An adjustable curved endovascular shockwave catheter assembly

Abstract

The application discloses a kind of adjustable bending intravascular shock wave catheter assembly, it is related to medical instrument technical field, including catheter, electrode fixed seat, balloon, forward shock wave generating electrode pair, handle, balloon control assembly, shock wave control assembly and four-way bending assembly;Electrode fixed seat and balloon are set in catheter one end;Forward shock wave generating electrode pair is located in balloon and is located on electrode fixed seat;Handle connects the other end of catheter;Balloon control assembly connects balloon;Shock wave control assembly connects forward shock wave generating electrode pair;Four-way bending assembly is located in catheter.The unique design structure of the application can be compatible with plaque opening electrode pair, can forwardly open occluded plaque, so that catheter can smoothly pass through the lesion location of higher degree of stenosis;And catheter can smoothly pass through various difficulty tortuous blood vessels without the aid of guide wire, so that catheter can smoothly reach the lesion location, and expand treatment.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, and particularly relates to a bend-adjustable intravascular shock wave catheter assembly. BACKGROUND

[0002] Chronic total occlusion (CTO) is a term used to describe a highly calcified atherosclerotic vessel that is so calcified that the vessel lumen is completely blocked. CTO can occur in the heart or peripheral arteries and significantly increases the risk of heart failure and lower extremity amputation. CTO cases in the operating room are also particularly challenging because it is difficult to pass a lesion with a traditional guide wire, resulting in nearly doubling of the procedure time and fluoroscopy exposure.

[0003] The advent of new techniques and devices has helped heart teams increase the chances of successful revascularization in CTO patients. The most important of these is a set of guide wire crossing techniques that follow a standard algorithm to adapt to different lesion morphologies. With specially designed crossing guide wires, skilled operators can cross CTOs in significantly less time. Once crossed, standard angioplasty balloon dilation and stent placement can be performed.

[0004] However, there is still an important problem that the guide wire can cross the lesion, but the balloon angioplasty catheter cannot pass due to its larger profile. These are called balloon crossing lesions and require the use of further specialized devices, called crossing devices or penetrating catheters. These devices are tracked over the guide wire and, when they reach the balloon non-crossable lesion, create a larger passage through which the balloon angioplasty catheter can pass using various techniques.

[0005] Since the advent of chronic total occlusion techniques in percutaneous coronary intervention (CTO-PCI), many devices and techniques have been described over time, from simple mechanical methods of drilling through lesions with high revolutions per minute (RPM) catheters, to the use of laser and radiofrequency energy to ablate and eliminate calcified material.

[0006] The existing angioplasty surgery is to place an inflatable balloon in the blood vessel, and through the mechanical stress of rapid expansion of the balloon, the calcified lesion is broken. However, balloon dilation surgery is only suitable for centralized large calcified deposits and cannot handle dispersed or deep intraventricular calcified lesions, and the calcium removal efficiency is low and incomplete. If the patient's arterial calcification is more serious, or the length of the stenotic blood vessel segment is longer, the effect of balloon dilation is relatively poor.

[0007] Rapid expansion of the balloon can cause a sudden change in pressure of the blood vessel wall, easily damaging the blood vessel and even causing 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 often causes a significant increase in the probability of rebound stenosis, dissection, perforation, and rupture of the blood vessel. 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 plaque in the blood vessel of the patient is hard and the degree of stenosis is heavy, it is possible that the balloon cannot pass through the calcified area at all, and cannot achieve a therapeutic effect. Therefore, more effective medical devices are needed to solve this problem. SUMMARY

[0009] To solve the above technical problems, the present application provides a bend-adjustable intravascular shock wave guide tube assembly, and the specific technical solutions are as follows:

[0010] A bend-adjustable intravascular shock wave guide tube assembly, comprising:

[0011] a catheter;

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

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

[0014] a pair of forward shock wave generating electrodes arranged on the electrode fixing seat and located in the balloon;

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

[0016] a balloon control assembly connected to the balloon;

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

[0018] a four-way bend-adjusting assembly arranged in the catheter.

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

[0020] an outer electrode in a sleeve structure, one end of the outer electrode being sleeved on the electrode fixing seat, and the other end of the outer electrode being surrounded by a plurality of first inner electrode mounting holes;

[0021] a plurality of inner electrodes corresponding in number to the plurality of first inner electrode mounting holes, one end of each inner electrode being connected to the electrode fixing seat, the other end of each inner electrode being arranged in the first inner electrode mounting hole, and an end surface of each inner electrode being lower than a hole surface of the first inner electrode mounting hole;

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

[0023] Preferably,

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

[0025] The balloon is a ring structure, the inner circumferential side of the ring structure is connected to the connecting part, and the outer circumferential side is connected to the outer circumferential surface of the catheter.

[0026] Preferably, the balloon control assembly includes a transfusion tube arranged in the catheter, one end of the transfusion tube being communicated with the balloon, and the other end of the transfusion tube extending out of the handle.

[0027] Preferably, the connecting part is a hole structure, one end of the transfusion tube communicated with the balloon is a side opening structure, and the side opening structure includes:

[0028] A closed end is provided in the hole structure and connected to the inner circumferential side of the ring structure;

[0029] A first communication hole is provided on the side of the closed end, and a second communication hole is provided on the outer circumferential surface of the catheter relative to the position of the first communication hole, and the transfusion tube is communicated with the balloon through the first communication hole and the second communication hole.

[0030] Preferably,

[0031] The electrode fixing seat is provided with a second inner electrode mounting hole relative to the position of 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 a transfusion tube mounting hole relative to the position of the connecting part, and the transfusion tube passes through the transfusion tube mounting hole.

[0033] Preferably,

[0034] The transfusion 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 arranged in the catheter, the number of telescopic cavities is four, the four telescopic cavities are arranged in a circumferential direction around the catheter and extend in a length direction of the catheter, and two ends of the telescopic cavity are communicated with the first end and the second end, respectively;

[0036] The number of pressure flaps is consistent with the number of telescopic cavities, the pressure flaps are arranged at the communication position of the telescopic cavity and the first end, and are used for controlling the communication and closure of the telescopic cavity and the first end, and the opening pressure of the pressure flap is greater than the elongation pressure of the telescopic cavity.

[0037] A magnetic adsorption opening and closing structure is arranged at the position where the telescopic cavity is communicated with the second end, and is used for controlling the communication and closure of the telescopic cavity and the second end.

[0038] Preferably,

[0039] The connection position of the first end and the second end forms a corrugated torus, a cross-shaped isolation film is arranged in the corrugated torus, and the corrugated torus and the cross-shaped isolation film form the telescopic cavity.

[0040] The magnetic adsorption opening and closing structure comprises a movable magnetic plug head arranged at the position near one end of the cross-shaped isolation film and an electromagnet arranged on the inner side wall of the telescopic cavity near one end of the second end.

[0041] Preferably, the conduit has an elastic telescopic surface relative to the circumferential surface of the corrugated torus, and a through hole is arranged on the elastic telescopic surface.

[0042] Preferably,

[0043] The balloon control assembly further comprises a luer joint connected to one end of the infusion tube away from the balloon.

[0044] The shock wave control assembly comprises an outer electrode lead wire and an inner electrode lead wire, one end of the outer electrode lead wire is connected to the outer electrode, the other end of the outer electrode lead wire passes through the conduit and extends to the outside of the handle and is connected to an electric control joint, one end of the inner electrode lead wire is connected to the inner electrode, and the other end of the inner electrode lead wire passes through the conduit and extends to the outside of the handle and is connected to the electric control joint.

[0045] The adjustable bending intravascular shock wave conduit assembly has the following beneficial effects:

[0046] 1. The conduit structure design without a guide wire is a low-profile conduit assembly.

[0047] 2. The unique design structure can be compatible with a plaque opening electrode pair, the opening electrode pair of the conduit can forwardly open the occluded plaque, so that the conduit can smoothly pass through a lesion position with high stenosis.

[0048] 3. The unique bending structure and multiple bending types can ensure that the conduit can smoothly pass through various difficult tortuous blood vessels without the aid of a guide wire, so that the conduit can smoothly reach the lesion position and be deployed for treatment. BRIEF DESCRIPTION OF DRAWINGS

[0049] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the drawings needed in the following embodiment or prior art description will be briefly introduced. Obviously, the drawings in the following description are only some embodiments described in the present application, and other drawings can be obtained by those skilled in the art without creative labor.

[0050] Figure 1 A perspective structural schematic diagram of the adjustable bending intravascular shock wave catheter assembly according to an embodiment of the present application is provided;

[0051] Figure 2 A connection structure diagram of the balloon and the catheter according to an embodiment of the present application is provided;

[0052] Figure 3 A perspective structural schematic diagram of the forward shock wave generating electrode pair according to an embodiment of the present application is provided;

[0053] Figure 4 A structural exploded view of the forward shock wave generating electrode pair according to an embodiment of the present application is provided;

[0054] Figure 5 A sectional front view of the distal end of the adjustable bending intravascular shock wave catheter assembly according to an embodiment of the present application is provided;

[0055] Figure 6 A sectional side view of the four-way adjustable bending assembly according to an embodiment of the present application is provided;

[0056] Figure 7 A unilateral bending schematic diagram of the adjustable bending intravascular shock wave catheter assembly according to an embodiment of the present application is provided;

[0057] Figure 8 A bilateral bending schematic diagram of the adjustable bending intravascular shock wave catheter assembly according to an embodiment of the present application is provided.

[0058] Reference numerals

[0059] 1 - catheter; 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 - outer electrode; 411 - first inner electrode mounting hole; 412 - connecting part; 42 - inner 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 annular surface; 614 - cross-shaped isolation film; 62 - luer joint;

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

[0066] 8 - Four-way bending assembly; 81 - Telescopic cavity; 82 - Pressure valve; 83 - Magnetic suction opening and closing structure; 831 - Movable magnetic plug; 832 - Electromagnet. DETAILED DESCRIPTION

[0067] In order to make the technical solution of the present application better understood by those skilled in the art, the present application will be described in detail below with reference to the accompanying drawings, and the description in this part is only exemplary and explanatory, and should not have any limiting effect on the protection scope of the present application.

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

[0069] It should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the product of the present application is usually placed during use, and are only for the convenience of describing the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application. In addition, the terms "first", "second" and the like 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 parts must be absolutely horizontal or overhanging, but can be slightly inclined. For example, "horizontal" only means that its direction is more horizontal relative to "vertical", and does not mean that the structure must be completely horizontal, but can be slightly inclined.

[0071] In the description of the present application, it should also be noted that, unless otherwise explicitly specified and limited, the terms "arrangement", "installation", "connection", "connection" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the communication inside two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0072] Please see Figures 1 to 8 The present embodiment provides a tunable bending intravascular shock wave catheter assembly, which comprises 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 electrode fixing seat 2 at one end away from the catheter 1.

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

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

[0077] The balloon control assembly 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] The balloon 3 can be a compliant balloon made of soft materials such as natural latex, silicone, TPU, etc. The effective length of the inflated balloon 3 is 3-18 mm, and the diameter of the inflated balloon 3 is 2-12 mm. The effective length of the catheter 1 is 50-150 cm, and the diameter of the catheter 1 is 1-3 mm. The balloon control assembly 6 can inject liquid into the balloon 3 to inflate the balloon 3, which can tightly adhere to the occluded plaque in the blood vessel in the forward direction. The shock wave control assembly 7 controls the forward shock wave generating electrode pair 4 to form an electric arc with a high instantaneous pressure, and the bubbles generated by the electric arc expand and collapse to generate shock waves. The shock waves generated by the electrode pair are radially transmitted to the surface of the balloon 3 through the liquid in the balloon 3, and then transmitted to the calcified lesion through the surface of the balloon 3. When the shock waves are transmitted to the calcified lesion in the forward direction, the compression stress of the shock waves can soften and crack the calcified tissue inside the occluded blood vessel, so that the balloon catheter can pass through the occluded blood vessel, achieving good effect of opening the blood vessel. The shock waves with appropriate intensity can destroy the calcified tissue without causing additional burden to the soft tissue around the calcified tissue.

[0081] The four-way bending assembly 8 can be used to control the bending of the catheter 1 in four directions. The bending modes can be divided into single-sided bending and multi-sided bending, and the types can be F-bend, L-bend, E-bend, T-bend, F-F-bend, L-L-bend, E-E-bend, T-T-bend, etc. For details, please refer to Figure 7 and Figure 8 .

[0082] The adjustable bending intravascular shock wave catheter assembly provided by the embodiment has the following beneficial effects:

[0083] 1. The catheter structure design without a guide wire is a low-profile catheter assembly.

[0084] 2. The unique design structure can be compatible with plaque opening electrode pairs. The opening electrode pairs of the catheter can open the occluded plaque in the forward direction, so that the catheter can smoothly pass through the lesion location with high stenosis.

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

[0086] Further, please refer to 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 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 inner electrodes 42 is consistent with the number of first inner electrode mounting holes 411, one end of the inner electrode 42 is connected to the electrode fixing seat 2, the other end is arranged in the first inner electrode mounting hole 411, and the end face of the inner electrode 42 is lower than the hole face 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] Among them, the outer electrode 41 is a wine cup cylinder, the diameter is 0.1-1.0mm, the wall thickness is 0.03-0.3mm, and the outer electrode 41 can be made of stainless steel, tungsten, platinum-iridium, nickel, iron, steel and / or other conductive materials.

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

[0092] The material of the electrode fixing seat 2 can be polyethylene, polypropylene, polycarbonate, Peek, nylon 12, nylon 66, polyurethane, polyimide, PET, etc.

[0093] When the liquid in the balloon 3 can flow into the liquid injection cavity 43, and when the outer electrode 41 and the inner electrode 42 generate an electric arc when applying a momentary high pressure to the electrode pair, the bubble expansion and collapse of the electric arc generates a shock wave, and since the end face of the inner electrode 42 is lower than the hole face of the first inner electrode mounting hole 411, the shock wave is guided by the inner wall of the first inner electrode mounting hole 411 and diverges forward.

[0094] Further, the other end of the outer electrode 41 is also provided with a connecting part 412, and the connecting part 412 is located at the center position of the plurality of first inner electrode mounting holes 411.

[0095] The balloon 3 is a ring structure, the inner circumferential side of the ring structure is connected to the connecting part 412, and the outer circumferential side is connected to the outer circumferential surface of the catheter 1, so that the balloon 3 can cover the forward shock wave generating electrode pair 4.

[0096] Further, referring to Figure 5 , the balloon control assembly 6 comprises a liquid delivery tube 61 arranged in the catheter 1, one end of the liquid delivery tube 61 being communicated with the balloon 3, and the other end extending out of the handle 5 through the handle 5, so as to inject liquid into the balloon 3.

[0097] Further, referring to Figure 4 and Figure 5 , the connecting part 412 is a hole type structure, one end of the liquid delivery tube 61 communicated with the balloon 3 is a side opening hole structure, and the side opening hole structure comprises a closed end 611 and a first communication hole 612.

[0098] The closed end 611 is arranged in the hole type structure and connected to the inner circumferential side of the annular structure.

[0099] The first communication hole 612 is arranged at the side of the closed end 611, and the outer circumferential surface of the catheter 1 is provided with a second communication hole 11 at a position opposite to the first communication hole 612, and the liquid delivery tube 61 is communicated with the balloon 3 through the first communication hole 612 and the second communication hole 11.

[0100] The connecting mode of the inner circumferential side of the annular structure to the closed end 611 and the connecting mode of the outer circumferential side to the outer circumferential surface of the catheter 1 can be gluing, welding, binding and the like. The diameter of the connecting part 412 can be 0.2-2.0 mm through the closed end 611. The first communication hole 612 and the second communication hole 11 can be formed by laser drilling, drilling and the like. The farthest end of the liquid delivery tube 61 is provided with the closed end 611, so as to ensure that the balloon 3 can be filled smoothly.

[0101] Further, referring to Figure 4 , the electrode fixing seat 2 is provided with a second inner electrode mounting hole 21 opposite 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] The electrode fixing seat 2 is provided with a liquid delivery tube mounting hole 22 opposite to the connecting part 412, and the liquid delivery tube 61 passes through the liquid delivery tube mounting hole 22.

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

[0104] Further, referring to Figure 6 , the liquid delivery tube 61 comprises a first end close 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, a pressure flap 82 and a magnetic adsorption opening and closing structure 83.

[0105] The telescopic cavities 81 are arranged in the catheter 1, and the number of the telescopic cavities 81 is four. The four telescopic cavities 81 are circumferentially arranged around the catheter 1 and extend along the length direction of the catheter 1. The two ends of the telescopic cavities 81 are respectively communicated with the first end and the second end.

[0106] The number of the pressure flaps 82 is consistent with the number of the telescopic cavities 81. The pressure flaps 82 are arranged at the positions where the telescopic cavities 81 are communicated with the first end, and are used to control the communication and closure of the telescopic cavities 81 with the first end. The opening pressure of the pressure flaps 82 is greater than the elongation pressure of the telescopic cavities 81.

[0107] The magnetic adsorption opening and closing structure 83 is arranged at the position where the telescopic cavities 81 are communicated with the second end, and is used to control the communication and closure of the telescopic cavities 81 with the second end.

[0108] The magnetic adsorption opening and closing structure 83 can be used to control the closure of one of the four telescopic cavities 81 with the second end. When one of the telescopic cavities 81 is closed, the second end of the infusion tube 61 can inject liquid into the other three telescopic cavities 81. Since the opening pressure of the pressure flaps 82 is greater than the elongation pressure of the telescopic cavities 81, the other three telescopic cavities 81 will elongate after the liquid is injected, so as to bend towards the closed telescopic cavity 81. When it is needed to control the bending of the catheter 1, only the corresponding telescopic cavity 81 needs to be closed by the magnetic adsorption opening and closing structure 83. When the four telescopic cavities 81 are all communicated with the second end, the second end can inject liquid into the four telescopic cavities 81. At this time, the four telescopic cavities 81 all elongate, and the catheter 1 is not bent. If the liquid continues to be injected, the telescopic cavities 81 will elongate to the longest, and the pressure will gradually increase, so as to push the pressure flaps 82 to open, and the liquid can flow into the first end of the infusion tube 61, so as to fill the balloon 3. If it is needed to reduce the balloon 3, the liquid can be extracted.

[0109] Further, please continue to refer to Figure 6 :

[0110] The connection between the first end and the second end forms a wrinkled ring surface 613. The wrinkled ring surface 613 is provided with a cross-shaped isolation film 614. The wrinkled ring surface 613 and the cross-shaped isolation film 614 form the telescopic cavities 81.

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

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

[0113] Further, the conduit 1 has an elastic expansion surface relative to the circumferential surface of the crimped ring surface 613, and a through hole 12 is arranged on the elastic expansion surface, so as to facilitate expansion of the crimped ring surface 613.

[0114] Further,

[0115] The balloon control assembly 6 further comprises a luer joint 62 connected to the infusion tube 61 at an end away from the balloon 3.

[0116] The shock wave control assembly 7 comprises an outer electrode lead wire 71 and an inner electrode lead wire 72, the outer electrode lead wire 71 is connected to the outer electrode 41 at one end and extends through the conduit 1 to the outside of the handle 5 and is connected to an electric control joint 73, the inner electrode lead wire 72 is connected to the inner electrode 42 at one end and extends through the conduit 1 to the outside of the handle 5 and is connected to the electric control joint 73.

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

[0118] Principle:

[0119] The balloon 3 can be a compliant balloon, and the material can be natural latex, silicone, TPU, etc. The effective length of the inflated balloon 3 is 3-18 mm, and the diameter of the inflated balloon 3 is 2-12 mm. The effective length of the conduit 1 is 50-150 cm, and the diameter of the conduit 1 is 1-3 mm. The balloon control assembly 6 can inject liquid into the balloon 3 to inflate the balloon 3, and the inflated balloon 3 can tightly adhere to the occluded plaque in the blood vessel in the forward direction. The shock wave control assembly 7 controls the formation of an electric arc between the electrode pair 4 by generating a transient high pressure, and the bubble expansion and collapse accompanied by the shock wave generated by the electric arc. The shock wave generated by the electrode pair is radially transmitted to the surface of the balloon 3 through the liquid in the balloon 3, and then transmitted to the calcified lesion through the surface of the balloon 3. When the shock wave is transmitted to the calcified lesion in the forward direction, the compression stress of the shock wave causes the calcified tissue inside the occluded blood vessel to soften and crack, so that the balloon catheter can pass through the occluded blood vessel, achieving good effect of opening the blood vessel. The shock wave of appropriate intensity can destroy the calcified tissue without causing additional burden to the soft tissue around the calcified tissue.

[0120] The four-way bending assembly 8 can be used to control the bending of the conduit 1, and the bending mode can be divided into single-sided bending and multi-sided bending, and the types can be F-bend, L-bend, E-bend, T-bend, F-F-bend, L-L-bend, E-E-bend, T-T-bend, etc. For details, see Figure 7 and Figure 8 .

[0121] It should be noted that, in this text, the term "comprising", "including" or any other variant thereof is intended to cover a non-exclusive inclusion, so that a process, method, article or apparatus that includes a list of elements not only includes those elements, but also includes other elements not explicitly listed, or inherent to such process, method, article or apparatus.

[0122] The principles and implementation manners of the present application are described by using specific examples in this text, and the above example description is only for helping to understand the method of the present application and its core idea. The above is only the preferred implementation manner of the present application, and it should be noted that, due to the limitedness of the expression, there are objectively infinite specific structures, and for the ordinary skilled in the art, on the premise of not departing from the principle of the present application, a number of improvements, refinements or changes can be made, or the above technical features can be combined in a proper manner; these improvements, refinements, changes or combinations, or the direct application of the inventive concept and technical solution to other occasions without improvement, shall be regarded as the protection scope of the present application.

Claims

1. An adjustable-bend intravascular shockwave catheter assembly, characterized in that, The application relates to a forward shock wave generating catheter, which comprises the following components: a catheter (1); an electrode fixing base (2) arranged at one end of the catheter (1); a balloon (3) connected to the electrode fixing base (2) and away from one end of the catheter (1); a forward shock wave generating electrode pair (4) arranged on the electrode fixing base (2) and located in the balloon (3); a handle (5) connected to the other end of the catheter (1); a balloon control assembly (6) connected to the balloon (3) and comprising a liquid delivery pipe (61) arranged in the catheter (1), one end of the liquid delivery pipe (61) being communicated with the balloon (3), the other end of the liquid delivery pipe (61) penetrating through the handle (5) and extending out of the handle (5), the liquid delivery pipe (61) comprising a first end close to the balloon (3) and a second end away from the balloon (3); a shock wave control assembly (7) connected to the forward shock wave generating electrode pair (4); a four-way bending adjusting assembly (8) arranged in the catheter (1); the four-way bending adjusting assembly (8) comprises: a plurality of telescopic cavities (81) arranged in the catheter (1), the number of the telescopic cavities (81) being four, the four telescopic cavities (81) being arranged in a circumferential direction of the catheter (1) and extending along a length direction of the catheter (1), and the two ends of the telescopic cavities (81) being communicated with the first end and the second end respectively; a plurality of pressure flaps (82) arranged at positions where the telescopic cavities (81) are communicated with the first end, the pressure flaps (82) being used for controlling the communication and closure of the telescopic cavities (81) and the first end, and the opening pressure of the pressure flaps (82) being greater than the elongation pressure of the telescopic cavities (81); and a magnetic adsorption opening and closing structure (83) arranged at positions where the telescopic cavities (81) are communicated with the second end, the magnetic adsorption opening and closing structure (83) being used for controlling the communication and closure of the telescopic cavities (81) and the second end; wherein: the connection positions of the first end and the second end form a wrinkled annular surface (613), a cross-shaped isolation film (614) is arranged in the wrinkled annular surface (613), and the telescopic cavities (81) are formed between the wrinkled annular surface (613) and the cross-shaped isolation film (614); the magnetic adsorption opening and closing structure (83) comprises a movable magnetic plug (831) arranged at one end of the cross-shaped isolation film (614) close to the second end and an electromagnet (832) arranged on an inner side wall of the telescopic cavity (81) close to the second end; the catheter (1) is an elastic telescopic surface relative to the circumferential surface of the wrinkled annular surface (613), and a through hole (12) is arranged on the elastic telescopic surface; the forward shock wave generating electrode pair (4) comprises: an outer electrode (41) in a sleeve structure, one end of the outer electrode (41) being sleeved on the electrode fixing base (2), and the other end of the outer electrode (41) being provided with a plurality of first inner electrode mounting holes (411); and a plurality of inner electrodes (42) arranged in the first inner electrode mounting holes (411), one end of the inner electrodes (42) being connected to the electrode fixing base (2), the other end of the inner electrodes (42) penetrating through the first inner electrode mounting holes (411), and the end surface of the inner electrodes (42) being lower than the hole surface of the first inner electrode mounting holes (411). ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 2. The adjustable bend endovascular shockwave catheter assembly of claim 1, wherein, ​ ​ ​ A liquid injection cavity (43) is formed between the first inner electrode mounting hole (411) and the inner electrode (42).

3. The adjustable curved endovascular shock wave catheter assembly of claim 2, wherein: The other end of the outer electrode (41) is further provided with a connecting portion (412), which is located at the center of the plurality of first inner electrode mounting holes (411); The balloon (3) has a ring structure, the inner periphery of which is connected to the connecting portion (412), and the outer periphery is connected to the outer periphery of the catheter (1).

4. The adjustable bend endovascular shockwave catheter assembly of claim 3, wherein, The connecting portion (412) is a hole structure, the infusion tube (61) is connected to one end of the balloon (3) in a side opening structure, and the side opening structure comprises: A closed end (611) is provided in the hole structure and connected to the inner periphery of the ring structure; A first communication hole (612) is provided on the side of the closed end (611), and a second communication hole (11) is provided on the outer periphery of the catheter (1) opposite to the first communication hole (612), and the infusion tube (61) is connected to the balloon (3) through the first communication hole (612) and the second communication hole (11).

5. The adjustable curved endovascular shock wave catheter assembly of claim 3, wherein: The electrode fixing seat (2) is provided with a second inner electrode mounting hole (21) opposite 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 mounting hole (22) opposite to the connecting portion (412), and the infusion tube (61) passes through the infusion tube mounting hole (22).

6. The adjustable curved endovascular shock wave catheter assembly of claim 3, wherein: The balloon control assembly (6) further comprises a luer joint (62) connected to one end of the infusion tube (61) away from the balloon (3); The shock wave control assembly (7) comprises an outer electrode lead wire (71) and an inner electrode lead wire (72), one end of the outer electrode lead wire (71) is connected to the outer electrode (41), the other end passes through the catheter (1) and extends to the outside of the handle (5) and is connected with an electric control joint (73), one end of the inner electrode lead wire (72) is connected to the inner electrode (42), the other end passes through the catheter (1) and extends to the outside of the handle (5) and is connected with the electric control joint (73).

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