CN217118522U

CN217118522U - Medical device and system

Info

Publication number: CN217118522U
Application number: CN202123214915.7U
Authority: CN
Inventors: 岳斌; 常兆华; 贾婧玮; 聂京闽; 陈国明; 张靖宜
Original assignee: Shanghai Microport Cardioflow Medtech Co Ltd
Current assignee: Shanghai Microport Cardioflow Medtech Co Ltd
Priority date: 2021-12-20
Filing date: 2021-12-20
Publication date: 2022-08-05
Anticipated expiration: 2031-12-20

Abstract

The utility model provides a medical device and a system, wherein the medical device comprises a catheter, a balloon component and a first electrode; the balloon component is sleeved at the distal end of the catheter and comprises a first balloon and a second balloon which are arranged along the axial direction; a first electrode is arranged in the first balloon, the first electrode is used for generating shock waves under the action of a shock wave generator, the first balloon also contains a first filling agent, and the first filling agent has conductivity and transmits the shock waves; the second balloon is for containing a second inflation agent for inflation. Medical system is used for softening the treatment to the calcification pathological change of blood vessel or aortic valve, and the during operation utilizes sacculus subassembly and regional butt including the target including calcification portion, and first sacculus and calcification portion butt, and sacculus subassembly has great area of contact with the target, strengthens the positioning stability of first sacculus, avoids first sacculus to shift and influence treatment in the course of the work.

Description

Medical device and system

Technical Field

The utility model relates to the technical field of medical equipment, concretely relates to medical device and system.

Background

Calcified lesions are of various types, such as aortic valve Calcification (CAVD), which is the ectopic accumulation of calcium nodules on the surface of the aortic valve, leading to thickening and functional stenosis of the aortic valve. Degenerative calcified aortic valve stenosis (CAS) is a degenerative change of the aortic valve with age, such as fibrosis, calcification and eventually dysfunctional valvular heart disease. CAS is the most common heart valvular disease in the elderly at present, and along with the gradual aging society of China, the improvement of the life quality and the prolongation of the average life span of people, the incidence and the prevalence of calcified aortic stenosis in China are increasing year by year.

Currently, surgical treatment is the more effective treatment for CAS, including Surgical Aortic Valve Replacement (SAVR) and Transcatheter Aortic Valve Replacement (TAVR), where SAVR is more traumatic and has a longer recovery time, and is being gradually replaced by TAVR in recent years. However, both SAVR and TAVR have more strict indications and contraindications, are more suitable for patients with severe stenosis, and have certain requirements on the anatomical structure of the aortic valve. Aiming at early mild and moderate aortic valve calcification, at present, the calcified part can be softened clinically by generating shock waves through a medical device loaded with an electrode, but the hardness of the calcified part is higher, so that the positioning stability of the medical device is poor, the medical device is easy to shift in the treatment process, and the treatment effect is further reduced.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to provide a medical device and system, aim at improving the positional stability of medical device distal end, reduce because of the treatment in-process takes place to shift and reduces the possibility of treatment.

In order to achieve the above object, the present invention provides a medical device, comprising a catheter, a balloon assembly and a first electrode; the balloon assembly is sleeved on the distal end of the catheter and comprises a first balloon and a second balloon which are arranged along the axial direction; the first balloon having a first lumen with the first electrode disposed therein for generating a shock wave, the first lumen further for containing a first inflation agent for inflating the first balloon, the first inflation agent further being configured to be electrically conductive and for transmitting a shock wave; the second balloon has a second lumen for receiving a second inflation agent to inflate the second balloon.

Optionally, the first balloon is located on a proximal side of the second balloon.

Optionally, the catheter comprises a main tube, the balloon assembly being fitted over a distal outer surface of the main tube.

Optionally, the catheter includes a main tube body and a plurality of branch tube bodies, the main tube body is of a linear structure, two axial ends of each branch tube body are respectively connected with the distal end of the main tube body, and the plurality of branch tube bodies are arranged around the axis of the main tube body at intervals; the first sacculus is a plurality of in quantity, a plurality of first sacculus sets up respectively on different the lateral mass body.

Optionally, the number of the second balloons is plural, and the plural second balloons are respectively disposed on the different branch pipe bodies.

Optionally, the number of the second balloons is one, and one second balloon is arranged on the main tube body.

Optionally, the medical device further comprises a second electrode disposed in the second lumen and configured to generate a shockwave, the second bulking agent further configured to be electrically conductive and configured to transmit the shockwave.

Optionally, the distance of the first electrode to the axis of the first balloon is adjustable, and/or the distance of the second electrode to the axis of the second balloon is adjustable.

Optionally, the catheter has a first liquid channel and a second liquid channel which are isolated from each other, a first liquid through hole and a second liquid through hole are formed in a side wall of the catheter, the first liquid through hole communicates the first liquid channel with the first inner cavity of the first balloon, and the second liquid through hole communicates the second liquid channel with the second inner cavity of the second balloon; the first filling agent flows into or out of the first lumen through the first fluid passage and the first through-hole, and the second filling agent flows into or out of the second lumen through the second fluid passage and the second through-hole.

Optionally, in a radial projection of the medical device, a contour line of a projection of the first balloon and/or the second balloon in the inflated state is a curve.

Optionally, the first balloon and/or the second balloon when inflated has a diameter of 8mm to 32mm and a length of 5mm to 30 mm.

Optionally, the balloon assembly has a hardness of less than or equal to 65D.

Optionally, the medical device further comprises a sheath for being movably sleeved outside the catheter and the balloon assembly.

In order to achieve the above object, the present invention further provides a medical system, comprising a shock wave generator and the medical device as described in any of the above, wherein the shock wave generator is at least used for electrically connecting to the first electrode and making the first electrode generate shock wave.

Compared with the prior art, the utility model discloses a medical device and system have following advantage:

the medical device comprises a balloon assembly and a first electrode; the balloon assembly is sleeved on the outer surface of the distal end of the catheter and comprises a first balloon and a second balloon which are axially arranged; the first balloon having a first lumen with the first electrode disposed therein for generating a shock wave, the first lumen further for containing a first inflation agent for inflating the first balloon, the first inflation agent being configured to be electrically conductive and for transmitting a shock wave; the second balloon has a second lumen for receiving a second inflation agent to inflate the second balloon. In operation, the balloon assembly is first delivered to a target area, the target area is at least partially calcified, and the first balloon is used for abutting against a lesion position for softening treatment; then the second balloon and the first balloon are inflated in sequence, or the second balloon and the first balloon are inflated simultaneously, so that the two balloons are abutted to a target area, the balloon assembly and the target area have a large contact area, the positioning stability of the balloon assembly is improved, the purpose of improving the positioning stability of the first balloon is achieved, the possibility of displacement of the first balloon is reduced, and the treatment effect is improved.

Drawings

The accompanying drawings are included to provide a better understanding of the present invention and are not intended to constitute an undue limitation on the invention. Wherein:

fig. 1 is a schematic structural diagram of a medical system according to an embodiment of the present invention;

fig. 2 is a schematic structural diagram of a medical system according to a second embodiment of the present invention, in which two branch pipes are shown;

fig. 3 is a schematic structural diagram of a medical system according to a second embodiment of the present invention, and the viewing orientation of fig. 3 is different from that of fig. 2;

fig. 4 is a schematic structural diagram of a medical system according to a second embodiment of the present invention, in which a shock wave generator is not shown and three branch pipe bodies are shown;

FIG. 5 is a schematic view of a partial structure of a medical device according to a third embodiment of the present invention, in which a shock wave generator is not shown

Fig. 6 is a schematic partial view of a medical system according to a fourth embodiment of the present invention, in which a first electrode is disposed against an outer surface of a catheter;

fig. 7 is a schematic view of a portion of a medical system according to a fourth embodiment of the present invention, illustrating a spacing between the first electrode and the outer surface of the catheter;

fig. 8 is a schematic partial structural view of a medical system according to an alternative implementation of the fourth embodiment of the present invention;

fig. 9 is a schematic partial structure diagram of a medical system according to another alternative implementation manner of the fourth embodiment of the present invention.

[ reference numerals are described below ]:

100-medical device, 110-catheter, 111-main tube, 111 a-first liquid through hole, 111 b-second liquid through hole, 112-branch tube, 120-balloon component, 121-first balloon, 122-second balloon, 130-first electrode, 140-second electrode, 150-developing element, 160-sheath tube, 170 support rod, 171-first part, 172-second part, 180-pull rope;

200-shock wave generator.

Detailed Description

The following description of the embodiments of the present invention is provided for illustrative purposes, and other advantages and effects of the present invention will be readily apparent to those skilled in the art from the disclosure herein. The present invention can also be implemented or applied through other different specific embodiments, and various details in the present specification can be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the drawings provided in the present embodiment are only for schematically illustrating the basic concept of the present invention, and the components related to the present invention are only shown in the drawings rather than drawn according to the number, shape and size of the components in actual implementation, and the type, amount and proportion of each component may be changed arbitrarily and the layout of the components may be more complicated.

Furthermore, each embodiment described below has one or more technical features, which does not mean that all technical features of any embodiment need to be implemented simultaneously by a person using the present invention, or that all technical features of different embodiments can be implemented separately. In other words, in the implementation of the present invention, based on the disclosure of the present invention, and depending on design specifications or implementation requirements, a person skilled in the art can selectively implement some or all of the technical features of any embodiment, or selectively implement a combination of some or all of the technical features of a plurality of embodiments, thereby increasing the flexibility in implementing the present invention.

As used in this specification, the singular forms "a", "an" and "the" include plural referents, and the plural forms "a plurality" includes more than two referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise, and the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either fixedly connected, detachably connected, or integrally connected. Either mechanically or electrically. Either directly or indirectly through intervening media, either internally or in any other relationship. The specific meaning of the above terms in the present invention can be understood according to specific situations by those of ordinary skill in the art.

As used herein, the terms "proximal" and "distal" refer to the relative orientation, relative position, and orientation of elements or actions with respect to one another from the perspective of a clinician using the medical device, and although "proximal" and "distal" are not intended to be limiting, the term "proximal" generally refers to the end of the medical device that is closer to the clinician during normal operation, and the term "distal" generally refers to the end that is first introduced into a patient.

To make the objects, advantages and features of the present invention clearer, the present invention will be described in further detail with reference to the accompanying drawings. It should be noted that the drawings are in simplified form and are not to precise scale, and are provided for convenience and clarity in order to facilitate the description of the embodiments of the present invention. The same or similar reference numbers in the drawings identify the same or similar elements.

An object of the utility model is to provide a medical device and system, medical system utilizes the hydroelectricity effect to treat the calcification pathological changes of blood vessel, heart valve (for example aortic valve, mitral valve, tricuspid valve), periphery vessel valve or other positions. Referring to fig. 1, 4, 6 and 7, the medical system includes a medical device 100 and a shock wave generator 200, the medical device 100 including a catheter 110, a balloon assembly 120 and a first electrode 130. The balloon assembly 120 is fitted over the distal end of the catheter 110 and includes first and second axially disposed

balloons

121, 122. The first balloon 121 has a first lumen in which at least one of the first electrodes 130 is disposed, the first lumen also being configured to receive a first inflation agent to inflate the first balloon 121. The second balloon 122 has a second lumen for receiving a second inflation agent to inflate the second balloon 122. The shock wave generator 200 is configured to electrically connect to the first electrode 130 and generate a shock wave from the first electrode 130, and the first filling agent is configured to be electrically conductive and to transmit the shock wave. By "axially disposed" is meant that the first balloon 121 is located on either the proximal or distal side of the second balloon 122. Here, the first balloon 121 is described as being located on the proximal end side of the second balloon 122.

In operation, a user first delivers the balloon assembly 120 of the medical device 100 to a target area within a patient's body that is at least partially diseased with calcification, wherein the first balloon 121 is located at a calcification site. The user then infuses the second balloon 122 with the second bulking agent to inflate the second balloon 122 against the target area, and then infuses the first balloon 121 with the first bulking agent to inflate the first balloon 121 against the calcified site. Or the user simultaneously infuses a respective filling agent into the second balloon 122 and the first balloon 121 so that both balloons fill simultaneously and abut the target area so that the first balloon 121 abuts the calcification. Then, the shock wave generator 200 is used to generate a shock wave to the first electrode 130, and the shock wave is transmitted to the calcified part through the first filling agent, so that the calcified part is softened. In this embodiment, the two balloons are abutted against the target region, so that the balloon assembly 120 has a larger contact area with the target region, and the positioning stability of the balloon assembly 120 is improved, thereby achieving the purpose of improving the positioning stability of the first balloon 121, reducing the possibility of displacement of the first balloon 121, and improving the treatment effect.

In some embodiments, the second balloon 122 is only used to assist the positioning of the first balloon 121 in the inflated state, which improves the positioning stability of the first balloon 121. Here, the second filling agent may be any suitable liquid or gas.

In other embodiments, the medical device 100 further comprises a second electrode 140, the second electrode 140 disposed within the second lumen of the second balloon 122. The shock wave generator 200 is further configured to be electrically connected to the second electrode 140, and enable the second electrode 140 to generate shock waves. In this case, the second filling agent is also configured to have electrical conductivity and to transmit the shock wave. In this case, the second filling agent and the first filling agent may have the same composition, for example, the second filling agent and the first filling agent are both formed by mixing physiological saline and a contrast medium at a predetermined ratio, and the predetermined ratio is 1:1 to 4: 1.

The structure of the medical device 100 will now be described with reference to specific embodiments. In the following description, an optional configuration of the medical device 100 will be described by way of example only, but the following configuration is not an essential choice of the medical device 100 and should not be construed as limiting the present invention.

< example one >

Referring to fig. 1, in the present embodiment, the catheter (not labeled in fig. 1) includes a main tube 111, the balloon assembly 120 is sleeved on the outer surface of the distal end of the main tube 111, and the first electrode 130 and the second electrode 140 are both disposed on the main tube 111.

The main pipe 111 has a first liquid passage (not shown) and a second liquid passage (not shown) which are isolated from each other, and a first liquid through hole 111a and a second liquid through hole 111b are formed in a side wall of the main pipe 111. The first liquid passage 111a communicates with the first lumen of the first balloon 121, and the second liquid passage 111b communicates with the second liquid passage and the second lumen of the second balloon 122. In this way, the user can inject the first filling agent into the first lumen along the first fluid passage and the first through-fluid hole 111a to fill the first balloon 121, and withdraw the first filling agent through the first through-fluid hole 111a and the first fluid passage to deflate the first balloon 121. Similarly, the user may inject the second inflation agent into the second lumen through the second fluid passage and the second fluid passage 111b to inflate the second balloon 122, and withdraw the second inflation agent through the second fluid passage 111b and the second fluid passage to deflate the second balloon 122.

In addition, the main tube 111 further has a guide wire channel (not shown), which is isolated from the first fluid channel and the second fluid channel and is used for a guide wire to pass through.

Optionally, the hardness of the material of the first balloon 121 and the second balloon 122 is lower than 65D, and particularly usable materials include, but are not limited to, any one of Pebax, TPU, and silicone. The first balloon 121 and the second balloon 122 are compliant balloons, so that the two balloons can be expanded under low pressure, compliant adhesion to a target area is realized, physiological structures of the target area are better matched, and damage to tissues of the target area caused by mechanical expansion under high pressure is avoided. Further, when the first balloon 121 and the second balloon 122 are inflated, in a radial projection of the medical device 100 (i.e. projecting the medical device onto a plane parallel to the axis of the catheter 110), the contour line of the projection of the first balloon 121 and/or the second balloon 122 is a curve, that is, the first balloon 121 and the second balloon 122 do not have a straight section when inflated. This has the advantage that, on the one hand, the smaller first lumen of the first balloon 121 and the smaller second lumen of the second balloon 122, the shorter withdrawal time and the lower risk during the withdrawal of the first and second filling agents; on the other hand, when the medical system is used for treating calcified lesions of an aortic valve, the shapes of the first balloon 121 and the second balloon 122 are more matched with the physiological structure of the aortic valve, the contact area is larger, and the positioning stability is better.

Further, optionally, the diameter of the first balloon 121 after filling may be 5-10 times the diameter before filling, and the diameter of the second balloon 122 after filling may be 5-10 times the diameter before filling. The first balloon 121 and the second balloon 122 may have a diameter of 8mm to 32mm and a length of 5mm to 30mm when inflated.

Optionally, the medical device 100 further comprises a visualization element 150, the visualization element 150 being disposed on the outer surface of the main tube 111 and located on the distal side of the second balloon 122 for visualizing the position of the distal end of the medical device 100. The developing member 150 may be an annular member.

Further, the medical device 100 further includes a sheath 160, and the sheath 160 is configured to be movably sleeved outside the catheter 110 and the balloon assembly 120. The outer diameter of the sheath 160 is generally 2mm to 6 mm.

< example two >

As shown in fig. 2 to 4, the present embodiment is different from the first embodiment in that the balloon assembly 120 includes a plurality of first balloons 121 and a plurality of second balloons 122. The catheter 110 includes a main tube 111 and a plurality of branch tubes 112, the main tube 111 is a linear structure, two axial ends of each branch tube 112 are respectively connected to the main tube 111, and the plurality of branch tubes 112 are arranged around an axis of the main tube 111 at intervals. Each of the branch pipe bodies 112 is provided with one of the first balloons 121 and one of the second balloons 122. One first electrode 130 is disposed in each first balloon 121, one second electrode 140 is disposed in each second balloon 122, and the first electrode 130 and the second electrode 140 are disposed on the branch pipe 112.

In this embodiment, the number of the branch pipes 112 may be two or more, for example, two (as shown in fig. 2 and 3), three (as shown in fig. 4), or more (not shown).

In some implementations, the first liquid channel may include a first segment located on the main pipe 111 and a plurality of second segments located on the branch pipes 112, respectively, and each of the second segments is communicated with the first segment. Similarly, the second liquid passage may include a third segment and a plurality of fourth segments, the third segment is located on the main pipe 111, the plurality of fourth segments are located on the plurality of branch pipes 112, and each of the fourth segments is communicated with the fourth segment. Alternatively, in other implementations, the number of the first liquid channels is multiple, each of the first liquid channels includes a first segment and a second segment that are communicated with each other, all the first segments are disposed on the main pipe body 111 and are isolated from each other, and each of the second segments is disposed on one of the branch pipe bodies 112. And the number of the second liquid passages is plural, each of the second liquid passages includes one of the third sections and one of the fourth sections which are communicated with each other, all of the third sections are provided on the main tube body 111 and are isolated from each other, and each of the fourth sections is provided on one of the branch tube bodies 112, so that either one of the balloons can be inflated or deflated individually.

In this embodiment, when all the first balloons 121 and all the second balloons 122 are in the inflated state, gaps exist between the plurality of first balloons 121 and between the plurality of second balloons 122, and these gaps can allow blood to flow therethrough, so as to avoid adverse reactions caused by blood flow blockage. Furthermore, when the medical system is used for softening calcified parts of one or some valve leaflets on the aortic valve, the valve leaflets with the calcified parts can be selectively treated, and the effect is improved. Of course, the medical system may simultaneously treat calcifications on a plurality of leaflets at one time, or may sequentially and individually treat calcifications on a plurality of leaflets.

< example three >

As shown in fig. 5, the present embodiment is different from the first embodiment in that the balloon assembly 120 includes a plurality of the first balloons 121 and one of the second balloons 122. The catheter 110 includes a linear main tube 111 and a plurality of branch tubes 112, the main tube 111 is of a linear structure, two axial ends of each branch tube 112 are respectively connected to the main tube 111, and the branch tubes 112 are spaced around the axis of the main tube 111. Each of the branch pipe bodies 112 is provided with one of the first balloons 121, and a portion of the main pipe body 111 located on the distal end side of the branch pipe body 112 is provided with the second balloon 122. Each of the first balloons 121 has the first electrode 130 disposed therein, and the first electrode 130 is disposed on the branch pipe body 112. The second electrode 140 is disposed on the main tube 111.

It is understood that, in the present embodiment, the number of the branch pipe bodies 112 may be more than two, for example, two (as shown in fig. 5), three, or more. And, the first liquid channel extends along the main pipe 111, the second liquid channel may include a third section and a plurality of fourth sections, the third section is located on the main pipe 111, the plurality of fourth sections are respectively located on the plurality of branch pipes 112, and each branch pipe 112 is communicated with the third section. Or, the number of the second liquid channels is multiple, each of the second liquid channels includes a third section and a fourth section that are communicated with each other, the third section is located on the main pipe body 111, and the fourth section is located on the branch pipe body 112.

< example four >

Referring to fig. 6 and 7, the difference between the present embodiment and the first to third embodiments is that the distance between the first electrode 130 and the axis of the first balloon 121 can be adjusted, so that the distance between the first electrode 130 and the axis of the first balloon 121 can be increased during treatment, so as to reduce the distance between the first electrode 130 and the calcified portion, so that the shock wave energy transmitted to the calcified portion is correspondingly increased, and the treatment effect is improved. Likewise, the distance of the second electrode 140 from the axis of the second balloon 122 may also be adjusted.

The arrangement of the first electrode 130 is described below, and the second electrode 140 may be referred to.

With continued reference to fig. 6 and 7, the first electrode 130 is connected to the catheter 110 via a support rod 170, and the support rod 170 is also disposed in the first lumen of the first balloon 121. Here, the first balloon 121 is disposed on the main tube 111 for example, but those skilled in the art can adapt the following description to adapt to the situation where the first balloon 121 is disposed on the branch tube 112.

The first balloon 121 is disposed coaxially with the main tube 111. The support rod 170 has a first end and a second end opposite to each other, the first end is connected to the main tube 111, the second end is connected to the first electrode 130, and the second end can move along a direction close to or away from the axis of the main tube 111, so as to drive the first electrode 130 to be close to the axis of the first balloon 121 or to be away from the axis of the first balloon 121.

In an alternative implementation, when the medical device 100 includes the sheath 160, the strut 170 is a self-expanding structural member and is pre-shaped in a V-shaped configuration. In other words, the support rod 170 includes a first portion 171 and a second portion 172 connected at an angle, wherein the first portion 171 is connected to the main pipe 111, the second portion 172 has the first end and the second end, and the first end is connected to the main pipe 111 through the first portion 171, and the second end is a free end. When the sheath 160 is sleeved outside the first balloon 121, the sheath 160 applies radial pressure to the second portion 172 of the support rod 170, so that the second portion 172 abuts (or substantially abuts) against the surface of the main tube 111 (as shown in fig. 6), and when the sheath moves distally and proximally relative to the catheter 110 and releases the radial pressure applied to the second portion 172, the second portion 172 expands radially and outwardly of the main tube 111, so that the second portion of the support rod 170 moves away from the axis of the main tube 111, and the first electrode 130 is further moved away from the axis of the first balloon 121 (as shown in fig. 7). Here, the "self-expandable structural member" means that the structural member itself has high elasticity, is deformed when pressure is applied, and can be restored to an original shape by its own elasticity once the pressure is removed, and the self-expandable structural member can be made of a shape memory alloy.

In an alternative implementation, as shown in fig. 8, the supporting rod 170 is a self-expanding structure that is pre-molded to form a V-shape, and the free ends of the first portion 171 and the second portion 172 respectively form two first ends, the two first ends are respectively connected to the main tube 111, and the joint of the first portion 171 and the second portion 172 forms the second end (such that each first end is disposed opposite to the second end), and is connected to the first electrode 130.

In another alternative implementation, as shown in fig. 9, the support bar 170 may be a linear structure and may be an elastic member. The medical device 100 further includes a pull cord 180, and a user can manipulate the pull cord 180 to control the second end of the support bar 170 to move in a direction away from the main tube 111. In detail, a proximal end of the pulling rope 180 extends to a proximal end of the main tube 111 for a user to operate, and a distal end of the pulling rope 180 is connected to the second end of the supporting rod 170. The support rod 170 may abut (or substantially abut) against a surface of the main tube 111 when a user does not apply a distally directed proximally directed pulling force to the pull cord 180, and the second end of the support rod 170 may be urged to move in a direction away from the axis of the main tube 111 when a user applies a distally directed proximally directed pulling force to the pull cord 180.

It will be understood by those skilled in the art that the manner for controlling the movement of the second end of the support rod 170 in the direction approaching or departing from the axis of the main pipe 111 is not limited thereto as long as the above-mentioned object can be achieved.

Although the present invention is disclosed above, it is not limited thereto. Various modifications and alterations of this invention may be made by those skilled in the art without departing from the spirit and scope of this invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims and their equivalents, the present invention is also intended to include such modifications and variations.

Claims

1. A medical device comprising a catheter, a balloon assembly, and a first electrode; the balloon assembly is sleeved on the distal end of the catheter and comprises a first balloon and a second balloon which are arranged along the axial direction; the first balloon having a first lumen with the first electrode disposed therein for generating a shock wave, the first lumen further for containing a first inflation agent for inflating the first balloon, the first inflation agent further being configured to be electrically conductive and for transmitting a shock wave; the second balloon has a second lumen for receiving a second inflation agent to inflate the second balloon.

2. The medical device of claim 1, wherein the first balloon is located on a proximal side of the second balloon.

3. The medical device of claim 1, wherein the catheter comprises a main tube, and the balloon assembly is fitted over a distal outer surface of the main tube.

4. The medical device of claim 1, wherein the catheter comprises a main tube body and a plurality of branch tube bodies, the main tube body is of a linear structure, two axial ends of each branch tube body are respectively connected with the far end of the main tube body, and the plurality of branch tube bodies are arranged around the axis of the main tube body at intervals; the first sacculus is a plurality of in quantity, a plurality of first sacculus sets up respectively on different the lateral mass body.

5. The medical device of claim 4, wherein the number of the second balloons is plural, and the plural second balloons are respectively provided on different branch pipe bodies.

6. The medical device of claim 4, wherein the number of second balloons is one, one second balloon being disposed on the main tube.

7. The medical device of any one of claims 1-6, further comprising a second electrode disposed in the second lumen and configured to generate a shockwave, the second bulking agent further configured to be electrically conductive and to transmit the shockwave.

8. The medical device of claim 7, wherein a distance of the first electrode from an axis of the first balloon is adjustable and/or a distance of the second electrode from an axis of the second balloon is adjustable.

9. The medical device of any one of claims 1-6, wherein the catheter has a first fluid channel and a second fluid channel isolated from each other, and a first fluid hole and a second fluid hole are formed in a side wall of the catheter, the first fluid hole communicating the first fluid channel with the first lumen of the first balloon, and the second fluid hole communicating the second fluid channel with the second lumen of the second balloon; the first filling agent flows into or out of the first lumen through the first fluid passage and the first through-hole, and the second filling agent flows into or out of the second lumen through the second fluid passage and the second through-hole.

10. The medical device according to any one of claims 1-6, wherein the contour line of the projection of the first balloon and/or the second balloon in the inflated state is a curve in a radial projection of the medical device.

11. The medical device of claim 10, wherein the first balloon and/or the second balloon when inflated has a diameter of 8mm to 32mm and a length of 5mm to 30 mm.

12. The medical device of any one of claims 1-6, wherein the balloon assembly has a durometer of less than or equal to 65D.

13. The medical device of any one of claims 1-6, further comprising a sheath adapted to be removably fitted over the catheter and balloon assembly.

14. A medical system comprising a shock wave generator and a medical device according to any of claims 1-13, said shock wave generator being adapted to be electrically connected to at least said first electrode and to cause said first electrode to generate a shock wave.