A shock wave device

Abstract

This invention discloses a shockwave device, comprising an inner tube; a balloon connected to the inner tube, the balloon having a accommodating cavity; a support wire, at least partially located within the accommodating cavity, the distal end of the support wire connected to the inner tube; and an electrode assembly disposed on the support wire, the radial distance between the electrode assembly and the balloon being constant. This invention, by placing the support wire within the accommodating cavity and the electrode assembly on the support wire, enables the electrode assembly to approach the inner wall of the balloon while maintaining a constant radial distance during balloon expansion, reducing the attenuation of shockwave energy propagation, improving treatment effectiveness, and simultaneously avoiding balloon rupture, thus enhancing treatment safety.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a shock wave device. Background Technology

[0002] In heart valve applications, shockwave balloon catheters often need to release higher shockwave energy than those used in intravascular applications. Shockwave energy, as a form of sound pressure energy, attenuates rapidly with increasing distance as it propagates through a medium. To address this issue, existing technologies often place the electrode close to the inner wall of the balloon to achieve better therapeutic effects. For example, patent CN115363689A provides a medical catheter and device configured such that, when switching from a first state to a second state, the distance between the electrode and the catheter's axis increases, and correspondingly, the distance between the electrode and the inner wall of the balloon decreases, bringing the electrode closer to the lesion area and meeting the requirements for effective treatment of the lesion location. However, electrodes placed too close to the balloon can easily rupture it, especially during the treatment discharge process, posing a safety risk. Existing technologies struggle to resolve this contradiction, making it difficult to balance therapeutic effectiveness and safety.

[0003] Furthermore, blood vessels often have a curved, net-like shape. During catheter-based intervention, the medical catheter may be curved or even bent. In this case, due to the bending force at the connection between the balloon and the proximal outer tube, and the lack of a relatively secure safety limit between the electrode and the balloon, the support rod inside the balloon may be biased towards one side of the balloon's inner wall, resulting in poor stability. Consequently, the radial distance between the electrode on the support rod and the balloon becomes uncontrollable, or even directly contacts the inner wall of the balloon, making it very easy to damage the balloon during the discharge process and creating a safety hazard. Summary of the Invention

[0004] To address the problems existing in the prior art, the present invention provides a shock wave device that can effectively reduce the attenuation of shock wave energy during propagation, and synergistically improve treatment efficiency, treatment effectiveness, treatment stability and treatment safety.

[0005] The present invention provides a shock wave device, comprising: Inner tube; A balloon, connected to a portion of the inner tube, the balloon having a accommodating cavity; A support wire, at least partially located within the accommodating cavity, has its distal end connected to the inner tube; An electrode assembly is disposed on the support wire, and the radial distance between the electrode assembly and the balloon is constant.

[0006] Furthermore, the support wire includes a limiting portion that can abut against the inner wall of the balloon in the radial direction, and the electrode assembly is located between two adjacent limiting portions in the axial direction.

[0007] Furthermore, the support wire is a deformable support wire, which can adjust the distance between itself and the inner wall of the balloon through deformation; and the deformable support wire can move in coordination with the electrode assembly through deformation, so that the deformable support wire and the electrode assembly can retract and move closer to the inner tube or arch and move away from the inner tube.

[0008] Furthermore, the shock wave device includes a plurality of balloons, which are arranged circumferentially around the inner tube.

[0009] Furthermore, the shock wave device includes a single balloon fitted over a portion of the inner tube, and the accommodating cavity is located between the balloon and the inner tube.

[0010] Furthermore, in the arched state of the deformable support wire, the radial distance between the electrode assembly and the inner wall of the balloon is 1 mm to 4 mm.

[0011] Furthermore, the deformable support wire includes a support portion, a bending portion, and a connecting portion. The electrode assembly is located on at least one of the support portion and the bending portion. One end of the support portion is connected to one end of the bending portion, and the other end of the bending portion is connected to the connecting portion. The connecting portion is connected to the inner tube. When the deformable support wire is bent, the radial distance between the support portion and the inner tube is greater than the radial distance between the connecting portion and the inner tube, and in the axial direction away from the support portion, the bending portion gradually bends toward the inner tube.

[0012] Furthermore, the deformable support wire includes a limiting part, which is the bending part. When the deformable support wire is in an arched state, the bending part is in contact with the inner wall of the conical segment of the balloon, and the length of the bending part in the axial direction of the inner tube is less than the length of the conical segment of the balloon in the axial direction of the inner tube.

[0013] Furthermore, the deformable support wire includes a limiting portion located between the support portion and the bending portion, and the end of the limiting portion connected to the support portion is radially recessed toward the inner tube.

[0014] Furthermore, the balloon is an irregularly shaped balloon, which includes a fitting portion and a protrusion portion. The protrusion portion is located axially between two adjacent fitting portions in the inner tube. In the balloon's expanded state, the radial distance between the inner wall of the protrusion portion and the inner tube is greater than the radial distance between the fitting portion and the inner tube. The deformable support wire includes a limiting part located at the end of the support part connected to the bending part. When the deformable support wire is in an arched state, the limiting part can fit against the inner wall of the fitting part.

[0015] Furthermore, the shock wave device includes a first connector and a second connector. The first connector is connected to the distal end of the inner tube, and the second connector is connected to the proximal end of the inner tube. The end of the deformable support wire is connected to the inner tube through the first connector and the second connector.

[0016] Furthermore, the first connector and the second connector are respectively fixedly connected to the inner tube; or, The first connector is fixedly or movably connected to the inner tube, and the second connector is movably connected to the inner tube. The second connector can reciprocate along the axial direction of the inner tube under the action of external force, thereby causing the deformable support wire to retract or arch.

[0017] Furthermore, the second connector is movably connected to the inner tube, and the shock wave device also includes a push-pull member, one end of which is fixedly connected to the second connector and used to apply an external force to the second connector so as to drive the second connector to reciprocate along the axial direction of the inner tube under the action of the external force.

[0018] Furthermore, when the circumferential cross-section of the balloon is irregularly shaped, the diameter of the circumferential circle of the balloon is 8mm to 28mm.

[0019] Furthermore, the shock wave device also includes an outer tube sleeved on the inner tube, with a gap between the outer tube and the inner tube, and the distal end of the outer tube is connected to the proximal end of the balloon.

[0020] Implementing this invention has the following beneficial effects: 1. This invention provides a support wire within the accommodating cavity of a balloon, with the electrode assembly mounted on the support wire. During balloon inflation, the support wire maintains a constant radial distance from the inner wall of the balloon, effectively keeping the radial distance between the electrode assembly and the inner wall of the balloon constant. This allows the electrode assembly to be relatively close to the inner wall of the balloon, reducing the attenuation of the shock wave energy released by the electrode assembly during propagation, improving the treatment effectiveness targeting the area to be treated, and maintaining a constant radial distance between the electrode assembly and the inner wall of the balloon. This prevents the electrode assembly from becoming too close to the balloon and damaging it, thus improving the safety of the treatment process. In summary, this invention synergistically improves treatment efficiency, treatment effectiveness, treatment stability, and treatment safety.

[0021] 2. This invention incorporates a deformable support wire within the balloon's accommodating cavity, upon which the electrode assembly is positioned. The distance between the deformable support wire and the inner wall of the balloon can be adjusted through deformation, thereby coordinating with the movement of the electrode assembly. This allows the electrode assembly to retract and approach the inner tube, facilitating a reduction in the overall circumferential dimensions of the balloon, the internal electrode assembly, and its tube ends during the balloon's coiled state. This enhances the permeability of the shock wave device, particularly meeting the stringent size requirements of vascular intervention and cardiac valve intervention scenarios. Furthermore, the deformable support wire, in coordination with the electrode assembly's movement, allows the electrode assembly to arch and approach the inner wall of the balloon during balloon expansion, shortening the radial distance between the electrode assembly and the inner wall. This helps reduce the attenuation of shock wave energy during propagation and maintains a constant radial distance between the electrode assembly and the inner wall of the balloon, preventing vascular bending that could lead to electrode assembly misalignment and balloon damage. This synergistically improves treatment efficiency, effectiveness, stability, and safety. Attached Figure Description

[0022] To more clearly illustrate the technical solution of the present invention, the accompanying drawings used in the embodiments will be briefly described below, wherein the same components are represented by the same reference numerals. Obviously, the drawings described below are merely some embodiments of the present invention, and those skilled in the art can obtain other drawings based on these drawings without any creative effort.

[0023] Figure 1 This is a three-dimensional structural diagram of a shock wave device provided in an embodiment of the present invention; Figure 2 for Figure 1 Schematic diagram of the assembly between the deformable support wire and the inner tube; Figure 3 for Figure 1 A schematic diagram of the cross-section of the deformable support wire in the circumferential direction of the inner tube; Figure 4 This is a schematic cross-sectional view of the shock wave device in the circumferential direction of the inner tube in some possible embodiments of the present invention. Figure 5 This is a three-dimensional structural schematic diagram of another shock wave device provided in an embodiment of the present invention; Figure 6 for Figure 5 Schematic diagram of the assembly between the deformable support wire and the inner tube; Figure 7 for Figure 5 A schematic diagram of the cross-section of the deformable support wire in the circumferential direction of the inner tube; Figure 8 This is a schematic cross-sectional view of the shock wave device in the circumferential direction of the inner tube in some possible embodiments of the present invention. Figure 9This is a schematic diagram of a shock wave device with multiple balloons in some possible embodiments of the present invention; Figure 10 for Figure 9 Cross-sectional view along section AA; Figure 11 This is a schematic diagram of a shock wave device with multiple balloons in some other possible embodiments of the present invention; Figure 12 for Figure 11 Cross-sectional view along section BB; Figure 13 This is a schematic diagram of a deformable support wire provided in an embodiment of the present invention; Figure 14 This is a schematic diagram illustrating the positional relationship between the limiting part and the balloon, provided in an embodiment of the present invention. Figure 15 This is a schematic diagram illustrating the positional relationship between the limiting part and the balloon, provided in another embodiment of the present invention. Figure 16 This is a schematic diagram showing the positional relationship between the limiting part and the balloon in some possible embodiments of the present invention; Figure 17 This is a schematic diagram showing the positional relationship between the limiting part and the balloon in some other possible embodiments of the present invention; Figure 18 This is a schematic diagram of the assembly steps of a shock wave device provided in an embodiment of the present invention; Figure 19 This is a schematic diagram of the assembly steps of another shock wave device provided in an embodiment of the present invention; Figure 20 for Figure 19 A three-dimensional structural diagram of the integrated deformable support wire structure; Figure 21 This is a schematic diagram of the structure of a shock wave device that switches between an arched state and a retracted state, provided in an embodiment of the present invention. Figure 22 A schematic diagram of the structure of another shock wave device provided in an embodiment of the present invention, showing the transition between an arched state and a retracted state; Figure 23 This is a cross-sectional schematic diagram of the second connector in some possible embodiments of the present invention; Figure 24 This is a schematic diagram of a second connecting member sliding method provided in an embodiment of the present invention; Figure 25 A schematic diagram of the peak pressure of a shock wave measured at a detection point under different bowing heights using a shock wave device provided in an embodiment of the present invention; Figure 26 This is a schematic diagram illustrating the change in acoustic pressure energy in a balloon at different operating frequencies using a shock wave device, as provided in an embodiment of the present invention. Figure 27 A schematic diagram showing the temperature rise of the balloon provided in an embodiment of the present invention at different operating frequencies in water at 37°C. Figure 28 This is a schematic diagram illustrating the lithotripsy probability and treatment time of a shock wave device provided in an embodiment of the present invention under the same number of pulses but different pulse frequencies.

[0024] The corresponding reference numerals in the figure are as follows: 1-Inner tube, 2-Balloon, 21-Accommodating cavity, 22-Fitting part, 23-Protrusion, 3-Deformable support wire, 30-Support wire, 31-Support part, 32-Bending part, 33-Connecting part, 34-Limiting part, 4-Electrode assembly, 5-First connector, 6-Second connector, 7-Push-pull part, 8-Outer tube, 81-Gap, 82-Annular guide. Detailed Implementation

[0025] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. It should be noted that the terms "upper," "lower," "left," "right," "inner," "outer," "front," "rear," "both ends," "one end," and "the other end," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing the present invention, and do not indicate or imply that the device or structure referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention; furthermore, the described embodiments are only some embodiments of the present invention, not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0026] To address the issue that existing shockwave devices struggle to balance treatment effectiveness and safety, such as Figure 1-24 As shown, this embodiment of the invention provides a shock wave device that can be applied to treat tissue calcifications such as those in blood vessels and heart valves. Figure 1 and Figure 5 As shown, the shockwave device includes an inner tube 1, a balloon 2 connected to a portion of the inner tube 1, a support wire 30 connected distally to the inner tube 1, and an electrode assembly 4 disposed on the support wire 30. The balloon 2 has a receiving cavity 21, and the support wire 30 is at least partially located in the receiving cavity 21. The radial distance between the electrode assembly 4 and the balloon 2 is constant. In this way, by reasonably setting the position of the support wire 30, the electrode assembly 4 can be made close to the balloon 2, reducing the attenuation of shockwave energy and improving the treatment effectiveness for the area to be treated. At the same time, it can also prevent the electrode assembly 4 from being too close to the side wall of the balloon 2 and breaking the balloon, thereby improving the lifespan and operational stability of the shockwave device and enhancing treatment safety.

[0027] Specifically, in some exemplary embodiments, the support wire 30 is a deformable support wire 3. This deformable support wire 3 can adjust the distance between itself and the inner wall of the balloon 2 through deformation. Furthermore, the deformable support wire 3 can move in conjunction with the electrode assembly 4, causing it to retract and move closer to the inner tube 1 or arch and move away from the inner tube 1. On one hand, during the intervention of the shockwave device, the balloon 2 is in a coiled and contracted state, resulting in a smaller circumferential cross-section of the entire shockwave device, including the deformable support wire 3 and the electrode assembly 4. This facilitates the passage of the shockwave device, improves its passability and effectiveness and stability in reaching the treatment area, and facilitates subsequent precise and effective treatment. On the other hand, after the balloon 2 of the shockwave device reaches the treatment area, the balloon 2 can expand, allowing for... When the deformable support wire 3 loses the pressure applied by the balloon 2, it can arch and move the electrode assembly 4 closer to the side wall of the balloon 2. That is, the electrode assembly 4 is closer to the area to be treated, which reduces the energy attenuation of the shock wave energy generated by the electrode assembly 4 when it reaches the area to be treated, effectively improving treatment efficiency and effect. It should be noted that when the deformable support wire 3 is in the arched state, the radial distance between the electrode assembly 4 and the balloon 2 is constant. This is to avoid the deformable support wire 3 in the distal balloon 2 being biased to one side due to the tortuous direction of the blood vessel during the connection process. This effectively prevents the deformable support wire 3 and the electrode assembly 4 from contacting the inner wall of the balloon 2 and damaging the balloon 2 during the discharge process, improving treatment stability, reliability and safety, and also helping to extend the life of the shock wave device.

[0028] In some exemplary embodiments, the inner tube 1 is an adjustable bend tube. During the intervention of the shock wave device, the bending direction and degree of the inner tube 1 can be freely adjusted so that the shock wave device can be flexibly adjusted in the human body, improving the passability of the shock wave device, and adjusting the position of the balloon 2 in the heart valve or blood vessel according to the area to be treated, thereby improving the effectiveness and accuracy of the balloon 2 of the shock wave device reaching the area to be treated, and thus improving treatment efficiency and treatment safety.

[0029] Specifically, in some exemplary embodiments, the shock wave device includes a single balloon 2, such as Figure 1As shown, balloon 2 is fitted onto part of the inner tube 1, and a receiving cavity 21 can be formed between balloon 2 and the inner tube 1. During the intervention of the shock wave device, balloon 2 is in a coiled and contracted state. At this time, the receiving cavity 21 has almost no volume. The pressure of the coiled and contracted balloon 2 can make the deformable support wire 3 be in a coiled or coiled state, and the deformable support wire 3 is close to the inner tube 1. After balloon 2 reaches the treatment area, liquid medium can be filled into balloon 2 to expand balloon 2 to an expanded state, increasing the volume of receiving cavity 21. At this time, the balloon 2 is no longer restrained, and the receiving cavity 21 can reserve space for the subsequent arching of deformable support wire 3, improving the effectiveness of the subsequent arching of deformable support wire 3.

[0030] Specifically, such as Figure 1 As shown, the shock wave device also includes an outer tube 8 sleeved on the inner tube 1. The inner diameter of the outer tube 8 is larger than the outer diameter of the inner tube 1. There is a gap 81 between the outer tube 8 and the inner tube 1. The distal end of the outer tube 8 is connected to the proximal end of the balloon 2. The gap 81 communicates with the accommodating cavity 21 so that a liquid medium can be introduced into the accommodating cavity 21 through the gap 81 between the outer tube 8 and the inner tube 1, so that the electrode assembly 4 generates shock wave energy through the electrohydraulic effect. The outer tube 8 can also be an adjustable bendable tube, which can be bent together with the inner tube 1. It has good flexibility and can adjust the position of the balloon 2 in the heart valve or blood vessel according to the area to be treated, thereby improving the efficiency and accuracy of the balloon 2 of the shock wave device reaching the treatment area.

[0031] Specifically, in some optional embodiments, the shock wave device includes a deformable support wire 3; in some preferred embodiments, such as Figure 2 and Figure 6 As shown, the shock wave device includes multiple deformable support wires 3. Exemplarily, the shock wave device may include two, three, four, five, or more deformable support wires 3. The multiple deformable support wires 3 are arranged circumferentially along the inner tube 1 within the accommodating cavity 21, which is beneficial for enhancing the energy intensity of the shock wave released by the shock wave device. In some specific embodiments, such as... Figure 1-4 As shown, the shock wave device may include three deformable support wires 3; in other specific embodiments, such as Figure 5-8 As shown, the shock wave device may include two deformable support wires 3.

[0032] Specifically, such as Figure 3 and Figure 7 As shown, multiple deformable support wires 3 are arranged at equal intervals along the circumference of the inner tube 1 in the accommodating cavity 21 to improve the uniformity of the shock wave released by the electrode assembly 4 when the deformable support wires 3 are bent.

[0033] Specifically, each deformable support wire 3 is provided with at least one electrode assembly 4; for example, the deformable support wire 3 may have one, two, three, four or more electrode assemblies 4. When multiple electrode assemblies 4 are provided on the same deformable support wire 3, the multiple electrode assemblies 4 located on the same deformable support wire 3 can be arranged at intervals along the axial direction of the inner tube 1 to meet different shock wave energy release requirements. At the same time, the various electrode assemblies 4 will not interfere with each other and affect the effectiveness, accuracy and stability of shock wave energy release.

[0034] Preferably, the shock wave device includes multiple deformable support wires 3 arranged circumferentially, each support wire being equipped with an electrode assembly 4, so that when the shock wave is released, it can cover all directions of the balloon 2, expand the coverage area of ​​the shock wave energy, and improve treatment efficiency and treatment effect.

[0035] Among them, such as Figure 4 and Figure 8 As shown, the circumferential cross-section of the balloon 2 can be a regular shape such as a circle, or an irregular shape such as a gourd shape, petal shape, ellipse shape, or circumferential protrusion. This invention does not specifically limit this. Any shape of the balloon 2 that can switch between coiled and expanded states and can reserve a certain accommodating cavity 21 in the expanded state is within the protection scope of this invention. In addition, it should be noted that when the balloon 2 is in the coiled and contracted state, the circumference of the circumferential cross-section of the externally tangent shape formed by the deformable support wire 3, electrode assembly 4 and inner tube 1 is smaller than the circumference of the inner wall of the tube foot at the proximal end of the balloon 2, so that the overall circumferential cross-sectional area of ​​the balloon 2 in the coiled and contracted state is smaller, thereby improving the passability of the balloon 2 during intervention.

[0036] Specifically, in some other exemplary embodiments, such as Figure 9 , Figure 10 , Figure 11 and Figure 12 As shown, the shock wave device includes multiple balloons 2, which are arranged circumferentially around the inner tube 1. The support wire 30 can be a rigid support wire or a deformable support wire 3. The distal end of the support wire 30 can axially protrude from the balloons 2 to facilitate fixing to the distal end of the inner tube 1.

[0037] Specifically, when the circumferential cross-section of the balloon 2 is irregular, the diameter of the circumscribed circle of the balloon 2 is 8mm to 28mm. This circumscribed circle diameter refers to the diameter of the circumscribed circle of the balloon 2 in its expanded state when the shape of the balloon 2 is irregular. Furthermore, when the circumferential cross-section of the balloon 2 is a circle made of silicon and germanium, the diameter of the balloon 2 is 8mm to 28mm. This diameter refers to the diameter of the balloon 2 in its expanded state when the cross-sectional shape of the balloon 2 is circular. It can be understood that the diameter or circumscribed circle diameter of the balloon 2 can be any value within the range of 8mm to 28mm. For example... The diameter or circumscribed circle diameter of the balloon 2 can be 8mm, 10mm, 12mm, 15mm, 18mm, 20mm, 22mm, 24mm, 25mm, 28mm, etc. Within this diameter or circumscribed circle diameter range, a certain volume of accommodating cavity 21 can be reserved for the deformable support wire 3 to arch, which is convenient to reach the treatment area during intervention. At the same time, the distance between the electrode assembly 4 and the side wall of the balloon 2 can be relatively small, which reduces the attenuation of the shock wave energy released by the electrode assembly 4 when it reaches the treatment area, thereby improving the treatment efficiency.

[0038] In the case where the shock wave device includes a single balloon 2, the diameter or circumscribed circle diameter of the single balloon 2 is 18mm to 28mm; in the case where the shock wave device includes multiple balloons 2, the diameter or circumscribed circle diameter of each balloon 2 is 8mm to 12mm, so as to meet the requirements of different shock wave devices and synergistically improve the treatment effectiveness and treatment safety.

[0039] Specifically, the wall thickness of the balloon 2 is greater than or equal to a preset wall thickness, which is 0.05mm to 0.07mm. Understandably, the preset wall thickness can be any value within the range of 0.05mm to 0.07mm. For example, the preset wall thickness can be 0.05mm, 0.055mm, 0.06mm, 0.065mm, 0.07mm, etc. The relatively thick wall of the balloon 2 provides greater restraining force, effectively pressing the electrode assembly 4 and the deformable support wire 3 onto the inner tube 1 in a coiled and contracted state, reducing the cross-sectional area of ​​the shock wave device during intervention and improving passability. For example, in one specific embodiment, the preset wall thickness is 0.05mm, meaning the wall thickness of the balloon 2 is greater than or equal to 0.05mm; in another specific embodiment, the preset wall thickness is 0.065mm, meaning the wall thickness of the balloon 2 is greater than or equal to 0.065mm.

[0040] Specifically, the deformable support wire 3 can be a pre-shaped support wire made of a metal material with memory function. That is, the deformable support wire 3 is shaped into an arched state after shaping and is relatively soft after shaping. Under the action of external force, it can deform to reach a closed state, which facilitates the compression of the electrode assembly 4 in the balloon 2 and the overall retraction of the shock wave device along with the deformable support wire 3. However, when the external force is removed, it can return to the arched state, which can effectively coordinate the movement of the electrode assembly 4 so that the electrode assembly 4 can play different roles in different working processes. When it is closed and close to the inner tube 1, it can facilitate the intervention of the shock wave device. Or when it is arched and away from the inner tube 1 (i.e. close to the side wall of the balloon 2), it can reduce the energy attenuation of the shock wave released by the electrode assembly 4 to the treatment area, thereby improving treatment efficiency and treatment stability.

[0041] The deformable support wire 3 is heat-set at a temperature of 350℃ to 500℃, so that the austenite completion temperature (AF point) of the deformable support wire 3 material reaches the preset temperature, improving the shape memory effect and superelasticity of the deformable support wire 3, and meeting the requirements of the deformable support wire 3 in the shock wave device. For example, in some embodiments, the material of the deformable support wire 3 includes a nickel-titanium alloy. By adjusting the nickel content in the nickel-titanium alloy, the AF point of the deformable support wire 3 can be adjusted. At the same time, by using a certain heat treatment temperature and heat treatment time, the phase transformation temperature and microstructure of the nickel-titanium alloy can be changed, further adjusting the AF point of the deformable support wire 3, so as to improve the performance of the nickel-titanium alloy and meet the requirements of the shock wave device.

[0042] Specifically, the radial distance between the electrode assembly 4 and the inner tube 1 when the deformable support wire 3 is arched is greater than the radial distance between the electrode assembly 4 and the inner tube 1 when the deformable support wire 3 is folded up. This allows the electrode assembly 4 to move closer to the side wall of the balloon 2 as the deformable support wire 3 deforms and arches, shortening the distance between the electrode assembly 4 and the area to be treated, reducing the attenuation of the shock wave energy generated by the electrode assembly 4 when it reaches the area to be treated, and improving treatment efficiency and reliability.

[0043] Specifically, such as Figure 13As shown, the deformable support wire 3 includes a support portion 31, a bending portion 32, and a connecting portion 33. The electrode assembly 4 is located on at least one of the support portion 31 and the bending portion 32. When the electrode assembly 4 is located on the support portion 31, the support portion 31 can be arched to help the electrode assembly 4 approach the sidewall of the balloon 2, reducing the attenuation of the shock wave energy released by the electrode assembly 4. When the electrode assembly 4 is located on the bending portion 32, the bending portion 32 has a certain angle with the axial direction of the inner tube 1, so that the electrode assembly 4 can emit shock wave energy obliquely. The shock wave force generated along the axial direction helps to widen the passage of the shock wave device when it encounters a narrow intervention position, thus improving the passability of the shock wave device. One end of the support part 31 is connected to one end of the bending part 32, and the other end of the bending part 32 is connected to the connecting part 33. Similarly, the other end of the support part 31 is connected to one end of another bending part 32, and the other end of the other bending part 32 is connected to another connecting part 33. The two connecting parts 33 are respectively connected to the inner tube 1, so that the deformable support wire 3 is connected to the inner tube 1.

[0044] like Figure 13 As shown, when the deformable support wire 3 is in the arched state, the radial distance between the support part 31 and the inner tube 1 is greater than the radial distance between the connecting part 33 and the inner tube 1. In the axial direction away from the support part 31, the bending part 32 gradually bends towards the inner tube 1. That is, the deformable support wire 3 gradually moves away from the inner tube 1 from the connecting part 33 towards the support part 31 and gets closer to the side wall of the balloon 2, reducing the attenuation of the shock wave energy generated by the electrode assembly 4. In some optional embodiments, the shape of the deformable support wire 3 can be trapezoidal, bow-shaped, arc-shaped, or irregular. The present invention does not specifically limit this, and the shape of the deformable support wire 3 that is close to the side wall of the balloon 2 when the support part 31 is in the arched state is within the protection scope of the present invention.

[0045] Specifically, when the deformable support wire 3 is in an arched state, or when the support wire 30 is a rigid support wire 30, the radial distance between the electrode assembly 4 and the inner wall of the balloon 2 is 1mm to 4mm. It can be understood that the radial distance between the electrode assembly 4 and the inner wall of the balloon 2 can be any value between 1mm and 4mm. For example, the radial distance between the electrode assembly 4 and the inner wall of the balloon 2 can be 1mm, 1.5mm, 2mm, 2.5mm, 3mm, 3.5mm, 4mm, etc. In this way, the radial distance between the electrode assembly 4 and the sidewall of the balloon 2 is small, which can effectively reduce the energy attenuation of the shock wave energy reaching the treatment area and improve the treatment efficiency and reliability. In some preferred embodiments, the radial distance between the electrode assembly 4 and the inner wall of the balloon 2 is 1mm to 4mm.

[0046] Specifically, the height A of the arching of the support portion 31 of the deformable support wire 3 is determined based on the size of the balloon 2; assuming the diameter of the balloon 2 is D, the height of the arching of the deformable support wire 3 satisfies the following formula:

[0047] That is, the difference between the radius of the balloon 2 and the arch height of the deformable support wire 3 is 1mm to 4mm.

[0048] In some preferred embodiments, the height of the deformable support wire 3 arches according to the following formula:

[0049] That is, the difference between the radius of the balloon 2 and the arch height of the deformable support wire 3 is 1mm to 3mm.

[0050] Specifically, in some exemplary embodiments, the support wire 30 includes a limiting portion 34, which abuts against the inner wall of the balloon 2 in a bowed state on its radially outer side. The electrode assembly 4 is located between two adjacent limiting portions 34 in the axial direction, resulting in good balance. The limiting portion 34 has a certain width in the radial direction. When the limiting portion 34 is in contact with the inner wall of the balloon 2, the deformable support wire 3, when bowed to its limit position or the rigid support wire 30, can ensure that the electrode assembly 4 and the balloon 2 always maintain a constant distance, avoiding contact between the electrode assembly 4 and the side wall of the balloon 2, thereby preventing the balloon 2 from breaking during subsequent discharge. Furthermore, the limiting portion 34 is relatively close to the electrode assembly 4 in the axial direction, which can improve the deformation resistance of the deformable support wire 3 around the electrode assembly 4 under undesirable external forces such as compression from the balloon 2 or proximal bending force. This further helps to maintain a constant radial distance between the electrode assembly 4 and the inner wall of the balloon 2, greatly improving the treatment effectiveness and safety.

[0051] Furthermore, when the support wire 30 is a deformable support wire 3, even if a section of the deformable support wire 3 may bend due to the bending of the blood vessel at the proximal end of the shock wave device, the limiting part 34 will only be displaced circumferentially due to the pressure between the limiting part 34 and the inner wall of the balloon 2. The radial distance between the position of the electrode assembly 4 and the side wall of the balloon 2 will not change, thereby effectively maintaining the constant distance between the electrode assembly 4 and the inner wall of the balloon 2, greatly improving the discharge stability, discharge reliability and discharge safety.

[0052] For example, such as Figure 9 and Figure 14As shown, the limiting part 34 can be an isolation block disposed on the support part 31. The isolation block has a certain width in the radial direction and can abut against the inner wall of the balloon 2. The width of the electrode assembly 4 in the radial direction is smaller than the radial width of the isolation block, so that a certain space can always be left between the electrode assembly 4 and the inner wall of the balloon 2, preventing the electrode assembly 4 from directly contacting the inner wall of the balloon 2 and breaking the balloon 2 during the discharge process. This greatly improves the stability and safety of treatment and extends the service life of the shock wave device.

[0053] Specifically, in some alternative implementations, such as Figure 15 As shown, the limiting part 34 is a bent part 32. When the deformable support wire 3 is arched, the bent part 32 fits against the inner wall of the conical segment of the balloon 2, or in other words, the bent part 32 is parallel to the conical segment of the balloon 2. This allows the inner wall of the conical segment of the balloon 2 to restrict the bent part 32. Even if the proximal end is bent due to pressure from the blood vessel during the intervention, it is not easy to affect the support part 31 located between the two bent parts 32. That is, the radial distance between the electrode assembly 4 on the support part 31 and the inside of the balloon 2 can still be effectively kept constant. Furthermore, the bent part... The length of the section 32 in the axial direction of the inner tube 1 is less than the length of the conical section of the balloon 2 in the axial direction of the inner tube 1. Similarly, the width of the bent section 32 in the radial direction of the inner tube 1 is also less than the width of the conical section of the balloon 2 in the radial direction of the inner tube 1. Thus, the maximum arching height of the support section 31 is always less than the arching height of the middle part of the balloon 2, avoiding contact between the electrode assembly 4 set on the support section 31 and the inner wall of the balloon 2, greatly reducing the risk of breaking the balloon 2 during the discharge process, improving the discharge stability and discharge safety, and extending the life of the shock wave device.

[0054] Specifically, in some alternative implementations, such as Figure 11 and Figure 16 As shown, the limiting part 34 is located between the supporting part 31 and the bending part 32, and the end of the limiting part 34 connected to the supporting part 31 is radially recessed towards the inner tube 1. In this way, the limiting part 34 can contact the inner wall of the balloon 2 at the position furthest from the inner tube 1 in the radial direction, so as to effectively limit the radial position of the supporting part 31 between the two limiting parts 34 to be constant. At the same time, the limiting part 34 gradually concaves inward towards the supporting part 31, increasing the radial distance between the supporting part 31 and the inner wall of the balloon 2. This allows the electrode assembly 4 provided on the supporting part 31 to have a certain radial distance from the inner wall of the balloon 2 and maintain this radial distance constant. This prevents the proximal bending from causing the deformable support wire 3 and the electrode assembly 4 to contact the inner wall of the balloon 2, greatly extending the life of the balloon 2 and improving the stability, reliability and safety of treatment during the discharge process.

[0055] Specifically, in other alternative implementations, such as Figure 17As shown, when the balloon 2 is an irregularly shaped balloon, the irregularly shaped balloon includes a fitting portion 22 and a protrusion 23, wherein the protrusion 23 is located between two adjacent fitting portions 22 in the axial direction of the inner tube 1. When the balloon 2 is in the expanded state, the radial distance between the inner wall of the protrusion 23 and the inner tube 1 is greater than the radial distance between the fitting portion 22 and the inner tube 1. The fitting portion 22 is used to abut against the limiting portion 34, thereby limiting the position of the electrode assembly 4 on the deformable support wire 3, and the protrusion 23 is used to expand the radial distance between the inner wall of the balloon 2 and the electrode assembly 4, so as to further avoid the electrode assembly 4 from contacting the inner wall of the balloon 2.

[0056] Optionally, in this irregularly shaped balloon, the limiting portion 34 can be as follows: Figure 14 The isolation block shown can also be as follows: Figure 16 The concave structure shown; in addition, as Figure 17 As shown, the limiting part 34 can also be located at the end of the support part 31 connected to the bending part 32. Through this end, the limiting part 34 can contact and abut against the inner wall of the fitting part 22 in the bent state of the deformable support wire 3. At the same time, it cooperates with the protrusion 23 that protrudes radially away from the inner tube 1 to prevent the electrode assembly 4 between the two limiting parts 34 from contacting the balloon 2 and to maintain a constant radial distance between the two, with good limiting reliability.

[0057] Specifically, such as Figure 18 As shown, in some exemplary embodiments, the two ends of the deformable support wire 3 in the axial direction are fixedly connected to the inner tube 1, which can be fixed by welding, bonding or other methods. During assembly, the two ends of one deformable support wire 3 can be fixedly assembled onto the inner tube 1 first, and then the above steps can be repeated to assemble multiple deformable support wires 3. Finally, the balloon 2 is sleeved to form a shock wave device. The assembly is simple and convenient, and the fixation is reliable.

[0058] Specifically, such as Figure 19 As shown, in some other exemplary embodiments, when the shock wave device includes multiple deformable support wires 3, at least two of the multiple deformable support wires 3 are integral structures. The ends of the two deformable support wires 3 located at the distal end of the inner tube 1 are connected to each other and fixedly connected to the inner tube 1, while the ends of the deformable support wires 3 located at the proximal end of the inner tube 1 are each fixedly connected to the inner tube 1. During assembly, two deformable support wires 3 can be assembled as a group, greatly improving assembly efficiency. Figure 20 As shown, in other exemplary embodiments, the ends of the two deformable support wires 3 located at the far end of the inner tube 1 are connected to each other as a whole, and the ends of the two deformable support wires 3 located at the near end of the inner tube 1 are also connected to each other as a whole, further improving the ease of assembly; and the two deformable support wires 3 are offset at their ends relative to the outer wall of the inner tube 1 to effectively avoid the inner tube 1.

[0059] In addition, in other alternative embodiments, one end of the deformable support wire 3 located near the inner tube 1 can be movably connected to the inner tube 1 so that the near end of the deformable support wire 3 can reciprocate along the axial direction of the inner tube 1, change the shape of the deformable support wire 3, and can be infinitely deformed between the arched state and the retracted state.

[0060] Specifically, in some exemplary implementations, such as Figure 1 and Figure 5 As shown, the shock wave device includes a first connector 5, which is connected to the distal end of the inner tube 1, and the distal end of the deformable support wire 3 is connected to the inner tube 1 via the first connector 5; in other exemplary embodiments, such as Figure 1 and Figure 5 As shown, the shock wave device includes a second connector 6, which is connected to the proximal end of the inner tube 1, and the proximal end of the deformable support wire 3 is connected to the inner tube 1 through the second connector 6; in some preferred embodiments, the shock wave device includes a first connector 5 and a second connector 6, the first connector 5 is connected to the distal end of the inner tube 1, the second connector 6 is connected to the proximal end of the inner tube 1, and the end of the deformable support wire 3 is connected to the inner tube 1 through the first connector 5 and the second connector 6; wherein, the first connector 5 and the second connector 6 may include at least one of the connecting parts such as heat shrink tubing and injection molded parts, to realize the assembly between the deformable support wire 3 and the inner tube 1, and improve the connection effectiveness and connection stability.

[0061] Specifically, such as Figure 1 and Figure 5 As shown, in some exemplary embodiments, the first connector 5 and the second connector 6 are fixedly connected to the inner tube 1 respectively. When the balloon 2 is in a coiled and contracted state, the deformable support wire 3 is compressed onto the surface of the inner tube 1 by the pressure of the balloon 2 coiling. After the balloon 2 expands, the deformable support wire 3, which is no longer restricted by external force, can restore its original shape. In particular, the support part 31 can work with the electrode assembly 4 to approach the side wall of the expanded balloon 2, reduce the energy attenuation of the shock wave generated by the electrode assembly 4 when it reaches the treatment area, increase the intensity of the shock wave energy acting on the treatment area, and improve the treatment efficiency.

[0062] Specifically, such as Figure 21As shown, in some other exemplary embodiments, the first connector 5 is fixedly connected to the inner tube 1 to fix the distal end of the deformable support wire 3 to the distal end of the inner tube 1; while the second connector 6 is movably connected to the inner tube 1, and the second connector 6 can reciprocate along the axial direction of the inner tube 1 under the action of external force, so that the proximal end of the deformable support wire 3 is in a movable state, driving the deformable support wire 3 to retract or arch; in the arched state, the axial length decreases and the radial height increases, especially the radial height of the support part 31 increases, and the synergistic electrode assembly 4 is close to the side wall of the balloon 2 to reduce energy attenuation, enhance the intensity of the shock wave energy acting on the treatment area, and improve treatment efficiency; during the deformation to the retracted state, the deformable support wire 3 is softer, the axial length of the deformable support wire 3 increases, or even straightens completely, and part of the structure of the deformable support wire 3 can extend into the gap 81 of the outer tube 8. At the same time, the radial height decreases, and the synergistic electrode assembly 4 is close to the inner tube 1 so that the shock wave device can be smoothly intervened or withdrawn when the treatment is completed.

[0063] Specifically, such as Figure 22 As shown, in some other exemplary embodiments, the first connector 5 is movably connected to the inner tube 1, and the second connector 6 is movably connected to the inner tube 1. This means that both ends of the deformable support wire 3 are movable, and the deformable support wire 3 itself has a pre-shaping force capable of maintaining its current shape without deformation. In other words, the deformable support wire 3 itself has a certain supporting strength. With both ends movable, when either the first connector 5 or the second connector 6 is subjected to force, it will preferentially drive the entire deformable support wire 3 to move, thereby enabling the entire deformable support wire 3 and... The electrode assembly 4 reciprocates along the axial direction of the inner tube 1, which can retract the structure of the deformable support wire 3, or even the electrode assembly 4 together, into the gap 81 of the outer tube 8 during the non-shock wave release phase. In the retracted state, the radial height of the deformable support wire 3 is greatly reduced, which makes it easier to reduce the overall circumferential area of ​​the balloon 2 to facilitate the intervention or retraction of the balloon 2. Conversely, it is also easy to push the deformable support wire 3 out of the gap 81 of the outer tube 8 into the receiving cavity 21, and effectively arch it up to work with the electrode assembly 4 to get close to the side wall of the balloon 2 without external force, shortening the radial distance between the electrode assembly 4 and the side wall of the balloon 2 and improving the treatment efficiency.

[0064] In some exemplary embodiments, the movable connection may employ a sliding connection, wherein, for example... Figure 23 As shown, the first connector 5 and / or the second connector 6 can be a ring structure. The end of the deformable support wire 3 is fixed to the inner wall of the ring structure or to the outer wall of the ring structure. It can also axially penetrate the ring structure. The assembly is simple and the cost is low. The end of the deformable support wire 3 can slide axially along the inner tube 1 with the first connector 5 and / or the second connector 6. The sliding is convenient and not easy to get stuck.

[0065] Alternatively, in some exemplary embodiments, such as Figure 24 As shown, the cross-sectional area of ​​the annular structure is smaller than that of the gap 81, so that the liquid medium is not blocked during the injection of the balloon 2; and an annular guide 82 is provided on the inner wall of the outer tube 8. The annular guide 82 is located in the tube foot area near the end of the balloon 2. Both the annular structure and the annular guide 82 are rigid and not easily deformed. When the balloon 2 is inflated or depressurized, the annular structure can slide axially along the annular guide 82 with the liquid medium, so as to realize the forward or backward movement of the deformable support wire 3.

[0066] Specifically, such as Figure 21 and Figure 22 As shown, in some exemplary embodiments, the second connector 6 is movably connected to the inner tube 1. The shock wave device also includes a push-pull member 7, one end of which is fixedly connected to the second connector 6. This push-pull member 7 is used to apply an external force to the second connector 6, thereby driving the second connector 6 to reciprocate along the axial direction of the inner tube 1 under the action of the external force. When the push-pull member 7 applies a pushing force to the second connector 6, it can push the second connector 6, together with the deformable support wire 3, into the receiving cavity 21 of the balloon 2. At this time, the deformable support wire 3 will not be subjected to pressure applied by the inner wall of the outer tube 8. At the same time, the balloon 2 is in an expanded state and will not exert pressure on the deformable support wire 3. The proximal end of the deformable support wire 3 gradually arches as it moves toward the distal end of the inner tube 1, cooperating with the electrode assembly 4. The flexible support wire 3 is positioned close to the sidewall of the balloon 2 to effectively reduce the attenuation of the shock wave energy. Conversely, when the push-pull member 7 applies a pulling force to the second connecting member 6, the proximal end of the flexible support wire 3 can be straightened along with the second connecting member 6, that is, the flexible support wire 3 gradually retracts and approaches the inner tube 1. The proximal end of the flexible support wire 3 can be pulled into the gap 81 between the outer tube 8 and the inner tube 1, or even the entire flexible support wire 3 and the electrode assembly 4 can be pulled into the gap 81 to retract. Then, the flexible support wire 3 will deform under the pressure of the outer tube 8 and the pulling force of the push-pull member 7, and gradually retract onto the inner tube 1. The push-pull member 7 is easy to operate and has high control precision. In some preferred embodiments, the push-pull member 7 can be a metal wire, which is easy to assemble, precise to control, and low in cost.

[0067] Furthermore, in some exemplary embodiments, the shock wave device also includes an operating handle, with the other end of the push-pull member 7 connected to the operating handle. The operating handle allows the push-pull member 7 to pull or push out the second connecting member 6 and the deformable support wire 3, making the control convenient and quick, and the stroke of the second connecting member 6 precisely controllable. Exemplarily, in some specific embodiments, the operating handle may include an adjustment knob. By rotating the adjustment knob, the length of the push-pull member 7 in the axial direction of the inner tube 1 can be adjusted, thereby realizing the traction or push-out of the second connecting member 6.

[0068] Specifically, the operating handle has an axially movable threaded tube inside, and the proximal end of the push-pull member 7 extends axially through the outer tube 8 and connects to the threaded tube; the adjusting knob is a threaded rotating member and is nested on the outside of the threaded tube so that rotating the adjusting knob can drive the threaded tube to move, thereby pulling or pushing the deformable support wire 3 to move; for example, the push-pull member 7 can be a metal wire, which can achieve a pulling force towards the proximal end; for another example, when the push-pull member 7 is a hollow tube, it has a certain supporting strength and can achieve the external force required for reciprocating push and pull.

[0069] In some alternative embodiments, a sealing ring is provided at the proximal end of the outer tube 8 and is located at the position where the push-pull member 7 passes through the outer tube 8. The sealing ring is fitted onto the push-pull member 7 and is interference-fitted with the push-pull member 7 to prevent leakage of liquid medium, improve the durability and safety of the shock wave device, and also improve the stability and safety of the treatment process.

[0070] The following test was conducted using the shock wave device provided in the embodiments of the present invention.

[0071] First, under different arch heights (A), the peak shock wave pressure at a point 24 mm from the center of the inner tube 1 was measured. Figure 25 As shown, under the same conditions, the greater the arch height A, the closer the electrode assembly 4 is to the side wall of the balloon 2, and the greater the detected peak pressure of the shock wave. This indicates that the shock wave device provided in this embodiment of the invention can effectively reduce the energy attenuation when the electrode assembly 4 is close to the side wall of the balloon 2, and the shock wave energy reaching the treatment area can be effectively enhanced, thereby improving treatment efficiency and reliability.

[0072] Secondly, the operating status of the shock wave device was tested at different pulse frequencies; among them, such as Figure 26 As shown, when shock waves are continuously released at 1Hz, 10Hz, and 20Hz, the sound pressure energy is almost always between 2MPa and 3MPa. The difference in sound pressure energy at different operating frequencies is small, or even almost non-existent, indicating that the shock wave device provided in this embodiment of the invention can achieve almost the same sound pressure energy at different operating frequencies; Figure 27 As shown, at a low frequency of 3Hz and a high frequency of 20Hz, the temperature of the surface of the balloon 2 is almost the same when the shock wave is released the same number of times, indicating that the temperature rise of the surface of the balloon 2 of the shock wave device provided in this embodiment of the invention is almost the same at different operating frequencies.

[0073] like Figure 28As shown, a plaster ring simulates the tissue structure of the area to be treated in the human body. The same number of shock waves were continuously released at both a low frequency of 1Hz and a high frequency of 20Hz. It can be seen that the number of plaster ring fragments is almost identical, and the fragmentation distance is also very small. However, under the same number of releases, the required shock wave release time is longer at low frequency and shorter at high frequency. That is, the treatment time is longer at low frequency and shorter at high frequency. This indicates that the shock wave device provided by this embodiment has almost consistent treatment effects at different operating frequencies, making it suitable for both low-frequency and high-frequency working conditions, meeting the needs of various applications. Furthermore, it can significantly shorten treatment time under high-frequency conditions, greatly improving treatment efficiency and avoiding prolonged vascular blockage, which is particularly significant in applications involving heart valves.

[0074] The following describes specific embodiments of the present invention in conjunction with the above-described specific implementation methods.

[0075] Example 1 like Figure 1 and Figure 5 As shown, the shock wave device includes an inner tube 1, a balloon 2 sleeved on the inner tube 1, a deformable support wire 3 connected to the inner tube 1, and an electrode assembly 4 disposed on the deformable support wire 3. A cavity 21 is provided between the balloon 2 and the inner tube 1, and the deformable support wire 3 is located within the cavity 21. The deformable support wire 3 can adjust its distance from the inner wall of the balloon 2 through deformation, and can move in conjunction with the electrode assembly 4 to retract and approach the inner tube 1 or arch and approach the inner wall of the balloon 2. During the intervention of the shock wave device, the balloon 2 is in a coiled and contracted state, allowing... The entire shockwave device, including the deformable support wire 3 and the electrode assembly 4, has a small circumferential cross-section, which facilitates the passage of the shockwave device, improves its passability and effectiveness and stability in reaching the treatment area, and facilitates subsequent precise and effective treatment. On the other hand, after the balloon 2 of the shockwave device reaches the treatment area, the balloon 2 can expand, and the deformable support wire 3 loses the pressure applied by the balloon 2. It can arch and move the electrode assembly 4 closer to the side wall of the balloon 2, that is, the electrode assembly 4 is closer to the treatment area, which reduces the energy attenuation of the shockwave energy generated by the electrode assembly 4 when it reaches the treatment area, effectively improving treatment efficiency and treatment effect.

[0076] Specifically, the inner tube 1 is an adjustable bend tube. During the intervention of the shock wave device, the bending direction and degree of the inner tube 1 can be freely adjusted so that the shock wave device can be flexibly adjusted in the human body, improving the passability of the shock wave device, and adjusting the position of the balloon 2 in the heart valve or blood vessel according to the area to be treated, thereby improving the effectiveness and accuracy of the balloon 2 of the shock wave device reaching the area to be treated, and thus improving treatment efficiency and safety.

[0077] like Figure 1 As shown, balloon 2 covers the inner tube 1, and a receiving cavity 21 can be formed between them. During the intervention of the shock wave device, balloon 2 is in a coiled and contracted state. At this time, the receiving cavity 21 is almost non-existent. The pressure of the coiled and contracted balloon 2 can make the deformable support wire 3 be in a coiled or coiled state, and the deformable support wire 3 is close to the inner tube 1. After balloon 2 reaches the treatment area, liquid medium can be filled into balloon 2 to expand balloon 2 to an expanded state, increasing the volume of receiving cavity 21. At this time, the balloon 2 is no longer restrained, and the receiving cavity 21 can reserve space for the subsequent arching of deformable support wire 3, improving the effectiveness of the subsequent arching of deformable support wire 3.

[0078] Specifically, the cross-section of the balloon 2 is circular, and the diameter of the balloon 2 is 20mm. This diameter refers to the diameter of the balloon 2 when it is in the expanded state. This allows for the provision of a certain volume of the receiving cavity 21 for the deformable support wire 3 to arch, facilitating its passage to the treatment area during intervention. It also allows for a relatively small distance between the electrode assembly 4 and the sidewall of the balloon 2, reducing the attenuation of the shock wave energy released by the electrode assembly 4 when it reaches the treatment area, thereby improving treatment efficiency.

[0079] Specifically, the wall thickness of the balloon 2 is greater than or equal to 0.065 mm. The relatively thick wall of the balloon 2 can provide a greater restraining force, so as to effectively press the electrode assembly 4 and the deformable support wire 3 onto the inner tube 1 in the coiled and contracted state, thereby reducing the cross-sectional area of ​​the shock wave device during the intervention process and improving the passability.

[0080] Specifically, such as Figure 1As shown, the shockwave device also includes an outer tube 8 sleeved on the inner tube 1. The inner diameter of the outer tube 8 is larger than the outer diameter of the inner tube 1. There is a gap 81 between the outer tube 8 and the inner tube 1. The distal end of the outer tube 8 is connected to the proximal end of the balloon 2. The gap 81 communicates with the accommodating cavity 21 so that a liquid medium can be introduced into the accommodating cavity 21 through the gap 81 between the outer tube 8 and the inner tube 1, so that the electrode assembly 4 can generate shockwave energy for treatment through the electrohydraulic effect. The outer tube 8 is an adjustable bendable tube that can be bent together with the inner tube 1, which is flexible and can adjust the position of the balloon 2 in the heart valve or blood vessel according to the area to be treated, thereby improving the efficiency and accuracy of the balloon 2 of the shockwave device reaching the treatment area.

[0081] Specifically, the shock wave device includes three deformable support wires 3, each of which is equipped with an electrode assembly 4. The three deformable support wires 3 are arranged at equal intervals along the circumference of the inner tube 1 in the accommodating cavity 21, so that the shock wave can cover all directions of the balloon 2 when it is released, thereby expanding the coverage area and uniformity of the shock wave energy release and improving the treatment efficiency and effect.

[0082] In addition, it should be noted that when the balloon 2 is in a coiled and contracted state, the circumferential cross-sectional perimeter of the externally tangential shape formed by the deformable support wire 3, electrode assembly 4 and inner tube 1 is smaller than the circumference of the inner wall at the proximal end of the balloon 2, so that the overall circumferential cross-sectional area of ​​the balloon 2 in the coiled and contracted state is smaller, thereby improving the passability of the balloon 2 during intervention.

[0083] Specifically, the deformable support wire 3 is a pre-shaped support wire made of a metal material with memory function. That is, the deformable support wire 3 is shaped into an arched state after shaping and is relatively soft after shaping. Under the action of external force, it can deform to reach a closed state, which facilitates the compression of the electrode assembly 4 in the balloon 2 and the overall retraction of the shock wave device along with the deformable support wire 3. However, when the external force is removed, it can return to the arched state, which can effectively coordinate the movement of the electrode assembly 4 so that the electrode assembly 4 can play different roles in different working processes. When it is closed and close to the inner tube 1, it can facilitate the intervention of the shock wave device, or when it is arched and close to the side wall of the balloon 2, it can reduce the energy attenuation of the shock wave released by the electrode assembly 4 to the treatment area, thereby improving treatment efficiency and treatment stability.

[0084] The deformable support wire 3 is made of nickel-titanium alloy. By adjusting the nickel content in the nickel-titanium alloy, the AF point of the deformable support wire 3 can be adjusted. At the same time, by using a heat treatment temperature of 350°C and a heat treatment time, the phase transformation temperature and microstructure of the nickel-titanium alloy can be changed, further adjusting the AF point of the deformable support wire 3 to improve the performance of the nickel-titanium alloy, so that the deformable support wire 3 meets the requirements for application in the shock wave device after heat setting.

[0085] Specifically, the radial distance between the electrode assembly 4 and the inner tube 1 when the deformable support wire 3 is arched is greater than the radial distance between the electrode assembly 4 and the inner tube 1 when the deformable support wire 3 is folded up. This allows the electrode assembly 4 to move closer to the side wall of the balloon 2 as the deformable support wire 3 deforms and arches, shortening the distance between the electrode assembly 4 and the area to be treated, reducing the attenuation of the shock wave energy generated by the electrode assembly 4 when it reaches the area to be treated, and improving treatment efficiency and reliability.

[0086] Specifically, such as Figure 13 As shown, the deformable support wire 3 is bow-shaped and includes a support portion 31, a bending portion 32, and a connecting portion 33. The electrode assembly 4 is located on the support portion 31. The support portion 31 can be bent to help the electrode assembly 4 approach the side wall of the balloon 2 and reduce the attenuation of the shock wave energy released by the electrode assembly 4. One end of the support portion 31 is connected to one end of the bending portion 32, and the other end of the bending portion 32 is connected to the connecting portion 33. Similarly, the other end of the support portion 31 is connected to one end of another bending portion 32, and the other end of the other bending portion 32 is connected to another connecting portion 33. The two connecting portions 33 are respectively connected to the inner tube 1, so that the deformable support wire 3 is connected to the inner tube 1.

[0087] like Figure 13 As shown, when the deformable support wire 3 is in the arched state, the radial distance between the support part 31 and the inner tube 1 is greater than the radial distance between the connecting part 33 and the inner tube 1. In the axial direction away from the support part 31, the bending part 32 gradually bends towards the inner tube 1. That is, the deformable support wire 3 gradually moves away from the inner tube 1 from the connecting part 33 towards the support part 31 and gets closer to the side wall of the balloon 2, reducing the attenuation of the shock wave energy generated by the electrode assembly 4.

[0088] Specifically, with the deformable support wire 3 in an arched state, the radial distance between the electrode assembly 4 and the inner wall of the balloon 2 is 2mm. The small radial distance between the electrode assembly 4 and the side wall of the balloon 2 can effectively reduce the energy attenuation of the shock wave energy reaching the treatment area, thereby improving treatment efficiency and reliability.

[0089] Specifically, the height A of the arching of the support portion 31 of the deformable support wire 3 is determined based on the size of the balloon 2; assuming the diameter of the balloon 2 is D, the height of the arching of the deformable support wire 3 satisfies the following formula:

[0090] That is, the difference between the radius of the balloon 2 and the arch height of the deformable support wire 3 is 2mm.

[0091] Specifically, such as Figure 1 As shown, the shockwave device includes a first connector 5 and a second connector 6. The first connector 5 is fixedly connected to the distal end of the inner tube 1, and the second connector 6 is fixedly connected to the proximal end of the inner tube 1. The end of the deformable support wire 3 is fixedly connected to the inner tube 1 through the first connector 5 and the second connector 6. The first connector 5 and the second connector 6 are injection molded parts, which can effectively realize the assembly between the deformable support wire 3 and the inner tube 1, and improve the connection effectiveness and connection stability. When the balloon 2 is in a coiled and contracted state, the deformable support wire 3 is compressed onto the surface of the inner tube 1 by the pressure of the balloon 2 coiling. After the balloon 2 expands, the deformable support wire 3, which is no longer restricted by external force, can restore its original shape. In particular, the support part 31 can work with the electrode assembly 4 to approach the side wall of the expanded balloon 2, reduce the energy attenuation of the shock wave generated by the electrode assembly 4 when it reaches the treatment area, increase the intensity of the shock wave energy acting on the treatment area, and improve the treatment efficiency.

[0092] Example 2 The difference between this embodiment and Embodiment 1 is that, as Figure 5-8 As shown, the shock wave device includes two deformable support wires 3 evenly arranged around the inner tube 1; the rest is the same as in Embodiment 1.

[0093] Example 3 The difference between this embodiment and embodiment 2 is that, as Figure 19 As shown, the two deformable support wires 3 are an integral structure. The ends of the two deformable support wires 3 located at the far end of the inner tube 1 are connected to each other and fixedly connected to the inner tube 1, while the ends of the deformable support wires 3 located at the near end of the inner tube 1 are fixedly connected to the inner tube 1. During assembly, the two deformable support wires 3 can be assembled as a group, which greatly improves the assembly efficiency.

[0094] Example 4 The difference between this embodiment and embodiment 1 is that the first connecting member 5 and the second connecting member 6 are annular structures, and the end of the deformable support wire 3 is fixed to the inner wall of the annular structure; as Figure 21As shown, the first connector 5 is fixedly connected to the inner tube 1 to fix the distal end of the deformable support wire 3 to the distal end of the inner tube 1; while the second connector 6 is slidably connected to the inner tube 1. The second connector 6 can reciprocate along the axial direction of the inner tube 1 under the action of external force, so that the proximal end of the deformable support wire 3 is in a movable state, which drives the deformable support wire 3 to retract or arch. In the arched state, the axial length decreases and the radial height increases, especially the radial height of the support part 31 increases, and the synergistic electrode assembly 4 is close to the side wall of the balloon 2 to reduce energy attenuation, enhance the intensity of the shock wave energy acting on the treatment area, and improve treatment efficiency. During the deformation to the retracted state, the deformable support wire 3 is softer, the axial length of the deformable support wire 3 increases, or even straightens completely, and part of the structure of the deformable support wire 3 can extend into the gap 81 of the outer tube 8. At the same time, the radial height decreases, and the synergistic electrode assembly 4 is close to the inner tube 1 so that the shock wave device can be smoothly intervened or withdrawn when the treatment is completed.

[0095] Specifically, the shock wave device also includes a push-pull member 7, one end of which is fixedly connected to the second connecting member 6. This push-pull member 7 applies an external force to the second connecting member 6, causing it to reciprocate along the axial direction of the inner tube 1 under the influence of the external force. When the push-pull member 7 applies a pushing force to the second connecting member 6, it can push the second connecting member 6, along with the deformable support wire 3, into the receiving cavity 21 of the balloon 2. At this time, the deformable support wire 3 will not be subjected to pressure from the inner wall of the outer tube 8, and the balloon 2, being in an expanded state, will not exert pressure on the deformable support wire 3. The proximal end of the deformable support wire 3... As it moves toward the distal end of the inner tube 1, it gradually arches up, and the synergistic electrode assembly 4 approaches the side wall of the balloon 2 to effectively reduce the attenuation of the shock wave energy. Conversely, when the push-pull member 7 applies a pulling force to the second connecting member 6, the proximal end of the deformable support wire 3 can be straightened along with the second connecting member 6. In other words, the deformable support wire 3 gradually retracts and approaches the inner tube 1. The proximal end of the deformable support wire 3 can be pulled into the gap 81 between the outer tube 8 and the inner tube 1. The deformable support wire 3 is deformed by the pressure of the outer tube 8 and the pulling force of the push-pull member 7, and gradually retracts onto the inner tube 1. The overall operation is convenient and the control precision is high.

[0096] The shock wave device also includes an operating handle. The other end of the push-pull member 7 is connected to the operating handle. The operating handle may include an adjustment knob. By rotating the adjustment knob, the push-pull member 7 can be controlled to pull or push out the second connecting member 6 and the deformable support wire 3, which is convenient and quick to control.

[0097] Example 5 The difference between this embodiment and embodiment 4 is that, Figure 22As shown, the first connector 5 is movably connected to the inner tube 1, meaning that both ends of the deformable support wire 3 are movable. Under external force, the entire deformable support wire 3 and electrode assembly 4 can be moved back and forth along the axial direction of the inner tube 1. During the non-shock wave release phase, the structure of the deformable support wire 3, and even the entire electrode assembly 4, can be gathered into the gap 81 of the outer tube 8. In the gathered state, the radial height of the deformable support wire 3 is greatly reduced, which makes it easier to reduce the overall circumferential area of ​​the balloon 2 to facilitate the intervention or retraction of the balloon 2. Conversely, it is also easy to push the deformable support wire 3 out of the gap 81 of the outer tube 8 into the receiving cavity 21. Without external force, it can effectively arch up to work with the electrode assembly 4 to get close to the side wall of the balloon 2, shortening the radial distance between the electrode assembly 4 and the side wall of the balloon 2, and improving treatment efficiency.

[0098] Example 6 The difference between this embodiment and Embodiment 1 is that, as Figure 14 As shown, the deformable support wire 3 includes a limiting part 34. The limiting part 34 abuts against the inner wall of the balloon 2 in an arched state on the outer side of the inner tube 1 in the radial direction. The electrode assembly 4 is located between two adjacent limiting parts 34 in the axial direction, with good balance. The limiting part 34 is an isolation block set on the support part 31. The isolation block has a certain width in the radial direction, which can abut against the inner wall of the balloon 2. The width of the electrode assembly 4 in the radial direction is smaller than the radial width of the isolation block, so that a certain space can always be left between the electrode assembly 4 and the inner wall of the balloon 2, preventing the electrode assembly 4 from directly contacting the inner wall of the balloon 2 and breaking the balloon 2 during the discharge process. This greatly improves the stability and safety of treatment and extends the service life of the shock wave device.

[0099] Example 7 The difference between this embodiment and embodiment 6 is that, as Figure 15 As shown, the limiting part 34 is a bent part 32. When the deformable support wire 3 is in the arched state, the bent part 32 fits against the inner wall of the conical segment of the balloon 2, so that the inner wall of the conical segment of the balloon 2 restricts the bent part 32. Even if the proximal end is bent due to the pressure of the blood vessel during the intervention, it is not easy to affect the support part 31 located between the two bent parts 32. That is, the radial distance between the electrode assembly 4 set on the support part 31 and the inner wall of the balloon 2 can still be kept constant. Furthermore, the length of the bent part 32 in the axial direction of the inner tube 1 is less than the length of the conical segment of the balloon 2 in the axial direction of the inner tube 1. Similarly, the width of the bent part 32 in the radial direction of the inner tube 1 is also less than the width of the conical segment of the balloon 2 in the radial direction of the inner tube 1. Thus, the maximum arching height of the support part 31 is always less than the arching height of the middle part of the balloon 2, avoiding contact between the electrode assembly 4 set on the support part 31 and the inner wall of the balloon 2, greatly reducing the risk of breaking the balloon 2 during the discharge process, improving the discharge stability and discharge safety, and extending the life of the shock wave device.

[0100] Example 8 The difference between this embodiment and embodiment 6 is that, as Figure 16 As shown, the limiting part 34 is located between the supporting part 31 and the bending part 32, and the end of the limiting part 34 connected to the supporting part 31 is radially recessed towards the inner tube 1. In this way, the limiting part 34 can contact the inner wall of the balloon 2 at the position furthest from the inner tube 1 in the radial direction, so as to effectively limit the radial position of the supporting part 31 between the two limiting parts 34 to be constant. At the same time, the limiting part 34 gradually concaves inward towards the supporting part 31, increasing the radial distance between the supporting part 31 and the inner wall of the balloon 2. This allows the electrode assembly 4 provided on the supporting part 31 to have a certain radial distance from the inner wall of the balloon 2, preventing the situation where the proximal bending drives the deformable support wire 3 and the electrode assembly 4 to contact the inner wall of the balloon 2, greatly extending the life of the balloon 2 and improving the stability, reliability and safety of treatment during the discharge process.

[0101] Example 9 The difference between this embodiment and embodiment 6 is that, as Figure 17 As shown, the balloon 2 is an irregularly shaped balloon, which includes a fitting part 22 and a protrusion 23. The protrusion 23 is located between two adjacent fitting parts 22 in the axial direction of the inner tube 1. When the balloon 2 is in the expanded state, the radial distance between the inner wall of the protrusion 23 and the inner tube 1 is greater than the radial distance between the fitting part 22 and the inner tube 1. The fitting part 22 is used to abut against the limiting part 34, thereby limiting the position of the electrode assembly 4 on the deformable support wire 3. The protrusion 23 is used to expand the radial distance between the inner wall of the balloon 2 and the electrode assembly 4 to further prevent the electrode assembly 4 from contacting the inner wall of the balloon 2.

[0102] The limiting part 34 is located at the end of the support part 31 that is connected to the bending part 32. It can contact and abut against the inner wall of the fitting part 22 when the deformable support wire 3 is bent. At the same time, it cooperates with the protrusion 23 that protrudes radially away from the inner tube 1 to prevent the electrode assembly 4 between the two limiting parts 34 from contacting the balloon 2 and to maintain a constant radial distance between them, thus ensuring good limiting reliability.

[0103] Example 10 The difference between this embodiment and embodiment 6 is that the shock wave device includes three balloons 2, which are arranged circumferentially around the inner tube 1. The support wire 30 is made of rigid material, and the distal end of the support wire 30 protrudes from the balloons 2 and is connected to the distal end of the inner tube 1.

[0104] Example 11 The difference between this embodiment and embodiment 8 is that the shock wave device includes three balloons 2, which are arranged circumferentially around the inner tube 1. The support wire 30 is made of rigid material, and the distal end of the support wire 30 protrudes from the balloons 2 and is connected to the distal end of the inner tube 1.

[0105] Example 12 The difference between this embodiment and embodiment 11 is that the support wire 30 is a deformable support wire 3; the rest is the same as in embodiment 11.

[0106] The above description is merely some embodiments of the present invention and is not intended to limit the present invention. Those skilled in the art should understand that the present invention can have various changes and improvements, and any modifications, equivalent substitutions and improvements made in accordance with the present invention fall within the scope of protection claimed by the present invention.

Claims

1. A shock wave device, characterized in that, include: Inner tube (1); A balloon (2) is connected to a portion of the inner tube (1), and the balloon (2) has a accommodating cavity (21). A support wire (30) is located at least partially in the accommodating cavity (21), and the distal end of the support wire (30) is connected to the inner tube (1); An electrode assembly (4) is disposed on the support wire (30), and the radial distance between the electrode assembly (4) and the balloon (2) is constant.

2. The shock wave device according to claim 1, characterized in that, The support wire (30) includes a limiting part (34) that can abut against the inner wall of the balloon (2) in the radial direction, and the electrode assembly (4) is located between two adjacent limiting parts (34) in the axial direction.

3. The shock wave device according to any one of claims 1-2, characterized in that, The support wire (30) is a deformable support wire (3), which can adjust the distance between itself and the inner wall of the balloon (2) by deformation; and the deformable support wire (3) can move in coordination with the electrode assembly (4) by deformation, so that the deformable support wire (3) and the electrode assembly (4) can retract and move closer to the inner tube (1) or arch and move away from the inner tube (1).

4. The shock wave device according to claim 3, characterized in that, The shock wave device includes a plurality of balloons (2), which are arranged circumferentially around the inner tube (1).

5. The shock wave device according to claim 3, characterized in that, The shockwave device includes a single balloon (2) fitted over a portion of the inner tube (1), and the accommodating cavity (21) is located between the balloon (2) and the inner tube (1).

6. The shock wave device according to claim 5, characterized in that, When the deformable support wire (3) is in the arched state, the radial distance between the electrode assembly (4) and the inner wall of the balloon (2) is 1 mm to 4 mm.

7. The shock wave device according to claim 5, characterized in that, The deformable support wire (3) includes a support part (31), a bending part (32) and a connecting part (33). The electrode assembly (4) is located on at least one of the support part (31) and the bending part (32). One end of the support part (31) is connected to one end of the bending part (32), and the other end of the bending part (32) is connected to the connecting part (33). The connecting part (33) is connected to the inner tube (1). When the deformable support wire (3) is in the arched state, the radial distance between the support part (31) and the inner tube (1) is greater than the radial distance between the connecting part (33) and the inner tube (1), and in the axial direction away from the support part (31), the bending part (32) gradually bends toward the inner tube (1).

8. The shock wave device according to claim 7, characterized in that, The deformable support wire (3) includes a limiting part (34), which is the bending part (32). When the deformable support wire (3) is in the arched state, the bending part (32) is in contact with the inner wall of the conical segment of the balloon (2), and the length of the bending part (32) in the axial direction of the inner tube (1) is less than the length of the conical segment of the balloon (2) in the axial direction of the inner tube (1).

9. The shock wave device according to claim 7, characterized in that, The deformable support wire (3) includes a limiting part (34) located between the support part (31) and the bending part (32), and the end of the limiting part (34) connected to the support part (31) is radially recessed toward the inner tube (1).

10. The shock wave device according to claim 7, characterized in that, The balloon (2) is an irregularly shaped balloon, which includes a fitting part (22) and a protrusion (23). The protrusion (23) is located between two adjacent fitting parts (22) in the axial direction of the inner tube (1). When the balloon (2) is in the expanded state, the radial distance between the inner wall of the protrusion (23) and the inner tube (1) is greater than the radial distance between the fitting part (22) and the inner tube (1). The deformable support wire (3) includes a limiting part (34), which is located at the end of the support part (31) connected to the bending part (32). When the deformable support wire (3) is in an arched state, the limiting part (34) can fit against the inner wall of the fitting part (22).

11. The shock wave device according to claim 5, characterized in that, The shock wave device includes a first connector (5) and a second connector (6). The first connector (5) is connected to the distal end of the inner tube (1), and the second connector (6) is connected to the proximal end of the inner tube (1). The end of the deformable support wire (3) is connected to the inner tube (1) through the first connector (5) and the second connector (6).

12. The shock wave device according to claim 11, characterized in that, The first connector (5) and the second connector (6) are respectively fixedly connected to the inner tube (1); or, The first connector (5) is fixedly connected or movably connected to the inner tube (1), and the second connector (6) is movably connected to the inner tube (1). The second connector (6) can reciprocate along the axial direction of the inner tube (1) under the action of external force, thereby causing the deformable support wire (3) to retract or arch.

13. The shock wave device according to claim 11, characterized in that, The second connector (6) is movably connected to the inner tube (1). The shock wave device also includes a push-pull member (7), one end of which is fixedly connected to the second connector (6) to apply an external force to the second connector (6) so that the second connector (6) can reciprocate along the axial direction of the inner tube (1) under the action of the external force.

14. The shock wave device according to any one of claims 1-2, characterized in that, When the circumferential cross-section of the balloon (2) is irregular, the diameter of the circumferential circle of the balloon (2) is 8mm to 28mm.

15. The shock wave device according to any one of claims 1-2, characterized in that, The shock wave device also includes an outer tube (8) sleeved on the inner tube (1), with a gap (81) between the outer tube (8) and the inner tube (1), and the distal end of the outer tube (8) is connected to the proximal end of the balloon (2).

Images