Shockwave balloon and shockwave balloon assembly

Abstract

Provided are a shockwave balloon and a shockwave balloon assembly. The shockwave balloon comprises a first balloon (1) and a second balloon (2). A shockwave emitting element (3) configured for releasing radial shockwaves in a radial direction of the second balloon (2) is arranged inside the second balloon (2). A part of an outer wall surface of the second balloon (2) is adhered to the first balloon (1), and a buffer chamber (4) configured for filling a medium is arranged inside the first balloon (1).

Description

Shock wave balloon and shock wave balloon components

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This disclosure claims priority to the Chinese patent application filed with the China Patent Office on February 6, 2024, with application number 202410172083.6 and titled “Shock Wave Balloon and Shock Wave Balloon Assembly,” the entire contents of which are incorporated by reference into this disclosure. Technical Field

[0003] The present disclosure relates to the technical field of medical devices, and in particular, to a shock wave balloon and a shock wave balloon assembly. Background Art

[0004] Cardiovascular stenosis refers to the abnormal lipid metabolism in the human body's arteriovenous vessels, including coronary, peripheral, and intracranial blood vessels. The lipids in the blood are deposited on the originally smooth vascular endothelium and gradually accumulate into atherosclerotic lipid plaques. Over time, these plaques increase and even calcify, causing narrowing of the blood vessel lumen, obstructing blood flow, leading to ischemia of downstream blood vessels and body, and producing corresponding clinical manifestations.

[0005] In related technologies, shock waves generated by discharge of electrodes within a shock wave balloon are usually used to act on the lesion site, thereby breaking up the calcified plaques at the lesion site. However, the above method is not very targeted due to the uniform pressure of the shock waves generated within the shock wave balloon. It cannot provide targeted treatment for the specificity of vascular calcification and is also prone to damage the non-lesioned areas of the vascular endothelium, resulting in low applicability. Summary of the Invention

[0006] The purpose of the present disclosure is to provide a shock wave balloon and a shock wave balloon assembly, which can perform targeted treatment on calcified plaques at the location of vascular endothelial lesions and can also effectively reduce damage to the non-lesioned location of the vascular endothelial lesions. It is highly targeted and applicable.

[0007] In order to achieve the above-mentioned objectives, the first aspect of the present disclosure provides a shock wave balloon, which includes a first balloon and a second balloon, a shock wave emitting element is provided inside the second balloon for releasing radial shock waves along the radial direction of the second balloon, part of the outer wall surface of the second balloon is attached to the first balloon and the first balloon has a buffer chamber inside for filling a medium.

[0008] Optionally, the impact force of the radial shock wave is 40 to 80 atm.

[0009] Optionally, the first balloon and the second balloon are bonded or integrally formed.

[0010] Optionally, the second balloon is arranged inside the first balloon, part of the outer wall of the second balloon is in contact with the inner wall of the first balloon, and the buffer chamber is formed between the inner wall of the first balloon that is not in contact with the second balloon and the outer wall of the second balloon.

[0011] Optionally, the shock wave balloon also includes a connecting catheter, and the first balloon and the second balloon are respectively arranged around the outer wall of the connecting catheter, so as to fill and discharge the medium into the buffer chamber and the second balloon respectively through the connecting catheter; the shock wave emitting element includes a plurality of electrode assemblies arranged at intervals along the axial direction of the second balloon and connected to the outer wall of the connecting catheter, so as to release shock waves along the radial direction of the second balloon through the electrode assemblies.

[0012] Optionally, the electrode assembly includes an outer sheath layer, a buffer structure layer, and a plurality of electrodes arranged between the outer sheath layer and the buffer structure layer. The inner wall of the buffer structure layer is connected to the outer wall of the connecting catheter. A shock wave zone connected to the interior of the second balloon is formed between two adjacent electrodes, and each of the electrodes has a conductive portion partially located within the shock wave zone.

[0013] Optionally, the plurality of electrodes are arranged at equal intervals along the circumference of the connecting catheter; and / or the plurality of electrodes are bonded between the outer sheath layer and the buffer structure layer; and / or a groove structure is formed on the outer wall of the buffer structure layer, and the number of the groove structures is multiple and is arranged one-to-one corresponding to the plurality of electrodes.

[0014] Optionally, the connecting catheter includes an outer catheter and an inner catheter arranged inside the outer catheter, the outer catheter is connected to the buffer chamber for charging and discharging the medium into the buffer chamber, the inner catheter includes a first chamber and a second chamber, the first chamber is connected to the shock wave zone for charging and discharging the medium into the shock wave zone, and the second chamber is connected to the electrode for allowing a wire electrically connected to the electrode to pass through.

[0015] Optionally, the second balloon is arranged outside the first balloon, and part of the outer wall surface of the second balloon is attached to the outer wall surface of the first balloon.

[0016] Optionally, there are one or more first balloons, and one or more first balloons are attached to part of the outer wall of the second balloon.

[0017] The second aspect of the present disclosure also provides a shock wave balloon assembly, which includes a pulse power supply, a syringe and the shock wave balloon as described above, wherein the pulse power supply is used to supply power to the shock wave emitting element, and the syringe is used to fill and release the medium into the first balloon and the second balloon respectively.

[0018] Through the above technical solution, that is, the shock wave balloon provided by the present invention, the shock wave balloon is formed by fitting part of the outer wall of a second balloon with a shock wave emitting element inside to a first balloon with a buffer chamber inside for filling a medium. In this way, when the shock wave emitting element inside the second balloon releases radial shock waves along the radial direction of the second balloon, the radial shock waves generated by the second balloon act on, for example, calcified plaques at the lesion site of the vascular endothelium, thereby enabling the second balloon to perform a targeted treatment operation of breaking up the calcified plaques at the lesion site; at the same time, since part of the outer wall of the second balloon is fitted to the first balloon, part of the radial shock waves generated by the shock wave emitting element can be attenuated by the medium in the buffer chamber, so that the shock waves after energy attenuation can be applied to, for example, the non-lesion site of the vascular endothelium, effectively reducing the damage to the non-lesion site of the vascular endothelium, and having higher applicability.

[0019] Other features and advantages of the present disclosure will be described in detail in the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The accompanying drawings are used to provide a further understanding of the present disclosure and constitute a part of the specification. Together with the following detailed description, they are used to explain the present disclosure but do not constitute a limitation of the present disclosure. In the accompanying drawings:

[0021] FIG1 is a schematic diagram of the structure of a shock wave balloon placed at the vascular intima in the related art;

[0022] FIG2 is a schematic structural diagram of a shock wave balloon provided in the first embodiment of the present disclosure placed at the vascular intima;

[0023] FIG3 is a schematic structural diagram of a shock wave balloon provided in a first embodiment of the present disclosure;

[0024] FIG4 is a schematic structural diagram of an electrode assembly of a shock wave balloon provided in a first embodiment of the present disclosure;

[0025] FIG5 is a schematic structural diagram of a shock wave balloon provided in a second embodiment of the present disclosure;

[0026] FIG6 is a schematic structural diagram of a shock wave balloon provided in a second embodiment of the present disclosure placed at the vascular intima;

[0027] FIG7 is a schematic structural diagram of a shock wave balloon provided in a third embodiment of the present disclosure placed at the vascular intima;

[0028] FIG8 is a schematic structural diagram of a shock wave balloon provided in a fourth embodiment of the present disclosure placed at the endothelium of a blood vessel.

[0029] Explanation of the reference numerals: 1-first balloon; 2-second balloon; 3-shock wave emitting element; 310-electrode assembly; 311-outer sheath layer; 312-buffer structure layer; 313-electrode; 314-shock wave zone; 315-conductive part; 316-groove structure; 4-buffer chamber; 5-connecting catheter; 510-outer catheter; 520-inner catheter; 521-first chamber; 522-second chamber; 530-first catheter; 540-second catheter; 6-vascular endothelium; 7-calcified plaque; 8-balloon body. DETAILED DESCRIPTION

[0030] The following describes the specific embodiments of the present disclosure in detail with reference to the accompanying drawings. It should be understood that the specific embodiments described herein are only used to illustrate and explain the present disclosure and are not intended to limit the present disclosure.

[0031] It should be noted that all actions of acquiring signals, information or data in the present disclosure are carried out in compliance with the corresponding data protection laws and policies of the country where they are located and with the authorization given by the owner of the corresponding device.

[0032] In this disclosure, unless otherwise indicated, "inside" and "outside" refer to the inside and outside relative to the outline of a component or structure. Furthermore, it should be noted that the use of terms such as "first" and "second" is intended to distinguish one element from another and does not imply order or importance. Furthermore, in the description with reference to the accompanying drawings, the same reference numerals in different drawings represent the same element.

[0033] In the related art, referring to Figure 1, the pressure of the shock wave (indicated by the arrow in Figure 1) generated inside the balloon body 8 of the shock wave balloon is relatively uniform. Specifically, when the balloon body 8 of the shock wave balloon contacts the calcified plaque 7 on the vascular endothelium 6 and breaks the calcified plaque 7 through the shock wave, since the contact position of the balloon body 8 with the calcified plaque 7 is usually area A, and part of the outer wall of the balloon body 8 will also contact part of the inner wall of the vascular endothelium 6, such as area B, during the operation of the balloon body 8 of the shock wave balloon, in the process of breaking the calcified plaque 7, it is also easy to cause endothelial damage at the non-lesioned position of the vascular endothelium 6 where the balloon body 8 of the shock wave balloon is connected, especially in area B shown in Figure 1. Therefore, the shock wave balloon in the related art cannot perform targeted treatment on the calcified plaque 7, and is also prone to the risk of damaging the vascular endothelium 6, and its applicability is low.

[0034] Based on this, according to the first aspect of the present disclosure, a shock wave balloon is provided, as shown in Figures 2 to 8, the shock wave balloon includes a first balloon 1 and a second balloon 2, and a shock wave emitting element 3 is provided inside the second balloon 2 for releasing radial shock waves along the radial direction of the second balloon 2, part of the outer wall surface of the second balloon 2 is attached to the first balloon 1 and the first balloon 1 has a buffer chamber 4 for filling a medium.

[0035] Through the above technical solution, that is, the shock wave balloon provided by the present invention, the shock wave balloon is formed by fitting part of the outer wall of the second balloon 2 with a shock wave emitting element 3 inside to the first balloon 1 with a buffer chamber 4 for filling a medium inside. In this way, when the shock wave emitting element 3 inside the second balloon 2 releases radial shock waves along the radial direction of the second balloon 2, the radial shock waves generated by the second balloon 2 act on, for example, calcified plaques at the location of vascular endothelial lesions, thereby enabling the second balloon 2 to perform targeted therapeutic operations of breaking up the calcified plaques at the location of the lesion; at the same time, since part of the outer wall of the second balloon 2 is fitted to the first balloon 1, part of the radial shock waves generated by the shock wave emitting element 3 can be attenuated by the medium in the buffer chamber 4, so that the shock waves after energy attenuation can be applied to, for example, the non-lesioned location of the vascular endothelial lining, effectively reducing the damage to the non-lesioned location of the vascular endothelial lining, and having higher applicability.

[0036] It should be noted that a shock wave refers to a shock wave with a certain energy generated in a medium due to some reason, such as electrode discharge, and the propagation of the shock wave is affected by the medium, which will cause the energy of the shock wave to gradually attenuate during the transmission process. Therefore, by filling the buffer chamber 4 with a medium, the energy of part of the shock wave can be attenuated. In this way, when the shock wave with energy attenuation acts on the non-lesion position of the vascular endothelium 6, for example, the damage to the non-lesion position of the vascular endothelium 6 is effectively reduced.

[0037] Optionally, in some embodiments, the medium filled in the buffer chamber 4 may be, for example, a mixed solution of contrast fluid and physiological saline, thereby achieving attenuation of the energy of the shock wave while also facilitating accurate placement of the shock wave balloon at the lesion location of the vascular intima 6 through, for example, angiography. Of course, the above-mentioned embodiment in which the medium is, for example, a mixed solution of contrast fluid and physiological saline is illustrative. In other embodiments, the medium filled in the buffer chamber 4 may also be, for example, a phosphate buffer solution, a borate buffer solution, a carbonate buffer solution, or the like. The present disclosure does not specifically limit such variations, as long as the purpose is to achieve attenuation of the energy of the shock wave. Those skilled in the art may adaptively design the medium according to actual application requirements. It should be noted that the medium filled in the buffer chamber 4 may not only be a liquid solution, but may also be, for example, a gas or an elastomer, and the present disclosure is not limited thereto.

[0038] Optionally, in some embodiments, the radial shock wave's impact force can be 40 to 80 atm, which helps ensure stable fragmentation of the calcified plaque 7 while also reducing damage to the vascular endothelium 6. Of course, the magnitude of the shock wave's impact force is exemplary only. In other embodiments, those skilled in the art can also adaptively adjust the magnitude of the impact force based on actual application requirements, as long as the calcified plaque 7 is fragmented. The present disclosure is not limited thereto.

[0039] In addition, in some embodiments, the first balloon 1 and the second balloon 2 can be connected by, for example, adhesive bonding, which is simple in structure and easy to install and manufacture. Of course, in other embodiments, the first balloon 1 and the second balloon 2 can also be integrally formed by, for example, 3D printing. This disclosure does not specifically limit such deformation methods, and those skilled in the art can adapt the design according to actual application requirements.

[0040] Optionally, in some embodiments, as shown in Figures 2 to 4, the second balloon 2 can be arranged inside the first balloon 1, with part of the outer wall of the second balloon 2 fitted to the inner wall of the first balloon 1, and a buffer chamber 4 is formed between the inner wall of the first balloon 1 that is not fitted to the second balloon 2 and the outer wall of the second balloon 2. In this way, when the shock wave emitting element 3 inside the second balloon 2 releases a radial shock wave along the radial direction of the second balloon 2, the fitting point between the first balloon 1 and the second balloon 2 can be adaptively adjusted to contact the calcified plaque 7 at the lesion position of, for example, the vascular endothelium 6, thereby achieving targeted treatment of the calcified plaque 7 at the lesion position.

[0041] In addition, as shown in Figure 2, since a buffer chamber 4 for filling a medium is formed between the inner wall surface of the first balloon 1 that is not in contact with the second balloon 2 and the outer wall surface of the second balloon 2, the radial shock wave generated by the shock wave emitting element 3 can be attenuated by the medium in the buffer chamber 4. In this way, the shock wave with attenuated energy acts on the non-diseased position of the vascular endothelium 6, for example, thereby effectively reducing the damage to the non-diseased position of the vascular endothelium 6 and having higher applicability.

[0042] In addition, it should be noted that due to the different levels of accumulation at the lesion location of the patient's vascular intima 6, the size and location of the formed calcified plaque 7 are also different. Therefore, those skilled in the art can adaptively adjust the contact area of ​​the second balloon 2 with the first balloon 1 according to the actual size of the calcified plaque 7, thereby increasing the effective range of the main impact area of ​​the shock wave balloon (the contact area between the second balloon 2 and the first balloon 1), thereby achieving targeted fragmentation treatment of the calcified plaque 7. In addition, those skilled in the art can adaptively adjust the position of the shock wave balloon to achieve adaptive targeted treatment of calcified plaques 7 at different locations.

[0043] In some embodiments, as shown in Figures 3 and 4, the shock wave balloon can also include a connecting catheter 5, and the first balloon 1 and the second balloon 2 are respectively wrapped around the outer wall of the connecting catheter 5, so that the first balloon 1 and the second balloon 2 can be stably fixed on the connecting catheter 5. The structure is simple and easy to install and manufacture. At the same time, the connecting catheter 5 also facilitates the delivery of the shock wave balloon to the lesion location through, for example, angiography technology, and has good controllability.

[0044] In addition, the connecting catheter 5 can also be used to charge and discharge media into the buffer chamber 4 and the second balloon 2, respectively, which has good controllability. It should be noted that the media in the buffer chamber 4 and the second balloon 2 can be the same medium, for example, both can be a mixed solution of contrast fluid and physiological saline, or the media in the buffer chamber 4 and the second balloon 2 can be different media, for example, the buffer chamber 4 can be filled with a solution such as a phosphate buffer solution, a borate buffer solution, or a carbonate buffer solution, while the second balloon 2 can be filled with a solution such as a sodium chloride solution, a hydrochloric acid solution, or a potassium chloride solution, and the present disclosure does not specifically limit this.

[0045] In some embodiments, as shown in FIG3 , the shock wave emitting element 3 may include a plurality of electrode assemblies 310 spaced apart along the axial direction of the second balloon 2 and connected to the outer wall of the connecting catheter 5 . The shock waves are released radially from the second balloon 2 via the electrode assemblies 310 to facilitate fragmentation of the calcified plaque 7 . It should be noted that the specific number of electrode assemblies 310 is not specifically limited in this disclosure, and those skilled in the art may adaptably design the number based on actual application requirements. The purpose is to ensure that a high impact force is generated within the shock wave balloon to facilitate fragmentation of the calcified plaque 7 .

[0046] Optionally, in some embodiments, as shown in Figure 4, the electrode assembly 310 may include an outer sheath layer 311, a buffer structure layer 312, and a plurality of electrodes 313 arranged between the outer sheath layer 311 and the buffer structure layer 312. The inner wall of the buffer structure layer 312 is connected to the outer wall of the connecting catheter 5. A shock wave zone 314 connected to the interior of the second balloon 2 is formed between two adjacent electrodes 313, and each electrode 313 has a conductive portion 315 partially located in the shock wave zone 314. In this way, after the shock wave zone 314 is filled with liquid medium through, for example, the connecting catheter 5, a shock wave can be formed between the conductive portions 315 of the two adjacent electrodes 313. The structure is simple and easy to install and manufacture.

[0047] Among them, it should be noted that by providing the outer sheath layer 311, it can play a protective role and protect the electrode assembly 310 to be able to work stably. In addition, by providing a buffer structure layer 312 between the electrode 313 and the connecting catheter 5, it is convenient to buffer the shock wave energy generated by the electrode 313 through the buffer structure layer 312, thereby reducing the impact on the connecting catheter 5, and by providing the buffer structure layer 312, it is also convenient to implement multiple electrodes 313 by, for example, adhesive bonding between the outer sheath layer 311 and the buffer structure layer 312, which is convenient for installation operation. At the same time, the buffer structure layer 312 can also be bonded to the connecting catheter 5 by, for example, adhesive bonding, and the structure is simple and easy to install and manufacture. In addition, the present disclosure does not limit the specific structures of the outer sheath layer 311 and the buffer structure layer 312, and those skilled in the art can design adaptively according to actual application requirements.

[0048] Optionally, in some embodiments, as shown in reference figure 4, multiple electrodes 313 can be arranged at equal intervals along the circumference of the connecting catheter 5, so as to ensure that the shock wave generated in the shock wave balloon is evenly divergent, and as it is transmitted in the medium, it can better ensure that, for example, the impact force acting on area A in Figure 2 is stronger, while the energy of the impact force acting on area B in Figure 2 is more attenuated, thereby achieving targeted fragmentation treatment of the calcified plaque 7 at the diseased position of the vascular endothelium 6, and can also effectively reduce damage to the non-lesioned position of the vascular endothelium 6.

[0049] Of course, the specific embodiment in which the above-mentioned multiple electrodes 313 are arranged at equal intervals along the circumference of the connecting catheter 5 is exemplary. Those skilled in the art can adaptively adjust the distance between two adjacent electrodes 313. For example, in other embodiments not shown in the figures, the multiple electrodes 313 can be concentratedly arranged in the upper half area of ​​the second balloon 2 shown in Figure 4, so as to improve the impact force effect at the fitting point between the first balloon 1 and the second balloon 2 and improve the treatment effect.

[0050] It should be noted that, since the direction and magnitude of the shock wave generated within shock wave zone 314 can be varied by adaptively adjusting the position between two adjacent electrodes 313, those skilled in the art can adaptively adjust the distance between two adjacent electrodes 313 based on actual application requirements to ensure a high shock wave effect and thereby achieve a better therapeutic effect. Furthermore, the specific structure of electrodes 313 is not specifically limited in this disclosure, and those skilled in the art can adaptively design it based on actual application requirements.

[0051] Optionally, in some embodiments, as shown in FIG. 4 , a groove structure 316 may be formed on the outer wall of the buffer structure layer 312 . The groove structures 316 are multiple and arranged in one-to-one correspondence with the multiple electrodes 313 to facilitate installation and fixation of the multiple electrodes 313 .

[0052] In some embodiments, as shown in Figures 3 and 4, the number of the first balloon 1 and the second balloon 2 can both be one, which is conducive to the lightweight and simplified design of the shock wave balloon. Accordingly, the connecting catheter 5 may include an outer catheter 510 and an inner catheter 520 arranged inside the outer catheter 510. The outer catheter 510 is connected to the buffer chamber 4 for charging and discharging the medium into the buffer chamber 4. The inner catheter 520 includes a first chamber 521 and a second chamber 522. The first chamber 521 is connected to the shock wave zone 314 for charging and discharging the medium into the shock wave zone 314. The second chamber 522 is connected to the electrode 313 for the wire electrically connected to the electrode 313 to pass through, thereby enabling the first balloon 1 and the second balloon 2 to be charged and discharged simultaneously through the connecting catheter 5, with good controllability and high efficiency.

[0053] Of course, it should be noted that the embodiment in which the number of the first balloon 1 and the second balloon 2 is one is exemplary. In other embodiments, the number of the first balloon 1 can also be multiple. For example, as shown in FIG8 , the number of the first balloon 1 can be two, so as to better achieve the attenuation of the radial shock wave generated by the shock wave emitting element 3. Of course, in other embodiments not shown, the number of the first balloon 1 can also be adaptively designed by those skilled in the art according to actual application requirements, the purpose of which is to enable the contact between the balloon located inside and the balloon located outside the balloon to converge at, for example, the area A shown in FIG8 , so as to achieve targeted fragmentation of calcified plaques at the lesion site. At the same time, when the number of the first balloon 1 is multiple, the connecting catheter 5 can be adaptively designed to include multiple outer catheters 510 that are connected to each other, the purpose of which is to enable the multiple first balloons 1 to be filled and discharged with medium.

[0054] In addition, it should be noted that the material and specific molding process of the connecting conduit 5 are not specifically limited in this disclosure. Those skilled in the art can adaptably design the connecting conduit 5 according to actual application requirements. For example, the connecting conduit 5 can be made of nylon, polyethylene terephthalate, or polyurethane; and the connecting conduit 5 can be manufactured by, for example, integral stretch blow molding or 3D printing. This disclosure is not limited thereto.

[0055] Furthermore, it should be noted that because the electrodes 313 are bonded between the outer jacket layer 311 and the buffer structure layer 312, for example, by adhesive, each electrode 313 has a conductive portion 315 partially located within the shock wave zone 314. This can better prevent liquid within the shock wave zone 314 from penetrating into the second chamber 522 and causing problems such as short circuits in the wires. Furthermore, the shock wave zone 314 can be connected to, for example, the interior of the second balloon 2 by providing a plurality of notches (not shown) in the outer jacket layer 311, thereby enabling communication between the shock wave zone 314 and the interior of the second balloon 2. This simple structure facilitates installation and manufacturing.

[0056] Optionally, in other embodiments, as shown in Figures 5 and 6, the second balloon 2 can also be arranged outside the first balloon 1, and part of the outer wall of the second balloon 2 is in contact with the outer wall of the first balloon 1. In this way, when the shock wave emitting element 3 inside the second balloon 2 releases radial shock waves along the radial direction of the second balloon 2, the part of the wall of the second balloon 2 that is not in contact with the first balloon 1 can be adaptively adjusted to contact the calcified plaque 7 at the lesion position of the vascular endothelium 6, for example, to achieve targeted treatment of breaking up the calcified plaque 7 at the lesion position.

[0057] In addition, since part of the outer wall of the second balloon 2 is in contact with the outer wall of the first balloon 1, part of the radial shock wave generated by the shock wave emitting element 3 can attenuate the shock wave energy through the medium in the buffer chamber 4. In this way, the shock wave with attenuated energy acts on the non-diseased position of the vascular endothelium 6, for example, effectively reducing the damage to the non-diseased position of the vascular endothelium 6, and having higher applicability.

[0058] In addition, it should be noted that due to the different degrees of accumulation at the lesion location of the patient's vascular endothelium 6, the size and position of the formed calcified plaque 7 are also different. Therefore, those skilled in the art can adaptively adjust the contact area of ​​the second balloon 2 with the lesion location according to the actual size of the calcified plaque 7, thereby increasing the range of action of the main impact area of ​​the shock wave balloon (the contact area of ​​the second balloon 2 with the lesion location), and thus achieving targeted fragmentation treatment of the calcified plaque 7.

[0059] Optionally, in some embodiments, as shown in Figures 5 and 6, the number of the first balloon 1 and the second balloon 2 can both be one, and one first balloon 1 is attached to a portion of the outer wall of one second balloon 2, which is beneficial to the lightweight and simplified design of the shock wave balloon. Accordingly, the connecting catheter 5 may include a first catheter 530 and a second catheter 540, which are used to fill and release the medium into the first balloon 1 and the second balloon 2 respectively through the first catheter 530 and the second catheter 540. It should be noted that the above-mentioned first catheter 530 can be a catheter structure well known in the art, and the present disclosure does not specifically limit this. Its purpose is to be able to achieve filling and releasing the medium into the first balloon 1. In addition, the specific structure of the second catheter 540 can also be adaptively designed by those skilled in the art according to actual application requirements. Its purpose is to be able to achieve filling and releasing the medium into the second balloon 2 while also being able to power the shock wave emitting element 3 located in the second balloon 2. For example, it can be the same as or different from the structure of the above-mentioned inner catheter 520, and the present disclosure does not specifically limit this.

[0060] In addition, it should be noted that, in order to facilitate the simultaneous delivery of the first balloon 1 and the second balloon 2 to the lesion location of the patient, as shown in FIG5 , the ends of the first catheter 530 and the second catheter 540 located outside the balloons can be fixedly connected by, for example, bonding or tape, to facilitate operation by on-site operators. The present disclosure is not limited thereto.

[0061] Furthermore, it should be noted that the embodiment described above in which the number of first balloon 1 and second balloon 2 is one is exemplary. In other embodiments, the number of first balloons 1 may be multiple. For example, as shown in FIG7 , the number of first balloons 1 may be two. Thus, the two first balloons 1 supporting the second balloon 2 help ensure the stable operation of the second balloon 2 and improve stability. It also attenuates the radial shock waves generated by the shock wave emitting element 3, reducing damage to the vascular intima 6 at non-lesioned locations. Of course, in other embodiments not shown, those skilled in the art can also adaptively design the number of first balloons 1 based on actual application requirements, with the goal of improving the stability of the second balloon 2 and achieving targeted fragmentation of calcified plaques at lesion locations, for example. Furthermore, when there are multiple first balloons 1, the number of first catheters 530 can be adaptively arranged in a one-to-one correspondence with the multiple first balloons 1, with the goal of enabling the multiple first balloons 1 to be filled and discharged with medium. The present disclosure is not limited thereto.

[0062] Optionally, in some embodiments, the materials of the first balloon 1 and the second balloon 2 can both be elastic materials such as polyvinylidene chloride, nylon or polyurethane, so as to ensure that the shock wave balloon has a high structural strength. At the same time, the soft material itself can enable the shock wave balloon to better cover the calcified plaque 7 when it comes into contact with the calcified plaque 7. That is, it can be understood that it can better adapt to the outer contour of the calcified plaque 7, thereby improving the treatment effect. At the same time, due to its soft material itself, it can also avoid damaging the vascular endothelium 6.

[0063] Of course, the specific examples of balloon materials described above are merely illustrative. In other embodiments, the balloon material may also be a polymer material such as polyvinyl chloride (PVC) or polyethylene (PE), and those skilled in the art may adaptably design the balloon material based on actual application requirements. Furthermore, it should be noted that the shock wave balloon may be manufactured using, for example, one-piece stretch blow molding or 3D printing. The present disclosure is not limited thereto.

[0064] According to the second aspect of the present disclosure, a shock wave balloon assembly is also provided, which includes a pulse power supply (not shown in the figure), a syringe (not shown in the figure) and the above-mentioned shock wave balloon, wherein the pulse power supply is used to power the shock wave emitting element 3, and the syringe is used to fill and discharge the medium into the first balloon 1 and the second balloon 2 respectively. The shock wave balloon assembly can perform targeted treatment on calcified plaques at the location of vascular endothelial lesions, and can also effectively reduce damage to the non-lesioned location of the vascular endothelial lesions. It has strong targeting and high applicability. In addition, the shock wave balloon assembly also has all the beneficial effects of the above-mentioned shock wave balloon, which will not be repeated in this disclosure.

[0065] Among them, it should be noted that the specific structure of the above-mentioned pulse power supply and syringe, as well as the specific connection method with the connecting catheter 5 are not specifically limited in this disclosure. The purpose is to be able to use the pulse power supply to power the shock wave emitting element 3, and to use the syringe to charge and discharge the medium into the first balloon 1 and the second balloon 2 respectively. Those skilled in the art can adaptively design it according to actual application requirements.

[0066] The preferred embodiments of the present disclosure are described in detail above in conjunction with the accompanying drawings. However, the present disclosure is not limited to the specific details of the above embodiments. Within the technical concept of the present disclosure, various simple modifications can be made to the technical solutions of the present disclosure, and these simple modifications all fall within the scope of protection of the present disclosure.

[0067] It should also be noted that the various specific technical features described in the above specific embodiments can be combined in any suitable manner without contradiction. To avoid unnecessary repetition, the present disclosure will not further describe various possible combinations.

[0068] In addition, the various embodiments of the present disclosure may be arbitrarily combined, and as long as they do not violate the concept of the present disclosure, they should also be regarded as the contents disclosed by the present disclosure.

Claims

1. A shock wave balloon, characterized in that: The shock wave balloon comprises a first balloon (1) and a second balloon (2), wherein a shock wave emitting element (3) for releasing radial shock waves along the radial direction of the second balloon (2) is provided inside the second balloon (2), a portion of the outer wall of the second balloon (2) is attached to the first balloon (1), and a buffer chamber (4) for filling a medium is provided inside the first balloon (1).

2. The shock wave balloon according to claim 1, characterized in that The impact force of the radial shock wave is 40 to 80 atm.

3. The shock wave balloon according to claim 1, characterized in that The first balloon (1) and the second balloon (2) are bonded or integrally formed.

4. The shock wave balloon according to any one of claims 1 to 3, characterized in that: The second balloon (2) is arranged inside the first balloon (1), a portion of the outer wall surface of the second balloon (2) is in contact with the inner wall surface of the first balloon (1), and the buffer chamber (4) is formed between the inner wall surface of the first balloon (1) that is not in contact with the second balloon (2) and the outer wall surface of the second balloon (2).

5. The shock wave balloon according to claim 4, characterized in that: The shock wave balloon further comprises a connecting catheter (5), wherein the first balloon (1) and the second balloon (2) are respectively arranged around the outer wall of the connecting catheter (5) and are used for respectively filling and discharging a medium into the buffer chamber (4) and the second balloon (2) through the connecting catheter (5); The shock wave emitting element (3) comprises a plurality of electrode assemblies (310) arranged at intervals along the axial direction of the second balloon (2) and connected to the outer wall of the connecting catheter (5), and is used to release shock waves along the radial direction of the second balloon (2) through the electrode assemblies (310).

6. The shock wave balloon according to claim 5, characterized in that: The electrode assembly (310) includes an outer sheath layer (311), a buffer structure layer (312), and a plurality of electrodes (313) arranged between the outer sheath layer (311) and the buffer structure layer (312); the inner wall of the buffer structure layer (312) is connected to the outer wall of the connecting catheter (5); a shock wave zone (314) connected to the interior of the second balloon (2) is formed between two adjacent electrodes (313), and each electrode (313) has a conductive portion (315) partially located within the shock wave zone (314).

7. The shock wave balloon according to claim 6, characterized in that: The plurality of electrodes (313) are arranged at equal intervals along the circumference of the connecting conduit (5); and / or The plurality of electrodes (313) are bonded between the outer sheath layer (311) and the buffer structure layer (312); and / or A groove structure (316) is formed on the outer wall of the buffer structure layer (312), and the groove structures (316) are multiple in number and are arranged in a one-to-one correspondence with the multiple electrodes (313).

8. The shock wave balloon according to claim 6, characterized in that: The connecting conduit (5) includes an outer conduit (510) and an inner conduit (520) arranged inside the outer conduit (510), the outer conduit (510) being connected to the buffer chamber (4) for charging or discharging a medium into the buffer chamber (4), the inner conduit (520) including a first chamber (521) and a second chamber (522), the first chamber (521) being connected to the shock wave zone (314) for charging or discharging a medium into the shock wave zone (314), and the second chamber (522) being connected to the electrode (313) for allowing a wire electrically connected to the electrode (313) to pass through.

9. The shock wave balloon according to any one of claims 1 to 3, characterized in that: The second balloon (2) is arranged outside the first balloon (1), and part of the outer wall surface of the second balloon (2) is attached to the outer wall surface of the first balloon (1).

10. The shock wave balloon according to claim 9, characterized in that: The number of the first balloon (1) is one or more, and the one or more first balloons (1) are attached to a portion of the outer wall surface of the second balloon (2).

11. A shock wave balloon assembly, characterized in that: It comprises a pulse power supply, a syringe and the shock wave balloon according to any one of claims 1 to 10, wherein the pulse power supply is used to supply power to the shock wave emitting element (3), and the syringe is used to fill and discharge a medium into the first balloon (1) and the second balloon (2) respectively.

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