Bending-adjustable endovascular shock wave catheter assembly

Abstract

The invention discloses a bending-adjustable intravascular shock wave catheter assembly, which relates to the technical field of medical instruments and comprises a catheter, an electrode fixing seat, a balloon, a forward shock wave generating electrode pair, a handle, a balloon control assembly, a shock wave control assembly and a four-way bending adjusting assembly, the electrode fixing seat and the balloon are arranged at one end of the catheter; the forward shock wave generating electrode pair is arranged on the electrode fixing seat and is positioned in the balloon; the handle is connected with the catheter; the balloon control assembly is connected with the balloon; the shock wave control assembly is connected with the forward shock wave generation electrode pair; the four-direction bending adjusting assembly is arranged in the guide pipe. The unique design structure can be compatible with a plaque opening electrode pair, and an occluded plaque can be opened forwards, so that the catheter can smoothly pass through a lesion position with relatively high stenosis; and the catheter can smoothly pass through tortuous blood vessels with various difficulties without the help of a guide wire, so that the catheter can smoothly reach a lesion position to carry out treatment.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to an adjustable curved intravascular shock wave catheter assembly. Background Art

[0002] Chronic total occlusion (CTO) is a term used to describe atherosclerotic vessels that are highly calcified to the point where the vessel lumen is completely blocked. CTOs can occur in the heart or in peripheral arteries and significantly increase the risk of heart failure and lower limb amputation. CTO cases in the operating room are also particularly challenging because the lesion is difficult to cross with a traditional guidewire, resulting in a nearly two-fold increase in procedure time and fluoroscopic exposure.

[0003] The advent of new technologies and devices has helped the heart team increase the chances of successful revascularization in patients with CTOs. Chief among these is a set of guidewire crossing techniques that follow a standard algorithm to accommodate different lesion morphologies. Using specially designed crossing guidewires, skilled operators can cross CTOs in a greatly reduced time. Once crossed, standard angioplasty balloon dilatation and stent placement can be performed.

[0004] However, there remains a significant problem where the guidewire is able to pass through a lesion but the balloon angioplasty catheter cannot due to its larger profile. These lesions, known as balloon-traversable lesions, require the use of further specialized devices, known as traversing devices or penetrating catheters. These devices are tracked over the guidewire and, when reaching the balloon-impenetrable lesion, utilize various techniques to create a larger channel through which the balloon angioplasty catheter can pass.

[0005] Since the advent of CTO technology in percutaneous coronary intervention (CTO-PCI), many devices and techniques have been described over time, ranging from simple mechanical methods using high-rpm catheters to drill through the lesion, to the use of laser and radiofrequency energy to ablate and eliminate calcified material.

[0006] The existing angioplasty surgery is to place an expandable balloon in the blood vessel, and the mechanical stress of the rapid expansion of the balloon acts on the calcification to break it up. However, balloon dilatation surgery is only suitable for large, centralized calcification deposits, and cannot handle calcification foci that are dispersed or deep into the ventricle. The calcium removal efficiency is low and incomplete. If the patient's arterial calcification is more serious, or the narrowed blood vessel segment is longer, the effect of balloon dilatation is relatively poor.

[0007] Rapid balloon expansion can cause a sudden change in pressure on the blood vessel wall, which can easily damage the blood vessel and even cause thrombosis. In addition, balloon expansion requires very high pressure (sometimes the pressure can reach 20 to 30 standard atmospheres, or even 40 standard atmospheres). Such pressure usually leads to a significant increase in the probability of rebound stenosis, dissection, perforation, and rupture of the blood vessels. Such surgical events are particularly serious in cases of eccentric calcified lesions because the pressure of the balloon acts on soft tissue without calcification.

[0008] When the patient's intravascular plaque is hard and the stenosis is severe, the balloon may not be able to pass through the calcified area at all, let alone have a therapeutic effect. Therefore, more effective medical devices are needed to solve this problem. Summary of the invention

[0009] In order to solve the above technical problems, the present invention provides an adjustable curved intravascular shock wave guide assembly, and the specific technical solution is as follows:

[0010] An adjustable curved intravascular shock wave catheter assembly, comprising:

[0011] catheter;

[0012] An electrode fixing seat is arranged at one end of the catheter;

[0013] A balloon connected to the electrode fixing seat away from one end of the catheter;

[0014] A forward shock wave generating electrode pair is disposed on the electrode fixing seat and is located inside the balloon;

[0015] A handle connected to the other end of the catheter;

[0016] A balloon control component connected to the balloon;

[0017] a shock wave control assembly connected to the forward shock wave generating electrode pair;

[0018] A four-way bending component is arranged in the catheter.

[0019] Preferably, the forward shock wave generating electrode pair comprises:

[0020] The outer electrode is a sleeve-shaped structure, one end of which is sleeved on the electrode fixing seat, and the other end of which is surrounded by a plurality of first inner electrode mounting holes;

[0021] An inner electrode, the number of which is consistent with the number of the first inner electrode mounting holes, one end of the inner electrode is connected to the electrode fixing seat, the other end is inserted into the first inner electrode mounting hole, and the end surface of the inner electrode is lower than the hole surface of the first inner electrode mounting hole;

[0022] A liquid injection cavity is formed between the first inner electrode mounting hole and the inner electrode.

[0023] Preferably:

[0024] The other end of the outer electrode is further provided with a connecting portion, and the connecting portion is located at the center of the plurality of first inner electrode mounting holes;

[0025] The balloon is an annular structure, the inner peripheral side of the annular structure is connected to the connecting part, and the outer peripheral side is connected to the outer peripheral surface of the catheter.

[0026] Preferably, the balloon control assembly includes an infusion tube disposed in the catheter, one end of the infusion tube is connected to the balloon, and the other end of the infusion tube passes through the handle and extends outside the handle.

[0027] Preferably, the connecting portion is a hole-type structure, and one end of the infusion tube connected to the balloon is a side opening structure, and the side opening structure includes:

[0028] A closed end is inserted into the hole structure and connected to the inner circumference of the annular structure;

[0029] A first communicating hole is provided on the side of the closed end, a second communicating hole is provided on the outer peripheral surface of the catheter at a position opposite to the first communicating hole, and the infusion tube is connected to the balloon through the first communicating hole and the second communicating hole.

[0030] Preferably:

[0031] A second inner electrode mounting hole is provided on the electrode fixing seat at a position opposite to the first inner electrode mounting hole, and one end of the inner electrode is fixed in the second inner electrode mounting hole;

[0032] The electrode fixing seat is provided with an infusion tube installation hole at a position opposite to the connecting portion, and the infusion tube passes through the infusion tube installation hole.

[0033] Preferably:

[0034] The infusion tube includes a first end adjacent to the balloon and a second end away from the balloon, and the four-way bending assembly includes:

[0035] A telescopic cavity is provided in the catheter, the number of the telescopic cavities is four, the four telescopic cavities are arranged around the circumference of the catheter and extend along the length direction of the catheter, and the two ends of the telescopic cavity are respectively connected to the first end and the second end;

[0036] A pressure flap, the number of which is consistent with the number of the telescopic chambers, the pressure flap is arranged at the connection between the telescopic chamber and the first end, and is used to control the connection and closure between the telescopic chamber and the first end, and the opening pressure of the pressure flap is greater than the extension pressure of the telescopic chamber;

[0037] The magnetic adsorption opening and closing structure is arranged at the connection point between the telescopic cavity and the second end, and is used to control the connection and closing of the telescopic cavity and the second end.

[0038] Preferably:

[0039] A pleated annular surface is formed at the connection between the first end and the second end, a cross-shaped isolation membrane is arranged inside the pleated annular surface, and the telescopic cavity is formed between the pleated annular surface and the cross-shaped isolation membrane;

[0040] The magnetic adsorption opening and closing structure includes a movable magnetic plug arranged at one end of the cross-shaped isolation membrane adjacent to the second end, and an electromagnet arranged on the inner side wall of one end of the telescopic cavity adjacent to the second end.

[0041] Preferably, the peripheral side surface of the conduit opposite to the pleated annular surface is an elastic expansion surface, and a through hole is provided on the elastic expansion surface.

[0042] Preferably:

[0043] The balloon control assembly further comprises a Luer connector, which is connected to an end of the infusion tube away from the balloon;

[0044] The shock wave control component includes an outer electrode wire and an inner electrode wire, wherein one end of the outer electrode wire is connected to the outer electrode, and the other end passes through the catheter and extends to the outside of the handle to be connected to an electric control connector, and one end of the inner electrode wire is connected to the inner electrode, and the other end passes through the catheter and extends to the outside of the handle to be connected to the electric control connector.

[0045] The adjustable curved intravascular shock wave catheter assembly provided by the present invention has the following beneficial effects:

[0046] 1. The guidewire-free catheter structure design is a low-profile catheter assembly.

[0047] 2. The unique design structure is compatible with the plaque opening electrode pair. The catheter's opening electrode pair can open the occluded plaque forward, allowing the catheter to pass smoothly through the lesion with a higher degree of stenosis.

[0048] 3. The unique bending structure and various bending types can ensure that the catheter can smoothly pass through tortuous blood vessels of various difficulties without the help of a guide wire, so that the catheter can smoothly reach the lesion site and start treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] In order to more clearly illustrate the embodiments of the present invention 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 recorded in the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0050] Figure 1 A schematic diagram of the three-dimensional structure of an adjustable curved intravascular shock wave guide tube assembly provided in an embodiment of the present invention;

[0051] Figure 2 A diagram showing the connection structure of a balloon and a catheter provided in an embodiment of the present invention;

[0052] Figure 3 A schematic diagram of the three-dimensional structure of a forward shock wave generating electrode pair provided in an embodiment of the present invention;

[0053] Figure 4 An exploded view of the structure of a forward shock wave generating electrode pair provided in an embodiment of the present invention;

[0054] Figure 5 A sectional front view of the distal end of an adjustable curved intravascular shock wave guide assembly provided by an embodiment of the present invention;

[0055] Figure 6 A cross-sectional side view of a four-way bending assembly provided in an embodiment of the present invention;

[0056] Figure 7 A schematic diagram of a single-side bending adjustment of an adjustable-bend intravascular shock wave catheter assembly provided in an embodiment of the present invention;

[0057] Figure 8 A schematic diagram of the double-sided bending of the adjustable intravascular shock wave catheter assembly provided in an embodiment of the present invention.

[0058] Reference numerals

[0059] 1-conduit; 11-second communication hole; 12-through hole;

[0060] 2-electrode fixing seat; 21-second inner electrode mounting hole; 22-infusion tube mounting hole;

[0061] 3-Balloon;

[0062] 4-forward shock wave generating electrode pair; 41-external electrode; 411-first internal electrode mounting hole; 412-connecting portion; 42-internal electrode; 43-liquid injection cavity;

[0063] 5-Handle;

[0064] 6-balloon control assembly; 61-infusion tube; 611-closed end; 612-first communication hole; 613-corrugated annulus; 614-cross-shaped isolation membrane; 62-Luer connector;

[0065] 7- shock wave control assembly; 71- outer electrode wire; 72- inner electrode wire; 73- electric control connector;

[0066] 8-four-way bending adjustment component; 81-telescopic chamber; 82-pressure flap; 83-magnetic adsorption opening and closing structure; 831-movable magnetic plug; 832-electromagnet. DETAILED DESCRIPTION

[0067] In order to enable those skilled in the art to better understand the technical solution of the present invention, the present invention is described in detail below in conjunction with the accompanying drawings. The description in this part is only exemplary and explanatory and should not have any limiting effect on the protection scope of the present invention.

[0068] It should be noted that similar reference numerals denote similar items in the following drawings, and therefore, once an item is defined in one drawing, it does not require further definition and explanation in the subsequent drawings.

[0069] It should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship are based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the invented product is usually placed when in use, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", etc. are only used to distinguish the description, and cannot be understood as indicating or implying relative importance.

[0070] In addition, the terms "horizontal", "vertical", "overhanging" and the like do not mean that the components are required to be absolutely horizontal or overhanging, but can be slightly tilted. For example, "horizontal" only means that its direction is more horizontal than "vertical", and does not mean that the structure must be completely horizontal, but can be slightly tilted.

[0071] In the description of the present invention, it is also necessary to explain that, unless otherwise clearly specified and limited, the terms "set", "install", "connect", and "connect" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0072] See also Figures 1 to 8 This embodiment provides an adjustable bending intravascular shock wave catheter assembly, including a catheter 1, an electrode fixing seat 2, a balloon 3, a forward shock wave generating electrode pair 4, a handle 5, a balloon control assembly 6, a shock wave control assembly 7 and a four-way bending assembly 8.

[0073] The electrode fixing seat 2 is arranged at one end of the catheter 1 .

[0074] The balloon 3 is connected to the end of the electrode fixing seat 2 away from the catheter 1 .

[0075] The forward shock wave generating electrode pair 4 is arranged on the electrode fixing seat 2 and is located inside the balloon 3 .

[0076] The handle 5 is connected to the other end of the catheter 1 .

[0077] The balloon control component 6 is connected to the balloon 3 .

[0078] The shock wave control assembly 7 is connected to the forward shock wave generating electrode pair 4 .

[0079] The four-way bending assembly 8 is arranged in the catheter 1 .

[0080] Among them, the balloon 3 can be a compliant balloon, made of soft materials such as natural latex, silicone, TPU, etc.; the effective length of the balloon 3 after expansion is 3 to 18 mm, and the diameter of the balloon 3 after expansion is 2 to 12 mm; the effective length of the catheter 1 is 50 to 150 cm, and the diameter of the catheter 1 is 1 to 3 mm. The balloon control component 6 can inject liquid into the balloon 3 to expand the balloon 3. After the balloon 3 expands, it can form a tight forward fit with the blocked plaque in the blood vessel. The shock wave control component 7 controls the forward shock wave generating electrode pair 4 to form an instantaneous high voltage to generate an arc. The bubble expansion and collapse generated by the arc are accompanied by shock waves. The shock waves generated by the electrode pair are radially transmitted to the surface of the balloon 3 through the liquid inside the balloon 3, and then transmitted to the calcified lesion through the surface of the balloon 3. When the shock wave is transmitted forward to the calcified lesion, the compression stress of the shock wave will cause the calcified tissue inside the vascular occlusion to soften and lyse, so that the balloon catheter can pass through the vascular occlusion to achieve a good effect of opening the blood vessel. Shock waves of appropriate intensity can destroy calcified tissue without causing additional burden on the soft tissue surrounding the calcified tissue.

[0081] The four-way bending assembly 8 can be used to control the catheter 1 to bend in four directions. The bending modes can be divided into single-side bending and multi-side bending. The types can be divided into F-bend, L-bend, E-bend, T-bend, FF-bend, LL-bend, EE-bend, TT-bend, etc. Figure 7 and Figure 8 .

[0082] The adjustable curved intravascular shock wave catheter assembly provided in this embodiment has the following beneficial effects:

[0083] 1. The guidewire-free catheter structure design is a low-profile catheter assembly.

[0084] 2. The unique design structure is compatible with the plaque opening electrode pair. The catheter's opening electrode pair can open the occluded plaque forward, allowing the catheter to pass smoothly through the lesion with a higher degree of stenosis.

[0085] 3. The unique bending structure and various bending types can ensure that the catheter can smoothly pass through tortuous blood vessels of various difficulties without the help of a guide wire, so that the catheter can smoothly reach the lesion site and start treatment.

[0086] For further information, see Figure 3 and Figure 4 The forward shock wave generating electrode pair 4 includes an outer electrode 41 , an inner electrode 42 and a liquid injection cavity 43 .

[0087] The outer electrode 41 is a sleeve-shaped structure. One end of the outer electrode 41 is sleeved on the electrode fixing seat 2, and the other end is surrounded by a plurality of first inner electrode mounting holes 411.

[0088] The number of the inner electrodes 42 is consistent with the number of the first inner electrode mounting holes 411 . One end of the inner electrode 42 is connected to the electrode fixing seat 2 , and the other end is passed through the first inner electrode mounting hole 411 . The end surface of the inner electrode 42 is lower than the hole surface of the first inner electrode mounting hole 411 .

[0089] The liquid injection cavity 43 is formed between the first inner electrode mounting hole 411 and the inner electrode 42 .

[0090] The outer electrode 41 is in the shape of a wine glass cylinder, with a diameter of 0.1-1.0 mm and a wall thickness of 0.03-0.3 mm. The outer electrode 41 may be made of stainless steel, tungsten, platinum-iridium, nickel, iron, steel and / or other conductive materials.

[0091] The first inner electrode mounting hole 411 may have a diameter of 0.2-1.0 mm, and the number thereof may be 1 or more, preferably 3, so the number of the forward electrode pairs may be 1-8 pairs.

[0092] The electrode holder 2 may be made of polyethylene, polypropylene, polycarbonate, Peek, nylon 12, nylon 66, polyurethane, polyimide, PET and other materials.

[0093] The liquid in the balloon 3 can flow into the injection cavity 43. When instantaneous high voltage is applied to the electrode pair, an arc is generated between the outer electrode 41 and the inner electrode 42. The bubble expansion and collapse caused by the arc generates a shock wave. Since the end face of the inner electrode 42 is lower than the hole surface of the first inner electrode mounting hole 411, the shock wave diverges forward under the guidance of the inner side wall of the first inner electrode mounting hole 411.

[0094] Furthermore, a connecting portion 412 is further provided at the other end of the outer electrode 41 , and the connecting portion 412 is located at the center of the plurality of first inner electrode mounting holes 411 .

[0095] The balloon 3 is an annular structure, the inner circumference of the annular structure is connected to the connecting portion 412 , and the outer circumference is connected to the outer circumference of the catheter 1 , so that the balloon 3 can cover the forward shock wave generating electrode pair 4 therein.

[0096] For further information, see Figure 5 The balloon control assembly 6 includes an infusion tube 61 disposed in the catheter 1 , one end of the infusion tube 61 is connected to the balloon 3 , and the other end passes through the handle 5 and extends outside the handle 5 , so as to inject liquid into the balloon 3 .

[0097] For further information, see Figure 4 and Figure 5 The connecting portion 412 is a hole-type structure, and one end of the infusion tube 61 connected to the balloon 3 is a side opening structure, which includes a closed end 611 and a first connecting hole 612 .

[0098] The closed end 611 is inserted into the hole structure and connected to the inner circumference of the annular structure.

[0099] The first connecting hole 612 is provided at the side of the closed end 611 , and the outer peripheral surface of the catheter 1 is provided with a second connecting hole 11 at a position opposite to the first connecting hole 612 . The infusion tube 61 is connected to the balloon 3 through the first connecting hole 612 and the second connecting hole 11 .

[0100] The connection method between the inner circumference of the annular structure and the closed end 611, and the connection method between the outer circumference and the outer circumference of the catheter 1 can be adhesive, welding, binding, etc. The connecting portion 412 is for passing through the closed end 611, and its diameter can be 0.2 to 2.0 mm. The first connecting hole 612 and the second connecting hole 11 can be formed by laser punching, drilling, etc. The closed end 611 is set at the farthest end of the infusion tube 61 to ensure that the balloon 3 can be filled smoothly.

[0101] For further information, see Figure 4 A second inner electrode mounting hole 21 is provided on the electrode fixing seat 2 at a position corresponding to the first inner electrode mounting hole 411 , and one end of the inner electrode 42 is fixed in the second inner electrode mounting hole 21 .

[0102] An infusion tube installation hole 22 is provided on the electrode fixing seat 2 at a position relative to the connecting portion 412 , and the infusion tube 61 passes through the infusion tube installation hole 22 .

[0103] The diameter of the second inner electrode mounting hole 21 may be 0.2-1.0 mm, and the number of the second inner electrode mounting holes 21 is consistent with the number of the first inner electrode mounting holes 411; the diameter of the infusion tube mounting hole 22 may be 0.2-2.0 mm.

[0104] For further information, see Figure 6 The infusion tube 61 includes a first end adjacent to the balloon 3 and a second end away from the balloon 3 , and the four-way bending assembly 8 includes a telescopic cavity 81 , a pressure flap 82 and a magnetic adsorption opening and closing structure 83 .

[0105] The telescopic chamber 81 is disposed in the catheter 1 . There are four telescopic chambers 81 . The four telescopic chambers 81 are arranged circumferentially around the catheter 1 and extend along the length direction of the catheter 1 . Two ends of the telescopic chamber 81 are connected to the first end and the second end respectively.

[0106] The number of pressure flaps 82 is consistent with the number of telescopic chambers 81. The pressure flap 82 is arranged at the connection between the telescopic chamber 81 and the first end, and is used to control the connection and closure between the telescopic chamber 81 and the first end. The opening pressure of the pressure flap 82 is greater than the extension pressure of the telescopic chamber 81.

[0107] The magnetic adsorption opening and closing structure 83 is arranged at the connection point between the telescopic cavity 81 and the second end, and is used to control the connection and closing of the telescopic cavity 81 and the second end.

[0108] Among them, the magnetic adsorption opening and closing structure 83 can be used to control one of the four telescopic chambers 81 to be closed with the second end. When one of them is closed, the second end of the infusion tube 61 can inject liquid into the other three telescopic chambers 81. Since the opening pressure of the pressure flap 82 is greater than the extension pressure of the telescopic chamber 81, the other three telescopic chambers 81 will extend after the liquid is injected, thereby bending toward the closed telescopic chamber 81. When it is necessary to control the bending of the catheter 1, it is only necessary to close the corresponding telescopic chamber 81 through the magnetic adsorption opening and closing structure 83; when the four telescopic chambers 81 are all connected to the second end, the second end can inject liquid into the four telescopic chambers 81. At this time, the four telescopic chambers 81 are all extended, the catheter 1 does not bend, and the liquid continues to be injected. After the telescopic chamber 81 is extended to the longest, the pressure gradually increases, thereby pushing the pressure flap 82, so that the four pressure flaps 82 are all opened, and the liquid can flow into the first end of the infusion tube 61, thereby filling the balloon 3. If the balloon 3 needs to be reduced, the liquid can be extracted.

[0109] For further information, please see Figure 6 :

[0110] A pleated annular surface 613 is formed at the connection between the first end and the second end. A cross-shaped isolation membrane 614 is provided inside the pleated annular surface 613 . A telescopic cavity 81 is formed between the pleated annular surface 613 and the cross-shaped isolation membrane 614 .

[0111] The magnetic attraction opening and closing structure 83 includes a movable magnetic plug 831 arranged on one end of the cross-shaped isolation membrane 614 near the second end, and an electromagnet 832 arranged on the inner side wall of one end of the telescopic cavity 81 near the second end.

[0112] The movable magnetic plug 831 may be a plastic plug doped with iron powder or magnetic powder, and the electromagnet 832 on the inner wall of the telescopic cavity 81 may magnetically attract the movable magnetic plug 831 to close the corresponding telescopic cavity 81 .

[0113] Furthermore, the peripheral side surface of the catheter 1 relative to the pleated annular surface 613 is an elastic expansion surface, and a through hole 12 is provided on the elastic expansion surface, so as to facilitate the expansion and contraction of the pleated annular surface 613 .

[0114] Further:

[0115] The balloon control assembly 6 further includes a Luer connector 62 , which is connected to an end of the infusion tube 61 away from the balloon 3 .

[0116] The shock wave control assembly 7 includes an outer electrode wire 71 and an inner electrode wire 72. One end of the outer electrode wire 71 is connected to the outer electrode 41, and the other end passes through the catheter 1 and extends to the outside of the handle 5 to be connected to an electric control connector 73. One end of the inner electrode wire 72 is connected to the inner electrode 42, and the other end passes through the catheter 1 and extends to the outside of the handle 5 to be connected to the electric control connector 73.

[0117] The connection method between the outer electrode 41 and the outer electrode wire 71, and between the inner electrode 42 and the inner electrode wire 72 can be brazing, laser welding, resistance welding, conductive silver paste connection, etc.

[0118] Principle description:

[0119] The balloon 3 can be a compliant balloon made of a soft material such as natural latex, silicone, TPU, etc.; the effective length of the balloon 3 after expansion is 3 to 18 mm, and the diameter of the balloon 3 after expansion is 2 to 12 mm; the effective length of the catheter 1 is 50 to 150 cm, and the diameter of the catheter 1 is 1 to 3 mm. The balloon control component 6 can inject liquid into the balloon 3 to expand the balloon 3. After the balloon 3 expands, it can form a tight forward fit with the blocked plaque in the blood vessel. The forward shock wave generating electrode pair 4 is controlled by the shock wave control component 7 to form an instantaneous high voltage to generate an arc. The expansion and collapse of the bubble generated by the arc is accompanied by the shock wave. The shock wave generated by the electrode pair is radially transmitted to the surface of the balloon 3 through the liquid inside the balloon 3, and then transmitted to the calcified lesion through the surface of the balloon 3. When the shock wave is transmitted forward to the calcified lesion, the compression stress of the shock wave will cause the calcified tissue inside the vascular occlusion to soften and lyse, so that the balloon catheter can pass through the vascular occlusion to achieve a good effect of opening the blood vessel. Shock waves of appropriate intensity can destroy calcified tissue without causing additional burden on the soft tissue surrounding the calcified tissue.

[0120] The four-way bending assembly 8 can be used to control the bending of the catheter 1. The bending modes can be divided into single-side bending and multi-side bending. The types can be divided into F-bend, L-bend, E-bend, T-bend, FF-bend, LL-bend, EE-bend, TT-bend, etc. Figure 7 and Figure 8 .

[0121] It should be noted that, in this article, the terms "comprises", "includes" or any other variations thereof are intended to cover non-exclusive inclusion, so that a process, method, article or apparatus that includes a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or apparatus.

[0122] This article uses specific examples to illustrate the principles and implementation methods of the present invention. The description of the above embodiments is only used to help understand the method of the present invention and its core ideas. The above are only preferred implementation methods of the present invention. It should be pointed out that due to the limitations of textual expression, there are objectively infinite specific structures. For ordinary technicians in this technical field, without departing from the principles of the present invention, several improvements, modifications or changes can be made, and the above technical features can be combined in an appropriate manner; these improvements, modifications, changes or combinations, or the direct application of the inventive concept and technical solution to other occasions without improvement, should be regarded as the protection scope of the present invention.

Claims

1. An adjustable curved intravascular shock wave catheter assembly, characterized in that: include: Catheter (1); An electrode fixing seat (2) is arranged at one end of the catheter (1); A balloon (3) connected to an end of the electrode fixing seat (2) away from the catheter (1); A forward shock wave generating electrode pair (4) is disposed on the electrode fixing seat (2) and is located inside the balloon (3); A handle (5) connected to the other end of the catheter (1); A balloon control component (6), connected to the balloon (3); A shock wave control component (7) connected to the forward shock wave generating electrode pair (4); A four-way bending component (8) is arranged in the catheter (1).

2. The adjustable curved intravascular shock wave guide tube assembly according to claim 1, characterized in that: The forward shock wave generating electrode pair (4) comprises: The outer electrode (41) is a sleeve-shaped structure, one end of the outer electrode (41) is sleeved on the electrode fixing seat (2), and the other end is surrounded by a plurality of first inner electrode mounting holes (411); The number of inner electrodes (42) is consistent with the number of the first inner electrode mounting holes (411), one end of the inner electrode (42) is connected to the electrode fixing seat (2), and the other end is inserted into the first inner electrode mounting hole (411), and the end surface of the inner electrode (42) is lower than the hole surface of the first inner electrode mounting hole (411); A liquid injection cavity (43) is formed between the first inner electrode mounting hole (411) and the inner electrode (42).

3. The adjustable curved intravascular shock wave catheter assembly according to claim 2, characterized in that: The other end of the outer electrode (41) is further provided with a connecting portion (412), and the connecting portion (412) is located at the center position of the plurality of first inner electrode mounting holes (411); The balloon (3) is an annular structure, the inner peripheral side of the annular structure is connected to the connecting portion (412), and the outer peripheral side is connected to the outer peripheral surface of the catheter (1).

4. The adjustable bend intravascular shock wave catheter assembly according to claim 3, characterized in that: The balloon control assembly (6) comprises an infusion tube (61) arranged in the catheter (1); one end of the infusion tube (61) is connected to the balloon (3), and the other end passes through the handle (5) and extends outside the handle (5).

5. The adjustable bend intravascular shock wave guide tube assembly according to claim 4, characterized in that: The connecting portion (412) is a hole-shaped structure, and one end of the infusion tube (61) connected to the balloon (3) is a side opening structure, and the side opening structure includes: A closed end (611) is inserted into the hole structure and connected to the inner circumference of the annular structure; A first connecting hole (612) is provided on the side of the closed end (611), and a second connecting hole (11) is provided on the outer peripheral surface of the catheter (1) at a position relative to the first connecting hole (612). The infusion tube (61) is connected to the balloon (3) through the first connecting hole (612) and the second connecting hole (11).

6. The adjustable bend intravascular shock wave catheter assembly according to claim 4, characterized in that: A second inner electrode mounting hole (21) is provided on the electrode fixing seat (2) at a position corresponding to the first inner electrode mounting hole (411), and one end of the inner electrode (42) is fixed in the second inner electrode mounting hole (21); The electrode fixing seat (2) is provided with an infusion tube installation hole (22) at a position relative to the connecting portion (412), and the infusion tube (61) passes through the infusion tube installation hole (22).

7. The adjustable bend intravascular shock wave guide tube assembly according to claim 4, characterized in that: The infusion tube (61) comprises a first end adjacent to the balloon (3) and a second end away from the balloon (3), and the four-way bending assembly (8) comprises: A telescopic cavity (81) is arranged in the catheter (1), the number of the telescopic cavities (81) is four, the four telescopic cavities (81) are arranged around the circumference of the catheter (1) and extend along the length direction of the catheter (1), and the two ends of the telescopic cavity (81) are respectively connected to the first end and the second end; pressure flaps (82), the number of which is consistent with the number of the telescopic chambers (81), the pressure flaps (82) being arranged at the connection between the telescopic chamber (81) and the first end, and being used to control the connection and closure between the telescopic chamber (81) and the first end, the opening pressure of the pressure flap (82) being greater than the extension pressure of the telescopic chamber (81); The magnetic adsorption opening and closing structure (83) is arranged at the connection point between the telescopic cavity (81) and the second end, and is used to control the connection and closing of the telescopic cavity (81) and the second end.

8. The adjustable bend intravascular shock wave guide tube assembly according to claim 7, characterized in that: A folded annular surface (613) is formed at the connection between the first end and the second end, a cross-shaped isolation membrane (614) is provided inside the folded annular surface (613), and the telescopic cavity (81) is formed between the folded annular surface (613) and the cross-shaped isolation membrane (614); The magnetic attraction opening and closing structure (83) comprises a movable magnetic plug (831) arranged on one end of the cross-shaped isolation membrane (614) adjacent to the second end, and an electromagnet (832) arranged on the inner side wall of one end of the telescopic cavity (81) adjacent to the second end.

9. The adjustable bend intravascular shock wave guide tube assembly according to claim 8, characterized in that: The peripheral side surface of the conduit (1) relative to the pleated annular surface (613) is an elastic and retractable surface, and a through hole (12) is provided on the elastic and retractable surface.

10. The adjustable bend intravascular shock wave guide tube assembly according to claim 4, characterized in that: The balloon control assembly (6) further comprises a Luer connector (62), wherein the Luer connector (62) is connected to an end of the infusion tube (61) away from the balloon (3); The shock wave control assembly (7) comprises an outer electrode wire (71) and an inner electrode wire (72); one end of the outer electrode wire (71) is connected to the outer electrode (41), and the other end passes through the catheter (1) and extends to the outside of the handle (5) and is connected to an electric control connector (73); one end of the inner electrode wire (72) is connected to the inner electrode (42), and the other end passes through the catheter (1) and extends to the outside of the handle (5) and is connected to the electric control connector (73).

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