WO2018103375A1 - 滤器 - Google Patents

滤器 Download PDF

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Publication number
WO2018103375A1
WO2018103375A1 PCT/CN2017/099026 CN2017099026W WO2018103375A1 WO 2018103375 A1 WO2018103375 A1 WO 2018103375A1 CN 2017099026 W CN2017099026 W CN 2017099026W WO 2018103375 A1 WO2018103375 A1 WO 2018103375A1
Authority
WO
WIPO (PCT)
Prior art keywords
filter
contour line
section
flexible
support
Prior art date
Application number
PCT/CN2017/099026
Other languages
English (en)
French (fr)
Inventor
陈卓
贾小乐
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
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 US16/464,614 priority Critical patent/US11166805B2/en
Priority to EP17877963.3A priority patent/EP3552576A4/en
Publication of WO2018103375A1 publication Critical patent/WO2018103375A1/zh

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Classifications

    • 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
    • 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
    • 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
    • A61F2002/018—Filters implantable into blood vessels made from tubes or sheets of material, e.g. by etching or laser-cutting
    • 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
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • 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
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting 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
    • 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
    • A61F2250/0018—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 elasticity, stiffness or compressibility

Definitions

  • the invention relates to a cardiovascular medical device, in particular to a retrievable vena cava filter implanted in a blood vessel by intervention.
  • 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.
  • pulmonary embolisms of the systemic circulation can cause pulmonary embolism.
  • the most common pulmonary embolism is thrombosis.
  • thrombosis There are many factors in the formation of blood clots, including trauma or fracture, trauma, large surgery, extensive burns, pregnancy, childbirth, long illness, bed, long-distance ride or long-staying, long sitting and down.
  • the sputum can make the venous blood flow slow, the blood stagnant, or the platelets and coagulation factors increase, the blood adhesion is enhanced, and the thrombus is formed.
  • These thrombi are generally slightly adhered to the wall of the tube and tend to fall off. Free emboli can cause serious diseases such as pulmonary embolism.
  • Venous thrombosis can occur anywhere, and the most common site is the lower extremity.
  • Vena cava filters have been clinically proven to be a safe and effective means of preventing pulmonary embolism, which can reduce the incidence of pulmonary embolism.
  • the filter support rod will be crawled and wrapped by the endothelial cells to varying degrees, which makes it difficult to remove, and can only be implanted into the human body as a permanent filter for a long time.
  • the permanent implantation of the filter into the human body has certain risks.
  • the filter is in contact with the blood and the vascular endothelium for a long time, protein adsorption may occur, platelet adhesion may occur, and eventually a thrombus may cause clogging of the venous blood vessel or cause recurrence of the pulmonary embolism; There are dangers such as deformation, tilting, displacement, breakage, and even penetration of blood vessels.
  • one is to form a layer of a coating for preventing cell growth on the surface of the filter by a surface modification method to prevent the endocardium from climbing on the surface of the filter.
  • the other is to make the filter into a closed structure at both ends by structural design, and to add an open support rod that abuts the blood vessel wall, thereby separating the filter from the blood vessel wall.
  • the Chinese patent No. CN102330059B is a typical representative of the first method, which uses a surface modification method to deposit a polyethylene glycol film on the surface of the filter, utilizing the anti-protein and cell adhesion properties of polyethylene glycol. Inhibiting the growth of cells on the surface of the filter prevents the endothelial cells from wrapping the filter support rods, thereby achieving filter recyclability.
  • the film layer prepared by this method has water solubility and can only prevent cell growth for a period of time, and has strict requirements on the timing of taking out.
  • the filter since the filter is in a state of being compressed in the sheath before being placed in the blood vessel, the filter is released when the sheath delivers the filter to the desired position, and the filter is deployed inside the blood vessel to open the blood vessel wall.
  • the filter When the filter is contracted or unfolded, there may be a problem of intertwining between the open support rods, which causes the filter to not smoothly spread in the blood vessel, which reduces the usability of the filter and causes the operation to be impossible. And the end of the open support rod has the risk of puncturing the vessel wall, increasing the incidence of postoperative complications.
  • the technical problem to be solved by the present invention is to provide a vena cava filter which does not puncture a blood vessel wall, is less prone to entanglement, and has higher usability, in view of the defects of the prior art.
  • a filter comprising a proximal end, a telecentric end, and a filter body connected between the proximal end and the telecentric end, the filter body
  • the first filter unit, the second filter unit, and the plurality of intermediate connecting rods connecting the first filter unit and the second filter unit are provided, and the intermediate connecting rod is provided with a support a rod comprising a transition from the intermediate connecting rod to a direction away from the filter axis and a support section bent from the transition section toward the filter axis and extending toward the telecentric end ;
  • the support section includes a body that extends from the end of the transition section and a flexible section that is coupled to the body, the flexible section having a stiffness that is lower than the stiffness of the body.
  • the flexible segment has a radial dimension of at least a portion of its length that is less than a radial dimension of the body.
  • the section of the flexible section along its length has an upper contour line and a lower contour line disposed opposite to the upper contour line, the upper contour line and the lower contour line edge
  • the extending directions of the flexible segments are close to each other.
  • the section of the flexible section along its length has an upper contour line and a lower contour line disposed opposite to the upper contour line, and the upper contour line and the lower contour line are both For wavy lines.
  • the peak of the upper contour line is opposite to the peak of the lower contour line
  • the valley of the upper contour line is opposite to the valley of the lower contour line
  • the peak of the upper contour line is opposite to the valley of the lower contour line.
  • the flexible segments are equal in radial dimension along their length and smaller than the radial dimension of the body.
  • the flexible section is made of a flexible material.
  • an angle between the body and the intermediate connecting rod is less than 90°.
  • the angle between the flexible segment and the body is an obtuse angle, and a smooth transition between the flexible segment and the body.
  • the support section further includes a rounded convex portion provided at an outer end of the flexible segment, and a smooth transition between the protruding portion and the flexible segment.
  • the support bars on two adjacent intermediate connecting rods are staggered.
  • the support rod end of the filter of the invention is provided with a flexible section and a rounded convex part of the outer contour, and the outer contour of the protrusion transitions to a part of the flexible section for a smooth transition, and the structural design reduces the support section piercing the blood vessel wall. Risk, try to avoid the complications caused by the puncture of the vessel wall after the support segment, solve the problem of the intertwining between the open support rods when the filter is contracted or unfolded, improve the usability of the filter, and ensure the smooth operation of the operation. .
  • FIG. 1 is a schematic structural view of a filter according to an embodiment of the present invention.
  • Figure 2 is a schematic view showing the structure of a support rod in the filter of the present invention
  • Figure 3 is a cross-sectional view showing a first embodiment of a flexible section of a support rod in the filter of the present invention
  • Figure 4 is a cross-sectional view showing a second embodiment of the flexible section of the support rod in the filter of the present invention.
  • Figure 5 is a cross-sectional view showing a third embodiment of the flexible section of the support rod in the filter of the present invention.
  • Figure 6 is a cross-sectional view showing a fourth embodiment of the flexible section of the support rod in the filter of the present invention.
  • a filter 10 includes a telecentric end 1, a proximal end 2, and a filter body coupled between the telecentric end 1 and the proximal end 2.
  • the filter body comprises a first filter unit 3, a second filter unit 4 and a plurality of intermediate connecting rods 5 connecting the first filter unit 3 and the second filter unit 4.
  • a plurality of intermediate connecting rods 5 are evenly spaced around the line connecting the telecentric end 1 and the proximal end 2 .
  • the first filter unit 3 is assembled by a plurality of Y-shaped filter rods 31 at the telecentric end 1 to form a first filter unit 3 having a conical mesh structure
  • the second filter unit 4 is also assembled by a plurality of Y-shaped filter rods 41.
  • a second filter unit 4 having a conical mesh structure is formed at the proximal end 2, and the number of the Y-shaped filter rods 31 of the first filter unit 3 is the number of the Y-shaped filter rods 41 of the second filter unit 4.
  • the filter 10 is made to have an asymmetrical structure as a whole. This asymmetric structure is selective for pre-filtered thrombi, ie, only the thrombus that causes pulmonary embolism is filtered, thereby ensuring long-term patency of the vena cava.
  • the telecentric end 1 of the filter is also provided with a recovery hook (not labeled) for connection with the catcher when the temporary filter is recovered.
  • the intermediate connecting rod 5 is further provided with a support rod 6 that abuts against the blood vessel wall.
  • the role of the support rod 6 is to keep the intermediate connecting rod 5 away from the blood vessel wall, thereby preventing the problem that the recovery time window caused by the endovascular membrane climbing on the filter surface is short.
  • the support rod 6 includes a transition portion 61 extending from the intermediate connecting rod 5 toward the axis away from the filter 10 and a support portion extending from the transition portion 61 toward the proximal end. The support portion is at least partially used to replace the connecting rod 5 and the vessel wall. Abut.
  • a fixed anchor 7 for piercing the wall of the blood vessel is also provided on some of the support rods 6. The anchor anchor 7 can make the filter more stable in the blood vessel.
  • only one support rod 6 is provided on one intermediate connecting rod 5, and the position of the support rods 6 on the adjacent intermediate connecting rods 5 on the connecting rod 5 is staggered, thereby supporting
  • the rod can provide a more uniform and stable supporting force for the filter in the blood vessel, preventing the filter from being weakened by the tilting and displacement of the filter, and the risk of pulmonary embolism is improved after the operation.
  • two or more support rods may be disposed on the intermediate connecting rod, and the support rods may be fixed at any position of the intermediate connecting rod, provided that the transition section and the supporting section of the supporting rod are The opening orientation formed should be opposite to the direction in which the filter is removed.
  • the support section includes a body 62 extending from the end of the transition section 61 and abutting against the vessel wall, a flexible section 63 extending from the body 62 toward the proximal end, and a distal end disposed at the end of the flexible section 63.
  • the smooth transitions referred to in the present invention all refer to arc transitions or chamfer transitions at the junction of two components.
  • the stiffness of the flexible section 63 is less than the stiffness of the body 62.
  • the stiffness of the flexible section 63 is less than the stiffness of the body 62.
  • the manner of achieving the flexible segment 63 has at least a portion of the radial dimension in the longitudinal direction smaller than the radial dimension of the body 62. By narrowing the radial dimension, the flexibility of the portion of the support segment can be increased. Thereby, when the support section abuts against the blood vessel wall, the support section can be prevented from piercing the blood vessel wall.
  • the flexible section 63 can also be made of a flexible material, such as silicone.
  • the angle between the body 62 and the intermediate connecting rod 5 is ⁇ 90°, and it is foreseen that when the angle between the body 62 and the intermediate connecting rod 5 is 90°, when the filter is deployed in the blood vessel, the body 62 Will point to the vessel wall, which undoubtedly increases the risk of the support segment piercing the vessel wall.
  • the angle between the body 62 and the intermediate connecting rod 5 is greater than 90°, for example, when the body 62 and the transition portion 61 are in the same straight line, the body 62 is still directed toward the blood vessel wall and cannot function to support the blood vessel wall.
  • the flexible section 63 and the body 62 are at an obtuse angle, and may be in the same line as the body 62. The flexible section 63 and the body 62 may not be at an acute angle for the reason described above.
  • the portion of the flexible section 63 having a radial dimension smaller than the radial dimension of the body 62 may be formed by blanking. And the flexible section 63 can have a different shape. The following is specifically illustrated by several specific embodiments:
  • Embodiment 1 is a diagrammatic representation of Embodiment 1:
  • the section of the flexible section 63 in the longitudinal direction thereof has an upper contour line 63a and a lower contour line 63b which is disposed to be spaced apart from the upper contour line 63a. And the upper contour line 63a and the lower contour line 63b are gradually approached in the extending direction of the flexible section 63. That is, the radial dimension of the flexible section 63 is gradually reduced in its extending direction.
  • the end of the flexible section 63 is provided with a convex portion 64 having a quadrangular cross-sectional shape.
  • the four side edges of the convex portion 64 have a smooth transition therebetween, and the convex portion 64 and the flexible portion 63 also have a circular arc transition.
  • the projections 64 can be treated to a smooth outer contour by mechanical or chemical means such as mechanical blasting, polishing or argon arc welding, and the addition of the projections 64 at the ends of the flexible section 63 further reduces the risk of the support section piercing the vessel wall.
  • Embodiment 2 is a diagrammatic representation of Embodiment 1:
  • the section of the flexible section 63 in the longitudinal direction thereof has an upper contour line 63c and a lower contour line 63d which is disposed at a distance from the upper contour line 63c.
  • the lower outline 63d is on the same line as the outline of the body 62
  • the upper outline 63c is closer to the downward outline 63d along the extending direction of the flexible section 63
  • the entire flexible section 63 has the same radial dimension.
  • the flexible section 63 can also be two sections of grooves formed by the blanking of the end section of the supporting section on the upper and lower sides, and have equal radial dimensions along the extending direction thereof.
  • the projection 64 provided at the end of the flexible section 63 has a substantially racetrack shape, and a chamfered transition between the projection 64 and the upper contour 63c of the flexible section 63.
  • Embodiment 3 is a diagrammatic representation of Embodiment 3
  • the section of the flexible section 63 in its longitudinal direction has an upper contour line 63e and a lower contour line 63f which is disposed at a distance from the upper contour line 63e, and the upper contour line 63e and the lower contour line 63f are both wavy lines. .
  • the peak of the upper contour line 63e is opposite to the peak of the lower contour line 63f, and the valley of the upper contour line 63e is opposed to the valley of the lower contour line 63f.
  • the convex portion 64 provided at the end of the flexible segment 63 has a teardrop shape, and the convex portion 64 and the flexible segment 63 have a circular arc transition. A flexible arc transition between the flexible section 63 and the body 62.
  • Embodiment 4 is a diagrammatic representation of Embodiment 4:
  • the section of the flexible section 63 in its longitudinal direction has an upper contour line 63e' and a lower contour line 63f' spaced apart from the upper contour line 63e', and
  • the outline 63e' and the lower outline 63f' are both wavy lines.
  • the peak of the upper contour line 63e' is opposite to the valley of the lower contour line 63f', and the valley of the upper contour line 63e' is opposed to the peak of the lower contour line 63f'.
  • the protruding portion 64 provided at the end of the flexible segment 63 has a circular cross section, and the convex portion 64 and the flexible segment 63 have a circular arc transition. There is a smooth transition between the flexible section 63 and the body 62.
  • the shape of the projection 64 may be any shape, for example, it may be an elliptical shape as long as the outer contour thereof is rounded and there is no risk of puncturing the blood vessel wall. And when a plurality of support bars 6 are present on the intermediate connecting rod 5, the projections 64 can be selectively disposed at the ends of the flexible segments 63.
  • the support rod end of the filter of the invention is provided with a flexible section and a rounded convex part of the outer contour, and the outer contour of the protrusion transitions to a part of the flexible section for a smooth transition, and the structural design reduces the support section piercing the blood vessel wall. Risk, try to avoid the complications caused by the puncture of the vessel wall after the support segment, solve the problem of the intertwining between the open support rods when the filter is contracted or unfolded, improve the usability of the filter, and ensure the smooth operation of the operation. .

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)

Abstract

一种滤器（10），其包括近心端（1）、远心端（2）以及连接于近心端（1）和远心端（2）之间的滤器主体。滤器主体包括均为锥形网状结构的第一过滤单元（3）、第二过滤单元（4）以及多个连接第一过滤单元和第二过滤单元的中间连接杆（5）。中间连接杆（5）上设有支撑杆（6）。支撑杆（6）包括自中间连接杆（5）向血管壁延伸的过渡段（61）以及自过渡段（61）弯折延伸并至少有部分与血管壁抵接的支撑段。支撑段包括自过渡段（61）末端弯折延伸的本体（62）以及自本体（62）弯延伸的柔性段（63）。柔性段（63）在其长度方向上至少有一部分的径向尺寸小于本体（62）的径向尺寸从而增大支撑段的柔性，防止所述支撑段刺破血管壁。

Description

滤器
【技术领域】
本发明涉及一种心血管医疗器械，尤其涉及一种通过介入方式植于血管内的可回收腔静脉滤器。
【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。
体循环的各种栓子脱落均可引起肺栓塞，最常见的肺栓子为血栓。血栓的形成因素有多种，其中包括，外伤或骨折、创伤、较大的手术、大面积烧伤、妊娠、分娩、久病卧床、长途乘车或飞机久坐不动、长时间的静坐及下蹲等均可使静脉血流缓慢，血液瘀滞，或血小板和凝血因子增多，血液黏附性增强，形成血栓。这些血栓一般与管壁轻度粘连，容易脱落，脱落的游离栓子可引起肺栓塞等严重病变。静脉血栓可发生于任何部位，最常见的部位为下肢。
腔静脉滤器（以下简称滤器）在临床上被证实为预防肺栓塞安全有效的手段，可降低肺栓塞的发生率。但是滤器植入下腔静脉一定时间后，由于对血管的刺激，滤器支撑杆会不同程度地被内皮细胞爬覆、包裹，造成难于取出，只能作为永久滤器长期植入人体。而滤器永久植入人体具有一定风险，例如：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。
目前业界为了解决滤器植入人体后不易取出的问题，主要有两个解决途径：一是通过表面改性的方法在滤器表面形成一层阻止细胞生长的涂层，防止血管内膜在滤器表面爬覆；另一种是通过结构设计的方法，将滤器制作成两端封闭的结构，并且在结构上增加与血管壁抵接的开放性支撑杆，从而将滤器与血管壁分隔开来。
专利公告号为CN102330059B的中国专利为第一种方法的典型代表，其使用表面改性方法在滤器表面沉积类聚乙二醇薄膜，利用聚乙二醇具有的抗蛋白质和细胞粘附的特性，抑制细胞在滤器表面生长，阻止内皮细胞包裹滤器支撑杆，从而实现滤器的可回收性。但是，使用该方法制备的膜层具有水溶性，只能在一段时间内阻止细胞生长，对取出时机的选择有严格的要求。
对于第二种方法来说，由于滤器被放入血管之前处于被压缩在鞘管内的状态，当鞘管将滤器输送到需要的位置后释放滤器，滤器在血管内展开从而将血管壁撑开。那么滤器在收缩或展开时，开放性支撑杆之间可能会存在相互缠绕的问题，导致滤器在血管内不能顺利展开，降低了滤器的可用性，导致手术无法顺利进行。且开放性支撑杆的末端存在刺破血管壁的风险，增加了术后并发症的发生几率。
因此，如何保证腔静脉滤器可以可靠固定，血栓过滤效率高、刺破血管风险小和尽量少的内皮爬覆，同时又能保证可回收是一个亟待解决的难题。
【发明内容】
本发明要解决的技术问题在于，针对现有技术的缺陷，提供一种不会刺破血管壁、不易发生缠绕、可用性更高的腔静脉滤器。
本发明解决其技术问题所采用的技术方案是：一种滤器，其包括近心端、远心端以及连接于所述近心端和所述远心端之间的滤器主体，所述滤器主体包括均为锥形网状结构的第一过滤单元、第二过滤单元，以及多个连接所述第一过滤单元和所述第二过滤单元的中间连接杆，所述中间连接杆上设有支撑杆，所述支撑杆包括自所述中间连接杆向远离所述滤器轴线方向延伸的过渡段以及自所述过渡段朝靠近所述滤器轴线方向弯折并朝所述远心端延伸的支撑段；
所述支撑段包括自所述过渡段末端弯折延伸的本体、以及和所述本体相连的柔性段，所述柔性段的刚度低于所述本体的刚度。
在本发明的一实施例中，所述柔性段在其长度方向上至少有一部分的径向尺寸小于所述本体的径向尺寸。
在本发明的一实施例中，所述柔性段沿其长度方向的截面具有上轮廓线和与所述上轮廓线相对间隔设置的下轮廓线，所述上轮廓线与所述下轮廓线沿所述柔性段的延伸方向相互靠近。
在本发明的一实施例中，所述柔性段沿其长度方向的截面具有上轮廓线和与所述上轮廓线相对间隔设置的下轮廓线，所述上轮廓线和所述下轮廓线均为波浪线。
在本发明的一实施例中，所述上轮廓线的波峰与所述下轮廓线的波峰相对，所述上轮廓线的波谷与所述下轮廓线的波谷相对。
在本发明的一实施例中，所述上轮廓线的波峰与所述下轮廓线的波谷相对。
在本发明的一实施例中，所述柔性段在沿其长度方向上的径向尺寸相等且小于所述本体的径向尺寸。
在本发明的一实施例中，所述柔性段采用柔性材料制成。
在本发明的一实施例中，所述本体与所述中间连接杆之间的夹角小于90°。
在本发明的一实施例中，所述柔性段与所述本体之间的夹角为钝角，且所述柔性段与所述本体之间为平滑过渡。
在本发明的一实施例中，所述支撑段还包括设于所述柔性段末端的外轮廓圆滑的凸出部，所述凸出部与所述柔性段之间为平滑过渡。
在本发明的一实施例中，相邻两所述中间连接杆上的所述支撑杆交错分布。
本发明滤器的支撑杆末梢设有柔性段和外轮廓圆滑的凸出部，且凸出部的外轮廓过渡到柔性段的部分为平滑过渡，这种结构设计降低了支撑段刺破血管壁的风险，尽量避免了术后因支撑段刺破血管壁带来的并发症，解决了滤器在收缩或展开时开放支撑杆之间的相互缠绕的问题，提升了滤器的可用性，确保手术的顺利进行。
【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是本发明一实施例提供的滤器的结构示意图；
图2是本发明的滤器中支撑杆的结构示意图；
图3是本发明的滤器中支撑杆柔性段第一实施例的截面图；
图4是本发明的滤器中的支撑杆柔性段第二实施例的截面图；
图5是本发明的滤器中的支撑杆柔性段第三实施例的截面图；
图6是本发明的滤器中的支撑杆柔性段第四实施例的截面图。
【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。
如图1和图2所示，一种滤器10包括远心端1、近心端2以及连接于远心端1和近心端2之间的滤器主体。滤器主体包括第一过滤单元3、第二过滤单元4和多个连接第一过滤单元3和第二过滤单元4的中间连接杆5。多个中间连接杆5环绕远心端1和近心端2的连线均匀间隔分布。第一过滤单元3由多个Y形滤网杆31汇集在远心端1形成呈锥形网状结构的第一过滤单元3，第二过滤单元4亦由多个Y形滤网杆41汇集在近心端2形成同样呈锥形网状结构的第二过滤单元4，且第一过滤单元3的Y形滤网杆31的数量是第二过滤单元4的Y形滤网杆41数量的一半，使滤器10在整体上呈非对称结构。此种非对称的结构对预过滤的血栓具有选择性，即只过滤会造成肺栓塞的血栓，从而保证腔静脉的长期通畅性。同时滤器远心端1还设置有回收钩（未标示），用于回收临时滤器时与抓捕器连接。
中间连接杆5上还设有与血管壁抵接的支撑杆6。支撑杆6的作用均是使中间连接杆5远离血管壁，从而防止血管内膜在滤器表面爬覆造成的回收时间窗短的问题。支撑杆6包括自中间连接杆5向向远离滤器10的轴线方向延伸的过渡段61以及自过渡段61朝近心端延伸的支撑段，支撑段至少有部分用于取代连接杆5与血管壁抵接。在有的支撑杆6上还设有用于刺入血管壁内的固定锚7，固定锚7可以使滤器在血管内固定更稳固。
且在该实施例中，一个中间连接杆5上只设有一个支撑杆6，且相邻的中间连接杆5上的支撑杆6在连接杆5上的位置不同，呈交错布置，从而使得支撑杆在血管中可以为滤器提供更加均匀、稳定的支撑力，防止滤器因在血管中倾斜、移位而造成血栓过滤效果减弱，术后病人肺栓塞的风险提高。在其它可能的实施例中，中间连接杆上也可以设置两个或两个以上的支撑杆，这些支撑杆可以被固定在中间连接杆的任意位置，前提是由支撑杆的过渡段和支撑段形成的开口朝向应当与滤器被取出的方向相反。
如图2所示，支撑段包括自过渡段61末端弯折延伸且用于与血管壁抵接的本体62、自本体62朝近心端延伸的柔性段63以及设于柔性段63末端且外轮廓圆滑的凸出部64。凸出部64与柔性段63之间、以及本体62与柔性段63之间均为平滑过渡。本发明中提到的平滑过渡均指的是两个元件连接处圆弧过渡或倒角过渡。柔性段63的刚度小于本体62的刚度。令柔性段63的刚度小于本体62的刚度有多种实现方式。在本实施例中，实现的方式为使柔性段63在长度方向上至少有部分的径向尺寸小于本体62的径向尺寸，通过径向尺寸的缩小，可以增大支撑段这部分的柔性，从而在支撑段与血管壁抵接时，可以防止支撑段刺破血管壁。在其他实施方式中，柔性段63也可以采用柔性材料制成，例如硅胶。
进一步的，本体62与中间连接杆5之间的夹角α＜90°，可以预见的是，当本体62与中间连接杆5的夹角为90°时，滤器在血管内展开时，本体62将指向血管壁，这无疑增加了支撑段刺破血管壁的风险。而当本体62与中间连接杆5的夹角大于90°时，例如当本体62与过渡段61处于同一直线时，本体62仍然是指向血管壁的，无法起到支撑血管壁的作用。在本实施例中，柔性段63与本体62之间呈钝角夹角，也可以与本体62处于同一直线上，柔性段63与本体62不可以呈锐角，理由如前所述。
柔性段63径向尺寸小于本体62的径向尺寸的部分可以通过去料形成。且柔性段63可有不同的形态。下面通过几个具体的实施例来具体说明：
实施例一：
如图3所示，柔性段63在其长度方向上的截面具有上轮廓线63a和与上轮廓线63a相对间隔设置的下轮廓线63b。且上轮廓线63a和下轮廓线63b沿柔性段63的延伸方向逐渐靠近。也就是说，柔性段63的径向尺寸在其延伸方向上是逐渐缩小的。柔性段63与本体62之间为圆弧过渡。柔性段63的末端设有截面形状为四边形的凸出部64，凸出部64截面的四条侧边之间同为平滑过渡，且凸出部64与柔性段63之间亦为圆弧过渡。凸出部64可通过机械喷砂、抛光等机械或化学方法或氩弧焊处理成圆滑的外轮廓，在柔性段63末端增加凸出部64进一步降低了支撑段刺破血管壁的风险。
实施例二：
如图4所示，柔性段63在其长度方向上的截面具有上轮廓线63c和与上轮廓线63c相对间隔设置的下轮廓线63d。在本实施例中，下轮廓线63d与本体62的轮廓线处于同一直线上，上轮廓线63c沿柔性段63的延伸方向向下轮廓线63d靠近，且整个柔性段63的径向尺寸相同。此外，柔性段62的上轮廓线63c与本体62的外轮廓之间为倒角过渡。从外观上看，柔性段63为由支撑段的末段通过去料形成的一段凹陷槽。可以理解的，柔性段63也可以为由支撑段的末段在上下两侧通过去料形成的两段凹槽，且沿其延伸方向具有相等的径向尺寸。在本实施例中，设于柔性段63末端的凸出部64的截面大致呈跑道形，且凸出部64与柔性段63的上轮廓线63c之间为倒角过渡。
实施例三：
如图5所示，柔性段63在其长度方向上的截面具有上轮廓线63e和与上轮廓线63e相对间隔设置的下轮廓线63f，且上轮廓线63e和下轮廓线63f均为波浪线。上轮廓线63e的波峰与下轮廓线63f的波峰相对，上轮廓线63e的波谷与下轮廓线63f的波谷相对。在本实施例中，设于柔性段63末端的凸出部64的截面呈水滴形，且凸出部64与柔性段63之间为圆弧过渡。柔性段63与本体62之间为圆弧过渡。
实施例四：
如图6所示，与上一实施例相同的是，柔性段63在其长度方向上的截面具有上轮廓线63e’和与上轮廓线63e’相对间隔设置的下轮廓线63f’，且上轮廓线63e’和下轮廓线63f’均为波浪线。但在该实施例中，上轮廓线63e’的波峰与下轮廓线63f’的波谷相对，上轮廓线63e’的波谷与下轮廓线63f’的波峰相对。在本实施例中，设于柔性段63末端的凸出部64的截面呈圆形，且凸出部64与柔性段63之间为圆弧过渡。柔性段63与本体62之间为圆滑过渡。
在上述各实施例中，凸出部64的形状可以是任何形状，例如还可以是椭圆形，只要其外轮廓被处理圆滑不存在刺破血管壁的风险即可。且当中间连接杆5上存在多个支撑杆6时，凸出部64可有选择性地设置在柔性段63的末端。
本发明滤器的支撑杆末梢设有柔性段和外轮廓圆滑的凸出部，且凸出部的外轮廓过渡到柔性段的部分为平滑过渡，这种结构设计降低了支撑段刺破血管壁的风险，尽量避免了术后因支撑段刺破血管壁带来的并发症，解决了滤器在收缩或展开时开放支撑杆之间的相互缠绕的问题，提升了滤器的可用性，确保手术的顺利进行。

Claims (12)

  1. 一种滤器，其包括近心端、远心端以及连接于所述近心端和所述远心端之间的滤器主体，所述滤器主体包括均为网状结构的第一过滤单元、第二过滤单元，以及多个连接所述第一过滤单元和所述第二过滤单元的中间连接杆，所述中间连接杆上设有支撑杆，其特征在于，所述支撑杆包括自所述中间连接杆向远离所述滤器轴线方向延伸的过渡段以及自所述过渡段朝靠近滤器轴线方向弯折并朝所述近心端延伸的支撑段，所述支撑段包括自所述过渡段末端弯折延伸的本体、以及和所述本体相连的柔性段，所述柔性段的刚度低于所述本体的刚度。
  2. 根据权利要求1所述的滤器，其特征在于，所述柔性段在其长度方向上至少有一部分的径向尺寸小于所述本体的径向尺寸。
  3. 根据权利要求2所述的滤器，其特征在于，所述柔性段沿其长度方向的截面具有上轮廓线和与所述上轮廓线相对间隔设置的下轮廓线，所述上轮廓线与所述下轮廓线沿所述柔性段的延伸方向相互靠近。
  4. 根据权利要求2所述的滤器，其特征在于，所述柔性段沿其长度方向的截面具有上轮廓线和与所述上轮廓线相对间隔设置的下轮廓线，所述上轮廓线和所述下轮廓线均为波浪线。
  5. 根据权利要求4所述的滤器，其特征在于，所述上轮廓线的波峰与所述下轮廓线的波峰相对，所述上轮廓线的波谷与所述下轮廓线的波谷相对。
  6. 根据权利要求4所述的滤器，其特征在于，所述上轮廓线的波峰与所述下轮廓线的波谷相对。
  7. 根据权利要求1所述的滤器，其特征在于，所述柔性段在沿其长度方向上任一点的径向尺寸相等且小于所述本体的径向尺寸。
  8. 根据权利要求1所述的滤器，其特征在于，所述柔性段采用柔性材料制成。
  9. 根据权利要求1-8任一项所述的滤器，其特征在于，所述本体与所述中间连接杆之间的夹角小于90°。
  10. 根据权利要求9所述的滤器，其特征在于，所述柔性段与所述本体之间的夹角为钝角，且所述柔性段与所述本体之间为平滑过渡。
  11. 根据权利要求1-8任一项所述的滤器，其特征在于，所述支撑段还包括设于所述柔性段末端的外轮廓圆滑的凸出部，所述凸出部与所述柔性段之间为平滑过渡。
  12. 根据权利要求1所述的滤器，其特征在于，相邻两所述中间连接杆上的所述支撑杆交错分布。
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US11166805B2 (en) 2021-11-09
CN108143518B (zh) 2020-10-27
US20210093434A1 (en) 2021-04-01
EP3552576A4 (en) 2020-10-14
CN108143518A (zh) 2018-06-12

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