WO2018188456A1 - 双向可控释放的腔静脉滤器 - Google Patents

双向可控释放的腔静脉滤器 Download PDF

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Publication number
WO2018188456A1
WO2018188456A1 PCT/CN2018/079698 CN2018079698W WO2018188456A1 WO 2018188456 A1 WO2018188456 A1 WO 2018188456A1 CN 2018079698 W CN2018079698 W CN 2018079698W WO 2018188456 A1 WO2018188456 A1 WO 2018188456A1
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WO
WIPO (PCT)
Prior art keywords
support
filter
support portion
vena cava
blood vessel
Prior art date
Application number
PCT/CN2018/079698
Other languages
English (en)
French (fr)
Inventor
张庭超
李阳
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
Priority claimed from CN201710233723.XA external-priority patent/CN107307921B/zh
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 EP18784622.5A priority Critical patent/EP3456291B1/en
Priority to US16/303,072 priority patent/US10856963B2/en
Publication of WO2018188456A1 publication Critical patent/WO2018188456A1/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
    • A61F2/0103—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
    • A61F2/0105—Open ended, i.e. legs gathered only at one side
    • 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
    • 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
    • A61F2230/005—Rosette-shaped, e.g. star-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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0093—Umbrella-shaped, e.g. mushroom-shaped

Definitions

  • the invention belongs to the technical field of medical instruments, and relates to a filter, in particular to a bidirectional controllable release vena cava filter.
  • Pulmonary embolism is a common health problem and an important cause of death in all age groups. Most pulmonary embolisms are caused by deep vein thrombosis (DVT) in the lower extremities or pelvis. Blood clots of deep vein thrombosis may migrate back to the heart through the veins and into the lungs, resulting in loss of blood and oxygen to a portion of the lungs. Supply causes lung infarction.
  • DVT deep vein thrombosis
  • the use of filters can prevent and reduce the occurrence of pulmonary embolism in the presence of anticoagulation contraindications or anticoagulation ineffectiveness.
  • the filter is delivered from the femoral vein to the inferior vena cava.
  • the jugular vein or the anterior elbow vein is required, and the filter is implanted into the inferior vena cava through the right atrium from the superior vena cava.
  • an ideal inferior vena cava filter should be implanted and recovered through the femoral vein, or can be implanted and recovered through the jugular vein, that is, the release of the filter through the jugular vein and the transfemoral vein into the blood vessel is controlled release.
  • the reason for adopting the bidirectional controlled release vena cava filter is that when the filter needs to be implanted into a specific part of the inferior vena cava during the operation, the position of the filter release may not meet the requirements due to misoperation, etc., and then it is required Re-retract the filter into the delivery sheath and reposition and release.
  • the filter in the prior art can only achieve one-way controlled release, and the other direction adopts the method of pushing out directly from the delivery sheath, and the controlled release cannot be realized. If the position of the filter is found to be inconsistent, the re-recycling cannot be performed. And adjust the position of the filter.
  • a cage-shaped inferior vena cava filter is now used to filter the thrombus.
  • the defects of this filter are as follows: 1.
  • the filter can only be controlled by one-way controlled release through the femoral vein. If the filter is released through the jugular vein, the filter is removed from the delivery sheath. After being pushed out, the delivery sheath cannot be re-released and then released again. 2.
  • the filter is provided with a vertical rod in the axial direction. After the filter is implanted into the blood vessel, the entire vertical rod is in close contact with the blood vessel wall, and the endovascular graft is recovered after a period of time. And completely covering the vertical rod, causing the filter to be recovered outside the time when the inner membrane has not yet climbed.
  • the implantation needs to be recovered in a short time, which cannot meet the needs of most clinical applications; 3.
  • the recovery hook of the filter In the protruding point of the cage structure, if the filter is tilted, the recovery hook is pressed against the blood vessel wall, and the trap of the catch cannot cover the recovery hook, so that the filter cannot be recovered, so that the filter is permanently left in the patient body to generate foreign matter.
  • vena cava filter with a tapered struts.
  • the filter of this structure is implanted into the inferior vena cava like a funnel to filter the thrombus.
  • the opening of the funnel can only be directed toward the bloodstream to effectively intercept the thrombus.
  • the funnel is inverted and released into the inferior vena cava.
  • the filter will appear as a reverse cone.
  • the blood flow velocity in the central region of the blood vessel is fast, and the blood flow velocity on the blood vessel wall is slow.
  • the blood clot generally follows the blood flow in the central region of the blood vessel.
  • the central region of the blood encounters a tapered tip that produces a shunting effect.
  • the thrombus also moves toward the vessel wall with the blood flow.
  • the technical problem to be solved by the present invention is that, in the prior art, the two-way controllable release of the filter cannot be realized, and the tilting of the filter causes the recovery hook to be attached to the outside of the hook, and the filter is not easily recovered after the endovascular graft.
  • the invention provides a bidirectional controllable release, which can be implanted and recovered through the femoral vein and through the jugular vein, has good thrombus filtering effect, can be implanted for a longer time, and is more easily recovered and recovered.
  • a bidirectional controlled release vena cava filter comprises a filter portion and a support portion; the filter portion is a mesh structure formed by cross-linking a plurality of struts; the support portion includes an opening opposite to the opening provided on both sides of the filter portion a support portion and a second support portion; the first support portion is gradually extended outward from the center forward direction and gradually reversely crimped; the second support portion is formed by gradually extending outward from the center.
  • the first support portion and the second support portion are respectively supported on the inner wall of the blood vessel.
  • a plurality of struts of the filter portion cross-link with each other and form a cross-linking node at the cross-linking.
  • the first support portion, the second support portion and the filter portion are integrated, and the first support portion is extended outward from the cross-linking node of the filter portion and is gradually reversed.
  • a plurality of curled first support rods, the second support portion being composed of a plurality of second support rods extending gradually from the cross-linking junction of the filter portion to the outer side in the forward direction;
  • first support portion, the second support portion and the filter portion are separate assembly structures, one of the first support portion and the second support portion is an independent structure, and the other is integrated with the filter portion, and the first structure is independent.
  • the support portion is composed of a plurality of first support rods extending from the center to the outer side and then gradually reversely curling, and the second support portion of the independent structure is composed of a plurality of second support rods extending from the center to the positive outer side;
  • first support portion, the second support portion and the filter portion are separate assembly structures, and the filter portion, the first support portion and the second support portion are all independent structures, the three are fixedly connected together, and the first support portion is from the center Firstly, a plurality of first support rods extending forwardly and then gradually reversely crimping, and the second support portion is composed of a plurality of second support rods extending from the center to the positive outer side; the filter portion is formed by cross-linking of the rods Funnel shape, hollow mesh sphere, grid disk or grid plate structure.
  • the first support rod or the second support rod and the struts of the filter portion are staggered in the axial direction; or the first support rod or/and the second support rod respectively
  • the first support rod and the second support rod are staggered in the axial direction in a unitary structure with a part of the struts in the filter portion.
  • the first support portion includes at least three first support rods arranged in an axisymmetric arrangement, and the plurality of first support rods extend outward and gradually reversely reverse to form a collection space.
  • the support structure has a first support rod point supported on the inner wall of the blood vessel; the second support portion includes at least three second support rods arranged in an axisymmetric manner, and the plurality of second support rods extend outwardly to form a support with a collection space Structure, the second support rod point is supported on the inner wall of the blood vessel.
  • the first support rod or the second support rod is provided with an anchor for anchoring on the inner wall of the blood vessel.
  • the second support rod is an outwardly extending curved rod or a straight rod.
  • the angle between the tangent of the first support rod end or the end of the first support rod and the central axis of the first support rod is greater than or equal to 180°, the first support portion
  • the maximum outer diameter coincides with the inner diameter of the blood vessel such that the first support rod point is supported on the inner wall of the blood vessel.
  • each of the first support rods includes a first support segment and a second support segment that are radiated outward from the center; the first support segment or the first support segment
  • the angle between the tangent line and the central axis of the first support portion ranges from 0 to 90°, and the angle between the tangent line of each point on the second support segment or the second support segment and the central axis is greater than or equal to 90°.
  • the angle between the tangent of the end of the second support section or the end of the second support section and the central axis is greater than or equal to 180°; the angle between the first support section and the second support section or the first support section and the second The angle between the tangent lines of each point of the support section is greater than 90°; the second support section point of the first support rod is supported on the inner wall of the blood vessel.
  • the filter further includes a recovery portion that connects the filter portion or/and the support portion.
  • the filter portion of the present invention is a crosslinked mesh structure, which can improve the filtering effect, and at the same time, the first support portion and the second support portion are respectively disposed on both sides thereof, and the first support portion and the second support portion are respectively formed in the forward direction and the reverse direction. It extends outward in both directions, so a funnel-shaped or cage-like structure is formed in both the forward and reverse directions.
  • the two supporting portions support the inner wall of the blood vessel and also have the function of gathering and intercepting the blood clot. The invention improves the filtering effect.
  • the filter of the present invention can be controlled in both directions, providing the operator with two options and improving the controllability of the surgical operation. Since the filter of the present invention can have a better filtering effect whether it is a positively implanted blood vessel or an inverted implanted blood vessel, the filter of the present invention can be located either through the femoral vein or through the jugular vein. At one end of the operator, when the delivery system is connected to the recovery hook for implantation into the filter, the controlled release function of repeated release of the filter can be achieved.
  • first support portion and the second support portion are both point supports, the contact area with the inner wall of the blood vessel is small, and the portion covering the filter after the inner film is climbed is small, and when the filter is recovered, the support rod can be pulled out from the inner membrane. It does not cause large damage to the intima of the blood vessel, thus prolonging the recovery time and expanding the patient's treatment time window.
  • the filter of the invention has a support portion at two positions at intervals, forming a stable support, so that the filter has better self-centering performance, prevents the filter from tilting, effectively avoids the recovery hook adhering to the wall, and is more advantageous for the recovery hook to be caught and recovered.
  • Fig. 1 is a schematic view showing the structure of a first embodiment of the present invention.
  • Fig. 2 is a plan view of the first embodiment.
  • Fig. 3 is a view showing the state of implantation of a blood vessel placed in the forward direction according to Embodiment 1 of the present invention.
  • Fig. 4 is a view showing the state of implantation of the inverted blood vessel according to the embodiment 1 of the present invention.
  • Figure 5 is a schematic view showing the structure of a first support rod according to Embodiment 1 of the present invention.
  • Figure 6 is a schematic view showing the structure of a second embodiment of the present invention.
  • Fig. 7 is a plan view showing a second embodiment of the present invention.
  • Figure 8 is a schematic view showing the structure of a first embodiment of the third embodiment of the present invention.
  • Figure 9 is a plan view showing a first embodiment of the third embodiment of the present invention.
  • FIG. 10 is a schematic structural view of a second embodiment of Embodiment 3 of the present invention.
  • Figure 11 is a plan view showing a second embodiment of the third embodiment of the present invention.
  • Azimuth definition In the two directions of the axial direction, the direction from the first support portion to the second support portion is defined as the forward direction, and the opposite direction is the reverse direction.
  • the forward and reverse directions are relative to the filter itself, and the filter is The position and orientation of the implanted blood vessels are independent.
  • the central axis refers to the central axis of the entire filter and is also the central axis of the first support, the filter and the second support.
  • a bidirectional controllable release vena cava filter includes a filter portion 1400 and a support portion, and the filter portion 1400 is a mesh structure formed by cross-linking a plurality of struts 1400a to each other.
  • the support portion includes a first support portion 1200 and a second support portion 1100 that are opposite to each other disposed on both sides of the filter portion 1400; the first support portion 1200 is gradually extended outward from the center forward direction and is formed by gradually inverting and curling;
  • the support portion 1100 is formed by gradually extending outward from the center.
  • the filter of the present invention comprises at least three parts: a filter portion 1400, a first support portion 1200 and a second support portion 1100 extending forward and backward respectively on both sides of the filter portion 1400, and the function of the filter portion 1400 is to filter the thrombus, the first support
  • the functions of the portion 1200 and the second support portion 1100 serve on the one hand to stably support the filter point on the inner wall of the blood vessel 2000, and on the other hand to function to collect and gather the thrombus.
  • the filter for implanting a blood vessel the filter portion 1400 is disposed laterally in the blood vessel for intercepting the thrombus, so that the main structure of the filter portion 1400 is a transversely crosslinked grid structure, and the cross-linking structure is a plurality of strut rods.
  • the 1400a is joined into a sheet or other shape extending circumferentially by nodes that are fixed or intersected at a distance.
  • the cross-linked structure is specifically an angular or rhombic grid structure formed by a plurality of struts 1400a extending forward and outward from the center, gradually expanding in diameter and cross-linking each other, and the grid structure can be radially expanded and contracted.
  • the cross-sectional shape such as an angle, a diamond shape or the like allows the filter portion 1400 to better intercept the thrombus.
  • the plurality of struts 1400a are cross-linked to each other to form a cross-linking node at the cross-section, the cross-linking node at the center of the filter portion 1400 is a central cross-linking node 1401, and the outermost cross-linking node at the periphery of the filter portion 1400 is an end-cross-linking node 1402. More preferably, the filter portion 1400 is an axisymmetric structure centered on the center cross-linking node 1401.
  • the filter portion 1400 gradually extends outward from the center forward with a plurality of long-length struts 1400a, and between the long struts 1400a, there are short struts 1400a for lateral connection to form an angular or diamond-shaped cross-linked structure.
  • the overall shape of the filter portion 1400 is a funnel shape in which the diameter is gradually enlarged.
  • the plurality of struts 1400a of the filter portion 1400 may be an integrally formed unitary structure, or the ends of the struts 1400a may be welded together to form a cross-linking node.
  • the filter portion 1400 may be a hollow mesh sphere, a mesh disk shape or a mesh plate structure formed by cross-linking of the struts in addition to the funnel shape.
  • the outermost cross-linking node is the end cross-linking node 1402, and the maximum spacing between the end cross-linking nodes 1402 does not exceed the vessel diameter.
  • the maximum spacing is less than 16 mm, and the outermost cross-linking node, that is, the end cross-linking node 1402, is smaller than the diameter of the blood vessel, so that the filter portion 1400 does not contact the inner wall 2000 of the blood vessel, and the inner wall 2000 of the blood vessel is reduced to facilitate filter recovery.
  • Both the first support portion 1200 and the second support portion 1100 are respectively supported on the inner wall of the blood vessel 2000.
  • the first support portion 1200 and the second support portion 1100 located on both sides of the filter portion 1400 may have a unitary structure or a separate structure with the filter portion 1400.
  • This embodiment adopts an integral structure.
  • the first support portion 1200, the second support portion 1100, and the filter portion 1400 are of a unitary structure; the first support portion 1200 is extended outward from the cross-linking node of the filter portion 1400 and is reversely reversed.
  • the plurality of first support bars 1200a are composed; the second support portion 1100 is composed of a plurality of second support bars 1100a that gradually extend outward from the cross-linking nodes of the filter portion 1400 in the forward direction.
  • the first support portion 1200 preferably extends outwardly from the end cross-linking node 1402 or the cross-linked junction of the middle portion and is reversed in reverse.
  • the second support portion 1100 preferably extends forward from the end cross-linking node 1402, i.e., the funnel shape of the filter portion 1400.
  • the integral structure is made in one piece, and is formed by heat-setting of the OD2.0mm nickel-titanium tube after laser cutting.
  • the first support portion 1200 is an axisymmetric structure, and thus the first support portion 1200 can prevent the filter from tilting and prevent the recovery portion 1300 from adhering.
  • the first support portion 1200 is composed of at least three first support rods 1200a arranged in an axisymmetric manner, and the plurality of first support rods 1200a extend outwardly and gradually reversely reverse to form a support structure having a collection space with a reverse opening, first
  • the support rod 1200a is supported on the inner wall 2000 of the blood vessel to reduce endothelial resuscitation.
  • the number of the first support rods 1200a of the first support portion 1200 is at least three. In the present embodiment, six first support rods 1200a are used, which are arranged symmetrically about the central axis.
  • the angle ⁇ between the end of the first support rod 1200a or the end of the first support rod 1200a and the central axis of the support portion is ⁇ 180°, and the maximum outer diameter D of the first support portion 1200 (the maximum outer diameter refers to the support rod)
  • the farthest point relative to the central axis forms the diameter of the circle, that is, the center line is the first boundary line, and the distance between the farthest point of the first support rod 1200a relative to the first boundary line and the first boundary line is
  • the inner diameter of the blood vessel is matched so that the first support rod 1200a is supported on the inner wall 2000 of the blood vessel.
  • the first support rod 1200a extends within the blood vessel, regardless of the structure of the first support rod 1200a, between the end of the first support rod 1200a or the tangent to the center axis of the end of the first support rod 1200a after release is completed.
  • the angle ⁇ is in the range of ⁇ ⁇ 180°, such that the end of the first support rod 1200a is offset from the inner wall 2000 of the blood vessel, at least in parallel with the inner wall 2000 of the blood vessel, and the end of the first support rod 1200a does not pierce the inner wall 2000 of the blood vessel.
  • the first support bar 1200a is mainly divided into two parts according to different shapes and structures of the first support bar 1200a, and the first support bar 1200a includes a first support segment 1210 that is radiated outward from the center.
  • the second support section 1230 may further be provided with a transition section 1220 between the first support section 1210 and the second support section 1230.
  • the three sections are of different structures and have different shapes and lengths.
  • the angle ⁇ between the tangent line of each point on the first support section 1210 or the first support section 1210 and the central axis ranges from 0 to 90°, and the tangent of each point on the second support section 1230 or the second support section 1230
  • the angle ⁇ between the central axis and the central axis is ⁇ >90°, and at the same time, since the end of the first support bar 1200a is the end of the second support segment 1230, the tangent and the central axis of the end or end of the second support segment 1230 The angle ⁇ between them is in the range of ⁇ ⁇ 180°.
  • Such a structure can ensure that after the first support bar 1200a is released, the end of the first support bar 1200a is flipped and curled before the wall is attached, and the flip angle is 180° or more.
  • the end of the first support section 1210 is assembled with the recovery portion 1300 and the second support portion 1100, and the second support segment 1230 is the end of the first support rod 1200a.
  • the angle between the first support section 1210 and the second support section 1230 or the angle ⁇ between the tangent lines of the first support section and the second support section is ⁇ >90°, and further, the first support
  • the angle ⁇ between the segment 1210 and the tangent to the end or end of the second support segment 1230 ranges from ⁇ ⁇ 180°, ensuring that the second support segment 1230 is turned back toward the filter portion 1400, and FIG. 1 is shown toward the filter portion 1400.
  • the transition section 1220 is a transition between the first support section 1210 and the second support section 1230. 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 support.
  • the first support section 1210, the second support section 1230, and the transition section 1220 may be curved lines, straight lines, and broken lines, and a mixed arrangement of two or more of the above-described linear shapes.
  • the first support section 1210, the second support section 1230, and the transition section 1220 are curves in which the radius of curvature continuously changes, and the radius of curvature is gradually reduced.
  • the point support is a relative concept, meaning that the first support rod 1200a contacts the inner wall 2000 of the blood vessel with a relatively small contact area, that is, with respect to the length and diameter of the first support rod 1200a, it can be considered that the contact with the inner wall of the blood vessel 2000 is a point support. can.
  • the first support portion 1200 has a maximum outer diameter of 10 to 40 mm, and a maximum diameter of the blood vessel is 2D (16 to 34 mm interval, usually 24 mm).
  • the second support section 1230 of the first support bar 1200a preferably includes a first sub-section 1230a, a second sub-section 1230b, and a third sub-section 1230c; wherein the second support section 1230 is a curve,
  • the radius of curvature of the two subsections 1230b is smaller than that of the first subsection 1230a, and the range of the angle ⁇ between the second subsection 1230b and the central axis is changed from 90° ⁇ 180° to ⁇ 180°, forming an inner wall surface of the blood vessel.
  • the second sub-section 1230b is a curved line or a broken line, forming a C-shape or a V-shape opening toward the central axis, forming a point contact with the inner wall surface of the blood vessel, and the first sub-section 1230a and the third sub-section 1230c are straight lines or broken lines And the second support section 1230 is entirely curved toward the opposite direction of the filter.
  • the radius of curvature of the second sub-segment 1230b is minimal, and the point at which the second sub-segment 1230b is furthest from the central axis is in contact with the inner wall of the blood vessel.
  • the second supporting portion 1100 is composed of at least three second supporting rods 1100a arranged in an axisymmetric manner, and the plurality of second supporting rods 1100a extend forward and outward to form a collection having a positive opening.
  • the support structure of the space, the second support rod 1100a is supported on the inner wall 2000 of the blood vessel.
  • the second support portion 1100 may be a strut structure, a cage structure, or other structure.
  • the second supporting portion 1100 may be a single-layer strut structure or a multi-layer strut structure. In this embodiment, as shown in FIG.
  • the second supporting portion 1100 adopts a single-layer strut structure
  • the single-layer strut structure is a plurality of second supporting rods 1100a and a plurality of second supporting rods 1100a uniformly disposed around the central axis.
  • the shape and structure are the same, and the number of the second support rods 1100a is set as needed.
  • six second support rods 1100a are provided, and the second support rods 1100a may be straight rods extending outward or may have a certain degree of curvature.
  • the curved rod and the curved rod can reduce the contact area between the second support rod 1100a and the inner wall of the blood vessel, and prevent the endothelium from climbing.
  • a curved rod is used, and the shape of the curved rod is recessed from the central portion of the curved rod toward the central axis, so that the contact area of the second support rod 1100a with the inner wall of the blood vessel can be reduced.
  • the angle between the second support rod 1100a and the central axis of the filter is greater than 0° and less than 90°, and the specific angle is set according to actual needs.
  • the first support bar 1200a or the second support bar 1100a is provided with an anchor 1500 for anchoring on the inner wall 2000 of the blood vessel, and the anchor 1500 is preferably disposed at the end of the first support bar 1200a or the second support bar 1100a.
  • the anchor 1500 on the first support rod 1200a is perpendicular to the central axis, and the end of the first support rod 1200a is fixed to the inner wall 2000 of the blood vessel, preventing the end of the first support rod 1200a from penetrating into the inner wall 2000 of the blood vessel too deep.
  • the anchor 1500 at the end of the second support rod 1100a is perpendicular to the central axis to prevent forward or reverse displacement of the filter.
  • the anchor sills 1500 at the ends of all the second support rods 1100a are not in the same plane, reducing the anchor 1500 kinks.
  • the recovery unit 1300 is used for filter recovery.
  • the collection unit 1300 is disposed at the center of the first support portion 1200, and is fixedly coupled to the first support portion 1200 or integrally formed with the first support portion 1200.
  • the recycling portion 1300 includes a hook (ie, a recycling hook) or a loop for recycling the filter into the delivery conduit.
  • the appropriate vena cava filter implantation path is selected.
  • FIG. 3 after the vena cava filter is delivered through the jugular vein, a schematic structural view of the implanted state, at this time, the space surrounded by the second support portion 1100 and the filter portion 1400 is mainly used for capturing the thrombus 3000, because the filter portion 1400 There is a cross-linked grid structure with better thrombus interception effect, and the second support portion 1100 is in a curved shape, which avoids the second support rod 1100a from adhering to the wall to reduce the endothelial climbing, and the anchor 1500 can prevent the filter from being forward and Reverse shift.
  • the first support portion 1200 is supported by the blood vessel wall point, and the filter has better self-centering performance, preventing the filter from tilting or recovering the hook adhering wall, and is more advantageous for recovering the filter.
  • the recovery hook of the recovery portion 1300 can be captured from the jugular vein through the recovery catheter and the grasper, and the entire filter is recovered to the sheath tube and taken out of the body.
  • the filter of the present invention has a wider range of applications than neck crushing after implantation.
  • FIG. 4 As shown in FIG. 4, after the vena cava filter is delivered through the femoral vein, a schematic structural view of the implanted state, in which the space surrounded by the first support portion 1200 and the filter portion 1400 is mainly used for capturing the thrombus 3000, due to the filter portion 1400
  • the thrombus intercepting effect is better
  • the first supporting portion 1200 is supported by the blood vessel wall point
  • the filter has better self-centering performance, preventing the filter from tilting or recycling the hook adhering wall, and is more advantageous for recovering the filter.
  • the second support portion 1100 is in a curved configuration, maximally avoiding the attachment of the struts and reducing the endothelial climb, while the anchor 1500 prevents the forward and reverse displacement of the filter.
  • the recovery hook can be captured from the cervical femoral puncture through the recovery catheter and the arrester, and the entire filter is recovered to the sheath and taken out of the body. Compared with the existing rod type filter, it cannot be recovered through the strand after implantation, and the filter of the present invention has a wider range of applications.
  • Embodiment 2 as shown in Figs. 6 and 7, this embodiment is improved on the basis of Embodiment 1.
  • the difference from the first embodiment is that the first support rod 1200a of the first support portion 1200 is separated from the end cross-linking node 1402 and the two first support rods 1200a are again concentrated and then turned over.
  • An anchor 1500 is disposed at the end of the second support rod 1100a.
  • the second support bar 1100a is a straight bar that prevents the anchor ribs 1500 at the ends of all of the second support bars 1100a from being twisted.
  • the first support portion 1200, the second support portion 1100, and the filter portion 1400 are a split assembly structure; the first support portion 1200 or the second support portion 1100 One is a separate component and the other is integrally formed with the filter portion 1400 to form a two-layer filter structure. After being shaped separately, they are welded together.
  • the first support portion 1200 of the independent structure is composed of a plurality of first support bars 1200a extending from the center to the outside and then gradually reversely curling; the second support portion 1100 of the independent structure extends from the center to the positive outer side.
  • a plurality of second support rods 1100a are formed. As shown in FIG. 8 and FIG.
  • the first support portion 1200 is integrally formed with the filter portion 1400
  • the second support portion 1100 is an independent component
  • the second support portion 1100 is stacked and fixedly connected with the filter portion 1400 to form a two-layer structure.
  • the second support portion 1100 is integrally formed with the filter portion 1400 .
  • the first support portion 1200 is a separate component, and the first support portion 1200 and the filter portion 1400 are stacked and fixedly connected to form a two-layer structure.
  • the first support rod 1200a or the second support rod 1100a is staggered in the axial direction with the support rod 1400a of the filter portion 1400; or the first support rod 1200a and the second support rod 1100a are respectively coupled to a portion of the rod in the filter portion 1400
  • the 1400a is a unitary structure, that is, the first support rod 1200a and the strut 1400 are integrated, or the second support rod 1100a is integrated with the strut 1400, and the first support rod 1200a and the second support rod 1100a are axially Staggered arrangement. Staggering in the axial direction enhances the filtering effect.
  • first support portion 1200, the second support portion 1100, and the filter portion 1400 are the same as those of the first and second embodiments, and are not described herein again.
  • the filter portion 1400, the first support portion 1200, and the second support portion 1100 are all independent structures, and the three are fixedly connected together to form a three-layer structure;
  • the first support The portion 1200 is composed of a plurality of first support bars 1200a extending from the center to the outside and then gradually reversely curling;
  • the second support portion 1100 is composed of a plurality of second support bars 1100a extending from the center to the positive outer side.
  • the specific structures of the filter portion 1400, the first support portion 1200, and the second support portion 1100 are the same as those in the first, second, and third embodiments, and are not described herein again.
  • the filter portion 1400 is a funnel shape formed by cross-linking of the struts, a hollow mesh ball shape, a mesh disk shape, or a mesh plate structure.

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Abstract

一种双向可控释放的腔静脉滤器，包括过滤部（1400）和支撑部（1100，1200），过滤部（1400）为由多根支杆相互交联形成的网格结构，支撑部（1100，1200）包括在过滤部（1400）两侧设置的开口相反的第一支撑部（1200）和第二支撑部（1100）；第一支撑部（1200）由中心正向逐步向外延伸并逐步反向翻转卷曲形成；第二支撑部（1100）由中心正向逐步向外延伸形成，是一种双向可控释放，既可以经股静脉又可以经颈静脉植入与回收、过滤血栓效果好、可植入更长时间回收的、更容易被捕获回收的腔静脉滤器。

Description

双向可控释放的腔静脉滤器 技术领域
本发明属于医疗器械技术领域，涉及一种滤器，尤其涉及一种双向可控释放的腔静脉滤器。
背景技术
肺栓塞(PE)是常见的健康问题，且是所有年龄群中导致死亡的一个重要因素。大多数肺栓塞由下肢或骨盆内的深静脉血栓(DVT)导致，深静脉血栓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。
目前治疗方案中，在具有抗凝禁忌或者抗凝无效的情况下，使用滤器可以预防和减小肺栓塞的发生。一般从股静脉将滤器输送至下腔静脉，但当双髂静脉或者下腔静脉存在漂浮血栓时，需要经颈静脉或者肘前静脉，从上腔静脉经右心房将滤器植入下腔静脉，所以一个理想的下腔静脉滤器应既可以经股静脉植入与回收，也可以经颈静脉植入与回收，即经颈静脉和经股静脉两个方向释放滤器到血管内都是可控释放。采用双向可控释放的腔静脉滤器的原因在于，在手术过程中需要将滤器植入下腔静脉血管特定的部位时，可能由于误操作等原因导致滤器释放的位置不符合要求，这时就需要重新收回滤器进入输送鞘并重新定位与释放。现有技术中的滤器仅能实现单向可控释放，另一个方向则采取直接从输送鞘中推出的方法，无法实现可控释放，此时如果发现滤器的位置不符合要求，则无法重新回收并调整滤器的位置。
现采用一种笼形的下腔静脉滤器用于过滤血栓，这种滤器的缺陷在于：1、该滤器只能经股静脉单向可控释放，如果经颈静脉释放时，滤器从输送鞘中被推出后不可以再次收入输送鞘再进行重新释放；2、该滤器沿轴向方向设有竖杆，滤器植入血管后整条竖杆与血管壁紧密接触，一段时间后血管内膜爬覆并完全覆盖竖杆，导致该滤器必须在内膜还没有爬覆的时间内回收出体外，植入较短的时间就需要回收，不能满足大部分临床应用的需求；3、该滤器的回收钩在笼状结构的凸出尖的部位，如果滤器发生倾斜，则导致回收钩紧贴血管壁， 抓捕器的圈套无法套住回收钩，导致无法回收滤器致使滤器永久留在病人体内产生异物。
另外还有一种常见的锥形支杆结构的腔静脉滤器，此种结构的滤器像一个漏斗一样植入下腔静脉来过滤血栓，漏斗的开口只能朝向血流以有效拦截血栓，如果将此漏斗倒过来释放到下腔静脉，滤器将呈现为倒锥形，根据流体动力学，血管内中心区域的血液流速快，靠血管壁的血液流速慢，血栓一般都跟随血管中心区域的血液流动，中央区血液遇到锥形的尖端便产生分流效应，血栓也会随血流向血管壁靠近，这种锥形支杆的滤器，越靠近锥形顶端部位的支杆越密集，越靠近支杆末端的部位支杆越稀疏，所以靠近血管壁的部位过滤孔更稀疏，血栓不容易被过滤拦截住，所以此滤器不能倒置释放。这种滤器的缺点包括：1、由于锥形结构的方向性，此滤器只能在经颈静脉植入的时候实现可控释放，当经股静脉释放的时候，滤器一旦被推出鞘管，即不能再次回收入鞘管并重新定位与释放；2、该结构滤器的回收钩在锥形的尖端，如果滤器发生倾斜，则导致位于尖端的回收钩会贴壁，导致不容易被抓捕器回收。
发明内容
本发明要解决的技术问题在于，针对现有技术中滤器不能实现双向可控释放，滤器倾斜导致回收钩贴壁不容易被抓捕回收出体外，血管内膜爬覆后滤器不易回收的问题。本发明提供一种双向可控释放，既可以经股静脉又可以经颈静脉植入与回收、过滤血栓效果好、可植入更长时间回收的、更容易被捕获回收的腔静脉滤器。
本发明解决其技术问题所采用的技术方案是：
一种双向可控释放的腔静脉滤器，包括过滤部和支撑部；过滤部为由多根支杆相互交联形成的网格结构；支撑部包括在过滤部两侧设置的开口相反的第一支撑部和第二支撑部；第一支撑部由中心正向逐步向外延伸并逐步反向翻转卷曲形成；第二支撑部由中心正向逐步向外延伸形成。
所述的双向可控释放的腔静脉滤器中，优选第一支撑部与第二支撑部都分别点支撑在血管内壁上。
所述的双向可控释放的腔静脉滤器中，优选过滤部的多根支杆相互交联并 在交联处形成交联结点。
所述的双向可控释放的腔静脉滤器中，优选第一支撑部、第二支撑部和过滤部为一体结构，第一支撑部由从过滤部的交联结点向外延伸并逐步反向翻转卷曲的多根第一支撑杆组成，第二支撑部由从过滤部的交联结点沿正向向外侧逐步延伸的多根第二支撑杆组成；
或者第一支撑部、第二支撑部和过滤部为分体组装结构，第一支撑部和第二支撑部中的其中一个为独立结构，另一个与过滤部组成一体结构，独立结构的第一支撑部由从中心先正向向外侧延伸再逐步反向翻转卷曲的多根第一支撑杆组成，独立结构的第二支撑部由从中心向正向外侧延伸的多根第二支撑杆组成；
或者第一支撑部、第二支撑部和过滤部为分体组装结构，过滤部、第一支撑部和第二支撑部都为独立结构，三者固定连接在一起，第一支撑部由从中心先正向向外侧延伸再逐步反向翻转卷曲的多根第一支撑杆组成，第二支撑部由从中心向正向外侧延伸的多根第二支撑杆组成；过滤部为支杆交联形成的漏斗状、中空网格球状、网格盘状或网格板状结构。
所述的双向可控释放的腔静脉滤器中，优选第一支撑杆或第二支撑杆与过滤部的支杆在轴向上交错排布；或者第一支撑杆或/和第二支撑杆分别与过滤部中的部分支杆为一体结构，第一支撑杆与第二支撑杆在轴向上交错排布。
所述的双向可控释放的腔静脉滤器中，优选第一支撑部包括至少三根呈轴对称排布的第一支撑杆，多根第一支撑杆向外延伸并逐渐反向翻转形成具有收集空间的支撑结构，第一支撑杆点支撑在血管内壁上；第二支撑部包括至少三根呈轴对称排布的第二支撑杆，多根第二支撑杆向正向外侧延伸形成具有收集空间的支撑结构，第二支撑杆点支撑在血管内壁上。
所述的双向可控释放的腔静脉滤器中，优选第一支撑杆或第二支撑杆设有用于在血管内壁上锚定的锚刺。
所述的双向可控释放的腔静脉滤器中，优选第二支撑杆为向外延伸的曲杆或直杆。
所述的双向可控释放的腔静脉滤器中，优选第一支撑杆末端或第一支撑杆末端的切线与第一支撑杆的中轴线之间的夹角大于或等于180°，第一支撑部 最大外径与血管内径配合一致使得第一支撑杆点支撑在血管内壁上。
所述的双向可控释放的腔静脉滤器中，优选每根第一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；第一支撑段或第一支撑段上各点的切线与第一支撑部中轴线之间的夹角的范围为0～90°，第二支撑段或第二支撑段上各点的切线与中轴线之间的夹角大于或等于90°，且第二支撑段末端或第二支撑段末端的切线与中轴线之间的夹角大于或等于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各点切线之间的夹角大于90°；所述第一支撑杆的第二支撑段点支撑在血管内壁上。
所述的双向可控释放的腔静脉滤器中，优选滤器还包括回收部，回收部连接过滤部或/和支撑部。
本发明过滤部为交联的网格结构，可以提高过滤效果，同时其两侧分别设置第一支撑部和第二支撑部，并且第一支撑部与第二支撑部分别正向和反向形成两个方向上向外延伸，因此在正向和反向两个方向都形成了漏斗形或笼形的结构，两个支撑部在支撑血管内壁的同时，还有聚拢和拦截血栓的功能，所以本发明提高了过滤效果。
另外，最为重要的是本发明的滤器可以双向可控释放，为操作者提供了两种可选项，并提高了手术操作的可控性。由于本发明的滤器不论是正向植入血管还是倒置植入血管都可以有较好的过滤效果，所以本发明的滤器无论是经股静脉植入或者是经颈静脉植入，回收钩都可位于操作者的一端，当将输送***连接回收钩进行植入滤器时，就可以实现滤器的反复释放反复回收的可控释放功能。
再者第一支撑部与第二支撑部都为点支撑，与血管内壁接触面积小，内膜爬覆后覆盖滤器的部位较小，当回收滤器时，可以把支杆从内膜中拔出而不对血管内膜造成大的损伤，因此延长了回收时间，使病人的治疗时间窗扩大。
本发明滤器在间隔的两个位置具有支撑部，形成稳定支撑，使滤器具有更好的自中心性能，防止滤器倾斜，有效避免回收钩贴壁，更有利于回收钩被抓捕而回收滤器。
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是本发明实施例1的结构示意图。
图2是实施例1的俯视图。
图3是本发明实施例1正向置入血管的植入状态示意图。
图4是本发明实施例1倒置置入血管的植入状态示意图。
图5是本发明实施例1第一支撑杆的结构示意图。
图6是本发明实施例2的结构示意图。
图7是本发明实施例2的俯视图。
图8是本发明实施例3第一种实施方式的结构示意图。
图9是本发明实施例3第一种实施方式的俯视图。
图10是本发明实施例3第二种实施方式的结构示意图。
图11是本发明实施例3第二种实施方式的俯视图。
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。
方位定义：轴向的两个方向中，定义从第一支撑部到第二支撑部的方向为正向，相反的方向为反向，正向和反向是相对于滤器本身而言，跟滤器植入血管的位置和方向无关。中轴线指整个滤器的中轴线，同时也是第一支撑部、过滤部和第二支撑部的中轴线。
实施例1，如图1-图5所示，一种双向可控释放的腔静脉滤器，包括过滤部1400和支撑部，过滤部1400为通过多根支杆1400a相互交联形成的网格结构，支撑部包括在过滤部1400两侧设置的开口相反的第一支撑部1200和第二支撑部1100；第一支撑部1200由中心正向逐步向外延伸并逐步反向翻转卷曲形成；第二支撑部1100由中心正向逐步向外延伸形成。
本发明的滤器至少包括三部分：过滤部1400、过滤部1400两侧分别正向和反向延伸的第一支撑部1200和第二支撑部1100，过滤部1400的功能为过滤血栓，第一支撑部1200和第二支撑部1100的功能一方面用于稳定地将滤器 点支撑在血管内壁2000上，另一方面起到收集、聚拢血栓的功能。
如图1及图2所示，植入血管的滤器，过滤部1400横向设置血管中，用于拦截血栓，因此过滤部1400的主体结构呈横向交联网格结构，交联结构为多根支杆1400a通过间隔一定距离固定或交叉在一起的结点连接成片或其他向四周延伸的形状。本实施例中交联结构具体为由多根支杆1400a从中心正向向外延伸、直径逐步扩大并相互交联形成的角形或菱形的网格结构，网格结构可以径向伸缩，适用收放在鞘管中，由于血栓呈团状，角形、菱形等交联形状使得过滤部1400可以更好拦截血栓。多根支杆1400a相互交联在交联处形成交联结点，位于过滤部1400中心的交联结点为中心交联结点1401，过滤部1400周边最外侧的交联结点为末端交联结点1402，更优选过滤部1400为以中心交联结点1401为中心的轴对称结构。过滤部1400从中心正向逐步向外延伸有多根长度较长的支杆1400a，在这些长的支杆1400a之间还有短的支杆1400a用于横向连接，形成角形或菱形交联结构，过滤部1400整体形状为直径逐步扩大的漏斗状。过滤部1400的多个支杆1400a可以是一体成型的整体结构，也可以是支杆1400a端部焊接在一起形成交联结点。过滤部1400除了漏斗状，还可以是支杆交联形成的中空网格球体、网格盘状或网格板状结构。
最外侧的交联结点为末端交联结点1402，末端交联结点1402之间的最大间距不超过血管直径。优选最大间距小于16mm，最外侧的交联结点即末端交联结点1402小于血管直径，使得过滤部1400不与血管内壁2000接触，减少血管内壁2000爬覆，利于滤器回收。
第一支撑部1200与第二支撑部1100都分别点支撑在血管内壁2000上。位于过滤部1400两侧的第一支撑部1200和第二支撑部1100，与过滤部1400之间可以是一体结构也可以是分体结构。本实施例采用一体结构。如图1-4所示，第一支撑部1200、第二支撑部1100和过滤部1400为一体结构；第一支撑部1200由从过滤部1400的交联结点向外延伸并逐步反向翻转的多根第一支撑杆1200a组成；第二支撑部1100由从过滤部1400的交联结点沿正向向外侧逐步延伸的多根第二支撑杆1100a组成。第一支撑部1200优选从末端交联结点1402或中部的交联结点向外延伸并逐步反向翻转。第二支撑部1100优选从末端交联结点1402正向，即顺过滤部1400的漏斗形正向向外延伸。一体 结构为一体成型制成，由OD2.0mm镍钛管材经激光切割后，通过模具热定型而成。
第一支撑部1200为轴对称结构，因此第一支撑部1200可以防止滤器倾斜，以及防止回收部1300贴壁。第一支撑部1200由至少三根呈轴对称排布的第一支撑杆1200a组成，多根第一支撑杆1200a向外延伸并逐渐反向翻转形成具有反向开口的收集空间的支撑结构，第一支撑杆1200a点支撑在血管内壁2000上，减少内皮爬覆。第一支撑部1200的第一支撑杆1200a数量至少是三根，本实施例中采用六根第一支撑杆1200a，关于中轴线轴对称排布。
第一支撑杆1200a末端或第一支撑杆1200a末端的切线与支撑部中轴线之间的夹角β的范围为β≥180°，第一支撑部1200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，即：以中轴线为第一边界线，第一支撑杆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第一支撑杆1200a点支撑在血管内壁2000上。在释放过程中，第一支撑杆1200a在血管内伸展，不管第一支撑杆1200a是什么样的结构，释放完成后第一支撑杆1200a末端或第一支撑杆1200a末端的切线与中轴线之间的夹角β的范围为β≥180°，这样第一支撑杆1200a末端错开血管内壁2000，至少是与血管内壁2000平行，第一支撑杆1200a端部不会刺破血管内壁2000。
如图5所示，根据第一支撑杆1200a的不同位置形状结构以及作用不同，第一支撑杆1200a主要分成二部分，第一支撑杆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，在第一支撑段1210、第二支撑段1230之间还可以设有过渡段1220，这三段为不同结构，其形状和长度都有所不同。其中第一支撑段1210或第一支撑段1210上各点的切线与中轴线之间的夹角α的范围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之间的夹角β的范围为β＞90°，同时，由于第一支撑杆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之间的夹角β的范围为β≥180°。这样的结构可以保证第一支撑杆1200a释放后，第一支撑杆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和第二支撑部1100固定在一起，第二支撑段1230是第一支撑杆1200a的末段。
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之间的夹角γ的范围为γ＞90°，进一步地，第一支撑段1210与第二支撑段1230末端或末端的切线之间的夹角γ的范围为γ≥180°，保证了第二支撑段1230是向背向过滤部1400方向翻转，图1显示朝向过滤部1400的反向翻转。过渡段1220为第一支撑段1210与第二支撑段1230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。第一支撑段1210、第二支撑段1230、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。优选第一支撑段1210、第二支撑段1230、过渡段1220为曲率半径连续变化的曲线，曲率半径逐步减小。
点支撑是一个相对概念，指第一支撑杆1200a以相对较小的接触面积接触血管内壁2000，即相对于第一支撑杆1200a的长度和直径，基本可以认为跟血管内壁2000接触是点支撑即可。第一支撑部1200最大外径为10～40mm，血管最大直径为2D(16～34mm区间，通常24mm)。
具体如图5所示，优选第一支撑杆1200a的第二支撑段1230优选包括第一子段1230a、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与中轴线之间的夹角β的范围由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，形成开口朝向中轴线的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整体朝向滤器反向的方向弯曲。第二子段1230b的曲率半径为最小，第二子段1230b距离中轴线最远的一点或多点与血管内壁接触。
如图1、及图2所示，第二支撑部1100由至少三根呈轴对称排布的第二支撑杆1100a组成，多根第二支撑杆1100a正向向外延伸形成具有正向开口的收集空间的支撑结构，第二支撑杆1100a点支撑在血管内壁2000上。第二支撑部1100可以为支杆结构、笼形结构或其他结构。支杆结构中，第二支撑部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，第二支撑部1100采用单层支杆结构，单层支杆结构就是围绕中轴线均匀设置多根第二支撑杆1100a，多根第二支撑杆1100a的形状和结构相同，第二支撑杆1100a的数量根据需要设置，本实施例中设置6根第二支撑杆1100a，第二支撑杆1100a可以是向外延伸的直杆，也可以是有一定弧度的曲杆，曲杆可以减少第二支撑杆1100a与血管内壁的接触面积，防止内皮爬覆。本实施例采用曲杆，曲杆的形状为从曲杆的中部向中轴线凹进，从而可减少第二支撑杆1100a与血管内壁的接触面积。第二支撑杆1100a与滤器的中轴线之间的夹角大于0°且小于90°，夹角具体大小根据实际需要设置。
第一支撑杆1200a或第二支撑杆1100a设有用于在血管内壁2000上锚定的锚刺1500，锚刺1500优选设置在第一支撑杆1200a或第二支撑杆1100a的末端。第一支撑杆1200a上的锚刺1500与中轴线垂直，将第一支撑杆1200a末端固定在血管内壁2000上，防止第一支撑杆1200a末端刺入血管内壁2000过深。优选第二支撑杆1100a末端的锚刺1500与中轴线垂直，防止滤器正向或反向的移位。并且所有第二支撑杆1100a末端的锚刺1500不在同一个平面上，减少锚刺1500绞结。
回收部1300是用于滤器回收的，回收部1300设置在第一支撑部1200的中心，跟第一支撑部1200固定连接或与第一支撑部1200一体形成。回收部1300包括挂钩(即，回收钩)或挂环，用于回收滤器进入输送导管。
根据临床术前评估，选择合适的腔静脉滤器植入路径。如图3所示，为腔静脉滤器经颈静脉输送后，植入状态的结构示意图，此时第二支撑部1100和过滤部1400所围成的空间主要用于捕获血栓3000，由于过滤部1400存在交联网格结构，具有较好的血栓拦截效果，第二支撑部1100为弯曲形态，最大程度地避免第二支撑杆1100a贴壁，减少内皮爬覆，同时锚刺1500可以防止滤器正向和逆向的移位。第一支撑部1200与血管壁点支撑，滤器具有较好的自中心性能，防止滤器倾斜或者回收钩贴壁，更有利于回收滤器。当需要回收滤器时，可以从颈静脉穿刺经回收导管和抓捕器捕获回收部1300的回收钩，将整个滤器回收至鞘管，并取出体外。相比笼形滤器植入后不能经颈回收，本发明的滤器具有更广泛的应用范围。
如图4所示，为腔静脉滤器经股静脉输送后，植入状态的结构示意图，此 时第一支撑部1200和过滤部1400所围成的空间主要用于捕获血栓3000，由于过滤部1400为交联网格结构，具有较好的血栓拦截效果，第一支撑部1200与血管壁点支撑，滤器具有较好的自中心性能，防止滤器倾斜或者回收钩贴壁，更有利于回收滤器。第二支撑部1100为弯曲形态，最大程度的避免的支杆贴壁，减少内皮爬覆，同时锚刺1500可以防止滤器正向和逆向的移位。当需要回收滤器时，可以从颈股脉穿刺经回收导管和抓捕器捕获回收钩，将整个滤器回收至鞘管，并取出体外。相比现有支杆型滤器，植入后不能经股回收，本发明的滤器具有更广泛的应用范围。
实施例2，如图6、7所示，本实施例是在实施例1的基础上改进。跟实施例1的区别为：第一支撑部1200的第一支撑杆1200a从末端交联结点1402分出两根第一支撑杆1200a再次汇聚后翻转。
第二支撑杆1100a末端设有锚刺1500。第二支撑杆1100a为直杆，防止所有的第二支撑杆1100a末端的锚刺1500绞结。
其余结构同实施例1，在此不再赘述。
实施例3，如图8-11所示，本实施例中，第一支撑部1200、第二支撑部1100和过滤部1400为分体组装结构；第一支撑部1200或第二支撑部1100其中之一为独立组件，另一个与过滤部1400一体成型，形成两层过滤结构。分别定型后，焊接在一起。独立结构的第一支撑部1200由从中心先正向向外侧延伸再逐步反向翻转卷曲的多根第一支撑杆1200a组成；独立结构的第二支撑部1100由从中心向正向外侧延伸的多根第二支撑杆1100a组成。如图8、图9所示，第一支撑部1200与过滤部1400一体成型，第二支撑部1100为独立组件，第二支撑部1100与过滤部1400叠放固定连接形成两层结构。如图10、图11所示，第二支撑部1100与过滤部1400一体成型，第一支撑部1200为独立组件，第一支撑部1200与过滤部1400叠放固定连接形成两层结构。
第一支撑杆1200a或第二支撑杆1100a与过滤部1400的支杆1400a在轴向上交错排布；或者第一支撑杆1200a和第二支撑杆1100a都分别与过滤部1400中的部分支杆1400a为一体结构，即第一支撑杆1200a与支杆1400成为 一根整体，或者第二支撑杆1100a与支杆1400成为一根整体，第一支撑杆1200a与第二支撑杆1100a在轴向上交错排布。在轴向上交错排布可以增强过滤效果。
第一支撑部1200、第二支撑部1100和过滤部1400的其他结构同实施例1、2，在此不再赘述。
除了上述分体组装结构外，还有分体组装结构为：过滤部1400、第一支撑部1200和第二支撑部1100都为独立结构，三者固定连接在一起成为三层结构；第一支撑部1200由从中心先正向向外侧延伸再逐步反向翻转卷曲的多根第一支撑杆1200a组成；第二支撑部1100由从中心向正向外侧延伸的多根第二支撑杆1100a组成。过滤部1400、第一支撑部1200和第二支撑部1100的具体结构，同实施例1、2、3，在此不再赘述。
过滤部1400为支杆交联形成的漏斗状、中空网格球状、网格盘状或网格板状结构。

Claims (11)

  1. 一种双向可控释放的腔静脉滤器，其特征在于，包括过滤部和支撑部；
    所述过滤部为由多根支杆相互交联形成的网格结构；
    所述支撑部包括在所述过滤部两侧设置的开口相反的第一支撑部和第二支撑部；
    所述第一支撑部由中心正向逐步向外延伸并逐步反向翻转卷曲形成；
    所述第二支撑部由中心正向逐步向外延伸形成。
  2. 根据权利要求1所述的双向可控释放的腔静脉滤器，其特征在于，所述第一支撑部与所述第二支撑部都分别点支撑在血管内壁上。
  3. 根据权利要求1所述的双向可控释放的腔静脉滤器，其特征在于，所述过滤部的多根所述支杆相互交联并在交联处形成交联结点。
  4. 根据权利要求3所述的双向可控释放的腔静脉滤器，其特征在于，所述第一支撑部、所述第二支撑部和所述过滤部为一体结构；所述第一支撑部由从所述过滤部的所述交联结点向外延伸并逐步反向翻转卷曲的多根第一支撑杆组成；所述第二支撑部由从所述过滤部的所述交联结点沿正向向外侧逐步延伸的多根第二支撑杆组成；
    或者所述第一支撑部、所述第二支撑部和所述过滤部为分体组装结构；所述第一支撑部和所述第二支撑部中的其中一个为独立结构，另一个与所述过滤部形成一体结构；所述独立结构的所述第一支撑部由从中心先正向向外侧延伸再逐步反向翻转卷曲的多根所述第一支撑杆组成；所述独立结构的所述第二支撑部由从中心向正向外侧延伸的多根所述第二支撑杆组成；
    或者所述第一支撑部、所述第二支撑部和所述过滤部为分体组装结构；所述过滤部、所述第一支撑部和所述第二支撑部都为独立结构并固定连接在一起；所述第一支撑部由从中心先正向向外侧延伸再逐步反向翻转卷曲的多根所述第一支撑杆组成；所述第二支撑部由从中心向正向外侧延伸的多根所述第二支撑杆组成；所述过滤部为支杆交联形成的漏斗状、中空网格球状、网格盘状或网格板状结构。
  5. 根据权利要求4所述的双向可控释放的腔静脉滤器，其特征在于，所 述第一支撑杆或所述第二支撑杆与所述过滤部的所述支杆在轴向上交错排布；
    或者所述第一支撑杆或/和所述第二支撑杆分别与所述过滤部中的部分所述支杆形成一体结构，所述第一支撑杆与所述第二支撑杆在轴向上交错排布。
  6. 根据权利要求4所述的双向可控释放的腔静脉滤器，其特征在于，所述第一支撑部包括至少三根呈轴对称排布的第一支撑杆，多根所述第一支撑杆向外延伸并逐渐反向翻转形成具有收集空间的支撑结构，所述第一支撑杆点支撑在血管内壁上；
    所述第二支撑部包括至少三根呈轴对称排布的第二支撑杆，多根所述第二支撑杆向正向外侧延伸形成具有收集空间的支撑结构，所述第二支撑杆点支撑在血管内壁上。
  7. 根据权利要求4所述的双向可控释放的腔静脉滤器，其特征在于，所述第一支撑杆或所述第二支撑杆设有用于在血管内壁上锚定的锚刺。
  8. 根据权利要求4所述的双向可控释放的腔静脉滤器，其特征在于，所述第二支撑杆为向外延伸的曲杆或直杆。
  9. 根据权利要求4所述的双向可控释放的腔静脉滤器，其特征在于，所述第一支撑杆末端或所述第一支撑杆末端的切线与所述第一支撑部的中轴线之间的夹角大于或等于180°，所述第一支撑部最大外径与血管内径配合一致使得所述第一支撑杆点支撑在血管内壁上。
  10. 根据权利要求9所述的双向可控释放的腔静脉滤器，其特征在于，每根所述第一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；
    所述第一支撑段或所述第一支撑段上各点的切线与所述第一支撑部的所述中轴线之间的夹角的范围为0～90°，所述第二支撑段或所述第二支撑段上各点的切线与所述中轴线之间的夹角大于或等于90°，且所述第二支撑段末端或所述第二支撑段末端的切线与所述中轴线之间的夹角大于或等于180°；所述第一支撑段与所述第二支撑段之间的夹角或所述第一支撑段与所述第二支撑段上各点切线之间的夹角大于90°；所述第一支撑杆的所述第二支撑段点支撑在血管内壁上。
  11. 根据权利要求4所述的双向可控释放的腔静脉滤器，其特征在于，所述滤器还包括回收部，所述回收部连接所述过滤部或/和所述支撑部。
PCT/CN2018/079698 2017-04-11 2018-03-21 双向可控释放的腔静脉滤器 WO2018188456A1 (zh)

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