SUMMERY OF THE UTILITY MODEL
An object of the utility model is to provide a thrombus capture device to solve among the prior art thrombus capture device and once accomplishing the problem that the thrombus was caught.
The utility model provides a device is arrested to thrombus, include: a support assembly comprising a first guide wire and a second guide wire; the second guide wire is in a hollow tubular shape; the first guide wire is inserted into the second guide wire, and two ends of the first guide wire extend out of the second guide wire; the weaving basket is in a tubular shape with one end sealed, and meshes are arranged on the tube wall; two ends of the woven basket are respectively fixed with the first guide wire, and the sealing end is positioned at the far end of the first guide wire; the thrombus cutting framework is tubular, and meshes are arranged on the wall of the thrombus cutting framework; the thrombus cutting framework is sleeved on the first guide wire, and the near end of the thrombus cutting framework is fixedly connected with the far end of the second guide wire.
The thrombus capture device as described above, preferably, the proximal end of the woven basket is provided with a first arc surface, the distal end of the thrombus cutting frame is provided with a second arc surface, and the first arc surface and the second arc surface are correspondingly shaped like a bowl.
The thrombus capture device as described above further preferably further comprises a first development code scale, a second development code scale, a third development code scale and a fourth development code scale; the first developing code scale and the second developing code scale are respectively fixed at two ends of the weaving basket and are fixedly connected with the first guide wire; the third is developed the sign indicating number and is carved with the fourth and develop the sign indicating number and be hollow tube-shape, fixes respectively the both ends of thrombus cutting skeleton, just the third is developed the sign indicating number and is carved the activity suit and be in on the first seal wire, the fourth is developed the sign indicating number and is carved fixed suit and be in the distal end of second seal wire.
The thrombus capture device as described above further preferably further comprises an isolation spring, wherein the isolation spring is fixedly connected to the first guide wire, and the isolation spring is located between the second developing marker and the third developing marker.
The thrombus capture device as described above further preferably further comprises an anchor tube which is fitted and fixed to the first guide wire; the anchor pipe with the hookup location of first seal wire is located the inside of thrombus cutting skeleton, just the external diameter of anchor pipe is greater than the internal diameter that the third development sign indicating number was carved is suitable for right the third development sign indicating number is carved spacingly.
Alternatively, it is further preferable that the anchor tube is connected to the first guide wire at a position proximal to the first guide wire, and the anchor tube has an outer diameter larger than an inner diameter of the second guide wire and is adapted to restrain the second guide wire.
The thrombus capture device as described above further preferably further comprises a head end spring, wherein the head end spring is sleeved on the distal end of the first guide wire, and both ends of the head end spring are fixedly connected to the first guide wire.
The thrombus capture device as described above, further preferably, the distal end of the woven basket is provided with a first inclined surface; the side projection of the weaving basket is in an irregular trapezoid shape, two waist lines of the side projection are projection lines of the first inclined plane and the first cambered surface, and the lower bottom line is superposed with the first guide wire.
The thrombus capture device as described above, further preferably, the tube wall of the thrombus cutting framework includes a plurality of cutting units, and the cutting units are closed loops or partially open loops around the tube wall; the closed loop or the local open loop is in sine wave or cosine wave shape; the adjacent closed loops or partial open loops form meshes of the pipe wall.
The thrombus capture device as described above, further preferably, the proximal end of the first guide wire is further provided with a first marker point and a second marker point, and the first marker point and the second marker point are arranged at an interval and are adapted to assist in positioning the second guide wire.
Compared with the prior art, the utility model has the following advantage:
in the application, the weaving basket with one sealed end is suitable for catching thrombus with the specification larger than meshes of the weaving basket, and the thrombus cutting framework is suitable for clamping large-specification thrombus through the thrombus cutting framework; the supporting assembly is used for conveying and providing an installation space, wherein the first guide wire and the second guide wire are sleeved in a combined mode and are suitable for enabling the weaving basket and the thrombus cutting framework which are fixedly installed with the first guide wire and the second guide wire to slide relatively, so that the structure further provides an embolus capturing area capable of being dynamically adjusted besides the weaving basket and the thrombus cutting framework, the thrombus capturing device disclosed by the embodiment can capture soft thrombus except AIS new thrombus according to the thrombus, the hard thrombus can be captured within the maximum size range of the embolus capturing area through dynamic adjustment, and the woven basket at the far section is sealed at the far end, so that large thrombus can be captured, and the escape of small embolus can be prevented.
Detailed Description
The technical solution of the present invention will be described clearly and completely with reference to the accompanying drawings, and obviously, the described embodiments are some, but not all embodiments of the present invention. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without creative work belong to the protection scope of the present invention.
In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplification of description, but do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
The thrombus capture device disclosed by the application is mainly used for interventional therapy, and during treatment, medical staff inserts the thrombus capture device into a blood vessel along the blood flow direction from an opening of the blood vessel to take out the thrombus and withdraw the thrombus, so that one end close to the handheld is a near end, one end far away from the handheld is a far end, and the far end is reflected in figures 1-11, namely the left end is the far end, and the right end is the near end. As shown in fig. 1 to 4, the thrombus capture device disclosed in the present embodiment includes: a support assembly comprising a first guide wire 1 and a second guide wire 2; the second guide wire 2 is in a hollow tubular shape, the first guide wire 1 is inserted into the second guide wire 2, and two ends of the first guide wire extend out of the second guide wire 2; the weaving net basket 3 is tubular, one end of the weaving net basket 3 is sealed, and meshes are arranged on the pipe wall; the weaving basket 3 is sleeved on the first guide wire 1, and two ends of the weaving basket are respectively fixed with the first guide wire 1; the sealing end of the woven basket 3 is positioned at the far end of the first guide wire 1; the thrombus cutting framework 4 is tubular, and meshes are arranged on the wall of the thrombus cutting framework 4; the thrombus cutting framework is sleeved on the first guide wire 1, and the near end of the thrombus cutting framework is fixedly connected with the far end of the second guide wire 2.
In the structure, the weaving basket 3 with one sealed end is suitable for catching thrombus with the specification larger than meshes of the weaving basket 3, and the thrombus cutting framework 4 is suitable for clamping large-specification thrombus through the thrombus cutting framework; the support assembly is used for conveying and providing an installation space, wherein the combined sleeving arrangement of the first guide wire 1 and the second guide wire 2 is suitable for enabling the woven basket 3 and the thrombus cutting framework 4 which are fixedly installed with the first guide wire 1 and the second guide wire 2 to slide relatively, so that the structure further provides a dynamically adjustable embolus capturing area besides the woven basket 3 and the thrombus cutting framework 4, the thrombus capturing device disclosed by the embodiment can capture new AIS soft thrombus 49 according to thrombus, the hard thrombus can be captured within the maximum size range through dynamically adjusting the embolus capturing area, and the woven basket 3 at the far end is sealed at the far end, so that large thrombus can be captured, and simultaneously tiny thrombus can be prevented from escaping.
Further, in the thrombus capture device disclosed in the above embodiment, the proximal end of the woven basket 3 is provided with a first cambered surface 5, the distal end of the thrombus cutting skeleton 4 is provided with a second cambered surface 6, and the combination of the first cambered surface 5 and the second cambered surface 6 is bowl-shaped. In this embodiment, through optimizing the shape of embolus capture area, make it be bowl form or circular-arc, and then with the shape adaptation of stereoplasm thrombus 51, make things convenient for stereoplasm thrombus 51 to fall into embolus capture area on the one hand, still make things convenient for clamping and carrying in later stage simultaneously.
Further, in the thrombus capture device disclosed in the above embodiment, the distal end of the woven basket 3 is provided with a first inclined surface; the side projection of the weaving basket 3 is in an irregular trapezoid shape, two waist lines of the side projection are projection lines of the first inclined plane and the first cambered surface 5, and a lower bottom line is overlapped with the first guide wire 1. Further, in the thrombus capture device disclosed in the above embodiment, the tube wall of the thrombus cutting framework 4 includes a plurality of cutting units, and the cutting units are closed loops or partially open loops around the tube wall; the closed loop or the local open loop is in sine wave or cosine wave shape; the adjacent closed loops or partial open loops form meshes of the pipe wall. Preferably, the thrombus cutting framework 4 is also in a trapezoidal arrangement, wherein the lower base line coincides with the first guide wire 1. In this embodiment, will weave the basket 3 with thrombus cutting skeleton 4 sets up to be trapezoidal be suitable for be convenient for weave the basket 3 with the receipts of thrombus cutting skeleton 4 are closed and are out of shape, and then make things convenient for withdrawing from of thrombus capture device.
Further, in the thrombus capture device disclosed in the above embodiment, the thrombus capture device further includes a first development code engraving 7, a second development code engraving 8, a third development code engraving 9, and a fourth development code engraving 10; the first developing code carving 7 and the second developing code carving 8 are respectively fixed at two ends of the weaving basket 3 and are fixedly connected with the first guide wire 1; the third is developed the sign indicating number and is carved 9 and the fourth is developed the sign indicating number and carves 10 and be hollow tube-shape, fixes respectively the both ends of thrombus cutting skeleton 4, just the third is developed the sign indicating number and is carved 9 movable suit and in on the first seal wire 1, the fourth is developed the sign indicating number and is carved 10 fixed suit and in the distal end of second seal wire 2. In this embodiment, the first developing code is carved 7, the second developing code is carved 8, the third developing code is carved 9 and the fourth developing code is carved 10 and is set up mainly for realizing weave basket 3, thrombus cutting skeleton 4 with the fixed connection of first seal wire 1, second seal wire 2, still be used for assistance-localization real-time simultaneously. The first developing code scale 7, the second developing code scale 8, the third developing code scale 9 and the fourth developing code scale 10 are made of conventional platinum-iridium alloy and are suitable for developing in the treatment process.
Further, in the thrombus capture device disclosed in the above embodiment, the thrombus capture device further comprises an isolation spring 11, the isolation spring 11 is fixedly sleeved on the first guide wire 1, and the isolation spring 11 is located between the second developing code scale 8 and the third developing code scale 9. The isolation spring 11 is fixed on the first guide wire, is positioned between the second developing code scale 8 and the third developing code scale 9, is suitable for separating the woven basket 3 from the thrombus cutting framework 4, further forms a bottom area of the adjustable embolus capturing area, and has developing performance and can increase the positioning of the initial state of the embolus capturing area. Preferably, in the embodiment, the length of the isolation spring 11 is 2-10mm, and the isolation spring is formed by winding a platinum-tungsten alloy or platinum-iridium alloy wire with a wire diameter range of 0.02-0.05mm, the pitch of the isolation spring 11 is equal to the wire diameter, and two ends of the isolation spring and the first guide wire 1 form a conical welding point or a bonding point respectively by soldering or bonding.
Further, in the thrombus capture device disclosed in the above embodiment, an anchor tube 12 is further included, and the anchor tube 12 is fixed on the first guide wire 1 in a sleeving manner; the connecting position of the anchoring tube 12 and the first guide wire is positioned inside the thrombus cutting framework 4, and the outer diameter of the anchoring tube 12 is larger than the inner diameter of the third developing code 9, so that the anchoring tube is suitable for limiting the third developing code 9; or the connecting position of the anchoring tube 12 and the first guide wire is positioned at the proximal end of the first guide wire 1, and the outer diameter of the anchoring tube 12 is larger than the inner diameter of the second guide wire 2, so that the anchoring tube is suitable for limiting the second guide wire 2. The present embodiment discloses two mounting positions of the anchoring tube 12, which are respectively shown in fig. 1-2, but the anchoring tube 12 of the two mounting structures has the same function, namely, the sliding displacement of the thrombus cutting frame 4 is limited by limiting the displacement of the third visualization code 9 or by limiting the displacement of the second guide wire 2. In practice, the anchoring tube 12 is adapted to limit the sliding distance of the thrombus-cutting scaffold 4 to within 20 mm.
Further, in the thrombus capture device disclosed in the above embodiment, a head end spring 13 is further included, the head end spring 13 is sleeved on the distal end of the first guide wire 1, and both ends of the head end spring are fixedly connected with the first guide wire 1. In this embodiment, the head end spring 13 is bonded to the first guide wire 1 through an ultraviolet curing agent, and a bonding point at a distal end is in a cap shape, so that damage to the blood vessel 20 is reduced, and a bonding point at a proximal end is in a conical shape. In the embodiment, the head end spring 13 is arranged to enhance the strength of the distal end of the first guide wire 1, so as to reduce the probability of deformation in the blood vessel 20, and on the other hand, to reduce the damage to the blood vessel 20.
Further, in the thrombus capture device disclosed in the above embodiment, the proximal end of the first guide wire 1 is further provided with a first marker point 14 and a second marker point 15, and the first marker point 14 and the second marker point 15 are arranged at intervals and are adapted to assist in positioning the second guide wire 2. The first marking point 14 and the second marking point 15 are arranged to facilitate observation, so as to assist an operator in positioning.
Preferably, in the above structure, the woven basket 3 is woven by metal composite wires, and the material is preferably nickel-titanium alloy wires and platinum alloy wires, wherein the nickel-titanium alloy wires are main woven wires and are used for providing a good shape memory function for the woven basket 3, and the platinum alloy wires are developing wires and provide a good developing and positioning effect for the whole body of the basket in the operation. The weaving basket 3 is preferably formed by weaving metal composite wires with the wire diameter of 0.02-0.05mm, and the total number of the weaving wires used by the weaving basket 3 is 36-64 during weaving, wherein the number of the platinum alloy wires is 2-8.
As shown in fig. 1-2, the woven basket 3 is in a shape of a mesh tube, and is suitable for being effectively attached to a blood vessel 20 after being opened in the blood vessel 20, preferably, the side projection shape of the woven basket is an irregular trapezoid, and the figure enclosed by ABCD in fig. 1-2, wherein the upper bottom AB and the lower bottom CD of the trapezoid are respectively side projection lines at the top and the bottom of the mesh tube, the waistlines AC and BD of the trapezoid are side projection lines of the first inclined plane and the first cambered surface 5, the plane where the waistline AC is located is in a sealed state, and the plane where the waistline BD is located is in an open state. The length of the CD section in the weaving basket 3 is 8-25mm, and the length ratio of the AB section to the CD section is about 0.15-0.40; the diameter of the weaving net basket 3 is 3-6 mm. Preferably, the pore diameter of the woven mesh basket 3 in the AC section is in gradient change, the average pore diameter is 50-350 microns, the AB section is used for achieving higher radial supporting force, and the average pore diameter is 30-300 microns. The first developing code carving 7 and the second developing code carving 8 are fixedly connected to two ends of the CD section respectively, then connected with the first guide wire 1 and suitable for being connected with the weaving basket 3 and the first guide wire 1.
The thrombus cutting framework 4 is made of a nickel-titanium alloy tube which is subjected to laser engraving and post-treatment processes, the unit cells of the thrombus cutting framework 4 have a thrombus cutting function, the side projection of the whole thrombus cutting framework 4 is in an irregular isosceles trapezoid shape, such as a trapezoid surrounded by EFGH in figures 1-2, wherein the length range of the EH section is 10-40mm, and the length ratio of the FG section to the EH section is about 0.20-0.80. In this example, the diameter of the nitinol tube used to make the thrombectomy framework 4 is 3-6 mm.
Be columnar structure the third develop the sign indicating number carve 9 with the fourth develops the sign indicating number and carves 10 and connect respectively the both ends of 4EH sections of thrombus cutting skeleton, simultaneously the third develops the sign indicating number and carves 9 movable suit in on the first seal wire 1, the fourth develops the sign indicating number and carves 10 fixed suit in the distal end of second seal wire 2 is suitable for with 4 slidable mounting of thrombus cutting skeleton are in on the first seal wire 1, and its slip accessible second seal wire 2 is adjusted.
In this embodiment, the side projection of the adjustable embolus capturing area formed between the thrombus cutting framework 4 and the woven basket 3 is an arc area formed by BDEF, the adjustable embolus capturing area is composed of three parts, namely a first arc surface 5, a second arc surface 6 and a DE section first guide wire 1, and the side projection shape is bowl-shaped or arc-shaped.
In the embodiment, the first guide wire 1 is made of stainless steel or nickel-titanium alloy materials, is designed in a multi-section taper mode, and the diameter of the first guide wire changes between 0.05mm and 0.30mm according to requirements; the total length of the guide wire of the first guide wire 1 is 180-300cm, and the section of the proximal end is about 160-280cm provided with the PTFE coating.
In this embodiment, the second guide wire 2 is a hollow stainless steel tube, the diameter of the hollow stainless steel tube is 0.40-0.65mm, the total length of the hollow stainless steel tube is 140-190cm, a sea wave threaded tube design is adopted at the position of 10-30cm of the distal end of the hollow stainless steel tube to increase the flexibility of the distal end of the conveying rod, and the distal end is fixed with the fourth code scale into a whole in a laser welding or bonding mode.
Further, the embodiment also discloses a processing method of the thrombus capture device with specific size, which comprises the following steps:
(1) selecting 36 metal composite wires to weave into a net tube with the diameter of 4mm on a precise weaving machine, wherein the number of the platinum-iridium alloy developing wires is 4, the rest are nickel-titanium alloy wires, the diameter range of all the metal wires is 0.03mm, the woven net tube is subjected to vacuum heat treatment at 500 ℃ for shaping, then the net tube is locked on a mould with the side projection being approximately trapezoidal, after the heat treatment and shaping are carried out again, a woven basket 3 is obtained, and then two ends of the woven basket 3 are respectively fixed in a first developing code scale 7 and a second developing code scale 8;
(2) carving a nickel-titanium alloy tube with the diameter of 4mm by using a femtosecond laser cutting machine, carrying out heat treatment setting at 550 ℃ after the carving is finished, then obtaining a skeleton with a bright surface by the procedures of acid washing, chemical polishing and the like to obtain a thrombus cutting skeleton 4, and respectively fixing two ends of the thrombus cutting skeleton 4 in a third development code carving 9 and a fourth development code carving 10;
(3) a precise spring winding machine is adopted, a platinum-tungsten alloy wire with the diameter of 0.04mm is wound into a compact head end spring 13, then the length of the blade is fixed to be 5mm, a platinum-tungsten alloy wire with the diameter of 0.05mm is wound into a compact isolation spring 11, and the length of the blade is fixed to be 5 mm;
(4) sleeving a thrombus cutting framework 4, an isolation spring 11 and a woven basket 3 on a first guide wire 1 which has a total length of 210cm and a diameter of 0.08-0.28mm and is provided with a near-end mark point from a far end in sequence, fixing a first developing code scale 7 and a second developing code scale 8 with the first guide wire 1 respectively by a soldering method, and fixing the isolation spring 11 and the first guide wire 1 by the soldering method to form two welding points;
(5) sleeving an anchoring pipe 12 with the length of 1.5mm on the first guide wire 1 through a gap part of the anchoring pipe, positioning the anchoring pipe at the position where the thrombus cutting framework 4 is 10mm away from the third development, and fixing the anchoring pipe and the first guide wire 1 in a soldering mode;
(6) the far end of the first guide wire 1 penetrates into the inner cavity of the head end spring 13, two ends of the head end spring 13 and the first guide wire 1 are fixed through ultraviolet light curing glue, the far end bonding point is in a spherical cap shape, and the near end bonding point is in a conical shape;
(7) and (3) carrying out thread machining on a section of 20cm far end of a second guide wire 2 with the total length of 160cm and the diameter of 0.50mm by using a laser cutting machine, then sheathing the machined second guide wire 2 on the first guide wire 1 from the far end, fixing the tip of the second guide wire 2 and a fourth developing code 10 together in a laser welding mode, and coating the far end thread section of the second guide wire 2 by using an ultrathin transparent heat-shrinkable tube so as to obtain the thrombus capture device with specific size.
Further, with reference to fig. 3 to 11, the present embodiment also discloses a specific use method of the thrombus capture device:
s1: as shown in fig. 3 and 8, the condition of the thrombus within the blood vessel 20 is detected and prepared;
s2: as shown in fig. 4 and 9, the proximal end of the first guidewire is held to deliver the thrombus capture device from the access port to the lesion site of the blood vessel through a microcatheter 21 having an inner diameter of about 0.027 inches, with the braided basket 3 at the distal end of the thrombus;
s3: as shown in fig. 5 and fig. 10, the microcatheter 21 is withdrawn to allow the thrombus capture device to be released in situ, when the thrombus is soft thrombus 49, the thrombus cutting framework 4 can easily self-expand and open in the blood vessel 20 and embed the soft thrombus 49 into the cutting unit of the thrombus cutting framework 4, and in the process, tiny small thrombus 50 may be generated and flow to the far end of the blood vessel 20; when the thrombus is hard thrombus 51, the thrombus can not be completely expanded and embedded after the thrombus cutting framework 4 is released in situ, and at the moment, the second guide wire is withdrawn, so that the thrombus capture area is further expanded until the large hard thrombus 51 completely falls into the arc area of the thrombus capture area; when the second guide wire is operated, auxiliary positioning can be carried out according to the first marking point and the second marking point, and the maximum area of the thrombus capture area is judged;
s4: as shown in fig. 6, the second guide wire 2 is withdrawn continuously, the thrombus cutting framework 4 is firstly recovered into the middle catheter 22, all the tiny emboli generated in the process are captured by the woven basket 3 and form larger lumps of thrombus, and the hard thrombus 51 is partially or completely fished into the woven basket 3;
s5: as shown in FIGS. 7 and 11, the second guide wire 2 is further withdrawn, the thrombus-capturing woven basket 3 is retracted into the intermediate catheter 22, and finally the thrombus-capturing device is withdrawn from the body together with the intermediate catheter 22.
The utility model provides a thrombus capture device for Acute Ischemic Stroke (AIS) treatment, owing to set up dynamic adjustable embolus and catch district (B-D-E-F arc district), can catch the soft thrombus 49 of AIS new issue, again can the furthest catch the thrombus of stereoplasm, the net basket 3 of weaving of distal end is owing to have thinner metal mesh design simultaneously, when catching bold thrombus, can prevent the escape of small embolus, weave the net basket 3 itself and form owing to adopt the filament to weave, possess soft characteristic, 20 damage to the blood vessel of farther end is lower, whole operation process adopts inside and outside two seal wire slidable operation technique, easy operation is controllable, above be the key place of this embodiment technique.
Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; although the present invention has been described in detail with reference to the foregoing embodiments, it should be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; such modifications and substitutions do not depart from the spirit and scope of the present invention.