CN115068060A

CN115068060A - Shock wave generating assembly and balloon catheter

Info

Publication number: CN115068060A
Application number: CN202210989808.1A
Authority: CN
Inventors: 黄海新; 杨哲
Original assignee: Shenzhen Beixin Medical Technology Co ltd
Current assignee: Shenzhen Beixin Medical Technology Co ltd
Priority date: 2022-08-18
Filing date: 2022-08-18
Publication date: 2022-09-20

Abstract

The invention relates to the technical field of medical instruments, and particularly discloses a shock wave generation assembly and a balloon catheter. Wherein the shock wave generating assembly comprises: a first electrode; the insulating layer is sleeved outside the first electrode; and the second electrode is sleeved outside the insulating layer, at least one row of source point hole sites are correspondingly arranged on the insulating layer and the second electrode, and each source point hole site penetrates through the second electrode and the insulating layer and exposes the first electrode so that the first electrode and the second electrode form a discharge electrode pair for generating shock waves. According to the invention, the shock wave generating assembly is provided with a plurality of source point hole sites, and shock waves generated at the source point hole sites in the discharging process are overlapped after meeting in the space around the shock wave generating assembly, so that the overlapping area of the shock waves in the space around the shock wave generating assembly is enhanced, the amplitude of the shock waves is increased, the energy is increased, the effective gravel crushing area is increased, the gravel crushing effect is enhanced, and the gravel crushing efficiency is improved.

Description

Shock wave generating assembly and balloon catheter

Technical Field

The invention relates to the technical field of medical instruments, in particular to a shock wave generation assembly and a balloon catheter.

Background

Coronary artery disease, peripheral artery disease, and the like are vascular obstructions caused by the accumulation of calcified plaque. At present, a new therapeutic method is to use a balloon catheter, which is tracked and positioned at the stenosis position of a blood vessel, then liquid is filled into the balloon to expand the balloon, so as to improve blood flow, and then intense discharge is generated through electrodes to generate strong shock waves, so as to achieve the effect of breaking the blood vessel. However, the balloon catheter in the prior art has unsatisfactory lithotripsy effect and low lithotripsy efficiency, and brings inconvenience to doctors and patients.

Disclosure of Invention

In view of this, the invention provides a shock wave generating assembly and a balloon catheter, aiming to improve the lithotripsy efficiency.

In one aspect, the present invention provides a shock wave generating assembly comprising: a first electrode; the insulating layer is sleeved outside the first electrode; the second electrode is sleeved outside the insulating layer, and the first electrode, the insulating layer and the second electrode are all annular bodies; at least one row of source point hole sites are correspondingly arranged on the insulating layer and the second electrode, and each source point hole site penetrates through the second electrode and the insulating layer and exposes the first electrode, so that the first electrode and the second electrode form a discharge electrode pair for generating shock waves.

Further, in the above-described shock wave generating assembly, the source point hole sites in each column may be arranged uniformly or non-uniformly along the axial direction of the annular body.

Further, in the above-described shock wave generating assembly, the arrangement density of the source point hole sites in each column varies from dense to sparse or from sparse to dense in a left-to-right direction along the axial direction of the annular body.

Further, in the above-mentioned shock wave generating assembly, the source point hole sites are at least two rows, and the source point hole sites of each row are uniformly or non-uniformly arranged along the circumferential direction of the ring-shaped body.

Further, in the above-described shock wave generating assembly, the source point hole sites are arranged in at least two rows, and the source point hole sites in each row are aligned or staggered in the circumferential direction of the annular body.

Further, in the above-mentioned shock wave generating assembly, the first electrode of the shock wave generating assembly is prepared on the outer surface of the inner guide tube by any one of weaving, spraying, chemical vapor deposition, electroplating, and ion sputtering.

Further, in the above-mentioned shock wave generating assembly, the insulating layer is formed on the outer surface of the first electrode by any one of printing, plating, CVD, PVD and ion sputtering.

Further, in the above-mentioned shock wave generating assembly, the second electrode is formed on the outer surface of the insulating layer by any one of printing, electroplating and magnetron sputtering.

Further, in the above-described shock wave generating assembly, a total thickness in a radial direction of the first electrode, the insulating layer, and the second electrode is 0.5mm or less.

The shock wave generating assembly is provided with a plurality of source point hole sites, the source point hole sites discharge to generate shock waves, the shock waves generated at the source point hole sites in the discharging process meet in the space around the shock wave generating assembly and then are superposed, so that the superposed area of the shock waves in the space around the shock wave generating assembly is enhanced, the amplitude of the shock waves is increased, the energy is increased, the effective gravel crushing area is increased, the gravel crushing effect is enhanced, and the gravel crushing efficiency is improved. In addition, the multiple source point hole sites arranged in the invention can also enable shock waves with different frequencies to be superposed, thereby further increasing the energy of the shock waves and further enhancing the stone crushing effect.

In another aspect, the present invention also provides a balloon catheter, including: an inner conduit; a distal outer tube; the far-end outer tube and the balloon are sleeved outside the inner catheter, a first end of the balloon is connected with the inner catheter in a sealing mode, a second end of the balloon is connected with the far-end outer tube in a sealing mode, a first cavity is formed between the inner catheter and the far-end outer tube, and the inner space of the balloon is communicated with the first cavity; any one of the shock wave generating assemblies, wherein the shock wave generating assembly is sleeved outside the inner catheter and is arranged in the balloon.

Further, in the balloon catheter, the number of the shock wave generation assemblies is at least two, and the shock wave generation assemblies are uniformly distributed along the axial direction of the inner catheter.

Since the shock wave generating assembly has the above effects, the balloon catheter having the shock wave generating assembly also has corresponding technical effects.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the application.

Drawings

The foregoing and other objects, features and advantages of the application will be apparent from the following more particular descriptions of exemplary embodiments of the application, as illustrated in the accompanying drawings wherein like reference numbers generally represent like parts throughout the exemplary embodiments of the application.

FIG. 1 is a schematic perspective view of a shockwave generating assembly provided in an embodiment of the present invention;

FIG. 2 is a transverse cross-sectional view of FIG. 1;

FIG. 3 is an expanded view of the arrangement of source holes of the shock wave generating assembly shown in FIG. 1;

FIG. 4 is a longitudinal cross-sectional view of FIG. 1;

FIG. 5 is a schematic perspective view of a shock wave generating assembly provided in an embodiment of the present invention;

FIG. 6 is a transverse cross-sectional view of FIG. 5;

FIG. 7 is an expanded view of the arrangement of source holes of the shock wave generating assembly shown in FIG. 5;

FIG. 8 is a schematic perspective view of a shock wave generating assembly provided in an embodiment of the present invention;

FIG. 9 is a transverse cross-sectional view of FIG. 8;

FIG. 10 is an expanded view of the arrangement of source holes of the shock wave generating assembly shown in FIG. 8;

FIG. 11 is a schematic perspective view of a shock wave generating assembly in accordance with an embodiment of the present invention;

FIG. 12 is a transverse cross-sectional view of FIG. 11;

FIG. 13 is an expanded view of the arrangement of source holes of the shock wave generating assembly of FIG. 11;

fig. 14 is a schematic structural view of a balloon catheter provided in an embodiment of the present invention.

Detailed Description

Preferred embodiments of the present application will be described in more detail below with reference to the accompanying drawings. While the preferred embodiments of the present application have been illustrated in the accompanying drawings, it should be understood that the present application may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used in this application and the appended claims, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should also be understood that the term "and/or" as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items.

It should be understood that although the terms "first," "second," "third," etc. may be used herein to describe various information, these information should not be limited to these terms. These terms are only used to distinguish one type of information from another. For example, first information may also be referred to as second information, and similarly, second information may also be referred to as first information, without departing from the scope of the present application. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present application, "a plurality" means two or more unless specifically limited otherwise.

In the description of the present application, it is to be understood that the terms "length," "width," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like are used in the orientation or positional relationship indicated in the drawings for convenience in describing the present application and for simplicity in description, and are not intended to indicate or imply that the referenced devices or elements must have a particular orientation, be constructed in a particular orientation, and be operated in a particular manner, and are not to be considered limiting of the present application.

Unless expressly stated or limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly and encompass, for example, being fixedly connected, releasably connected, or integral to one another; can be mechanically or electrically connected; either directly or indirectly through intervening media, either internally or in any other relationship. The specific meaning of the above terms in the present application can be understood by those of ordinary skill in the art as appropriate.

The technical solutions of the embodiments of the present invention are described in detail below with reference to the accompanying drawings.

The shock wave generating assembly 100 provided by the embodiment of the invention is applied to a balloon catheter. Referring to fig. 1 to 4, the shock wave generating assembly 100 includes: a first electrode 110, an insulating layer 120, and a second electrode 130. The first electrode 110, the insulating layer 120, and the second electrode 130 are all ring-shaped bodies, the insulating layer 120 is sleeved on the outer surface of the first electrode 110, and the second electrode 130 is sleeved on the outer surface of the insulating layer 120. At least one row of source hole sites 140 is formed in the insulating layer 120 and the second electrode 130 in a corresponding manner, and each row includes a plurality of source hole sites 140. Each source hole site 140 penetrates the insulating layer 120 and the second electrode 130 and exposes the first electrode 110, so that the first electrode 110 and the second electrode 130 form a discharge electrode pair to generate a shock wave.

In a specific implementation, the plurality of source point hole sites 140 in each row may be arranged along the axial direction of the annular body, or may be arranged along the circumferential direction of the annular body, or of course, may be arranged in a spiral line, or the like.

In practical applications, the plurality of the embodiments includes three or more.

In one implementation, the source point aperture location 140 may be a cylindrical aperture, and the axis of the cylindrical aperture is perpendicular to, or at an angle to, the axis of the first electrode 110. Of course, the source point aperture locations 140 may have other shapes. The material of the first electrode 110 and the second electrode 130 may be a metal or an alloy having good conductivity, such as gold, silver, copper, platinum, or tungsten, and the insulating layer 120 may be a polymer material having good insulating and heat resistance, such as polyurethane or polyimide.

It is understood that, in operation, the first electrode 110 and the second electrode 130 in this embodiment should be connected to the positive or negative electrode of the high voltage pulse power source through the conducting wire, so that the first electrode 110 and the second electrode 130 receive the high voltage pulse. When an external power supply applies high-voltage pulses to the shock wave generating assembly 100, the first electrode 110 and the second electrode 130 are broken down, and shock waves with certain energy are generated after the breakdown, in the embodiment, the shock waves generated at the source point hole positions 140 are overlapped in the propagation process, the intersection of the solid lines A shown in the figure 4 is an overlapping point, and the energy of the shock waves at the overlapped position is enhanced, so that the stone breaking effect is improved.

It can be seen that, in the embodiment of the present invention, the shock wave generating assembly 100 is provided with a plurality of source point hole sites 140, the source point hole sites 140 generate shock waves by discharging, and the shock waves generated at the plurality of source point hole sites 140 in the axial direction and/or the circumferential direction during the discharging process are overlapped after meeting in the space around the shock wave generating assembly 100, so that the overlapping area of the shock waves in the space around the shock wave generating assembly 100 is enhanced, the amplitude of the shock waves is increased, the energy is increased, the effective gravel area is increased, the gravel crushing effect is enhanced, and the gravel crushing efficiency is improved. In addition, the multiple source point hole sites 140 provided in this embodiment can also enable shock waves of different frequencies to be superimposed, so that the energy of the shock waves is further increased, and the stone crushing effect is further enhanced.

In some embodiments, with continued reference to fig. 1-13, the source point apertures 140 in each column are uniformly arranged along the axial direction of the annulus to enhance the energy field of the shock wave, enhance the crushing effect, and improve crushing efficiency. In addition, an energy field with the same strength can be formed in the peripheral space of the shock wave generating assembly 100 along the axial direction, that is, the shock wave energy field can be uniformly distributed along the axial direction of the shock wave generating assembly 100, so that the same energy can be used for crushing the diseased regions around the shock wave generating assembly 100, the peripheral space has the same crushing effect, and the crushing efficiency can be improved.

In other embodiments, the source point aperture locations 140 in each column are non-uniformly arranged along the axis of the toroid. For example, the arrangement density of the source hole sites 140 in each row varies from dense to sparse or from sparse to dense along the axial direction of the ring body from left to right (the lower end is left and the upper end is right as shown in fig. 1), and of course, the density may vary from dense to sparse first and then from sparse to dense, and the arrangement density may vary sequentially from dense to sparse, uniformly, and then from sparse to dense.

In this embodiment, the shock wave in the surrounding space of the source point holes 140 with higher arrangement density is stronger, and the shock wave in the surrounding space of the source point holes 140 with lower arrangement density is weaker, and the shock wave generating assembly 100 in this embodiment can apply stronger energy to the diseased position and less energy to the non-diseased position or the diseased position, so as to reduce the energy application to the diseased or less diseased position, and further reduce the unnecessary damage that may be caused, so as to achieve better lithotripsy effect.

In some embodiments, there are at least two rows of source hole locations 140, and the source hole locations 140 in each row are arranged along the axial direction of the annular body, and the source hole locations 140 in each row are arranged uniformly along the circumferential direction of the annular body, i.e., uniformly along the circumferential direction of the shock wave generating assembly 100.

In a specific implementation, the ultrasonic wave generating assembly 100 shown in fig. 1 to 3 is provided with two rows of source point hole sites 140, and the two rows of source point hole sites 140 are uniformly distributed along the circumferential direction of the ring body at an included angle of 180 degrees. The ultrasonic wave generating assembly 100 shown in fig. 5 to 7 is provided with four rows of source point hole sites 140, and the four rows of source point hole sites 140 are uniformly distributed along the circumferential direction of the ring-shaped body at an included angle of 90 degrees. The ultrasonic wave generating assembly 100 shown in fig. 8 to 10 is provided with three rows of source hole sites 140, and the three rows of source hole sites 140 are uniformly distributed along the circumferential direction of the ring body at an included angle of 120 degrees. The ultrasound generating assembly shown in fig. 11 and 13 is provided with eight rows of source hole sites 140, and the eight rows of source hole sites 140 are uniformly distributed along the circumferential direction of the ring-shaped body at an included angle of 45 degrees.

The shock waves generated by the source point hole sites 140 in this embodiment can be superimposed in the circumferential direction of the shock wave generating assembly 100 to enhance the circumferential energy field and improve the stone crushing effect. In addition, since the source point holes 140 are uniformly changed along the circumferential direction of the annular body, a uniform energy field can be formed in the circumferential direction of the ultrasonic wave generating assembly 100, and further, the same lithotripsy energy can be applied to the circumferential direction, and thus, lithotripsy can be performed on lesion parts at different positions in the circumferential direction.

In other embodiments, the source hole locations 140 are in at least two rows, the source hole locations 140 in each row being arranged along the axial direction of the annular body, and the source hole locations 140 in each row being non-uniformly arranged along the circumferential direction of the annular body, i.e., the shock wave generating assembly 100.

In a specific implementation, the source point hole sites 140 in each row may be distributed from dense to sparse or from sparse to dense along the circumferential direction of the annular body, or may be distributed from dense to sparse first and then from sparse to dense.

In this embodiment, the shock wave energy in the peripheral space of each row of source point hole sites 140 arranged in the circumferential direction of the annular body at a larger interval is weaker, and the shock wave energy in the peripheral space of each row of source point hole sites 140 arranged in the circumferential direction of the annular body at a smaller interval is stronger, so that during lithotripsy, stronger shock waves are applied to the portion with a heavier lesion and lighter shock waves are applied to the portion with a lighter lesion, thereby reducing the energy application to the portion without or with a lighter lesion, and further reducing unnecessary damage which may be caused, so as to achieve a better lithotripsy effect.

In some embodiments, the source hole locations 140 are in at least two rows, the source hole locations 140 in each row are arranged along the axial direction of the annular body, and the source hole locations 140 in each row are aligned in the circumferential direction of the annular body, i.e., the source hole locations 140 in each row are arranged circumferentially about the shock wave generating assembly 100.

In a specific implementation, the number of the source hole sites 140 in each column may be the same, and the source hole sites 140 corresponding to the arrangement sequence in each column are located on the same circumference of the shockwave generating assembly 100. For example, the shockwave generating assembly 100 shown in fig. 1-3 is provided with two rows of source hole sites 140, wherein the source hole sites 140 in the same row are located on the same circumference, i.e., the source hole sites 140 in each row are aligned. The shockwave generating assembly 100 shown in fig. 5-7 is provided with four rows of source hole sites 140, the source hole sites 140 in the same arrangement sequence in each row are located on the same circumference, i.e., the source hole sites 140 in each row are also aligned.

This embodiment can make the shock wave carry out better stack in circumference, and then makes the shock wave amplitude further increase, and the energy increases, has promoted rubble efficiency effectively.

In other embodiments, the source hole locations 140 are at least two rows, and the source hole locations 140 in each row are arranged in a staggered manner in the circumferential direction of the ring body, i.e., the source hole locations 140 in each row are arranged in a staggered manner in the circumferential direction of the shock wave generating assembly 100.

In one specific implementation, the number of the rows of source hole sites 140 is even, and the source hole sites 140 in adjacent rows are arranged in a staggered manner, i.e., the source hole sites 140 in adjacent rows with the same arrangement sequence are not located on the same circumference. For example, in fig. 11 to 13, the number of rows of source hole sites 140 is eight, and the source hole sites 140 in adjacent rows are arranged in a staggered manner, and the source hole sites 140 in alternate rows are arranged in an aligned manner.

This kind of arrangement can make the reinforcing energy field after the stack more even along shock wave takes place subassembly 100's axial distribution, and then can further promote the rubble effect.

It should be noted that in the embodiments of the present invention, the transverse sectional view is a direction perpendicular to the axis of the shock wave assembly 100, and the longitudinal sectional view is a direction passing through the axis of the shock wave generation assembly 100.

In some embodiments, the source hole locations 140 may be cylindrical holes, and in consideration of the service life of the shock wave generating assembly 100, the distance between the source hole locations 140 (along the axial and/or circumferential direction of the annular body) may be greater than or equal to 50um, and the hole size of the source hole locations 140 may be not less than 0.005mm, and thus, the shock wave generating assembly 100 having a smaller size may be formed in a row due to the smaller size of the hole size.

It should be noted that, in the specific implementation, the length of the shock wave generating assembly 100 along the axial direction, and the size, number and shape of the source point hole sites 140 can be determined according to the actual situation, and the embodiment does not limit the length, the number and the shape.

In some embodiments, the total thickness of the shockwave generating assembly 100 in the radial direction is less than or equal to 0.5mm, i.e., the total thickness of the first electrode 110, the insulating layer 120, and the second electrode 130 in the radial direction is less than or equal to 0.5mm, to further reduce the size of the shockwave generating assembly, thereby increasing the flexibility of the balloon catheter and reducing the risk of breakage. Preferably, the radial total thickness of the first electrode 110, the insulating layer 120 and the second electrode 130 may range from 0.2mm to 0.5 mm.

It can be seen that in the present embodiment, by providing a plurality of source point hole sites 140, the shock wave generating assembly 100 has a plurality of shock wave generating source points, and shock waves generated at the source points are superposed, so that shock wave energy at the superposed position is enhanced, and a stone breaking effect is further improved.

It will be appreciated that referring to fig. 14, the first electrode 110 should be sleeved on the outer surface of the inner catheter 200 of the balloon catheter. In some embodiments, the first electrode 110 may be prepared on the outer surface of the inner catheter 200 by any one of weaving, spraying, chemical vapor deposition, electroplating, ion sputtering, and the like. The insulating layer 120 may be formed on the outer surface of the first electrode 110 by any one of printing, plating, CVD (Chemical Vapor Deposition), PVD (Physical Vapor Deposition), ion sputtering, and the like. The second electrode 130 can be prepared on the outer surface of the insulating layer 120 by any one of printing, electroplating, magnetron sputtering and the like. It should be noted that the above preparation methods are well known to those skilled in the art, and therefore are not described in detail.

In this embodiment, the electrode structure of the shockwave generating assembly 100 includes three layers, namely a first electrode 110, an insulating layer 120, and a second electrode 130. During preparation, the first electrode 110 is prepared on the outer surface of the inner conduit 200 by printing, electroplating, CVD, PVD, ion sputtering, and the like, and then an insulating layer 120 is prepared on the surface of the first electrode 110 by printing, electroplating, CVD, PVD, ion sputtering, and the like, and is not insulated, for example, opened at a designated position, i.e., the source hole position 140, to expose the first electrode 110; similarly, the second electrode 130 is prepared on the surface of the insulating layer 120 by printing, electroplating, magnetron sputtering, or the like, and non-insulating treatment, such as opening a hole, is performed at the exposed position of the first electrode 110, so that the first electrode 110 and the second electrode 130 are exposed in the source hole 140, so that the first electrode 110 and the second electrode 130 form a group of discharge electrode pairs, i.e. a source point of the shock wave.

It can be seen that, in the present embodiment, the first electrode 110, the insulating layer 120, and the third electrode 430 of the shock wave generating assembly 100 are directly prepared on the outer surface of the inner catheter 200 of the balloon catheter, and compared with the related art, the present embodiment not only can effectively reduce the size of the electrode balloon catheter, but also greatly improves the flexibility of the electrode balloon catheter, and reduces the risk of breaking the electrode balloon catheter during clinical use while improving the trafficability characteristic.

Referring to fig. 14, a balloon catheter in accordance with an embodiment of the present invention includes an inner catheter 200, a distal outer tube 300, a balloon 400, and any of the shock wave generating assemblies 100 described above. The inner space of the inner catheter 200 is a second cavity 210, and the second cavity 210 may be used for a guide wire (not shown in the figure) to pass through, and the guide wire may convey the balloon catheter to a lesion position to be treated.

The distal outer tube 300 and the balloon 400 are both sleeved outside the inner catheter 200, and a gap is formed between the distal outer tube 300 and the inner catheter 200. The first end (left end shown in fig. 14) of the balloon 400 is connected with the inner catheter 200 in a sealing manner, the second end (right end shown in fig. 14) of the balloon 400 is connected with the distal outer tube 300 in a sealing manner, a first cavity 310 is formed by a gap between the distal outer tube 300 and the inner catheter 200, the first end (left end shown in fig. 14) of the first cavity 310 is communicated with the inner space of the balloon 400, the second end (right end shown in fig. 14) of the second cavity 210 is connected with a driving device (not shown), and the driving device injects gas or liquid into the balloon 400 through the first cavity 310, so as to control the expansion or contraction of the balloon 400. In one implementation, the driving device may be a syringe pump, which may inject saline, contrast agent, etc. into the balloon 400 through the first lumen 310 to inflate or deflate the balloon 400.

The balloon 400 is made of an elastic material, and the balloon 400 may be expanded outward when gas or liquid is injected into the balloon 400 by the driving means, and the balloon 400 may be contracted inward when gas or liquid is withdrawn. In one particular implementation, the material of the balloon 400 may be rubber, nylon elastomer, nylon 11, etc., and the shape of the balloon 400 may be olive-shaped, spindle-shaped, etc. The material of the distal outer tube 300 may be the same as that of the balloon 400, but may be different from that of the balloon 400 as long as an injection passage to the balloon 400 is formed.

The shock wave generating assembly 100 is sleeved outside the inner catheter 200 and is placed in the balloon 400. In particular, one shock wave generating assembly 100 may be provided, or two or more shock wave generating assemblies may be provided. In addition, the shock wave generating unit 100 in fig. 14 has a lower end as shown in fig. 1 at the left end and an upper end as shown in fig. 1 at the right end, with respect to the state shown in fig. 14.

It will be appreciated that the shock wave generating assembly 100 may be connected to an external power source (not shown) to allow the shock wave generating assembly 100 to generate a powerful shock wave. In one specific implementation, the connecting wires between the shock wave generating assembly 100 and the power source may be disposed in the first cavity 310, and the voltage range of the power source may be 2 kv-4 kv.

After the balloon catheter is conveyed to the calcification disease position by the guide wire, the balloon 400 contracts and expands under the action of gas or liquid controlled by the driving device. After the balloon 400 is punched and expanded, the shock wave generating assembly 100 is powered by the power supply, and the electrodes of the shock wave generating assembly 100 break through liquid in the balloon 400 to generate violent discharge to generate strong shock waves so as to achieve the effect of breaking the blood vessels.

In the lithotripsy operation process, the expansion and expansion of the saccule 400 after stamping can play a role in pre-expanding the lesion part, and the saccule 400 is tightly attached to the lesion part after expansion, thereby being beneficial to the breaking of calcified lesion. And the integrity of the balloon 400, i.e., whether it is ruptured, can be determined by monitoring the pressure within the balloon 400 during the lithotripsy procedure. Generally, since the pressure inside the balloon 400 is reduced after the calcified lesion is broken, it is also possible to determine the broken stone by the pressure change inside the balloon 400. In addition, the liquid in the balloon 400 may be a contrast agent, and the rupture of the calcified lesion may be judged by the change in the shape of the balloon 400.

In this embodiment, contain a plurality of shock waves in the shock wave emergence subassembly 100 and take place source point hole site 140, the shock wave homoenergetic of the different frequencies that a plurality of source point hole sites 140 departments that arrange axially and/or circumference in the discharge process produced superpose after meeting in the space around the shock wave emergence subassembly 100, makes the shock wave amplitude increase, and the energy increases, and the regional increase of effective rubble has promoted rubble efficiency effectively.

In some embodiments, there are at least two shock wave generating assemblies 100, each shock wave generating assembly 100 is distributed along the axial direction of the inner catheter 200, and each shock wave generating assembly 100 is disposed within the balloon 400. In particular, at least two shock wave generating assemblies 100 may be disposed within a distance such that the shock waves generated by each shock wave generating assembly 100 may be superimposed within a certain range. It should be noted that, in specific implementation, the installation distance of the plurality of shock wave generating assemblies 100 may be determined according to actual situations, and this embodiment does not limit the installation distance at all.

In addition, the position of the balloon 400 is provided with a plurality of shock wave generating assemblies 100 so as to form a plurality of effective shock wave generating source points, the superposition enhancement area of shock waves in the space around the shock wave generating source points is increased, the shock wave amplitude is increased, the energy is increased, the effective gravel area is increased, and the gravel crushing efficiency is effectively improved.

In this embodiment, the shock wave generating assemblies 100 are uniformly distributed along the axial direction of the inner guide tube 200 to form a shock wave field with uniform energy distribution in a certain spatial range, so as to further improve the stone crushing efficiency and the stone crushing effect.

In other embodiments, when the number of the shock wave generating assemblies 100 is greater than two, the shock wave generating assemblies 100 are unevenly distributed along the axial direction of the inner catheter 200, the energy field formed by overlapping the shock wave generating assemblies 100 at closer intervals is stronger, and the energy field formed by overlapping the shock wave generating assemblies 100 at farther intervals is weaker, so as to perform lithotripsy on the parts with different calcified lesion conditions.

In other embodiments, the source point holes 140 of each shockwave generating assembly 100 are arranged at different densities, so that different shockwave generating assemblies 100 can emit shockwaves with different energies, and shockwave energy fields with different energies can be formed at different lesion positions, so as to treat different calcified lesion degrees at different parts.

It will be apparent to those skilled in the art that various changes and modifications may be made in the present invention without departing from the spirit and scope of the invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include such modifications and variations.

Claims

1. A shock wave generating assembly for a balloon catheter, comprising:

a first electrode;

the insulating layer is sleeved outside the first electrode;

the second electrode is sleeved outside the insulating layer, and the first electrode, the insulating layer and the second electrode are all annular bodies;

at least one row of source point hole sites are correspondingly arranged on the insulating layer and the second electrode, and each source point hole site penetrates through the second electrode and the insulating layer and exposes the first electrode, so that the first electrode and the second electrode form a discharge electrode pair for generating shock waves.

2. The shock wave generating assembly according to claim 1,

the source point hole locations in each column are uniformly or non-uniformly arranged along the axial direction of the annular body.

3. The shock wave generating assembly according to claim 1,

the arrangement density of the source point hole sites in each column changes from dense to sparse or from sparse to dense along the axial direction of the ring body in the left-to-right direction.

4. The shock wave generating assembly according to claim 2,

the source point hole sites are at least two rows, and the source point hole sites in each row are uniformly or non-uniformly arranged along the circumferential direction of the annular body.

5. The shock wave generating assembly according to claim 2,

the source point hole sites are at least two rows, and the source point hole sites in each row are arranged in the circumferential direction of the annular body in an aligned or staggered manner.

6. The shock wave generating assembly according to any one of claims 1 to 5,

the first electrode of the shock wave generation assembly is prepared on the outer surface of the inner catheter of the balloon catheter by any one method of weaving, spraying, chemical vapor deposition, electroplating and ion sputtering.

7. The shock wave generating assembly according to claim 6,

the insulating layer is prepared on the outer surface of the first electrode by any one method of printing, electroplating, CVD, PVD and ion sputtering.

8. The shock wave generating assembly according to claim 7,

the second electrode is prepared on the outer surface of the insulating layer by any one of printing, electroplating and magnetron sputtering.

9. The shockwave generating assembly of any one of claims 1-5, wherein a combined radial thickness of the first electrode, the insulating layer, and the second electrode is 0.5 millimeters or less.

10. A balloon catheter, comprising:

an inner conduit;

a distal outer tube;

the far-end outer tube and the balloon are sleeved outside the inner catheter, a first end of the balloon is connected with the inner catheter in a sealing mode, a second end of the balloon is connected with the far-end outer tube in a sealing mode, a first cavity is formed between the inner catheter and the far-end outer tube, and the inner space of the balloon is communicated with the first cavity;

the shock wave generating assembly of any one of claims 1-9, sleeved outside the inner catheter and disposed within the balloon.

11. The balloon catheter of claim 10,

the number of the shock wave generating assemblies is at least two, and the shock wave generating assemblies are uniformly distributed along the axial direction of the inner guide pipe.