CN119279849B - Intravascular filter and intravascular calcified tissue removal device - Google Patents

Abstract

The invention provides a blood vessel built-in filter and a blood vessel calcified tissue removing device, wherein the filter comprises a guide wire, a support frame and a filter membrane, the support frame comprises a plurality of support rods, the support rods comprise a first end, a second end and a transition part between the first end and the second end, the first ends of the support rods are connected together in a concentrated mode to form a fixed end of the support frame, the second ends of the support rods are opened in a circumferential radiation mode to form a first opening end of the support frame, the filter membrane is arranged at the first opening end in a covering mode, the filter membrane allows blood flow to pass 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 support rods can be abutted against the inner wall of a blood vessel where the support rods are located, and the first opening end can be elastically folded under the action of restraining force to reduce the caliber of the first opening end. Based on the filter, broken pathological change fragments can be intercepted and blocked during interventional therapy, and other potential safety hazards caused by the flowing of the broken pathological change fragments to the far end are prevented.

Description

Intravascular filter and intravascular calcified tissue removing device

Technical Field

The invention relates to the technical field of interventional medical equipment, in particular to a blood vessel built-in filter and a blood vessel calcified tissue removing device.

Background

The balloon dilation catheter has remarkable clinical significance in treating recanalization of severely calcified blood vessels. At present, some moderate or severe calcified lesions are usually treated by using a shock wave balloon, and during treatment, the shock wave balloon is conveyed to a lesion part, and after the shock wave balloon is filled with an expanding medium and attached to the inner wall of a blood vessel, an ultrasonic wave generating device is started to generate shock waves so as to crush the moderate or severe calcified lesions.

For the existing shock wave balloon dilation catheter, although the calcified lesions can be crushed to achieve a good treatment effect, in the treatment process, the crushed calcified lesion particles cannot be blocked and plugged, so that the lesion particles move randomly along with blood flow, and therefore, new lesions are formed by accumulation in other places.

Accordingly, there is a need to design a device for use with balloon dilation catheters to intercept fragmented calcified tissue.

Disclosure of Invention

The invention aims to provide an intravascular filter capable of intercepting pathological change group fabrics in a free state in blood vessels and an intravascular calcified tissue removing device.

In order to achieve the above purpose, the invention provides a intravascular filter, which comprises a guide wire, a support frame and a filter membrane, wherein the support frame and the filter membrane are arranged at the distal end of the guide wire, the guide wire is used for delivering the filter membrane and the support frame to a vascular target area, the support frame comprises a plurality of struts, the struts comprise a first end, a second end and a transition part between the first end and the second end, the first ends of the struts are connected together in a concentrated mode to form a fixed end of the support frame, the fixed end is fixed at the distal end of the guide wire, the second ends of the struts are radially opened along the circumferential direction to form a first opening end of the support frame, the filter membrane is covered at the first opening end, the filter membrane allows blood flow to pass through and blocks abnormal tissues in the blood flow from passing through, the first opening end is in an open state so that the second ends of the struts can be abutted against the inner wall of a blood vessel of the blood vessel in a natural state, and the first opening end can be elastically contracted under the restraint force to reduce the caliber of the first opening end.

Preferably, at the first opening end, the second ends of two adjacent struts are connected by a connecting rod, when the first opening end is in an open state, the connecting rod is abutted with the inner wall of the blood vessel, or/and,

The filter membrane is of a bag-shaped structure and comprises a tail end and a second open end, wherein the second open end is connected with the first open end and is used for completely coating the first open end, and the tail end is located at one side far away from the fixed end.

The invention also provides an intravascular calcified tissue removing device which comprises a balloon catheter and the intravascular filter, wherein the balloon catheter comprises a dilating balloon and a catheter piece, the dilating balloon is arranged at the distal end of the catheter piece, a first channel and a second channel which are independent from each other are arranged in the catheter piece, the first channel is communicated with the dilating balloon and used for inputting or outputting filling media into the dilating balloon, the second channel is used for penetrating a guide wire, the filter is used for being placed at the distal end of a lesion part, the dilating balloon is used for being placed at the lesion position, the filter is used for blocking abnormal tissue falling off in the action process of the dilating balloon from flowing along with blood, and the catheter piece is further provided with an electrode transmitting piece which is used for transmitting shock waves which can act on intravascular tissue.

Preferably, the electrode emitting member includes a first electrode and a second electrode having conductive properties, and an insulating member having insulating properties, the first electrode is sleeved on the insulating member, the insulating member is sleeved on the second electrode, and the emitting hole penetrates through the first electrode and the insulating member.

Preferably, the length of the second electrode is greater than the length of the first electrode, and the length of the insulating member is greater than the length of the second electrode.

Preferably, the peripheral wall of the expanding balloon is further provided with a plurality of score wires, the score wires extend from the most distal end to the proximal end, the electrode emitting piece is provided with an emitting hole for emitting the shock wave, and the central axis of the emitting hole passes through at least one score wire.

Preferably, the score wire comprises a bottom part and a top part, wherein the bottom part is used for being connected with the expansion balloon, the top part is positioned on one side of the bottom part, which is away from the peripheral wall of the expansion balloon, and the top part is a tip end protruding towards one side away from the peripheral wall of the expansion balloon.

Preferably, the characteristic parameters of the score wire include any one or more of the following:

The total height of the score wire is 0.2 mm-0.35 mm;

The included angle of the tip end of the top is 20-60 degrees;

The chamfer diameter of the tip on the top is 0.01 mm-0.03 mm;

The chamfer diameters of the two sides of the bottom in the length direction are 0.02 mm-0.04 mm.

Preferably, the device further comprises a first converging tube arranged at the distal end of the expansion balloon and a second converging tube arranged at the proximal end of the expansion balloon, one end of any one of the score wires is connected with the first converging tube, the other end of any one of the score wires is connected with the second converging tube, the first converging tube and the second converging tube are used for converging and fixing the end head of the score wire, and the second converging tube can deform in a telescopic way under the action of the tension of the score wire.

Preferably, the catheter further comprises a delivery catheter capable of constricting the filter therein, the delivery catheter being used to deliver the filter along a guidewire at a target site within a vessel.

Preferably, the filter further comprises a suction catheter comprising a third open end at a distal end and a suction port at a proximal end, based on the third open end, the suction catheter being capable of receiving the balloon catheter together with the filter therein, the suction port being for providing negative pressure within the suction catheter for sucking the heterogeneous fabric filtered by the filter.

Preferably, the third opening end of the suction catheter is further provided with a suction head with a hollow structure, the suction head comprises a connecting portion, an expanding portion and an opening portion, the diameters of the connecting portion, the expanding portion and the opening portion are sequentially increased, the expanding portion is conical, the connecting portion is used for being connected with the third opening end, and the opening portion is used for receiving objects to be extracted.

Compared with the prior art, the intravascular filter provided by the technical scheme of the invention can be used in combination with a balloon dilation catheter, comprises a guide wire, a support frame and a filter membrane, wherein the filter membrane allows blood flow to pass through, and does not allow different tissues such as calcified fragments to pass through. Therefore, the filter can intercept and block broken pathological fragments during interventional therapy, and prevent the pathological fragments from flowing to the far end to cause other potential safety hazards.

Drawings

Fig. 1 is a plan view of a calcified tissue removing apparatus according to an embodiment of the present invention.

FIG. 2 is a schematic perspective view of a support frame of a filter according to an embodiment of the present invention.

FIG. 3 is a schematic perspective view of a filter membrane of a filter according to an embodiment of the invention.

Fig. 4 is a plan view of a filter having a developing function in an embodiment of the present invention.

Fig. 5 is a projection view of the support frame from the fixed end to the first opening end in the embodiment of the invention.

Fig. 6 is a schematic plan view of a suction tube according to an embodiment of the present invention.

FIG. 7 is a schematic plan view of a suction head according to an embodiment of the present invention.

Fig. 8 is a cross-sectional view of an embodiment of the invention with the dilation balloon perpendicular to its central axis.

Fig. 9 is a longitudinal cross-sectional view of the score wire of fig. 8.

Fig. 10 is an exploded view of an electrode emitting member in an embodiment of the present invention.

FIG. 11 is a diagram showing electrical connection between two electrode emitters in FIG. 1.

Fig. 12 to 19 are state diagrams of the calcified tissue removing device at various stages in the embodiment of the present invention.

Detailed Description

In order to describe the technical content, the constructional features, the achieved objects and effects of the present invention in detail, the following description is made in connection with the embodiments and the accompanying drawings.

This embodiment discloses an intravascular calcified tissue removing device, as shown in fig. 1, which comprises a guide wire 5, a balloon catheter 2 and a filter 1 matched with the balloon catheter 2, wherein the balloon catheter 2 comprises an expanding balloon 20 and a catheter piece 21, the expanding balloon 20 is arranged at the distal end of the catheter piece 21, a first channel L1 and a second channel L2 which are independent from each other are arranged in the catheter piece 21, the first channel L1 is communicated with the expanding balloon 20 and used for inputting or outputting filling media into or from the expanding balloon 20, and the second channel L2 is used for penetrating the guide wire 5. The filter 1 is intended to be placed at the distal end of a calcified site, the dilatation balloon 20 is intended to be placed at the lesion site, and the filter 1 is intended to block the flow of the foreign fabric coming off during the action of the dilatation balloon 20 with the blood. The guide wire is used for providing a moving path in the blood vessel for the balloon catheter 2 and the filter 1, and plays a role of navigation.

Referring to fig. 1 to 5 in combination, the filter 1 includes a support frame 10 fixed to the guide wire 5 and a filter membrane 11.

The support frame 10 includes a plurality of struts 100, the struts 100 including a first end 101, a second end 102, and a transition 103 between the first end 101 and the second end 102.

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

The second ends 102 of the plurality of struts 100 radiate circumferentially to form a first open end 105 of the stent 10. In this embodiment, the transition portion 103 has an arc-shaped structure curved toward the central axis of the first opening end 105.

The filter membrane 11 is disposed over the first open end 105, the filter membrane 11 allowing blood flow therethrough and blocking the passage of foreign tissue within the blood flow.

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 in which the blood vessel is located, and the escape of the foreign substances through the gap between the first open end 105 and the inner wall of the blood vessel is avoided.

In addition, the first opening end 105 can be elastically folded under the action of the restraining force, so as to reduce the caliber of the first opening end 105. Thus, the stent 10 can be folded to smoothly enter the target site in the blood vessel and to avoid damaging the blood vessel during the process of feeding the filter 1 into the blood vessel.

When the balloon catheter 2 is used to crush the calcified site G in the blood vessel, as shown in fig. 15, the filter 1 is placed at the distal end of the calcified site G, and the resulting crushed pieces of calcified tissue are free in the blood vessel and can move with the blood flow during the treatment. When these pieces of calcified tissue reach the filter membrane 11 via 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 broken pathological fragments during interventional therapy, and prevent the pathological fragments from flowing to the distal end of a blood vessel to cause other potential safety hazards.

On the other hand, as shown in fig. 2, at the first open end 105, the second ends 102 of two adjacent struts 100 are connected by a connecting rod 106, and when the first open end 105 is in an expanded state, the connecting rod 106 abuts against the inner wall of the blood vessel in which the blood vessel is located. In this embodiment, the number of the connecting rods 106 between two adjacent struts 100 may be one or more. Through the arrangement of the plurality of connecting rods 106 at the first opening end 105, the first opening end 105 is in a circular structure when in an open state, so that the adhesiveness between the outer side of the first opening end 105 and the inner wall of a blood vessel can be effectively improved, and the second end 102 of the supporting rod 100 is prevented from being damaged to the blood vessel.

In another embodiment, two adjacent connecting rods 106 are connected by a joint JO, so that each connecting rod 106 can be folded mutually. In this way, when in use, the joint structure JO is used to drive each connecting rod 106 to open in the expansion process of the supporting rod 100, each connecting rod 106 is in a circular structure after opening, so that the first open end 105 is opened, and before or after use, the supporting rod 100 is used to drive each connecting rod 106 to fold each other by the joint structure JO in the folding process, so that the first open end 105 is folded. Further, the lengths of the respective connecting rods 106 are equal.

On the other hand, in the support frame 10, when the first open end 105 is opened, the diameter of the inner space between the fixed end 104 and the first open end 105 increases in order to avoid the blockage of the blood flow at the first open end 105.

Furthermore, as shown in fig. 3, the filter 11 has a bag-shaped structure including a tail end 110 and a second open end 111, wherein the second open end 111 is connected with the first open end 105 and completely encloses the first open end 105, and the tail end 110 is located at a side far from the fixed end 104. In this embodiment, the first open end 105 coincides 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 located on opposite sides of the first open end 105 and the second open end 111, respectively.

Specifically, as shown in fig. 4, the filter membrane 11 includes a membrane body 112 and a plurality of through holes 113 provided on the membrane body 112, and the pore diameter Φ of the through holes 113 satisfies the following conditions:

phi is more than or equal to 80 mu m and less than or equal to 180 mu m so as to ensure that blood flow can flow smoothly without leakage of thrombus or calcification fragments.

On the other hand, the struts 100 are made of a shape memory alloy, and when no restraining force is applied, the second ends 102 of the struts 100 are expanded, and the first open ends 105 and the second open ends 111 are in the maximally expanded state. When the filter 1 is introduced into a blood vessel, a restraining force is applied to each strut 100 so that the first opening end 105 and the second opening end 111 are in a collapsed state.

On the other hand, referring to fig. 4 again, the first opening end 105 is further provided with a developing portion 107, and the developing portion 107 is configured to develop the current position of the mark on the medical image.

Specifically, the developed wire may be wound around each of the connection bars 106 of the first open end 105 to form the developing part 107. The connection lever 106 may also be directly made of a developing material so that the connection lever 106 can be used as the developing portion 107.

On the other hand, in order to facilitate the delivery of the filter 1 having the above-described structure to a target site within a blood vessel, as shown in fig. 12, the present embodiment also discloses a delivery catheter 3, in which the delivery catheter 3 is capable of converging the filter 1, the delivery catheter 3 being used to deliver the filter 1 along a guidewire 5 to the target site within the blood vessel.

On the other hand, as shown in fig. 6, 18 and 19, the present embodiment also discloses a suction catheter 4, the suction catheter 4 comprising a third open end 40 at the distal end and a suction port 41 at the proximal end.

Based on the third open end 40, the aspiration catheter 4 is able to house the balloon catheter 2 therein together with the filter 1.

The suction port 41 is used to provide negative pressure in the suction duct 4 to suck the foreign fabric filtered by the filter 1. In use, the aspiration port 41 may be in communication with an aspiration device via a luer fitting.

The following describes in detail the manner of use of the filter 1 having the above-described structure.

(1) As shown in fig. 12, the proximal ends of the filter 1 and the guidewire 5 are housed within the delivery catheter 3, the filter 1 is inserted into the blood vessel along the guidewire 5 and entirely through the calcification site G, and the delivery of the filter 1 is continued until the filter 1 is delivered to the distal end of the calcification site G.

(2) As shown in fig. 13, the delivery catheter 3 is withdrawn from the blood vessel, the stent 10 in the filter 1 loses its restraining force and self-expands, and the respective connecting rods 106 of the first open end 105 are attached to the inner wall of the blood vessel.

(3) As shown in fig. 14, the balloon catheter 2 is housed in the aspiration catheter 4, and the dilatation balloon 20 is inserted through the aspiration catheter 4 along the guide wire 5 to a position proximal to the calcification site G.

(4) As shown in fig. 15, the aspiration catheter 4 is held stationary and the balloon catheter 2 is continued to be accessed distally so that the dilation balloon 20 is in the position of the calcification site G.

(5) As shown in fig. 16, the balloon 20 is inflated through the first channel L1 to initiate the disruption treatment of the calcified site G.

(6) As shown in fig. 17, calcified fragments generated during the treatment are intercepted by the filter 1, and after the treatment is completed, the balloon 20 is contracted and expanded through the first passage L1.

(7) As shown in fig. 18, the suction catheter 4 is pushed distally so that the third open end 40 of the suction catheter 4 is close to the filter 1 and the suction device is turned on through the suction port 41 in the suction catheter 4, whereby calcified fragments intercepted by the filter 1 are drawn out of the body through the suction catheter 4.

(7) As shown in fig. 19, the suction catheter 4 is continuously pushed distally so that the filter 1 is also accommodated in the suction catheter 4. The filter 1 and the balloon catheter 2 are then withdrawn together from the body through the aspiration catheter 4.

On the other hand, as shown in fig. 6 and 7, the third open end 40 of the suction duct 4 is further provided with a suction head 42 having a hollow structure, and the suction head 42 includes a connection part 420, an expansion part 421 and an opening part 422. The diameters of the connection portion 420, the expansion portion 421, and the opening portion 422 become larger in order, and the expansion portion 421 is tapered. The connecting portion 420 corresponds to the aperture of the third open end 40 of the suction duct 4, the connecting portion 420 being adapted to be connected to the third open end 40, and the opening 422 being adapted to receive the object to be extracted.

In this embodiment, the expansion portion 421 is tapered, so that the caliber of the third opening end 40 becomes larger, and the suction head 42 has a funnel-shaped structure as a whole, thereby ensuring that thrombus can enter the suction catheter 4 through the suction head 42 more and more quickly, and the thrombus can be cleared more quickly.

Specifically, the suction head 42 includes a frame and a film provided on the peripheral side of the frame. The film may be made of polyamide or polyurethane based thermo-elastic materials. 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 thermal elastic material is 30 HD-45 HD, and the thickness of the film is 0.05-0.15 mm.

The skeleton is expandable net, and may be formed with metal pipe with shape memory effect, or with metal wire with shape memory effect, such as super elastic nickel-titanium alloy wire, or with high elastic polymer material through injection molding.

On the other hand, as shown in fig. 1, an electrode emitting member 6 is further provided on the catheter member 21 in the dilatation balloon 20, and the electrode emitting member 6 is adapted to emit a shock wave which can be applied to the intravascular tissue.

During treatment, after the dilating balloon 20 is conveyed to the calcified part G, the dilating balloon 20 is filled with the dilating medium, and after the dilating balloon is attached to the inner wall of a blood vessel, the electrode driving device 8 is started to drive the electrode emitting part 6 to emit shock waves so as to shake 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 emitting element 6 can be made to emit shock waves of different specifications, for example, the output voltage of the electrode emitting element 6 is controlled to be in the range of 4KV to 10KV for lesions for eliminating calcification of heart valves, and the output voltage of the electrode emitting element 6 is controlled to be in the range of 0.5KV to 6KV for lesions for eliminating calcification of blood vessels.

Further, a plurality of score lines 7 are provided on the outer peripheral wall of the dilatation balloon 20, and an emitting hole 60 for emitting a shock wave is provided on the electrode emitting member 6, and the central axis of the emitting hole 60 passes through at least one score line 7.

Specifically, three emission holes 60 are provided at intervals circumferentially on an electrode emission member 6 in the present embodiment, and the score lines 7 have three or more. Each of the emission holes 60 is opposite to one of the score lines 7, and the score lines 7 corresponding to the different emission holes 60 are different.

In this embodiment, since the central axis of the transmitting hole 60 passes through the score wire 7, the shock wave vibration energy can be directly conducted by using the score wire 7, thereby effectively increasing the vibration breaking efficiency thereof, and the hard calcified portion G can be physically crushed by using the physical properties of the score wire 7 alone when the shock wave energy is not used, thereby greatly increasing the crushing ability of the hard calcified portion.

Further, as shown in fig. 8 and 9, the score wire 7 includes a bottom portion 70 and a top portion 71, the bottom portion 70 is used for connecting with the expansion balloon 20, the top portion 71 is located at a side of the bottom portion 70 facing away from the outer peripheral wall of the expansion balloon 20, and the top portion 71 is in a tip end protruding toward a side facing away from the outer peripheral wall of the expansion balloon 20.

In this embodiment, the base 70 is connected to the dilation balloon 20 with a large contact area, ensuring a stable attachment of the score wire 7. While the tip 71 is pointed for contact with calcification in the vessel, so that the stress is more concentrated and the calcification is more easily broken.

In particular, the characteristic parameters of the score wire 7 include any one or more of the following:

the total height H of the score wire 7 is 0.2 mm-0.35 mm;

The tip angle theta of the top 71 is 20-60 degrees;

the chamfer diameter R1 of the tip on the top 71 is 0.01 mm-0.03 mm;

the chamfer diameter R of the two sides of the bottom 70 in the length direction is 0.02 mm-0.04 mm.

In this way, the cross section perpendicular to the length direction of the score wire 7 is in an equilateral triangle (as shown in fig. 9, in this cross section shape, the shape formed by connecting the top 71 as a vertex to the two ends of the bottom 70 and connecting the two ends of the bottom 70 is enclosed), and the score wire 7 can provide enough stress, and also can obtain a smaller folding profile of the whole balloon catheter 2, so that the balloon catheter 2 can smoothly pass through the lesion position.

In addition, the bottom 70 and the top 71 of the cross section of the score wire 7 are chamfered, so that the score wire 7 can be prevented from scratching the expansion balloon 20 when the expansion balloon 20 is folded, and the use safety of the expansion balloon 20 can be improved.

On the other hand, on the outer peripheral wall of the dilation balloon 20, either score wire 7 extends from the most distal end to the proximal end. In this way, the score wire 7 extends in the shape of the outline of the dilation balloon 20, such that upon inflation or deflation of the dilation balloon 20, the score wire 7 is able to follow the shape of the dilation balloon 20 without imposing a limit on the shape change of the dilation balloon 20. The connection between the distal end of the score wire 7 and the distal end of the dilation balloon 20, and between the proximal end of the score wire 7 and the proximal end of the dilation balloon 20, may be achieved by laser welding or adhesive bonding, etc.

On the other hand, as shown in fig. 1, the distal end of the dilation balloon 20 is provided with a first constriction 72 and the proximal end of the dilation balloon 20 is provided with a second constriction 73. One end of any score wire 7 is connected with a first converging tube 72, the other end of any score wire 7 is connected with a second converging tube 73, the first converging tube 72 and the second converging tube 73 are used for converging and fixing the end of the score wire 7, and the second converging tube 73 can deform in a telescopic way under the action of the tensile force of the score wire 7.

Specifically, the material of the first constriction 72 is Pebax (chinese name: polyether block polyamide), and the second constriction 73 is a silicone tube capable of elastic deformation. Since the second convergent tube 73 is elastically deformed under the tensile force of the score wire 7, when the inflatable balloon 20 is inflated and depressurized, the shape of the inflatable balloon 20 is changed, and the second convergent tube 73 provided at the proximal end of the score wire 7 is elastically deformed to move in the axial direction without affecting the shape of the inflatable balloon 20.

On the other hand, as shown in fig. 10, the electrode emitting member 6 includes a first electrode 61 and a second electrode 62 having conductive properties and an insulating member 63 having insulating properties, the first electrode 61 is fitted over the insulating member 63, the insulating member 63 is fitted over the second electrode 62, and the emitting hole 60 penetrates the first electrode 61 and the insulating member 63 so that the exposed portion of the second electrode 62 communicates with the first electrode 61.

Specifically, the first electrode 61 and the second electrode 62, and the insulator 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 alloy and tungsten-copper alloy, so that the conductive performance is good. The material of the insulating member 63 may be polyimide, polyurethane or a mixture of both, and good insulating properties have been achieved. The insulating member 63 is disposed between the first electrode 61 and the second electrode 62, and since the emission holes 60 penetrate the first electrode 61 and the insulating member 63, a portion of the second electrode 62 exposed at the insulating member 63 forms a potential difference generating a shock wave with an edge of the emission holes 60 on the first electrode 61, so that the shock wave can be effectively generated.

In addition, the shape of the emission hole 60 is not limited, and may be circular, rectangular, elliptical, triangular, diamond-shaped, or the like. The diameter is 0.05-0.5mm when the emission hole 60 is circular, the length and width of the through hole 113 are 0.05-0.5mm when the emission hole 60 is rectangular and diamond-shaped, the length and short axis range is 0.05-0.5mm when the emission hole 60 is elliptical, and the side length is 0.05-0.5mm when the emission hole 60 is triangular. When the emission hole 60 is triangular, rectangular or diamond-shaped, since the discharge through hole 113 discharges through the tip, a shock wave can be generated using a lower input voltage, reducing the load of the electrical equipment.

On the other hand, the length of the second electrode 62 is longer than that of the first electrode 61, and the length of the insulating member 63 is longer than that of the second electrode 62, so that the generation of shock waves at both ends of the first electrode 61 and the second electrode 62 is preferably avoided, thereby not affecting the stability of the potential difference at the position of the emission hole 60. In addition, the second electrode 62 with a longer size has a larger contact area with the catheter member 21, so that the second electrode 62 is beneficial to prevent the electrode emitting member 6 from sliding by being fixed on the catheter member 21.

On the other hand, multiple sets of electrode firing members 6, such as two, three or more sets, may be provided at intervals on the catheter member 21 within the dilation balloon 20. The distance between the two electrode emitting elements 6 adjacent to each other can be adjusted and selected according to the treatment site, preferably 2-10mm.

If two sets of electrode transmitters 6 are spaced apart on the catheter member 21 within the dilation balloon 20, as shown in fig. 11, the electrode transmitters 6A near the distal end of the dilation balloon 20 and the electrode transmitters 6B near the proximal end of the dilation balloon 20, respectively.

The first electrode 61 of the electrode emitting member 6A is connected to an external power source through a first wire P1, the second electrode 62 of the electrode emitting member 6A is connected to the second electrode 62 of the electrode emitting member 6B through a second wire P2, and the first electrode 61 of the electrode emitting member 6B is connected to the external power source through a third wire P3. Thus, the two sets of electrode emitters 6 are connected in series by the first, second and third wires P1, P2 and P3 to form a power supply loop. The other ends of the first wire P1 and the third wire P3 are connected to the electrode driving device 8. Moreover, one end of the first wire P1 for connecting with the external electrode driving device 8 can pass through the second electrode 62 of the electrode emitting piece 6B, so that the outline dimension of the dilating balloon 20 is not additionally increased, the outline of the dilating balloon 20 after being folded is reduced, and the dilating balloon 20 can pass through a blood vessel of a stenotic lesion easily. In addition, the connection mode between each wire and each electrode can be a laser welding mode, a soldering mode and the like, and the conductivity of each connection position is well ensured.

On the other hand, as shown in fig. 1, the catheter member 21 includes a first catheter 210 and a second catheter 211 penetrating the first catheter 210, the lumen of the second catheter 211 forms a second channel L2, a gap between the outer peripheral wall of the first catheter 210 and the outer peripheral wall of the second catheter 211 forms a first channel L1, and the proximal opening of the second catheter 211 is connected to the side wall of the first catheter 210 to form an inlet and an outlet of the guide wire.

Specifically, the distal end of the second catheter 211 passes internally through the self-expanding balloon 20 and at least partially out of the distal end of the self-expanding balloon 20, the distal end of the expanding balloon 20 being sealingly 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 sealingly connected to the proximal end of the dilation balloon 20. In this way, the two ends of the expansion balloon 20 are connected in a sealing manner, so that the inner cavity of the expansion balloon 20 can be communicated with the outside only through the first channel L1, and the filling medium can enter the inner cavity of the expansion balloon 20 through the first channel L1 to expand the expansion balloon 20. Meanwhile, a second channel L2 formed inside the second catheter 211 is used as a guide wire cavity for the guide wire 5 (refer to fig. 14-18) to pass through, a guide wire port K for the guide wire 5 to enter and exit is formed in the side wall of the second catheter 211, and the guide wire cavity extends to a distal end opening along the length direction of the second catheter 211. In addition, the first channel L1 may also serve as a channel for wires (including the first wire P1, the second wire P2, and the third wire P3). A part of the length of the wire may be disposed in the first channel L1, and another part of the length of the wire may be disposed in a separate channel provided on the outer peripheral wall of the second conduit 211.

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

For the first catheter 210 and the second catheter 211, the inner layer is a polytetrafluoroethylene layer, polytetrafluoroethylene has extremely low friction coefficient, the passage of the guide wire 5 in operation is facilitated, and the outer layer is a polyether block polyamide or nylon layer, so that sufficient supporting strength can be provided, and the whole pushability is improved.

The foregoing description of the preferred embodiments of the present invention is not intended to limit the scope of the claims, which follow, as defined in the claims.

Claims (11)

1. The intravascular calcified tissue removing device is characterized by comprising a balloon catheter and a filter, wherein the balloon catheter comprises a dilating balloon and a catheter piece, the dilating balloon is arranged at the distal end of the catheter piece, a first channel and a second channel which are independent from each other are arranged in the catheter piece, the first channel is communicated with the dilating balloon and used for inputting or outputting filling media into the dilating balloon, the second channel is used for penetrating a guide wire, the filter is used for being placed at the distal end of a lesion site, the dilating balloon is used for being placed at the lesion site, the filter is used for blocking a foreign tissue falling off during the action of the dilating balloon from flowing along with blood, and an electrode transmitting piece is further arranged on the catheter piece and used for transmitting shock waves which can act on intravascular tissues;

the peripheral wall of the expansion saccule is also provided with a plurality of score wires, and the score wires extend from the most distal end to the proximal end;

The device comprises an expanding balloon, a first converging tube and a second converging tube, wherein the first converging tube is arranged at the far end of the expanding balloon, the second converging tube is arranged at the near end of the expanding balloon, one end of any score wire is connected with the first converging tube, the other end of any score wire is connected with the second converging tube, the first converging tube and the second converging tube are used for converging and fixing the end head of the score wire, and the second converging tube can be deformed in a telescopic way under the action of the tensile force of the score wire.

2. The endovascular calcified tissue removal device of claim 1, wherein the filter comprises a guidewire and a support frame disposed at a distal end of the guidewire, a filter membrane disposed over the first open end, the filter membrane permitting blood flow therethrough and blocking passage of foreign tissue within the blood vessel, the support frame comprising a plurality of struts including first ends, second ends and transitions therebetween, the first ends of the plurality of struts being collectively connected together to form a fixed end of the support frame, the fixed end being secured to the distal end of the guidewire, the second ends of the plurality of struts being circumferentially radially expanded to form a first open end of the support frame, the filter membrane being disposed over the first open end, the filter membrane permitting passage of blood flow therethrough and blocking passage of foreign tissue within the blood vessel, the first open end being in a natural state in which the second ends of the plurality of struts are capable of abutting an inner wall of the blood vessel, the first open end being elastically contracted under a restraining force to reduce the first open end.

3. The endovascular calcified tissue removal device of claim 2, wherein at the first open end, the second ends of two struts adjacent to each other are connected by a connecting rod that abuts an inner wall of a vessel in which the first open end is positioned when the first open end is in an expanded state, or/and,

The filter membrane is of a bag-shaped structure and comprises a tail end and a second open end, wherein the second open end is connected with the first open end and is used for completely coating the first open end, and the tail end is located at one side far away from the fixed end.

4. The endovascular calcified tissue removal device of claim 1, wherein the electrode emitting element comprises a first electrode and a second electrode having electrical conductivity properties and an insulating element having insulating properties, the first electrode is sleeved on the insulating element, the insulating element is sleeved on the second electrode, and an emitting hole for emitting the shock wave is provided on the electrode emitting element, and the emitting hole penetrates through the first electrode and the insulating element.

5. The endovascular calcified tissue removal device of claim 4, wherein the second electrode has a length greater than a length of the first electrode, and the insulator has a length greater than a length of the second electrode.

6. The endovascular calcified tissue removal device of claim 1, wherein the electrode firing member has a firing aperture disposed therein for firing the shock wave, a central axis of the firing aperture passing through at least one of the score lines.

7. The endovascular calcified tissue removal device of claim 1, wherein the score wire comprises a base for connection with the dilation balloon and a top on a side of the base facing away from the dilation balloon peripheral wall, the top being a tip protruding toward a side away from the dilation balloon peripheral wall.

8. The endovascular calcified tissue removal device of claim 7, wherein the characteristic parameters of the score wire comprise any one or more of:

The total height of the score wire is 0.2 mm-0.35 mm;

The included angle of the tip end of the top is 20-60 degrees;

The chamfer diameter of the tip on the top is 0.01 mm-0.03 mm;

The chamfer diameters of the two sides of the bottom in the length direction are 0.02 mm-0.04 mm.

9. The endovascular calcified tissue removal device of claim 1, further comprising a delivery catheter capable of constricting the filter therein, the delivery catheter for delivering the filter along a guidewire at a target site within a blood vessel.

10. The endovascular calcified tissue removal device of claim 1, further comprising a suction catheter including a third open end at a distal end and a suction port at a proximal end, the suction catheter being capable of receiving the balloon catheter with the filter therein based on the third open end, the suction port for providing negative pressure within the suction catheter to suction the filter-filtered heterogeneous fabric.

11. The endovascular calcified tissue removal device of claim 10, wherein the third open end of the aspiration catheter is further provided with an aspiration head having a hollow structure, the aspiration head comprising a connecting portion, an expanding portion and an opening portion, the connecting portion, the expanding portion and the opening portion having successively larger diameters, the expanding portion being tapered, the connecting portion being adapted to connect with the third open end, the opening portion being adapted to receive an object to be extracted.