Shock wave balloon catheter

Abstract

The invention discloses a shock wave balloon catheter, and belongs to the technical field of medical equipment, the shock wave balloon catheter comprises an inner-layer catheter, an electrode assembly and an outer-layer balloon assembly, the inner-layer catheter is provided with a working section, the electrode assembly and the outer-layer balloon assembly are both installed on the working section, the outer-layer balloon assembly comprises an outer-layer balloon and a blocking part, and the blocking part is arranged on the outer-layer balloon. The outer-layer balloon wraps the electrode assembly, the blocking part is provided with an expansion area capable of being folded and unfolded in the radial direction of the working section, and the blocking part can block the inner-layer catheter from moving in the radial direction after the expansion area is unfolded, so that a safe distance is formed between the electrode assembly and the outer-layer balloon. After the expansion area expands in the radial direction, a safe distance can be formed between the electrode assembly and the outer-layer balloon, and therefore it can be guaranteed that a certain safe distance is always formed between the electrode assembly and the blood vessel wall, the eccentric degree of the electrode assembly is reduced, the circumferential uniformity of the electrode assembly for treating the vascular calcification lesion position is improved, and the blood vessel is prevented from being damaged.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a shock wave balloon catheter. Background Art

[0002] For intravascular calcified lesions, especially severe calcified lesions, or severe calcified lesions accompanied by tortuosity, angulation, and diffusion, there are various optional current interventional treatment methods. Among them, intravascular lithotripsy (IVL) is an innovative technology for treating severe calcified lesions. Research data shows that it has a good modifying effect in treating severe calcified lesions, can significantly reduce the operation time, and lower the operation risk.

[0003] The shock wave balloon catheter is composed of an inner catheter, an outer balloon, and an electrode assembly. The working principle is that the outer balloon expands, and through the energy provided by a shock wave device, the mechanical energy is conducted by the electrode assembly, passes through the mixed solution of physiological saline and contrast agent in the outer balloon, and reaches the calcified lesion, emitting non-focused, pulsed shock waves to the lesion to safely fragment shallow and deep calcifications. However, after the balloon catheter enters a curved diseased blood vessel, as Figure 14 and Figure 15 shown, the electrode assembly 3 inside the outer balloon 2 will undergo corresponding eccentric displacement, especially more obvious for the longer outer balloon 2. When the eccentricity is severe, the electrode assembly 3 will stick to the inner wall on one side of the outer balloon 2, and problems such as uneven energy emission and blood vessel injury will occur during the treatment process. Summary of the Invention

[0004] The object of the present invention is to solve the above technical problems, and provide a shock wave balloon catheter, which is provided with a blocking part. The blocking part has an expandable expansion area. After the expansion area expands, the blocking part can radially limit the inner catheter, so that a safety distance is maintained between the electrode assembly on the inner catheter and the outer balloon, thereby reducing the eccentricity degree of the electrode assembly, improving the uniformity of energy emission, and avoiding the electrode assembly being too close to the blood vessel and causing blood vessel injury.

[0005] To achieve the above object, the present invention provides the following solution: The present invention discloses a shock wave balloon catheter, including an inner catheter, an electrode assembly, and an outer balloon assembly. The inner catheter has a working section, and both the electrode assembly and the outer balloon assembly are installed on the working section. The outer balloon assembly includes an outer balloon and a blocking part. The outer balloon wraps the electrode assembly inside. The blocking part has an expansion area that can expand and contract radially along the working section. The blocking part can block the inner catheter from moving radially after the expansion area expands, so that a safety distance is provided between the electrode assembly and the outer balloon.

[0006] Preferably, the distal end of the outer balloon is fixedly and sealingly connected to the inner catheter. A liquid injection tube is provided at the proximal end of the outer balloon. The liquid injection tube is sleeved on the inner catheter, and a first liquid injection gap is formed between the liquid injection tube and the inner catheter.

[0007] Preferably, a limiting area is further provided on the blocking part. The limiting area is adjacent to the expansion area, and the inner wall of the limiting area is used for contacting the inner catheter.

[0008] Preferably, the blocking part includes a support tube sleeved on the inner catheter. The distal end of the support tube is fixedly and sealingly connected to the inner catheter. The proximal end of the support tube extends out of the first liquid injection gap. A second liquid injection gap is formed between the support tube and the inner catheter. The support tube has a support section located inside the outer balloon. The support section wraps the electrode assembly inside. The limiting area and the expansion area are provided on the support section. The limiting area and the expansion area are arranged at intervals along the axial direction of the support section. The expansion area corresponds to the electrode assembly. After the expansion area is injected with liquid, it can expand. The outer wall of the expanded expansion area can contact the inner wall of the expanded outer balloon. A separation distance greater than the safety distance is formed between the outer wall of the limiting area and the outer balloon.

[0009] Preferably, the blocking part includes a traction wire, a medical stent, and a limiting tube sleeved on the medical stent. The two ends of the medical stent are fixedly connected to the inner catheter. The medical stent and the electrode assembly are arranged in a staggered manner in the axial direction of the inner catheter. The middle part of the medical stent is the expansion area, and the two ends of the medical stent are the limiting areas. The outer wall of the expanded expansion area can contact the inner wall of the expanded outer balloon. A separation distance greater than the safety distance is formed between the outer wall of the limiting area and the outer balloon. The limiting tube is fixedly connected to the traction wire. The inner diameter of the limiting tube matches the diameter of the retracted expansion area. The traction wire extends out of the first liquid injection gap.

[0010] Preferably, one medical stent is provided between two adjacent electrode assemblies.

[0011] Preferably, the medical stent is a metal stent.

[0012] Preferably, the blocking portion includes a support tube sleeved on the inner catheter. The distal end of the support tube is fixedly and sealingly connected to the inner catheter. The proximal end of the support tube extends out of the first liquid injection gap. There is a second liquid injection gap between the support tube and the inner catheter. The support tube has a support section located inside the outer balloon. The support section wraps the electrode assembly therein. The support section extends along the axial direction of the working section. The whole of the support section is the expansion area. After the expansion area is injected with liquid, it can expand. There is a separation distance greater than the safety distance between the outer wall of the expanded expansion area and the outer balloon.

[0013] Preferably, the outer balloon and the blocking portion are integrally provided. The limiting area and the expansion area are arranged at intervals along the axial direction of the outer balloon. The expansion area corresponds to the electrode assembly. After the expansion area is injected with liquid, it can expand. The outer wall of the expanded expansion area can contact the blood vessel wall. There is a separation distance greater than the safety distance between the outer wall of the limiting area and the blood vessel wall.

[0014] Preferably, imaging rings are provided at both ends of the working section.

[0015] The present invention has achieved the following technical effects compared with the prior art:

[0016] The present invention provides a blocking portion for the shock wave balloon catheter. The blocking portion has an expandable expansion area. After the expansion area expands, the blocking portion can radially limit the inner catheter, so that a safety distance is maintained between the electrode assembly on the inner catheter and the outer balloon, reducing the eccentricity of the electrode assembly, improving the uniformity of energy emission, and avoiding the electrode assembly being too close to the blood vessel and causing damage to the blood vessel. Description of the Drawings

[0017] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required to be used in the embodiments. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings.

[0018] Figure 1 It is a schematic structural diagram of a shock wave balloon catheter of type one in the embodiment;

[0019] Figure 2 For the Figure 1 Detailed partial cross-sectional schematic diagram;

[0020] Figure 3 It is a cross-sectional schematic diagram of the shock wave balloon catheter of type one in the embodiment entering a calcified blood vessel;

[0021] Figure 4 is Figure 3 a partially enlarged schematic view;

[0022] Figure 5 is a schematic structural view of a shock wave balloon catheter of type two in the embodiment;

[0023] Figure 6 is a schematic cross-sectional view of a medical stent and an outer balloon after inflation in the embodiment;

[0024] Figure 7 is Figure 6 a partially enlarged schematic view;

[0025] Figure 8 is a schematic cross-sectional view of a medical stent in a shock wave balloon catheter of type two in the embodiment;

[0026] Figure 9 is a schematic structural view of a shock wave balloon catheter of type three in the embodiment;

[0027] Figure 10 is a schematic cross-sectional view of a shock wave balloon catheter of type three entering a calcified blood vessel in the embodiment;

[0028] Figure 11 is Figure 10 a partially enlarged view;

[0029] Figure 12 is a schematic structural view of a shock wave balloon catheter of type four in the embodiment;

[0030] Figure 13 is a schematic cross-sectional view of a shock wave balloon catheter of type four entering a calcified blood vessel in the embodiment;

[0031] Figure 14 is the electrode eccentric state of a shock wave balloon catheter of the prior art in a curved blood vessel;

[0032] Figure 15 is a schematic view of energy emission after the electrode assembly of a shock wave balloon catheter of the prior art is eccentric.

[0033] Explanation of reference numerals: 1, inner catheter; 2, outer balloon; 3, electrode assembly; 4, liquid injection tube; 5, support tube; 6, inflation area; 7, limiting area; 8, traction wire; 9, limiting tube; 10, medical stent; 11, radiopaque ring; 12, energy wave; 13, blood vessel wall; 14, safety distance. Detailed implementation manners

[0034] The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0035] The object of the present invention is to provide a shock wave balloon catheter to solve the problems existing in the prior art. By using the blocking part, inflation can be achieved. After inflation, the blocking part can block the radial movement of the inner catheter 1 to ensure a certain safety distance 14 between the electrode assembly 3 on the inner catheter 1 and the outer balloon 2, that is, there is a safety distance from the blood vessel wall 13, so as to reduce the eccentricity of the electrode assembly 3, improve the uniformity of energy emission, and avoid the problem of blood vessel injury.

[0036] To make the above objects, features, and advantages of the present invention more obvious and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0037] This embodiment provides a shock wave balloon catheter, as Figures 1 to 15 shown, including an inner catheter 1, an electrode assembly 3, and a balloon assembly. The inner catheter 1 has a working section, and the balloon assembly, the electrode assembly 3, and the blocking part are all installed on the working section of the inner catheter 1. The balloon assembly includes an outer balloon 2 and a blocking part. The outer balloon 2 wraps the electrode assembly 3 inside. After the outer balloon 2 is injected with liquid, it can expand, and the outer wall of the expanded outer balloon 2 will directly contact the lesion site. The electrode assembly 3 can emit energy, and the energy passes through the mixed solution of physiological saline and contrast agent in the outer balloon 2 to the calcified lesion, and emits non-focused and pulsed shock waves to the lesion to safely fragment the shallow and deep calcifications. The blocking part has an expansion area 6, and the expansion area 6 can expand and contract along the radial direction of the working section. After the expansion area 6 of the blocking part expands, it can block the radial movement of the inner catheter 1 to ensure a safety distance 14 between the electrode assembly 3 and the outer balloon 2, so as to ensure that there is always a safety distance between the electrode assembly 3 and the inner wall of the blood vessel wall 13, reduce the eccentricity of the electrode assembly 3, improve the circumferential uniformity of the energy emitted by the electrode assembly 3 and the treatment of the blood vessel calcification lesion position, and ensure that the electrode assembly 3 will not be too close to the blood vessel wall 13, causing damage to the blood vessel and resulting in an insignificant treatment effect on the side of the blood vessel wall far from the lesion.

[0038] In one embodiment, as Figures 1 to 15As shown, the distal end (the end away from the operator) of the outer balloon 2 is fixedly and sealingly connected to the inner catheter 1. The proximal end (the end close to the operator) of the outer balloon 2 is provided with a liquid injection tube 4. The liquid injection tube 4 is sleeved on the inner catheter 1, and there is a first liquid injection gap between the liquid injection tube 4 and the inner catheter 1. A mixed solution of physiological saline and contrast agent can be injected into the outer balloon 2 through the first liquid injection gap.

[0039] In one embodiment, as Figures 1 to 15 shown, a limiting area 7 is further provided on the blocking part. The limiting area 7 is adjacent to the expansion area 6, and the inner wall of the limiting area 7 is used to contact the inner catheter 1 to limit it. After the expansion area 6 expands, it will provide a radial supporting force for the limiting area 7 to radially limit the inner catheter 1, so that a safe distance 14 is always maintained between the electrode assembly 3 on the inner catheter 1 and the outer balloon 2, ensuring that there is an adequate safety distance between the electrode assembly 3 and the blood vessel wall 13, and reducing the eccentricity of the outer balloon 2.

[0040] In one embodiment, as Figures 1 to 4 shown, it is a shock wave balloon catheter of type one:

[0041] The blocking part and the outer balloon 2 are two components, and the blocking part is located inside the outer balloon 2. The blocking part includes a support tube 5. The support tube 5 is sleeved on the inner catheter 1. The distal end (the end away from the operator) of the support tube 5 is fixedly connected to the inner catheter 1 in a sealed manner. The proximal end (the end close to the operator) of the support tube 5 extends out of the first liquid injection gap. There is a second liquid injection gap between the support tube 5 and the inner catheter 1. The support tube 5 has a support section located inside the outer balloon 2. The support section wraps the electrode assembly 3 inside. An expansion area 6 and a limiting area 7 are provided on the support section. The expansion area 6 and the limiting area 7 are arranged at intervals along the axial direction of the support section. The number and position of the expansion areas 6 correspond one by one to the number and position of the electrode assemblies 3, that is, each expansion area 6 wraps one electrode assembly 3 inside. Through the second liquid injection gap, a mixed liquid of normal saline and contrast agent can be introduced into the support section. After the expansion area 6 is injected with liquid, it can be filled and expanded. The outer wall of the expanded expansion area 6 can be closely attached to the inner wall of the expanded outer balloon 2. The outer balloon 2 provides a circumferential supporting force for the expansion area 6, so that a stable relative position relationship is maintained between the expansion area 6 and the outer balloon 2, so as to ensure that a relative position relationship is maintained between the limiting area 7 and the outer balloon 2. At the same time, the energy of the electrode assembly 3 can also be transmitted to the outer balloon 2 through the liquid in the expansion area 6. The limiting area 7 will limit the inner catheter 1 in the radial direction. There is a separation distance between the outer wall of the limiting area 7 and the outer balloon 2, and this separation distance is greater than the safety distance 14, so as to ensure that there is a safety distance 14 between the inner catheter 1 and the outer balloon 2, reduce the degree of eccentric movement of the electrode assembly 3 on the inner catheter 1, and ensure that there is a safety distance 14 between the electrode assembly 3 and the outer balloon 2, that is, the electrode assembly 3 maintains a safe distance from the blood vessel wall 13. During treatment, through interventional treatment, this shock wave balloon catheter enters the lesion site, and liquid is filled into the outer balloon 2. The outer balloon 2 is filled and expanded and will fit with the blood vessel wall 13 in the vascular calcification lesion area. If the blood vessel at the lesion site is long and curved, the outer balloon 2 will be correspondingly bent and deformed. At this time, the electrode assembly 3 will have circumferential eccentricity, as Figure 14 、 Figure 15 shown. At this time, liquid is injected into the support tube 5. The expansion area 6 is filled and expanded and closely attached to the outer balloon 2. The limiting area 7 will push the inner catheter 1 back, so that the electrode assembly 3 is limited to the center and emits energy waves 12 evenly, as Figure 4 shown.

[0042] In one embodiment, as Figures 1 to 4 shown, after the expansion area 6 expands, it is spherical, cylindrical or irregular. After the expansion area 6 expands, it will cause the support section of the support tube 5 to form relative convex parts (expansion area 6) and concave parts (limiting area 7). The convex parts will be close to the outer balloon 2, and the concave parts limit the radial offset range of the inner catheter 1, and the radial offset of the electrode assembly 3 connected to the inner catheter 1 can be controlled. The expansion area 6 is a non-compliant balloon or a semi-compliant balloon, and different shapes of the expansion area 6 are controlled by the balloon blow molding process.

[0043] In one embodiment, as Figures 5 to 8 shown, it is a shock wave balloon catheter of type two:

[0044] The blocking part and the outer balloon 2 are two components, and the blocking part is located inside the outer balloon 2. The blocking part includes a traction wire 8, a medical stent 10, and a limiting tube 9. The limiting tube 9 is used to sleeve on the medical stent 10, and both ends of the medical stent 10 are fixedly connected to the inner catheter 1. The medical stent 10 and the electrode assembly 3 are arranged offset in the axial direction of the inner catheter 1 to prevent the medical stent 10 from affecting the propagation of the energy emitted by the electrode assembly 3. The middle part of the medical stent 10 is an expansion area 6, and both ends of the medical stent 10 are limiting areas 7. There is a spacing between the outer wall of the limiting area 7 and the outer balloon 2, and this spacing is greater than the safety spacing 14. The limiting tube 9 is fixedly connected to the traction wire 8, and the inner diameter of the limiting tube 9 matches the diameter of the retracted expansion area 6. The traction wire 8 extends out from the first liquid injection gap. In the initial state, the medical stent 10 is connected to the inner catheter 1 and pre-compressed and held, assembled in the limiting tube 9, and the medical stent 10 remains in a contracted state. The medical stent 10 can be single or multiple, and is adjusted according to the length of the outer balloon 2. After the shock wave balloon catheter reaches the vascular calcification lesion area, liquid is filled into the outer balloon 2, and the outer balloon 2 expands and fills, and will fit against the blood vessel wall 13 of the vascular calcification lesion area. The limiting tube 9 is pulled out of the outer balloon 2 through the traction wire 8, and the medical stent 10 is released from the restraint and limitation of the limiting tube 9. The expansion area 6 of the medical stent 10 will automatically expand and support inside the outer balloon 2. Under the support of the expansion area 6, the limiting area 7 can support the inner catheter 1 so that it will not be eccentric as much as possible, so as to ensure that there is a safety spacing 14 between the electrode assembly 3 and the outer balloon 2, so as to ensure that there is an adequate safety distance between the electrode assembly 3 and the blood vessel wall 13.

[0045] In one embodiment, as Figures 5 to 8 shown, a medical stent 10 is provided between two adjacent electrode assemblies 3.

[0046] In one embodiment, as Figures 5 to 8 shown, the medical stent 10 is a metal stent, and the metal stent is formed by heat treatment and electrochemical polishing processes. The traction wire 8 is made of one or a combination of metal or polymer materials. The traction wire 8 can be filamentous or can be combined with the limiting tube 9 into an integral thin-walled sheath. After the outer balloon 2 is filled, the thin-walled sheath is retracted to release the medical stent 10 close to the outer balloon 2. The limiting tube 9 can be a braided and coated material, only covering the medical stent 10, which can ensure better passability of the outer balloon 2 after folding.

[0047] In one embodiment, as Figures 9 to 11 shown, it is a shock wave balloon catheter of type three:

[0048] The blocking part and the outer balloon 2 are two components, and the blocking part is located inside the outer balloon 2. The blocking part includes a support tube 5, which is sleeved on the inner catheter 1. The distal end of the support tube 5 is fixedly connected to the inner catheter 1 in a sealed manner. The proximal end of the support tube 5 extends out of the first liquid injection gap. There is a second liquid injection gap between the support tube 5 and the inner catheter 1. The support tube 5 has a support section located inside the outer balloon 2, and the support section wraps the electrode assembly 3. The support section extends along the axial direction of the working section, and the entire support section is an inflation area 6. After the support section is inflated by injecting liquid, it is also a limiting area 7. When the outer balloon 2 is a long tubular balloon, the support section is also a long tubular balloon, and the inflation area 6 is a non-compliant balloon or a semi-compliant balloon. After the inflation area 6 is injected with liquid, it can expand, but the inflated inflation area 6 does not contact the outer balloon 2, but there is a separation distance between the inflation area 6 and the outer balloon 2, and this separation distance is greater than the safety distance 14. If the blood vessel at the lesion site is bent in a long section, the outer balloon 2 will be bent and deformed accordingly. Under the action of the liquid in the outer balloon 2 and the inflation area 6, at this time, the inflation area 6 will bend synchronously, and the bending degrees of the outer balloon 2 and the inflation area 6 are roughly the same, so as to intercept the inner catheter 1 and the electrode assembly 3 on the inner catheter 1. At this time, the inflation area 6 is also the limiting area 7, so that the distance between the electrode assembly 3 and the outer balloon 2 will not be less than the safety distance 14, thus ensuring that there is an adequate safety distance between the electrode assembly 3 and the outer balloon 2, such as Figures 9 to 11 shown. This method actually implements the structure of an inner and outer double balloon, which can increase the distance between the electrode assembly 3 and the outer balloon 2 of the outer layer, reduce the risk of damage to the outer balloon 2, and is a shock wave balloon catheter of type four.

[0049] In one embodiment, as Figures 12 to 13 shown, it is a shock wave balloon catheter of type four:

[0050] The outer balloon 2 and the blocking part are integrally provided, that is, the outer balloon 2 and the blocking part are actually the same component. The specific method is to provide an inflation area 6 and a limiting area 7 on the outer balloon 2, and the inflation area 6 and the limiting area 7 are arranged at intervals along the axial direction of the outer balloon 2. The number and position of the inflation areas 6 correspond one by one to the number and position of the electrode assemblies 3, that is, each inflation area 6 wraps one electrode assembly 3. Through the first liquid injection gap, a mixed liquid of normal saline and contrast agent can be introduced into the outer balloon 2. After the inflation area 6 is injected with liquid, it can be filled and inflated, and the inflation area 6 and the limiting area 7 form relative convex and concave parts. The outer wall of the inflated inflation area 6 can closely adhere to the inner wall of the blood vessel wall 13, and the blood vessel wall 13 provides a circumferential supporting force for the inflation area 6, so that there is a safety distance 14 between the limiting area 7 and the blood vessel wall 13, and the limiting area 7 will limit the inner catheter 1 in the radial direction, ensuring that there is a safety distance 14 between the inner catheter 1 and the blood vessel wall 13, reducing the degree of eccentric movement of the inner catheter 1, and thus reducing the degree of eccentric movement of the electrode assembly 3 on the inner catheter 1, and ensuring that there is a safety distance 14 between the electrode assembly 3 and the blood vessel wall 13.

[0051] In one embodiment, as Figures 1 to 15 shown, both ends of the working section of the inner catheter 1 are provided with a radiopaque ring 11.

[0052] Specific examples are used in the present invention to elaborate on the principles and embodiments of the present invention. The description of the above embodiments is only used to help understand the method and its core idea of the present invention; at the same time, for those of ordinary skill in the art, according to the idea of the present invention, there will be changes in the specific implementation manners and application scopes. In summary, the content of this specification should not be construed as a limitation to the present invention.

Claims

1. A shock wave balloon catheter, characterized in that: The invention comprises an inner catheter, an electrode assembly and an outer balloon assembly, wherein the inner catheter is provided with a working section, the electrode assembly and the outer balloon assembly are both mounted on the working section, the outer balloon assembly comprises an outer balloon and a blocking portion, the outer balloon wraps the electrode assembly inside, the blocking portion is provided with an expansion area which can be expanded and contracted along the radial direction of the working section, and the blocking portion can block the inner catheter from moving radially after the expansion area is expanded, so that a safe distance is provided between the electrode assembly and the outer balloon.

2. The shock wave balloon catheter according to claim 1, characterized in that: The distal end of the outer balloon is sealed and fixedly connected to the inner catheter, and the proximal end of the outer balloon is provided with an injection tube, which is sleeved on the inner catheter, and a first injection gap is provided between the injection tube and the inner catheter.

3. The shock wave balloon catheter according to claim 2, characterized in that: The blocking portion is further provided with a limiting area, the limiting area is adjacent to the expansion area, and the inner wall of the limiting area is used for contacting with the inner layer conduit.

4. The shock wave balloon catheter according to claim 3, characterized in that: The blocking part includes a support tube sleeved on the inner layer catheter, the distal end of the support tube is sealed and fixedly connected to the inner layer catheter, the proximal end of the support tube extends out of the first injection gap, and a second injection gap is provided between the support tube and the inner layer catheter. The support tube has a support section located in the outer layer balloon, and the support section wraps the electrode assembly therein. The support section is provided with the limiting area and the expansion area, and the limiting area and the expansion area are spaced apart along the axial direction of the support section. The expansion area corresponds to the electrode assembly, and the expansion area can expand after liquid injection. The outer wall of the expanded area can contact the inner wall of the expanded outer layer balloon, and the outer wall of the limiting area and the outer layer balloon have a spacing greater than the safety spacing.

5. The shock wave balloon catheter according to claim 3, characterized in that: The blocking part includes a traction wire, a medical stent and a limiting tube for being sleeved on the medical stent, the two ends of the medical stent are fixedly connected to the inner layer catheter, the medical stent and the electrode assembly are staggered in the axial direction of the inner layer catheter, the middle part of the medical stent is the expansion zone, the two ends of the medical stent are the limiting zones, the outer wall of the expansion zone after expansion can contact the inner wall of the expanded outer layer balloon, the outer wall of the limiting zone and the outer layer balloon have a spacing greater than the safety spacing, the limiting tube is fixedly connected to the traction wire, the inner diameter of the limiting tube matches the diameter of the folded expansion zone, and the traction wire extends out of the first injection gap.

6. The shock wave balloon catheter according to claim 5, characterized in that: A medical support is arranged between two adjacent electrode assemblies.

7. The shock wave balloon catheter according to claim 6, characterized in that: The medical stent is a metal stent.

8. The shock wave balloon catheter according to claim 2, characterized in that: The blocking part includes a support tube sleeved on the inner layer catheter, the distal end of the support tube is sealed and fixedly connected to the inner layer catheter, the proximal end of the support tube extends out of the first liquid injection gap, and a second liquid injection gap is provided between the support tube and the inner layer catheter. The support tube has a support section located inside the outer layer balloon, the support section wraps the electrode assembly inside, the support section extends axially along the working section, and the entire support section is the expansion zone. The expansion zone can expand after liquid injection, and the outer wall of the expanded expansion zone has a spacing greater than the safety spacing from the outer layer balloon after expansion.

9. The shock wave balloon catheter according to claim 3, characterized in that: The outer balloon and the blocking part are integrally arranged, the limiting zone and the expansion zone are spaced apart along the axial direction of the outer balloon, the expansion zone corresponds to the electrode assembly, the expansion zone can expand after being injected with liquid, the outer wall of the expansion zone after expansion can contact the blood vessel wall, and the outer wall of the limiting zone and the blood vessel wall have a spacing greater than the safety spacing.

10. The shock wave balloon catheter according to claim 1, characterized in that: The two ends of the working section are provided with developing rings.

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