; 130. Electrode hole; 131. Outer electrode; 132. Inner electrode; 1321. Notch; 133. Insulating tube; 1331. Insulating hole; 134. First wire; 135. Second wire; 136. Third wire; 14. Notch assembly; 141. Notch wire; 1411. Bottom; 1412. Tip end; 142. Distal fixing tube; 143. Proximal telescopic tube; 15. Radiopaque ring. Detailed implementation manners

[0026] In order to make the objectives, technical solutions and advantages of the present utility model clearer, the present utility model will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present utility model and are not used to limit the present utility model.

[0027] In the various specific technical features described in the specific embodiments, they can be combined in any suitable manner without contradiction. For example, different embodiments and technical solutions can be formed by combining different specific technical features. In order to avoid unnecessary repetition, various possible combination methods of the various specific technical features in the present utility model will not be described separately.

[0028] In the following description, the terms "first, second,..." only distinguish different objects and do not indicate that there are the same or related connections between the objects. It should be understood that the orientation descriptions "above", "below", "outside", and "inside" are all in the orientation in the normal use state, and the "left" and "right" directions represent the left and right directions shown in the specific corresponding schematic diagrams, which can be the left and right directions in the normal use state or not.

[0029] It should be noted that the term "comprising", "including" or any other variant thereof is intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements not only includes those elements, but also includes other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. Without further limitation, the element defined by the statement "including one..." does not exclude the existence of another identical element in the process, method, article or device including the element. "Plurality" means greater than or equal to two.

[0030] As Figure 1As shown, a notch shock wave balloon catheter 1 provided by an embodiment of the present utility model is used to be inserted into a calcified blood vessel and generate shock waves in an energized state to act on calcified substances, so as to achieve the purpose of crushing the calcified substances and treating the calcified blood vessel. The term "distal end" in this article refers to the end of the notch shock wave balloon catheter 1 inserted into the blood vessel or the end close to the treatment site to be treated. The "proximal end" refers to the end of the notch shock wave balloon catheter 1 close to the operator or the end connected to the operating device.

[0031] As Figure 1 and Figure 2 As shown, a notch shock wave balloon catheter 1 provided by an embodiment of the present utility model includes a balloon 11, a catheter assembly 12, an electrode assembly 13, and a notch assembly 14. The balloon 11 is made of a semi-compliant material Pebax (Chinese name: polyether block polyamide) or a non-compliant material nylon. The balloon 11 has an inner cavity 111, and the inner cavity 111 can be filled with a conductive liquid to inflate the balloon 11. The burst pressure of the balloon 11 can reach up to 24 atm (atm, unit of atmospheric pressure), and the high burst pressure performance can reduce the risk of the balloon 11 rupturing during the operation.

[0032] As Figure 1 As shown, in some embodiments, the catheter assembly 12 is mainly used to be inserted into the blood vessel, send the balloon 11 to the calcified part of the blood vessel, and is used to introduce a filling medium (such as gas or liquid) into the inner cavity 111 of the balloon 11 to inflate the balloon 11. Specifically, the distal end of the catheter assembly 12 is inserted into the balloon 11 and is hermetically connected to the distal end of the balloon 11. The proximal end of the balloon 11 is hermetically connected between the distal end and the proximal end of the catheter assembly 12. The catheter assembly 12 has a first channel 120 that communicates with the inner cavity 111 of the balloon 11 and is at least used to input a filling medium into the balloon 11. With this setting, the two ends of the balloon 11 are hermetically connected, so that the inner cavity 111 of the balloon 11 can only communicate with the outside through the first channel 120, so that the filling medium can enter the inner cavity 111 of the balloon 11 through the first channel 120 to inflate the balloon 11. At the same time, the catheter assembly 12 may also have a second channel 123. The second channel 123 extends along the length direction of the catheter assembly 12 to the distal end and is completely separated from the first channel 120. The second channel 123 is used for a guide wire to penetrate. The guide wire has high flexibility and strength to improve the strength of the catheter assembly 12 through the guide wire, so as to improve the passing performance of the catheter assembly 12 when being pushed in the blood vessel.

[0033] Specifically, when the catheter assembly 12 is configured to have at least a first channel 120 and a second channel 123, it can be a tube structure with at least two hollow channels inside, that is, the catheter assembly 12 is a tube with multiple hollow structures; or the catheter assembly 12 can be configured to have at least two separate tubes, each tube having a channel to form the first channel 120 and the second channel 123. Then, the multiple tubes can be connected into one body, arranged side by side, or coaxially sleeved to form the catheter assembly 12. The specific setting is selected according to the design requirements, and the setting flexibility is good.

[0034] As Figure 1 and Figure 2 shown, in some embodiments, the electrode assembly 13 is disposed on the catheter assembly 12 located within the balloon 11, and the electrode assembly 13 has electrode holes 130 for generating shock waves. Specifically, the electrode assembly 13 is connected to a device that can provide high voltage and large current from the outside. After being energized, a potential difference for generating shock waves can be formed, and the generated shock waves act on the scoring assembly 14, thereby achieving the purpose of shattering the vascular calcifications in contact with the scoring assembly 14. The scoring assembly 14 includes scoring wires 141 disposed on the outer surface of the balloon 11, and the scoring wires 141 are used to conduct shock waves to the calcified parts of the blood vessels; wherein, the axes of the electrode holes 130 intersect on the scoring wires 141. Specifically, the material of the scoring wires 141 is a superelastic metal material. The scoring wires 141 formed by the superelastic metal material are easily restored to the original state after deformation, so that it is easier for the doctor to withdraw the scoring shock wave balloon 11 catheter 1 from the patient's blood vessel. The scoring wires 141 are preferably made of nitinol alloy. The scoring wires 141 can be fixed to the balloon 11 by means such as laser welding. The distal end of the scoring wires 141 is fixed to the distal end of the balloon 11, and the proximal end of the scoring wires 141 is connected to the proximal end of the balloon 11. The provided scoring wires 141 contact the vascular calcifications after the balloon 11 is inflated, so that the energy of the shock waves can be transmitted to the calcifications. Moreover, the axes of the scoring wires 141 intersect with those of the electrode holes 130, that is, the scoring wires 141 are distributed directly above the electrode holes 130. This design enables the scoring wires 141 to withstand the maximum shock wave energy from the front to improve the efficiency of shattering calcifications.

[0035] An indentation shock wave balloon catheter 1 provided in an embodiment of the present utility model includes a balloon 11, a catheter assembly 12, an electrode assembly 13, and an indentation assembly 14. The distal end of the catheter assembly 12 is inserted into the balloon 11, and the proximal end of the balloon 11 is hermetically connected between the distal end and the proximal end of the catheter assembly 12. Thus, a filling medium can be introduced into the inner cavity 111 of the balloon 11 through a first channel 120 in the catheter assembly 12 to inflate and expand the balloon 11. The electrode assembly 13 is disposed on the catheter assembly 12 located within the balloon 11, and electrode holes 130 for generating shock waves are provided on the electrode assembly 13. The indentation assembly 14 includes an indentation wire 141 disposed on the outer surface of the balloon 11, and the axis of the electrode hole 130 intersects the indentation wire 141. In the embodiment of the present utility model, by making the axis of the electrode hole 130 intersect the indentation wire 141, in this way, the indentation wire 141 is directly above the electrode hole 130. When the shock wave reaches the top of the indentation wire 141, the calcified substances in contact with the top of the indentation wire 141 are more likely to generate regular and axially penetrating cracks due to stress concentration, further improving the shock-breaking efficiency. Moreover, the generated regular cracks are beneficial for subsequent treatment, improving the surgical success rate and reducing the complications of patients, with good design ingenuity.

[0036] In some embodiments, N electrode holes 130 are provided, and M indentation wires 141 are provided, and moreover, the axis of at least one electrode hole 130 intersects an indentation wire 141; wherein, N≥1, M≥1. Specifically, the number of electrode holes 130 provided can be more than the number of indentation wires 141. In this way, part of the shock waves generated by the electrode holes 130 can be transmitted to the indentation wires 141, and the other part directly acts on the blood vessel. It can also be that the number of electrode holes 130 provided is less than the number of indentation wires 141. In this way, part of the indentation wires 141 correspond to the electrode holes 130 and can thus receive the shock waves generated by the electrode holes 130, while the other indentation wires 141 that do not correspond to the electrode holes 130 only play the role of indentation positioning. It can also be that the number of electrode holes 130 provided is equal to the number of indentation wires 141 and they correspond one by one. In this way, each indentation wire 141 can receive the shock waves generated by the electrode holes 130. The specific setting method can be selected according to actual design requirements.

[0037] Such as Figure 1 And Figure 2As shown, in some embodiments, to better ensure the effect of crushing the calcified substances in the blood vessels, optionally, three electrode holes 130 are provided, and at least three scoring wires 141 are provided. The axis of each electrode hole 130 intersects at least one scoring wire 141, and the scoring wires 141 intersected by the axis of each electrode hole 130 are different. Specifically, the electrode holes 130 are evenly distributed in the circumferential direction of the electrode assembly 13. In this way, the scoring wires 141 are also evenly distributed in the circumferential direction of the balloon 11, and at least one electrode hole 130 is directly opposite to one scoring wire 141. With such a setting, it is beneficial for the shock wave energy generated by the electrode holes 130 to be evenly distributed along the circumference of the balloon 11 surface and the energy is relatively strong, thereby achieving the purpose of effectively shock-shattering the calcified substances in contact with the scoring wires 141.

[0038] In some possible implementation schemes, in addition to ensuring that the corresponding parts of the scoring wires 141 provided on the balloon 11 are directly opposite to the electrode holes 130, the remaining parts can extend towards the two ends of the balloon 11. The extended length can extend to the proximal end and the distal end of the balloon 11, or can have a preset distance interval, such as an interval of 1 mm or 2 mm, etc. The extended manner can be a straight extension along the length direction of the balloon 11, so that the shock waves on the scoring wires 141 can be linearly distributed, and the shattered calcified substances can generate regular linear cracks. Of course, the scoring wires 141 can also adopt ways such as spiral extension or corrugated extension. The extended length and the extended manner of the scoring wires 141 only need to meet the requirement of being able to effectively treat the calcified part. The setting methods are flexible and diverse, and can meet different design requirements.

[0039] As Figure 2 and Figure 3 As shown, in some embodiments, the scoring wire 141 includes a bottom 1411 and a tip 1412. The bottom 1411 is connected to the outer surface of the balloon 11, the tip 1412 is connected to the bottom 1411, and the tip faces away from the balloon 11; wherein, the cross-section perpendicular to the length direction of the scoring wire 141 is in the shape of a "triangle". Specifically, the shape of the scoring wire 141 provided on the balloon 11 is such that the cross-section obtained in the direction perpendicular to the length direction of the scoring wire 141 is in the shape of a "triangle". In this way, the bottom 1411 is connected to the balloon 11 and has a relatively large contact area, while one end of the tip 1412 is connected to the bottom 1411, and the other end extends away from the bottom 1411 and forms a tip, which is used to contact the calcified substances in the blood vessels, so that the stress is more concentrated, which is beneficial to shock-shattering the calcified substances.

[0040] As Figure 2 and Figure 3As shown, in some embodiments, the notched wire can be configured to have at least one of the following characteristics: (1) The total height H of the notched wire 141 is set to 0.2 mm to 0.35 mm; (2) The height H1 of the bottom 1411 is set to 0.08 mm to 0.17 mm; (3) The included angle θ of the tip portion 1412 is set to 20° to 60°; (4) The chamfer R1 of the upper tip of the tip portion 1412 is set to 0.01 mm to 0.03 mm; (5) The chamfers R on both sides in the length direction of the bottom 1411 are set to 0.02 mm to 0.04 mm. With such a setting, the cross-section perpendicular to the length direction of the notched wire 141 is in an equilateral triangle (as Figure 3 As shown, in this cross-sectional shape, with the tip as the vertex, connecting lines are drawn to the two ends of the bottom 1411, and the shape enclosed by the connecting lines between the two ends of the bottom 1411), when the notched wire 141 can provide sufficient stress, it also enables the entire notched shock wave balloon catheter 1 to have a smaller folding profile, which is beneficial for the notched shock wave balloon catheter 1 to smoothly pass through the lesion site. Further, the bottom 1411 of the cross-section of the notched wire 141 can be rounded, the rounded corner R is 0.02 to 0.04 mm, and the top rounded corner R1 is 0.005 to 0.015 m. The rounded corners R and R1 can prevent the notched wire 141 from cutting the balloon 11 when folding the balloon 11, improving the safety of using the balloon 11.

[0041] In some embodiments, the notched wire 141 extends along the length direction of the balloon 11, the distal end of the notched wire 141 extends to the distal end of the balloon 11, and the proximal end of the notched wire 141 extends to the proximal end of the balloon 11. Specifically, the notched wire 141 extends according to the outer contour shape of the balloon 11, so that it can change following the shape of the balloon 11 when the balloon 11 expands or contracts, without restricting the shape change of the balloon 11. The connection between the distal end of the notched wire 141 and the distal end of the balloon 11, and the connection between the proximal end of the notched wire 141 and the proximal end of the balloon 11 can be achieved by laser welding or bonding, etc., and the connection method has good flexibility.

[0042] As Figure 1As shown, in some embodiments, the scoring assembly 14 also includes a distal fixed tube 142 and a proximal telescopic tube 143, the distal fixed tube 142 is sleeved on the distal end of the balloon 11 and connected, one end of the proximal telescopic tube 143 is connected to the proximal end of the scoring wire 141, and the other end of the proximal telescopic tube 143 is connected to the catheter assembly 12. Specifically, the material of the distal fixed tube 142 is Pebax (Chinese name: polyether block polyamide), and the proximal telescopic tube 143 is a silicone tube that can undergo elastic deformation. One end of the proximal telescopic tube 143 is connected to the scoring wire 141, and the other end is welded to the catheter assembly 12. By setting the proximal telescopic tube 143, when the balloon 11 is pressurized and depressurized, the shape of the balloon 11 will change, and the proximal telescopic tube 143 set at the proximal end of the scoring wire 141 will follow the elastic deformation, and can move in the axial direction without affecting the shape of the balloon 11, and the design is ingenious.

[0043] like Figure 4 and Figure 5 As shown, in some embodiments, the electrode assembly 13 includes an outer electrode 131, an inner electrode 132 and an insulating tube 133. The electrode hole 130 is formed on the outer electrode 131 and is set through the thickness of the outer electrode 131. The inner electrode 132 is sleeved in the outer electrode 131, and the insulating tube 133 is set between the outer electrode 131 and the inner electrode 132. The insulating tube 133 is provided with an insulating hole 1331, and the insulating hole 1331 corresponds to the electrode hole 130 one by one and is coaxially arranged. Specifically, since the electrode assembly 13 is fixed on the catheter assembly 12 located in the balloon 11, when the electrode assembly 13 includes the above-mentioned structural design, the inner electrode 132 is fixed to the catheter assembly 12 by UV glue (UV is the abbreviation of Ultraviolet Rays, and the Chinese name of UV glue is: shadowless glue or photosensitive glue) to achieve the fixation of each group of electrode assemblies 13. The outer electrode 131 and the inner electrode 132, as well as the insulating tube 133 and the inner electrode 132 are also bonded together by UV glue. The materials of the outer electrode 131 and the inner electrode 132 can be nickel-titanium alloy, stainless steel, platinum, titanium and titanium alloy, tungsten-copper alloy, so as to have good conductivity. The material of the insulating tube 133 can be polyimide, polyurethane and a mixture of the two, which has achieved good insulation performance. The insulating tube 133 is arranged between the outer electrode 131 and the inner electrode 132, and the number of insulating holes 1331 arranged on the insulating tube 133 is the same as the number of electrode holes 130 arranged on the outer electrode 131, and the size of the insulating hole 1331 is the same as the electrode hole 130 on the outer electrode 131 and is concentric. In this design, the part of the inner electrode 132 exposed at the insulating hole 1331 of the insulating tube 133 and the edge of the electrode hole 130 on the outer electrode 131 form a potential difference that generates a shock wave, so that the shock wave can be effectively generated.

[0044] like Figure 5 andFigure 6 As shown, in some embodiments, two sets of electrode assemblies 13 are spaced apart on the catheter assembly 12 located within the balloon 11. The outer electrode 131 near the distal end of the balloon 11 is connected to an external power source through a first wire 134. The inner electrode 132 near the distal end of the balloon 11 is connected to the inner electrode 132 near the proximal end of the balloon 11 through a second wire 135. The outer electrode 131 near the proximal end of the balloon 11 is connected to a third wire 136 and then to the external power source. In this way, the outer electrode 131 near the distal end of the balloon 11 is connected to the external power source through the first wire 134, the inner electrode 132 near the distal end of the balloon 11 is connected to the inner electrode 132 near the proximal end of the balloon 11 through the second wire 135, and the outer electrode 131 near the proximal end of the balloon 11 is connected to the external power source through the third wire 136. Thus, a circuit loop is formed by connecting the two sets of electrode assemblies 13 in series through the first wire 134, the second wire 135, and the third wire 136. The other ends of the first wire 134 and the third wire 136 can be connected to a high-voltage and high-current device to obtain electrical energy. Moreover, the end of the first wire 134 for connecting to the external high-voltage and high-current device can pass through the inner electrode 132 near the proximal end of the balloon 11, so as not to additionally increase the outer contour size of the balloon 11, thereby reducing the contour after the balloon 11 is folded, which is beneficial for the balloon 11 to pass through the narrow diseased blood vessel. In addition, the connection manner between each wire and each electrode can be laser welding, soldering, etc., which can preferably ensure the electrical conductivity at each connection point.

[0045] As Figure 1 and Figure 5 As shown, in some embodiments, the length of the inner electrode 132 is set to be greater than the length of the outer electrode 131, and the length of the insulating tube 133 is set to be greater than the length of the inner electrode 132. In this way, the outer electrode 131 and the inner electrode 132 are separated by the insulating tube 133, which preferably avoids the generation of shock waves at both ends of the outer electrode 131 and the inner electrode 132, thus not affecting the stability of the potential difference at the position of the electrode holes 130. Moreover, the inner electrode 132 with a longer size has a larger contact area with the catheter assembly 12, which is conducive to fixing the inner electrode 132 on the catheter assembly 12 with UV glue to prevent the electrode assembly 13 from sliding.

[0046] As Figure 6 ​As shown, in some embodiments, notches 1321 may also be provided at both ends of the inner electrode 132. Specifically, the number of notches 1321 provided may be one or multiple. When multiple notches 1321 are provided, the notches 1321 may be arranged in a uniformly distributed manner. The notches 1321 are used to fix the wires, that is, when the first wire 134, the second wire 135, and the third wire 136 are arranged as described above, they can be snapped into the corresponding notches 1321 to achieve fixation. Moreover, the notches 1321 can also accommodate the wires connected to the outer electrode 131, thereby preventing the wires connected to the outer electrode 131 from protruding, and thus increasing the overall flexibility of the scored shock wave balloon catheter 1.

[0047] As Figure 1 shown, in some embodiments, the catheter assembly 12 includes a first catheter 121 and a second catheter 122. The distal end of the first catheter 121 is hermetically connected to the proximal end of the balloon 11, and a first channel 120 is formed inside the first catheter 121; the distal end of the second catheter 122 passes through the first channel 120 and is inserted into the balloon 11 to be hermetically connected to the distal end of the balloon 11. The electrode assembly 13 is connected to the distal end of the second catheter 122. A second channel 123 is formed inside the second catheter 122, and a guiding head 124 is connected to the distal end of the second catheter 122. Specifically, the catheter assembly 12 is formed by combining the coaxially arranged first catheter 121 and second catheter 122. The second catheter 122 is inserted into the first catheter 121 and has a gap with the inner wall of the first catheter 121 to form the first channel 120. The first channel 120 communicates with the inner cavity 111 of the balloon 11, so that the filling medium can enter the inner cavity 111 of the balloon 11 through the first channel 120 to inflate the balloon 11; or the filling medium in the inner cavity 111 of the balloon 11 is discharged through the first channel 120 to deflate the balloon 11. A second channel 123 is formed inside the second catheter 122, and this channel is used for the guide wire to pass through, so as to improve the smoothness of the overall advancement of the scored shock wave balloon catheter 1 in the blood vessel.

[0048] In some embodiments, the first catheter 121 is a hollow tube extruded from nylon material. The second catheter 122 is a multi-layer composite hollow tube composed of PTFE (PTFE is the abbreviation of Polytetrafluoroethylene, and the Chinese name is: polytetrafluoroethylene), PE (PE is the abbreviation of Polyethylene, and the Chinese name is: polyethylene), Pebax (Chinese name: polyether block polyamide) or nylon material. The inner layer (the inner wall of the second channel 123) is a PTFE layer, and PTFE has an extremely low coefficient of friction, which is beneficial for the passage of the guide wire during the operation. The outermost layer is a Pebax or nylon layer, which can provide sufficient support strength, thereby improving the overall pushability.

[0049] As Figure 1As shown, in some embodiments, the distal end of the balloon 11 is welded to the distal end of the second catheter 122. At the same time, a guiding head 124 is connected to the distal end of the second catheter 122. The guiding head 124 is a relatively soft composite hollow tube composed of low-density polyethylene and high-density polyethylene. The guiding head 124 is the first to enter the blood vessel. The distal end of the guiding head 124 is provided with a tip and is subjected to a smooth chamfering treatment. In this way, it is not only beneficial to enter the blood vessel, but also can prevent damage to the blood vessel wall caused by pushing the balloon 11 during the operation.

[0050] As Figure 1 shown, in some embodiments, a radiopaque ring 15 is provided on the second catheter 122 located in the inner cavity 111 of the balloon 11. The radiopaque ring 15 is used for the doctor to accurately position the balloon 11 during the operation. Specifically, the radiopaque ring 15 is usually provided in two and is arranged in a spaced-apart manner. One radiopaque ring 15 is close to the distal end of the balloon 11, and the other is close to the proximal end of the balloon 11. The two radiopaque rings 15 are both installed on the second catheter 122 by forging. The setting of the radiopaque ring 15 can become an imaging marker (such as for X-ray imaging), so that the specific position can be determined in the image, preventing the doctor from pushing the balloon 11 to other blood vessel positions of the patient and causing unnecessary harm to the patient. The material of the radiopaque ring 15 is tantalum, platinum-tungsten alloy, platinum, platinum-iridium alloy, etc. In the embodiment of the present invention, the radiopaque ring 15 is set as a platinum-iridium alloy, and the imaging performance is excellent.

[0051] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, and improvements made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A notched shock wave balloon catheter, characterized in that: include: Balloon; A catheter assembly, wherein the distal end of the catheter assembly is inserted into the balloon and sealedly connected to the distal end of the balloon, and the proximal end of the balloon is sealedly connected between the distal end and the proximal end of the catheter assembly; the catheter assembly has a first channel that is communicated with the inner cavity of the balloon and is at least used to input a filling medium into the balloon; an electrode assembly, disposed on the catheter assembly located in the balloon, the electrode assembly having an electrode hole for generating shock waves; A scoring assembly, comprising a scoring wire disposed on the outer surface of the balloon, the scoring wire being used to conduct the shock wave to the calcified part of the blood vessel; Wherein, the axis of the electrode hole intersects on the notched wire.

2. The notched shock wave balloon catheter according to claim 1, characterized in that: There are N electrode holes, and M scoring wires. The axis of at least one electrode hole intersects with one scoring wire; wherein N≥1, M≥1.

3. The notched shock wave balloon catheter according to claim 2, characterized in that: There are three electrode holes, at least three scoring wires, the axis of each electrode hole intersects with at least one scoring wire, and the axis of each electrode hole intersects with different scoring wires.

4. The notched shock wave balloon catheter according to claim 1, characterized in that: The scoring wire comprises a bottom portion and a tip portion, wherein the bottom portion is connected to the outer surface of the balloon, the tip portion is connected to the bottom portion, and the tip portion faces away from the balloon; Wherein, the cross section perpendicular to the length direction of the scored wire is in the shape of a "triangle".

5. The notched shock wave balloon catheter according to claim 4, characterized in that: The scored wire has at least one of the following characteristics: (1) The total height of the scored wire is 0.2 mm to 0.35 mm; (2) The height of the bottom is 0.08 mm to 0.17 mm; (3) The angle of the tip portion is 20° to 60°; (4) The chamfer of the tip of the tip portion is 0.01 mm to 0.03 mm; (5) The chamfers on both sides of the bottom in the length direction are 0.02 mm to 0.04 mm.

6. The notched shock wave balloon catheter according to claim 1, characterized in that: The scoring wire is extended along the length direction of the balloon, the distal end of the scoring wire extends to the distal end of the balloon, and the proximal end of the scoring wire extends to the proximal end of the balloon.

7. The notched shock wave balloon catheter according to claim 6, characterized in that: The scoring assembly also includes a distal fixing tube and a proximal telescopic tube, wherein the distal fixing tube is sleeved on and connected to the distal end of the balloon, one end of the proximal telescopic tube is connected to the proximal end of the scoring wire, and the other end of the proximal telescopic tube is connected to the catheter assembly.

8. The notched shock wave balloon catheter according to any one of claims 1 to 7, characterized in that: The electrode assembly comprises: An outer electrode, wherein the electrode hole is formed on the outer electrode and is arranged through the thickness of the outer electrode; An inner electrode is sleeved inside the outer electrode; The insulating tube is arranged between the outer electrode and the inner electrode. The insulating tube is provided with insulating holes, which correspond to the electrode holes one by one and are coaxially arranged.

9. The notched shock wave balloon catheter according to claim 8, characterized in that: Two groups of electrode assemblies are arranged at intervals on the catheter assembly located in the balloon, the outer electrode near the distal end of the balloon is connected to an external power supply through a first wire, the inner electrode near the distal end of the balloon is connected to the inner electrode near the proximal end of the balloon through a second wire, and the outer electrode near the proximal end of the balloon is connected to the external power supply through a third wire.

10. The notched shock wave balloon catheter according to claim 8, characterized in that: The length of the inner electrode is greater than that of the outer electrode, and the length of the insulating tube is greater than that of the inner electrode.

11. The notched shock wave balloon catheter according to claim 8, characterized in that: Notches are arranged at both ends of the inner electrode.

12. The notched shock wave balloon catheter according to any one of claims 1 to 7, characterized in that: The catheter assembly includes a first catheter and a second catheter, the distal end of the first catheter is sealedly connected to the proximal end of the balloon, and the first channel is formed in the first catheter; the distal end of the second catheter passes through the first channel and is inserted in the balloon to be sealedly connected to the distal end of the balloon, the electrode assembly is connected to the distal end of the second catheter, a second channel is formed in the second catheter, and the distal end of the second catheter is connected to a guide head.

Images