WO2018120414A1 - Filter - Google Patents

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Publication number
WO2018120414A1
WO2018120414A1 PCT/CN2017/075790 CN2017075790W WO2018120414A1 WO 2018120414 A1 WO2018120414 A1 WO 2018120414A1 CN 2017075790 W CN2017075790 W CN 2017075790W WO 2018120414 A1 WO2018120414 A1 WO 2018120414A1
Authority
WO
WIPO (PCT)
Prior art keywords
support
filter
section
blood vessel
support rod
Prior art date
Application number
PCT/CN2017/075790
Other languages
French (fr)
Chinese (zh)
Inventor
张庭超
李阳
赵珺
Original Assignee
杭州唯强医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 杭州唯强医疗科技有限公司 filed Critical 杭州唯强医疗科技有限公司
Priority to CN201780076618.8A priority Critical patent/CN110062610A/en
Publication of WO2018120414A1 publication Critical patent/WO2018120414A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01Filters implantable into blood vessels
    • A61F2/0105Open ended, i.e. legs gathered only at one side
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01Filters implantable into blood vessels
    • A61F2/0103With centering means

Definitions

  • the present invention belongs to the technical field of medical devices and relates to a filter.
  • Pulmonary embolism is a common disease, most pulmonary embolism is caused by deep vein thrombosis (DVT) in the lower extremities or pelvis, and the formation of blood clots may migrate back to the heart through the veins and into the lungs. Pulmonary infarction is caused by loss of blood and oxygen supply to a portion of the lungs. According to statistics, the mortality rate of untreated pulmonary embolism is 20%-30%; the number of newly added cases accounts for 0.2% of the total population every year. According to China's 1.35 billion population, there are about 2.7 million new patients each year.
  • the filter structure mainly includes two types of cage filters of TrapEase structure (such as Cordis TRAPEASE/
  • TmpEase structure filter In order to strengthen the fixation effect of the instrument in the inferior vena cava, the area of the rod contacting the blood vessel wall is increased, but the increase of the area is likely to cause the endothelium to climb the pole, in the recovery device During the process, it is easy to tear the endothelium and damage the blood vessel wall, and even cause the device to be unrecyclable.
  • the disadvantages of the Kimray-Greenfield structure filter are: When the instrument is implanted in the inferior vena cava, the instrument is easily tilted after implantation into the inferior vena cava due to poor self-centering ability of the conical instrument. Close to the blood vessel wall; During the recycling process, the recovery device can not capture the recovery head smoothly, which will increase the operation time of the device, and even lead to the failure of the recovery operation of the device.
  • the disadvantages of the filter of TmpEase structure are: In order to strengthen the fixation effect of the instrument in the inferior vena cava, the area of the rod contacting the vessel wall is increased, but the increase of the area is likely to cause the endothelium to climb the pole, in the recovery device During the process, it is easy to tear the endothelium and damage the blood vessel wall, and even cause the device to be unrecyclable.
  • the disadvantages of the Kimray-Greenfield structure of the filter are: when the instrument is implanted in the inferior vena cava, due to the circle The self-centering ability of the cone device is poor.
  • the instrument is easy to tilt after being implanted into the inferior vena cava. After the instrument is tilted, the recovery head is close to the vessel wall. During the recycling process, the recovery device cannot smoothly capture the recovery head, which increases the operation of the instrument. During the day, even the recycling operation of the device failed.
  • the technical problem to be solved by the present invention is to provide a filter which has a higher radial support force in contact with the inner wall of the blood vessel and prevents the inclination of the instrument against the above-mentioned defects of the prior art, and the filter of the present invention can effectively reduce the filter. Endothelial climbing, which facilitates instrument capture and recovery, shortens surgical stenosis, and extends device life
  • the technical solution adopted by the present invention to solve the technical problem thereof is: a filter including a support portion for preventing the filter from tilting, and a filter portion for capturing the plug;
  • the support portion in the free state, includes at least three support rods radiated outward from the center and all of the support rods are arranged in an axisymmetric manner;
  • the tangential line of the end of the support rod or the end of the support rod is at an angle ⁇ ⁇ 180° with the central axis of the support portion, and the maximum outer diameter of the support portion is matched with the inner diameter of the blood vessel such that the support rod point is supported on the inner wall of the blood vessel.
  • the support rod includes a first support segment and a second support segment that are radiated outward from the center;
  • the angle between the tangent of each point on the first support section or the first support section and the central axis is 0-90°, and the tangent and the central axis of each point on the second support section or the second support section
  • the angle of the tangent of each point on the support section is ⁇ ⁇ 180°; the second support section of the support rod is supported on the inner wall of the blood vessel.
  • the shape of the support rod in a free state satisfies: 02 ⁇ half of the inner diameter of the blood vessel, and D1 ⁇ half of the inner diameter of the blood vessel, D1 : a second boundary line at a tangent line at the end of the support rod , the distance between the farthest point of the support rod relative to the second boundary line and the second boundary line; D2: the third boundary line is a straight line passing through the end of the support rod and perpendicular to the second boundary line, and the support rod is opposite to the third The distance from the farthest point on the outer side of the boundary line.
  • the D1 ⁇ 17 mm and D2 ⁇ 8 mm are each at least one of a curved segment, a straight segment, and a polygonal segment.
  • the first support section and the second support section are curves in which the radius of curvature continuously changes.
  • the radius of curvature is gradually reduced.
  • the second support section of the support rod includes a first subsection, a second subsection, and a third subsection;
  • the radius of curvature of the second sub-segment is smaller than the first sub-segment, and the angle between the second sub-segment and the central axis is changed from 90° ⁇ ⁇ ⁇ 180° to ⁇ ⁇ 180°, forming an inner wall surface of the blood vessel Point contact
  • the second sub-section is a curved line or a broken line, forming a C-shaped or V-shaped structure with the cornice facing the central axis, the second sub-section is in point contact with the inner wall surface of the blood vessel, and the first sub-section and the third sub-section are straight lines. Or a fold line, and the second support section is entirely curved away from the filter portion or toward the filter portion.
  • the first support section and the second support section each have a smooth transition and a smooth transition therebetween.
  • the end of the support rod is provided with an anchor for limited penetration into a blood vessel.
  • the filter portion is a strut structure, or the filter portion is a cage structure.
  • the support portion is connected to a recovery portion for recovering the entire filter.
  • the present invention realizes point support through the support rod of the support portion, the support portion is an axisymmetric structure, and at least three support rods form a stable support, so that the instrument has better self-center performance, preventing the instrument from tilting, and the support portion is the largest.
  • the outer diameter is matched with the inner diameter of the blood vessel.
  • the support rod is supported on the inner wall of the blood vessel, and the contact area with the inner wall of the blood vessel is small, which reduces the endothelial climbing, which is beneficial to the recovery and recovery of the instrument, shortens the operation time, increases the service life of the instrument, and prolongs the recovery period. .
  • the structure of the support rod is a flipped structure, and the angle between the tangent of the end of the support rod or the end of the support rod and the central axis is ⁇ 180°, which ensures that the end of the support rod is curled after the release process and release of the filter, the support rod The end of the end does not penetrate the inner wall of the blood vessel, ensuring safe use of the filter.
  • Embodiment 1 is a schematic structural view of Embodiment 1 of the present invention.
  • Figure 2 is a plan view of Figure 1;
  • FIG. 3 is a schematic structural view of a first embodiment of a support rod according to Embodiment 1 of the present invention.
  • FIG. 4 is a schematic structural view of a second embodiment of a support rod according to Embodiment 1 of the present invention.
  • FIG. 5 is a schematic structural view of a third embodiment of a support rod according to Embodiment 1 of the present invention.
  • FIG. 6 is a schematic structural view showing an initial stage of release of a support rod in a filter release process according to Embodiment 1 of the present invention
  • FIG. 7 is a schematic structural view showing a middle stage of release of a support rod during a filter release process according to Embodiment 1 of the present invention.
  • FIG. 8 is a schematic structural view showing a later stage of release of a support rod in a filter release process according to Embodiment 1 of the present invention.
  • Embodiment 9 is a schematic structural view of Embodiment 2 of the present invention.
  • Figure 10 is a partial enlarged view of a portion I in Figure 9;
  • Embodiment 3 of the present invention is a schematic structural view of Embodiment 3 of the present invention.
  • Figure 12 is a partial enlarged view of M at Figure 11;
  • Embodiment 4 of the present invention is a schematic structural view of Embodiment 4 of the present invention.
  • FIG. 14 is a partial structural view showing the fixing of a support rod according to Embodiment 4 of the present invention.
  • Embodiment 6 of the present invention is a schematic structural view of Embodiment 6 of the present invention.
  • Embodiment 7 of the present invention is a schematic structural view of Embodiment 7 of the present invention.
  • the orientation definition of the present invention is the location of the recovery section is the top, and the location of the filter section is the bottom.
  • the filter is an axisymmetric structure, and the various portions of the filter are axially symmetrical with respect to the central axis of the filter.
  • the central axis described in the present invention is the central axis of the filter, and is also the central axis of the support portion and the filter portion.
  • the filter of the present invention There are two states in the filter of the present invention, one is a free state after release, and the other is a restrained contraction state in the income delivery catheter.
  • the structure and shape are generally free after release. The structure and shape underneath.
  • the filter is classified into a recyclable filter and a permanent filter depending on the possibility of recovery.
  • the permanent filter mainly includes support And a filter, the recyclable filter includes a recovery portion, a support portion, and a filter portion.
  • Embodiment 1 as shown in FIGS. 1-8, a filter, the filter is a recyclable filter.
  • the recovery part 1300 for filter recovery, the support part 1200 for preventing the filter from tilting, the filter part 1100 for capturing the plug; the recovery part 1300 and the support part 1200 and the filter part 1100 may be an integral structure, or may be divided into The body structure is assembled into a whole.
  • the recovery portion 1300, the support portion 1200, and the filter portion 1100 of the filter have an integral structure, and are formed by heat-setting a mold by laser cutting the OD 2.0 mm nickel-titanium tube.
  • the support portion has an axisymmetric structure and has a central axis.
  • the support portion has a recovery portion extending in the top direction.
  • the recovery portion is preferably located on the central axis of the support portion, preferably an axisymmetric structure, and the inclination of the filter can be reduced during the recovery process.
  • the filter portion also extends from the support portion to the bottom portion, preferably symmetrically with respect to the central axis.
  • the filter portion 1100 is for capturing an emboss from the direction of blood flow, and the structure thereof has various embodiments.
  • the filter portion 11 00 may be a strut structure or a cage structure.
  • the filter portion 1100 may be a single-layer strut structure or a multi-layer strut structure.
  • the filter part 1100 adopts a single-layer strut structure, and the single-layer strut structure uniformly sets a plurality of strut 1100a around the central axis, and the strut 110 0a has the same shape and structure, and the strut 1100a
  • the number of the support rods 1100a is set in the embodiment.
  • the shape of the support rods 1100a may be a straight rod or a curved shape having a certain curvature.
  • the struts 1100 a extend outward from the center of the instrument, that is, the central axis, and the angle from the central axis of the instrument is 0 to 90°, and the specific angle of the angle is set according to actual needs.
  • a barb 1110 for preventing displacement of the instrument is provided at the end of the strut 1100a, and at least two of the strut 1100a of the filter portion 1100 are provided with a barb 1110, and the barb 1110 penetrates the vessel wall to achieve anchoring.
  • the support portion 1200 is the most important structure in the present invention.
  • the first function of the support portion 1200 is to prevent the instrument from tilting, and the collection portion 1300 is prevented from adhering.
  • the support rod 1200a is required to have a corresponding axisymmetric structure, and the support portion 1200 is supported.
  • the support rod 1200a is included, radiated outward from the center and all of the support rods 1200a are arranged in an axisymmetric manner, and in order to reduce endothelial resuscitation, it is supported relative to the inner wall of the blood vessel.
  • the number of the support rods 1200a of the support portion 1200 is at least three. In the present embodiment, six support rods 1200a are used, which are arranged symmetrically about the axis of the instrument.
  • the angle between the tangent of the end of the support rod 1200a or the end of the support rod 1200a and the central axis of the support portion is ⁇ 180°.
  • the maximum outer diameter D of the support portion (the maximum outer diameter refers to the diameter of the farthest point of the support rod relative to the central axis forming a circle, D: the first boundary line with the central axis, and the farthest distance of the support rod 1200a relative to the first boundary line Point and first side
  • D the first boundary line with the central axis
  • Point and first side The double of the distance between the boundaries
  • the support rod 1200a is extended within the blood vessel, regardless of the structure of the support rod 1200a, the angle between the tangent of the end of the support rod 1200a or the end of the support rod 1200a and the central axis is ⁇ ⁇ 180° after the release is completed, so that the support The end of the rod 1200a is staggered to the inner wall of the blood vessel, at least in parallel with the inner wall of the blood vessel, and the end of the support rod 1200a does not pierce the inner wall surface of the blood vessel.
  • the support rods 1200a are mainly divided into two parts, and the support rods 1200a include a first support section 1210 and a second support section 1230 which are radiated outward from the center.
  • a transition section 1220 may also be provided between a support section 1210 and a second support section 1230.
  • the three sections are different in structure and shape and length.
  • the angle between the tangent of each point on the first support section 1210 or the first support section 1210 and the central axis is 01 to 0° 90°, and the tangent of each point on the second support section 1230 or the second support section 1230
  • the angle ⁇ with the central axis is ⁇ >90°.
  • the end of the support rod 1200a is the end of the second support section 1230
  • the tangent of the end or end of the second support section 1230 forms an angle with the central axis ⁇ 180. °.
  • Such a structure can ensure that after the support rod 1200a is released, the end of the support rod 1200a is turned over and curled before the wall is attached, and the flip angle is more than 180°.
  • the end of the first support section 1210 is assembled with the return portion 1300 and the filter portion 1100, and the second support portion 1230 is the end of the support rod 1200a.
  • the angle between the first support section 1210 and the second support section 1230 or the angle between the first support section and the tangent line of each point on the second support section is ⁇ ⁇ 180°, which ensures that the second support section 1230 is back.
  • the transition section 1220 is a transition between the first support section 1210 and the second support section 123 0 . Therefore, the length and shape of the transition section 1220 are determined according to the shapes of the first support section 1210 and the second support section 1230 to facilitate the first A smooth transition between the support section 1210 and the second support section 1230, and a corresponding flip effect.
  • the transition section 1220 may be a curved line, a straight line, and a broken line, and a mixed arrangement of the above two or more linear shapes.
  • the first support segment 1210 and the second support segment 1230 are each at least one of a curved segment, a straight segment, and a polygonal segment, respectively. That is, each of the second support segments 1230 of the first support segment 1210 can be selected only as a curved segment, a straight segment or a polygonal segment, or two or even three linear shapes can be selected, and two or more linear arrangements are not used. Limited, can be any way.
  • the same transition section 1220 can also be at least one of a curved section, a straight section, and a polygonal section.
  • the first support section 1210 and the second support section 1230 are curves in which the radius of curvature continuously changes, and the radius of curvature is gradually reduced.
  • the first support section 1210 is a straight section, and the transition section 1220 and the second support section 1230 are curved segments; as shown in FIG. 4, the first support section 1210, the transition section 1220, and the second support The segments 1230 are all line segments; as shown in FIG. 5, the first support segment 1210, the transition segment 1220, and the second support segment 1230 are all straight segments, and the chamfers smoothly transition between the straight segments.
  • the first support section 1210 , the transition section 1220 , and the second support section 1230 of the support rod 1200 a are all curved segments, and the three sections of the support rod 1200 a have no clear boundary, and the third section
  • a curve in which the radius of curvature continuously changes is formed, and the radius of curvature is gradually reduced.
  • the lengths of the support rods 1200a are also designed according to actual needs.
  • the angle between the tangent of each point on the first support section 1210 and the central axis is 0-90°, and the angle ⁇ can be arbitrarily selected within the range of 0-90°.
  • the angle ⁇ is at least 0°, that is, parallel to the central axis, and the angle ⁇ is at most 90°, which is perpendicular to the central axis.
  • the second supporting section 1230 is a section that is turned to the top. Therefore, in the free state after the release, the angle between the tangent of each point on the second supporting section 1230 or the second supporting section 1230 and the central axis is ⁇ 90°, and The angle between the tangent of the end or end of the two support segments 1230 and the central axis is ⁇ 180°; the maximum flip angle of the second support segment 1230 is reversed toward the central axis, and the end does not contact the wall of the blood vessel.
  • the support portion 1200 is an axisymmetric structure, and the maximum outer diameter of the support portion 1200 is matched with the inner diameter of the blood vessel.
  • the maximum outer diameter D of the support portion 1200 and the inner diameter of the blood vessel refer to the maximum outer diameter D of the support portion 1200. Consistent with the inner diameter of the blood vessel, D can be slightly larger than, equal to, or smaller than the inner diameter of the blood vessel.
  • the second support section 1230 of the support rod 1200a is supported on the inner wall of the blood vessel.
  • the point support is a relative concept, and the support rod 1200a contacts the inner wall of the blood vessel with a relatively small contact area, that is, the length and diameter of the support rod 1200a.
  • contact with the inner wall of the blood vessel is a point support.
  • the maximum outer diameter D of the support portion 1200 is 10 ⁇ 40mm, and the maximum diameter of the blood vessel is 2D (16 ⁇ 34mm interval, usually 24mm). Considering the normal size of the blood vessel, Dl ⁇ 17mm and D2 ⁇ 8mm are preferred.
  • the second support section 1230 of the support bar 1200a preferably includes a first sub-section 12 30a, a second sub-section 1230b, and a third sub-section 1230c; wherein, the second support section 1230
  • the radius of curvature of the second sub-section 1230b is smaller than the first sub-section 1230a, and the angle ⁇ between the second sub-section 1230b and the central axis is 90.
  • the second sub-section 1230b is a curved line or a broken line forming a C-shape or a V-shape of the gargle toward the central axis, forming an inner wall surface of the blood vessel
  • the first sub-section 1230a and the third sub-section 1230c are straight lines or broken lines, and the second support section 1230 is bent in the direction of the top of the filter.
  • the radius of curvature of the second sub-section 1230b is the smallest, such a structure, the second sub- Paragraph 1230
  • the point or segment of b becomes the most distal end of the support portion 1200, i.e., the circumference on which the point or section of the second sub-section 1230b of all of the support bars 1200a is located forms the maximum circumference of the support portion 1200, and the position of the second sub-section 1230b becomes The position in contact with the inner wall of the blood vessel.
  • the support rod 1200a is a unitary body, and thus the first support section 1210, the transition section 1220, and the second support Segments 1230 each have a smooth transition and a smooth transition therebetween to achieve the formation of a complete support rod 1200a.
  • FIG. 6-8 is a schematic diagram of a release process of the support portion.
  • the second support section 1230 of the support rod 1200a is swung out from the duct 1600.
  • the support rod 1200a is halfway, and the transition section 1220 is gradually extended, with the support rod 1200a being extended. ⁇ , the third support section 1230 at the end of the support rod 1200a starts to bend toward the top of the filter.
  • this state is the most dangerous state in the release process, and the end of the support rod 1200a faces the blood vessel wall 1800, if the support rod 1200a passes If the length of the support rod 1200a is insufficient, the end of the support rod 1200a will pierce the blood vessel.
  • the shape of the support rod 1200a in the free state is required to satisfy: D 2 ⁇ half of the inner diameter of the blood vessel, and D1 ⁇ half of the inner diameter of the blood vessel;
  • D1 a tangent line at the end of the support rod 1200a as a second boundary line, a distance between the farthest point of the support rod 1200a relative to the second boundary line and the second boundary line;
  • D2 to pass through the end of the support rod 1200a and The straight line perpendicular to the second boundary line is the third boundary line, and the distance of the support rod 1200a with respect to the outermost point of the outer side of the third boundary line.
  • the support rod 1200a does not pierce the inner wall surface 1800 of the blood vessel during the release of the stent.
  • the delivery catheter 1600 is retracted, and the first support section 1210 of the support portion 1200 is swollen, and the end of the support rod 1200a is bent toward the central axis before the wall of the blood vessel 1800 is attached, so that the inner wall surface of the blood vessel 1800 is not pierced.
  • the second sub-section 1230b of the second support section 1230 of the support rod 1200a is adhered to the inner wall of the blood vessel 1800, and then the recovery portion 1300 is released from the delivery catheter.
  • the filter 1000 Under the action of the support portion 1200, the filter 1000 is less prone to tilting, and the recovery portion 1300 is difficult to adhere to the wall, so that the device is more easily recovered.
  • the filter and the blood vessel wall are mainly in point contact non-surface contact, which can effectively reduce the endothelium. Climb, reduce filter recovery time.
  • the recovery unit 1300 is used for filter recovery, and the recovery unit 1300 is disposed at the top center of the support portion 1200, and has a body structure with the support portion 1200.
  • the recycling portion 1300 includes a hook 1310 or a loop for hooking back into the delivery catheter.
  • Embodiment 2 As shown in FIGS. 9 and 10, in the present embodiment, on the basis of Embodiment 1, an anchor rib 1231 for limiting penetration of the blood vessel 1800 is provided at the end of the support rod 1200a of the support portion 1200.
  • the support portion 1200 is a smooth screw rod, in order to further prevent the support rod 1200a from penetrating into the wall surface of the blood vessel 1800, and causing the penetration to be too deep, piercing the wall surface of the blood vessel 1800, causing damage to the blood vessel 1800 or difficult to recover the instrument, the second support in this embodiment
  • the end of the segment 1 230 is provided with an anchor 1231 such that the end 1232 of the second support segment 1230 forms two branches together with the anchor 1231. Due to the formation of the bifurcation, when the support portion 1200 releases the ankle, the anchor 1231 is used for stabbing.
  • the wall of the blood vessel 1800 is inserted to realize the anchoring of the instrument to prevent displacement.
  • the end 1232 of the second support section 1230 defines the anchor thorn 1231 to prevent the penetration from being too deep.
  • Embodiment 3 as shown in FIGS. 11 and 12, this embodiment is based on Embodiment 1, and the third sub-section 1230c of the second support section 1230 has a smaller radius of curvature than the second sub-section 1230b.
  • the second support portion 1230 has returned to the curved state, so that the head end of the support portion 1200 does not penetrate the blood vessel wall, thereby preventing the support portion 1200 from damaging the blood vessel. risk.
  • Embodiment 4 as shown in FIGS. 13 and 14, the structure of this embodiment is the same as that of Embodiment 1-3, and the respective portions of the filter are a separate structure, the support rod 1200a of the support portion 1200 and the filter rod of the filter portion 1100.
  • the 1100a is a filament-like structure, and is fixedly coupled to the recovery portion 1300 through the ferrule 1260.
  • the support portion 1200 is formed by using a wire of 0.1 to 0.6 mm, and the wire material includes, but is not limited to, one or more of stainless steel, nickel titanium alloy, cobalt chromium alloy, titanium alloy, and the like.
  • the support portion 1200 is composed of six support rods 1200a made of 0.35 mm nickel-titanium wire, and the support rod 1200a is sleeved on the end sleeve 1260, and then connected by argon arc welding, and then heat-shaped through the mold to form a continuous smooth bending. Support rod 1200a.
  • the filter portion 1100 in the present embodiment is formed by heat setting after laser cutting.
  • the filter portion 11 00, the support portion 1200, and the recovery portion 1300 in this embodiment are separately molded and then welded together, and the support portion 1200 is located inside the filter portion 1100.
  • Embodiment 5 This embodiment has the same support portion 1200 and recovery portion 1300 as in Embodiment 4. The difference is that the struts 1100a of the filter portion 1100 in the present example are also formed by using 0. l ⁇ 0.6mm wire materials, including but not limited to stainless steel, nickel titanium alloy, cobalt chrome alloy, titanium alloy, etc. One or more of them.
  • the filter portion 1100 and the support portion 1200 may be separately formed by welding, or may be integrally molded.
  • the filter portion 1100 is composed of 12 struts 1100a made of 0.40 mm nickel-titanium wire
  • the support portion 1200 is composed of 6 support rods 1200a made of 0 35 mm nickel-titanium wire
  • the sleeve 1260 is sheathed by argon arc welding. It is connected with laser spot welding and finally heat-set by mold.
  • Embodiment 6, as shown in FIG. 6 is a specific implant example:
  • the vena cava filter is generally implanted under the renal artery.
  • the filter is inserted across the renal artery to increase the filter.
  • Anchor zone expand the range of use of the filter.
  • the rod 1100a of the filter portion 1100 is formed by using a wire of 0.1 to 0.6 mm, and the wire includes, but is not limited to, one or more of stainless steel, nickel titanium alloy, cobalt chromium alloy, titanium alloy, and the like.
  • the filter portion 1100 and the support portion 1200 may be separately formed by welding, or may be integrally molded.
  • the struts 1100a of the specific filter portion 1100 are formed by argon arc welding of 12 0.40 mm nickel-titanium wires, and the mold is heat-set. Since the filter portion 1100 is composed of a nickel-titanium wire in a straight section, the wire and the wire are relatively high. The degree of freedom has better flexibility.
  • the support rod 1200a of the support portion 1200 is laser-cut with a 2.70 mm nickel-titanium tube, and the mold is heat-set.
  • the filter portion 1100, the support portion 1200, and the recovery portion 1300 are connected by laser spot welding, one of which is shown in Fig. 15, wherein the filter portion 1100 is located below the renal artery 2100 and the renal artery 2200, and the support portion 1200 and the recovery portion 1300 are in the renal artery. 2100 and 2 renal arteries above 200.
  • Example 7 is a permanent filter. Only the support portion 1200 and the filter portion 1100 are included. In the free state, the support portion 1200 includes at least three support rods 1200a radiated outward from the center and all the support rods 1200a are arranged in an axisymmetric manner, and there are four in this embodiment.
  • the support rod 1200a; the structure of the support rod 1200a is the same as that of the embodiment 1, and details are not described herein again.
  • the tangential line of the end of the support rod 1200a or the end of the support rod 1200a is at an angle ⁇ ⁇ 180° with the central axis of the support portion, and the maximum outer diameter of the support portion is matched with the inner diameter of the blood vessel such that the support rod 1200a is supported on the inner wall of the blood vessel.
  • the difference from the first embodiment is the turning direction of the support rod 1200a.
  • the support rod 1200a is turned in the direction of the filter portion 1100 to form a support.
  • the structure of the filter portion 1100 is the same as that of the first embodiment.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
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Abstract

A filter, comprising a support part (1200) used for preventing tilting of the filter and a filter part (1100) used for capturing emboli; in a free state, the support part (120) comprises at least three support rods (1200a) radiating outward from the centre, all of the support rods (1200a) being arranged axisymmetrically; the tail end of the support rods (1200a) or a tangent of the tail end of the support rods (1200a) forms a β≥180° included angle with the central axis of the support part (1200), and the maximum outer diameter of the support part (1200) matches the inner diameter of a blood vessel, such that the support rod (1200a) points are supported on the inner wall of the blood vessel. The present filter is in point contact with the inner walls of a blood vessel, prevents tilting of the instrument, and has a uniform radial support force, effectively reducing endothelial coverage, facilitating instrument capture and recycling, reducing operating time, and prolonging the service life of the instrument.

Description

发明名称:一种滤器  Title of the invention: a filter
技术领域  Technical field
[0001] 本发明属于医疗器械技术领域, 涉及一种滤器。  [0001] The present invention belongs to the technical field of medical devices and relates to a filter.
背景技术  Background technique
[0002] 肺栓塞 (PE)是一种常见疾病, 大多数肺栓塞由下肢或骨盆内的深静脉血栓 (DVT )导致, 形成的血凝块可能通过静脉迁移回到心脏并进入肺中, 从而由于丧失了 通向肺的一部分的血液和氧供给而导致肺梗塞。 有资料统计, 不经治疗的肺栓 塞的死亡率为 20%-30%; 每年新增病例约占总人口的 0.2%, 以我国 13.5亿人口 计算, 每年约有 270万新增患者。  [0002] Pulmonary embolism (PE) is a common disease, most pulmonary embolism is caused by deep vein thrombosis (DVT) in the lower extremities or pelvis, and the formation of blood clots may migrate back to the heart through the veins and into the lungs. Pulmonary infarction is caused by loss of blood and oxygen supply to a portion of the lungs. According to statistics, the mortality rate of untreated pulmonary embolism is 20%-30%; the number of newly added cases accounts for 0.2% of the total population every year. According to China's 1.35 billion population, there are about 2.7 million new patients each year.
[0003] 滤器在临床上被证实可降低肺栓塞的发生率。 现有技术中, 滤器结构主要包括 两大类, TrapEase结构的笼型滤器 (如 Cordis TRAPEASE/  [0003] Filters have been clinically proven to reduce the incidence of pulmonary embolism. In the prior art, the filter structure mainly includes two types of cage filters of TrapEase structure (such as Cordis TRAPEASE/
OPTEASE和 LifetechAegisy) 和 Kimray-Greenfield结构的支杆型滤器 (如 Boston Scientific Greenfield, St.JudeAmplatz, Bard Denali, COOK Celect和 Rex Medical Option) 。  Strut-type filters from OPTEASE and LifetechAegisy) and Kimray-Greenfield structures (eg Boston Scientific Greenfield, St.JudeAmplatz, Bard Denali, COOK Celect and Rex Medical Option).
[0004] TmpEase结构的滤器的缺点在于: 为了加强器械在下腔静脉的固定效果, 增加 了器械接触血管壁的支杆的面积, 然而面积的增加容易造成内皮对支杆的爬覆 , 在回收器械的过程中容易撕裂内皮而损伤血管壁, 甚至导致器械不可回收。  [0004] The disadvantages of the TmpEase structure filter are: In order to strengthen the fixation effect of the instrument in the inferior vena cava, the area of the rod contacting the blood vessel wall is increased, but the increase of the area is likely to cause the endothelium to climb the pole, in the recovery device During the process, it is easy to tear the endothelium and damage the blood vessel wall, and even cause the device to be unrecyclable.
[0005] Kimray-Greenfield结构的滤器的缺点在于: 当该器械植入下腔静脉吋, 由于圆 锥形器械的自中心能力差, 该器械植入下腔静脉后容易倾斜, 器械倾斜后, 回 收头紧贴血管壁; 在回收过程中, 回收器械无法顺利捕捉到回收头, 会增加器 械手术操作吋间, 甚至导致器械的回收操作失败。  [0005] The disadvantages of the Kimray-Greenfield structure filter are: When the instrument is implanted in the inferior vena cava, the instrument is easily tilted after implantation into the inferior vena cava due to poor self-centering ability of the conical instrument. Close to the blood vessel wall; During the recycling process, the recovery device can not capture the recovery head smoothly, which will increase the operation time of the device, and even lead to the failure of the recovery operation of the device.
技术问题  technical problem
[0006] TmpEase结构的滤器的缺点在于: 为了加强器械在下腔静脉的固定效果, 增加 了器械接触血管壁的支杆的面积, 然而面积的增加容易造成内皮对支杆的爬覆 , 在回收器械的过程中容易撕裂内皮而损伤血管壁, 甚至导致器械不可回收。  [0006] The disadvantages of the filter of TmpEase structure are: In order to strengthen the fixation effect of the instrument in the inferior vena cava, the area of the rod contacting the vessel wall is increased, but the increase of the area is likely to cause the endothelium to climb the pole, in the recovery device During the process, it is easy to tear the endothelium and damage the blood vessel wall, and even cause the device to be unrecyclable.
[0007] Kimray-Greenfield结构的滤器的缺点在于: 当该器械植入下腔静脉吋, 由于圆 锥形器械的自中心能力差, 该器械植入下腔静脉后容易倾斜, 器械倾斜后, 回 收头紧贴血管壁; 在回收过程中, 回收器械无法顺利捕捉到回收头, 会增加器 械手术操作吋间, 甚至导致器械的回收操作失败。 [0007] The disadvantages of the Kimray-Greenfield structure of the filter are: when the instrument is implanted in the inferior vena cava, due to the circle The self-centering ability of the cone device is poor. The instrument is easy to tilt after being implanted into the inferior vena cava. After the instrument is tilted, the recovery head is close to the vessel wall. During the recycling process, the recovery device cannot smoothly capture the recovery head, which increases the operation of the instrument. During the day, even the recycling operation of the device failed.
问题的解决方案  Problem solution
技术解决方案  Technical solution
[0008] 本发明要解决的技术问题在于, 针对现有技术的上述缺陷, 提供一种与血管内 壁点接触、 防止器械倾斜具有更高的径向支撑力的滤器, 本发明的滤器可以有 效降低内皮爬覆、 有利于器械捕获回收、 缩短手术吋间, 并延长器械使用寿命  [0008] The technical problem to be solved by the present invention is to provide a filter which has a higher radial support force in contact with the inner wall of the blood vessel and prevents the inclination of the instrument against the above-mentioned defects of the prior art, and the filter of the present invention can effectively reduce the filter. Endothelial climbing, which facilitates instrument capture and recovery, shortens surgical stenosis, and extends device life
[0009] 本发明解决其技术问题所采用的技术方案是: 一种滤器, 包括用于防止滤器倾 斜的支撑部、 用于捕获栓子的过滤部; [0009] The technical solution adopted by the present invention to solve the technical problem thereof is: a filter including a support portion for preventing the filter from tilting, and a filter portion for capturing the plug;
[0010] 自由状态下, 所述支撑部包括至少三个由中心向外辐射的支撑杆且所有的支撑 杆呈轴对称排布; [0010] in the free state, the support portion includes at least three support rods radiated outward from the center and all of the support rods are arranged in an axisymmetric manner;
[0011] 所述支撑杆末端或支撑杆末端的切线与支撑部的中轴线夹角 β≥180°, 所述支撑 部最大外径与血管内径配合一致使得所述支撑杆点支撑在血管内壁上。  [0011] The tangential line of the end of the support rod or the end of the support rod is at an angle β ≥ 180° with the central axis of the support portion, and the maximum outer diameter of the support portion is matched with the inner diameter of the blood vessel such that the support rod point is supported on the inner wall of the blood vessel. .
[0012] 所述的滤器中, 优选所述支撑杆包括依次由中心向外辐射的第一支撑段、 第二 支撑段;  [0012] In the filter, preferably, the support rod includes a first support segment and a second support segment that are radiated outward from the center;
[0013] 所述第一支撑段或第一支撑段上各点的切线与中轴线的夹角 01为0~90°, 第二支 撑段或第二支撑段上各点的切线与中轴线的夹角 β≥90°, 且第二支撑段末端或末 端的切线与中轴线的夹角 β≥180°; 第一支撑段与第二支撑段之间的夹角或第一 支撑段与第二支撑段上各点切线的夹角 γ≥180°; 所述支撑杆的第二支撑段点支 撑在血管内壁上。  [0013] The angle between the tangent of each point on the first support section or the first support section and the central axis is 0-90°, and the tangent and the central axis of each point on the second support section or the second support section The angle β ≥ 90°, and the angle between the tangent of the end or end of the second support section and the central axis β ≥ 180°; the angle between the first support section and the second support section or the first support section and the second The angle of the tangent of each point on the support section is γ ≥ 180°; the second support section of the support rod is supported on the inner wall of the blood vessel.
[0014] 所述的滤器中, 优选所述支撑杆自由状态下的形状满足: 02<血管内径的一半 、 且 Dl <血管内径的一半, D1 : 以支撑杆末端处的切线为第二边界线, 支撑杆 相对第二边界线的最远点与第二边界线之间的距离; D2: 以通过支撑杆末端且 与第二边界线垂直的直线为第三边界线, 支撑杆相对于第三边界线的外侧最远 点的距离。  [0014] In the filter, it is preferable that the shape of the support rod in a free state satisfies: 02 < half of the inner diameter of the blood vessel, and D1 < half of the inner diameter of the blood vessel, D1 : a second boundary line at a tangent line at the end of the support rod , the distance between the farthest point of the support rod relative to the second boundary line and the second boundary line; D2: the third boundary line is a straight line passing through the end of the support rod and perpendicular to the second boundary line, and the support rod is opposite to the third The distance from the farthest point on the outer side of the boundary line.
[0015] 所述的滤器中, 优选所述 Dl<17mm且 D2<8mm。 [0016] 所述的滤器中, 优选所述第一支撑段、 第二支撑段各自分别为曲线段、 直线段 和折线段中的至少一种。 [0015] Among the filters, it is preferable that the D1<17 mm and D2<8 mm. [0016] In the filter, preferably, the first support segment and the second support segment are each at least one of a curved segment, a straight segment, and a polygonal segment.
[0017] 所述的滤器中, 优选所述第一支撑段、 第二支撑段为曲率半径连续变化的曲线[0017] Among the filters, preferably, the first support section and the second support section are curves in which the radius of curvature continuously changes.
, 曲率半径逐步减小。 , the radius of curvature is gradually reduced.
[0018] 所述的滤器中, 优选所述支撑杆的第二支撑段包括第一子段、 第二子段和第三 子段;  [0018] In the filter, preferably, the second support section of the support rod includes a first subsection, a second subsection, and a third subsection;
[0019] 其中, 第二子段的曲率半径小于第一子段, 且第二子段与中轴线的夹角由 90°≤ β < 180°过渡到 β≥180°, 形成与血管内壁面的点接触;  [0019] wherein, the radius of curvature of the second sub-segment is smaller than the first sub-segment, and the angle between the second sub-segment and the central axis is changed from 90° ≤ β < 180° to β ≥ 180°, forming an inner wall surface of the blood vessel Point contact
[0020] 或者第二子段为曲线或折线, 形成幵口朝向中轴线的 C字形或 V字形结构, 第 二子段与血管内壁面形成点接触, 第一子段和第三子段为直线或折线, 且第二 支撑段整体背向过滤部或朝向过滤部弯曲。 [0020] or the second sub-section is a curved line or a broken line, forming a C-shaped or V-shaped structure with the cornice facing the central axis, the second sub-section is in point contact with the inner wall surface of the blood vessel, and the first sub-section and the third sub-section are straight lines. Or a fold line, and the second support section is entirely curved away from the filter portion or toward the filter portion.
[0021] 所述的滤器中, 优选第一支撑段、 第二支撑段各自平滑过渡以及它们之间平滑 过渡。 [0021] Among the filters, it is preferable that the first support section and the second support section each have a smooth transition and a smooth transition therebetween.
[0022] 所述的滤器中, 优选所述支撑杆末端设有用于有限刺入血管的锚刺。  [0022] In the filter, preferably, the end of the support rod is provided with an anchor for limited penetration into a blood vessel.
[0023] 所述的滤器中, 优选所述过滤部为支杆结构, 或者所述过滤部为笼形结构。 [0023] In the filter, preferably, the filter portion is a strut structure, or the filter portion is a cage structure.
[0024] 所述的滤器中, 优选所述支撑部连接有用于回收整个滤器的回收部。 [0024] In the filter, it is preferable that the support portion is connected to a recovery portion for recovering the entire filter.
发明的有益效果  Advantageous effects of the invention
有益效果  Beneficial effect
[0025] 本发明通过支撑部的支撑杆实现点支撑, 支撑部为轴对称结构, 采用至少三个 支撑杆形成稳定支撑, 使器械具有更好的自中心性能, 防止器械倾斜, 加之支 撑部最大外径与血管内径配合, 支撑杆点支撑在血管内壁上, 与血管内壁接触 面积小, 减少了内皮爬覆, 有利于器械捕获回收, 缩短手术吋间, 增加了器械 使用寿命, 延长回收吋间。 并且支撑杆的结构为翻转的结构, 所述支撑杆末端 或支撑杆末端的切线与中轴线的夹角 ≥180°, 保证了滤器在释放过程以及释放 后, 支撑杆末端呈卷曲状, 支撑杆末端的端部不会刺入血管内壁, 保证了滤器 使用安全。  [0025] The present invention realizes point support through the support rod of the support portion, the support portion is an axisymmetric structure, and at least three support rods form a stable support, so that the instrument has better self-center performance, preventing the instrument from tilting, and the support portion is the largest. The outer diameter is matched with the inner diameter of the blood vessel. The support rod is supported on the inner wall of the blood vessel, and the contact area with the inner wall of the blood vessel is small, which reduces the endothelial climbing, which is beneficial to the recovery and recovery of the instrument, shortens the operation time, increases the service life of the instrument, and prolongs the recovery period. . And the structure of the support rod is a flipped structure, and the angle between the tangent of the end of the support rod or the end of the support rod and the central axis is ≥180°, which ensures that the end of the support rod is curled after the release process and release of the filter, the support rod The end of the end does not penetrate the inner wall of the blood vessel, ensuring safe use of the filter.
对附图的简要说明  Brief description of the drawing
附图说明 [0026] 下面将结合附图及实施例对本发明作进一步说明, 附图中: DRAWINGS The present invention will be further described with reference to the accompanying drawings and embodiments in which:
[0027] 图 1是本发明实施例 1的结构示意图;  1 is a schematic structural view of Embodiment 1 of the present invention;
[0028] 图 2是图 1的俯视图;  Figure 2 is a plan view of Figure 1;
[0029] 图 3是本发明实施例 1支撑杆第一种实施方式的结构示意图;  3 is a schematic structural view of a first embodiment of a support rod according to Embodiment 1 of the present invention;
[0030] 图 4是本发明实施例 1支撑杆第二种实施方式的结构示意图;  4 is a schematic structural view of a second embodiment of a support rod according to Embodiment 1 of the present invention;
[0031] 图 5是本发明实施例 1支撑杆第三种实施方式的结构示意图;  5 is a schematic structural view of a third embodiment of a support rod according to Embodiment 1 of the present invention;
[0032] 图 6是本发明实施例 1的滤器释放过程支撑杆释放初期的结构示意图;  6 is a schematic structural view showing an initial stage of release of a support rod in a filter release process according to Embodiment 1 of the present invention;
[0033] 图 7是本发明实施例 1的滤器释放过程支撑杆释放中期的结构示意图;  7 is a schematic structural view showing a middle stage of release of a support rod during a filter release process according to Embodiment 1 of the present invention;
[0034] 图 8是本发明实施例 1的滤器释放过程支撑杆释放后期的结构示意图;  8 is a schematic structural view showing a later stage of release of a support rod in a filter release process according to Embodiment 1 of the present invention;
[0035] 图 9是本发明实施例 2的结构示意图;  9 is a schematic structural view of Embodiment 2 of the present invention;
[0036] 图 10是图 9中 I处的局部放大图;  Figure 10 is a partial enlarged view of a portion I in Figure 9;
[0037] 图 11是本发明实施例 3的结构示意图;  11 is a schematic structural view of Embodiment 3 of the present invention;
[0038] 图 12是图 11的 M处的局部放大图;  Figure 12 is a partial enlarged view of M at Figure 11;
[0039] 图 13是本发明实施例 4的结构示意图;  13 is a schematic structural view of Embodiment 4 of the present invention;
[0040] 图 14是本发明实施例 4的支撑杆固定的局部结构示意图;  14 is a partial structural view showing the fixing of a support rod according to Embodiment 4 of the present invention;
[0041] 图 15是本发明实施例 6的结构示意图;  15 is a schematic structural view of Embodiment 6 of the present invention;
[0042] 图 16是本发明实施例 7的结构示意图。  16 is a schematic structural view of Embodiment 7 of the present invention.
实施该发明的最佳实施例  BEST MODE FOR CARRYING OUT THE INVENTION
本发明的最佳实施方式  BEST MODE FOR CARRYING OUT THE INVENTION
[0043] 为了对本发明的技术特征、 目的和效果有更加清楚的理解, 现对照附图详细说 明本发明的具体实施方式。 [0043] In order to more clearly understand the technical features, objects and advantages of the present invention, the specific embodiments of the present invention are described in detail with reference to the accompanying drawings.
[0044] 本发明的方位定义: 回收部所在位置为顶部, 过滤部所在位置为底部。 滤器为 轴对称结构, 滤器的各部分都相对于滤器的中轴线呈轴对称, 本发明中所述的 中轴线都是滤器的中轴线, 也同吋是支撑部和过滤部的中轴线。 [0044] The orientation definition of the present invention: the location of the recovery section is the top, and the location of the filter section is the bottom. The filter is an axisymmetric structure, and the various portions of the filter are axially symmetrical with respect to the central axis of the filter. The central axis described in the present invention is the central axis of the filter, and is also the central axis of the support portion and the filter portion.
[0045] 本发明滤器中有两种状态, 一种是释放后的自由状态, 一种是收入输送导管内 的束缚收缩状态, 以下实施例中, 所称的结构和形状一般为释放后自由状态下 的结构和形状。 [0045] There are two states in the filter of the present invention, one is a free state after release, and the other is a restrained contraction state in the income delivery catheter. In the following embodiments, the structure and shape are generally free after release. The structure and shape underneath.
[0046] 滤器根据回收的可能分为可回收滤器和永久滤器。 其中永久滤器主要包括支撑 部和过滤部, 可回收滤器包括回收部、 支撑部和过滤部。 [0046] The filter is classified into a recyclable filter and a permanent filter depending on the possibility of recovery. The permanent filter mainly includes support And a filter, the recyclable filter includes a recovery portion, a support portion, and a filter portion.
[0047] 实施例 1, 如图 1-8所示, 一种滤器, 本滤器为可回收滤器。 包括用于滤器回收 的回收部 1300、 用于防止滤器倾斜的支撑部 1200、 用于捕获栓子的过滤部 1100 ; 回收部 1300和支撑部 1200和过滤部 1100可以是一体结构, 也可以是分体结构 组装成一个整体。 本实施例中滤器的回收部 1300、 支撑部 1200和过滤部 1100为 一体结构, 由 OD2.0mm镍钛管材经激光切割后, 通过模具热定型而成。 支撑部 为轴对称结构, 具有中轴线, 则支撑部向顶部方向延伸有回收部, 回收部优选 位于支撑部中轴线上, 优选为轴对称结构, 在回收过程中, 可减少滤器的倾斜 。 过滤部也从支撑部向底部延伸, 优选相对于中轴线对称的结构。  [0047] Embodiment 1, as shown in FIGS. 1-8, a filter, the filter is a recyclable filter. The recovery part 1300 for filter recovery, the support part 1200 for preventing the filter from tilting, the filter part 1100 for capturing the plug; the recovery part 1300 and the support part 1200 and the filter part 1100 may be an integral structure, or may be divided into The body structure is assembled into a whole. In the present embodiment, the recovery portion 1300, the support portion 1200, and the filter portion 1100 of the filter have an integral structure, and are formed by heat-setting a mold by laser cutting the OD 2.0 mm nickel-titanium tube. The support portion has an axisymmetric structure and has a central axis. The support portion has a recovery portion extending in the top direction. The recovery portion is preferably located on the central axis of the support portion, preferably an axisymmetric structure, and the inclination of the filter can be reduced during the recovery process. The filter portion also extends from the support portion to the bottom portion, preferably symmetrically with respect to the central axis.
[0048] 过滤部 1100用于捕获来自血流方向的栓子, 其结构有多种实施方式, 过滤部 11 00可以为支杆结构, 也可以为笼形结构。 支杆结构中, 过滤部 1100可以是单层 支杆结构, 也可以是多层支杆结构。 本实施例中, 如图 1所示, 过滤部 1100采用 单层支杆结构, 单层支杆结构就是围绕中心轴均匀设置多根支杆 1100a, 支杆 110 0a形状和结构相同, 支杆 1100a的数量根据需要设置, 本实施例中设置 6根支撑杆 1100a, 支杆 1100a的形状可以是直杆, 也可以是有一定弧度的曲线状。 支杆 1100 a从器械中心即中轴线处向外延伸, 与器械的中轴线夹角为 0~90°, 夹角具体大小 根据实际需要设置。  [0048] The filter portion 1100 is for capturing an emboss from the direction of blood flow, and the structure thereof has various embodiments. The filter portion 11 00 may be a strut structure or a cage structure. In the strut structure, the filter portion 1100 may be a single-layer strut structure or a multi-layer strut structure. In this embodiment, as shown in FIG. 1 , the filter part 1100 adopts a single-layer strut structure, and the single-layer strut structure uniformly sets a plurality of strut 1100a around the central axis, and the strut 110 0a has the same shape and structure, and the strut 1100a The number of the support rods 1100a is set in the embodiment. The shape of the support rods 1100a may be a straight rod or a curved shape having a certain curvature. The struts 1100 a extend outward from the center of the instrument, that is, the central axis, and the angle from the central axis of the instrument is 0 to 90°, and the specific angle of the angle is set according to actual needs.
[0049] 优选在支杆 1100a的末端设有防止器械移位的倒勾 1110, 过滤部 1100至少有两 根支杆 1100a的末端设有倒勾 1110, 倒勾 1110刺入血管壁实现锚定。  Preferably, at the end of the strut 1100a, a barb 1110 for preventing displacement of the instrument is provided, and at least two of the strut 1100a of the filter portion 1100 are provided with a barb 1110, and the barb 1110 penetrates the vessel wall to achieve anchoring.
[0050] 支撑部 1200是本发明中最为重要的结构, 支撑部 1200第一作用是用于防止器械 倾斜, 防止回收部 1300贴壁, 则需要支撑杆 1200a具有相应的轴对称结构, 支撑 部 1200包括支撑杆 1200a, 由中心向外辐射且所有的支撑杆 1200a呈轴对称排布, 另外为了减少内皮爬覆, 要相对于血管内壁点支撑。 支撑部 1200的支撑杆 1200a 数量至少是三根, 本实施例中采用六根支撑杆 1200a, 关于器械中轴线轴对称排 布。  [0050] The support portion 1200 is the most important structure in the present invention. The first function of the support portion 1200 is to prevent the instrument from tilting, and the collection portion 1300 is prevented from adhering. The support rod 1200a is required to have a corresponding axisymmetric structure, and the support portion 1200 is supported. The support rod 1200a is included, radiated outward from the center and all of the support rods 1200a are arranged in an axisymmetric manner, and in order to reduce endothelial resuscitation, it is supported relative to the inner wall of the blood vessel. The number of the support rods 1200a of the support portion 1200 is at least three. In the present embodiment, six support rods 1200a are used, which are arranged symmetrically about the axis of the instrument.
[0051] 所述支撑杆 1200a末端或支撑杆 1200a末端的切线与支撑部中轴线的夹角 β≥180° [0051] The angle between the tangent of the end of the support rod 1200a or the end of the support rod 1200a and the central axis of the support portion is β≥180°.
, 所述支撑部最大外径 D (最大外径指支撑杆相对中轴线的最远点形成圆的直径 , D: 以中轴线为第一边界线, 支撑杆 1200a相对第一边界线的最远点与第一边 界线之间距离的两倍) 与血管内径配合一致使得所述支撑杆 1200a点支撑在血管 内壁上。 在释放过程中, 支撑杆 1200a在血管内伸展, 不管支撑杆 1200a是什么样 的结构, 释放完成后支撑杆 1200a末端或支撑杆 1200a末端的切线与中轴线的夹角 β≥180°, 这样支撑杆 1200a末端错幵血管内壁, 至少是与血管内壁平行状态, 支 撑杆 1200a端部不会刺破血管内壁面。 The maximum outer diameter D of the support portion (the maximum outer diameter refers to the diameter of the farthest point of the support rod relative to the central axis forming a circle, D: the first boundary line with the central axis, and the farthest distance of the support rod 1200a relative to the first boundary line Point and first side The double of the distance between the boundaries) coincides with the inner diameter of the blood vessel such that the support rod 1200a is supported on the inner wall of the blood vessel. During the release process, the support rod 1200a is extended within the blood vessel, regardless of the structure of the support rod 1200a, the angle between the tangent of the end of the support rod 1200a or the end of the support rod 1200a and the central axis is β ≥ 180° after the release is completed, so that the support The end of the rod 1200a is staggered to the inner wall of the blood vessel, at least in parallel with the inner wall of the blood vessel, and the end of the support rod 1200a does not pierce the inner wall surface of the blood vessel.
[0052] 根据支撑杆 1200a的不同位置形状结构以及作用不同, 支撑杆 1200a主要分成二 部分, 所述支撑杆 1200a包括依次由中心向外辐射的第一支撑段 1210、 第二支撑 段 1230, 在一支撑段 1210、 第二支撑段 1230之间还可以设有过渡段 1220, 这三 段跟不同结构, 其形状和长度都有所不同。 其中所述第一支撑段 1210或第一支 撑段 1210上各点的切线与中轴线的夹角为 01为0~90°, 且第二支撑段 1230或第二 支撑段 1230上各点的切线与中轴线的夹角 β为 β〉90°, 同吋, 由于支撑杆 1200a末 端即为第二支撑段 1230的末端, 则第二支撑段 1230末端或末端的切线与中轴线 夹角 β≥180°。 这样的结构可以保证支撑杆 1200a释放后, 支撑杆 1200a末端在贴壁 以前就发生翻转卷曲, 且翻转角度达到 180°以上。 第一支撑段 1210端部汇集与回 收部 1300和过滤部 1100固定在一起, 第二支撑段 1230是支撑杆 1200a的末段。  [0052] According to different positions and structures of the support rods 1200a, the support rods 1200a are mainly divided into two parts, and the support rods 1200a include a first support section 1210 and a second support section 1230 which are radiated outward from the center. A transition section 1220 may also be provided between a support section 1210 and a second support section 1230. The three sections are different in structure and shape and length. The angle between the tangent of each point on the first support section 1210 or the first support section 1210 and the central axis is 01 to 0° 90°, and the tangent of each point on the second support section 1230 or the second support section 1230 The angle β with the central axis is β>90°. Similarly, since the end of the support rod 1200a is the end of the second support section 1230, the tangent of the end or end of the second support section 1230 forms an angle with the central axis β≥180. °. Such a structure can ensure that after the support rod 1200a is released, the end of the support rod 1200a is turned over and curled before the wall is attached, and the flip angle is more than 180°. The end of the first support section 1210 is assembled with the return portion 1300 and the filter portion 1100, and the second support portion 1230 is the end of the support rod 1200a.
[0053] 第一支撑段 1210与第二支撑段 1230之间的夹角或第一支撑段与第二支撑段上各 点切线的夹角 γ≥180°, 保证了第二支撑段 1230是向背向过滤部方向翻转, 图中 显示朝向滤器的顶部方向翻转。 过渡段 1220为第一支撑段 1210与第二支撑段 123 0之间的过渡, 因此, 过渡段 1220的长度和形状根据第一支撑段 1210和第二支撑 段 1230的形状确定, 以利于第一支撑段 1210与第二支撑段 1230之间的平滑过渡 , 以及达到相应翻转效果。 过渡段 1220可以是曲线、 直线和折线, 以及上述两 种或两种以上线形的混合排布。  [0053] The angle between the first support section 1210 and the second support section 1230 or the angle between the first support section and the tangent line of each point on the second support section is γ ≥ 180°, which ensures that the second support section 1230 is back. Flip in the direction of the filter, the figure shows the flip in the direction towards the top of the filter. The transition section 1220 is a transition between the first support section 1210 and the second support section 123 0 . Therefore, the length and shape of the transition section 1220 are determined according to the shapes of the first support section 1210 and the second support section 1230 to facilitate the first A smooth transition between the support section 1210 and the second support section 1230, and a corresponding flip effect. The transition section 1220 may be a curved line, a straight line, and a broken line, and a mixed arrangement of the above two or more linear shapes.
[0054] 第一支撑段 1210和第二支撑段 1230各自分别为曲线段、 直线段和折线段中的至 少一种。 即第一支撑段 1210第二支撑段 1230每段都可以只选择是曲线段、 直线 段或折线段, 也可以选择两种甚至三种的线形, 两种或两种以上的线形排布方 式不作限定, 可以是任意方式。 同样过渡段 1220也可以为曲线段、 直线段和折 线段中的至少一种。 优选所述第一支撑段 1210、 第二支撑段 1230为曲率半径连 续变化的曲线, 曲率半径逐步减小。 [0055] 如图 3所示, 第一支撑段 1210为直线段, 过渡段 1220和第二支撑段 1230为曲线 段; 如图 4所示, 第一支撑段 1210、 过渡段 1220和第二支撑段 1230都为折线段; 如图 5所示, 第一支撑段 1210、 过渡段 1220和第二支撑段 1230都为直线段, 各个 直线段之间倒角平滑过渡。 [0054] The first support segment 1210 and the second support segment 1230 are each at least one of a curved segment, a straight segment, and a polygonal segment, respectively. That is, each of the second support segments 1230 of the first support segment 1210 can be selected only as a curved segment, a straight segment or a polygonal segment, or two or even three linear shapes can be selected, and two or more linear arrangements are not used. Limited, can be any way. The same transition section 1220 can also be at least one of a curved section, a straight section, and a polygonal section. Preferably, the first support section 1210 and the second support section 1230 are curves in which the radius of curvature continuously changes, and the radius of curvature is gradually reduced. [0055] As shown in FIG. 3, the first support section 1210 is a straight section, and the transition section 1220 and the second support section 1230 are curved segments; as shown in FIG. 4, the first support section 1210, the transition section 1220, and the second support The segments 1230 are all line segments; as shown in FIG. 5, the first support segment 1210, the transition segment 1220, and the second support segment 1230 are all straight segments, and the chamfers smoothly transition between the straight segments.
[0056] 如图 1所示, 本实施例中, 支撑杆 1200a的第一支撑段 1210、 过渡段 1220、 第二 支撑段 1230都为曲线段, 支撑杆 1200a的三段没有明确界限, 三段为连续结构, 形成曲率半径连续变化的曲线, 曲率半径逐步减小。 支撑杆 1200a各段长度也根 据实际需要设计, 第一支撑段 1210上各点的切线与中轴线的夹角 α为 0~90°, 夹 角 α可以在 0~90°范围内任意选择, 夹角 α最小是 0°, 即与中轴线平行, 夹角 α最 大是 90°即与中轴线垂直。 第二支撑段 1230为向顶部翻转的段, 因此, 释放后的 自由状态下, 第二支撑段 1230或第二支撑段 1230上各点的切线与中轴线的夹角 β ≥90°, 且第二支撑段 1230末端或末端的切线与中轴线的夹角 β≥180°; 第二支撑 段 1230最大翻转角度是朝向中心轴翻转, 末端不接触血管壁面。  As shown in FIG. 1 , in this embodiment, the first support section 1210 , the transition section 1220 , and the second support section 1230 of the support rod 1200 a are all curved segments, and the three sections of the support rod 1200 a have no clear boundary, and the third section For the continuous structure, a curve in which the radius of curvature continuously changes is formed, and the radius of curvature is gradually reduced. The lengths of the support rods 1200a are also designed according to actual needs. The angle between the tangent of each point on the first support section 1210 and the central axis is 0-90°, and the angle α can be arbitrarily selected within the range of 0-90°. The angle α is at least 0°, that is, parallel to the central axis, and the angle α is at most 90°, which is perpendicular to the central axis. The second supporting section 1230 is a section that is turned to the top. Therefore, in the free state after the release, the angle between the tangent of each point on the second supporting section 1230 or the second supporting section 1230 and the central axis is ≥ 90°, and The angle between the tangent of the end or end of the two support segments 1230 and the central axis is β≥180°; the maximum flip angle of the second support segment 1230 is reversed toward the central axis, and the end does not contact the wall of the blood vessel.
[0057] 自由状态下, 所述支撑部 1200为轴对称结构, 支撑部 1200最大外径与血管内径 配合, 支撑部 1200最大外径 D与血管内径配合是指支撑部 1200的最大外径 D基本 与血管内径一致, D可以稍大于、 等于或小于血管内径。 所述支撑杆 1200a的第 二支撑段 1230点支撑在血管内壁上, 点支撑是一个相对概念, 指支撑杆 1200a以 相对较小的接触面积接触血管内壁, 即相对于支撑杆 1200a的长度和直径, 基本 可以认为跟血管内壁接触是点支撑即可。 支撑部 1200最大外径 D为 10~40mm, 血 管最大直径为 2D ( 16~34 mm区间, 通常 24mm) , 考虑到血管的通常尺寸, 优 选 Dl<17mm且 D2<8mm。  [0057] In the free state, the support portion 1200 is an axisymmetric structure, and the maximum outer diameter of the support portion 1200 is matched with the inner diameter of the blood vessel. The maximum outer diameter D of the support portion 1200 and the inner diameter of the blood vessel refer to the maximum outer diameter D of the support portion 1200. Consistent with the inner diameter of the blood vessel, D can be slightly larger than, equal to, or smaller than the inner diameter of the blood vessel. The second support section 1230 of the support rod 1200a is supported on the inner wall of the blood vessel. The point support is a relative concept, and the support rod 1200a contacts the inner wall of the blood vessel with a relatively small contact area, that is, the length and diameter of the support rod 1200a. Basically, it can be considered that contact with the inner wall of the blood vessel is a point support. The maximum outer diameter D of the support portion 1200 is 10~40mm, and the maximum diameter of the blood vessel is 2D (16~34mm interval, usually 24mm). Considering the normal size of the blood vessel, Dl<17mm and D2<8mm are preferred.
[0058] 具体如图 3所示, 优选所述支撑杆 1200a的第二支撑段 1230优选包括第一子段 12 30a、 第二子段 1230b和第三子段 1230c; 其中, 第二支撑段 1230为曲线, 第二子 段 1230b的曲率半径小于第一子段 1230a, 第二子段 1230b与中轴线的夹角 β由 90。 ≤β < 180°过渡到 β≥180°, 形成与血管内壁面的点接触; 或者第二子段 1230b为曲 线或折线, 形成幵口朝向中轴线的 C字形或 V字形, 与血管内壁面形成点接触, 第一子段 1230a和第三子段 1230c为直线或折线, 且第二支撑段 1230整体朝向滤器 顶部的方向弯曲第二子段 1230b的曲率半径为最小, 这样的结构, 第二子段 1230 b的点或段成为支撑部 1200的最远端, 即所有支撑杆 1200a的第二子段 1230b上的 一点或一段所在的圆周形成支撑部 1200的最大圆周, 第二子段 1230b的该位置成 为与血管内壁点接触的位置。 [0058] Specifically, as shown in FIG. 3, the second support section 1230 of the support bar 1200a preferably includes a first sub-section 12 30a, a second sub-section 1230b, and a third sub-section 1230c; wherein, the second support section 1230 For the curve, the radius of curvature of the second sub-section 1230b is smaller than the first sub-section 1230a, and the angle β between the second sub-section 1230b and the central axis is 90. ≤ β < 180° transition to β ≥ 180°, forming a point contact with the inner wall surface of the blood vessel; or the second sub-section 1230b is a curved line or a broken line forming a C-shape or a V-shape of the gargle toward the central axis, forming an inner wall surface of the blood vessel In the point contact, the first sub-section 1230a and the third sub-section 1230c are straight lines or broken lines, and the second support section 1230 is bent in the direction of the top of the filter. The radius of curvature of the second sub-section 1230b is the smallest, such a structure, the second sub- Paragraph 1230 The point or segment of b becomes the most distal end of the support portion 1200, i.e., the circumference on which the point or section of the second sub-section 1230b of all of the support bars 1200a is located forms the maximum circumference of the support portion 1200, and the position of the second sub-section 1230b becomes The position in contact with the inner wall of the blood vessel.
[0059] 第一支撑段 1210、 过渡段 1220和第二支撑段 1230虽然将支撑杆 1200a分成了三 部分, 但是支撑杆 1200a是一个整体, 因此第一支撑段 1210、 过渡段 1220和第二 支撑段 1230各自平滑过渡以及它们之间平滑过渡, 以实现形成一个完整的支撑 杆 1200a。 [0059] Although the first support section 1210, the transition section 1220, and the second support section 1230 divide the support rod 1200a into three parts, the support rod 1200a is a unitary body, and thus the first support section 1210, the transition section 1220, and the second support Segments 1230 each have a smooth transition and a smooth transition therebetween to achieve the formation of a complete support rod 1200a.
[0060] 图 6-8为支撑部释放过程示意图。 如图 6所示是支撑杆 1200a的第二支撑段 1230 从导管 1600中展幵情况, 如图 7所示是支撑杆 1200a展幵一半, 过渡段 1220逐步展 幵, 随着支撑杆 1200a的展幵, 支撑杆 1200a末端的第三支撑段 1230幵始向滤器顶 部弯曲, 如图 7所示, 此状态为释放过程中的最危险状态, 支撑杆 1200a末端朝向 血管壁面 1800, 如果支撑杆 1200a过长或支撑杆 1200a弯曲度不足, 都会造成支撑 杆 1200a末端刺破血管, 因此, 要求所述支撑杆 1200a自由状态下的形状满足: D 2<血管内径的一半、 且 Dl <血管内径的一半; 其中, D1 : 以支撑杆 1200a末端处 的切线为第二边界线, 支撑杆 1200a相对第二边界线的最远点与第二边界线之间 的距离; D2: 以通过支撑杆 1200a末端且与第二边界线垂直的直线为第三边界线 , 支撑杆 1200a相对于第三边界线的外侧最远点的距离。 根据上述要求, 则支撑 杆 1200a在释放展幵过程中, 支撑杆 1200a末端不会刺到血管内壁面 1800。 如图 8 所示再后撤输送导管 1600, 支撑部 1200的第一支撑段 1210展幵, 则支撑杆 1200a 末端在贴血管 1800壁面以前就朝向中轴线弯曲, 不会刺破血管 1800内壁面。 支 撑杆 1200a的第二支撑段 1230中的第二子段 1230b贴壁, 支撑到血管 1800内壁上, 随后, 回收部 1300从输送导管中释放。 在支撑部 1200的作用下, 滤器 1000不容 易发生倾斜, 回收部 1300难以贴壁, 这样器械更容易回收, 同吋, 该滤器与血 管壁主要为点接触非面接触, 这样可以有效的降低内皮爬覆, 减少滤器回收吋 间。  6-8 is a schematic diagram of a release process of the support portion. As shown in FIG. 6, the second support section 1230 of the support rod 1200a is swung out from the duct 1600. As shown in FIG. 7, the support rod 1200a is halfway, and the transition section 1220 is gradually extended, with the support rod 1200a being extended.第三, the third support section 1230 at the end of the support rod 1200a starts to bend toward the top of the filter. As shown in FIG. 7, this state is the most dangerous state in the release process, and the end of the support rod 1200a faces the blood vessel wall 1800, if the support rod 1200a passes If the length of the support rod 1200a is insufficient, the end of the support rod 1200a will pierce the blood vessel. Therefore, the shape of the support rod 1200a in the free state is required to satisfy: D 2 < half of the inner diameter of the blood vessel, and D1 < half of the inner diameter of the blood vessel; Wherein, D1: a tangent line at the end of the support rod 1200a as a second boundary line, a distance between the farthest point of the support rod 1200a relative to the second boundary line and the second boundary line; D2: to pass through the end of the support rod 1200a and The straight line perpendicular to the second boundary line is the third boundary line, and the distance of the support rod 1200a with respect to the outermost point of the outer side of the third boundary line. According to the above requirements, the support rod 1200a does not pierce the inner wall surface 1800 of the blood vessel during the release of the stent. As shown in Fig. 8, the delivery catheter 1600 is retracted, and the first support section 1210 of the support portion 1200 is swollen, and the end of the support rod 1200a is bent toward the central axis before the wall of the blood vessel 1800 is attached, so that the inner wall surface of the blood vessel 1800 is not pierced. The second sub-section 1230b of the second support section 1230 of the support rod 1200a is adhered to the inner wall of the blood vessel 1800, and then the recovery portion 1300 is released from the delivery catheter. Under the action of the support portion 1200, the filter 1000 is less prone to tilting, and the recovery portion 1300 is difficult to adhere to the wall, so that the device is more easily recovered. Similarly, the filter and the blood vessel wall are mainly in point contact non-surface contact, which can effectively reduce the endothelium. Climb, reduce filter recovery time.
[0061] 回收部 1300是用于滤器回收的, 回收部 1300设置在支撑部 1200的顶部中心, 跟 支撑部 1200—体结构。 回收部 1300包括挂钩 1310或挂环, 用于钩挂回收进入输 送导管。 [0062] 实施例 2, 如图 9、 10所示, 本实施例是在实施例 1的基础上, 在支撑部 1200的 支撑杆 1200a末端设有用于有限刺入血管 1800的锚刺 1231。 支撑部 1200为光滑的 丝杆, 为了进一步防止支撑杆 1200a刺入血管 1800壁面, 并造成刺入过深, 刺穿 血管 1800壁面, 造成血管 1800损伤或者器械难以回收, 本实施例中第二支撑段 1 230末端设有锚刺 1231, 使得第二支撑段 1230的末端 1232与锚刺 1231—起形成两 个分叉, 由于分叉的形成, 当支撑部 1200释放吋, 锚刺 1231用于刺入血管 1800 壁面, 实现器械的锚定, 防止移位, 第二支撑段 1230的末端 1232限定锚刺 1231 进一步, 用于防止刺入过深。 [0061] The recovery unit 1300 is used for filter recovery, and the recovery unit 1300 is disposed at the top center of the support portion 1200, and has a body structure with the support portion 1200. The recycling portion 1300 includes a hook 1310 or a loop for hooking back into the delivery catheter. [0062] Embodiment 2 As shown in FIGS. 9 and 10, in the present embodiment, on the basis of Embodiment 1, an anchor rib 1231 for limiting penetration of the blood vessel 1800 is provided at the end of the support rod 1200a of the support portion 1200. The support portion 1200 is a smooth screw rod, in order to further prevent the support rod 1200a from penetrating into the wall surface of the blood vessel 1800, and causing the penetration to be too deep, piercing the wall surface of the blood vessel 1800, causing damage to the blood vessel 1800 or difficult to recover the instrument, the second support in this embodiment The end of the segment 1 230 is provided with an anchor 1231 such that the end 1232 of the second support segment 1230 forms two branches together with the anchor 1231. Due to the formation of the bifurcation, when the support portion 1200 releases the ankle, the anchor 1231 is used for stabbing. The wall of the blood vessel 1800 is inserted to realize the anchoring of the instrument to prevent displacement. The end 1232 of the second support section 1230 defines the anchor thorn 1231 to prevent the penetration from being too deep.
[0063] 其余结构同实施例 1, 在此不再赘述。  [0063] The rest of the structure is the same as Embodiment 1, and details are not described herein again.
[0064] 实施例 3、 如图 11、 12所示, 本实施例是在实施例 1的基础上, 将第二支撑段 12 30中的第三子段 1230c曲率半径小于第二子段 1230b, 这样, 当支撑部 1200逐渐释 放展幵并贴壁吋, 第二支撑段 1230已经恢复至弯曲状态, 这样, 支撑部 1200的 头端不会刺到血管壁, 从而避免了支撑部 1200损伤血管的风险。  [0064] Embodiment 3, as shown in FIGS. 11 and 12, this embodiment is based on Embodiment 1, and the third sub-section 1230c of the second support section 1230 has a smaller radius of curvature than the second sub-section 1230b. In this way, when the support portion 1200 gradually releases the abutment and adheres to the wall, the second support portion 1230 has returned to the curved state, so that the head end of the support portion 1200 does not penetrate the blood vessel wall, thereby preventing the support portion 1200 from damaging the blood vessel. risk.
[0065] 其余结构同实施例 1, 在此不再赘述。  [0065] The rest of the structure is the same as Embodiment 1, and details are not described herein again.
[0066] 实施例 4, 如图 13、 14所示, 本实施例的结构同实施例 1-3, 滤器的各个部分为 分体结构, 支撑部 1200的支撑杆 1200a和过滤部 1100的过滤杆 1100a分别为丝状结 构, 通过套头 1260与回收部 1300固定连接在一起。  [0066] Embodiment 4, as shown in FIGS. 13 and 14, the structure of this embodiment is the same as that of Embodiment 1-3, and the respective portions of the filter are a separate structure, the support rod 1200a of the support portion 1200 and the filter rod of the filter portion 1100. The 1100a is a filament-like structure, and is fixedly coupled to the recovery portion 1300 through the ferrule 1260.
[0067] 支撑部 1200采用 0.1~0.6mm的丝材定型而成, 丝材包括但不限于不锈钢、 镍钛 合金、 钴铬合金、 钛合金等等中的一种或者多种。 本实施例中支撑部 1200由 6根 0.35mm镍钛丝制成的支撑杆 1200a组成, 支撑杆 1200a—端套上套头 1260, 然后 通过氩弧焊接连接, 然后通过模具热定型而成连续平滑弯曲的支撑杆 1200a。  [0067] The support portion 1200 is formed by using a wire of 0.1 to 0.6 mm, and the wire material includes, but is not limited to, one or more of stainless steel, nickel titanium alloy, cobalt chromium alloy, titanium alloy, and the like. In this embodiment, the support portion 1200 is composed of six support rods 1200a made of 0.35 mm nickel-titanium wire, and the support rod 1200a is sleeved on the end sleeve 1260, and then connected by argon arc welding, and then heat-shaped through the mold to form a continuous smooth bending. Support rod 1200a.
[0068] 本实施例中的过滤部 1100通过激光切割后热定型而成。 本实施例中的过滤部 11 00、 支撑部 1200和回收部 1300分别成型, 然后焊接在一起, 支撑部 1200处于过 滤部 1100的内侧。  [0068] The filter portion 1100 in the present embodiment is formed by heat setting after laser cutting. The filter portion 11 00, the support portion 1200, and the recovery portion 1300 in this embodiment are separately molded and then welded together, and the support portion 1200 is located inside the filter portion 1100.
[0069] 实施例 5、 本实施例与是实施例 4具有相同的支撑部 1200和回收部 1300。 所不同 的是本实例中的过滤部 1100的支杆 1100a也是采用 0. l~0.6mm的丝材定型而成, 丝材包括但不限于不锈钢, 镍钛合金, 钴铬合金, 钛合金等等中的一种或者多 种。 过滤部 1100和支撑部 1200可以分幵成型后焊接, 也可以一体成型。 本实施 例中过滤部 1100由 12根 0.40mm镍钛丝制成的支杆 1100a构成, 支撑部 1200由 6根 0 35mm镍钛丝制成的支撑杆 1200a构成, 然后套上套头 1260, 通过氩弧焊接和激 光点焊连接, 最后通过模具热定型而成。 [0069] Embodiment 5 This embodiment has the same support portion 1200 and recovery portion 1300 as in Embodiment 4. The difference is that the struts 1100a of the filter portion 1100 in the present example are also formed by using 0. l~0.6mm wire materials, including but not limited to stainless steel, nickel titanium alloy, cobalt chrome alloy, titanium alloy, etc. One or more of them. The filter portion 1100 and the support portion 1200 may be separately formed by welding, or may be integrally molded. This implementation In the example, the filter portion 1100 is composed of 12 struts 1100a made of 0.40 mm nickel-titanium wire, and the support portion 1200 is composed of 6 support rods 1200a made of 0 35 mm nickel-titanium wire, and then the sleeve 1260 is sheathed by argon arc welding. It is connected with laser spot welding and finally heat-set by mold.
[0070] 实施例 6、 如图 6所示为具体植入实例: 现有技术中, 腔静脉滤器一般都植入在 肾动脉以下, 本实施例以是滤器横跨肾动脉以上, 增加滤器的锚定区, 扩大滤 器的使用范围。 过滤部 1100的支杆 1100a采用采用 0.1~0.6mm的丝材定型而成, 丝材包括但不限于不锈钢、 镍钛合金、 钴铬合金、 钛合金等等中的一种或者多 种。 过滤部 1100和支撑部 1200可以分幵成型后焊接, 也可以一体成型。 具体过 滤部 1100的支杆 1100a由 12根 0.40mm镍钛丝通过氩弧焊接后, 模具热定型而成, 由于过滤部 1100直段采用的是镍钛丝组成, 丝与丝之间具有较高的自由度, 具 有较好的柔顺性。 支撑部 1200的支撑杆 1200a采用 2.70mm镍钛管材激光切割后, 模具热定型而成。 过滤部 1100、 支撑部 1200和回收部 1300通过激光点焊连接, 其中一种植入状态见图 15, 其中过滤部 1100处于肾动脉 2100和肾动脉 2200以下 , 支撑部 1200和回收部 1300处于肾动脉 2100和 2肾动脉 200以上。  [0070] Embodiment 6, as shown in FIG. 6 is a specific implant example: In the prior art, the vena cava filter is generally implanted under the renal artery. In this embodiment, the filter is inserted across the renal artery to increase the filter. Anchor zone, expand the range of use of the filter. The rod 1100a of the filter portion 1100 is formed by using a wire of 0.1 to 0.6 mm, and the wire includes, but is not limited to, one or more of stainless steel, nickel titanium alloy, cobalt chromium alloy, titanium alloy, and the like. The filter portion 1100 and the support portion 1200 may be separately formed by welding, or may be integrally molded. The struts 1100a of the specific filter portion 1100 are formed by argon arc welding of 12 0.40 mm nickel-titanium wires, and the mold is heat-set. Since the filter portion 1100 is composed of a nickel-titanium wire in a straight section, the wire and the wire are relatively high. The degree of freedom has better flexibility. The support rod 1200a of the support portion 1200 is laser-cut with a 2.70 mm nickel-titanium tube, and the mold is heat-set. The filter portion 1100, the support portion 1200, and the recovery portion 1300 are connected by laser spot welding, one of which is shown in Fig. 15, wherein the filter portion 1100 is located below the renal artery 2100 and the renal artery 2200, and the support portion 1200 and the recovery portion 1300 are in the renal artery. 2100 and 2 renal arteries above 200.
[0071] 实施例 7, 如图 16所示, 为永久滤器。 只包括支撑部 1200和过滤部 1100, 自由 状态下, 所述支撑部 1200包括至少三个由中心向外辐射的支撑杆 1200a且所有的 支撑杆 1200a呈轴对称排布, 本实施例有四根支撑杆 1200a; 支撑杆 1200a的结构 同实施例 1, 在此不再赘述。 所述支撑杆 1200a末端或支撑杆 1200a末端的切线与 支撑部的中轴线夹角 β≥ 180°, 所述支撑部最大外径与血管内径配合一致使得所 述支撑杆 1200a点支撑在血管内壁上。 与实施例 1不同的是支撑杆 1200a的翻转方 向, 本实施例支撑杆 1200a向过滤部 1100方向翻转, 形成支撑; 过滤部 1100的结 构同实施例 1。  [0071] Example 7, as shown in Fig. 16, is a permanent filter. Only the support portion 1200 and the filter portion 1100 are included. In the free state, the support portion 1200 includes at least three support rods 1200a radiated outward from the center and all the support rods 1200a are arranged in an axisymmetric manner, and there are four in this embodiment. The support rod 1200a; the structure of the support rod 1200a is the same as that of the embodiment 1, and details are not described herein again. The tangential line of the end of the support rod 1200a or the end of the support rod 1200a is at an angle β ≥ 180° with the central axis of the support portion, and the maximum outer diameter of the support portion is matched with the inner diameter of the blood vessel such that the support rod 1200a is supported on the inner wall of the blood vessel. . The difference from the first embodiment is the turning direction of the support rod 1200a. In this embodiment, the support rod 1200a is turned in the direction of the filter portion 1100 to form a support. The structure of the filter portion 1100 is the same as that of the first embodiment.

Claims

权利要求书 Claim
一种滤器, 包括用于防止滤器倾斜的支撑部、 用于捕获栓子的过滤部 ; 其特征在于: A filter comprising a support portion for preventing tilting of the filter, and a filter portion for capturing the plug; characterized in that:
自由状态下, 所述支撑部包括至少三个由中心向外辐射的支撑杆且所 有的支撑杆呈轴对称排布; In the free state, the support portion includes at least three support rods radiated outward from the center and all of the support rods are arranged in an axisymmetric manner;
所述支撑杆末端或支撑杆末端的切线与支撑部的中轴线夹角 β≥180°, 所述支撑部最大外径与血管内径配合一致使得所述支撑杆点支撑在血 管内壁上。 The tangential line of the end of the support rod or the end of the support rod is at an angle β ≥ 180° with the central axis of the support portion, and the maximum outer diameter of the support portion is matched with the inner diameter of the blood vessel such that the support rod point is supported on the inner wall of the blood vessel.
根据权利要求 1所述的滤器, 其特征在于, 每根所述支撑杆包括依次 由中心向外辐射的第一支撑段、 第二支撑段; The filter according to claim 1, wherein each of said support rods comprises a first support section and a second support section radiated outward from the center;
所述第一支撑段或第一支撑段上各点的切线与支撑部中轴线的夹角 α为 0~90°, 第二支撑段或第二支撑段上各点的切线与中轴线的夹角 β ≥90°, 且第二支撑段末端或末端的切线与中轴线的夹角 β≥180°; 第 一支撑段与第二支撑段之间的夹角或第一支撑段与第二支撑段上各点 切线的夹角 γ≥180°; 所述支撑杆的第二支撑段点支撑在血管内壁上。 根据权利要求 2所述的滤器, 其特征在于, 所述支撑杆自由状态下的 形状满足: D2<血管内径的一半、 且 Dl <血管内径的一半, D1 : 以支 撑杆末端处的切线为第二边界线, 支撑杆相对第二边界线的最远点与 第二边界线之间的距离; D2: 以通过支撑杆末端且与第二边界线垂 直的直线为第三边界线, 支撑杆相对于第三边界线的外侧最远点的距 离。  An angle α between a tangent line of each point on the first support section or the first support section and a central axis of the support part is 0-90°, and a tangent line and a central axis of each point on the second support section or the second support section are clamped The angle β ≥ 90°, and the angle between the tangent of the end or end of the second support section and the central axis β ≥ 180°; the angle between the first support section and the second support section or the first support section and the second support The angle of the tangent of each point on the segment is γ ≥ 180°; the second support segment of the support rod is supported on the inner wall of the blood vessel. The filter according to claim 2, wherein the shape of the support rod in a free state satisfies: D2 < half of the inner diameter of the blood vessel, and D1 < half of the inner diameter of the blood vessel, D1: the tangent at the end of the support rod a boundary line, a distance between a farthest point of the support rod relative to the second boundary line and a second boundary line; D2: a third boundary line passing through a line passing through the end of the support rod and perpendicular to the second boundary line, the support rod is opposite The distance from the farthest point on the outer side of the third boundary line.
根据权利要求 3所述的滤器, 其特征在于, 所述 Dl<17mm且 D2<8mm 根据权利要求 2-4任意一项所述的滤器, 其特征在于, 所述第一支撑 段、 第二支撑段各自分别为曲线段、 直线段和折线段中的至少一种。 根据权利要求 5所述的滤器, 其特征在于, 所述第一支撑段、 第二支 撑段为曲率半径连续变化的曲线, 曲率半径逐步减小。 The filter according to claim 3, wherein the filter according to any one of claims 2 to 4, wherein the first support section and the second support are The segments are each at least one of a curved segment, a straight segment, and a polygonal segment. The filter according to claim 5, wherein the first support section and the second support section are curves in which the radius of curvature continuously changes, and the radius of curvature is gradually reduced.
根据权利要求 2-4任意一项所述的滤器, 其特征在于, 所述支撑杆的 第二支撑段包括第一子段、 第二子段和第三子段; A filter according to any one of claims 2 to 4, wherein the support rod The second support section includes a first subsection, a second subsection, and a third subsection;
其中, 第二子段的曲率半径小于第一子段, 且第二子段与中轴线的 夹角 β由 90°≤β < 180°过渡到 β≥180°, 形成与血管内壁面的点接触; 或者第二子段为曲线或折线, 形成幵口朝向中轴线的 c字形或 V字形 结构, 第二子段与血管内壁面形成点接触, 第一子段和第三子段为直 线或折线, 且第二支撑段整体背向过滤部或朝向过滤部弯曲。  Wherein, the radius of curvature of the second sub-segment is smaller than the first sub-segment, and the angle β between the second sub-segment and the central axis transitions from 90° ≤ β < 180° to β ≥ 180°, forming a point contact with the inner wall surface of the blood vessel Or the second sub-section is a curve or a broken line, forming a c-shaped or V-shaped structure with the cornice facing the central axis, the second sub-section forming a point contact with the inner wall surface of the blood vessel, and the first sub-section and the third sub-section are straight lines or broken lines And the second support section is entirely curved away from the filter portion or toward the filter portion.
[权利要求 8] 根据权利要求 1-4任意一项所述的滤器, 其特征在于, 所述支撑杆末 端设有用于有限刺入血管的锚刺。  [Claim 8] The filter according to any one of claims 1 to 4, wherein the end of the support rod is provided with an anchor for limited penetration into a blood vessel.
[权利要求 9] 根据权利要求 1-4任意一项所述的滤器, 其特征在于, 所述过滤部为 支杆结构, 或者所述过滤部为笼形结构。  [Claim 9] The filter according to any one of claims 1 to 4, wherein the filter portion is a strut structure, or the filter portion is a cage structure.
[权利要求 10] 根据权利要求 1所述的滤器, 其特征在于, 所述滤器还设有用于回收 整个滤器的回收部。  [Claim 10] The filter according to claim 1, wherein the filter is further provided with a recovery portion for recovering the entire filter.
PCT/CN2017/075790 2016-12-26 2017-03-06 Filter WO2018120414A1 (en)

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