Shockwave balloon catheter

Abstract

This invention provides a shockwave balloon catheter, comprising an inner tube, a balloon, and a first electrode assembly. The balloon covers a portion of the inner tube. The first electrode assembly is mounted on the side wall of the inner tube, and at least one first discharge hole is provided on the side wall. The angle between the axis of the first discharge hole and the axis of the inner tube is 15 to 90 degrees. The shockwave balloon catheter provided by this invention, on the one hand, relatively reduces the radial dimension of the distal balloon leg, improving the balloon catheter's permeability; on the other hand, the orientation of the discharge hole of the electrode assembly can be adjusted, thereby generating a stronger shockwave in the lateral direction.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a shockwave balloon catheter. Background Technology

[0002] Angioplasty balloons are commonly used to open calcified lesions in the blood vessel wall. With the development of electrohydraulic lithotripsy technology in recent years, shockwave balloon catheters have been increasingly applied to the vascular system for treating calcified lesions within blood vessels. The basic principle of shockwave balloon catheters is to place a shockwave generator (electrode assembly) inside the balloon catheter. Providing pulsed driving electrical energy to the shockwave generator allows for the release of circumferential, intermittent shockwave energy from its discharge port. The shockwave energy propagates outward through the fluid inside the balloon and impacts the calcified lesion area.

[0003] Figure 1 This diagram illustrates a common shockwave balloon catheter 400. A shockwave generator 406 is fixed to the inner tube 402, and a discharge port 404 is formed on its side wall, facing the vessel wall. When pulsed electrical energy is supplied to the shockwave generator 406, shockwave energy is released outward from the discharge port 404 and propagates through the liquid within the balloon 408, thus acting on the vessel wall. Because the angle of deviation of the vessel wall from the axis of the discharge port varies at different locations, and the distance between the vessel wall and the discharge port also varies, the impact effect of the shockwave released from the discharge port on the vessel wall at different locations also varies. For a shockwave balloon catheter with the discharge port facing the vessel wall, such as... Figure 2 As shown, the impact force of the shock wave on the vessel wall along the axial direction gradually decreases from the position directly opposite the discharge hole towards both ends. Therefore, to achieve better treatment results, the balloon needs to be passed through the calcified lesion area, with the discharge hole directly facing the calcified lesion. This increases the difficulty of the surgical procedure to some extent, making it difficult to achieve good treatment results for other types of lesions such as complete occlusion and valve calcification. In addition, existing shock wave balloon catheters often suffer from large size and poor permeability. Summary of the Invention

[0004] Based on this, the purpose of the present invention is to provide a shockwave balloon catheter that has better permeability during implantation and can release a strong shockwave to the anterior side of the implanted shockwave balloon catheter.

[0005] The present invention aims to provide a shockwave balloon catheter, comprising an inner tube, a balloon, and a first electrode assembly, wherein the balloon covers a portion of the outer side of the inner tube; the first electrode assembly is mounted on the side wall of the inner tube, and at least one first discharge hole is provided on the side wall of the first electrode assembly, wherein the angle between the axis of the first discharge hole and the axis of the inner tube is 15 to 90 degrees.

[0006] Furthermore, the proximal end of the balloon contracts outside the inner tube to form a first tube leg; the distal end of the balloon contracts outside the inner tube to form a second tube leg; the radial dimension of the second tube leg is smaller than the radial dimension of the first tube leg.

[0007] Furthermore, the radial dimension of the first pin ranges from 1.0 to 1.5 mm; the radial dimension of the second pin ranges from 0.4 to 0.8 mm.

[0008] Furthermore, the inner tube located inside the balloon includes a proximal tube, a transition tube, and a distal tube connected in sequence. The proximal tube has a first radial dimension, and the distal tube has a second radial dimension smaller than the first radial dimension. The two ends of the transition tube are respectively connected to the proximal tube and the distal tube, and its radial dimension gradually decreases from the first radial dimension to the second radial dimension from the proximal end to the distal end. The first electrode assembly is mounted on the side wall of the transition tube, and the angle between the axis of the first discharge hole and the axis of the inner tube is 15 degrees to 80 degrees.

[0009] Furthermore, the angle between the axis of the first discharge hole and the axis of the inner tube is 30 to 60 degrees.

[0010] Furthermore, the balloon has a length of 6 to 25 mm and a diameter of 1.5 to 4.5 mm after inflation; the radial dimension of the proximal tube is 0.55 to 0.8 mm; and the radial dimension of the distal tube is 0.3 to 0.6 mm.

[0011] Furthermore, the proximal tube has a first cavity extending from the proximal end to the distal end, and the transition tube and the distal tube have a second cavity and a third cavity extending from the proximal end to the distal end, respectively. The first cavity, the second cavity, and the third cavity are aligned and connected in sequence to form a guide wire cavity for inserting a guide wire. The proximal tube has a first wire channel extending from the proximal end to the distal end, and the transition tube has a second wire channel extending from the proximal end to the mounting position of the first electrode assembly. The first wire channel and the second wire channel are aligned and connected to form a wire cavity for inserting a wire.

[0012] Furthermore, the first electrode assembly includes two inner electrodes, an insulating ring, and an outer electrode. The two inner electrodes are sheet-like structures, symmetrically arranged on the outer wall of the transition tube. The insulating ring has a conical ring structure and is fitted over the two inner electrodes. The insulating ring has two first through holes, each corresponding to one of the two inner electrodes. The outer electrode has a conical ring structure and is fitted over the insulating ring. The outer electrode has two second through holes, each corresponding to one of the two first through holes, forming two discharge holes.

[0013] Furthermore, when the first electrode assembly is sleeved on the transition tube, the distal end of the first electrode assembly is in close contact with the transition tube, and the proximal end of the first electrode assembly is fixed to the transition tube by an adhesive.

[0014] Furthermore, the shockwave balloon catheter also includes at least one second electrode assembly having an annular structure and being sleeved on the outside of the proximal tube.

[0015] This invention improves the inner tube structure. Since there is no need to set up a lead cavity for threading the lead in the inner tube at the proximal and distal ends, the radial dimensions of the inner tube at both ends can be relatively reduced. On the one hand, compared with the prior art, the radial dimensions of the distal tube foot of the balloon can be relatively reduced, making the shock wave balloon catheter provided by this invention more permeable. On the other hand, by setting up a transition tube with a decreasing size from the proximal end to the distal end and installing the electrode assembly outside the transition tube, the orientation of the discharge hole of the electrode assembly can be adjusted, thereby generating a stronger shock wave in the lateral direction. This makes the shock wave balloon catheter provided by this invention particularly suitable for the treatment of severe calcified lesions that are difficult to pass through. Attached Figure Description

[0016] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0017] Figure 1 This is a schematic diagram of the structure of a shockwave balloon catheter in the prior art.

[0018] Figure 2 for Figure 1 A schematic diagram showing the axial distribution of the impact force on the blood vessel wall when the shock wave is released by the shock wave balloon catheter.

[0019] Figure 3 This is a schematic diagram of the shockwave balloon catheter in the first embodiment of the present invention.

[0020] Figure 4 This is a schematic diagram of the shockwave balloon catheter in the second embodiment of the present invention.

[0021] Figure 5 This is a schematic diagram of the shockwave balloon catheter in the third embodiment of the present invention.

[0022] Figure 6 This is a schematic diagram of the structure of a portion of the inner tube in the third embodiment of the present invention.

[0023] Figure 7 From Figure 6 View from direction A.

[0024] Figure 8 From Figure 6 View from direction B.

[0025] Figure 9 This is a schematic diagram of the installation of the electrode assembly in the third embodiment of the present invention. Detailed Implementation

[0026] The technical solution of the present invention will be clearly and completely described below with reference to the embodiments. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0027] refer to Figure 3 The present invention provides a shock wave balloon catheter 100, including an inner tube 110, a balloon 120, and a first electrode assembly 130. The balloon 120 covers a portion of the outer side of the inner tube 110 and defines an internal space that can be filled with a liquid medium. The first electrode assembly 130 is mounted on the outer wall of the inner tube 110, and at least one first discharge hole is provided on the side wall of the first electrode assembly 130. The angle between the axis of the first discharge hole and the axis of the inner tube is 15 to 90 degrees. When a pulsed high voltage is applied to the first electrode assembly, the first electrode assembly 130 can release a shock wave through the first discharge hole.

[0028] In the first embodiment of the present invention, the angle between the axis of the first discharge hole and the axis of the inner tube is 90 degrees. This design facilitates the installation and fabrication of the first electrode assembly.

[0029] Furthermore, the distal contractile segment of balloon 120 has a taper of 0.5 to 2. The balloon with a smaller taper in its distal contractile segment, provided by this design, has a smaller radial dimension when folded, thus allowing for better permeability of the shockwave balloon catheter. In addition, balloons with a smaller contractile segment taper exhibit better wall apposition when implanted into severely calcified lesion areas, resulting in better therapeutic outcomes.

[0030] In this embodiment, the taper of the distal contractile segment of the balloon 120 is 0.5.

[0031] It should be noted that the shockwave balloon catheter 100 also includes an outer tube and a distal tube. The outer tube is fitted over the proximal end of the inner tube 110, and the proximal end of the balloon 120 is contracted and connected to the distal opening of the outer tube, forming the first leg 121 of the balloon 120. A fluid filling channel is formed between the outer tube and the inner tube 110, through which the balloon can be filled with liquid medium. The distal tube is fitted over the distal end of the inner tube 110, and the distal end of the balloon 120 is contracted and connected to the proximal opening of the distal tube, forming the second leg 122 of the balloon 120.

[0032] In this invention, the radial dimension of the first pin ranges from 1.0 to 1.5 mm; the radial dimension of the second pin ranges from 0.4 to 0.8 mm. Reducing the radial dimension of the first pin at the distal end of the shockwave balloon catheter can avoid damage to blood vessels due to excessive radial dimension at the catheter tip, thereby effectively improving the permeability of the shockwave balloon catheter.

[0033] It should be noted that, in this invention, the inner tube 110 has a guidewire lumen located in the middle, which is used to insert the guidewire for interventional treatment; in addition, since the first electrode assembly 130 needs to be connected to an external pulse high-voltage power supply through a wire, a wire lumen for inserting the wire needs to be provided on the inner tube 110.

[0034] refer to Figure 4 In the second embodiment of the present invention, the inner tube 210 located in the balloon 220 includes a proximal tube 211 and a distal tube 212 connected to each other. The first electrode assembly 230 is installed on the proximal tube 211. The proximal tube 211 has a first cavity extending from the proximal end to the distal end, and the distal tube 212 has a second cavity extending from the proximal end to the distal end. The first cavity and the second cavity are aligned and connected to form a guidewire cavity for inserting a guidewire.

[0035] Since the first electrode assembly 230 is mounted on the proximal tube 211, the wire cavity for threading the wire only needs to extend from the proximal end of the inner tube to the location of the first electrode assembly 230, without extending into the distal tube 212. This allows the radial dimension of the distal tube 212 to be set smaller than the radial dimension of the proximal tube 211.

[0036] In this embodiment, the proximal tube 211 has a wire channel extending from the proximal end to the distal end within its tube wall.

[0037] Compared to existing technologies, the radial dimension of the second prong 222 of the balloon can be reduced accordingly due to the relatively smaller radial dimension of the distal tube 212. This relatively smaller radial dimension of the distal prong of the shockwave balloon catheter makes it easier to insert into narrow lumens, thereby improving the catheter's permeability.

[0038] refer to Figure 5 , Figure 6A third embodiment of the present invention provides another shockwave balloon catheter 300, including an inner tube 310, a balloon 320, and a first electrode assembly 330. The balloon 320 covers a portion of the inner tube 310 and defines an internal space that can be filled with a liquid medium. The inner tube 310 located inside the balloon 320 includes a proximal tube 311, a distal tube 312, and a transition tube 313. The proximal tube 311 has a first radial dimension, the distal tube 312 has a second radial dimension smaller than the first radial dimension, and the transition tube 313... The two ends are connected to the proximal tube 311 and the distal tube 312 respectively, and its radial dimension gradually decreases from the first radial dimension to the second radial dimension from the proximal end to the distal end; the first electrode assembly 330 is installed on the outer wall of the transition tube 313, and at least one first discharge hole 330a is provided on the side wall of the first electrode assembly 330. The angle between the axis of the first discharge hole 330a and the axis of the inner tube is an acute angle; when a pulsed high voltage is applied to the first electrode assembly 330, the first electrode assembly 330 can release a shock wave through the first discharge hole 330a.

[0039] Shockwave balloon catheters are implantable interventional medical devices used to treat endovascular calcification. Because the radial dimension of the blood vessel lumen is relatively small, it is generally necessary to minimize the radial dimension of the implanted device to reduce damage to the vessel during implantation. Therefore, such as Figure 1 As shown, the electrode assembly of existing shock wave balloon catheters is generally designed as a ring structure and sleeved on the outer wall of the inner tube. The axis of the discharge hole of this type of electrode assembly is set perpendicular to the axis of the inner tube, releasing shock wave energy to the surroundings.

[0040] For a discharge hole with its axis perpendicular to the inner tube axis, the axial distribution of the impact force of the released shock wave on the surrounding blood vessels is as follows: Figure 2 As shown, the shock wave exerts the greatest impact force on the vessel wall directly opposite the discharge orifice, and the force gradually decreases towards both ends. This means that the shock wave balloon catheter provided by the existing technology needs to pass through the calcified lesion area so that the discharge orifice is directly opposite the calcified lesion area in order to achieve a better treatment effect. However, it is not effective for treating severe calcified lesions such as complete occlusion of CTO, which are difficult for the balloon catheter to pass through.

[0041] This embodiment adjusts the inner tube structure by setting a tapered transition tube 313 on the inner tube 310 and mounting the first electrode assembly 330 on the transition tube 313, so that the axis of the first discharge hole 330a is tilted distally relative to the axis of the inner tube 310, thereby maximizing the impact force of the shock wave released from the first discharge hole 330a toward the anterior side of the blood vessel, thus enabling the shock wave balloon catheter provided by the present invention to produce a better therapeutic effect on calcified lesions located anteriorly.

[0042] Preferably, the angle between the axis of the first discharge hole 330a and the axis of the inner tube 310 is between 15 and 80 degrees. Within this range, it can produce good therapeutic effects on common calcified lesions.

[0043] Preferably, the angle between the axis of the first discharge hole 330a and the axis of the inner tube 310 is 30 to 60 degrees. The smaller the angle, the greater the taper of the outer wall of the first electrode assembly 330. This requires a larger difference in the radial dimensions of the proximal tube 311 and the distal tube 312 of the inner tube 310. This can easily affect the passage of the shock wave balloon catheter due to the larger radial dimension of the proximal tube 311, or cause poor support due to the smaller radial dimension of the distal tube 312. The larger the angle, the smaller the forward deflection angle of the shock wave released by the discharge hole, resulting in poor treatment effect on anterior calcified lesions.

[0044] In this embodiment, the angle between the axis of the first discharge hole 330a and the axis of the inner tube 310 is 60 degrees.

[0045] In this invention, the balloon length is 6 to 25 mm, and the balloon diameter after inflation is 1.5 to 4.5 mm; the radial dimension of the proximal tube 311 is 0.55 to 0.8 mm; and the radial dimension of the distal tube 312 is 0.3 to 0.6 mm.

[0046] In this embodiment, reference is made to Figure 7 , Figure 8 The inner tube 310 has a guidewire lumen 310a located in the middle, which is used to insert a guidewire for interventional treatment. In addition, since the first electrode assembly 330 needs to be connected to an external pulsed high-voltage power supply via a wire, a wire lumen for inserting a wire is required on the inner tube 310.

[0047] In this embodiment, the proximal tube 311 is provided with a first cavity extending from the proximal end to the distal end, and the distal tube 312 and the transition tube 313 are respectively provided with a second cavity extending from the proximal end to the distal end. The first cavity, the second cavity and the third cavity are aligned and connected in sequence to form a guide wire cavity 310a for inserting a guide wire.

[0048] Since the first electrode assembly 330 is mounted on the transition tube 313, the wire cavity for threading the wire only needs to extend from the proximal end of the inner tube to the location of the first electrode assembly 330, without extending into the distal tube 312. This allows the radial dimension of the distal tube 312 to be set smaller than the radial dimension of the proximal tube 311.

[0049] In this embodiment, the proximal tube 311 is provided with a first wire channel extending from the proximal end to the distal end, and the transition tube 313 is provided with a second wire channel extending from the proximal end to the mounting position of the first electrode assembly 330. The first wire channel and the second wire channel are aligned and connected to form a wire cavity 310b for threading wires.

[0050] In this embodiment, the first wire channel is disposed within the wall of the proximal tube 311; the second wire channel is disposed within the wall of the transition tube 313.

[0051] In this embodiment, the proximal end of the balloon 320 contracts outside the proximal tube 311 of the inner tube 310 to form a first leg 321; the distal end of the balloon 320 contracts outside the distal tube 312 of the inner tube 310 to form a second leg 322. Compared with the prior art, due to the relatively reduced radial dimension of the distal tube 312, the radial dimension of the second leg 322 of the balloon is also correspondingly reduced. Relatively reducing the radial dimension of the distal leg of the shockwave balloon catheter makes it easier to implant the shockwave balloon catheter into narrow lumens, thus improving the permeability of the shockwave balloon catheter.

[0052] In this embodiment, the shockwave balloon catheter 300 further includes an outer tube and a terminal tube. The outer tube is fitted over the proximal end of the inner tube 310, and the proximal end of the balloon 320 is contracted and connected to the distal opening of the outer tube, forming the first tube leg 321 of the balloon 320. A fluid filling channel is formed between the outer tube and the inner tube 310, through which liquid medium can be filled into the balloon. The terminal tube is fitted over the distal end of the inner tube 310, and the distal end of the balloon 320 is contracted and connected to the proximal opening of the terminal tube, forming the second tube leg 322 of the balloon 320.

[0053] In this invention, the radial dimension of the first pin ranges from 1.0 to 1.5 mm; the radial dimension of the second pin ranges from 0.4 to 0.8 mm.

[0054] In this invention, the first electrode assembly 330 is sleeved outside the transition tube 313 of the inner tube 310 and has a conical annular structure. It can be provided with one discharge hole or multiple discharge holes can be uniformly arranged circumferentially.

[0055] In this embodiment, reference is made to Figure 9The first electrode assembly 330 has two discharge holes 330a. Specifically, the first electrode assembly 330 includes two inner electrodes 331, an insulating ring 332, and an outer electrode 333. The two inner electrodes 331 are sheet-like structures, symmetrically arranged on the outer walls of both sides of the transition tube 313. The insulating ring 332 has a conical ring structure, sleeved on the outside of the two inner electrodes 331, and has two first through holes 332a, which are respectively opposite to the two inner electrodes 331. The outer electrode 333 has a conical ring structure, sleeved on the outside of the insulating ring 332, and has two second through holes 333a, which correspond one-to-one with the two first through holes 332a, forming two discharge holes 330a. The two inner electrodes 331 are respectively connected to the positive and negative terminals of an external pulse high-voltage power supply through wires. After the shockwave balloon catheter 300 is implanted into the patient, the balloon 320 is filled with a liquid medium. When a pulsed high voltage is applied to the first electrode assembly 330, the first electrode assembly 130 forms two series-connected discharge electrode pairs and releases shock waves outward from the two discharge holes 330a respectively.

[0056] The axes of the two discharge holes on the first electrode assembly 331 provided by the present invention are at an angle to the axis of the inner tube 310. The shock wave released outward along the axis of the discharge hole has the greatest impact effect, thereby making the shock wave balloon catheter suitable for treating calcified lesions located in front of the balloon.

[0057] The taper of the outer wall of the first electrode assembly 330 can be the same as the taper of the transition tube 313, or it can be slightly larger than the taper of the outer wall of the transition tube 313.

[0058] In this embodiment, the taper of the outer wall of the first electrode assembly 330 is slightly greater than the taper of the outer wall of the transition tube 313. The distal opening of the first electrode assembly 330 is in close contact with the transition tube 313, and the proximal inner wall is fixed to the outer wall of the transition tube 313 by adhesive.

[0059] The fourth embodiment of the present invention provides yet another shockwave balloon catheter, which differs from the first embodiment in that the shockwave balloon catheter provided in this embodiment further includes a second electrode assembly mounted on the proximal tube. This solution includes an electrode assembly capable of releasing shockwaves in different directions, thereby making the shockwave balloon catheter suitable for the treatment of different types of calcified lesions.

[0060] The fifth embodiment of the present invention provides another shockwave balloon catheter, which differs from the first embodiment in that the shockwave balloon catheter provided in this embodiment further includes two second electrode assemblies, which are installed at intervals on the proximal end of the inner tube.

[0061] The above-mentioned shockwave balloon catheter is further illustrated below through specific embodiments and comparative examples.

[0062] Example 1 refer to Figure 3 A shockwave balloon catheter 100 includes an inner tube 110, a balloon 120, and a first electrode assembly 130. The balloon has a diameter of 3.0 mm and a length of 15 mm when inflated. The radial dimension of the first tube of the balloon is 1.0 mm, and the radial dimension of the second tube of the balloon is 0.4 mm.

[0063] The shockwave balloon catheter was implanted into an in vitro calcification model, demonstrating good permeability. The catheter and the in vitro calcification model were then immersed in physiological saline for testing. The in vitro calcification model was a tubular plaster model closed anteriorly and laterally, with an inner diameter of 3.0 mm. The balloon was inflated to a nominal pressure of 12 atm, and 30 discharge pulses were applied to the electrode assembly. Severe cracks were observed in the plaster on the sidewall of the discharge orifice directly opposite the first electrode assembly 130.

[0064] Example 2 refer to Figure 5 , Figure 6 A shockwave balloon catheter 300 includes an inner tube 310, a balloon 320, and a first electrode assembly 330. The inner tube, located inside the balloon 320, includes a proximal tube 311, a distal tube 312, and a transition tube 313. The balloon, when inflated, has a diameter of 3.0 mm and a length of 15 mm. The radial dimension of the proximal tube 311 is 0.8 mm, the radial dimension of the distal tube 312 is 0.5 mm, the radial dimension of the first tube leg of the balloon is 1.0 mm, and the radial dimension of the second tube leg of the balloon is 0.6 mm. The two ends of the transition tube 313 are connected to the proximal tube 311 and the distal tube 312, respectively, and its radial dimension gradually decreases from the proximal end to the distal end. The first electrode assembly 330 is a conical annular structure, fitted outside the transition tube 313. The angle between the axis of the discharge hole on the sidewall of the first electrode assembly 330 and the axis of the inner tube 310 is 60 degrees.

[0065] The shockwave balloon catheter was implanted into an in vitro calcification model, demonstrating good permeability. The balloon and the in vitro calcification model were immersed in physiological saline for testing. The in vitro calcification model was a tubular plaster model closed at both the front and sides, with an inner diameter of 3.0 mm. The balloon was inflated to a nominal pressure of 12 atm, and 30 discharge pulses were applied to the electrode assembly. Severe cracks were observed in the plaster at the sidewall of the discharge hole 330a directly opposite the first electrode assembly 330, while slight cracks appeared in the plaster anterior to the shockwave balloon catheter.

[0066] Example 3 A shockwave balloon catheter includes an inner tube, a balloon, a first electrode assembly, and a second electrode assembly. The inner tube, located inside the balloon, includes a proximal tube, a transition tube, and a distal tube. The balloon, when inflated, has a diameter of 3.0 mm and a length of 15 mm. The radial dimension of the proximal tube is 0.6 mm, the radial dimension of the distal tube is 0.3 mm, the radial dimension of the first tube leg of the balloon is 1.0 mm, and the radial dimension of the second tube leg of the balloon is 0.5 mm. The first electrode assembly is a conical annular structure fitted over the transition tube. The second electrode assembly is an annular structure fitted over the proximal tube. The angle between the axis of the discharge hole on the sidewall of the first electrode assembly and the axis of the inner tube is 60 degrees.

[0067] The shockwave balloon catheter was implanted into an in vitro calcification model, demonstrating good permeability. The balloon and the in vitro calcification model were immersed in physiological saline for testing. The in vitro calcification model was a tubular plaster model closed anteriorly and laterally, with an inner diameter of 3.0 mm. The balloon was inflated to a nominal pressure of 12 atm, and 30 discharge pulses were applied to the electrode assembly. Severe cracks were observed in the plaster on the sidewall of the discharge hole facing the first electrode assembly, slight cracks appeared on the anterior plaster, and severe cracks appeared in the sidewall of the plaster facing the discharge hole facing the second electrode assembly.

[0068] Comparative Example 1 This embodiment provides a method such as Figure 1 The shockwave balloon catheter 400 shown includes an inner tube 402, a balloon, and an electrode assembly 406. The electrode assembly 406 has a ring-shaped structure, is disposed inside the balloon, and is sleeved on the outside of the inner tube 402. The balloon has a diameter of 3.0 mm and a length of 15 mm when inflated; the radial dimension of both ends of the balloon is 1.5 mm.

[0069] The shockwave balloon catheter was implanted into an in vitro calcification model, where it encountered significant resistance during passage. The balloon and the in vitro calcification model were immersed in physiological saline for testing. The in vitro calcification model was a tubular plaster model closed at both the front and sides, with an inner diameter of 3.0 mm. The balloon was inflated to a nominal pressure of 12 atm, and 30 discharge pulses were applied to the electrode assembly. Severe cracks were observed on the plaster on both sides directly opposite the discharge holes of the electrode assembly; fewer cracks were observed on the sidewalls further away from the discharge holes.

[0070] By comparing the experimental results of the embodiments and comparative examples provided by the present invention, it can be clearly seen that the shockwave balloon catheter provided by the present invention has good permeability, and is especially suitable for the treatment of severe calcified lesions such as complete occlusion of CTO that are difficult for balloon catheters to pass through, thereby making the balloon catheter applicable to the treatment of calcified lesions in different locations and of different types.

[0071] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A shockwave balloon catheter, characterized in that, The device includes an inner tube, a balloon, and a first electrode assembly, wherein the balloon covers a portion of the outer side of the inner tube; the first electrode assembly is mounted on the side wall of the inner tube, and the side wall of the first electrode assembly is provided with at least one first discharge hole, wherein the angle between the axis of the first discharge hole and the axis of the inner tube is 15 to 90 degrees.

2. The shockwave balloon catheter according to claim 1, characterized in that, The proximal end of the balloon contracts outside the inner tube to form a first tube leg; the distal end of the balloon contracts outside the inner tube to form a second tube leg; the radial dimension of the second tube leg is smaller than the radial dimension of the first tube leg.

3. The shockwave balloon catheter according to claim 2, characterized in that, The radial dimension of the first pin ranges from 1.0 to 1.5 mm; the radial dimension of the second pin ranges from 0.4 to 0.8 mm.

4. The shockwave balloon catheter according to claim 1, characterized in that, The inner tube located inside the balloon includes a proximal tube, a transition tube, and a distal tube connected in sequence. The proximal tube has a first radial dimension, and the distal tube has a second radial dimension smaller than the first radial dimension. The two ends of the transition tube are respectively connected to the proximal tube and the distal tube, and its radial dimension gradually decreases from the first radial dimension to the second radial dimension from the proximal end to the distal end. The first electrode assembly is mounted on the side wall of the transition tube, and the angle between the axis of the first discharge hole and the axis of the inner tube is 15 degrees to 80 degrees.

5. The shockwave balloon catheter according to claim 4, characterized in that, The angle between the axis of the first discharge hole and the axis of the inner tube is 30 to 60 degrees.

6. The shockwave balloon catheter according to claim 4, characterized in that, The balloon is 6 to 25 mm long and has a diameter of 1.5 to 4.5 mm when inflated; the radial dimension of the proximal tube is 0.55 to 0.8 mm; and the radial dimension of the distal tube is 0.3 to 0.6 mm.

7. The shockwave balloon catheter according to claim 4, characterized in that, The proximal tube has a first cavity extending from the proximal end to the distal end. The transition tube and the distal tube each have a second cavity extending from the proximal end to the distal end, and a third cavity, respectively. The first cavity, the second cavity, and the third cavity are aligned and connected in sequence to form a guidewire cavity for inserting a guidewire. The proximal tube has a first wire channel extending from the proximal end to the distal end. The transition tube has a second wire channel extending from the proximal end to the mounting position of the first electrode assembly. The first wire channel and the second wire channel are aligned and connected to form a wire cavity for inserting a wire.

8. The shockwave balloon catheter according to claim 4, characterized in that, The first electrode assembly includes two inner electrodes, an insulating ring, and an outer electrode. The two inner electrodes are sheet-like structures symmetrically arranged on the outer wall of the transition tube. The insulating ring has a conical ring structure and is fitted over the two inner electrodes. The insulating ring has two first through holes, which are respectively aligned with the two inner electrodes. The outer electrode has a conical ring structure and is fitted over the insulating ring. The outer electrode has two second through holes, which correspond one-to-one with the two first through holes to form two discharge holes.

9. The shockwave balloon catheter according to claim 8, characterized in that, When the first electrode assembly is sleeved on the transition tube, the distal end of the first electrode assembly is in close contact with the transition tube, and the proximal end of the first electrode assembly is fixed to the transition tube by adhesive.

10. The shockwave balloon catheter according to claim 4, characterized in that, The shockwave balloon catheter also includes at least one second electrode assembly, which has an annular structure and is sleeved on the outside of the proximal tube.

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