Intravascular filter and intravascular calcified tissue removal device

Abstract

The present invention provides an intravascular filter and an intravascular calcified tissue removal device, wherein the filter includes a guide wire, a support frame, and a filter membrane; the support frame includes a plurality of struts, and the struts include a first end, a second end, and a transition portion located between the first end and the second end; the first ends of the plurality of struts are centrally connected together to form a fixed end of the support frame, and the second ends of the plurality of struts are radially opened circumferentially to form a first open end of the support frame, and the filter membrane is covered on the first open end, and the filter membrane allows blood to flow through and blocks foreign tissue in the blood flow from passing through; in a natural state, the first open end is in an open state, so that the second ends of the plurality of struts can abut against the inner wall of the blood vessel in which it is located; the first open end can be elastically retracted under the action of a restraining force to reduce the caliber of the first open end. Based on the above filter, broken lesion fragments can be intercepted and blocked during interventional treatment to prevent them from flowing to the distal end and causing other safety hazards.

Description

Technical Field

[0001] The present invention relates to the technical field of interventional medical equipment, and in particular to an intravascular filter and an intravascular calcified tissue removal device. Background Art

[0002] Balloon dilatation catheters have significant clinical significance in the recanalization of severely calcified blood vessels. Currently, shock wave balloons are commonly used to treat moderate or severe calcified lesions. During treatment, the shock wave balloon is delivered to the lesion. Once the shock wave balloon is filled with an expansion medium and adheres to the vessel wall, an ultrasonic generator is activated to generate shock waves, shattering the moderate or severe calcified lesions.

[0003] Although existing shock wave balloon dilatation catheters can shatter calcified lesions and achieve good treatment effects, they are unable to intercept and block the shattered calcified lesion particles during the treatment process, causing these lesion particles to move freely with the blood flow and accumulate in other places to form new lesions.

[0004] Therefore, it is necessary to design a device for use with a balloon dilatation catheter to intercept fragmented calcified tissue. Summary of the Invention

[0005] The purpose of the present invention is to provide an intravascular filter and an intravascular calcified tissue removal device capable of intercepting free diseased tissue in the blood vessel.

[0006] In order to achieve the above-mentioned purpose, the present invention provides an intravascular filter, comprising a guidewire and a support frame and a filter membrane arranged at the distal end of the guidewire, the guidewire being used to deliver the filter membrane and the support frame to the target area of ​​the blood vessel; the support frame comprises a plurality of struts, the struts comprising a first end, a second end and a transition portion located between the first end and the second end; the first ends of the plurality of struts are centrally connected together to form a fixed end of the support frame, the fixed end is fixed to the distal end of the guidewire, the second ends of the plurality of struts are radially opened along the circumferential direction to form a first open end of the support frame, the filter membrane is covered on the first open end, the filter membrane allows blood to flow through, and blocks foreign tissue in the blood flow from passing through; in a natural state, the first open end is in an open state, so that the second ends of the plurality of struts can abut against the inner wall of the blood vessel in which they are located; the first open end can be elastically contracted under the action of a restraining force to reduce the caliber of the first open end.

[0007] Preferably, at the first open end, the second ends of two adjacent support rods are connected by a connecting rod, and when the first open end is in an open state, the connecting rod abuts against the inner wall of the blood vessel; or / and,

[0008] The filter membrane is in a bag-like structure, including a tail end and a second open end, wherein the second open end is connected to the first open end and completely covers the first open end, and the tail end is located on a side away from the fixed end.

[0009] The present invention also provides an intravascular calcified tissue removal device, which includes a balloon catheter and the intravascular filter as described above, the balloon catheter including an expansion balloon and a catheter component, the expansion balloon is arranged at the distal end of the catheter component, and the catheter component is provided with a first channel and a second channel independent of each other, the first channel is connected to the expansion balloon for inputting or outputting filling medium into or out of the expansion balloon, and the second channel is used for threading a guide wire; the filter is used to be placed at the distal end of the lesion site, the expansion balloon is used to be placed at the lesion site, and the filter is used to prevent foreign tissue matter detached during the action of the expansion balloon from flowing with the blood; the catheter component is also provided with an electrode transmitter, and the electrode transmitter is used to emit shock waves that can act on the intravascular tissue.

[0010] Preferably, the electrode emitting element includes a first electrode and a second electrode with conductive properties and an insulating element with insulating properties, the first electrode is sleeved on the insulating element, the insulating element is sleeved on the second electrode, and the emitting hole passes through the first electrode and the insulating element.

[0011] Preferably, the length of the second electrode is greater than that of the first electrode, and the length of the insulating member is greater than that of the second electrode.

[0012] Preferably, a plurality of scoring wires are further provided on the peripheral wall of the expansion balloon, and the scoring wires extend from the most distal end to the proximal end. The electrode emitting element is provided with an emission hole for emitting the shock wave, and the central axis of the emission hole passes through at least one of the scoring wires.

[0013] Preferably, the scoring wire includes a bottom and a top, the bottom is used to connect to the expansion balloon, the top is located on the side of the bottom facing away from the peripheral wall of the expansion balloon, and the top is in the shape of a pointed tip protruding toward the side away from the peripheral wall of the expansion balloon.

[0014] Preferably, the characteristic parameters of the scored wire include any one or more of the following:

[0015] The total height of the scored wire is 0.2 mm to 0.35 mm;

[0016] The tip angle of the top is 20° to 60°;

[0017] The chamfer diameter of the top tip is 0.01mm~0.03mm;

[0018] The chamfer diameters on both sides of the bottom in the length direction are 0.02 mm to 0.04 mm.

[0019] Preferably, it also includes a first bundling tube arranged at the distal end of the expansion balloon and a second bundling tube arranged at the proximal end of the expansion balloon, one end of any of the scored wires is connected to the first bundling tube, and the other end of any of the scored wires is connected to the second bundling tube, the first bundling tube and the second bundling tube are used to bundle and fix the ends of the scored wires, and the second bundling tube can be telescopically deformed under the tension of the scored wires.

[0020] Preferably, the device further comprises a delivery catheter, wherein the delivery catheter can contain the filter, and the delivery catheter is used to deliver the filter to a target location in a blood vessel along a guide wire.

[0021] Preferably, a suction catheter is further included, which includes a third open end located at the distal end and a suction port located at the proximal end. Based on the third open end, the suction catheter can accommodate the balloon catheter together with the filter therein, and the suction port is used to provide negative pressure in the suction catheter to suction foreign tissue matter filtered out by the filter.

[0022] Preferably, the third open end of the suction catheter is also provided with a suction head with a hollow structure, and the suction head includes a connecting portion, an expansion portion and an opening portion, and the diameters of the connecting portion, the expansion portion and the opening portion increase successively, and the expansion portion is conical, and the connecting portion is used to be connected to the third open end, and the opening portion is used to receive the object to be extracted.

[0023] Compared with the prior art, the intravascular filter provided by the above technical solution of the present invention can be used in conjunction with a balloon dilatation catheter, and includes a guidewire, a support frame, and a filter membrane. The filter membrane allows blood to flow through, but does not allow foreign tissue such as calcified fragments to pass through. When in use, the filter is placed at the distal end of the lesion. During the treatment process, the fragmented calcified tissue generated is free in the blood vessels and can move with the blood flow. When it reaches the filter membrane through the first open end of the support frame, it is blocked by the filter membrane, limiting the further movement of the fragmented calcified tissue. It can be seen that the above filter can intercept and block broken lesion fragments during interventional treatment, preventing them from flowing to the distal end and causing other safety hazards. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 2 is a planar structural diagram of a calcified tissue removal device according to an embodiment of the present invention.

[0025] Figure 2 Schematic diagram of the three-dimensional structure of the support frame of the filter in an embodiment of the present invention.

[0026] Figure 3Schematic diagram of the three-dimensional structure of the filter membrane of the filter in an embodiment of the present invention.

[0027] Figure 4 FIG. 4 is a planar structural diagram of a filter with a developing function in an embodiment of the present invention.

[0028] Figure 5 This is a projection diagram of the support frame viewed from the fixed end toward the first open end in an embodiment of the present invention.

[0029] Figure 6 Schematic diagram of the planar structure of the suction tube in an embodiment of the present invention.

[0030] Figure 7 Schematic diagram of the planar structure of the suction head in an embodiment of the present invention.

[0031] Figure 8 It is a cross-sectional view of the expansion balloon perpendicular to its central axis in an embodiment of the invention.

[0032] Figure 9 for Figure 8 Longitudinal cross-section of the scored wire.

[0033] Figure 10 This is an exploded view of the electrode emitter in an embodiment of the present invention.

[0034] Figure 11 for Figure 1 Electrical connection diagram of the two electrode emitters.

[0035] Figures 12 to 19 1 is a state diagram of the calcified tissue removal device at different stages according to an embodiment of the present invention. DETAILED DESCRIPTION

[0036] In order to explain the technical content, structural features, achieved objectives and effects of the present invention in detail, the following is a detailed description in conjunction with the embodiments and the accompanying drawings.

[0037] This embodiment discloses a device for removing intravascular calcified tissue. Figure 1 The invention comprises a guidewire 5, a balloon catheter 2, and a filter 1 used in conjunction with the balloon catheter 2. The balloon catheter 2 comprises an expansion balloon 20 and a catheter member 21. The expansion balloon 20 is disposed at the distal end of the catheter member 21. The catheter member 21 is provided with a first channel L1 and a second channel L2, which are independent of each other. The first channel L1 is connected to the expansion balloon 20 for inputting or outputting a filling medium into or out of the expansion balloon 20. The second channel L2 is used for passing the guidewire 5. The filter 1 is used to be placed at the distal end of the calcified area, the expansion balloon 20 is used to be placed at the lesion site, and the filter 1 is used to prevent foreign tissue that is detached during the action of the expansion balloon 20 from flowing with the blood. The guidewire is used to provide a movement path for the balloon catheter 2 and the filter 1 in the blood vessel, playing a navigation role.

[0038] Please refer to Figures 1 to 5 The filter 1 includes a support frame 10 fixed on the guide wire 5 and a filter membrane 11.

[0039] The support frame 10 includes a plurality of support rods 100 . The support rods 100 include a first end 101 , a second end 102 , and a transition portion 103 between the first end 101 and the second end 102 .

[0040] The first ends 101 of a plurality of support rods 100 are collectively connected together to form a fixed end 104 of the support frame 10 .

[0041] The second ends 102 of the plurality of support rods 100 are radially spread out along the circumferential direction to form a first open end 105 of the support frame 10. In this embodiment, the transition portion 103 is an arc-shaped structure that bends toward the central axis of the first open end 105.

[0042] The filter membrane 11 is covered on the first open end 105 . The filter membrane 11 allows blood to flow through and blocks foreign tissues in the blood from passing through.

[0043] In a natural state, the first open end 105 is in an open state, so that the second ends 102 of the plurality of struts 100 can abut against the inner wall of the blood vessel, thereby preventing foreign tissue from escaping through the gap between the first open end 105 and the inner wall of the blood vessel.

[0044] In addition, the first open end 105 can be elastically retracted under the action of a restraining force to reduce the diameter of the first open end 105. In this way, when the filter 1 is delivered into a blood vessel, the support frame 10 can be retracted to smoothly enter the target position in the blood vessel without damaging the blood vessel.

[0045] When the balloon catheter 2 is used to break up the calcified part G in the blood vessel, Figure 15 The filter 1 is placed distally to the calcified site G. During treatment, fragments of calcified tissue are free in the blood vessels and can migrate with the bloodstream. When these fragments reach the filter membrane 11 via the first open end 105 of the support frame 10, they are blocked by the membrane 11, restricting their further movement. Thus, the filter 1 can intercept and block broken lesion fragments during interventional therapy, preventing them from flowing to the distal end of the blood vessel and posing other safety risks.

[0046] On the other hand, Figure 2At the first open end 105, the second ends 102 of two adjacent struts 100 are connected by a connecting rod 106. When the first open end 105 is in an open state, the connecting rod 106 abuts the inner wall of the blood vessel in which it is located. In this embodiment, the connecting rod 106 between two adjacent struts 100 can be one or more. By providing multiple connecting rods 106 at the first open end 105, the first open end 105 forms a circular structure when in an open state, effectively improving the adhesion between the outer side of the first open end 105 and the inner wall of the blood vessel, thereby preventing the second ends 102 of the struts 100 from damaging the blood vessel.

[0047] In another embodiment, adjacent connecting rods 106 are connected by a joint structure JO, allowing the connecting rods 106 to fold together. Thus, during use, the joint structure JO allows the support rod 100 to expand and unfold, forming a circular structure and thus opening the first open end 105. Before or after use, when the support rod 100 is collapsed, the joint structure JO allows the connecting rods 106 to fold together and close the first open end 105. Furthermore, the connecting rods 106 are of equal length.

[0048] On the other hand, on the support frame 10 , when the first open end 105 is in an open state, the diameter of the internal space from the fixed end 104 to the first open end 105 increases sequentially, thereby preventing blood flow from being blocked at the first open end 105 .

[0049] Furthermore, if Figure 3 The filter membrane 11 has a bag-like structure, including a tail end 110 and a second open end 111. The second open end 111 is connected to the first open end 105 and completely covers the first open end 105, and the tail end 110 is located on the side away from the fixed end 104. In this embodiment, the first open end 105 and the second open end 111 coincide with each other, and the tail end 110 of the filter membrane 11 and the fixed end 104 of the support frame 10 are respectively located on opposite sides of the first open end 105 and the second open end 111.

[0050] Specifically, if Figure 4 The filter membrane 11 includes a membrane body 112 and a plurality of through holes 113 provided on the membrane body 112. The aperture φ of the through holes 113 satisfies the following conditions:

[0051] 80μm≤φ≤180μm to ensure that no thrombus or calcified fragments are missed while blood flow can flow smoothly.

[0052] Furthermore, the struts 100 are made of a shape memory alloy. When no restraining force is applied, the second end 102 of each strut 100 is open, and the first open end 105 and the second open end 111 are in a fully extended state. When the filter 1 is introduced into a blood vessel, a restraining force is applied to each strut 100, causing the first open end 105 and the second open end 111 to collapse.

[0053] On the other hand, see again Figure 4 The first opening end 105 is further provided with a developing portion 107 , and the developing portion 107 is used to develop and mark the current location on the medical image.

[0054] Specifically, a developed metal wire may be wound around each connecting rod 106 at the first open end 105 to form the developing portion 107. Alternatively, the connecting rod 106 may be directly made of a developing material so that the connecting rod 106 can serve as the developing portion 107.

[0055] On the other hand, in order to facilitate the delivery of the filter 1 having the above structure to the target position in the blood vessel, as shown in FIG. Figure 12 This embodiment further discloses a delivery catheter 3 , which can hold the filter 1 therein. The delivery catheter 3 is used to deliver the filter 1 along the guide wire 5 to the target location in the blood vessel.

[0056] On the other hand, Figure 6 、 Figure 18 and Figure 19 This embodiment further discloses a suction catheter 4, which includes a third open end 40 located at the distal end and a suction port 41 located at the proximal end.

[0057] Based on the third open end 40 , the suction catheter 4 can accommodate the balloon catheter 2 together with the filter 1 therein.

[0058] The suction port 41 is used to provide negative pressure in the suction conduit 4 to suck out foreign matter filtered out by the filter 1. When in use, the suction port 41 can be connected to the suction device through a Luer connector.

[0059] The following describes in detail how to use the filter 1 having the above structure.

[0060] (1) If Figure 12 , the filter 1 and the proximal end of the guide wire 5 are housed in the delivery catheter 3, the filter 1 is inserted into the blood vessel along the guide wire 5, and the entire filter 1 passes through the calcified site G, and the filter 1 is continued to be delivered until it is delivered to the distal end of the calcified site G.

[0061] (2) If Figure 13 , the delivery catheter 3 is withdrawn from the blood vessel, the support frame 10 in the filter 1 loses its restraining force and self-expands, and the connecting rods 106 at the first open end 105 adhere to the inner wall of the blood vessel.

[0062] (3) If Figure 14 The balloon catheter 2 is housed in the suction catheter 4 , and the expansion balloon 20 is introduced into the proximal position of the calcified site G along the guide wire 5 through the suction catheter 4 .

[0063] (4) If Figure 15 , keep the suction catheter 4 stationary, and continue to connect the balloon catheter 2 to the distal end, so that the expansion balloon 20 is located at the calcification site G.

[0064] (5) If Figure 16 , the balloon 20 is filled and expanded through the first channel L1 to start the fragmentation treatment of the calcified area G.

[0065] (6) If Figure 17 During the treatment, the calcified fragments generated are intercepted by the filter 1. After the treatment, the balloon 20 is contracted and expanded through the first channel L1.

[0066] (7) If Figure 18 , push the suction catheter 4 toward the distal end so that the third open end 40 of the suction catheter 4 is close to the filter 1, and connect the suction device through the suction port 41 on the suction catheter 4, so that the calcified fragments intercepted by the filter 1 are extracted from the body through the suction catheter 4.

[0067] (7) If Figure 19 , continue to push the suction catheter 4 toward the distal end, so that the filter 1 is also accommodated in the suction catheter 4. Then the filter 1 and the balloon catheter 2 are withdrawn from the body together through the suction catheter 4.

[0068] On the other hand, Figure 6 and Figure 7 The third open end 40 of the suction catheter 4 is further provided with a hollow suction head 42, which comprises a connecting portion 420, an expansion portion 421, and an opening 422. The diameters of the connecting portion 420, expansion portion 421, and opening 422 increase in size, with the expansion portion 421 being tapered. The connecting portion 420 has a diameter comparable to that of the third open end 40 of the suction catheter 4 and is used to connect to the third open end 40. The opening 422 is used to receive the material to be extracted.

[0069] In this embodiment, the expansion portion 421 is conical, so that the diameter of the third opening end 40 becomes larger, and the suction head 42 is funnel-shaped as a whole, thereby ensuring that more thrombi can enter the suction catheter 4 through the suction head 42 more quickly, and the thrombi can be cleared more quickly.

[0070] Specifically, the suction head 42 comprises a frame and a film covering the frame. The film can be made of a polyamide or polyurethane thermoelastic material. For example, the film can be made of one or more of PTFE, ePTFE, PU, ​​TPU, and TPE. The polyamide or polyurethane thermoelastic material has a Shore hardness of 30HD to 45HD, and the film has a thickness of 0.05 to 0.15 mm.

[0071] Furthermore, the skeleton is in the form of an expandable mesh, which can be formed by laser cutting and thermal expansion of a metal tube with shape memory effect; or, it can be woven from a metal wire with shape memory effect (such as a superelastic nickel-titanium alloy wire); or, it can be formed by injection molding of a highly elastic polymer material; or, it can be formed by injection molding of a highly elastic polymer material.

[0072] On the other hand, Figure 1 The catheter part 21 in the expansion balloon 20 is also provided with an electrode transmitter 6, which is used to emit shock waves that can act on the tissue inside the blood vessel.

[0073] During treatment, after the expansion balloon 20 is delivered to the calcified area G and filled with the expansion medium, adhering to the inner wall of the blood vessel, the electrode drive device 8 is activated, driving the electrode transmitter 6 to emit shock waves to shatter moderate or severe calcified areas G, thereby enhancing the treatment effect. Furthermore, by adjusting the drive parameters of the electrode drive device 8, the electrode transmitter 6 can emit shock waves of varying specifications. For example, to eliminate calcified heart valve lesions, the output voltage of the electrode transmitter 6 can be controlled within a range of 4kV to 10kV, while to eliminate vascular calcification lesions, the output voltage of the electrode transmitter 6 can be controlled within a range of 0.5kV to 6kV.

[0074] Furthermore, a plurality of scoring wires 7 are provided on the outer peripheral wall of the expansion balloon 20 , and an emission hole 60 for emitting shock waves is provided on the electrode emission element 6 , and the central axis of the emission hole 60 passes through at least one scoring wire 7 .

[0075] Specifically, in this embodiment, an electrode emitting element 6 has three emitting holes 60 circumferentially spaced apart, and there are three or more scoring wires 7. Each emitting hole 60 is opposite to one of the scoring wires 7, and different emitting holes 60 correspond to different scoring wires 7.

[0076] In this embodiment, since the central axis of the launch hole 60 passes through the scored wire 7, the scored wire 7 can be used to directly transmit the shock wave vibration energy, thereby effectively enhancing its shattering efficiency. It is also possible to use the physical properties of the scored wire 7 alone to physically squeeze and crush the hard calcified area G when no shock wave energy is used, thereby greatly increasing the crushing ability of the hard calcified area.

[0077] Furthermore, if Figure 8 and Figure 9 The scoring wire 7 includes a bottom 70 and a top 71. The bottom 70 is used to connect with the expansion balloon 20. The top 71 is located on the side of the bottom 70 that is away from the outer wall of the expansion balloon 20. The top 71 is in the shape of a pointed tip that protrudes toward the side away from the outer wall of the expansion balloon 20.

[0078] In this embodiment, the bottom 70 is connected to the expansion balloon 20, with a large contact area, ensuring stable attachment of the scoring wire 7. The top 71 is pointed and is used to contact calcifications in the blood vessel, thereby concentrating stress and facilitating shattering of the calcifications.

[0079] Specifically, the characteristic parameters of the scored wire 7 include any one or more of the following:

[0080] The total height H of the scored wire 7 is 0.2 mm to 0.35 mm;

[0081] The tip angle θ of the top portion 71 is 20° to 60°;

[0082] The chamfer diameter R1 of the tip of the top 71 is 0.01 mm to 0.03 mm;

[0083] The chamfer diameter R of both sides of the bottom 70 in the longitudinal direction is 0.02 mm to 0.04 mm.

[0084] In this way, the cross section perpendicular to the length direction of the scored wire 7 is in an equilateral triangle (e.g. Figure 9 As shown, under this cross-sectional shape, the shape is formed by the top 71 as the vertex, the connecting line to the two ends of the bottom 70, and the connecting line between the two ends of the bottom 70). The notched wire 7 can provide sufficient stress and also enable the entire balloon catheter 2 to obtain a smaller folding profile, which is conducive to the smooth passage of the balloon catheter 2 through the lesion location.

[0085] In addition, the bottom 70 and the top 71 of the cross section of the scoring wire 7 are chamfered to prevent the scoring wire 7 from scratching the expansion balloon 20 when the expansion balloon 20 is folded, thereby improving the safety of the expansion balloon 20 in use.

[0086] On the outer circumferential wall of the expansion balloon 20, each scored thread 7 extends from the distal end to the proximal end. This allows the scored thread 7 to extend along the outer contour of the expansion balloon 20, allowing it to follow the shape of the expansion balloon 20 as it expands or contracts, without restricting the shape change of the expansion balloon 20. The distal end of the scored thread 7 and the distal end of the expansion balloon 20, as well as the proximal end of the scored thread 7 and the proximal end of the expansion balloon 20, can be connected by laser welding or adhesive bonding.

[0087] On the other hand, Figure 1 The distal end of the expansion balloon 20 is provided with a first constricting tube 72, and the proximal end of the expansion balloon 20 is provided with a second constricting tube 73. One end of each scored wire 7 is connected to the first constricting tube 72, and the other end of each scored wire 7 is connected to the second constricting tube 73. The first constricting tube 72 and the second constricting tube 73 are used to constrict and fix the ends of the scored wire 7, and the second constricting tube 73 can be stretched and deformed under the tension of the scored wire 7.

[0088] Specifically, the first constricting tube 72 is made of Pebax (polyether block polyamide), and the second constricting tube 73 is an elastically deformable silicone tube. Because the second constricting tube 73 is capable of stretching and deforming under the tension of the scored wire 7, the shape of the balloon 20 changes during inflation and depressurization. The second constricting tube 73, located proximal to the scored wire 7, elastically deforms accordingly, allowing axial movement without affecting the shape of the balloon 20.

[0089] On the other hand, Figure 10 The electrode emitter 6 includes a first electrode 61 and a second electrode 62 with conductive properties and an insulating member 63 with insulating properties. The first electrode 61 is sleeved on the insulating member 63, and the insulating member 63 is sleeved on the second electrode 62. The emission hole 60 passes through the first electrode 61 and the insulating member 63 so that the exposed part of the second electrode 62 is connected to the first electrode 61.

[0090] Specifically, the first electrode 61 and the second electrode 62, as well as the insulating member 63 and the second electrode 62, are bonded together by UV glue. The materials of the first electrode 61 and the second electrode 62 can be nickel-titanium alloy, stainless steel, platinum, titanium and titanium alloy, tungsten-copper alloy, so as to have good electrical conductivity. The material of the insulating member 63 can be polyimide, polyurethane, and a mixture of the two, which has achieved good insulation performance. The insulating member 63 is arranged between the first electrode 61 and the second electrode 62. Since the emission hole 60 passes through the first electrode 61 and the insulating member 63, a potential difference is formed between the portion of the second electrode 62 exposed on the insulating member 63 and the edge of the emission hole 60 on the first electrode 61 to generate a shock wave, so that the shock wave can be effectively generated.

[0091] Furthermore, the shape of the emitting aperture 60 is not limited and can be circular, rectangular, elliptical, triangular, or diamond-shaped. When the emitting aperture 60 is circular, its diameter is 0.05-0.5 mm. When the emitting aperture 60 is rectangular or diamond-shaped, the length and width of the through-hole 113 are 0.05-0.5 mm. When the emitting aperture 60 is elliptical, the major and minor axes range from 0.05-0.5 mm. When the emitting aperture 60 is triangular, the side length is 0.05-0.5 mm. When the emitting aperture 60 is triangular, rectangular, or diamond-shaped, since the discharge through-hole 113 discharges through the tip, a lower input voltage can be used to generate shock waves, reducing the load on electrical equipment.

[0092] On the other hand, the length of the second electrode 62 is greater than that of the first electrode 61, and the length of the insulating member 63 is greater than that of the second electrode 62. This effectively prevents the generation of shock waves at both ends of the first and second electrodes 61, 62, thereby maintaining the stability of the potential difference at the location of the emitting aperture 60. Furthermore, the longer second electrode 62 provides a larger contact area with the conduit member 21, thereby facilitating the second electrode 62's fixation to the conduit member 21 and preventing the electrode emitting member 6 from sliding.

[0093] On the other hand, multiple groups of electrode emitters 6, such as two, three or more groups, can be spaced apart on the catheter 21 in the expansion balloon 20. The distance between two adjacent electrode emitters 6 can be adjusted and selected according to the treatment site, preferably 2-10 mm.

[0094] If two sets of electrode emitting elements 6 are arranged on the catheter 21 in the expansion balloon 20, such as Figure 11 , which are the electrode transmitter 6A close to the distal end of the expansion balloon 20 and the electrode transmitter 6B close to the proximal end of the expansion balloon 20 respectively.

[0095] The first electrode 61 of the electrode emitter 6A is connected to an external power source via a first wire P1. The second electrode 62 of the electrode emitter 6A is connected to the second electrode 62 of the electrode emitter 6B via a second wire P2. The first electrode 61 of the electrode emitter 6B is connected to the external power source via a third wire P3. Thus, a power circuit is formed between the two sets of electrode emitters 6 via the series connection of the first wire P1, the second wire P2, and the third wire P3. The other ends of the first wire P1 and the third wire P3 are connected to the electrode driver 8. Furthermore, the end of the first wire P1 intended for connection to the external electrode driver 8 can be passed through the second electrode 62 of the electrode emitter 6B, thereby minimizing the overall dimensions of the balloon 20 after folding and facilitating its passage through stenotic vessels. Furthermore, the connections between the wires and electrodes can be laser welding, soldering, or other methods to ensure good electrical conductivity at each connection.

[0096] On the other hand, Figure 1 The catheter member 21 includes a first catheter 210 and a second catheter 211 passing through the first catheter 210. The inner cavity of the second catheter 211 forms a second channel L2. The gap between the outer wall of the first catheter 210 and the outer wall of the second catheter 211 forms a first channel L1. The proximal opening of the second catheter 211 is connected to the side wall of the first catheter 210 to form an inlet and outlet of the guide wire.

[0097] Specifically, the distal end of the second catheter 211 passes through the expansion balloon 20 and at least partially passes out from the distal end of the expansion balloon 20, and the distal end of the expansion balloon 20 is sealed and connected to the distal end of the second catheter 211. The first catheter 210 is connected to the second catheter 211, and the distal end of the first catheter 210 is sealed and connected to the proximal end of the expansion balloon 20. With this arrangement, the two ends of the expansion balloon 20 are sealed and connected, so that the inner cavity of the expansion balloon 20 can only be connected to the outside world through the first channel L1, so that the filling medium can enter the inner cavity of the expansion balloon 20 through the first channel L1 and expand the expansion balloon 20. At the same time, the second channel L2 formed inside the second catheter 211 is used as a guidewire cavity, which is used to supply the guidewire 5 (refer to Figure 14-18 ) passes through the second catheter 211. A guidewire port K is defined in the sidewall of the second catheter 211 for the entry and exit of the guidewire 5. The guidewire lumen extends along the length of the second catheter 211 to an opening at the distal end. Furthermore, the first channel L1 can also serve as a passage for guidewires (including the first guidewire P1, the second guidewire P2, and the third guidewire P3). Alternatively, a portion of the guidewire length can be placed in the first channel L1, while the remaining portion can be placed in a separate channel defined on the outer wall of the second catheter 211.

[0098] Specifically, the first conduit 210 is a multi-layer composite hollow tube made of polytetrafluoroethylene, polyethylene, polyether block polyamide or nylon material, and the second conduit 211 is a hollow tube extruded from nylon material.

[0099] For the first catheter 210 and the second catheter 211: the inner layer is a polytetrafluoroethylene layer, which has an extremely low friction coefficient and is conducive to the passage of the guide wire 5 during surgery. The outer layer is a polyether block polyamide or nylon layer, which can provide sufficient support strength and thereby improve the overall pushability.

[0100] The above disclosure is only the preferred embodiment of the present invention, which certainly cannot be used to limit the scope of the present invention. Therefore, equivalent changes made according to the scope of the patent application of the present invention are still within the scope of the present invention.

Claims

1. A device for removing intravascular calcified tissue, characterized in that: The invention comprises a balloon catheter and a filter, wherein the balloon catheter comprises an expansion balloon and a catheter member, wherein the expansion balloon is arranged at the distal end of the catheter member, and wherein a first channel and a second channel are independently provided in the catheter member, wherein the first channel is in communication with the expansion balloon for inputting or outputting a filling medium into or out of the expansion balloon, and the second channel is for passing a guide wire; The filter is used to be placed at the distal end of the lesion site, and the expansion balloon is used to be placed at the lesion site. The filter is used to prevent foreign tissue that is shed during the expansion balloon from flowing with the blood. The catheter is also provided with an electrode transmitter, which is used to emit shock waves that can act on the tissue within the blood vessel. The outer peripheral wall of the expansion balloon is also provided with a plurality of scoring threads, the scoring threads extending from the most distal end to the proximal end; It also includes a first bundling tube arranged at the distal end of the expansion balloon and a second bundling tube arranged at the proximal end of the expansion balloon. One end of any of the scored wires is connected to the first bundling tube, and the other end of any of the scored wires is connected to the second bundling tube. The first bundling tube and the second bundling tube are used to bundle and fix the ends of the scored wires, and the second bundling tube can be telescopically deformed under the tension of the scored wires.

2. The intravascular calcified tissue removal device according to claim 1, characterized in that: The filter includes a guide wire and a support frame and a filter membrane arranged at the distal end of the guide wire, and the guide wire is used to deliver the filter membrane and the support frame to the target area of ​​the blood vessel; the support frame includes a plurality of struts, and the struts include a first end, a second end and a transition portion located between the first end and the second end; the first ends of the plurality of struts are connected together to form a fixed end of the support frame, and the fixed end is fixed to the distal end of the guide wire, and the second ends of the plurality of struts are radially opened along the circumferential direction to form a first open end of the support frame, and the filter membrane is covered on the first open end, and the filter membrane allows blood to flow through and blocks foreign tissue in the blood flow from passing through; in a natural state, the first open end is in an open state, so that the second ends of the plurality of struts can abut against the inner wall of the blood vessel in which they are located; the first open end can be elastically contracted under the action of a restraining force to reduce the caliber of the first open end.

3. The intravascular calcified tissue removal device according to claim 2, characterized in that: At the first open end, the second ends of the two adjacent struts are connected by a connecting rod, and when the first open end is in an open state, the connecting rod abuts against the inner wall of the blood vessel; or / and, The filter membrane is in a bag-like structure, including a tail end and a second open end, wherein the second open end is connected to the first open end and completely covers the first open end, and the tail end is located on a side away from the fixed end.

4. The intravascular calcified tissue removal device according to claim 1, characterized in that: The electrode transmitter includes a first electrode and a second electrode with conductive properties and an insulating member with insulating properties. The first electrode is sleeved on the insulating member, and the insulating member is sleeved on the second electrode. The electrode transmitter is provided with a transmitting hole for emitting the shock wave, and the transmitting hole passes through the first electrode and the insulating member.

5. The intravascular calcified tissue removal device according to claim 4, characterized in that: The length of the second electrode is greater than that of the first electrode, and the length of the insulating member is greater than that of the second electrode.

6. The intravascular calcified tissue removal device according to claim 1, characterized in that: The electrode emitting element is provided with an emitting hole for emitting the shock wave, and the central axis of the emitting hole passes through at least one of the scoring wires.

7. The intravascular calcified tissue removal device according to claim 1, characterized in that: The scoring wire includes a bottom and a top, wherein the bottom is used to connect with the expansion balloon, the top is located on the side of the bottom facing away from the peripheral wall of the expansion balloon, and the top is in the shape of a pointed tip protruding toward the side away from the peripheral wall of the expansion balloon.

8. The intravascular calcified tissue removal device according to claim 7, characterized in that: The characteristic parameters of the scored wire include any one or more of the following: The total height of the scored wire is 0.2 mm to 0.35 mm; The tip angle of the top is 20° to 60°; The chamfer diameter of the top tip is 0.01mm~0.03mm; The chamfer diameters on both sides of the bottom in the length direction are 0.02 mm to 0.04 mm.

9. The intravascular calcified tissue removal device according to claim 1, characterized in that: The invention also includes a delivery catheter, which can contain the filter and is used to deliver the filter to a target site in a blood vessel along a guide wire.

10. The intravascular calcified tissue removal device according to claim 1, characterized in that: It also includes a suction catheter, which includes a third open end located at the distal end and a suction port located at the proximal end. Based on the third open end, the suction catheter can accommodate the balloon catheter together with the filter therein, and the suction port is used to provide negative pressure in the suction catheter to suction foreign tissue matter filtered out by the filter.

11. The intravascular calcified tissue removal device according to claim 10, characterized in that: The third open end of the suction catheter is also provided with a suction head with a hollow structure, and the suction head includes a connecting portion, an expansion portion and an opening portion. The diameters of the connecting portion, the expansion portion and the opening portion increase successively. The expansion portion is conical. The connecting portion is used to connect to the third open end, and the opening portion is used to receive the object to be extracted.

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