Shock wave balloon catheter device

Abstract

The embodiment of the utility model provides a shock wave balloon catheter device. The shock wave balloon catheter device comprises a first outer electrode sheath; the first inner electrode comprises a first discharging part and a first fixing part; the first fixing part is positioned between the outer wall of the catheter and the inner wall of the first outer electrode sheath; the second inner electrode comprises a second discharging part and a second fixing part; the second fixing part is positioned between the outer wall of the catheter and the inner wall of the first outer electrode sheath; a second external electrode sheath; the third inner electrode comprises a third discharging part and a third fixing part; the third fixing part is positioned between the outer wall of the catheter and the inner wall of the second outer electrode sheath; the fourth inner electrode comprises a fourth discharging part and a fourth fixing part; the fourth fixing part is positioned between the outer wall of the catheter and the inner wall of the second outer electrode sheath; the first discharge part, the second discharge part, the third discharge part and the fourth discharge part are all located at the gap between the first outer electrode sheath and the second outer electrode sheath, so that the distance between two axially adjacent electrode pairs can be adjusted to generate shock waves with enhanced interference.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a shock wave balloon catheter device. Background Art

[0002] As heart disease patients age and the disease progresses, plaques in peripheral blood vessels and coronary arteries gradually calcify. This bone-like structure analogue can cause vascular stenosis, reduce vascular blood flow, and ultimately may lead to complete vascular occlusion. A shock wave balloon catheter device is provided for vascular calcification lesions; during treatment, the balloon on the catheter is pushed into the calcified area of ​​the vessel; the balloon is then inflated and pressurized with liquid; high-voltage pulses are applied to the electrode pairs in the balloon, causing the electrode pairs to discharge and generate shock waves in the liquid; the shock waves strike the balloon wall, rupturing the calcified plaque; after the calcified plaque ruptures, the balloon can expand further to open the vessel. However, some patients have hard calcified plates in their blood vessels,

[0003] In some schemes of the shock wave balloon catheter device, there are multiple electrode pairs arranged axially in the balloon; experiments show that when the distance between two adjacent electrode pairs is small enough (for example, less than 6 mm), the shock waves generated by the two adjacent electrode pairs will interfere with each other to enhance the shock wave energy, and the smaller the distance between the two adjacent electrode pairs, the greater the enhanced shock wave energy; and when the distance between the two adjacent electrode pairs is large enough (for example, greater than 6 mm), the shock waves generated by the two adjacent electrode pairs will not interfere with each other, and the shock wave energy generated by each electrode pair is less than the enhanced shock wave energy. The enhancement of the shock wave energy enables it to break calcified plaques with greater hardness. Therefore, the structural design of the electrode pairs should facilitate the axially arranged electrode pairs to be close to each other to an appropriate distance. Utility Model Content

[0004] The embodiments of the present application provide a shock wave balloon catheter device, which facilitates the axially arranged electrode pairs to be close to each other to a proper distance.

[0005] In one embodiment of the present application, a shock wave balloon catheter device is provided, comprising a catheter, a balloon sealed around the outer circumference of the catheter, a first electrode assembly and a second electrode assembly disposed in the balloon, wherein the balloon can be filled with a liquid;

[0006] The first electrode assembly includes

[0007] A first outer electrode sheath; the first outer electrode sheath is sleeved on the outer circumference of the catheter;

[0008] a first inner electrode; the first inner electrode comprises a first discharge portion and a first fixing portion; the first fixing portion is located between the outer wall of the catheter and the inner wall of the first outer electrode sheath; the first discharge portion can contact the liquid in the balloon; the first outer electrode sheath and the first inner electrode are configured to be insulated and separated;

[0009] a second inner electrode; the second inner electrode comprises a second discharge portion and a second fixing portion; the second fixing portion is located between the outer wall of the catheter and the inner wall of the first outer electrode sheath; the second discharge portion can contact the liquid in the balloon; the second discharge portion and the first discharge portion are arranged at intervals along the circumference of the catheter; the first outer electrode sheath and the second inner electrode are configured to be insulated and separated;

[0010] The second electrode assembly includes

[0011] a second outer electrode sheath; the second outer electrode sheath is sleeved on the outer periphery of the catheter; and the second outer electrode sheath and the first outer electrode sheath are arranged axially at intervals;

[0012] a third inner electrode; the third inner electrode comprises a third discharge portion and a third fixing portion; the third fixing portion is located between the outer wall of the catheter and the inner wall of the second outer electrode sheath; the third discharge portion can contact the liquid in the balloon; the third inner electrode is electrically connected to the second inner electrode; the second outer electrode sheath and the third inner electrode are configured to be insulated and separated;

[0013] a fourth inner electrode; the fourth inner electrode comprises a fourth discharge portion and a fourth fixing portion; the fourth fixing portion is located between the outer wall of the catheter and the inner wall of the second outer electrode sheath; the fourth discharge portion can contact the liquid in the balloon; the fourth discharge portion and the third discharge portion are arranged at intervals along the circumference of the catheter; the second outer electrode sheath and the fourth inner electrode are configured to be insulated and separated;

[0014] When a voltage is applied between the first inner electrode and the fourth inner electrode, an electrode pair is formed between the first discharge portion and the first outer electrode sheath to generate a discharge arc in the liquid, an electrode pair is formed between the first outer electrode sheath and the second discharge portion to generate a discharge arc in the liquid, an electrode pair is formed between the third discharge portion and the second outer electrode sheath to generate a discharge arc in the liquid, and an electrode pair is formed between the second outer electrode sheath and the fourth discharge portion to generate a discharge arc in the liquid; so that current is allowed to pass through the first discharge portion, the first outer electrode sheath, the second discharge portion, the third discharge portion, the second outer electrode sheath, and the fourth discharge portion in sequence;

[0015] The first discharge portion, the second discharge portion, the third discharge portion, and the fourth discharge portion are all located at a gap between the first outer electrode sheath and the second outer electrode sheath.

[0016] In the embodiments provided in the present application, the first discharge portion, the second discharge portion, the third discharge portion and the fourth discharge portion are all located in the gap between the first outer electrode sheath and the second outer electrode sheath, so the electrode pairs are all located between the first outer electrode sheath and the second outer electrode sheath, and the distance between two axially adjacent electrode pairs can be adjusted as needed to generate interference-enhanced shock waves; the first outer electrode sheath and the second outer electrode sheath will not separate two axially adjacent electrode pairs. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For those skilled in the art, other drawings can be obtained based on these drawings without paying any creative labor.

[0018] Figure 1 A schematic diagram of the structure of a shock wave balloon catheter device provided in one embodiment of the present application;

[0019] Figure 2 A schematic diagram of the structure of an electrode assembly provided in one embodiment of the present application;

[0020] Figure 3 A longitudinal cross-sectional view of a second electrode assembly provided in one embodiment of the present application;

[0021] Figure 4 A schematic diagram of the structure of an electrode assembly provided in another embodiment of the present application;

[0022] Figure 5 A longitudinal cross-sectional view of a first electrode assembly provided in another embodiment of the present application;

[0023] Figure 6 A schematic diagram of the structure of an electrode assembly provided in another embodiment of the present application;

[0024] Figure 7 A schematic diagram of the structure of an electrode assembly provided in yet another embodiment of the present application;

[0025] Figure 8 For this application Figure 7 A schematic structural diagram of the first discharge part and the second discharge part in the AA direction view;

[0026] Fig. 9 For this application Figure 7A schematic structural diagram of the first discharge unit, the second discharge unit, the third discharge unit, and the fourth discharge unit in a BB-direction view;

[0027] Fig.10 A schematic diagram of an exploded view of an electrode assembly provided in accordance with one embodiment of the present application. DETAILED DESCRIPTION

[0028] The technical solution of the present invention will be described in detail below in conjunction with the accompanying drawings and specific implementation methods. It should be understood that these implementation methods are only used to illustrate the present invention and are not used to limit the scope. After reading the present invention, modifications of various equivalent forms of the present invention by those skilled in the art all fall within the scope defined in this application.

[0029] It should be noted that when an element is referred to as being "disposed on" another element, it may be directly on the other element or there may be an element in the middle. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be an element in the middle. The "proximal end" in this application refers to the side close to the operator, and the "distal end" refers to the side away from the operator.

[0030] The following will be combined Figures 1 to 10 The shock wave balloon catheter device of the embodiment of this specification is explained and described. It should be noted that in the embodiment of the utility model, the same reference numerals represent the same components. For the sake of brevity, the detailed description of the same components is omitted in different embodiments, and the descriptions of the same components can be referenced and quoted to each other.

[0031] As heart disease patients age and the disease progresses, plaques in peripheral blood vessels and coronary arteries gradually calcify. This bone-like structure can cause narrowing of the vessels, reduce blood flow in the vessels, and may eventually lead to complete occlusion of the vessels.

[0032] The indications of the shock wave balloon catheter device include interventional treatment of vascular calcification lesions. The shock wave balloon catheter device includes a catheter, a balloon sealed around the outer circumference of the catheter, and at least one electrode pair arranged in the balloon; the balloon can be filled with liquid; each of the electrode pairs includes a first electrode and a second electrode; when a voltage is applied between the first electrode and the second electrode, a plasma arc is formed in the liquid in the balloon between the first electrode and the second electrode, thereby generating bubbles in the liquid, which expand and collapse, and then forming a mechanical shock wave in the balloon, which is mechanically transmitted through the liquid and the balloon to apply mechanical force or pressure to split any calcified plaque on or in the wall of the vascular system.

[0033] When the device is used clinically, the balloon in a decompressed state should first be delivered to the site of the calcified lesion, and the balloon should be pressurized to ensure that it fits tightly against the blood vessel wall; then a voltage is applied between the first electrode and the second electrode, and the liquid in the balloon between the first electrode and the second electrode forms a discharge shock wave. The shock wave impacts and destroys the calcified lesion, causing the calcification of the intima and the media to break. The modification effect of the calcified lesion can be judged by evaluating the symmetrical expansion of the balloon.

[0034] The shock wave balloon catheter device efficiently and safely destroys superficial and deep calcifications, thereby significantly improving vascular compliance. The device is effective not only for superficial and deep calcifications, but also for eccentric and non-eccentric lesions, reducing the risk of complications such as dissection and perforation.

[0035] In some schemes of the shock wave balloon catheter device, there are multiple electrode pairs arranged axially in the balloon; experiments show that when the distance between two adjacent electrode pairs is small enough (for example, less than 6 mm), the shock waves generated by the two adjacent electrode pairs will interfere with each other to enhance the shock wave energy, and the smaller the distance between the two adjacent electrode pairs, the greater the enhanced shock wave energy; and when the distance between the two adjacent electrode pairs is large enough (for example, greater than 6 mm), the shock waves generated by the two adjacent electrode pairs will not interfere with each other, and the shock wave energy generated by each electrode pair is less than the enhanced shock wave energy. The enhancement of the shock wave energy enables it to break calcified plaques with greater hardness. Therefore, the structural design of the electrode pairs should facilitate the axially arranged electrode pairs to be close to each other to an appropriate distance.

[0036] like Figures 1 to 3 As shown, an optional embodiment of the shock wave balloon catheter device provided by the present application includes a catheter 107, a balloon 108 sealed around the outer periphery of the catheter 107, and a first electrode assembly and a second electrode assembly disposed in the balloon 108; the balloon 108 can be filled with a liquid, wherein the liquid is not limited to water, saline, contrast agent and a mixture thereof;

[0037] The first electrode assembly includes

[0038] A first outer electrode sheath 101; the first outer electrode sheath 101 is sleeved on the outer circumference of the catheter 107;

[0039] A first inner electrode; the first inner electrode comprises a first discharge portion 1021 and a first fixing portion; the first fixing portion is located between the outer wall of the catheter 107 and the inner wall of the first outer electrode sheath 101; the first discharge portion 1021 can contact the liquid in the balloon 108; the first outer electrode sheath 101 and the first inner electrode are configured to be insulated and separated;

[0040] a second inner electrode; the second inner electrode comprises a second discharge portion 1031 and a second fixing portion; the second fixing portion is located between the outer wall of the catheter 107 and the inner wall of the first outer electrode sheath 101; the second discharge portion 1031 can contact the liquid in the balloon 108; the second discharge portion 1031 and the first discharge portion 1021 are arranged at intervals along the circumference of the catheter 107; the first outer electrode sheath 101 and the second inner electrode are configured to be insulated and separated;

[0041] The second electrode assembly is Figure 3 ,include

[0042] A second outer electrode sheath 104; the second outer electrode sheath 104 is sleeved on the outer periphery of the catheter 107; and the second outer electrode sheath 104 and the first outer electrode sheath 101 are arranged axially spaced apart from each other;

[0043] A third inner electrode 105; the third inner electrode 105 comprises a third discharge portion 1051 and a third fixing portion; the third fixing portion is located between the outer wall of the catheter 107 and the inner wall of the second outer electrode sheath 104; the third discharge portion 1051 can contact the liquid in the balloon 108; the third inner electrode 105 is electrically connected to the second inner electrode; the second outer electrode sheath 104 and the third inner electrode 105 are configured to be insulated and separated;

[0044] A fourth inner electrode 106; the fourth inner electrode 106 comprises a fourth discharge portion 1061 and a fourth fixing portion; the fourth fixing portion is located between the outer wall of the catheter 107 and the inner wall of the second outer electrode sheath 104; the fourth discharge portion 1061 can contact the liquid in the balloon 108; the fourth discharge portion 1061 and the third discharge portion 1051 are arranged at intervals along the circumference of the catheter 107; the second outer electrode sheath 104 and the fourth inner electrode 106 are configured to be insulated and separated;

[0045] When a voltage is applied between the first inner electrode and the fourth inner electrode 106, a first electrode pair is formed between the first discharge portion 1021 and the first outer electrode sheath 101, which can generate a discharge arc in the liquid; a second electrode pair is formed between the first outer electrode sheath 101 and the second discharge portion 1031, which can generate a discharge arc in the liquid; a third electrode pair is formed between the third discharge portion 1051 and the second outer electrode sheath 104, which can generate a discharge arc in the liquid; and a fourth electrode pair is formed between the second outer electrode sheath 104 and the fourth discharge portion 1061, which can generate a discharge arc in the liquid; so as to allow current to pass through the first discharge portion 1021, the first outer electrode sheath 101, the second discharge portion 1031, the third discharge portion 1051, the second outer electrode sheath 104, and the fourth discharge portion 1061 in sequence.

[0046] like Figure 2 As shown, optionally, the first electrode assembly is located proximal to the second electrode assembly; the first discharge portion 1021 is located distal to the distal end surface of the first outer electrode sheath 101; the second discharge portion 1031 is located proximal to the proximal end surface of the first outer electrode sheath 101; the third discharge portion 1051 is located distal to the distal end surface of the second outer electrode sheath 104; and the fourth discharge portion 1061 is located distal to the distal end surface of the second outer electrode sheath 104.

[0047] In this embodiment, the second outer electrode sheath 104 is located between the first discharge portion 1021 and the third discharge portion 1051, and the distance between the first electrode pair and the third electrode pair is greater than the axial width of the second outer electrode sheath 104; for example, if the axial width of the second outer electrode sheath 104 is 5 mm, the distance between the first electrode pair and the third electrode pair must be greater than 5 mm.

[0048] In this embodiment, the first outer electrode sheath 101 and the second outer electrode sheath 104 are located between the second discharge portion 1031 and the third discharge portion 1051, and the distance between the second electrode pair and the third electrode pair is greater than the sum of the axial width of the first outer electrode sheath 101 and the axial width of the second outer electrode sheath 104; for example, the axial widths of the first outer electrode sheath 101 and the second outer electrode sheath 104 are both 5 mm, and the distance between the second electrode pair and the third electrode pair must be greater than 10 mm.

[0049] It can be seen that in this embodiment, since at least one of the first outer electrode sheath 101 and the second outer electrode sheath 104 is located between two axially adjacent electrode pairs, the two axially adjacent electrode pairs must be spaced apart by a certain distance, which may affect the interference enhancement of the shock wave between the two axially adjacent electrode pairs; on the other hand, when the interference enhancement of the shock wave is generated between the two axially adjacent electrode pairs, the area between the two axially adjacent electrode pairs will generate enhanced shock wave energy, and the above-mentioned enhanced shock wave energy will generate a mechanical impact on the outer electrode sheath located between the two axially adjacent electrode pairs, which may easily cause the outer electrode sheath to deform and loosen.

[0050] To solve the above technical problems, the present application provides an optional embodiment of a shock wave balloon catheter device, such as Figure 4 As shown, it includes a catheter, a balloon sealed around the outer circumference of the catheter, and a first electrode assembly and a second electrode assembly arranged in the balloon; the balloon can be filled with liquid, wherein the liquid includes but is not limited to water, saline, contrast agent and a mixture thereof;

[0051] The first electrode assembly is Figure 5 ,include

[0052] A first outer electrode sheath 201; the first outer electrode sheath 201 is sleeved on the outer circumference of the catheter;

[0053] A first inner electrode 202; the first inner electrode 202 comprises a first discharge portion 2021 and a first fixing portion; the first fixing portion is located between the outer wall of the catheter and the inner wall of the first outer electrode sheath 201; the first discharge portion 2021 can contact the liquid in the balloon; the first outer electrode sheath 201 and the first inner electrode 202 are configured to be insulated and separated;

[0054] a second inner electrode 203; the second inner electrode 203 comprises a second discharge portion 2031 and a second fixing portion; the second fixing portion is located between the outer wall of the catheter and the inner wall of the first outer electrode sheath 201; the second discharge portion 2031 can contact the liquid in the balloon; the second discharge portion 2031 and the first discharge portion 2021 are arranged at intervals along the circumference of the catheter; the first outer electrode sheath 201 and the second inner electrode 203 are configured to be insulated and separated;

[0055] The second electrode assembly includes

[0056] A second outer electrode sheath 204; the second outer electrode sheath 204 is sleeved on the outer periphery of the catheter; and the second outer electrode sheath 204 and the first outer electrode sheath 201 are arranged axially at intervals;

[0057] A third inner electrode; the third inner electrode comprises a third discharge portion 2051 and a third fixing portion; the third fixing portion is located between the outer wall of the catheter and the inner wall of the second outer electrode sheath 204; the third discharge portion 2051 can contact the liquid in the balloon; the third inner electrode is electrically connected to the second inner electrode 203; the second outer electrode sheath 204 and the third inner electrode are configured to be insulated and separated;

[0058] A fourth inner electrode; the fourth inner electrode comprises a fourth discharge portion 2061 and a fourth fixing portion; the fourth fixing portion is located between the outer wall of the catheter and the inner wall of the second outer electrode sheath 204; the fourth discharge portion 2061 can contact the liquid in the balloon; the fourth discharge portion 2061 and the third discharge portion 2051 are arranged at intervals along the circumference of the catheter; the second outer electrode sheath 204 and the fourth inner electrode are configured to be insulated and separated;

[0059] When a voltage is applied between the first inner electrode 202 and the fourth inner electrode, a first electrode pair is formed between the first discharge portion 2021 and the first outer electrode sheath 201, which can generate a discharge arc in the liquid; a second electrode pair is formed between the first outer electrode sheath 201 and the second discharge portion 2031, which can generate a discharge arc in the liquid; a third electrode pair is formed between the third discharge portion 2051 and the second outer electrode sheath 204, which can generate a discharge arc in the liquid; and a fourth electrode pair is formed between the second outer electrode sheath 204 and the fourth discharge portion 2061, which can generate a discharge arc in the liquid; so as to allow current to sequentially pass through the first discharge portion 2021, the first outer electrode sheath 201, the second discharge portion 2031, the third discharge portion 2051, the second outer electrode sheath 204, and the fourth discharge portion 2061;

[0060] In this embodiment, the first electrode assembly is located at the proximal end of the second electrode assembly; the first discharge portion 2021 is located at the distal side of the distal end surface of the first outer electrode sheath 201; the second discharge portion 2031 is located at the distal side of the distal end surface of the first outer electrode sheath 201; the third discharge portion 2051 is located at the proximal side of the proximal end surface of the second outer electrode sheath 204; the fourth discharge portion 2061 is located at the proximal side of the proximal end surface of the second outer electrode sheath 204; then the first discharge portion 2021, the second discharge portion 2031, the third discharge portion 205 The first and fourth discharge parts 1061 are both located at the gap between the first outer electrode sheath 201 and the second outer electrode sheath 204, so the electrode pairs are both located between the first outer electrode sheath 201 and the second outer electrode sheath 204, and the distance between two axially adjacent electrode pairs can be adjusted as needed to generate interference-enhanced shock waves; the first outer electrode sheath 201 and the second outer electrode sheath 204 will not separate the two axially adjacent electrode pairs, and will not bear the enhanced shock wave energy in the area between the two axially adjacent electrode pairs.

[0061] The circumferential direction in the embodiment of the present application is based on the axis of the catheter.

[0062] In order to make two axially adjacent electrode pairs interfere with each other and thus enhance shock wave energy, optionally, the axial distance between adjacent end surfaces of the first outer electrode sheath 201 and the second outer electrode sheath 204 is between 1 mm and 5 mm.

[0063] In addition, in this embodiment, when the angle (central angle) of the circumferential spacing between the first discharge portion 2021 and the second discharge portion 2031 is small enough (for example, the angle of the circumferential spacing between the first discharge portion 2021 and the second discharge portion 2031 is greater than 30° and less than 150°), the shock waves generated by the first electrode pair and the second electrode pair will interfere with each other, thereby enhancing the shock wave energy; and when the angle of the circumferential spacing between the first discharge portion 2021 and the second discharge portion 2031 is large enough (for example, greater than 150°), the shock waves generated by two adjacent electrode pairs will not interfere with each other, and the shock wave energy generated by each electrode pair is less than the above-mentioned enhanced shock wave energy.

[0064] exist Figure 4 In an optional embodiment, the angle between the first discharge section 2021 and the second discharge section 2031 along the circumferential direction is 180°; the first discharge section 2021 and the fourth discharge section 2061 are located at substantially the same position in the circumferential direction, and the shock waves generated by the first electrode pair and the fourth electrode pair will interfere with each other, thereby enhancing the shock wave energy; the second discharge section 2031 and the third discharge section 2051 are located at substantially the same position in the circumferential direction, and the shock waves generated by the second electrode pair and the third electrode pair will interfere with each other, thereby enhancing the shock wave energy. The enhanced shock waves generated by the first electrode pair and the fourth electrode pair, and the enhanced shock waves generated by the second electrode pair and the third electrode pair are symmetrically distributed on both sides of the catheter, so that shock waves can be applied more evenly at multiple positions in the circumferential direction of the blood vessel.

[0065] exist Figure 6 In another optional embodiment shown, the angle between the first discharge portion 2021 and the second discharge portion 2031 along the circumferential direction is 120°, the first discharge portion 2021 and the fourth discharge portion 2061 are located at substantially the same position in the circumferential direction, and the second discharge portion 2031 and the fourth discharge portion 2051 are located at substantially the same position in the circumferential direction; then the shock waves generated by the first electrode pair, the second electrode pair, the third electrode pair and the fourth electrode pair will interfere with each other to enhance the shock wave energy. In this embodiment, the direction of the shock waves generated by the four electrode pairs is relatively more concentrated; compared with the shock waves enhanced by the interference of two electrode pairs, the shock waves enhanced by the interference of four electrode pairs have stronger energy.

[0066] In the above optional implementation scheme, the first discharge portion 2021 and the third discharge portion 2051 may be located at substantially the same circumferential position; the second discharge portion 2031 and the fourth discharge portion 2061 may be located at substantially the same circumferential position.

[0067] In such Figures 7 to 9In another optional embodiment shown in FIG. 1 , the first discharge portion 2021 and the second discharge portion 2031 have a first circumferential gap 2101 and a second circumferential gap 2102 along the circumferential direction. Figure 8 As shown in the figure, the circumferential angle corresponding to the first circumferential gap 2101 is greater than 30° and less than 150°; the circumferential angle corresponding to the second circumferential gap 2102 is greater than the circumferential angle corresponding to the first circumferential gap 2101. Among the third discharge portion 2051 and the fourth discharge portion 2061, at least part of the circumferential position of one discharge portion is located in the first circumferential gap 2101, and the circumferential position of the other discharge portion is located at approximately the center of the second circumferential gap 2102.

[0068] In this embodiment, the circumferential position of the third discharge portion 2051 is located in the first circumferential gap 2101, and the shock waves generated by the first electrode pair, the second electrode pair and the third electrode pair will interfere with each other to enhance the shock wave energy; compared with the shock wave enhanced by the interference of two electrode pairs, the shock wave energy enhanced by the interference of three electrode pairs is stronger. The circumferential position of the fourth discharge portion 2061 is located in the second circumferential gap 2102 ( Figure 7 The fourth electrode pair is located on the back of the catheter (not shown), and the shock waves of the other three electrode pairs do not interfere with each other, so that shock waves can be applied more evenly at multiple positions in the circumferential direction of the blood vessel.

[0069] Optionally, the circumferential position of the fourth discharge portion 2061 is located approximately at the center of the second circumferential gap 2102, so that the distribution of the shock wave of the fourth electrode pair and the shock waves of the other three electrode pairs is more dispersed.

[0070] Optionally, the circumferential position of the third discharge portion 2051 is located approximately at the center of the second circumferential gap 2102 .

[0071] Optionally, the third discharge portion 2051 and the fourth discharge portion 2061 are arranged substantially symmetrically along the axis.

[0072] Optional, such as Fig. 9 As shown, the third discharge portion 2051 and the first discharge portion 2021 have a first circumferential gap 2101a along the circumferential direction, and the third discharge portion 2051 and the second discharge portion 2031 have a first second circumferential gap 2101b along the circumferential direction; the fourth discharge portion 2061 and the first discharge portion 2021 have a second circumferential gap 2102a along the circumferential direction, and the fourth discharge portion 2061 and the second discharge portion 2031 have a second second circumferential gap 2102b along the circumferential direction;

[0073] The circumferential angle corresponding to the first circumferential gap 2101a is smaller than the circumferential angle corresponding to the second circumferential gap 2102a, and the circumferential angle corresponding to the first circumferential gap 2101a is smaller than the circumferential angle corresponding to the second circumferential gap 2102b;

[0074] The circumferential angle corresponding to the first second circumferential gap 2101b is smaller than the circumferential angle corresponding to the second circumferential gap 2102a, and the circumferential angle corresponding to the first second circumferential gap 2101b is smaller than the circumferential angle corresponding to the second second circumferential gap 2102b.

[0075] In the above embodiment, optionally, the first inner electrode, the second inner electrode, the third inner electrode, and the fourth inner electrode in the shock wave balloon catheter device are all composed of insulated wires; specifically, the shock wave balloon catheter device includes a catheter, and a balloon sealed around the outer circumference of the catheter, and the balloon can be filled with liquid;

[0076] A first outer electrode sheath; the first outer electrode sheath is sleeved on the outer circumference of the catheter;

[0077] a second outer electrode sheath; the second outer electrode sheath is sleeved on the outer periphery of the catheter; and the second outer electrode sheath and the first outer electrode sheath are arranged axially at intervals;

[0078] a first insulated wire; a portion of the first insulated wire is crimped between the outer wall of the catheter and the inner wall of the first outer electrode sheath; the first insulated wire passes through the insulating layer of the wire, so that the conductor of the wire and the first outer electrode sheath are insulated; a portion of the insulating layer of the first insulated wire is removed to form a first discharge portion; the first discharge portion can contact the liquid in the balloon; the first discharge portion is located at the gap between the first outer electrode sheath and the second outer electrode sheath;

[0079] a second insulated conductor; a portion of the second insulated conductor is crimped between the outer wall of the catheter and the inner wall of the first outer electrode sheath, and another portion of the second insulated conductor is crimped between the outer wall of the catheter and the inner wall of the second outer electrode sheath; a portion of the insulation layer of the second insulated conductor is removed to form a second discharge portion, and another portion of the insulation layer of the second insulated conductor is removed to form a third discharge portion; both the second discharge portion and the third discharge portion can contact the liquid in the balloon; both the second discharge portion and the third discharge portion are located in the gap between the first outer electrode sheath and the second outer electrode sheath;

[0080] a third insulated wire; a portion of the third insulated wire is crimped between the outer wall of the catheter and the inner wall of the second outer electrode sheath; a portion of the insulation layer of the third insulated wire is removed to form a fourth discharge portion; the fourth discharge portion can contact the liquid in the balloon; the fourth discharge portion is located in the gap between the first outer electrode sheath and the second outer electrode sheath;

[0081] When a voltage is applied between the first insulated wire and the third insulated wire, a discharge arc may be generated in the liquid between the first discharge part and the first outer electrode sheath, a discharge arc may be generated in the liquid between the first outer electrode sheath and the second discharge part, a discharge arc may be generated in the liquid between the third discharge part and the second outer electrode sheath, and a discharge arc may be generated in the liquid between the second outer electrode sheath and the fourth discharge part; so as to allow current to pass through the first discharge part, the first outer electrode sheath, the second discharge part, the third discharge part, the second outer electrode sheath, and the fourth discharge part in sequence.

[0082] In the above embodiment, optionally, Fig.10 As shown, the first inner electrode 303, the second inner electrode 304, the third inner electrode 307, and the fourth inner electrode 308 are all in the shape of arc plates; and the inner walls of the first inner electrode 303, the second inner electrode 304, the third inner electrode 307, and the fourth inner electrode 308 are all attached to the outer wall of the catheter;

[0083] The first electrode assembly further includes a first insulating sheath 302; the first insulating sheath 302 is located between the first outer electrode sheath 301 and the first inner electrode 303, and is used to insulate and separate the first outer electrode sheath 301 and the first inner electrode 303; and the first insulating sheath 302 is located between the first outer electrode sheath 301 and the second inner electrode 304, and is used to insulate and separate the first outer electrode sheath 301 and the second inner electrode 304;

[0084] The second electrode assembly also includes a second insulating sheath 306; the second insulating sheath 306 is located between the second outer electrode sheath 305 and the third inner electrode 307, and is used to insulate and separate the second outer electrode sheath 305 and the third inner electrode 307; and the second insulating sheath 306 is located between the second outer electrode sheath 305 and the fourth inner electrode 308, and is used to insulate and separate the second outer electrode sheath 305 and the fourth inner electrode 308.

[0085] Optionally, the arc angle corresponding to the first inner electrode 303 is 30° to 120°; the arc angle corresponding to the second inner electrode 304 is 30° to 120°; the arc angle corresponding to the third inner electrode 307 is 30° to 120°; and the arc angle corresponding to the fourth inner electrode 308 is 30° to 120°.

[0086] The first inner electrode 303 , the second inner electrode 304 , the third inner electrode 307 , and the fourth inner electrode 308 are all in the shape of arc plates, so that the discharge position of each electrode pair is random, and shock waves can be applied to more positions on the circumference of the blood vessel.

[0087] In the embodiment of the present application, the circumferential spacing angle between the discharge portions may be the circumferential spacing angle between the geometric centers of the discharge portions, or may be the spacing angle between adjacent circumferential end faces of the discharge portions.

[0088] It should be noted that, in the description of this specification, the terms "first", "second", etc. are only used for descriptive purposes and to distinguish similar objects. There is no order of precedence between the two, and they cannot be understood as indicating or implying relative importance. In addition, in the description of this specification, unless otherwise specified, the meaning of "plurality" is two or more.

[0089] The above embodiments are only for illustrating the technical concept and features of the present application, and their purpose is to enable people familiar with the technology to understand the content of the present application and implement it accordingly, and they cannot be used to limit the protection scope of the present application. Any equivalent changes or modifications made according to the spirit of the present application should be included in the protection scope of the present application.

[0090] It should be understood that the above description is for illustration and not for limitation. By reading the above description, many embodiments and many applications beyond the provided examples will be apparent to those skilled in the art. For comprehensive purposes, all articles and references, including the disclosures of patent applications and announcements, are incorporated herein by reference.

Claims

1. A shock wave balloon catheter device, comprising a catheter, a balloon sealed around the outer circumference of the catheter, a first electrode assembly and a second electrode assembly arranged in the balloon, wherein the balloon can be filled with liquid; The first electrode assembly includes A first outer electrode sheath; the first outer electrode sheath is sleeved on the outer circumference of the catheter; a first inner electrode; the first inner electrode comprises a first discharge portion and a first fixing portion; the first fixing portion is located between the outer wall of the catheter and the inner wall of the first outer electrode sheath; the first discharge portion can contact the liquid in the balloon; the first outer electrode sheath and the first inner electrode are configured to be insulated and separated; a second inner electrode; the second inner electrode comprises a second discharge portion and a second fixing portion; the second fixing portion is located between the outer wall of the catheter and the inner wall of the first outer electrode sheath; the second discharge portion can contact the liquid in the balloon; the second discharge portion and the first discharge portion are arranged at intervals along the circumference of the catheter; the first outer electrode sheath and the second inner electrode are configured to be insulated and separated; The second electrode assembly includes a second outer electrode sheath; the second outer electrode sheath is sleeved on the outer periphery of the catheter; and the second outer electrode sheath and the first outer electrode sheath are arranged axially at intervals; a third inner electrode; the third inner electrode comprises a third discharge portion and a third fixing portion; the third fixing portion is located between the outer wall of the catheter and the inner wall of the second outer electrode sheath; the third discharge portion can contact the liquid in the balloon; the third inner electrode is electrically connected to the second inner electrode; the second outer electrode sheath and the third inner electrode are configured to be insulated and separated; a fourth inner electrode; the fourth inner electrode comprises a fourth discharge portion and a fourth fixing portion; the fourth fixing portion is located between the outer wall of the catheter and the inner wall of the second outer electrode sheath; the fourth discharge portion can contact the liquid in the balloon; the fourth discharge portion and the third discharge portion are arranged at intervals along the circumference of the catheter; the second outer electrode sheath and the fourth inner electrode are configured to be insulated and separated; When a voltage is applied between the first inner electrode and the fourth inner electrode, a discharge arc may be generated in the liquid between the first discharge portion and the first outer electrode sheath, a discharge arc may be generated in the liquid between the first outer electrode sheath and the second discharge portion, a discharge arc may be generated in the liquid between the third discharge portion and the second outer electrode sheath, and a discharge arc may be generated in the liquid between the second outer electrode sheath and the fourth discharge portion; To allow current to sequentially pass through the first discharge portion, the first outer electrode sheath, the second discharge portion, the third discharge portion, the second outer electrode sheath, and the fourth discharge portion; Features: The first discharge portion, the second discharge portion, the third discharge portion, and the fourth discharge portion are all located at a gap between the first outer electrode sheath and the second outer electrode sheath.

2. The device according to claim 1, characterized in that: The first discharge portion and the third discharge portion are located at substantially the same position in the circumferential direction; the second discharge portion and the fourth discharge portion are located at substantially the same position in the circumferential direction; or, The first discharge portion and the fourth discharge portion are located at substantially the same position in the circumferential direction; the second discharge portion and the third discharge portion are located at substantially the same position in the circumferential direction.

3. The device according to claim 2, characterized in that: The angle between the first discharge portion and the second discharge portion in the circumferential direction is greater than 150°; or, An angle between the first discharge portion and the second discharge portion along the circumferential direction is greater than 30° and less than 150°.

4. The device according to claim 1, characterized in that: The first discharge portion and the second discharge portion have a first circumferential gap along the circumferential direction; the circumferential angle corresponding to the first circumferential gap is greater than 30° and less than 150°; The third discharge portion and the fourth discharge portion are arranged substantially symmetrically along the axis; and at least a portion of a circumferential position of one of the third discharge portion and the fourth discharge portion is located within the first circumferential gap.

5. The device according to claim 1, characterized in that: The first discharge portion and the second discharge portion have a first circumferential gap and a second circumferential gap along the circumferential direction; the circumferential angle corresponding to the first circumferential gap is greater than 30° and less than 150°; the circumferential angle corresponding to the second circumferential gap is greater than the circumferential angle corresponding to the first circumferential gap; Among the third discharge portion and the fourth discharge portion, at least a portion of the circumferential position of one discharge portion is located at the first circumferential gap, and the circumferential position of the other discharge portion is located at approximately the center of the second circumferential gap.

6. The device according to claim 1, characterized in that: The first discharge portion and the second discharge portion have a first circumferential gap and a second circumferential gap along the circumferential direction; the circumferential angle corresponding to the first circumferential gap is greater than 30° and less than 150°; the circumferential angle corresponding to the second circumferential gap is greater than the circumferential angle corresponding to the first circumferential gap; Among the third discharge portion and the fourth discharge portion, at least part of the circumferential position of one discharge portion is located in the first circumferential gap, and the circumferential position of the other discharge portion is located in the second circumferential gap; the one discharge portion and the first discharge portion have a first circumferential gap along the circumference, and the one discharge portion and the second discharge portion have a first second circumferential gap along the circumference; The other discharge portion and the first discharge portion have a second circumferential gap along the circumferential direction, and the other discharge portion and the second discharge portion have a second second circumferential gap along the circumferential direction; The circumferential angle corresponding to the first circumferential gap is smaller than the circumferential angle corresponding to the second circumferential gap, and the circumferential angle corresponding to the first circumferential gap is smaller than the circumferential angle corresponding to the second circumferential gap; The circumferential angle corresponding to the first two circumferential gaps is smaller than the circumferential angle corresponding to the second circumferential gap, and the circumferential angle corresponding to the first two circumferential gaps is smaller than the circumferential angle corresponding to the second two circumferential gaps.

7. The device according to any one of claims 1 to 6, characterized in that: An axial distance between adjacent end surfaces of the first outer electrode sheath and the second outer electrode sheath is between 1 mm and 5 mm.

8. The device according to claim 1, characterized in that: The first inner electrode constitutes a first insulated wire, and a portion of the insulating layer of the first insulated wire is removed to constitute the first discharge portion; The second inner electrode and the third inner electrode constitute a second insulated wire, a portion of the insulation layer of the second insulated wire is removed to constitute the second discharge portion, and another portion of the insulation layer of the second insulated wire is removed to constitute the third discharge portion; The third internal electrode constitutes a third insulated conductive line, and a portion of the insulating layer of the third insulated conductive line is removed to constitute the fourth discharge portion.

9. The device according to claim 1, characterized in that: The first inner electrode, the second inner electrode, the third inner electrode, and the fourth inner electrode are all in the shape of arc plates; and the inner walls of the first inner electrode, the second inner electrode, the third inner electrode, and the fourth inner electrode are all attached to the outer wall of the catheter; The first electrode assembly further includes a first insulating sheath; the first insulating sheath is located between the first outer electrode sheath and the first inner electrode, and is used to insulate and separate the first outer electrode sheath and the first inner electrode; and the first insulating sheath is located between the first outer electrode sheath and the second inner electrode, and is used to insulate and separate the first outer electrode sheath and the second inner electrode; The second electrode assembly also includes a second insulating sheath; the second insulating sheath is located between the second outer electrode sheath and the third inner electrode, and is used to insulate and separate the second outer electrode sheath and the third inner electrode; and the second insulating sheath is located between the second outer electrode sheath and the fourth inner electrode, and is used to insulate and separate the second outer electrode sheath and the fourth inner electrode.

10. The device according to claim 9, characterized in that: The arc angle corresponding to the first inner electrode is 30° to 120°; the arc angle corresponding to the second inner electrode is 30° to 120°; the arc angle corresponding to the third inner electrode is 30° to 120°; and the arc angle corresponding to the fourth inner electrode is 30° to 120°.

11. A shock wave balloon catheter device, comprising a catheter, and a balloon sealed around the outer circumference of the catheter, wherein the balloon can be filled with a liquid; A first outer electrode sheath; the first outer electrode sheath is sleeved on the outer circumference of the catheter; A second outer electrode sheath; the second outer electrode sheath is sleeved on the outer circumference of the catheter; The second outer electrode sheath and the first outer electrode sheath are arranged spaced apart in the axial direction; a first insulated wire; a portion of the first insulated wire is crimped between the outer wall of the catheter and the inner wall of the first outer electrode sheath; a portion of the insulation layer of the first insulated wire is removed to form a first discharge portion; the first discharge portion can contact the liquid in the balloon; a second insulated wire; a portion of the second insulated wire is crimped between the outer wall of the catheter and the inner wall of the first outer electrode sheath, and another portion of the second insulated wire is crimped between the outer wall of the catheter and the inner wall of the second outer electrode sheath; a portion of the insulation layer of the second insulated wire is removed to form a second discharge portion, and another portion of the insulation layer of the second insulated wire is removed to form a third discharge portion; both the second discharge portion and the third discharge portion can contact the liquid in the balloon; a third insulated wire; a portion of the third insulated wire is crimped between the outer wall of the catheter and the inner wall of the second outer electrode sheath; a portion of the insulation layer of the third insulated wire is removed to form a fourth discharge portion; the fourth discharge portion can contact the liquid in the balloon; When a voltage is applied between the first insulated wire and the third insulated wire, a discharge arc may be generated in the liquid between the first discharge portion and the first outer electrode sheath, a discharge arc may be generated in the liquid between the first outer electrode sheath and the second discharge portion, a discharge arc may be generated in the liquid between the third discharge portion and the second outer electrode sheath, and a discharge arc may be generated in the liquid between the second outer electrode sheath and the fourth discharge portion; To allow current to sequentially pass through the first discharge portion, the first outer electrode sheath, the second discharge portion, the third discharge portion, the second outer electrode sheath, and the fourth discharge portion; Features: The first discharge portion, the second discharge portion, the third discharge portion, and the fourth discharge portion are all located at a gap between the first outer electrode sheath and the second outer electrode sheath.

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