Intravascular filter and intravascular calcified tissue removal device

Abstract

The invention provides an intravascular filter and an intravascular calcified tissue removal device. The filter comprises a guide wire, a support frame and a filter membrane, the supporting frame comprises a plurality of supporting rods. Each supporting rod comprises a first end, a second end and a transition part located between the first end and the second end. The first ends of the multiple supporting rods are connected together in a concentrated mode to form the fixed end of the supporting frame, the second ends of the multiple supporting rods are radially opened in the circumferential direction to form the first open end of the supporting frame, the first open end is covered with the filter membrane, and the filter membrane allows blood flow to pass through and blocks heterogenous tissue substances in the blood flow to pass through; in a natural state, the first opening ends are in an open state, so that the second ends of the supporting rods can abut against the inner wall of the blood vessel where the supporting rods are located. The first opening end can be elastically folded under the action of restraining force so as to reduce the caliber of the first opening end. Based on the filter, broken lesion fragments can be intercepted and blocked during interventional therapy, and the situation that the broken lesion fragments flow to the far end to cause other potential safety hazards is prevented.

Description

Technical Field

[0001] The present invention relates to the technical field of interventional medical equipment, and in particular to a blood vessel internal filter and a device for removing intravascular calcified tissue. Background Art

[0002] The application of balloon dilatation catheters in the treatment of severe calcified blood vessels has significant clinical significance. At present, shock wave balloons are usually used to treat some moderate or severe calcified lesions. During treatment, the shock wave balloon is delivered to the lesion, and after the shock wave balloon is filled with expansion medium and attached to the inner wall of the blood vessel, the ultrasonic generator is turned on to generate shock waves to shatter the moderate or severe calcified lesions.

[0003] Although the existing shock wave balloon dilatation catheter can shatter calcified lesions and achieve good treatment effects, it is 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, thereby accumulating in other places and forming 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 a blood vessel internal filter and a blood vessel 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 is 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 comprise 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 opening end, the second ends of the two adjacent support rods are connected by a connecting rod, and when the first opening end is in an open state, the connecting rod abuts against the inner wall of the blood vessel where the blood vessel is located; 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.

[0008] The present invention also provides an intravascular calcified tissue removal device, which includes a balloon catheter and the intravascular filter as described above, wherein the balloon catheter includes an expansion balloon and a catheter component, wherein the expansion balloon is arranged at the distal end of the catheter component, wherein a first channel and a second channel independent of each other are arranged in the catheter component, wherein the first channel is connected to the expansion balloon for inputting or outputting a filling medium into or out of the expansion balloon, and the second channel is used for threading a guide wire; wherein the filter is used for being placed at the distal end of the lesion site, wherein the expansion balloon is used for being placed at the lesion site, wherein the filter is used for preventing foreign tissue matter detached during the action of the expansion balloon from flowing with the blood; wherein the catheter component is also provided with an electrode transmitter, wherein the electrode transmitter is used for emitting shock waves that can act on the intravascular tissue.

[0009] Preferably, the electrode emitting element comprises 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.

[0010] 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.

[0011] Preferably, a plurality of scored wires are further provided on the peripheral wall of the expansion balloon, and the scored wires extend from the most distal end to the proximal end. The electrode transmitter is provided with a launch hole for emitting the shock wave, and the central axis of the launch hole passes through at least one of the scored wires.

[0012] Preferably, the scored 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.

[0013] Preferably, 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°~60°; The chamfer diameter of the tip on the top 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.

[0014] Preferably, it also includes a first constricting tube arranged at the distal end of the dilation balloon and a second constricting tube arranged at the proximal end of the dilation balloon, one end of any one of the scored wires is connected to the first constricting tube, and the other end of any one of the scored wires is connected to the second constricting tube, the first constricting tube and the second constricting tube are used to constrict and fix the ends of the scored wires, and the second constricting tube can be telescopically deformed under the tension of the scored wires.

[0015] Preferably, it further comprises a delivery catheter, wherein the delivery catheter can contain the filter, and the delivery catheter is used to deliver the filter along the guide wire to the target site in the blood vessel.

[0016] Preferably, it also includes a suction catheter, which includes a third opening end located at the distal end and a suction port located at the proximal end. Based on the third opening 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.

[0017] Preferably, the third open end of the suction catheter is also provided with a suction head with a hollow structure, 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 be connected to the third open end, and the opening portion is used to receive the object to be extracted.

[0018] 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 guide wire, a support frame, and a filter membrane. The filter membrane allows blood to flow through, but does not allow foreign tissues 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 generated fragmented calcified tissue is free in the blood vessel 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 the broken lesion fragments during interventional treatment to prevent them from flowing to the distal end and causing other safety hazards. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 4 is a plan view of the structure of the calcified tissue removal device in an embodiment of the present invention.

[0020] Figure 2 A schematic diagram of the three-dimensional structure of a support frame of a filter in an embodiment of the present invention.

[0021] Figure 3 It is a schematic diagram of the three-dimensional structure of the filter membrane of the filter in an embodiment of the present invention.

[0022] Figure 4 It is a planar structural diagram of a filter with a developing function in an embodiment of the present invention.

[0023] Figure 5 It is a projection diagram of the support frame viewed from the fixed end toward the first opening end in an embodiment of the present invention.

[0024] Figure 6 Schematic diagram of the planar structure of the suction tube in an embodiment of the present invention.

[0025] Figure 7 Schematic diagram of the planar structure of the suction head in an embodiment of the present invention.

[0026] Figure 8 It is a cross-sectional view of the expansion balloon in an embodiment of the invention perpendicular to its central axis.

[0027] Fig. 9 for Figure 8 Longitudinal section of the scored wire.

[0028] Fig.10 Schematic diagram of the electrode emitter in the embodiment of the present invention.

[0029] Fig.11 for Figure 1 Electrical connection diagram of the two electrode emitters.

[0030] Figures 12 to 19 1 is a state diagram of the calcified tissue removal device in different stages according to an embodiment of the present invention. DETAILED DESCRIPTION

[0031] 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 implementation methods and the accompanying drawings.

[0032] This embodiment discloses a device for removing intravascular calcified tissue. Figure 1 , which includes a guide wire 5, a balloon catheter 2 and a filter 1 used in conjunction with the balloon catheter 2. The balloon catheter 2 includes an expansion balloon 20 and a catheter member 21. The expansion balloon 20 is arranged 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 to input or output a filling medium into or out of the expansion balloon 20. The second channel L2 is used to pass the guide wire 5. The filter 1 is used to be placed at the distal end of the calcified part, the expansion balloon 20 is used to be placed at the lesion site, and the filter 1 is used to prevent foreign tissues that fall off during the action of the expansion balloon 20 from flowing with the blood. The guide wire is used to provide a moving path for the balloon catheter 2 and the filter 1 in the blood vessel, and plays a role in navigation.

[0033] Please refer to Figures 1 to 5The filter 1 includes a support frame 10 fixed on the guide wire 5 and a filter membrane 11.

[0034] 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 .

[0035] 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 .

[0036] The second ends 102 of the plurality of support rods 100 are radially spread out in 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 is bent toward the central axis of the first open end 105.

[0037] The filter membrane 11 is covered on the first open end 105 , and the filter membrane 11 allows blood to flow through and blocks foreign tissues in the blood from passing through.

[0038] 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.

[0039] In addition, the first open end 105 can be elastically collapsed under the action of the restraining force to reduce the diameter of the first open end 105. In this way, when the filter 1 is delivered into the blood vessel, the support frame 10 can be collapsed to smoothly enter the target position in the blood vessel and avoid damaging the blood vessel.

[0040] When the calcified part G in the blood vessel is broken up by using the balloon catheter 2, Fig.15 , the filter 1 is placed at the distal end of the calcified part G. During the treatment, the generated fragmented calcified tissue is free in the blood vessel and can move with the blood flow. When these fragmented calcified tissues reach the filter membrane 11 through the first open end 105 of the support frame 10, they are blocked by the filter membrane 11, limiting their further movement. Therefore, the filter 1 can intercept and block the broken lesion fragments during interventional treatment to prevent them from flowing to the distal end of the blood vessel and causing other safety hazards.

[0041] On the other hand, Figure 2At the first open end 105, the second ends 102 of the two adjacent support rods 100 are connected by a connecting rod 106. When the first open end 105 is in an open state, the connecting rod 106 abuts against the inner wall of the blood vessel where the support rod 100 is located. In this embodiment, the connecting rod 106 between the two adjacent support rods 100 can be one or more. By providing a plurality of connecting rods 106 at the first open end 105, the first open end 105 is in a circular structure when in an open state, which can effectively improve the adhesion between the outer side of the first open end 105 and the inner wall of the blood vessel, and prevent the second end 102 of the support rod 100 from damaging the blood vessel.

[0042] In another embodiment, two adjacent connecting rods 106 are connected by a joint structure JO, so that each connecting rod 106 can be folded with each other. In this way, when in use, with the help of the joint structure JO, the support rod 100 expands and drives each connecting rod 106 to open, and each connecting rod 106 is in a circular structure after opening, thereby opening the first open end 105; before or after use, when the support rod 100 is folded, with the help of the joint structure JO, it drives each connecting rod 106 to fold together, thereby folding the first open end 105. Further, the lengths of each connecting rod 106 are equal.

[0043] 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 successively, thereby preventing blood flow from being blocked at the first open end 105 .

[0044] Furthermore, if Figure 3 The filter membrane 11 is in 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 overlaps with the second open end 111, 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.

[0045] Specifically, Figure 4 The filter membrane 11 includes a membrane body 112 and a plurality of through holes 113 disposed on the membrane body 112. The aperture φ of the through holes 113 satisfies the following conditions: 80μm≤φ≤180μm to ensure that no thrombus or calcified debris is missed and blood flows smoothly.

[0046] On the other hand, the struts 100 are made of 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 the maximum expanded state. When the filter 1 is introduced into the blood vessel, a restraining force is applied to each strut 100, so that the first open end 105 and the second open end 111 are in a closed state.

[0047] On the other hand, please refer again to Figure 4 The first opening end 105 is also provided with a developing unit 107, and the developing unit 107 is used to develop and mark the current location on the medical image.

[0048] 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. The connecting rod 106 may also be directly made of a developing material so that the connecting rod 106 can be used as the developing portion 107.

[0049] 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, Fig.12 This embodiment further discloses a delivery catheter 3, which can gather the filter 1 therein, and is used to deliver the filter 1 along the guide wire 5 to the target location in the blood vessel.

[0050] On the other hand, Figure 6 , Fig.18 and Fig.19 This embodiment further discloses a suction catheter 4, which includes a third opening end 40 located at the distal end and a suction port 41 located at the proximal end.

[0051] Based on the third open end 40 , the suction catheter 4 can receive the balloon catheter 2 together with the filter 1 therein.

[0052] 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.

[0053] The following describes in detail how to use the filter 1 having the above structure.

[0054] (1) If Fig.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 filter 1 is passed through the calcified site G as a whole, and the filter 1 is continuously delivered until the filter 1 is delivered to the distal end of the calcified site G.

[0055] (2) If Fig.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 each connecting rod 106 of the first open end 105 fits against the inner wall of the blood vessel.

[0056] (3) If Fig.14 The balloon catheter 2 is housed in the suction catheter 4, and the expansion balloon 20 is inserted into the proximal position of the calcification site G along the guide wire 5 through the suction catheter 4.

[0057] (4) If Fig.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.

[0058] (5) If Fig.16 , the balloon 20 is filled and expanded through the first channel L1 to start the fragmentation treatment of the calcified part G.

[0059] (6) Fig.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.

[0060] (7) Fig.18 , push the suction catheter 4 to 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 sucked out of the body through the suction catheter 4.

[0061] (7) Fig.19 , continue to push the suction catheter 4 to 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 through the suction catheter 4.

[0062] On the other hand, Figure 6 and Figure 7 The third open end 40 of the suction catheter 4 is also provided with a suction head 42 having a hollow structure, and the suction head 42 includes a connecting portion 420, an expansion portion 421, and an opening portion 422. The diameters of the connecting portion 420, the expansion portion 421, and the opening portion 422 are successively larger, and the expansion portion 421 is conical. The connecting portion 420 is equivalent to the caliber of the third open end 40 of the suction catheter 4, and the connecting portion 420 is used to connect to the third open end 40, and the opening portion 422 is used to receive the object to be extracted.

[0063] 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 and faster thrombi can enter the suction catheter 4 through the suction head 42, and the thrombi can be cleared faster.

[0064] Specifically, the suction head 42 includes a frame and a film covering the periphery of the frame. The film can be made of a polyamide or polyurethane thermoelastic material. For example, the film is made of one or more of PTFE, ePTFE, PU, ​​TPU and TPE. In addition, the Shore hardness of the polyamide or polyurethane thermoelastic material is 30HD to 45HD, and the thickness of the film is 0.05 to 0.15 mm.

[0065] Furthermore, the skeleton is an expandable mesh, which can be formed by laser cutting and thermal expansion of metal tubes with shape memory effect; or, it can be woven from metal wires with shape memory effect (such as superelastic nickel-titanium alloy wires); or, it can be formed by injection molding of high-elastic polymer materials; or, it can be formed by injection molding of high-elastic polymer materials.

[0066] On the other hand, Figure 1 The catheter part 21 in the expansion balloon 20 is also provided with an electrode transmitter 6, and the electrode transmitter 6 is used to emit shock waves that can act on the intravascular tissue.

[0067] During treatment, after the expansion balloon 20 is delivered to the calcified part G, the expansion balloon 20 is filled with the expansion medium and attached to the inner wall of the blood vessel, the electrode driving device 8 is turned on to drive the electrode transmitter 6 to emit shock waves to shatter the moderate or severe calcified part G, thereby improving the treatment effect. In addition, by adjusting the driving parameters of the electrode driving device 8, the electrode transmitter 6 can emit shock waves of different specifications. For example, for the lesions used to eliminate heart valve calcification, the output voltage range of the electrode transmitter 6 is controlled to be 4KV to 10KV, and for the lesions used to eliminate vascular calcification, the output voltage range of the electrode transmitter 6 is controlled to be 0.5KV to 6KV.

[0068] Furthermore, a plurality of notched 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 notched wire 7 .

[0069] Specifically, in this embodiment, three emitting holes 60 are arranged circumferentially at intervals on an electrode emitting element 6, and there are three or more notched wires 7. Each emitting hole 60 is opposite to one of the notched wires 7, and different emitting holes 60 correspond to different notched wires 7.

[0070] In this embodiment, since the central axis of the launch hole 60 passes through the notched wire 7, the notched wire 7 can be used to directly conduct the shock wave vibration energy, thereby effectively enhancing its shattering efficiency. The physical properties of the notched wire 7 can also be used alone to physically squeeze and crush the hard calcified area G when the shock wave energy is not used, thereby greatly increasing the crushing ability of the hard calcified area.

[0071] Furthermore, if Figure 8 and Fig. 9 The notched 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 faces away from the outer wall of the expansion balloon 20. The top 71 is in a pointed shape that protrudes toward the side away from the outer wall of the expansion balloon 20.

[0072] In this embodiment, the bottom 70 is connected to the expansion balloon 20, and has a large contact area, ensuring the stable attachment of the scoring wire 7. The top 71 is pointed, and is used to contact the calcification in the blood vessel, so that the stress is more concentrated, which is conducive to breaking the calcification.

[0073] Specifically, the characteristic parameters of the scored wire 7 include any one or more of the following: The total height H of the scored wire 7 is 0.2 mm to 0.35 mm; The tip angle θ of the top 71 is 20° to 60°; The chamfer diameter R1 of the tip of the top 71 is 0.01 mm to 0.03 mm; The chamfer diameter R of both sides of the bottom 70 in the length direction is 0.02 mm to 0.04 mm.

[0074] In this way, the cross section perpendicular to the length direction of the scored wire 7 is in an equilateral triangle (such as Fig. 9 As shown, under this cross-sectional shape, the shape is formed by the top 71 as the vertex, the lines connecting the two ends of the bottom 70, and the lines connecting the two ends of the bottom 70), while 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.

[0075] In addition, the bottom 70 and the top 71 of the cross section of the notched wire 7 are chamfered to prevent the notched wire 7 from scratching the expansion balloon 20 when the expansion balloon 20 is folded, thereby improving the safety of the use of the expansion balloon 20.

[0076] On the other hand, on the outer peripheral wall of the expansion balloon 20, any scored wire 7 extends from the most distal end to the proximal end. In this way, the scored wire 7 extends according to the outer contour shape of the expansion balloon 20, so that when the expansion balloon 20 expands or contracts, the scored wire 7 can change with the shape of the expansion balloon 20 without restricting the shape change of the expansion balloon 20. The connection between the distal end of the scored wire 7 and the distal end of the expansion balloon 20, and between the proximal end of the scored wire 7 and the proximal end of the expansion balloon 20 can be achieved by laser welding or bonding.

[0077] On the other hand, Figure 1The 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 any notched wire 7 is connected to the first constricting tube 72, and the other end of any notched 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 end of the notched wire 7, and the second constricting tube 73 can be retracted and deformed under the tension of the notched wire 7.

[0078] Specifically, the material of the first bundle tube 72 is Pebax (Chinese name: polyether block polyamide), and the second bundle tube 73 is a silicone tube that can undergo elastic deformation. Since the second bundle tube 73 can be stretched and deformed under the tension of the scoring wire 7, when the expansion balloon 20 is pressurized and depressurized, the shape of the expansion balloon 20 will change, and the second bundle tube 73 set at the proximal end of the scoring wire 7 will follow the elastic deformation and can move in the axial direction without affecting the shape of the expansion balloon 20.

[0079] On the other hand, Fig.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.

[0080] 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 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 runs through the first electrode 61 and the insulating member 63, a portion of the second electrode 62 exposed on the insulating member 63 forms a potential difference with 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.

[0081] In addition, the shape of the emitting hole 60 is not limited, and can be circular, rectangular, elliptical, triangular, rhombus, etc. When the emitting hole 60 is circular, the diameter is 0.05-0.5 mm; when the emitting hole 60 is rectangular and rhombus, the length and width of the through hole 113 are 0.05-0.5 mm; when the emitting hole 60 is elliptical, the long and short axis range is 0.05-0.5 mm; when the emitting hole 60 is triangular, the side length is 0.05-0.5 mm. When the emitting hole 60 is triangular, rectangular or rhombus, 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. 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, which better avoids the generation of shock waves at both ends of the first electrode 61 and the second electrode 62, thereby not affecting the stability of the potential difference at the position of the launch hole 60. In addition, the second electrode 62 with a longer size has a larger contact area with the conduit member 21, which is conducive to the second electrode 62 being fixed on the conduit member 21 to prevent the electrode launch member 6 from sliding.

[0082] On the other hand, multiple groups of electrode emitters 6, such as two, three or more groups, may be arranged at intervals on the catheter 21 in the expansion balloon 20. The distance between two adjacent electrode emitters 6 may be adjusted and selected according to the treatment site, preferably 2-10 mm.

[0083] If two sets of electrode emitting elements 6 are arranged at intervals on the catheter element 21 in the expansion balloon 20, such as Fig.11 , respectively, 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.

[0084] The first electrode 61 of the electrode emitter 6A is connected to the external power supply through the first wire P1, the second electrode 62 of the electrode emitter 6A is connected to the second electrode 62 of the electrode emitter 6B through the second wire P2, and the first electrode 61 of the electrode emitter 6B is connected to the external power supply through the third wire P3. In this way, the two groups of electrode emitters 6 are connected in series through the first wire P1, the second wire P2 and the third wire P3 to form a power supply circuit. The other ends of the first wire P1 and the third wire P3 are connected to the electrode driving device 8. In addition, the end of the first wire P1 used for connecting to the external electrode driving device 8 can pass through the second electrode 62 of the electrode emitter 6B, so as not to increase the external outline size of the expansion balloon 20, so as to reduce the outline of the expansion balloon 20 after folding, which is conducive to the expansion balloon 20 passing through the blood vessels with stenotic lesions. In addition, the connection between each wire and each electrode can be laser welding, soldering, etc., which better ensures the conductivity of each connection.

[0085] On the other hand, Figure 1 The catheter member 21 includes a first catheter 210 and a second catheter 211 inserted into 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.

[0086] 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. In this configuration, the two ends of the expansion balloon 20 are sealed and connected, so that the inner cavity of the expansion balloon 20 can only communicate with 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 to 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, and a guide wire port K for the guide wire 5 to enter and exit is provided on the side wall of the second catheter 211, and the guide wire cavity extends along the length direction of the second catheter 211 to the distal end opening. In addition, the first channel L1 can also be used as a guide wire (including the first guide wire P1, the second guide wire P2 and the third guide wire P3) channel. A part of the length of the guide wire can be set in the first channel L1, and the other part of the length of the guide wire can be set in a separate channel opened on the outer peripheral wall of the second catheter 211.

[0087] 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.

[0088] 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 thus improve the overall pushability.

[0089] The above disclosure is only the preferred embodiment of the present invention, which certainly cannot be used to limit the scope of rights 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 covered by the present invention.

Claims

1. A blood vessel internal filter, characterized in that: It comprises a guide wire and a support frame and a filter membrane arranged at the distal end of the guide wire, wherein 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 comprises a plurality of struts, wherein the struts comprise 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, wherein 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 in a circumferential direction to form a first opening end of the support frame, wherein the filter membrane is covered on the first opening end, wherein 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 opening 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 opening end can be elastically contracted under the action of a restraining force to reduce the caliber of the first opening end.

2. The intravascular filter according to claim 1, characterized in that: At the first opening end, the second ends of the two adjacent support rods are connected by a connecting rod, and when the first opening end is in an open state, the connecting rod abuts against the inner wall of the blood vessel where the blood vessel is located; 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.

3. A device for removing intravascular calcified tissue, characterized in that: A device comprising a balloon catheter and an intravascular filter as claimed in any one of claims 1 to 2, 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, wherein a first channel and a second channel independent of each other are arranged in the catheter member, wherein the first channel is communicated with the expansion balloon for inputting or outputting a filling medium into or out of the expansion balloon, and the second channel is used for inserting 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 that falls off during the action of the expansion balloon from flowing with the blood; the catheter is also provided with an electrode transmitter, and the electrode transmitter is used to emit shock waves that can act on the tissue within the blood vessel.

4. The intravascular calcified tissue removal device according to claim 3, characterized in that: The electrode emitting element comprises 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.

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 3, characterized in that: The outer wall of the expansion balloon is also provided with a plurality of scored wires, which 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 scored wires.

7. The intravascular calcified tissue removal device according to claim 6, characterized in that: The notched wire includes a bottom and a top, wherein the bottom is used to connect with the expansion balloon, and 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 a pointed shape protruding toward a 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 0.01 mm to 0.03 mm; The chamfer diameters of 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 7, characterized in that: It also includes a first constricting tube arranged at the distal end of the expansion balloon and a second constricting tube arranged at the proximal end of the expansion balloon, one end of any of the scored wires is connected to the first constricting tube, and the other end of any of the scored wires is connected to the second constricting tube, the first constricting tube and the second constricting tube are used to constrict and fix the ends of the scored wires, and the second constricting tube can be telescopically deformed under the tension of the scored wires.

10. The intravascular calcified tissue removal device according to claim 3, characterized in that: The invention also comprises a delivery catheter, wherein the delivery catheter can contain the filter and is used to deliver the filter to a target site in a blood vessel along a guide wire.

11. The intravascular calcified tissue removal device according to claim 3, 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.

12. The intravascular calcified tissue removal device according to claim 11, 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 part, an expansion part and an opening part. The diameters of the connecting part, the expansion part and the opening part increase successively. The expansion part is conical, the connecting part is used to be connected to the third open end, and the opening part is used to receive the object to be extracted.

Images