WO2019128652A1 - 滤器 - Google Patents

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Publication number
WO2019128652A1
WO2019128652A1 PCT/CN2018/119275 CN2018119275W WO2019128652A1 WO 2019128652 A1 WO2019128652 A1 WO 2019128652A1 CN 2018119275 W CN2018119275 W CN 2018119275W WO 2019128652 A1 WO2019128652 A1 WO 2019128652A1
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WO
WIPO (PCT)
Prior art keywords
filter
section
support
central axis
longitudinal central
Prior art date
Application number
PCT/CN2018/119275
Other languages
English (en)
French (fr)
Inventor
贾小乐
唐辉强
李安宁
Original Assignee
先健科技(深圳)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
Priority claimed from CN201711434036.0A external-priority patent/CN109953838B/zh
Priority claimed from CN201711437874.3A external-priority patent/CN109953839B/zh
Application filed by 先健科技(深圳)有限公司 filed Critical 先健科技(深圳)有限公司
Priority to US16/956,782 priority Critical patent/US20200315769A1/en
Priority to EP18897532.0A priority patent/EP3733119A4/en
Publication of WO2019128652A1 publication Critical patent/WO2019128652A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/012—Multiple filtering units
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/0108—Both ends closed, i.e. legs gathered at both ends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/0103—With centering means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/011—Instruments for their placement or removal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/01—Filters implantable into blood vessels
    • A61F2002/016—Filters implantable into blood vessels made from wire-like elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/006—Y-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0029—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in bending or flexure capacity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0037—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in height or in length

Definitions

  • the present invention relates to an implantable medical device, and more particularly to a filter.
  • Pulmonary embolism is a common disease with high mortality. According to statistics, the untreated pulmonary embolism mortality rate is 20%-30%, and the annual new cases account for about 0.2% of the population. With a population of 1.35 billion, China has about 2.7 million new patients each year.
  • Vena cava filters have been clinically proven to reduce the incidence of pulmonary embolism. If the filter is permanently implanted, it will bring the following risks: the filter will be in contact with blood and vascular endothelium for a long time, protein adsorption, platelet adhesion may occur, and eventually thrombosis may cause venous clogging or recurrence of pulmonary embolism; long-term implantation in the body, There are dangers such as deformation, tilting, displacement, breakage, and even penetration of blood vessels. Therefore, it is recommended to use a temporary filter in the acute phase of the patient's deep venous thrombosis. After the acute phase, the risk of thrombus detachment is reduced and the filter is removed.
  • the filter support rod After the vena cava filter is placed in the inferior vena cava for a certain period of time, the filter support rod will be climbed and wrapped by the endothelial cells to varying degrees, and the endocardium may be damaged when taken out. Therefore, it is convenient to take out without damaging the blood vessel. Membrane filters are necessary.
  • the technical problem to be solved by the present invention is to provide a filter for solving the defect that the filter of the prior art is inconvenient to take out when implanted into a blood vessel.
  • a filter comprising a body portion, the body portion including a proximal end, a plurality of connecting segments, and a first screen connected between the proximal end and the plurality of connecting segments, the connecting segment One end for connecting to the first screen toward one side of the longitudinal center axis of the filter is bent to form a bent portion, and a vertical distance of a proximal end of the bent portion from a longitudinal central axis of the filter is smaller than The vertical distance of the distal end of the bend from the longitudinal central axis of the filter.
  • a filter comprising a main body portion and a plurality of support portions, the support portion including at least one support body, the support body including a guiding portion connected to the main body portion of the connecting body, natural release at the filter
  • the angle between the line between the two ends of the guiding section and the longitudinal central axis of the filter is 20° to 85°
  • the height of the support body in the radial direction of the filter The ratio of the maximum distance from the support to the longitudinal central axis of the filter is 1/8 to 1/3.
  • a filter embodying the present invention has the following advantageous effects: the present invention provides a bent portion bent toward one side of a longitudinal central axis of the filter at one end of the connecting portion for connection with the first screen. Not only can the surface of the first filter screen be away from the surface of the blood vessel, but also avoid the top wall of the blood vessel when the first filter mesh is bulged, and the bending portion can share a part of the stress, thereby avoiding the stress concentration on the connection between the first filter mesh and the connecting segment. At the office.
  • the provision of the bent portion on the connecting section can increase the length of the connecting section, delay the time when the endothelial tissue clings to the first filter mesh, and increase the difficulty of adhering the endothelial cells.
  • FIG. 1 is a schematic structural view of a filter provided by one of the preferred embodiments of the present invention.
  • Figure 2 is a perspective view of the main body of the filter of Figure 1;
  • Figure 3 is a front elevational view of the main body of the filter of Figure 1;
  • Figure 4 is a schematic view showing the distance between the proximal end of the bent portion of the filter of Figure 1 and the distance from the distal end to the longitudinal central axis;
  • Figure 5 is an enlarged view of a portion A of the filter shown in Figure 1;
  • Figure 6 is a schematic view showing the structure of the connecting portion of the filter shown in Figure 1 provided with a concave structure
  • Figure 7 is a schematic view showing the structure of the filter shown in Figure 1 placed inside a blood vessel;
  • Figure 8 is a schematic view showing the structure of a filter placed in a blood vessel in the prior art
  • Figure 9 is a schematic view showing the structure of the support portion of the filter shown in Figure 1 disposed on the connecting portion;
  • Figure 10 is a schematic view showing the structure of the support portion of the filter shown in Figure 1 disposed on the bent portion;
  • Figure 11 is a schematic view showing the structure of a connecting portion of the filter of Figure 1 provided with a support portion;
  • Figure 12 is a schematic view showing the structure of the support portion of the filter shown in Figure 1 having two support bodies;
  • Figure 13 is a schematic view showing the support section of the support portion of the filter shown in Figure 1 in a circular arc structure
  • Figure 14 is a schematic view showing the structure of the support portion of the filter shown in Figure 1 without a fixed anchor;
  • Figure 15 is a schematic view showing the structure of a filter provided in the second preferred embodiment of the present invention.
  • the section closer to the heart after the filter is implanted into the human body is called the proximal end, and the end farther from the heart is called the telecentric end.
  • one of the preferred embodiments of the present invention provides a filter 100 for implantation into a body lumen to capture a thrombus in a lumen, which includes a body portion 1 and a plurality of connections to the body portion.
  • the support portion 2 on the upper side, at least one fixed anchor 3 connected to the support portion 2, and a recovery hook 4 provided at one end of the main body portion 1.
  • the main body portion 1 includes a proximal end 11 , a telecentric end 12 , and a connecting body 13 disposed between the proximal end 11 and the telecentric end 12 .
  • the connecting body 13 includes a first screen 131, a second screen 133, and a plurality of connecting sections 132 between the first screen 131 and the second screen 133.
  • the plurality of connecting sections 132 are along the connecting body 13. The circumferential direction is equally divided.
  • the first screen 131 is a mesh structure extending from one end of the plurality of connecting sections 132 toward the direction away from the connecting section 132 and condensing to the proximal end 11
  • the second screen 133 is the other end from the plurality of connecting sections 132 .
  • a mesh structure that extends away from the connecting section 132 and converges to the telecentric end 12.
  • the first filter screen 131 is composed of a plurality of first Y-shaped bars 1311 which are equally divided along the circumferential direction of the connecting body 13.
  • the number of the first Y-shaped bars 1311 is the same as the number of the connecting segments 132.
  • Each of the first Y-shaped bars 1311 includes a first main branch 1312 and two first branch segments 1313 separated by one end of the first main leg 1312.
  • the first main branch 1313 is connected between the proximal end 11 and the two first branch segments 1313, and the two adjacent first branch segments 1313 of the two adjacent first Y-shaped bars 1311 are away from the proximal end.
  • the ends of 11 converge on a connecting section 132.
  • first main branch 1312 near the proximal end 11 is the proximal end of the first screen 131, and the first branch section 1313 of the first Y-shaped rod 1311 is away from the proximal end 11 The end is the distal end of the first screen 131.
  • the second screen 133 is constituted by a set of second Y-shaped bars 1331 which are equally divided in the circumferential direction of the connecting body 13, and the number of the second Y-shaped bars 1331 is half the number of the connecting sections 132.
  • Each of the second Y-shaped bars 1331 includes a second main branch 1332 and two second branch segments 1333 separated by one end of the second main branch 1332.
  • the second main branch 1333 is connected between the telecentric end 12 and the two second branch segments 133, and each second branch segment 1333 of the second Y-shaped rod 1331 is coupled to a connecting segment 132.
  • each of the second branch segments 1333 of the second Y-shaped rod 1331 is away from the end of the telecentric end 12. It is the proximal end of the second filter 133.
  • the main body portion 1 of the filter 100 has an asymmetrical structure as a whole, and the number of the first Y-shaped bars 1311 is twice the number of the second Y-shaped bars 1331, that is, the density of the first filter mesh 131 is greater than that of the second filter 131.
  • the density of the rod of the screen 133 is the density of the rod of the screen 133.
  • the connecting body 13 is made of a material having a shape memory function, such as a nickel-titanium alloy, and can be restored to the unfolded after the filter 100 is delivered to the inner lumen of the human body and released from the delivery sheath of the conveyor. status.
  • a shape memory function such as a nickel-titanium alloy
  • the thrombus first passes through the void formed by the second Y-shaped rod 1331 having a smaller density of the rod, enters the inside of the filter 100, and then passes through The first Y-shaped rod 1311 having a larger rod body is blocked to be retained inside the filter 100, thereby effecting filtration of the thrombus.
  • the recovery hook 4 can be selectively disposed at the proximal end 11 or the telecentric end 12.
  • the recovery hook 4 can be a hook or a threaded structure for removing the thrombus-filtered filter 100.
  • one end of the connecting section 132 connected to the first screen 131 is bent toward one side of the longitudinal central axis of the filter 100 to form a bent portion 1321.
  • the vertical distance h1 between the proximal end of the bent portion 1321 and the longitudinal central axis of the filter 100 is smaller than the vertical distance h2 between the distal end of the bent portion 1321 and the longitudinal central axis of the filter 100.
  • the proximal end of the bent portion 1321 refers to one end of the bent portion 1321 that is connected to the first filter mesh 131
  • the distal end of the bent portion 1321 refers to one end of the bent portion 1321 away from the first filter screen 131.
  • the lumen wall When the filter 100 is implanted into the lumen, the lumen wall has a radially inward pressure on the filter 100, causing the connecting section 132 to move toward one side of the longitudinal central axis of the filter 100, while the first screen 131 is in close proximity to the connection.
  • the position of the segment 132 is bulged upward by the reaction force to contact the inner wall of the blood vessel, causing the blood vessel endothelium to climb to the bulge, which is disadvantageous for the filter 100 to be recovered.
  • the first filter screen 131 when the first filter screen 131 is bulged upward, the angle between the two first branch segments 1313 concentrated on one connecting portion 132 becomes large, resulting in stress concentration on the two first branch segments 1313 and the connection.
  • the junction of segment 132 When the filter 100 is implanted into the lumen, the lumen wall has a radially inward pressure on the filter 100, causing the connecting section 132 to move toward one side of the longitudinal central axis of the filter 100, while the first
  • the pressure exerted on the support portion 2 by the lumen wall is an alternating stress.
  • the first filter mesh 131 is concentrated in a connecting segment.
  • the two first branch segments 1313 on 132 are susceptible to fatigue fracture.
  • the surface of the first filter mesh 131 can be prevented from moving away from the surface of the blood vessel, and the inner wall of the blood vessel can be prevented from being touched when the first filter mesh 131 is bulged.
  • the lowest point of the bent portion 1321 will pull the distal end of the first screen 131 toward the side of the longitudinal central axis of the filter 100, so that the bulging position on the first screen 131 is from the distal end of the first screen 131.
  • the position is transferred to the middle or proximal position of the first screen 131 to avoid stress concentration at the junction of the two first branch segments 1313 and the connecting portion 132.
  • the lowest point of the bent portion 1321 referred to herein refers to a point at which the vertical distance from the longitudinal center axis of the filter 100 on the bent portion 1321 is the shortest.
  • the bent portion 1321 can share a part of the stress and reduce the concentration at the junction of the two first branch segments 1313 and the connecting portion 132. stress.
  • the provision of the bent portion 1321 on the connecting portion 132 can also increase the length of the connecting portion 132, delay the time when the endothelial tissue clings to the first filter screen 131, and increase the adhesion of the endothelial cells. The difficulty to the first filter screen 131.
  • the first screen 131 is projected on a plane perpendicular to the longitudinal central axis of the filter 100.
  • the smaller area results in a reduced ability of the filter 100 to catch a thrombus.
  • the vertical distance h1 between the proximal end of the bent portion 1321 and the longitudinal central axis of the filter 100 is 1 mm to 5 mm, preferably 2 mm to 3 mm.
  • the ratio of the distance L2 between the proximal end of the bent portion 1321 and the distal end of the bent portion 1321 in the longitudinal central axis direction of the filter 100 to the distance L1 of the both ends of the connecting portion 132 along the longitudinal central axis direction of the filter 100 is 1/ 20 to 3/5, preferably 1/10 to 1/3.
  • the connecting section 132 includes an associated bent portion 1321 and a connecting portion 1322.
  • the connecting portion 1322 is substantially distributed in a direction parallel to the longitudinal central axis of the filter 100.
  • the bent portion 1321 includes a first bent portion 1341 and a second bent portion 1342 that are connected, the first bent portion 1341 is connected to the distal end of the first screen 131, and the second bent portion 1342 is connected to the connecting portion 1322. Near end.
  • the first bending section 1341 and the first filter screen 131, the first bending section 1341 and the second bending section 1342, and the second bending section 1342 and the connecting portion 1322 are smooth. connection.
  • the ratio of the distance L3 between the both ends of the first bent section 1341 along the longitudinal central axis direction of the filter 100 to the distance L2 between the both ends of the bent portion 1321 along the longitudinal central axis direction of the filter 100 is 1/5. ⁇ 3/5, preferably 1/4 to 1/3.
  • the present invention does not limit the specific structure of the bent portion 1321.
  • the first bent portion 1341 and the second bent portion 1342 may be straight segments, curved segments or straight segments and curved segments. Connected blend segments.
  • the lowest point of the bent portion 1321 may be at the proximal end of the bent portion 1321 or at the intermediate portion of the bent portion 1321.
  • the bend 1321 includes three or more bend segments with a smooth connection between the three or more bend segments.
  • the first bent section 1341 is a straight line segment parallel to the direction of the longitudinal central axis of the filter 100 to facilitate processing.
  • the connecting portion 1322 may also be a straight line segment, a curved line segment or a straight line segment which is inclined with respect to the longitudinal central axis direction of the filter 100.
  • the combined line segment of the curved line segment For example, referring to Fig. 6, the connecting portion 1322 is provided with a concave structure 1323 which is designed such that most of the surface of the connecting portion 132 is away from the surface of the blood vessel, further increasing the difficulty of adherence of the endothelial cells.
  • the vertical distance h3 between the distal end of the connecting portion 1322 and the longitudinal central axis of the filter 100 is not less than a vertical distance h1 between the proximal end of the bent portion 1321 and the longitudinal central axis of the filter 100, and is not greater than The vertical distance h2 between the distal end of the curved portion 1321 and the longitudinal central axis of the filter 100.
  • the distal end of the connecting portion 1322 refers to one end of the connecting portion 1322 that is connected to the second filter 133.
  • the filter 100 is stabilized. Bad sex, easy to tilt.
  • the vertical distance h3 between the distal end of the connecting portion 1322 and the longitudinal central axis of the filter 100 is equal to the vertical distance h2 between the distal end of the bent portion 1321 and the longitudinal central axis of the filter 100.
  • the second branch section 1333 of the second screen 133 is provided with a flexible portion 1334 bent toward one side of the longitudinal central axis of the filter 100, and the second screen 133 is at the flexible portion 1334.
  • the bending strength is lower than the bending strength of the remaining portion of the second screen 133 except the flexible portion 1334.
  • each support portion 2 is connected to the main body portion 1, and the other end extends toward one side of the proximal end 11.
  • the support portion 2 directly contacts the inner wall of the lumen, and the main body portion 1 is separated from the inner wall of the lumen, so that only the support portion is required when the filter 100 is taken out. 2 It can be separated from the lumen wall. Since the contact surface of the support portion 2 and the lumen wall is small, the stimulation of the lumen wall can be reduced, and the filter 100 can be conveniently taken out. Further, by providing the support portion 2, the time during which the endothelial tissue clumps to the first filter mesh 131 and the connecting portion 132 can be further delayed, and the filter recovery time is extended.
  • the lumen wall When the filter 100 is implanted into the lumen, the lumen wall has a radially inward pressure on the filter 100, by providing a bend 1321 on the connecting section 132 and a flexible portion 1334 on the second screen 133, When the support portion 2 is subjected to pressure from the radial direction of the filter 100, the bent portion 1321 and the flexible portion 1334 can be bent and deformed toward one side of the longitudinal central axis of the filter 100, so that the support portion 2 is always kept straight and deformed.
  • 7 is a schematic view showing the deformation of the filter 100 of the present embodiment after being implanted into a blood vessel, and FIG.
  • FIG. 8 is a schematic view showing the deformation of the filter 100 without the bent portion 1321 and the flexible portion 1334 after implantation into a blood vessel. Compared with FIG. 7 and FIG. It is apparent that after the filter 100 in FIG. 7 is implanted into the blood vessel, the bent portion 1321 and the flexible portion 1334 are deformed, so that the support portion 2 can be kept straight and deformed, and the joint between the support portion 2 and the connecting portion 132 is prevented from being raised. Touching the blood vessel wall makes the filter more stable in the blood vessel, and in the joint of the support portion 2 and the connecting portion 132 in Fig. 8, it is easy to bump and touch the blood vessel wall.
  • the present invention does not limit the specific position of the support portion 2 on the connecting portion 132. As shown in FIG. 9, the intersection 20 of the support portion 2 and the connecting portion 132 is located on the connecting portion 1322; or, as shown in FIG. As shown, the junction 20 of the support portion 2 and the connecting portion 132 is located within the bent portion 1321. It will also be appreciated that the present invention does not limit the specific number of supports 2 on each connecting section 132 to which one or more supports 2 may be attached. As shown in FIG. 11, only one support portion 2 is connected to each of the connecting segments 132, and the support portions 2 on the adjacent two connecting segments 132 are staggered.
  • each support portion 2 includes at least one support body 21, see Fig. 5, each support body 21 includes a guide section 211, and a support section 212 connected to the guide section 211, the guide section 211 and The support section 212 is smoothly connected.
  • the guiding section 211 has one end connected to the connecting section 132 and the other end radiating outwardly away from the recovery hook 4.
  • the connection between the two ends of the guiding section 211 is The angle a between the longitudinal central axes of the filter 100 is 20° to 85°.
  • the ratio of the height m1 of the support body 21 in the radial direction of the filter to the maximum distance m2 of the support body 21 to the longitudinal central axis of the filter 100 is 1/8 to 1/3.
  • the height m1 of the support body 21 in the radial direction of the filter refers to the distance between the highest point of the support body 21 and the junction point 20 of the support body 21 and the connection section 132 in the radial direction of the filter.
  • the outer diameter of the filter body 100 is specific, if the height m1 of the support body 21 in the radial direction of the filter 100 is too large, not only the support body 21 is easily bent, but also the support effect is poor, and the main body portion 1 is also caused.
  • the corresponding outer diameter is small, which affects the effect of filtering the thrombus of the filter 100; if the height m1 of the support body 21 in the radial direction of the filter 100 is too small, the endothelial tissue easily climbs onto the main body portion 1, which is disadvantageous for the filter 100 to be recovered.
  • the present application adjusts the ratio between the height m1 of the support body 21 in the radial direction of the filter 100 and the maximum distance m2 of the support body 21 to the longitudinal central axis of the filter 100 while adjusting the connection between the two ends of the guiding section 211.
  • the angle a between the wire and the longitudinal central axis of the filter 100 can provide the support body 21 with a better supporting force and delay the time of endothelial adhesion without affecting the effect of the filter 100 filtering the thrombus.
  • the angle a between the connecting line between the two ends of the guiding section 211 and the longitudinal central axis of the filter 100 is 30° to 60°, and the height m1 of the supporting body 21 along the radial direction of the filter and the supporting body
  • the ratio between the maximum distance m2 of 21 to the longitudinal central axis of the filter 100 is 1/6 to 5/18.
  • one end of the support section 212 is connected to the guiding section 211, and the other end radiates outwardly in a direction away from the recovery hook 4.
  • the angle b between the guide segments 211 is 1/2 of the height m3 of the support member 211 in the radial direction of the filter and the height m1 of the support body 21 in the radial direction of the filter 100. 5/6.
  • the height b3 is constant, if the angle b is too large, the distance between the two ends of the support section 212 along the longitudinal central axis of the filter 100 is too short, and the contact area between the support section 212 and the lumen wall is small, The stimulation of the lumen wall is large. If the angle b is too small, the support section 212 moves toward the side of the longitudinal central axis of the filter 100 under the pressure of the lumen wall, which will connect the guiding section 211 with the supporting section 212. The convex touches the wall of the lumen, which easily pierces the vessel wall.
  • the present invention does not limit the specific structure of the support section 212.
  • the support section 212 can also be other structures. As shown in FIG. 13, the support section 212 has a circular arc structure.
  • the support body 21 may also include a lower fold section 213 that is smoothly joined to the support section 212, the lower fold section 213 being bent toward one side of the longitudinal centerline of the filter 100. It can be understood that when the angle between the lower folding section 213 and the longitudinal center line of the filter 100 is larger, the lower folding section 213 is easy to pierce the blood vessel wall, and the angle between the lower folding section 213 and the longitudinal center line of the filter 100 is smaller. The sheathing force is affected, so the angle between the lower folded section 213 and the longitudinal center line of the filter 100 is preferably 20° to 75°. Further, the distal end of the lower folding section 213 is provided with a spherical portion 214 having a smooth outer contour to prevent the supporting portion 212 from piercing the blood vessel wall.
  • each support portion 2 includes a support body 21 on one side of the connecting portion 132. It can be understood that, in other embodiments, as shown in FIG. 12, each support portion 2 may further include two or more support bodies 21, and two or more support bodies 21 are respectively connected to the two of the connection segments 132. side. It can be understood that when two or more supporting bodies 21 are disposed on each connecting section 132, the structures of the two or more supporting bodies 21 may be the same or different.
  • the anchor 3 is disposed on the support portion 2.
  • the anchor 3 is inserted into the inner wall of the lumen to function as the filter 100.
  • the anchor anchor 3 can be selectively disposed on the guiding section 211 or the supporting section 212 as long as the filter 100 is implanted into the lumen.
  • the anchor anchor 3 can be inserted into the lumen wall tissue.
  • the anchor anchor 3 can be selectively disposed on one or more of the plurality of support bodies 21, or the fixed anchor 3 is not disposed on the support body 21, but the lumen wall is supported by the support body 21.
  • the support force realizes the fixing of the filter 100 to the lumen wall
  • FIG. 14 shows a schematic view of the structure in which no fixed anchor is provided on the support body of the filter.
  • each connecting section 132 is provided with two supporting portions, and the two supporting portions include a first supporting portion connected to the proximal end region of the connecting portion 132, and a connecting portion connected to the distal end region of the connecting portion 132.
  • Two support portions, the fixed anchor 3 is disposed on the second support portion.
  • the distance between the intersection of the first support portion and the connecting portion 132 and the distal end of the bent portion 1321 in the longitudinal central axis direction of the filter is 0.3 mm to 3 mm, and the intersection of the second supporting portion and the connecting portion 132 is located at the connecting portion 132.
  • the connecting portion 1322 is provided with a concave structure
  • the intersection 20 of the first supporting portion and the connecting portion 132 may also be located between the bent portion 1321 and the concave structure 1323.
  • a filter according to a second preferred embodiment of the present invention is different from one of the embodiments in that the filter 1 is not provided with a support portion 2, and the fixed anchor 3 is directly disposed on the connecting body 13. on.

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Abstract

一种滤器(100)，包括主体部(1)，该主体部(1)包括近心端(11)、多个连接段(132)，以及连接在该近心端(11)与多个该连接段(132)之间的第一滤网(131)，该连接段(132)用于与该第一滤网(131)连接的一端朝向该滤器(100)的纵向中心轴的一侧折弯形成折弯部(1321)，该折弯部(1321)的近端与该滤器(100)的纵向中心轴的垂直距离(h1)小于该折弯部(1321)的远端与该滤器(100)的纵向中心轴的垂直距离(h2)。该滤器(100)通过在连接段(132)用于与第一滤网(131)连接的一端设置朝向滤器(100)的纵向中心轴的一侧折弯的折弯部(1321)，不仅可以使第一滤网(131)的表面远离血管表面，避免第一滤网(131)鼓起时顶触血管内壁，而且折弯部(1321)可以分担一部分应力，可以避免应力集中在第一滤网(131)与连接段(132)的连接处。

Description

滤器 技术领域
本发明涉及一种植入医疗器械，尤其涉及一种滤器。
背景技术
肺栓塞(PE)是一种常见疾病，病死率高，有资料统计，不经治疗的肺栓塞死亡率为20％-30％，每年新增病例约占人口的0.2％。我国以13.5亿人口计算，每年约有270万新增患者。
腔静脉滤器(以下简称滤器)在临床上被证实为可降低肺栓塞的发生率。若永久植入滤器，会带来以下风险：滤器长期与血液和血管内皮接触，可能发生蛋白质吸附、血小板粘附，最终形成血栓导致静脉血管堵塞，或导致肺栓塞再发生；长期植入体内，有发生滤器变形、倾斜、移位、断裂，甚至穿透血管的危险等。因此，临床上推荐使用临时性滤器，在病人深静脉血栓发生的急性期置入，急性期过后，血栓脱落的风险减少时再将滤器取出。
腔静脉滤器在置入下腔静脉一定时间后，滤器支撑杆会不同程度地被内皮细胞爬覆、包裹，取出时可能会损伤血管内膜,因此，提供一种可方便取出且不损伤血管内膜的滤器实为必要。
发明内容
本发明要解决的技术问题在于提供一种滤器，以解决现有技术中滤器在植入到血管之中时，不方便取出的缺陷。
本发明解决其技术问题所采用的技术方案是：
提供一种滤器，包括主体部，所述主体部包括近心端、多个连接段，以及连接在所述近心端与多个所述连接段之间的第一滤网，所述连接段用于与所述第一滤网连接的一端朝向所述滤器的纵向中心轴的一侧折弯形成折弯部，所述折弯部的近端与所述滤器的纵向中心轴的垂直距离小于所述折弯部的远端与 所述滤器的纵向中心轴的垂直距离。
提供一种滤器，包括主体部及多个支撑部，所述支撑部包括至少一个支撑体，所述支撑体包括连接在所述连接体主体部上的导引段，在所述滤器的自然释放状态下，所述导引段的两端之间的连线与所述滤器的纵向中心轴之间的夹角为20°～85°，所述支撑体沿所述滤器的径向方向的高度与所述支撑体到所述滤器的纵向中心轴的最大距离的比值为1/8～1/3。
综上所述，实施本发明的一种滤器，具有以下有益效果：本发明通过在连接段用于与第一滤网连接的一端设置朝向滤器的纵向中心轴的一侧折弯的折弯部，不仅可以使第一滤网的表面远离血管表面，避免第一滤网鼓起时顶触血管内壁，而且折弯部可以分担一部分应力，可以避免应力集中在第一滤网与连接段的连接处。并且，相较于平直的连接段，在连接段上设置折弯部还可以增加连接段的长度，延缓内皮组织爬附至第一滤网的时间，加大内皮细胞的爬附难度。
附图说明
下面将结合附图及实施例对本发明作进一步说明，附图中：
图1是本发明较佳实施例之一提供的一种滤器的结构示意图；
图2是图1所示滤器的主体部的立体图；
图3是图1所示滤器的主体部的主视图；
图4是图1所示滤器的折弯部的近端与远端至纵向中心轴线的距离的结构示意图；
图5是图1所示滤器的A部放大图；
图6是图1所示滤器的连接部上设有内凹结构的结构示意图；
图7是图1所示滤器放置在血管内的结构示意图；
图8是现有技术中的滤器放置在血管内的结构示意图；
图9是图1所示滤器的支撑部设置在连接部上的结构示意图；
图10是图1所示滤器的支撑部设置在折弯部上的结构示意图；
图11是图1所示滤器的一个连接段上设置有一个支撑部的结构示意图；
图12是图1所示滤器的支撑部具有两个支撑体的结构示意图；
图13是图1所示滤器的支撑部的支撑段为圆弧结构的示意图；
图14是图1所示滤器的支撑部上未设置固定锚的结构示意图；
图15是本发明较佳实施例之二提供的一种滤器的结构示意图。
具体实施方式
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。
需要说明的是，当元件被称为“固定于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“垂直的”、“水平的”、“左”、“右”、“上”、“下”、“远”、“近”以及类似的表述只是为了说明的目的。
在滤器领域，将滤器植入人体后相对心脏较近的一段称为近心端，相对心脏较远的一端称为远心端。
如图1所示，本发明较佳实施例之一提供了一种滤器100，用于植入至人体管腔中以捕获管腔中的血栓，其包括主体部1、多个连接在主体部1上的支撑部2、至少一个连接在支撑部2上的固定锚3，以及设置在主体部1一端的回收钩4。
请一并参阅图2，主体部1包括近心端11、远心端12，以及设置于近心端11以及远心端12之间的连接体13。连接体13包括一个第一滤网131、一个第二滤网133，以及多个位于第一滤网131与第二滤网133之间的连接段132，多个连接段132沿连接体13的圆周方向等分设置。第一滤网131为从多个连接段132的一端朝向远离所述连接段132的方向延伸并汇聚至近心端11的网状结构，第二滤网133为从多个连接段132的另一端朝向远离所述连接段132的方向延伸并汇聚至远心端12的网状结构。
请一并参阅图3，第一滤网131由一组沿连接体13的圆周方向等分设置的第一Y形杆1311构成，第一Y形杆1311的数量与连接段132的数量一致， 每根第一Y形杆1311均包括一根第一主支段1312及由所述第一主支段1312的一端分出的两根第一分支段1313。第一主支段1313连接于近心端11与两个第一分支段1313之间，且相邻的两根第一Y形杆1311的两根相邻的第一分支段1313远离近心端11的端部汇聚于一根连接段132上。需要说明的是，第一主支段1312的靠近近心端11的端部为第一滤网131的近端，第一Y形杆1311的每根第一分支段1313的远离近心端11的端部为第一滤网131的远端。
第二滤网133由一组沿连接体13的圆周方向等分设置的第二Y形杆1331构成，第二Y形杆1331的数量为连接段132数量的一半。每根第二Y形杆1331均包括一根第二主支段1332及由第二主支段1332的一端分出的两根第二分支段1333。第二主支段1333连接于远心端12与两根第二分支段133之间，且第二Y形杆1331的每根第二分支段1333连接于一根连接段132上。需要说明的是，第二主支段1332靠近远心端12的部分为第二滤网133的远端，第二Y形杆1331的每根第二分支段1333远离远心端12的端部为第二滤网133的近端。
如上述可知，滤器100的主体部1在整体上呈非对称结构，第一Y形杆1311的数量是第二Y形杆1331数量的两倍，即第一滤网131的杆体密度大于第二滤网133的杆体密度。
需要说明的是，连接体13是由具有形状记忆功能的材料如镍钛合金制成，在将滤器100输送至人体内部管腔并从输送器的输送管鞘中释放后，可恢复形变至展开状态。在进行血栓过滤的过程中，血流从远心端12向近心端11流动，血栓首先从杆体密度较小的第二Y形杆1331形成的空隙中通过，进入到滤器100内部，之后经由杆体密度较大的第一Y形杆1311阻挡以留置在滤器100内部，从而实现对血栓的过滤。回收钩4可选择性的设置在近心端11或远心端12，回收钩4可以为勾体或者是螺纹结构等，用于将进行血栓过滤后的滤器100取出。
如图3和图4所示，连接段132与第一滤网131连接的一端朝向滤器100的纵向中心轴的一侧折弯，形成折弯部1321。其中，折弯部1321的近端与滤 器100的纵向中心轴之间的垂直距离h1小于折弯部1321的远端与滤器100的纵向中心轴之间的垂直距离h2。此处折弯部1321的近端指的是折弯部1321与第一滤网131连接的一端，折弯部1321的远端指的是折弯部1321远离第一滤网131的一端。
在滤器100植入到管腔内时，管腔壁对滤器100具有一个径向向内的压力，使连接段132朝滤器100的纵向中心轴的一侧移动，而第一滤网131靠近连接段132的位置处在反作用力的作用下会向上鼓起而顶触血管内壁，造成血管内皮爬附到该鼓起处，不利于滤器100回收。并且，第一滤网131在向上鼓起时，汇聚于一根连接段132上的两根第一分支段1313间的夹角会变大，导致应力集中在两根第一分支段1313与连接段132的连接处。由于血管的舒张功能，管腔壁作用在支撑部2上的压力为交变应力，在交变应力的作用下，经过较长时间的工作后，第一滤网131的汇聚于一根连接段132上的两根第一分支段1313容易发生疲劳断裂。
本发明通过在连接段132与第一滤网131连接的一端设置折弯部1321，不仅可以使第一滤网131的表面远离血管表面，避免第一滤网131鼓起时顶触血管内壁，而且折弯部1321的最低点会牵引第一滤网131的远端朝向滤器100的纵向中心轴的一侧移动，使第一滤网131上的鼓起位置由第一滤网131的远端位置处转移至第一滤网131的中部或近端位置处，避免应力集中在两根第一分支段1313与连接段132的连接处。此处所说的折弯部1321的最低点指的是折弯部1321上与滤器100的纵向中心轴的垂直距离最短的点。并且，通过在连接段132与第一滤网131连接的一端设置折弯部1321，可以使折弯部1321分担一部分应力，减少集中在两根第一分支段1313与连接段132的连接处的应力。相较于平直的连接段132，在连接段132上设置折弯部1321还可以增加连接段132的长度，延缓内皮组织爬附至第一滤网131的时间，加大内皮细胞的爬附至第一滤网131的难度。
可以理解的是，当折弯部1321的近端与滤器100的纵向中心轴之间的垂直距离h1太小时，会使第一滤网131投影在垂直于滤器100的纵向中心轴的平面上的面积较小，导致滤器100抓捕血栓的能力降低。但是，若折弯部1321 的近端下折的距离太小，则设置折弯部1321的意义不大，故折弯部1321的近端与滤器100的纵向中心轴之间的垂直距离h1与折弯部1321的远端与滤器100的纵向中心轴之间的垂直距离h2的高度差为1mm～5mm，优选为2mm～3mm。
结合图5所示，在折弯部1321的近端与折弯部1321的远端沿滤器100的径向方向的高度差一定的情况下，若折弯部1321的近端与折弯部1321的远端沿滤器100的纵向中心轴方向的距离L2越短，则折弯部1321的近端与折弯部1321的远端的连线与滤器100的纵向中心轴之间的夹角越大，会影响滤器100进出鞘管的顺应性，但是当L2太长时，会导致滤器100的稳定性不好，容易倾斜。故折弯部1321的近端与折弯部1321的远端沿滤器100的纵向中心轴方向的距离L2与连接段132的两端沿滤器100的纵向中心轴方向的距离L1的比值为1/20～3/5，优选为1/10～1/3。
连接段132包括相连的折弯部1321和连接部1322，本实施例中，连接部1322基本沿平行于滤器100的纵向中心轴方向分布。折弯部1321包括相连的第一折弯段1341和第二折弯段1342，第一折弯段1341连接至第一滤网131的远端，第二折弯段1342连接至连接部1322的近端。为了避免应力集中，第一折弯段1341与第一滤网131、第一折弯段1341与第二折弯段1342之间、及第二折弯段1342与连接部1322之间均为光滑连接。可以理解的是，当第一折弯段1341的两端之间沿滤器100的纵向中心轴方向的距离L3太短时，容易导致应力集中在第一滤网131的远端，但是若L3太长，会影响滤器100进出鞘管的顺应性。故第一折弯段1341的两端之间沿滤器100的纵向中心轴方向的距离L3与折弯部1321的两端之间沿滤器100的纵向中心轴方向的距离L2的比值为1/5～3/5，优选为1/4～1/3。
可以理解的是，本发明并不限定折弯部1321的具体结构，在其它实施例中，第一折弯段1341与第二折弯段1342可以为直线段、曲线段或直线段与曲线段连接的混合线段。折弯部1321的最低点可以在折弯部1321的近端，也可以在折弯部1321的中间部位。或者，在其它实施例中，折弯部1321包括三个或更多折弯段，三个或更多折弯段之间光滑连接。优选的，第一折弯段1341 为平行于滤器100的纵向中心轴的方向的直线段，以方便加工。
还可以理解的是，本发明并不限定连接部1322的具体结构，在其它实施例中，连接部1322还可以为相对滤器100的纵向中心轴方向倾斜设置的直线段、弯曲线段或直线段与弯曲线段的组合线段。例如，参见图6，连接部1322上设置有内凹结构1323，该内凹设计使得连接段132的大部分表面远离血管表面，进一步的加大内皮细胞的爬附难度。
参见图4，连接部1322的远端与滤器100的纵向中心轴之间的垂直距离h3不小于折弯部1321的近端与滤器100的纵向中心轴之间的垂直距离h1，且不大于折弯部1321的远端与滤器100的纵向中心轴之间的垂直距离h2。此处连接部1322的远端指的是连接部1322与第二滤网133连接的一端。若h3小于h1，会使第二滤网133投影在垂直于滤器100的纵向中心轴的平面上的面积较小，导致滤器100抓捕血栓的能力降低；若h3大于h2会使滤器100的稳定性不好，容易倾斜。优选的，连接部1322的远端与滤器100的纵向中心轴之间的垂直距离h3与折弯部1321的远端与滤器100的纵向中心轴之间的垂直距离h2相等。
进一步的，如图3所示，第二滤网133的第二分支段1333上设置有朝向滤器100的纵向中心轴的一侧弯折的柔性部1334，第二滤网133在柔性部1334处的弯曲强度低于第二滤网133除柔性部1334外的其余区域的弯曲强度。当滤器100受径向挤压时，柔性部1334朝滤器100的纵向中心轴的一侧弯折变形，不仅可以使第二滤网133的表面远离血管表面，避免第二滤网133鼓起时顶触血管内壁，而且还可以延缓内皮组织爬附至第二滤网133的时间，加大内皮细胞爬附至第二滤网133的爬附难度。
如图1所示，每一支撑部2的一端连接在主体部1上，另一端朝向近心端11的一侧延伸。在将具有支撑部2的滤器100植入到人体管腔中后，支撑部2直接与管腔内壁接触，而主体部1与管腔内壁分离，使得在取出滤器100时，仅需要将支撑部2与管腔壁分离即可，由于支撑部2与管腔壁接触面较小，可以减少对管腔壁的刺激，方便将滤器100取出。并且，通过设置支撑部2可以进一步延缓内皮组织爬附至第一滤网131及连接段132的时间，延长滤器的回 收时间。
在滤器100植入到管腔内时，管腔壁对滤器100具有一个径向向内的压力，通过在连接段132上设置折弯部1321以及在第二滤网133上设置柔性部1334，当支撑部2受到来自沿滤器100径向方向的压力时，折弯部1321与柔性部1334能够朝向滤器100的纵向中心轴的一侧弯折变形，使支撑部2始终保持平直变形。图7是本实施例的滤器100植入血管后的形变示意图，图8是未设置折弯部1321和柔性部1334的滤器100植入血管后的形变示意图，对比图7和图8，可以很明显的看出，图7中的滤器100植入血管后，折弯部1321与柔性部1334发生形变，可以使支撑部2保持平直变形，避免支撑部2与连接段132的连接处凸起触碰血管壁，使滤器在血管内更加稳定，而图8中支撑部2与连接段132连接处容易凸起触碰血管壁。
可以理解的是，本发明并不限定支撑部2在连接段132上的具体位置，如图9所示，支撑部2与连接段132的交汇点20位于连接部1322上；或者，如图10所示，支撑部2与连接段132的交汇点20位于折弯部1321内。还可以理解的是，本发明不限定每一连接段132上支撑部2的具体数量，连接段132上可以连接一个或多个支撑部2。如图11所示，每一连接段132上仅连接一个支撑部2，相邻两个连接段132上的支撑部2交错设置。
参见图12，每一支撑部2包括至少一个支撑体21，参见图5，每一支撑体21包括一个导引段211，以及一个与导引段211相连的支撑段212，导引段211与支撑段212光滑连接。
其中，导引段211的一端连接在连接段132上，另一端朝向远离回收钩4的方向向外辐射延伸，在滤器的自然释放状态下，导引段211的两端之间的连线与滤器100的纵向中心轴之间的夹角a为20°～85°。结合图4所示，支撑体21沿滤器的径向方向的高度m1与支撑体21到滤器100的纵向中心轴的最大距离m2之间的比值为1/8～1/3。此处支撑体21沿滤器的径向方向的高度m1指的是支撑体21的最高点与支撑体21与连接段132的交汇点20之间沿滤器的径向方向的距离。
可以理解的是，当滤器100的外径特定时，若支撑体21沿滤器100的径 向方向的高度m1太大，则不仅支撑体21容易弯曲，支撑效果不佳，还会导致主体部1对应的外径尺寸较小，影响滤器100过滤血栓的效果；若支撑体21沿滤器100的径向方向的高度m1太小时，内皮组织容易爬附到主体部1上，不利于滤器100回收。在支撑体21沿滤器100的径向方向的高度m1一定的情况下，若导引段211的两端之间的连线与滤器100的纵向中心轴之间的夹角a太大，会影响滤器100进出鞘管的顺应性，若夹角a太小，会影响支撑体21的支撑效果。本申请通过调整支撑体21沿滤器100的径向方向的高度m1与支撑体21到滤器100的纵向中心轴的最大距离m2之间的比值，同时调整导引段211的两端之间的连线与滤器100的纵向中心轴之间的夹角a，可以在不影响滤器100过滤血栓的效果的情况下，使支撑体21具有较好的支撑力，延缓内皮爬附的时间。优选的，导引段211的两端之间的连线与滤器100的纵向中心轴之间的夹角a为30°～60°，支撑体21沿滤器的径向方向的高度m1与支撑体21到滤器100的纵向中心轴的最大距离m2之间的比值为1/6～5/18。
本实施例中，支撑段212的一端连接在导引段211上，另一端朝向远离回收钩4的方向向外辐射延伸，支撑段212两端之间的连线与滤器100的纵向中心轴之间的夹角b为10°～20°，且导引段211的两端沿滤器的径向方向的高度m3与支撑体21沿滤器100的径向方向的高度m1的比值为1/2～5/6。在高度m3一定的情况下，若夹角b太大，会导致支撑段212的两端沿滤器100的纵向中心轴方向的距离太短，支撑段212与管腔壁的接触面积较小，对管腔壁的刺激较大，若夹角b太小，支撑段212在管腔壁的压力作用下朝滤器100的纵向中心轴线的一侧移动，会使导引段211与支撑段212的连接处凸起触碰管腔壁，容易刺破血管壁。
可以理解的是，本发明并不限定支撑段212的具体结构，在其它实施例中，支撑段212还可以为其它结构。如图13所示，支撑段212为圆弧结构。
支撑体21还可以包括与支撑段212光滑连接的下折段213，下折段213朝向滤器100的纵向中心线的一侧折弯延伸。可以理解的是，当下折段213与滤器100的纵向中心线的夹角越大时，下折段213容易刺破血管壁，而当下折段213与滤器100的纵向中心线的夹角越小时，会影响进出鞘力，故下折段 213与滤器100的纵向中心线的夹角优选为20°～75°。进一步的，下折段213的末梢设有外轮廓圆滑的球形部214，以避免支撑段212刺破血管壁。
本实施例中，每一支撑部2包括一个支撑体21，支撑体21位于连接段132的一侧。可以理解的是，在其它实施例中，如图12所示，每一支撑部2还可以包括两个或更多支撑体21，两个或更多支撑体21分别连接在连接段132的两侧。可以理解的是，当每一连接段132上设置有两个或多个支撑体21时，两个或多个支撑体21的结构可以相同，也可以不同。
如图1所示，固定锚3设置在支撑部2上，当滤器100植入至管腔中后，固定锚3刺入管腔内壁组织，起到固定滤器100的作用。可以理解的是，本发明并不限定固定锚3的具体结构及设置位置，固定锚3可选择性的设置于导引段211或支撑段212上，只要滤器100植入至管腔中后，固定锚3能够刺入到管腔壁组织中即可。
还可以理解的是，固定锚3可选择性的设置于多个支撑体21中的一个或多个上，或者并不在支撑体21上设置固定锚3，而是通过支撑体21对管腔壁的支撑力实现滤器100与管腔壁的固定，图14示出了滤器的支撑体上均不设置固定锚的结构示意图。
本实施例中，每一连接段132上设置有两个支撑部，两个支撑部包括连接在连接段132的近端区域的第一支撑部，及连接在连接段132的远端区域的第二支撑部，固定锚3设置在第二支撑部上。第一支撑部与连接段132的交汇点20与折弯部1321的远端沿滤器的纵向中心轴方向的距离为0.3mm～3mm，第二支撑部与连接段132的交汇点位于连接段132的远端。当连接部1322上设置有内凹结构时，第一支撑部与连接段132的交汇点20还可以位于折弯部1321与内凹结构1323之间。
如图15所示，本发明较佳实施例之二提供的一种滤器，其与实施例之一的不同之处在于，滤器1上不设置支撑部2，固定锚3直接设置在连接体13上。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这 些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (28)

  1. 一种滤器，包括主体部，所述主体部包括近心端、多个连接段，以及连接在所述近心端与多个所述连接段之间的第一滤网，其特征在于，所述连接段与所述第一滤网连接的一端朝向所述滤器的纵向中心轴的一侧折弯形成折弯部，所述折弯部的近端与所述滤器的纵向中心轴的垂直距离小于所述折弯部的远端与所述滤器的纵向中心轴的垂直距离。
  2. 根据权利要求1所述的滤器，其特征在于，所述折弯部的两端沿所述滤器的径向方向的高度差为1mm～5mm。
  3. 根据权利要求1所述的滤器，其特征在于，所述折弯部的两端沿所述滤器的纵向中心轴方向的距离与所述连接段的两端沿所述滤器的纵向中心轴方向的距离的比值为1/20～3/5。
  4. 根据权利要求1所述的滤器，其特征在于，所述折弯部包括与所述第一滤网连接的第一折弯段，所述第一折弯段沿所述滤器的纵向中心轴方向的距离与所述折弯部的两端沿所述滤器的纵向中心轴方向的距离的比值为1/5～3/5。
  5. 根据权利要求4所述的滤器，其特征在于，所述第一折弯段沿平行于所述滤器的纵向中心轴设置。
  6. 根据权利要求1～5中任一所述的滤器，其特征在于，所述主体部还包括远心端，以及连接在所述远心端与多个所述连接段之间的第二滤网，所述连接段还包括连接在所述折弯段与所述第二滤网之间的连接部。
  7. 根据权利要求6所述的滤器，其特征在于，所述连接部的远端与所述滤器的纵向中心轴的垂直距离不小于所述折弯部的近端与所述滤器的纵向中心轴的垂直距离，且不大于所述折弯部的远端与所述滤器的纵向中心轴的垂直距离。
  8. 根据权利要求6所述的滤器，其特征在于，所述连接部上设置有内凹结构。
  9. 根据权利要求6所述的滤器，其特征在于，所述第二滤网上设置有朝向所述滤器的纵向中心轴的一侧弯折的柔性部，所述柔性部的弯曲强度低于所 述第二滤网上除柔性部以外的部分的弯曲强度。
  10. 根据权利要求6所述的滤器，其特征在于，所述滤器还包括回收钩，所述回收钩设置在所述近心端或所述远心端上。
  11. 根据权利要求1所述的滤器，其特征在于，所述滤器还包括多个连接在所述主体部上的支撑部，每一所述支撑部包括至少一个支撑体。
  12. 根据权利要求11所述的滤器，其特征在于，所述支撑体包括一个与所述连接段相连的导引段，以及一个与所述导引段相连的支撑段；所述导引段朝向所述近心端的方向向外辐射延伸，所述支撑段朝向所述近心端的方向向外辐射延伸。
  13. 根据权利要求12所述的滤器，其特征在于，所述支撑体还包括连接在所述支撑段上的下折段，所述下折段朝向所述滤器的纵向中心线的一侧折弯延伸，所述下折段与所述滤器的纵向中心线的夹角为20°～75°。
  14. 根据权利要求13所述的滤器，其特征在于，所述下折段的末梢设有球形部。
  15. 根据权利要求11所述的滤器，其特征在于，所述滤器还包括固定锚，所述固定锚连接在所述主体部或所述支撑部上。
  16. 一种滤器，包括主体部及多个支撑部，所述支撑部包括至少一个支撑体，所述支撑体包括连接在所述主体部上的导引段，其特征在于，在所述滤器的自然释放状态下，所述导引段的两端之间的连线与所述滤器的纵向中心轴之间的夹角为20°～85°，所述支撑体沿所述滤器的径向方向的高度与所述支撑体到所述滤器的纵向中心轴的最大距离的比值为1/8～1/3。
  17. 根据权利要求16所述的滤器，其特征在于，在所述滤器的自然释放状态下，所述导引段的两端之间的连线与所述滤器的纵向中心轴之间的夹角为30°～60°，所述支撑体沿所述滤器的径向方向的高度与所述支撑体到所述滤器的纵向中心轴的最大距离的比值为1/6～5/18。
  18. 根据权利要求16或17所述的滤器，其特征在于，所述滤器还包括回收钩，所述导引段朝远离所述回收钩的一侧向外辐射延伸，所述导引段上连接有支撑段。
  19. 根据权利要求18所述的滤器，其特征在于，所述支撑段朝远离所述回收钩的一侧向外辐射延伸，所述支撑段两端之间的连线与所述滤器的纵向中心轴之间的夹角为10°～20°。
  20. 根据权利要求19所述的滤器，其特征在于，所述导引段的两端沿所述滤器的径向方向的高度与所述支撑体沿所述滤器的径向方向的高度的比值为1/2～5/6。
  21. 根据权利要求18所述的滤器，其特征在于，所述支撑段为圆弧结构，所述支撑段连接在所述导引段远离所述回收钩的一端。
  22. 根据权利要求18所述的滤器，其特征在于，所述支撑体还包括连接在所述支撑段上的下折段，所述下折段朝向所述滤器的纵向中心线的一侧折弯延伸，所述下折段与所述滤器的纵向中心线的夹角为20°～75°。
  23. 根据权利要求22所述的滤器，其特征在于，所述支撑体还包括球形部，所述球形部连接在所述下折段末梢，或者，所述球形部连接在所述支撑段远离所述导引段的一端。
  24. 根据权利要求18所述的滤器，其特征在于，所述主体部包括近心端、远心端，及连接在所述近心端与所述远心端之间的连接体，所述回收钩连接在所述近心端或所述远心端上。
  25. 根据权利要求24所述的滤器，其特征在于，所述连接体包括与所述近心端连接的第一滤网、与所述远心端连接的第二滤网，以及多个连接在所述第一滤网与所述第二滤网之间的连接段，所述支撑部连接在所述连接段上。
  26. 根据权利要求25所述的滤器，其特征在于，所述连接段包括相连的折弯部与连接部，所述折弯部位于所述连接段的一端、并朝向所述滤器的纵向中心轴的一侧延伸，所述支撑部连接在所述连接部上。
  27. 根据权利要求26所述的滤器，其特征在于，所述连接部上设置有内凹结构。
  28. 根据权利要求27所述的滤器，其特征在于，每一所述连接段上连接有两个支撑部，两个所述支撑部中的一个所述支撑部位于所述折弯部与所述内凹结构之间，两个所述支撑部中的另一个所述支撑部位于所述连接部的远端。
PCT/CN2018/119275 2017-12-26 2018-12-05 滤器 WO2019128652A1 (zh)

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