Improved Shock Wave Balloon

Abstract

The present application provides an improved shock wave balloon, which includes an outer tube and an inner tube. The distal end of the outer tube is provided with a balloon body located outside the inner tube. The area between the outer tube and the inner tube surrounded by the balloon body is a deformable balloon chamber. The inner tube is fixed with a plurality of electrode pairs for discharging in the balloon chamber. Each electrode pair includes a first electrode and a second electrode that interact with each other. The first electrode and the second electrode of each electrode pair are respectively extended to the proximal end through a conductor with an insulating layer to connect to a driving circuit. The first electrode and / or the second electrode have a convergence state attached to the inner tube and a working state away from the inner tube. The first electrode and / or the second electrode in the working state form a guiding space by moving away from the inner tube. The guiding space is used to guide the running direction of the shock wave formed by the discharge of the electrode pair. The present application guides the shock wave to converge in the same preset direction by tilting the electrode in the working state, thereby increasing the impact force of the balloon.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to an improved shock wave balloon. Background Art

[0002] During angioplasty, a balloon is used to open up calcified lesions in the arterial wall. When the balloon is inflated, causing the lesion to expand, the inflation pressure stores a significant amount of energy in the balloon until the calcified lesion ruptures, or breaks, releasing the stored energy. This process can compress and damage the vessel wall.

[0003] In recent years, shock wave balloons have been used to destroy calcium deposits in arteries or veins. For example, U.S. Patent Publication No. 2009 / 03127682009 describes a catheter having a distal end, such as a balloon, arranged to be inflated with a fluid. A shock wave generator is disposed within the balloon, for example in the form of a pair of electrodes coupled to a high-voltage source at the proximal end of the catheter via a connector. When the balloon is placed adjacent to a calcified area of a vein or artery and a high-voltage pulse is applied across the electrodes, a shock wave is generated that propagates through the fluid and strikes the balloon wall and the calcified area. The repeated pulses destroy the calcium without damaging surrounding soft tissue.

[0004] The shockwave generator's large dimensions, particularly along the axial cross-section of the balloon catheter, reduce its flexibility and increase the difficulty of traversing narrow, tortuous vascular lesions. Existing products have a wire connected to each electrode, increasing the overall size of the balloon. Furthermore, the wires of existing shockwave balloons pass under the electrodes. Despite the insulation layer, this layer can easily break down during high-voltage pulses, causing a short circuit. Summary of the Invention

[0005] In response to the deficiencies of the prior art, the present application provides an improved shock wave balloon disclosed herein, having opposite distal and proximal ends. The improved shock wave balloon comprises an outer tube and an inner tube, wherein the distal end of the outer tube is provided with a balloon body located outside the inner tube, and the area between the outer tube and the inner tube and surrounded by the balloon body is a deformable balloon chamber. The inner tube is fixed with a plurality of electrode pairs for discharging within the balloon chamber, each electrode pair comprising a first electrode and a second electrode that interact with each other, and the first electrode and the second electrode of each electrode pair respectively extend to the proximal end through a conductor with an insulating layer to connect to a driving circuit;

[0006] The first electrode and / or the second electrode has a convergent state adhered to the inner tube and a working state away from the inner tube. The first electrode and / or the second electrode in the working state forms a guiding space by being away from the inner tube, and the guiding space is used to guide the running direction of the shock wave formed by the discharge of the electrode.

[0007] Several optional methods are also provided below, but they are not intended to be additional limitations on the above-mentioned overall solution. They are merely further supplements or optimizations. Under the premise that there are no technical or logical contradictions, each optional method can be combined separately for the above-mentioned overall solution, or multiple optional methods can be combined.

[0008] Optionally, the first electrode and / or the second electrode is in an elongated strip shape and in a working state, one end of the first electrode and / or the second electrode is attached to the inner tube and the other end is away from the inner tube to form the guiding space.

[0009] Optionally, the angle between the axial extension line of the first electrode and / or the second electrode and the surface of the inner tube is a working angle, the working angle range is 1 to 89 degrees, and the distance between the first electrode and the second electrode in the axial direction of the inner tube is 0.3-6 mm.

[0010] Optionally, before the balloon is expanded, the first electrode and / or the second electrode is maintained in a contracted state; after the balloon is expanded, the first electrode and / or the second electrode achieves the working state through its own stress or external stress.

[0011] Optionally, the first electrode and the second electrode both have a converged state in contact with the inner tube and a working state tilted relative to the inner tube. In the working state, the first electrode and the second electrode have the same shape or are differently arranged, and the guide spaces of the first electrode and the second electrode are interconnected.

[0012] Optionally, the first electrode has a converged state in which it is adhered to the inner tube and a working state in which it is tilted relative to the inner tube, and the second electrode is fixedly arranged on the inner tube and located in the guide space of the first electrode.

[0013] Optionally, the first electrode is in the shape of an elongated strip, and the distal end of the first electrode in a working state is aligned with the second electrode in the axial position of the inner tube.

[0014] Optionally, the second electrode is in a ring shape and is sleeved on the inner tube, and a plurality of first electrodes are provided on the circumference of the inner tube and respectively correspond to different positions of the second electrode.

[0015] Optionally, the second electrode is an electrode point fixed on the inner tube, and the first electrode and the second electrode are arranged in pairs.

[0016] Optionally, a plurality of electrode pairs are fixed on the inner tube, and the first electrode and the second electrode in each electrode pair are arranged in the same manner or independently.

[0017] The technical solution disclosed in this application generates shock waves by utilizing the potential difference between an electrode pair. The positive electrode of the electrode pair is composed of a wire, which increases the flexibility of the balloon. This reduces the contact surface area between the positive and negative wires, minimizing the risk of puncture. This reduces the number of electrodes and the size of the balloon. By tilting the electrodes in their operating state, the shock waves are guided in a predetermined direction, increasing the impact force of the balloon.

[0018] The specific beneficial technical effects will be further explained in conjunction with specific structures or steps in the specific implementation methods. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 This is a schematic structural diagram of an improved shock wave balloon in one embodiment of the present application;

[0020] Figure 2 This is a schematic diagram of the internal structure of an electrode pair in one embodiment of the present application;

[0021] Figure 3 for Figure 2 Enlarged schematic diagram of the middle guidance space;

[0022] Figure 4 This is a schematic diagram of the internal structure of an electrode pair in another embodiment of the present application;

[0023] Figure 5 This is a schematic diagram of the internal structure of an electrode pair in another embodiment of the present application;

[0024] Figures 6 to 9 Schematic diagram of the cross section of the first electrode in different embodiments of the present application.

[0025] The reference numerals in the figures are described as follows:

[0026] 11. distal end; 12. proximal end;

[0027] 2. Outer tube; 21. Balloon body; 22. Balloon chamber;

[0028] 3. Inner tube; 31. Electrode pair; 32. First electrode; 33. Second electrode; 34. Conductor; 35. Guide space. DETAILED DESCRIPTION

[0029] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0030] It should be noted that when a component is referred to as being "connected" to another component, it may be directly connected to the other component or there may be an intermediate component. When a component is referred to as being "disposed on" another component, it may be directly disposed on the other component or there may be an intermediate component.

[0031] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which this application pertains. The terms used herein in the specification of this application are for the purpose of describing specific embodiments only and are not intended to limit this application.

[0032] In existing shock wave balloons, the electrodes adopt a cylindrical structure, the flexibility of the catheter is poor, and it is difficult for the catheter to pass through a narrow cavity.

[0033] In response to the above problems, the present application provides an improved shock wave balloon with good flexibility, easy operation, strong shock wave directionality and good use effect.

[0034] Reference Attachment Figure 1 To the attached Figure 3 The present application discloses an improved shock wave balloon having a distal end 11 and a proximal end 12 relative to each other. The improved shock wave balloon includes an outer tube 2 and an inner tube 3. The distal end 11 of the outer tube 2 has a balloon body 21 located outside the inner tube 3. The area between the outer tube 2 and the inner tube 3 and surrounded by the balloon body 21 is a deformable balloon chamber 22. The inner tube 3 is fixed with a plurality of electrode pairs 31 for discharging in the balloon chamber 22. Each electrode pair 31 includes a first electrode 32 and a second electrode 33 that interact with each other. The first electrode 32 and the second electrode 33 of each electrode pair 31 extend to the proximal end 12 through a conductor 34 with an insulating layer to connect to a driving circuit.

[0035] The first electrode 32 and / or the second electrode 33 has a convergent state adhered to the inner tube 3 and a working state away from the inner tube 3. The first electrode 32 and / or the second electrode 33 in the working state forms a guide space 35 by being away from the inner tube 3. The guide space 35 is used to guide the running direction of the shock wave formed by the discharge of the electrode pair 31.

[0036] There is no contact between the positive and negative wires of the first electrode 32 and / or the second electrode 33 that are far away, which avoids the risk of the electrode breaking through the insulation layer and causing a short circuit; at the same time, the electrode far away from the inner tube 3 is similar to a guide plate, which can guide part of the shock wave to gather in one direction, increasing the directionality of the wave. The guiding space 35 is specifically shown in the accompanying figure as a triangular area between the electrode and the inner tube. Among them, the electrode is composed of a guide wire, and no additional electrode is added, which can increase the flexibility of the balloon and reduce the size of the balloon. The main function of the electrode is to accumulate charge and discharge, and the main function of the conductor 34 is to conduct charge. The electrode is also conductive and can be used as a part of the conductor 34. Therefore, the electrode and the conductor 34 in the present application may have a clear dividing line in structure and shape, or there may be no clear dividing line. In theory, the parts of the conductor 34 that are not covered by the insulation layer may cause discharge and become electrodes.

[0037] The technical solution disclosed in this application generates shock waves by utilizing the potential difference between electrode pairs 31. The positive electrode of the electrode pair 31 is composed of a wire, which increases the flexibility of the balloon. This reduces the contact surface area between the positive and negative wires, minimizing the risk of puncture. This reduces the number of electrodes and the size of the balloon. By tilting the electrodes in their operating state, the shock waves are guided in a predetermined direction, increasing the impact force of the balloon.

[0038] Regarding the specific implementation method of being away from the inner tube 3, please refer to an embodiment in which the first electrode 32 and / or the second electrode 33 are long strips and in the working state, one end is attached to the inner tube 3 and the other end is away from the inner tube 3 to form a guide space 35. In this embodiment, the first electrode 32 and / or the second electrode 33 are away from the inner tube 3 by setting the extension direction of a part of themselves. In the specific product, it is manifested as the first electrode 32 and / or the second electrode 33 being tilted relative to the inner tube 3. For specific dimensions, please refer to the attached Figure 3 In the illustrated embodiment, the angle between the axial extension of the first electrode 32 and / or the second electrode 33 and the surface of the inner tube 3 is the working angle A, and the working angle ranges from 1 to 89 degrees. The working angle is more preferably 20 to 85 degrees. The axial extension of the first electrode 32 and / or the second electrode 33 is specifically represented by the line connecting the distal end 11 of the first electrode 32 and / or the second electrode 33 and the contact point between the first electrode 32 and / or the second electrode 33 and the inner tube 3. In terms of geometric dimensions, the distance between the first electrode 32 and / or the second electrode 33 and the inner tube 3 is the standoff distance, which ranges from 0.3 to 6 mm. In the accompanying drawings, the standoff distance is specifically represented as the maximum dimension of the guide space in the radial direction of the inner tube. In other embodiments, the standoff distance can be preferably 0.5 to 5 mm. The axial spacing between the first electrode 32 and the second electrode 33 in the inner tube 3 is 0.3 to 6 mm. This spacing can be further preferably 0.5 to 5 mm.

[0039] The placement of the electrodes away from the inner tube 3 interacts with the balloon's motion. Referring to one embodiment, before expansion, the balloon body 21 maintains the first electrode 32 and / or the second electrode 33 in a contracted state. After expansion, the first electrode 32 and / or the second electrode 33 achieve an active state through self-stress or external stress. In this embodiment, the self-stress can manifest as the elastic force of the first electrode 32 and / or the second electrode 33. For example, the first electrode 32 and / or the second electrode 33 can be configured as a metal material with a memory effect or a conductive material with a certain degree of elasticity, switching states through the elastic force of its own deformation. Similarly, the first electrode 32 and / or the second electrode 33 can also switch states through external stress. The external stress can specifically manifest as the action of other components, such as the pull of the balloon or other components. In one embodiment, a material that can change its shape under different conditions is positioned between the electrodes and the inner tube 3 to drive the electrodes to change state. The conditions that cause the material to change its shape can include temperature, humidity, pressure, etc.

[0040] Referring to an embodiment, the first electrode 32 and the second electrode 33 both have a converged state in which they are attached to the inner tube 3 and a working state in which they are tilted relative to the inner tube 3. In the working state, the first electrode 32 and the second electrode 33 have the same shape or are set differently, and the guide spaces 35 of the first electrode 32 and the second electrode 33 are connected to each other. In this embodiment, the first electrode 32 and the second electrode 33 can both switch their working states, and in terms of the specific degree of change, the two can be set in coordination. Figure 2 In the embodiment shown, in the working state, the first electrode 32 and the second electrode 33 have the same shape. In other embodiments, in the working state, the first electrode 32 and the second electrode 33 can be configured differently to meet different design requirements.

[0041] Similarly, when multiple electrode pairs 31 are fixed on the inner tube 3, the first electrode 32 and the second electrode 33 in each electrode pair 31 are arranged in the same manner or independently. The electrode pairs 31 arranged in the same manner can enhance each other's working effects; similarly, the electrode pairs 31 arranged independently can differentiate the working effects, thereby providing a structural basis for different shock wave balloon working effects. For example, during discharge, an expansion pressure wave is first generated around the plasma region, and then a cavitation pressure wave is generated around the plasma region. The tensile strength of the calcified layer is significantly less than the compressive strength, and the cavitation pressure wave has a more obvious peeling effect on the calcified layer. The propagation direction of the expansion pressure wave and the cavitation pressure wave in this embodiment is basically perpendicular to the interface between the calcified layer and the blood vessel wall, which is conducive to the peeling of the calcified layer.

[0042] Reference Attachment Figure 4 To the attached Figure 5As can be seen in the illustrated embodiment, the first electrode 32 has different states, while the second electrode 33 is fixed. Specifically, the first electrode 32 has a converged state, where it adheres to the inner tube 3, and an operating state, where it is tilted relative to the inner tube 3. The second electrode 33 is fixed to the inner tube 3 and located within the guide space 35 of the first electrode 32. This arrangement improves the discharge effect and guides the shock wave. From another perspective, the first electrode 32 in the operating state faces the second electrode 33. In the accompanying drawings, the first electrode 32 is elongated, and in the operating state, the distal end of the first electrode 32 is aligned axially with the second electrode 33. Alignment in this context is not limited to absolute geometric alignment; rather, it emphasizes matching the positions of the two electrodes. For example, in the following description, when the second electrode 33 is annular, at least a portion of the second electrode 33 extends through the guide space 35 of the first electrode 32, thereby ensuring that the distal end of the first electrode 32 in the operating state is aligned axially with the second electrode 33. In the accompanying drawings, the orientation of the electrodes refers to the lateral direction of the extension direction of the electrodes, rather than the axial direction of the electrodes. The advantage of this arrangement is that different electrodes have a larger facing area, thereby improving the discharge effect.

[0043] Regarding the differentiated arrangement of the second electrode 33, refer to the attached Figure 4 The second electrode 33 is annular and sleeved around the inner tube 3. Multiple first electrodes 32 are provided around the inner tube 3, corresponding to different positions of the second electrode 33. The central angle of the annular electrode can be 360° or less. The second electrode 33 can control the discharge effect through the provision of its own insulating layer.

[0044] For example, in one embodiment, when the central angle of the annular electrode approaches 360 degrees and no insulating layer is provided circumferentially, the arc generated by the discharge can be randomly generated near any generatrix of the conical surface, thereby distributing the shock wave source relatively evenly along the circumference within the balloon chamber 22, effectively preventing excessive exfoliation of the calcified layer on one radial side of the vessel wall and insufficient exfoliation on the opposite radial side. This arrangement also ensures uniform circumferential distribution of the shock wave energy. Furthermore, because the discharge point can be any point on the annular electrode, the spacing between the electrodes remains essentially unchanged as the electrodes are continuously etched during the discharge process. This effectively extends the service life of the electrodes compared to traditional tip-to-tip discharge.

[0045] In another embodiment, except for the positions on the second electrode 33 corresponding to the first electrode 32, the rest of the annular second electrode 33 is covered with an insulating layer. This allows for precise control of the discharge position and direction of the electrode pair, providing a structural basis for controlling the direction of the shock wave.

[0046] Regarding the differentiated arrangement of the second electrode 33, refer to the attached Figure 5 The second electrode 33 is an electrode point fixed to the inner tube 3. The first electrode 32 and the second electrode 33 are arranged in pairs. The arrangement of the electrode points can optimize the layout within the balloon, thereby providing a structural foundation for achieving smaller balloon specifications. In specific implementations, the electrode points can be circular dots, circular blocks, square dots, square blocks, welded semicircular rings, circular rings, ellipses, or other irregular shapes with raised dots located on the outer circumference of the inner tube 3.

[0047] The material of the electrode can be gold, silver, copper, aluminum, platinum and other metals and alloys formed by various processes. The electrode is a conductive material and can be stainless steel, shape memory alloy, etc., preferably shape memory alloy. Figure 6 To the attached Figure 9 As can be seen, the first electrode 32 can be cylindrical or elongated, and its cross-section can be square, circular, semicircular, crescent-shaped, etc. The same applies to the second electrode 33. In one embodiment, when the electrode cross-section is non-circular, the electrode's maximum axial cross-section faces electrodes of different polarity. For example, when the electrode cross-section is crescent-shaped, the center side of the crescent-shaped electrode faces electrodes of different polarity. This arrangement has the advantage of providing a larger facing area between the different electrodes, thereby improving the discharge effect.

[0048] The total number of electrode pairs 31 can be 1, 2, 3, 4, 5, etc. The discharge voltage between two electrodes of opposite polarity in the same electrode pair 31 is 100V to 10,000V. In a single electrode pair 31, the number of first electrodes 32 and second electrodes 33 can be equal or unequal. Electrodes with multiple numbers can be connected in series or in parallel. Electrodes of the same polarity in different electrode pairs 31 can be connected in series or in parallel.

[0049] Conductor 34 can be insulated using an insulating wire. Electrode insulation can be achieved by applying a layer of insulating glue to the inner tube 3 wall where the electrodes are in contact, and to the surface of the corresponding electrode pair 31. In terms of layout, conductors 34 of different polarities and their corresponding electrodes do not intersect, thus avoiding the risk of breakdown from repeated use. The first electrode 32 mentioned above can function as either a positive or negative electrode, and similarly, the second conductor 34 has the opposite polarity to the first conductor 34.

[0050] In this application, the optimized electrode arrangement reduces the number of conductors 34 connecting the electrode pairs 31, thereby reducing the size of the balloon catheter, particularly in its axial cross-section. The conductors 34 can be fixed to the catheter surface, fixed in a groove on the outer surface of the inner tube 3, or in a hypotube.

[0051] The technical features of the above-described embodiments may be combined in any manner. To simplify the description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as no contradiction exists between these combinations of technical features, they should be considered to be within the scope of this specification. When technical features of different embodiments are embodied in the same drawing, it can be deemed that the drawing also discloses examples of combinations of the various embodiments involved.

[0052] The above-described embodiments merely represent several implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that a person of ordinary skill in the art may make various modifications and improvements without departing from the spirit of the present application, and these modifications and improvements fall within the scope of protection of the present application. Therefore, the scope of protection of the present patent application shall be determined by the appended claims.

Claims

1. An improved shock wave balloon having opposite distal and proximal ends, the improved shock wave balloon comprising an outer tube and an inner tube, the distal end of the outer tube having a balloon body disposed outside the inner tube, the area between the outer tube and the inner tube surrounded by the balloon body being a deformable balloon chamber, characterized in that: The inner tube is fixed with a plurality of electrode pairs for discharging in the balloon chamber, each electrode pair including a first electrode and a second electrode that interact with each other, and the first electrode and the second electrode of each electrode pair are respectively extended to the proximal end through a conductor with an insulating layer to be connected to a driving circuit; The first electrode and / or the second electrode has a convergent state adhered to the inner tube and a working state away from the inner tube. The first electrode and / or the second electrode in the working state forms a guiding space by being away from the inner tube, and the guiding space is used to guide the running direction of the shock wave formed by the discharge of the electrode.

2. The improved shock wave balloon according to claim 1, characterized in that: The first electrode and / or the second electrode is in a long strip shape and in a working state, one end of the first electrode and / or the second electrode is attached to the inner tube and the other end is away from the inner tube to form the guide space.

3. The improved shock wave balloon according to claim 1, characterized in that: The angle between the axial extension line of the first electrode and / or the second electrode and the surface of the inner tube is a working angle, and the working angle ranges from 1 to 89 degrees. The distance between the first electrode and the second electrode in the axial direction of the inner tube is 0.3-6 mm.

4. The improved shock wave balloon according to claim 1, characterized in that: Before the balloon is expanded, the first electrode and / or the second electrode are kept in a contracted state; after the balloon is expanded, the first electrode and / or the second electrode achieve the working state through self-stress or external stress.

5. The improved shock wave balloon according to claim 1, characterized in that: Both the first electrode and the second electrode have a converged state in which they are adhered to the inner tube and a working state in which they are tilted compared to the inner tube. In the working state, the first electrode and the second electrode have the same shape or are differently arranged, and the guide spaces of the first electrode and the second electrode are connected to each other.

6. The improved shock wave balloon according to claim 1, characterized in that: The first electrode has a converged state in which it is adhered to the inner tube and a working state in which it is tilted relative to the inner tube. The second electrode is fixedly arranged on the inner tube and is located in a guiding space of the first electrode.

7. The improved shock wave balloon according to claim 6, characterized in that: The first electrode is in the shape of an elongated strip, and the distal end of the first electrode in a working state is aligned with the second electrode in the axial position of the inner tube.

8. The improved shock wave balloon according to claim 6, characterized in that: The second electrode is in a ring shape and is sleeved on the inner tube. A plurality of first electrodes are provided on the circumference of the inner tube and respectively correspond to different positions of the second electrode.

9. The improved shock wave balloon according to claim 6, characterized in that: The second electrode is an electrode point fixed on the inner tube, and the first electrode and the second electrode are arranged in pairs.

10. The improved shock wave balloon according to claim 1, characterized in that: A plurality of electrode pairs are fixed on the inner tube, and the first electrode and the second electrode in each electrode pair are arranged in the same manner or independently.

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