CN115919408A

CN115919408A - Shock wave generating device and balloon catheter

Info

Publication number: CN115919408A
Application number: CN202211579621.0A
Authority: CN
Inventors: 黄海新
Original assignee: Shenzhen Beixin Medical Technology Co ltd
Current assignee: Shenzhen Beixin Medical Technology Co ltd
Priority date: 2022-12-09
Filing date: 2022-12-09
Publication date: 2023-04-07

Abstract

The application relates to the technical field of medical instruments, and particularly discloses a shock wave generating device and a balloon catheter. Wherein the shock wave generating device includes: the first electrode is sleeved outside the inner catheter of the balloon catheter; the insulating layer is sleeved outside the first electrode; the second electrode is sleeved outside the insulating layer; the second electrode and the insulating layer are correspondingly provided with electrode holes, the electrode holes penetrate through the second electrode and the insulating layer and expose the first electrode, so that the first electrode and the second electrode form an electrode pair in the electrode holes, and the electrode pair can be subjected to breakdown discharge to generate shock waves; the number of the electrode pairs is at least two to form an electrode group, breakdown gaps of the electrode pairs in the electrode group are different, and the electrode pairs in the electrode group are successively breakdown-discharged when a voltage is applied to the first electrode and the second electrode. Each electrode pair in the electrode group arranged in the application can be punctured and discharged in sequence, and the service life of the electrode group is prolonged.

Description

Shock wave generating device and balloon catheter

Technical Field

The application relates to the technical field of medical equipment, in particular to a shock wave generating device and a balloon catheter.

Background

Coronary artery disease, peripheral artery disease, and the like are vascular obstructions caused by the accumulation of calcified plaque, and an emerging treatment currently employs a balloon catheter. According to the method, after a balloon catheter is tracked and positioned to the stenosis resistance of a blood vessel, liquid is filled into the balloon to expand the balloon, blood flow is improved, and then violent discharge is generated through a first electrode and a second electrode in a shock wave generating device in the balloon to generate powerful shock waves so as to carry out lithotripsy on the blood vessel.

In the related art, all the shock wave generating devices of the balloon catheter are made of metal materials, and when the first electrode and the second electrode are broken down by external high voltage, the first electrode and the second electrode are quickly ablated and damaged under high temperature and high shock, and gradually lose the function of triggering shock waves to cause product failure. Although researchers use metal with a higher melting point as a metal electrode to prolong the service life of the electrode, the defects of high cost and difficult processing technology are forced, the problem of the service life of the electrode is not well solved, and clinical inconvenience is brought to doctors and patients.

Disclosure of Invention

In view of this, the present application provides a shock wave generating device and a balloon catheter, which aims to solve the problem that the electrode life is affected due to the rapid ablation and damage of the electrode.

In one aspect, the present application proposes a shock wave generating device for a balloon catheter, the shock wave generating device comprising: a first electrode sleeved outside an inner catheter of the balloon catheter; the insulating layer is sleeved outside the first electrode; the second electrode is sleeved outside the insulating layer; the second electrode and the insulating layer are correspondingly provided with electrode holes, the electrode holes penetrate through the second electrode and the insulating layer and expose the first electrode, so that the first electrode and the second electrode form an electrode pair in the electrode holes, and the electrode pair can be broken down to discharge to generate shock waves; the number of the electrode pairs is at least two, the electrode pairs are connected in parallel, and when voltage is applied to the first electrode and the second electrode, the electrode pairs are subjected to breakdown discharge successively.

Further, in the above-described shock wave generator, when no voltage is applied to the first electrode and the second electrode, the breakdown gaps of the electrode pairs are the same.

Further, in the above-described shock wave generator, when no voltage is applied to the first electrode and the second electrode, the breakdown gaps of the electrode pairs are different from each other.

Further, in the above-described shock wave generator, when no voltage is applied to the first electrode and the second electrode, the breakdown gaps of a part of the electrode pairs are the same, and the breakdown gaps of another part of the electrode pairs are different.

Further, in the above shock wave generator, the electrode hole includes: a first via hole penetrating the second electrode; and the second through hole penetrates through the insulating layer and is communicated with the first through hole.

Further, in the above shock wave generator, the first through holes of the electrode pairs in the electrode group communicate with each other.

Further, in the above shock wave generator, an aperture of the first through hole is larger than an aperture of the second through hole.

Further, in the above-described shock wave generator, the second through holes of the electrode pairs in the electrode group communicate with each other.

Further, in the above shock wave generator, the second through hole has a larger aperture than the first through hole.

Further, in the above shock wave generating apparatus, the aperture of the second through hole ranges from 0.05 to 0.3mm, and the aperture of the first through hole ranges from 0.3 to 0.4mm.

Further, in the above shock wave generating apparatus, the first through hole and the second through hole of each of the electrode holes are coaxially provided; the electrode pairs are arranged along the axial direction and/or the circumferential direction of the inner catheter.

Further, in the above shock wave generating apparatus, each of the electrode pairs connected in parallel forms an electrode group, and the electrode groups are at least one group; when the number of the electrode groups is two or more, the electrode groups are arranged along the axial direction and/or the circumferential direction of the annular body.

The shock wave generating device is provided with the electrode group, the electrode group comprises at least two electrode pairs, when voltage is applied, each electrode pair can be broken down to break down the broken stone in sequence, namely, after one electrode pair is ablated and damaged, the other electrode pair can be broken down to emit the shock wave, the number of the arranged electrode pairs is more, the number of times of the total shock wave which can be accumulated to be emitted can be increased, and the broken stone can be repeatedly carried out in the same area. It can be seen that the electrode group in this embodiment has improved the whole number of times of sending shock wave, has improved the life of electrode group promptly, has also promoted rubble effect and doctor and patient's use simultaneously and has experienced.

In another aspect, the present application also proposes a balloon catheter, including: an inner conduit; an outer tube; the 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 outer tube in a sealing mode, a first cavity is formed between the inner catheter and the outer tube, and the inner space of the balloon is communicated with the first cavity; in any of the above shock wave generating devices, the shock wave generating device is sleeved outside the inner catheter and is disposed in the balloon.

Further, in the balloon catheter, at least one of the shock wave generating devices is provided; when the number of the shock wave generating devices is larger than or equal to two, the shock wave generating devices are distributed along the axial direction of the inner guide pipe.

Since the shock wave generating device has the above-described effects, the balloon catheter having the shock wave generating device 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 structural view of a balloon catheter provided in an embodiment of the present application;

FIG. 2 is a schematic perspective view of a shockwave generating device provided in an embodiment of the present application;

FIG. 3 is a side view of a shockwave generating device provided in an embodiment of the present application;

FIG. 4 is a transverse cross-sectional view of a shockwave generating device provided in an embodiment of the present application;

FIG. 5 is a schematic perspective view of a shockwave generating device provided in an embodiment of the present application;

FIG. 6 is a side view of the shock wave generating device shown in FIG. 5;

FIG. 7 is a transverse cross-sectional view of the shock wave generating device shown in FIG. 5;

FIG. 8 is a schematic perspective view of a shockwave generating device provided in an embodiment of the present application;

FIG. 9 is a side view of the shock wave generating device shown in FIG. 8;

FIG. 10 is a transverse cross-sectional view of the shock wave generating device shown in FIG. 8;

FIG. 11 is a schematic perspective view of a shockwave generating device provided in an embodiment of the present application;

FIG. 12 is a side view of the shock wave generating device shown in FIG. 11;

FIG. 13 is a transverse cross-sectional view of the shock wave generating device shown in FIG. 11;

fig. 14 is an equivalent circuit diagram of a breakdown circuit of the shock wave generating apparatus shown in fig. 2.

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 orientations and positional relationships indicated in the drawings for convenience in describing the present application and to simplify the description, but are not intended to indicate or imply that the device or element so referred to must have a particular orientation, be constructed and operated in a particular orientation, and are not to be construed as limiting the present application.

Unless expressly stated or limited otherwise, the terms "mounted," "connected," "secured," and the like are intended to be inclusive and mean that, for example, they may be fixedly connected or detachably connected or integrally formed; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or may be connected through the use of two elements or the interaction of two elements. The specific meaning of the above terms in the present application can be understood by those of ordinary skill in the art as the case may be.

The embodiment of the application provides a shock wave generation device 100, and the shock wave generation device 100 is used for a balloon catheter.

Referring to fig. 1, the balloon catheter generally includes a shock wave generating device 100, an inner catheter 200, an outer tube 300 and a balloon 400, the outer tube 300 and the balloon 400 are both sleeved outside the inner catheter 200, a first end (a left end shown in fig. 1) of the balloon 400 is hermetically connected with the inner catheter 200, a second end (a right end shown in fig. 1) of the balloon 400 is hermetically connected with the outer tube 300, a first cavity a is formed between the inner catheter 200 and the outer tube 300, and an inner space of the balloon 400 is communicated with the first cavity a. The shock wave generator 100 is sleeved outside the inner catheter 200 and is disposed inside the balloon 400, and the shock wave generator 100 is connected to an external power source (not shown).

It is understood that the present embodiment only schematically describes the structure of the balloon catheter, and in particular, the balloon catheter may also have other structures, which are not limited herein.

When the balloon catheter is used, the balloon catheter is sent to a diseased narrow position of a blood vessel, and the shock wave generating device 100 sends shock waves to smash the narrow position.

The technical solution of the shockwave generating device 100 in the embodiment of the present application is described in detail below with reference to the drawings.

Referring to fig. 1 to 4, a shockwave generating device 100 according to one embodiment of the present application includes a first electrode 110, an insulating layer 120, and a second electrode 130. The first electrode 110 is sleeved outside the inner catheter 200 of the balloon catheter, the insulating layer 120 is sleeved outside the first electrode 110, and the second electrode 130 is sleeved outside the insulating layer 120.

The second electrode 130 and the insulating layer 120 are correspondingly provided with electrode holes 140, the electrode holes 140 penetrate through the second electrode 130 and the insulating layer 120 and expose the first electrode 110, so that the first electrode 110 and the second electrode 130 form a discharge electrode pair in the electrode holes 140, and when a voltage is applied to the first electrode 110 and the second electrode 130, the electrode pair can be broken down to discharge to generate a shock wave.

In a specific implementation, the first electrode 110 and the second electrode 130 may be metal electrodes, and the material of the metal electrodes may be metal or alloy with good conductivity, such as gold, silver, copper, platinum, tungsten, stainless steel, and the like. The insulating layer 120 may be a polymer material such as polyurethane or polyimide having high insulating and heat resistance.

In the preparation, the first electrode 110 may be prepared on the outer surface of the inner tube 200 by any one of printing, plating, CVD (Chemical Vapor Deposition), PVD (Physical Vapor Deposition), ion sputtering, and the like. Then, an insulating layer 120 is 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, etc., and the insulating layer is not insulated, for example, opened at the position corresponding to the electrode hole 140 to expose the first electrode 110. Finally, the second electrode 130 is prepared on the outer surface of the insulating layer 120 by any one of printing, electroplating, CVD (Chemical Vapor Deposition), PVD (Physical Vapor Deposition), ion sputtering, and the like, and the same process is performed on the exposed position of the first electrode 110, such as opening, the opening of the insulating layer 120 and the opening of the second electrode 130 form an electrode hole 140, the first electrode 110 and the second electrode 130 exposed in the electrode hole 140 form a set of discharge electrode pairs, and a shock wave can be generated by discharge after a voltage is applied.

In order to ensure that the balloon catheter has certain passability, the thickness of the shock wave generating device 100 along the radial direction of the inner catheter 200 is not more than 0.5mm, and may be set to other thicknesses according to actual conditions in specific implementation, which is not limited herein.

In this embodiment, the inner catheter 200 may be a torus, and accordingly, the first electrode 110, the insulating layer 120 and the second electrode 130 prepared on the outer surface of the inner catheter 200 are also a torus. Of course, the inner catheter 200 may have other shapes, such as an elliptical cross-section, and the first electrode 110, the insulating layer 120, and the second electrode 130 may be shaped to conform to the outer surface of the inner catheter 200, which is not limited herein.

In this embodiment, the openings of the electrode hole 140 on the insulating layer 120 and the second electrode 130 may be cylindrical holes, and the axis of the cylindrical hole may be perpendicular to the axis of the first electrode 110 or disposed at an angle. Of course, the electrode hole 140 may have other shapes, such as an oval cross section, and is not limited herein.

In this embodiment, at least two pairs of electrodes are connected in parallel in the breakdown circuit, and when a voltage is applied to the first electrode 110 and the second electrode 130, the pairs of electrodes are sequentially breakdown-discharged. That is, when a voltage is applied to the first electrode 110 and the second electrode 130, one of the electrode pairs is breakdown-discharged, and as the ablation of the breakdown gap of the breakdown-discharged electrode pair changes, the breakdown discharge is transferred between the electrode pairs.

Specifically, after the voltage is applied to the first electrode 110 and the second electrode 130, one electrode pair is breakdown-discharged, and when the electrode pair is breakdown-discharged, energy is rapidly consumed by the electrode pair, and the gaps between the remaining electrode pairs are not breakdown. After repeated discharges of the broken-down electrode pair, the gap between the electrode pair becomes larger, the breakdown discharge becomes relatively difficult compared with the gaps of other electrode pairs, the breakdown discharge is transferred to the gap between another electrode pair which is relatively easy to break down, and so on, the breakdown discharge is carried out between the electrode pairs one after another.

When one electrode pair stops discharging, the electrode pair discharging next can continue to lithotripsy the lesion area.

In specific implementation, repeated discharge can occur in each electrode pair within the total discharge period, and a strict discharge sequence does not exist between each electrode pair, that is, after the discharge is performed for a plurality of times, the discharge is transferred to the gap of another electrode pair for carrying out

In this embodiment, the more electrode pairs are provided, the more the number of times of the total shock waves that can be generated cumulatively by each electrode group is, and in specific implementation, two pairs, three pairs, four pairs, or more than four pairs may be provided.

In this embodiment, the arrangement distance between the electrode pairs can meet a preset requirement, so that the electrode pairs are arranged relatively compactly, and further, the sequential discharge can concentrate the lithotripsy on a certain region of the blood vessel. In specific implementation, the distance between each electrode pair can be the distance between the axes of each electrode hole 140, and the smaller the distance is, the more compact each electrode pair is arranged, the stronger the concentrated stone breaking capability of a certain area is, and the better the stone breaking effect is; the larger the distance, the looser the electrode pair arrangement is, and although the lithotripsy concentrating ability for a certain area is poor, the lithotripsy area can be increased. In a specific implementation, the arrangement distance between each electrode pair may be determined according to an actual situation, and is not limited herein.

In the related art, the first electrode and the second electrode are quickly ablated and damaged at high temperature and high pressure after being punctured, and gradually lose the function of triggering shock waves to cause product failure, so that great inconvenience is brought to doctors and patients.

The shock wave generating device in the embodiment is provided with the electrode group, the electrode group comprises at least two electrode pairs, when voltage is applied, each electrode pair can be broken down to break down the broken stone in sequence, namely, after one electrode pair is ablated and damaged, the other electrode pair is broken down to generate the shock wave, the number of the arranged electrode pairs is more, the total number of times of the generated shock wave can be increased, and the broken stone can be performed on the same area for multiple times. It can be seen that electrode group in this embodiment has improved the whole number of times of sending shock wave, has improved electrode group's life promptly, has also promoted rubble effect and doctor and patient's use simultaneously and has experienced.

In some embodiments, the breakdown gap of each electrode pair is the same when no voltage is applied to the first electrode 110 and the second electrode 130.

It is understood that although the gaps between the electrode pairs are the same, since the electrode pairs are in parallel relationship in the breakdown circuit, the breakdown between the first electrode 110 and the third electrode 130 occurs along only one of the electrode pairs, and it is unlikely that the electrode pairs will be broken down at the same time.

In one particular implementation, referring to fig. 4, the electrode aperture 140 may include: a first via hole 131 penetrating the second electrode 130 and a second via hole 121 penetrating the insulating layer 120, the second via hole 121 communicating with the first via hole 131. In a specific implementation, the first through holes 131 in the electrode holes 140 forming each electrode pair are communicated, and the second through holes 121 are not communicated.

Specifically, the first through holes 131 may have a larger diameter than the second through holes 121, and the first through holes 131 may be connected. The aperture of the second through hole 121 may be selected to be 0.05mm to 0.3mm, and the aperture of the first through hole 131 may be selected to be 0.3mm to 0.4mm, for example, the aperture of the first through hole 131 is 0.3, and the aperture of the second through hole 121 is 0.29.

Referring to fig. 2 to 4, two electrode pairs are provided, the first electrode 110a and the second electrode 130a in the first electrode hole 140a form the first electrode pair, the first electrode 110b and the second electrode 130b in the second electrode hole 140b form the second electrode pair, and the first through hole in the first electrode hole 140a and the first through hole in the second electrode hole 140b communicate with each other.

The breakdown gap of the first electrode pair is the same as the breakdown gap of the second electrode pair, the gap between the first electrode 110a and the second electrode 130a, and the gap between the first electrode 110b and the second electrode 130b are the same and are connected in parallel, and fig. 14 is an equivalent circuit diagram thereof. It is understood that the positive or negative electrode lead is connected to the first electrode 110 by welding, and the external power source receives the high voltage pulse. The breakdown between the first electrode 101 and the third electrode 103 may be performed only along one of the gap between the first electrode 110a and the second electrode 130a or the gap between the first electrode 110b and the second electrode 130b, and it is impossible to perform the breakdown simultaneously.

Assuming that the first electrode 110a and the second electrode 130a are first discharge-broken down, it becomes difficult to establish a high-temperature, high-density plasma channel between the first electrode 110a and the second electrode 130a, and when the first electrode 110a and the second electrode 130a are worn down to a certain extent, it becomes relatively easy to establish a plasma channel between the first electrode 110b and the second electrode 130b, so that the first electrode 110b and the second electrode 130b are discharge-broken down, and when the effective position of the generated shock wave is shifted from between the first electrode 110a and the first electrode 130a to between the first electrode 110b and the second electrode 130b, two sets of electrode pairs may be disposed on the same side of the curved surface of the inner guide tube 200 and at a relatively close distance, so that the release action area of the generated shock wave is substantially in the same crushed stone area, thus the effective first electrode pair and the second electrode pair may be formed at the same shock wave generation position, and two sets of shock waves may be alternately discharged to generate a shock wave, i.e., when the first electrode 110b and the second electrode 130b are discharge-broken down, the plasma channel between the first electrode 110a and the second electrode 130b may be established again to a high-broken down, and when the plasma channel is established between the first electrode 110a, it becomes difficult to establish a plasma channel between the second electrode 130b, and the plasma channel between the first electrode 130b, and the plasma channel.

Therefore, the alternate breakdown mode greatly improves the overall times of the electrode group for sending shock waves and prolongs the service life of the electrode group.

In a specific implementation, three electrode pairs (first and

second electrodes

110a and 130a, first and

second electrodes

110b and 130b, and first and

second electrodes

110c and 130 c) may also be provided in order to obtain a longer-life electrode group, see fig. 5 to 7. Four electrode pairs (first and

second electrodes

110a and 130a, first and

second electrodes

110b and 130b, first and

second electrodes

110c and 130c, and first and

second electrodes

110d and 130 d) may also be provided, see fig. 8 to 10. Of course, five electrode pairs (the first and

second electrodes

110a and 130a, the first and

second electrodes

110b and 130b, the first and

second electrodes

110c and 130c, the first and

second electrodes

110d and 130d, and the first and

second electrodes

110e and 130 e) may also be provided, see fig. 11 to 13. Of course, more than five electrode pairs may be provided, and this embodiment is not illustrated.

In another specific implementation, the second through holes 121 of each electrode pair in the electrode group are communicated, and the first through holes 131 are not communicated, so that each electrode pair can be sequentially subjected to breakdown discharge.

In a specific implementation, the aperture of the second through hole 121 is larger than that of the first through hole 131, and the second through holes 121 may be connected. The aperture of the second through hole 121 may be selected to be 0.05mm to 0.3mm, and the aperture of the first through hole 131 may be selected to be 0.3mm to 0.4mm.

In a specific implementation, the first through hole 131 and the second through hole 121 of each electrode hole may be coaxially disposed, and each electrode pair may be arranged along the axial direction and/or the circumferential direction of the inner catheter 200, or may be arranged along the outer surface of the inner catheter 200 in a spiral line. Of course, the first through hole 131 and the second through hole 121 may be disposed non-coaxially, and are not limited herein.

In some embodiments, when no voltage is applied to the first electrode 110 and the second electrode 130, the breakdown gap of each electrode pair is different, i.e., the distance between the first electrode 110 and the second electrode 130 in each electrode hole is different.

It will be appreciated that the discharge breakdown between the first electrode 110 and the second electrode 130 always proceeds along a path that is relatively easy to break down, and one important factor affecting the breakdown is the breakdown distance, i.e., the breakdown gap between the electrodes, which is the first breakdown discharge with a small breakdown gap.

In the actual discharging process, the electrode pair with the smallest breakdown gap is broken down first, when the gap between the electrode pair is broken down, the energy is rapidly consumed by the electrode pair, and the gaps between the other electrode pairs are not broken down. After repeated discharges of the broken electrode pair, the gap distance becomes longer after the metal electrode of the electrode pair is ablated, so that the breakdown becomes relatively difficult compared with the gap discharge of the other electrode pair, and the breakdown discharge is transferred to the gap of the other electrode pair which is relatively easy to break down. By analogy, the breakdown discharge is performed successively between each pair of electrodes.

In some embodiments, when no voltage is applied to the first electrode 110 and the second electrode 130, a portion of the electrodes may have the same breakdown gap and another portion of the electrodes may have different breakdown gaps.

In some embodiments, the at least two electrode pairs form an electrode group, and the electrode group is at least one group, but may be two or more groups. When the number of the electrode sets is two or more, each electrode set may be uniformly or non-uniformly arranged along the axial direction of the inner catheter 200, certainly, may also be uniformly or non-uniformly arranged along the circumferential direction of the inner catheter 200, may also be simultaneously arranged along the axial direction and the circumferential direction, may be arranged along a spiral line, and the like, which is not limited herein.

When the number of the electrode groups is two or more, the breakdown gaps of the electrode pairs of each electrode group may be the same, may also be different, or may be partially the same, which is not limited herein.

Set up a plurality of electrode groups in this embodiment, widened the rubble region, promoted the rubble effect.

The embodiment of the application also provides a balloon catheter, which is shown in figure 1. The balloon catheter includes: an inner catheter 200, an outer tube 300, a balloon 400, and a shock wave generating device 100. The outer tube 300 and the balloon 400 are both sleeved outside the inner catheter 200, a first end (the left end shown in fig. 1) of the balloon 400 is hermetically connected with the inner catheter 200, a second end (the right end shown in fig. 1) of the balloon 400 is hermetically connected with the outer tube 300, a first cavity a is formed between the inner catheter 200 and the outer tube 300, the inner space of the balloon 400 is communicated with the first cavity a, and the shock wave generating device 100 is sleeved outside the inner catheter and is placed in the balloon 400.

The inner space of the inner catheter 200 is a second cavity B, and the second cavity B can be used for a guide wire (not shown in the figure) to penetrate through, and the guide wire can convey the balloon catheter to a lesion position to be treated.

It is understood that an external driving device injects a gas or a liquid into the balloon 400 through the first cavity a, thereby controlling the expansion or contraction of the balloon 400. In one implementation, the driving device may be a syringe pump, and the syringe pump may inject saline, contrast agent, etc. into the balloon 400 through the first lumen a 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 outer tube 300 and the balloon 400 may be made of the same material, but may be different from each other as long as an injection/suction passage to the balloon 400 is formed.

The shock wave generating device 100 is prepared outside the inner catheter 200 and placed inside the balloon 400. In concrete implementation, there may be one or two or more shock wave generators 100. When the number of the shock wave generating devices 100 is two or more, the respective shock wave generating devices 100 are distributed along the axial direction of the inner guide duct 200.

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 device 100 is powered by a power supply, and the electrodes of the shock wave generating device 100 break through liquid in the balloon 400 to generate violent discharge to generate strong shock waves so as to achieve the effect of crushing the blood vessels.

During lithotripsy operation, the expansion and expansion of the balloon 400 after stamping can play a role in pre-expanding the lesion part, and the balloon 400 is tightly attached to the lesion part after expansion, so that the calcified lesion part can be crushed. 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 can be a contrast agent, and the situation that the calcified lesion is broken can be judged through the change of the shape of the balloon 400.

In the embodiment, the shock wave generating device of the balloon catheter is provided with the electrode group, the electrode group comprises at least two electrode pairs, when voltage is applied, each electrode pair can be punctured for crushing stones successively, namely, after one electrode pair is ablated and damaged, the other electrode pair can be punctured for emitting shock waves, the more the number of the electrode pairs is, the longer the time of the emitted shock waves is, and the multiple times of crushing stones can be carried out on the same area. It can be seen that the electrode group in this embodiment has improved the whole number of times of sending shock wave, has improved the life of electrode group promptly, has also promoted rubble effect and doctor, patient's use simultaneously and has experienced.

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

Claims

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

the first electrode is sleeved outside the inner catheter of the balloon catheter;

the insulating layer is sleeved outside the first electrode;

the second electrode is sleeved outside the insulating layer, electrode holes are correspondingly formed in the positions of the second electrode and the insulating layer, the electrode holes penetrate through the second electrode and the insulating layer and expose the first electrode, so that the first electrode and the second electrode form an electrode pair in the electrode holes, and the electrode pair can be subjected to breakdown discharge to generate shock waves;

the number of the electrode pairs is at least two, the electrode pairs are connected in parallel, and when voltage is applied to the first electrode and the second electrode, the electrode pairs are subjected to breakdown discharge successively.

2. A shock wave generating device according to claim 1,

when no voltage is applied to the first electrode and the second electrode, the breakdown gaps of the electrode pairs are the same.

3. A shock wave generating device according to claim 1,

when no voltage is applied to the first electrode and the second electrode, the breakdown gap of each electrode pair is different.

4. The shock wave generating apparatus according to claim 1,

when no voltage is applied to the first electrode and the second electrode, the breakdown gaps of a part of the electrode pairs are the same, and the breakdown gaps of the other part of the electrode pairs are different.

5. The shock wave generating apparatus according to claim 1, wherein the electrode hole includes:

a first via hole penetrating the second electrode;

and the second through hole penetrates through the insulating layer and is communicated with the first through hole.

6. The shock wave generating apparatus according to claim 5,

the first through holes in the electrode holes of the electrode pairs are communicated.

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

the aperture of the first through hole is larger than that of the second through hole.

8. The shock wave generating apparatus according to claim 5,

and the second through holes in the electrode holes of each electrode pair are communicated.

9. The shock wave generating apparatus according to claim 8,

the aperture of the second through hole is larger than that of the first through hole.

10. The shock wave generating apparatus according to claim 5,

the aperture range of the second through hole is 0.05-0.3mm, and the aperture range of the first through hole is 0.3-0.4mm.

11. The shock wave generating apparatus according to claim 5,

the first through hole and the second through hole of each electrode hole are coaxially arranged;

each of the electrode pairs is arranged along an axial direction and/or a circumferential direction of the inner catheter.

12. The shock wave generating apparatus according to any one of claims 1 to 11,

each electrode pair connected in parallel forms an electrode group, and the electrode groups are at least one group;

when the number of the electrode groups is two or more, the electrode groups are arranged along the axial direction and/or the circumferential direction of the inner catheter.

13. A balloon catheter, comprising:

an inner conduit;

an outer tube;

the 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 outer tube in a sealing mode, a first cavity is formed between the inner catheter and the outer tube, and the inner space of the balloon is communicated with the first cavity;

the shock wave generating device of any one of claims 1-12, sleeved outside the inner catheter and disposed within the balloon.

14. The balloon catheter of claim 13,

at least one shock wave generating device is arranged;

when the number of the shock wave generating devices is larger than or equal to two, the shock wave generating devices are distributed along the axial direction of the inner guide pipe.