WO2017113633A1 - 滤器 - Google Patents

滤器 Download PDF

Info

Publication number
WO2017113633A1
WO2017113633A1 PCT/CN2016/086117 CN2016086117W WO2017113633A1 WO 2017113633 A1 WO2017113633 A1 WO 2017113633A1 CN 2016086117 W CN2016086117 W CN 2016086117W WO 2017113633 A1 WO2017113633 A1 WO 2017113633A1
Authority
WO
WIPO (PCT)
Prior art keywords
filter
telecentric
proximal end
shaped
central axis
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/CN2016/086117
Other languages
English (en)
French (fr)
Inventor
李安宁
兰娟
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Lifetech Scientific Shenzhen Co Ltd
Original Assignee
Lifetech Scientific Shenzhen Co Ltd
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 Lifetech Scientific Shenzhen Co Ltd filed Critical Lifetech Scientific Shenzhen Co Ltd
Publication of WO2017113633A1 publication Critical patent/WO2017113633A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • 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

Definitions

  • the present invention relates to an implantable medical device, and more particularly to a filter.
  • PE Pulmonary embolism
  • embolisms of the systemic circulation can cause pulmonary embolism.
  • the most common embolus is a thrombus.
  • Filters have been clinically proven to be a safe and effective means of preventing pulmonary embolism, reducing the incidence of pulmonary embolism. The filter is implanted into the inferior vena cava to prevent thrombosis of the lower extremity from reaching the lungs along the bloodstream, thereby preventing pulmonary embolism.
  • the taper of the near-end filter of the filter near the proximal end of the filter is smaller than the taper of the telecentric filter near the telecentric end of the filter, and the radial support force of the near-end filter is smaller than the radial support of the telecentric filter. .
  • the radial support force of the near-end filter increases, which reduces the radial support force of the near-end filter and the radial support of the telecentric filter.
  • the gap between the two reduces the possibility of filter skew, improves the efficiency of the filter plug, and reduces the risk of re-embedding after surgery.
  • the present invention provides a filter comprising a body portion having opposing proximal and distal ends.
  • the body portion includes a proximal end filter and a telecentric filter positioned between the proximal end and the distal end.
  • the near-end filter and the telecentric filter are spatially tapered structures composed of a plurality of mesh wires.
  • the taper of the proximal end filter is smaller than the taper of the telecentric filter.
  • the proximal end filter comprises a plurality of connected first Y-shaped units.
  • Each of the first Y-shaped units includes a first network line and two second network lines formed by a fork extending from one end of the first network line.
  • the plurality of first mesh lines of the plurality of first Y-shaped cells converge at the proximal end.
  • An end of each of the first Y-shaped cells that is away from the proximal end is connected to the telecentric filter.
  • the distance between the connection point of the first wire and the second wire in the first Y-shaped unit to the longitudinal central axis of the filter in a state in which the filter is naturally released The ratio of the size of the filter to the largest outer diameter in the direction perpendicular to the longitudinal central axis of the filter ranges from 1:10 to 7:16.
  • a first diamond shaped filter unit is formed.
  • a projected area of a plurality of first rhombic filter units of the filter in a cross section perpendicular to a longitudinal central axis of the filter and a longitudinal direction of the filter perpendicular to the filter in a state in which the filter is naturally released The ratio of the area of the circle corresponding to the largest outer diameter in the direction of the central axis ranges from 1:10 to 9:10.
  • the telecentric filter comprises a plurality of connected second Y-shaped cells.
  • Each of the second Y-shaped units includes a third network cable and two fourth network cables formed by a bifurcation extension of one end of the third network cable.
  • a plurality of third network lines of the plurality of the second Y-type cells converge at the telecentric end.
  • the end of the fourth network line of each second Y-shaped unit remote from the telecentric end is connected to the near-end filter.
  • the distance between the connection point of the third wire and the fourth wire in any of the second Y-shaped cells to the longitudinal central axis of the filter in a state in which the filter is naturally released is in the range of 1:10 to 7:16.
  • the telecentric filter comprises a plurality of linear fifth wires.
  • the ends of the plurality of fifth mesh lines near the telecentric end converge at the telecentric end.
  • An end of each of the fifth network wires remote from the telecentric end is connected to the support segment.
  • the body portion further includes a support section coupled between the proximal end filter and the telecentric filter.
  • the support section includes a plurality of straight rods.
  • the straight rod is generally parallel to the longitudinal central axis of the filter.
  • the number of the straight rods is plural, and the lengths of the plurality of straight rods are the same.
  • the width of the straight rod in the circumferential direction of the filter is greater than the circumferential direction of the filter in any of the proximal end filter and the distal end filter. width.
  • the support section further includes at least one curved rod.
  • One end of the curved rod is connected to the near-end filter and the other end is connected to the telecentric filter.
  • the straight rod and the curved rod are spaced apart in a circumferential direction of the filter.
  • the straight rod and the curved rod are not spaced apart from each other in the circumferential direction of the filter.
  • At least one of the straight rods is provided with at least one fixing anchor for fixing the filter.
  • One end of the fixing anchor is fixed to the straight rod, and the other end of the fixing anchor is a free end and extends toward the proximal end.
  • the angle between the anchor and the straight rod directly connected thereto is less than 90 degrees.
  • the vertical distance of the free end of the anchor to the straight rod directly connected to the fixed anchor is less than or equal to 3 mm.
  • the filter further comprises a recovery hook.
  • the recovery hook is disposed at a telecentric end or a proximal end of the main body portion.
  • the recovery hook is a tubular structure having an opening.
  • the opening direction of the recovery hook extends outward in the radial direction of the filter and is offset toward the main body portion.
  • the opening of the recovery hook has a width in a direction perpendicular to the opening that is greater than or equal to 1/5 of an outer diameter of the tubular structure of the recovery hook.
  • the opening of the recovery hook has a depth in a direction perpendicular to a longitudinal central axis of the filter that is less than or equal to 19/20 of an outer diameter dimension of the tubular structure of the recovery hook.
  • the material of the filter is a nickel titanium alloy.
  • the filter is formed by cutting a mesh line of the near-end end filter and the telecentric end filter on a nickel-titanium tube.
  • the invention has the following beneficial effects:
  • the taper of the near-end filter near the proximal end of the filter of the invention is smaller than the taper of the telecentric filter near the telecentric end of the filter, and the radial support force of the near-end filter is smaller than the radial support of the telecentric filter.
  • the radial support force of the near-end filter increases, which reduces the radial support force of the near-end filter and the radial support force of the telecentric filter.
  • the gap between the two reduces the possibility of filter skew, improves the efficiency of the filter plug, and reduces the risk of re-embedding after surgery.
  • FIGS. 1a-1b are schematic diagrams showing the overall structure of a filter according to a first embodiment of the present invention, the main body of the filter comprising a proximal end filter, a telecentric filter, and a proximal end filter and a telecentric end.
  • a support section of the filter, the near-end filter comprises a plurality of first diamond-shaped filter units; wherein, Figure 1a is a perspective view, Figure 1b is a front view;
  • Figure 1c is a cross-sectional view of the filter of Figure 1a in cross section with a longitudinal central axis of the filter;
  • Figure 1d is a partial front elevational view of the main body of the filter of Figure 1a;
  • Figure 1e is a projection view of the proximal end filter of the filter of Figure 1a in a cross section perpendicular to the longitudinal central axis of the filter;
  • Figure 1f is a projected area of a plurality of first rhombic filter units of the filter of Figure 1a in a cross section perpendicular to a longitudinal central axis of the filter and the filter is oriented perpendicular to a longitudinal central axis of the filter Schematic diagram of the ratio of the area of the circle corresponding to the outer diameter;
  • Figure 1g is a projection view of the telecentric end filter of the filter of Figure 1a in a cross section perpendicular to the longitudinal central axis of the filter;
  • Figure 2 is a schematic view showing the structure of the recovery hook of the filter of Figure 1a;
  • Figure 3 is a schematic view showing the structure of the anchor of the filter of Figure 1a;
  • Figure 4 is a schematic view of the filter of Figure 1a rotated about a fixed anchor
  • FIGS. 5a-5b are schematic diagrams showing the overall structure of a filter according to a second embodiment of the present invention.
  • the main body of the filter includes a proximal end filter, a telecentric filter, and a proximal end filter and a telecentric end. a support section of the filter; wherein, Figure 5a is a perspective view, and Figure 5b is a front view;
  • Figure 5c is a partial front elevational view of the main body of the filter of Figure 5a;
  • Figure 5d is a projection view of the telecentric end filter of the filter of Figure 5a in a cross section perpendicular to the longitudinal central axis of the filter;
  • Figure 6 is a developed image of the inferior vena cava taken after 14 days of implantation of the filter of Comparative Example 1 into the inferior vena cava.
  • the end of the filter near the heart, the blood outflow filter is referred to as the proximal end, and the end of the filter away from the heart and blood into the filter is referred to as the telecentric end.
  • the main body portion of the filter is cut and shaped by a nickel-titanium tube having an outer diameter of 0.2-4 mm. It can be understood that the filter can also be woven and shaped by a nickel-titanium wire having an outer diameter of 0.05-0.8 mm or a nickel-titanium flat belt having a width of 0.05-0.5 mm and a length of 0.15-1 mm.
  • the filter has superelastic and self-expanding properties.
  • the filter 100 of the first embodiment includes a main body portion 10 and a recovery hook 20 and a fixed anchor 30 disposed at one end of the main body portion 10 .
  • the body portion 10 has opposite proximal ends 101 and distal ends 102, including a proximal end filter 11 near the proximal end 101, a telecentric filter 12 near the telecentric end 102, and a proximal end filter.
  • the proximal end filter 11 is gathered by a plurality of mesh wires at the proximal end 101 to form a spatially tapered structure.
  • the telecentric filter 12 is converged by a plurality of mesh wires at the telecentric end 102 to form a spatially tapered structure.
  • Each wire can be straight, curved, or partially straight, with the rest being curved.
  • the network cable of the near-end filter 11 and the network cable of the telecentric filter 12 can also be an irregular curve or a combination of a curve and a straight line.
  • the taper of the proximal end filter 11 is such that the outer diameter dimension of the telecentric end of the proximal end filter 11 and the proximal end filter 11 have the longitudinal central axis of the filter 100 when the filter 100 is in the natural release state.
  • the ratio of the projection on the cross section along the longitudinal length of the longitudinal center axis of the filter 100; the taper of the telecentric end filter 12 is the outer diameter of the proximal end of the telecentric filter 12 when the filter 100 is naturally released.
  • the ratio of the projection of the telecentric filter 12 on the section having the longitudinal central axis of the filter 100 along the longitudinal length L2 of the longitudinal center axis of the filter 100, and the taper of the proximal end filter 11 is smaller than that of the telecentric filter 12 Taper.
  • the outer diameter dimension of the telecentric end of the proximal end filter 11 is equal to the outer diameter of the proximal end of the telecentric filter 12, and is equal to the longitudinal center axis of the filter 100 perpendicular to the filter 100.
  • the projection of the proximal end filter 11 on the section having the longitudinal central axis of the filter 100 along the longitudinal center axis of the filter 100 has a maximum length L1 greater than that of the telecentric end filter 12 in the longitudinal direction of the filter 100.
  • the projection on the section of the central axis is along the maximum length L2 of the longitudinal central axis of the filter 100.
  • the proximal end filter 11 near the proximal end 101 has a long length, and can buffer the blood flow from the distal end 102 to the main body 10 at a high speed, so that the thrombus enters the proximal end filter 11 in an orderly manner.
  • the eddy current is not formed to cause a large impact force on the near-end filter 11 to cause the filter 100 to be displaced.
  • the longer proximal cardiac filter 11 can ensure that the blood flow of the two renal veins to the thrombus of the proximal cardiac filter 11 produces a large enough area and a long enough scouring and cutting action to ensure the long-term vena cava. unobstructed.
  • the proximal end filter 11 includes a plurality of connected first Y-shaped units 110, each of the first Y-shaped units 110 including a first wire 111 and a fork extending from one end of the first wire.
  • the plurality of first mesh wires 111 of the plurality of first Y-shaped cells 110 converge at the proximal end 101, whereby the proximal-end filter 11 has a spatially tapered structure when the filter 100 is naturally released.
  • the end of the second wire of each first Y-shaped unit 110 away from the proximal end 101 is connected to the support section 13.
  • the distance from the projection point of the second network line 112 of each first Y-shaped unit 110 to the first network line 111 on the longitudinal central axis of the filter 100 to the proximal end 101 and the corresponding second network line 112 and support section 13 The ratio of the intersection of the intersection point on the longitudinal central axis of the filter 100 to the distance from the proximal end 101 ranges from 1:10 to 9:10. Specifically, in the present embodiment, the ratio is 1:2.
  • Each of the first wire 111 and the second wire 112 may be linear or curved, and may be partially curved, and the remaining portions are linear.
  • the proximal end filter 11 includes six linear first linear wires 111 of equal length and twelve linear second mesh wires 112 of equal length. The angle formed by each adjacent two first mesh wires 111 at the proximal end 101 is equal.
  • the distance h1 between the connection point A of the first wire 111 and the second wire 112 in the first Y-shaped unit 110 to the longitudinal central axis of the filter 100 is perpendicular to the filter 100.
  • the ratio of the dimension H at the outer diameter in the longitudinal central axis direction of the filter 100 is in the range of 1:10 to 7:16. Specifically, in the present embodiment, the ratio is 1:4.
  • the two first network lines 111 of each adjacent two first Y-type units 110 and the adjacent two second network lines 112 of the corresponding two first Y-type units 110 are enclosed.
  • a first diamond filter unit 113 is formed.
  • the projected area S1 of the plurality of first rhombic filter units 113 of the near-end filter 11 in a cross section perpendicular to the longitudinal central axis of the filter 100 and the longitudinal central axis direction of the filter 100 The ratio of the area S0 of the circle corresponding to the largest outer diameter is in the range of 1:10 to 9:10. Specifically, in the present embodiment, the ratio is 5.5:10.
  • the size of the first rhomboid filter unit 113 is moderate, the thrombus which causes pulmonary embolism can be sufficiently filtered, and the vascular obstruction caused by the interception of the large and small blood vessels is not ensured, and the long-term patency of the vein is ensured.
  • the telecentric filter 12 includes a plurality of connected second Y-shaped units 120.
  • Each of the second Y-shaped units 120 includes a third network line 121 and two fourth network lines 122 formed by a bifurcation extension of one end of the third network line.
  • a plurality of third mesh lines 121 of the plurality of second Y-shaped cells 120 converge at the telecentric end 102.
  • the telecentric end filter 12 has a spatially tapered configuration when the filter 100 is naturally released.
  • the end of the fourth wire 122 of each second Y-shaped unit 120 remote from the telecentric end 102 is connected to the support segment 13.
  • Each of the third mesh wires 121 and the fourth mesh wires 122 may be linear or curved, and may be partially curved, and the remaining portions are linear.
  • the telecentric end filter 12 includes six linear third network wires 121 of equal length and six linear fourth mesh wires 122 of equal length. The angle formed by each adjacent two third mesh wires 121 at the telecentric end 102 is equal.
  • the distance h2 between the connection point B of the third network line 121 and the fourth network line 122 in each second Y-shaped unit 120 to the longitudinal central axis of the filter 100 is with the filter 100.
  • the ratio of the dimension H at the outermost diameter perpendicular to the longitudinal central axis direction of the filter 100 ranges from 1:10 to 7:16. Specifically, in the present embodiment, the ratio is 1:8.
  • the main body portion 10 of the filter 100 has an asymmetrical structure as a whole, and the number of the first Y-shaped units 110 in the near-heart end filter 11 is the number of the second Y-shaped units 120 in the telecentric end filter 12. Twice, that is, the density of the network structure of the near-end filter 11 is greater than the density of the network structure of the telecentric filter 12.
  • the support section 13 includes six straight rods 131 of equal length.
  • Each of the straight rods 131 is substantially parallel to the longitudinal central axis of the filter 100 and evenly spaced along the circumferential direction of the filter 100.
  • the straight rod 131 can be directly connected to the proximal end filter 11 and the telecentric filter 12, and the straight rod 131 can also pass through the curved section between the proximal end filter 11 and the telecentric end filter 12. Connected.
  • each straight rod 131 in the circumferential direction of the filter 100 is greater than the width of any of the mesh lines of the proximal end filter 11 and the telecentric end filter 12 in the circumferential direction of the filter 100.
  • the width of each of the straight rods 131 in the circumferential direction of the filter 100 is 0.8 mm, and the width of the wire along the circumferential direction of the filter 100 is 0.4 mm.
  • one or more straight rods of the plurality of straight rods 131 may be replaced by the curved rods, as long as the taper of the near-end filter of the filter is smaller than the taper of the telecentric filter. . It can also be understood that, in other embodiments, at least one of the plurality of straight rods 131 may be connected to the near-end filter or the telecentric filter through at least one curved rod, as long as the filter is close to the center The taper of the end filter is smaller than the taper of the telecentric filter. It can also be understood that in other embodiments, a plurality of straight rods 131 may also have a straight rod omitted. In this case, a network cable of the near-end filter is directly connected to a network cable of the telecentric filter. Connected as long as the taper of the near-end filter of the filter is less than the taper of the telecentric filter.
  • the plurality of straight rods 131 and the curved rods may be spaced apart from each other in the circumferential direction of the filter. It can also be understood that in other embodiments, the straight rod 131 and the curved rod can also be distributed in the circumferential direction of the filter without spacing. For example, all the straight rods 131 can be sequentially distributed in the circumferential direction of the filter, and all the curved rods can follow the straight line. The rods 131 continue to be sequentially distributed in the circumferential direction of the filter, that is, the curved rods can be randomly arranged between the plurality of straight rods 131.
  • the structure of the curved rod may include one or more curved wavy lines.
  • the recovery hook 20 is disposed at the telecentric end 102 of the main body portion 10.
  • the connection of the recovery hook 20 to the grasper can remove the filter 100 implanted into the blood vessel from the blood vessel. Recovered in vitro.
  • the recovery hook 20 is a tubular structure having an opening.
  • the opening direction of the recovery hook 20 extends outward in the radial direction of the filter 100 and is offset toward the main body portion 10, that is, the angle ⁇ between the opening direction of the recovery hook 20 and the longitudinal central axis of the filter 100 is less than 90 degrees.
  • the width D of the opening of the recovery hook 20 in the direction perpendicular to the opening is greater than or equal to 1/5 of the outer diameter dimension d of the tubular structure of the recovery hook 20, so that the recovery device can easily catch the recovery hook 20.
  • the depth S of the opening of the recovery hook 20 in the direction perpendicular to the longitudinal central axis of the filter 100 is less than or equal to 19/20 of the outer diameter dimension d of the tubular structure of the recovery hook 20, so that when the recovery device catches the recovery hook 20, the recovery device The recovery hook 20 can be pulled into the recovery sheath.
  • the width D of the opening of the recovery hook 20 in the direction perpendicular to the opening is 1 mm
  • the depth S of the opening of the recovery hook 20 in the direction perpendicular to the longitudinal central axis of the filter 100 is 1.5 mm.
  • the filter 100 of the present embodiment When the filter 100 of the present embodiment is subjected to high-speed flushing of blood flow in a blood vessel, the filter 100 may be inclined. However, since the taper of the telecentric filter 12 near the telecentric end 102 is greater than the taper of the proximal end filter 11 near the proximal end 101, the proximal end 101 of the filter 100 will first contact the vessel wall when the filter 100 is skewed, thereby avoiding The recovery hook 20 at the telecentric end 102 is unable to catch the risk of recovery due to contact with the vessel wall.
  • the filter 100 of the present embodiment when the filter 100 of the present embodiment is implanted in a human body, the filter 100 in a radially contracted state is released from the sheath tube, and the radial support force of the proximal-end filter 11 which is released first is slightly small, so the release speed is slow.
  • the release position is found to be poor, the partially released proximal end filter 11 can be withdrawn from the sheath, the position of the sheath can be adjusted and released again, and the slowly released proximal end filter 11 will also adhere to the vessel wall, ensuring that The stability of the filter 100 after implantation.
  • the filter 100 further includes a fixing anchor 30.
  • the anchor 30 is disposed on at least one of the straight rods 131 of the support section 13 and has an angle ⁇ of less than 90 degrees with the straight rod 131 directly connected thereto.
  • the anchor 30 has an elongated shape, one end of which is fixed to the straight rod 131, and the other end is a free end and extends toward the proximal end 101.
  • the vertical distance of the free end of the anchor 30 to the straight rod 131 directly connected to the fixed anchor 30 is less than or equal to 3 mm.
  • the straight rod 131 of the support section 13 supports the vessel wall, and the anchor anchor 30 penetrates the vessel wall, further providing a reliable fixation for the filter 100, preventing the filter 100 from moving in the blood vessel.
  • two or more fixing anchors 30 can be disposed on one straight rod 131 according to actual needs.
  • the fixed anchor 30 can also be disposed on the curved rod according to actual needs.
  • the filter 100 of the present embodiment when the filter 100 of the present embodiment is subjected to high-speed flushing of blood flow in a blood vessel, the filter 100 may be inclined. However, since the taper of the telecentric end filter 12 near the telecentric end 102 is greater than the taper of the proximal end filter 11 near the proximal end 101, the radial support force of the telecentric end filter 12 is large, which facilitates fixing the anchor 30 away from the far side. The free end of the heart end 102 penetrates the vessel wall. When the filter 100 is flushed by the blood flow, the filter 100 will only rotate at a small angle around the fixed anchor 30 without displacement, ensuring stability of the filter 100 after implantation.
  • the filter 100 is implanted into the inferior vena cava by percutaneous puncture of the femoral vein, and the X-ray developing device detects that the filter 100 is not tilted, displaced or inverted after being implanted into the inferior vena cava.
  • the filter 100 was taken out after 14 days of implantation, and the patient did not have symptoms such as abdominal pain, that is, the filter 100 was not damaged when the filter 100 was taken out.
  • the filter 200 includes a main body portion 40 and a recovery hook 50 provided at one end of the main body portion 40 and a fixing anchor 60.
  • the body portion 40 has opposite proximal ends 401 and distal ends 402, including a proximal end filter 41 near the proximal end 401, a telecentric filter 42 near the telecentric end 402, and a proximal end filter.
  • the filter 200 differs from the filter 100 in that the structure of the telecentric filter 42 is different from the structure of the telecentric filter 12.
  • the telecentric filter 42 of the present embodiment is different from the telecentric filter 42 of the first embodiment in that the telecentric filter 42 comprises six linear types.
  • the fifth network cable 421, the ends of the six fifth network cables 421 near the telecentric end 402 converge at the telecentric end 402.
  • the telecentric end filter 42 has a spatially tapered configuration when the filter 200 is naturally released.
  • the angle formed by each of the fifth mesh wires 421 at the telecentric end 402 is equal.
  • the end of each of the fifth wire 421 remote from the telecentric end 402 is connected to the proximal end filter 41.
  • Each of the fifth network wires 421 may be linear or curved, and may be partially curved, and the remaining portions are linear.
  • the filter 200 is implanted into the inferior vena cava by percutaneous puncture of the femoral vein, and the X-ray developing device detects that the filter 200 has not been tilted, displaced or inverted after being implanted into the inferior vena cava.
  • the filter 200 was taken out after 14 days of implantation, and the patient did not have symptoms such as abdominal pain, that is, the filter 200 was not damaged when the container 200 was taken out.
  • the filter of the present invention when cut and shaped by a nickel-titanium tube having an outer diameter d, the plurality of strips of the near-end filter and the telecentric filter can be cut on the same nickel-titanium tube.
  • the width of each straight rod along the circumferential direction of the filter is less than 1/2 of the outer diameter dimension d of the nickel-titanium tube, and the width of the straight rod along the circumferential direction of the filter is greater than the composition of the near-end filter and the telecentric filter.
  • the width of the curved segment and/or the straight segment of the wire along the circumferential direction of the filter are examples of the width of the curved segment and/or the straight segment of the wire along the circumferential direction of the filter.
  • the recovery hook When the filter is cut and shaped by a nickel-titanium tube having an outer diameter d, the recovery hook can be integrally formed with the main body of the filter, that is, the recovery hook can be directly cut at the end of the nickel-titanium tube.
  • the recovery hook When the filter is woven and shaped by using a nickel-titanium wire or a nickel-titanium flat belt, the recovery hook may also be a nickel-titanium tube having an opening and an outer diameter d, which may be adjacent to the proximal end of the main body of the filter or The telecentric end is connected by welding.
  • the recovery hook may also be disposed at the proximal end of the main body portion according to actual needs, as long as the delivery device of the delivery filter can place the filter at a predetermined position of the blood vessel, and the recovery device of the recovery filter can be connected with the recovery hook, and Recover the filter and withdraw it from the blood vessel.
  • the filter of the present invention may also be made of other superelastic materials (for example, stainless steel wire, cobalt-chromium-nickel-molybdenum-iron alloy, cobalt-chromium alloy or polymer), or may be self-expanding. Any other suitable material is formed.
  • the filter of the present invention after the filter of the present invention is implanted into a blood vessel of a human body and naturally released in a blood vessel, the taper of the near-end filter near the proximal end of the filter is smaller than the taper of the telecentric filter near the distal end of the filter, near The radial support force of the cardiac filter is less than the radial support force of the telecentric filter.
  • the filter of the present invention has the following advantages: 1) when the emboli is intercepted by the near-end filter, the radial support force of the near-end filter increases, and the near-end filter is reduced.
  • the difference between the radial supporting force and the radial supporting force of the telecentric filter reduces the possibility of filter skew, improves the efficiency of the filter plug, and reduces the risk of re-embedding of the patient after surgery;
  • the filter in the radial contraction state is released from the sheath tube, and the radial support force of the proximal-end filter that is released first is slightly smaller, so the release speed is Slowly, when the release position is found to be poor, the partially released proximal end filter can be retracted from the sheath, the position of the sheath can be adjusted and released again, and the slowly released proximal end filter will also adhere to the vessel wall, ensuring the filter.
  • the radial support force of the telecentric filter is slightly larger, and the filter will be quickly ejected from the sheath when it is released.
  • the anchor will receive a greater rebound force, and the free end of the anchor will penetrate.
  • the strength of the blood vessels is greater, ensuring the filter planting Post-stability;
  • the length of the proximal-end filter is greater than the length of the telecentric filter, which allows multiple thrombi to enter the proximal-end filter in an orderly manner, avoiding multiple thrombus at the entrance of the near-end filter.
  • the occurrence of eddy currents avoids the occurrence of eddy current impact on the filter body, reducing the possibility of filter skew; 5)
  • the near-end filter includes a plurality of diamond-shaped filter units of moderate size, and the sizes are moderate.
  • the rhomboid filter unit can not only fully filter the thrombus, but also avoid the occurrence of vascular obstruction due to the interception of large and small blood clots, ensuring long-term patency of the vein.
  • the structure of the filter of the first embodiment is substantially the same as the structure of the filter 100 of the first embodiment, and includes a near-end filter near the proximal end, a telecentric filter near the telecentric end, and a filter connected to the proximal end and the far end.
  • the filter of Comparative Example 1 was implanted into the inferior vena cava by percutaneous puncture of the femoral vein using a delivery sheath. Since the taper of the near-end filter is larger than the taper of the telecentric filter, the radial support force of the near-end filter is greater than the radial support of the telecentric filter. After implantation, the near-end filter intercepts the emboli in the blood, and the gap gradually increases, eventually causing the filter to be skewed, affecting the filtration efficiency of the filter; and, due to the skew of the filter, the partial anchor is caused. The position where the free end is in contact with the blood vessel wall is unstable.
  • the anchor anchor During the breathing, due to the change of the abdominal cavity pressure, the anchor anchor penetrates and pulls out the blood vessel wall several times, causing the blood vessel at the position to be punctured, and the patient has symptoms such as abdominal pain. After the detection by the developing device, the patient developed abdominal hematoma, and the filter was taken out in advance, and the expected therapeutic effect was not achieved.
  • the blood is exuded to form a hematoma after the blood vessel wall of the inferior vena cava is punctured at the implantation position before the filter of the inferior vena cava is removed by the developing device. From this, it can be seen that the filter of the present comparative example caused damage to the blood vessel after implantation.

Landscapes

  • 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)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)

Abstract

一种滤器(100)包括近心端过滤网(11)、远心端过滤网(12)和支撑段(13)，近心端过滤网(11)靠近近心端(101)，远心端过滤网(12)靠近远心端(102)，支撑段(13)连接于近心端过滤网(11)和远心端过滤网(12)之间，近心端过滤网(11)的锥度小于远心端过滤网(12)的锥度。近心端过滤网(11)的径向支撑力小于远心端过滤网(12)的径向支撑力，当血栓被拦截于近心端过滤网(11)时，近心端过滤网(11)的径向支撑力增大，减小了滤器(100)歪斜的可能，提高了滤器(100)过滤血栓的效率，降低了术后再次发生栓塞的风险。

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（简称：PE）是指体循环的各种栓子脱落阻塞肺动脉及其分支引起肺循环障碍的临床病理生理综合症，具有发病率高、发病急、病死率高等特点。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%，按照我国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。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。滤器在临床上被证实为预防肺栓塞的安全有效的手段，可降低肺栓塞的发生率。滤器被植入到下腔静脉中，防止下肢脱落的血栓顺着血流到达肺部，从而预防肺栓塞。
现有的滤器待栓子被拦截于近心端滤网时，易发生歪斜。而歪斜的滤器过滤栓子的效率降低，增加了术后病患再次栓塞的风险。
【发明内容】
本发明的目的在于，针对上述现有技术的不足，提供一种滤器。本发明滤器靠近滤器近心端的近心端过滤网的锥度小于靠近滤器远心端的远心端过滤网的锥度，近心端过滤网的径向支撑力小于远心端过滤网的径向支撑力。待栓子被拦截于近心端过滤网时，近心端过滤网的径向支撑力增大，缩小了近心端过滤网的径向支撑力与远心端过滤网的径向支撑力之间的差距，减小了滤器歪斜的可能，提高了滤器过滤栓子的效率，减低了术后病患再次栓塞的风险。
本发明提供一种滤器，其包括具有相对的近心端及远心端的主体部。所述主体部包括位于所述近心端及远心端之间且相连的近心端过滤网及远心端过滤网。在所述滤器自然释放的状态下，所述近心端过滤网和远心端过滤网均为多条网线构成的空间锥形结构。所述近心端过滤网的锥度小于所述远心端过滤网的锥度。
在其中一个实施例中，所述近心端过滤网包括多个相连的第一Y型单元。每个第一Y型单元均包括第一网线和由所述第一网线一端分叉延伸形成的两条第二网线。多个所述第一Y型单元的所述多条第一网线在所述近心端处汇聚。每个所述第一Y型单元的所述第二网线远离近心端的端部均与所述远心端过滤网相连。
在其中一个实施例中，在所述滤器自然释放的状态下，任一所述第一Y型单元中的所述第一网线与第二网线的连接点到所述滤器的纵向中心轴的距离与所述滤器在垂直于所述滤器的纵向中心轴方向上的外径最大处的尺寸的比值范围为1:10至7:16。
在其中一个实施例中，每相邻两个所述第一Y型单元的两条所述第一网线和相应的两个所述第一Y型单元的相邻的两条第二网线围合形成一个第一菱形过滤单元。在所述滤器自然释放的状态下，所述滤器的多个第一菱形过滤单元在垂直于所述滤器的纵向中心轴的横截面上的投影面积与所述滤器在垂直于所述滤器的纵向中心轴方向上的最大外径所对应的圆的面积之比范围为1:10至9:10。
在其中一个实施例中，所述远心端过滤网包括多个相连的第二Y型单元。每个第二Y型单元均包括第三网线和由所述第三网线一端分叉延伸形成的两条第四网线。多个所述第二Y型单元的多条第三网线在所述远心端处汇聚。每个第二Y型单元的的所述第四网线远离所述远心端的端部均与所述近心端过滤网相连。
在其中一个实施例中，在所述滤器自然释放的状态下，任一所述第二Y型单元中的所述第三网线与第四网线的连接点到所述滤器的纵向中心轴的距离与所述滤器自然释放后所述滤器在垂直于所述滤器的纵向中心轴方向上的外径最大处的尺寸的比值范围为1:10至7:16。
在其中一个实施例中，所述远心端过滤网包括多条直线型的第五网线。所述多条第五网线靠近所述远心端的端部在所述远心端处汇聚。每条所述第五网线的远离所述远心端的端部均与所述支撑段相连。
在其中一个实施例中，所述主体部还包括连接于所述近心端过滤网及远心端过滤网之间的支撑段。所述支撑段包括多根直杆。所述直杆大致平行于所述滤器的纵向中心轴。
在其中一个实施例中，所述直杆的数量为多根，且多根所述直杆的长度相同。
在其中一个实施例中，所述直杆沿所述滤器的周向方向的宽度大于所述近心端过滤网和所述远心端过滤网的任一网线沿所述滤器的周向方向的宽度。
在其中一个实施例中，所述支撑段还包括至少一根曲线型杆。所述曲线型杆的一端与所述近心端过滤网相连，另一端与所述远心端过滤网相连。
在其中一个实施例中，所述直杆和所述曲线型杆间隔分布于所述滤器的圆周方向。
在其中一个实施例中，所述直杆和所述曲线型杆不间隔分布于所述滤器的圆周方向。
在其中一个实施例中，至少一根所述直杆上设有至少一个用于固定所述滤器的固定锚。所述固定锚的一端固定于所述直杆上，所述固定锚的另一端为自由端且向所述近心端的方向延伸。
在其中一个实施例中，所述固定锚与与其直接相连的所述直杆之间的夹角小于90度。
在其中一个实施例中，所述固定锚的自由端至与其所在的所述固定锚直接相连的所述直杆的垂直距离小于或者等于3毫米。
在其中一个实施例中，所述滤器还包括回收钩。所述回收钩设置于所述主体部的远心端或近心端。所述回收钩为具有一开口的管状结构。所述回收钩的开口方向沿所述滤器的径向方向向外延伸且朝所述主体部偏移。所述回收钩的开口在垂直于所述开口方向上的宽度大于或等于所述回收钩的管状结构外径尺寸的1/5。所述回收钩的开口在垂直于所述滤器的纵向中心轴方向上的深度小于或等于所述回收钩的管状结构外径尺寸的19/20。
在其中一个实施例中，所述滤器的材料为镍钛合金。所述滤器通过在镍钛管上切割形成所述近心端过滤网和所述远心端过滤网的网线，并进行定型而成。
本发明与现有技术相比，具有以下有益效果：
本发明靠近滤器近心端的近心端过滤网的锥度小于靠近滤器远心端的远心端过滤网的锥度，近心端过滤网的径向支撑力小于远心端过滤网的径向支撑力。待栓子被拦截于近心端滤网时，近心端过滤网的径向支撑力增大，缩小了近心端过滤网的径向支撑力与远心端过滤网的径向支撑力之间的差距，减小了滤器歪斜的可能，提高了滤器过滤栓子的效率，减低了术后病患再次栓塞的风险。
【附图说明】
图1a-图1b为本发明第一实施例的滤器的整体结构示意图，所述滤器的主体部包括近心端过滤网、远心端过滤网和连接所述近心端过滤网和远心端过滤网的支撑段，所述近心端过滤网包括多个第一菱形过滤单元；其中，图1a为立体图，图1b为主视图；
图1c为图1a中所述滤器在具有滤器的纵向中心轴的截面上的剖视图；
图1d为图1a中所述滤器的主体部的局部结构主视图；
图1e为图1a中所述滤器的近心端过滤网在垂直于滤器的纵向中心轴的横截面上的投影图；
图1f为图1a中所述滤器的多个第一菱形过滤单元在垂直于所述滤器的纵向中心轴的横截面上的投影面积与所述滤器在垂直于所述滤器的纵向中心轴方向上的外径所对应的圆的面积之比示意图；
图1g为图1a中所述滤器的远心端过滤网在垂直于滤器的纵向中心轴的横截面上的投影图；
图2为图1a中的滤器的回收钩的结构示意图；
图3为图1a中的滤器的固定锚的结构示意图；
图4为图1a中的滤器绕着固定锚旋转的示意图；
图5a-图5b为本发明第二实施例的滤器的整体结构示意图，所述滤器的主体部包括近心端过滤网、远心端过滤网和连接所述近心端过滤网和远心端过滤网的支撑段；其中，图5a为立体图，图5b为主视图；
图5c为图5a中所述滤器的主体部的局部结构主视图；
图5d为图5a中所述滤器的远心端过滤网在垂直于滤器的纵向中心轴的横截面上的投影图；
图6为对比例一的滤器植入下腔静脉14天后取出，所述下腔静脉的显影图像。
【具体实施方式】
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本发明，并不用于限定本发明。
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文在说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本发明。
为了描述清晰，以下将滤器靠近心脏、血液流出滤器的一端称作近心端，将滤器远离心脏、血液流入滤器的一端称作远心端。
以下将结合具体实施例进一步详细说明本发明的技术方案。
实施例一
本实施例中滤器的主体部采用外径尺寸为0.2-4mm的镍钛管切割、定型而成。可以理解，滤器也可由外径尺寸为0.05-0.8mm的镍钛丝或宽为0.05-0.5mm，长度为0.15-1mm的镍钛扁带通过编织、定型而成。所述滤器具有超弹性和自膨胀特性。
请参阅图1a及图1b，实施例一的滤器100包括主体部10和设置于主体部10一端的回收钩20以及固定锚30。
主体部10具有相对的近心端101和远心端102，其包括靠近近心端101的近心端过滤网11、靠近远心端102的远心端过滤网12及连接于近心端过滤网11及远心端过滤网12之间的支撑段13。当滤器100在血管中自然释放后，支撑段13用于支撑血管壁，近心端过滤网11和远心端过滤网12用于过滤血栓。近心端过滤网11由多条网线在近心端101汇聚形成空间锥形结构。远心端过滤网12由多条网线在远心端102汇聚形成空间锥形结构。
每条网线可为直线型，或为曲线型，或部分为直线，其余部分为曲线型。
可以理解的是，近心端过滤网11的网线和远心端过滤网12的网线还可以为不规则曲线或曲线与直线的组合。
请参阅图1c，近心端过滤网11的锥度为滤器100在自然释放状态时，近心端过滤网11的远心端的外径尺寸与近心端过滤网11在具有滤器100的纵向中心轴的截面上的投影沿滤器100的纵向中心轴的最大长度L1之比；远心端过滤网12的锥度为滤器100在自然释放状态时，远心端过滤网12的近心端的外径尺寸与远心端过滤网12在具有滤器100的纵向中心轴的截面上的投影沿滤器100的纵向中心轴的最大长度L2之比，并且近心端过滤网11的锥度小于远心端过滤网12的锥度。优选地，本实施例中，近心端过滤网11的远心端的外径尺寸等于远心端过滤网12的近心端的外径尺寸，且均等于滤器100在垂直于滤器100的纵向中心轴方向上的外径最大处的尺寸H。
在滤器100自然释放时，近心端过滤网11在具有滤器100的纵向中心轴的截面上的投影沿滤器100的纵向中心轴的最大长度L1大于远心端过滤网12在具有滤器100的纵向中心轴的截面上的投影沿滤器100的纵向中心轴的最大长度L2。
靠近近心端101的近心端过滤网11长度较长，可以对由远心端102高速流入主体部10后的血流起到一定的缓冲作用，使血栓有序进入近心端过滤网11，不会形成涡流对近心端过滤网11造成较大冲击力导致滤器100移位。同时，较长的近心端过滤网11可以保证两股肾静脉回心血流对停留在近心端过滤网11的血栓产生足够大面积和足够长时间的冲刷切割作用，保证腔静脉的长期通畅。
请同时参阅图1d和1e，近心端过滤网11包括多个相连的第一Y型单元110，每个第一Y型单元110均包括第一网线111和由第一网线一端分叉延伸形成的两条第二网线112。多个第一Y型单元110的多条第一网线111在近心端101处汇聚，由此，当滤器100自然释放后，近心端过滤网11具有空间锥形结构。每个第一Y型单元110的第二网线远离近心端101的端部均与支撑段13相连。
每个第一Y型单元110的第二网线112与第一网线111的交点A在滤器100的纵向中心轴上的投影点到近心端101的距离与相应的第二网线112与支撑段13的交点在滤器100的纵向中心轴上的投影点到近心端101的距离之比范围为1:10至9:10。具体地，在本实施例中，该比值为1:2。
每条第一网线111和第二网线112皆可分别呈直线型，也可呈曲线型，还可部分呈曲线型，其余部分呈直线型。本实施例中，近心端过滤网11包括六条长度相等的直线型第一网线111和十二条长度相等的直线型第二网线112。每相邻两条第一网线111在近心端101处形成的夹角相等。
请继续参阅图1c，在滤器100自然释放时，第一Y型单元110中的第一网线111与第二网线112的连接点A到滤器100的纵向中心轴的距离h1与滤器100在垂直于滤器100的纵向中心轴方向上的外径最大处的尺寸H的比值范围为1:10至7:16。具体地，在本实施例中，该比值为1:4。
请同时参阅图1e和图1f，每相邻两个第一Y型单元110的两条第一网线111和相应的两个第一Y型单元110的相邻的两条第二网线112围合形成一个第一菱形过滤单元113。在所述滤器自然释放的状态下，近心端过滤网11的多个第一菱形过滤单元113在垂直于滤器100的纵向中心轴的横截面上的投影面积S1与滤器100的纵向中心轴方向上的最大外径所对应的圆的面积S0之比范围为1:10至9:10。具体地，在本实施例中，该比值为5.5:10。
由于第一菱形过滤单元113的尺寸适中，既能充分过滤会引起肺栓塞的血栓，也不存在由于大小血栓均被拦截造成血管阻塞的情况，保证了静脉的长期通畅。
请同时参阅图1d和图1g，远心端过滤网12包括多个相连的第二Y型单元120。每个第二Y型单元120均包括第三网线121和由第三网线一端分叉延伸形成的两条第四网线122。多个第二Y型单元120的多条第三网线121在远心端102处汇聚。由此，当滤器100自然释放后，远心端过滤网12具有空间锥形结构。每个第二Y型单元120的第四网线122远离远心端102的端部均与支撑段13相连。
每条第三网线121和第四网线122皆可分别呈直线型，也可呈曲线型，还可部分呈曲线型，其余部分呈直线型。本实施例中，远心端过滤网12包括六条长度相等的直线型第三网线121和六条长度相等的直线型第四网线122。每相邻两条第三网线121在远心端102处形成的夹角相等。
请继续参阅图1c，在滤器100自然释放时，每个第二Y型单元120中的第三网线121与第四网线122的连接点B到滤器100的纵向中心轴的距离h2与滤器100在垂直于滤器100的纵向中心轴方向上的外径最大处的尺寸H的比值范围为1:10至7:16。具体地，在本实施例中，该比值为1:8。
如上可知，滤器100的主体部10在整体上呈非对称结构，近心端过滤网11中的第一Y型单元110的数量为远心端过滤网12中的第二Y型单元120的数量的两倍，即近心端过滤网11的网状结构的密度大于远心端过滤网12的网状结构的密度。
请再次参阅图1a及图1b，支撑段13包括六根长度相等的直杆131。每根直杆131均大致平行于滤器100的纵向中心轴并且沿滤器100的圆周方向均匀间隔分布。
可以理解的是，直杆131可以与近心端过滤网11和远心端过滤网12直接连接，直杆131也可以与近心端过滤网11和远心端过滤网12之间通过曲线段相连。
每根直杆131沿滤器100的周向方向的宽度大于近心端过滤网11和远心端过滤网12的任一网线沿滤器100的周向方向的宽度。
在本实施例中，每根直杆131沿滤器100的周向方向的宽度为0.8毫米，网线沿滤器100的周向方向的宽度为0.4毫米。
可以理解的是，其他实施例中，多根直杆131中可以有一根或者多根直杆被曲线型杆替换，只要滤器的近心端过滤网的锥度小于远心端过滤网的锥度即可。还可以理解的是，其他实施例中，多根直杆131中可以有至少一根直杆通过至少一根曲线型杆与近心端过滤网或者远心端过滤网相连，只要滤器的近心端过滤网的锥度小于远心端过滤网的锥度即可。还可以理解的是，其他实施例中，多根直杆131中也可以有一根直杆省略不要，此时，近心端过滤网的一根网线直接与远心心端过滤网的一根网线直接相连，只要滤器的近心端过滤网的锥度小于远心端过滤网的锥度即可。
可以理解的是，其他实施例中，多根直杆131和曲线型杆可以间隔分布于滤器的圆周方向。还可以理解的是，其他实施例中，直杆131和曲线型杆也可以不间隔分布于滤器的圆周方向，例如全部直杆131可以顺序分布于滤器的圆周方向，全部曲线型杆可以跟随直杆131继续顺序分布于滤器的圆周方向，即曲线型杆可以随意排列于多根直杆131之间。
同时应当理解，曲线型杆的结构可以包括一个或多个弯曲的波状线。请参阅图2，本实施例中回收钩20设置于主体部10的远心端102处，利用回收钩20与抓捕器（图未示）的连接可以将植入血管中的滤器100从血管中回收至体外。回收钩20为具有一开口的管状结构。回收钩20的开口方向沿滤器100的径向方向向外延伸且朝主体部10偏移，即回收钩20的开口方向与滤器100的纵向中心轴之间的夹角β小于90度。回收钩20的开口在垂直于开口方向上的宽度D大于或等于回收钩20的管状结构外径尺寸d的1/5，从而回收装置可以方便地抓捕回收钩20。回收钩20的开口在垂直于滤器100的纵向中心轴方向上的深度S小于或等于回收钩20的管状结构外径尺寸d的19/20，从而当回收装置抓捕回收钩20后，回收装置可以将回收钩20拉进回收鞘管。在本实施例中，回收钩20的开口在垂直于开口方向上的宽度D为1mm，回收钩20的开口在垂直于滤器100的纵向中心轴方向上的深度S为1.5mm。
当本实施例的滤器100在血管中受到血流高速冲刷时，滤器100可能会倾斜。但是由于靠近远心端102的远心端过滤网12的锥度大于靠近近心端101的近心端过滤网11的锥度，因此滤器100出现歪斜时近心端101会先接触血管壁，避免了位于远心端102处的回收钩20因接触血管壁而无法抓捕回收的风险。此外，当本实施例的滤器100在植入人体时，处于径向收缩状态的滤器100由鞘管中释放，先行释放的近心端过滤网11的径向支撑力稍小，因此释放速度缓慢，当发现释放位置不佳时可以将部分释放的近心端过滤网11收回鞘管，调整鞘管位置后再次释放，而缓慢释放的近心端过滤网11也会贴紧血管壁，保证了滤器100植入后的稳定性。
请参阅图3，本实施例中，滤器100还包括固定锚30。固定锚30设置于支撑段13的至少一根直杆131上，并与与其直接相连的直杆131之间的夹角α小于90度。固定锚30呈长条状，其一端固定在直杆131上，另一端为自由端且向近心端101的方向延伸。固定锚30的自由端至与其所在的固定锚30直接相连的直杆131的垂直距离小于或者等于3毫米。由此，当滤器100在血管内自然释放后，支撑段13的直杆131支撑着血管壁，固定锚30刺入血管壁，进一步地为滤器100提供可靠固定，防止滤器100在血管中产生移位。可以理解的是，一根直杆131上可以根据实际需要设置两个或者更多个固定锚30。可以理解的是，当支撑段13里面有曲线型杆时，固定锚30也可以根据实际需要设置于曲线型杆上。
请参阅图4，本实施例的滤器100在血管中受到血流高速冲刷时，滤器100可能会倾斜。但是由于靠近远心端102的远心端过滤网12锥度大于靠近近心端101的近心端过滤网11锥度，远心端过滤网12的径向支撑力较大，利于固定锚30远离远心端102的自由端刺入血管壁。当滤器100受到血流冲刷时，滤器100仅会绕着固定锚30小角度旋转，而不移位，保证了滤器100植入后的稳定性。
滤器100采用输送鞘管经皮穿刺股静脉植入下腔静脉中，通过X射线显影设备检测出滤器100在植入下腔静脉后，没有产生倾斜、移位或翻转。滤器100植入14天后取出，患者未出现腹痛等不适症状，即滤器100取出时未对血管内壁造成损伤。
实施例二
请参阅图5a，本实施例的滤器200的结构与实施例一的滤器100的结构大致相同。滤器200包括主体部40和设置于主体部40一端的回收钩50以及固定锚60。主体部40具有相对的近心端401和远心端402，其包括靠近近心端401的近心端过滤网41、靠近远心端402的远心端过滤网42及连接于近心端过滤网41与远心端过滤网42之间的支撑段43。滤器200与滤器100的区别之处在于：远心端过滤网42的结构不同于远心端过滤网12的结构。
请同时参阅图5b、图5c和和图5d，本实施例的远心端过滤网42与第一实施例的远心端过滤网42的区别在于，远心端过滤网42包括六条直线型的第五网线421，六条第五网线421靠近远心端402的端部在远心端402处汇聚。由此，当滤器200自然释放后，远心端过滤网42具有空间锥形结构。每条第五网线421在远心端402处形成的夹角相等。每条第五网线421的远离远心端402的端部均与近心端过滤网41相连。
每条第五网线421可分别呈直线型，也可呈曲线型，还可部分呈曲线型，其余部分呈直线型。
滤器200采用输送鞘管经皮穿刺股静脉植入下腔静脉中，通过X射线显影设备检测出滤器200在植入下腔静脉后，没有产生倾斜、移位或翻转。滤器200植入14天后取出，患者未出现腹痛等不适症状，即滤器200取出时未对血管内壁造成损伤。
可以理解的是，当本发明的滤器采用外径尺寸为d的镍钛管切割、定型制备时，可以在同一根镍钛管上切割形成近心端过滤网和远心端过滤网的多条网线和支撑段的直杆。每根直杆沿滤器的周向方向的宽度小于镍钛管的外径尺寸d的1/2，且直杆沿滤器的周向方向的宽度大于组成近心端过滤网和远心端过滤网的网线的曲线段和/或直线段沿滤器的周向方向的宽度。
当滤器采用外径尺寸为d的镍钛管切割、定型而成时，回收钩可以与滤器的主体部一体成型，即回收钩可以直接在镍钛管的端部切割一开口而成。当滤器采用镍钛丝或镍钛扁带通过编织、定型而成时，回收钩也可以为一具有开口且外径尺寸为d的镍钛管，其可以与滤器的主体部的近心端或远心端通过焊接的方式连接为一体。
也应当理解，回收钩也可以根据实际需要设置于主体部的近心端处，只要输送滤器的输送装置可以将滤器放于血管的预定位置处，且回收滤器的回收装置可以连接回收钩，并将滤器回收并退出血管即可。
可以理解的是，本发明的滤器还可以采用其他超弹性材料（例如，不锈钢丝、钴-铬-镍-钼-铁合金、钴-铬合金或聚合物）制成，也可以由具有自膨胀的任何其它合适材料形成。
综上所述，本发明的滤器植入至人体血管，并在血管中自然释放后，靠近滤器近心端的近心端过滤网的锥度小于靠近滤器远心端的远心端过滤网的锥度，近心端过滤网的径向支撑力小于远心端过滤网的径向支撑力。与现有技术相比，本发明的滤器的优点是：1）待栓子被拦截于近心端过滤网时，近心端过滤网的径向支撑力增大，缩小了近心端过滤网的径向支撑力与远心端过滤网的径向支撑力之间的差距，减小了滤器歪斜的可能，提高了滤器过滤栓子的效率，减低了术后病患再次栓塞的风险；2）在回收钩设于远心端处的滤器被植入人体时，处于径向收缩状态的滤器由鞘管中释放，先行释放的近心端过滤网的径向支撑力稍小，因此释放速度缓慢，当发现释放位置不佳时可以将部分释放的近心端过滤网收回鞘管，调整鞘管位置后再次释放，而缓慢释放的近心端过滤网也会贴紧血管壁，保证了滤器植入后的稳定性；3）远心端过滤网的径向支撑力稍大，滤器释放时会由鞘管中快速弹出，固定锚会受到更大的反弹力，固定锚的自由端刺入血管的力度更大，保证了滤器植入后的稳定性；4）近心端过滤网长度大于远心端过滤网长度，可以使多个血栓有序地进入近心端过滤网，避免了多个血栓在近心端过滤网入口处引起涡流的情况的发生，也就避免了涡流对滤器主体产生冲击的情况的发生，减小了滤器歪斜的可能；5）近心端过滤网包括多个尺寸适中的菱形过滤单元，多个尺寸适中的菱形过滤单元既能充分过滤血栓，也避免了由于大小血栓均被拦截造成血管阻塞的情况的发生，保证了静脉的长期通畅。
对比例一
对比例一的滤器的结构与实施例一的滤器100的结构大致相同，其包括靠近近心端的近心端过滤网、靠近远心端的远心端过滤网及连接于近心端过滤网及远心端过滤网之间的支撑段。区别之处在于，当对比例一的滤器在血管中自然释放后，近心端过滤网的锥度大于远心端过滤网的锥度。
对比例一的滤器采用输送鞘管经皮穿刺股静脉植入下腔静脉中。由于近心端过滤网的锥度大于远心端过滤网的锥度，因此近心端过滤网的径向支撑力大于远心端过滤网的径向支撑力。而在植入后，近心端过滤网拦截下血液中的栓子，这种差距逐渐增大，最终导致滤器歪斜，影响了滤器的过滤效率；并且，由于滤器发生歪斜，导致部分固定锚的自由端和血管壁接触的位置不稳定，在呼吸时，由于腹腔压力的变化，固定锚多次刺入和拔出血管壁，导致该位置血管被刺破，患者出现腹痛等不适症状。经显影设备检测，患者发生腹部血肿，滤器被提前取出，没有达到预期的治疗效果。
请参阅图6，经显影设备检测，在下腔静脉的该滤器未取出前的植入位置处，下腔静脉的血管壁被刺破后血液外流形成血肿。由此可知，本对比例的滤器在植入后对血管造成了损伤。
以上结合附图对本发明的实施例进行了描述，但是本发明并不局限于上述的具体实施方式，上述的具体实施方式仅仅是示意性的，而不是限制性的，本领域的普通技术人员在本发明的启示下，在不脱离本发明宗旨和权利要求所保护的范围情况下，还可做出很多形式，这些均属于本发明的保护之内。

Claims (18)

  1. 一种滤器，所述滤器包括具有相对的近心端及远心端的主体部，所述主体部包括位于所述近心端及远心端之间且相连的近心端过滤网及远心端过滤网，在所述滤器自然释放的状态下，所述近心端过滤网和远心端过滤网均为多条网线构成的空间锥形结构，其特征在于，所述近心端过滤网的锥度小于所述远心端过滤网的锥度。
  2. 根据权利要求1所述的滤器，其特征在于，所述近心端过滤网包括多个相连的第一Y型单元，每个第一Y型单元均包括第一网线和由所述第一网线一端分叉延伸形成的两条第二网线，多个所述第一Y型单元的所述多条第一网线在所述近心端处汇聚，每个所述第一Y型单元的所述第二网线远离近心端的端部均与所述远心端过滤网相连。
  3. 根据权利要求2所述的滤器，其特征在于，在所述滤器自然释放的状态下，任一所述第一Y型单元中的所述第一网线与第二网线的连接点到所述滤器的纵向中心轴的距离与所述滤器在垂直于所述滤器的纵向中心轴方向上的外径最大处的尺寸的比值范围为1:10至7:16。
  4. 根据权利要求2所述的滤器，其特征在于，每相邻两个所述第一Y型单元的两条所述第一网线和相应的两个所述第一Y型单元的相邻的两条第二网线围合，形成一个第一菱形过滤单元，在所述滤器自然释放的状态下，所述滤器的多个所述第一菱形过滤单元在垂直于所述滤器的纵向中心轴的横截面上的投影面积与所述滤器在垂直于所述滤器的纵向中心轴方向上的最大外径所对应的圆的面积之比范围为1:10至9:10。
  5. 根据权利要求1所述的滤器，其特征在于，所述远心端过滤网包括多个相连的第二Y型单元，每个第二Y型单元均包括第三网线和由所述第三网线一端分叉延伸形成的两条第四网线，多个所述第二Y型单元的多条第三网线在所述远心端处汇聚，每个第二Y型单元的的所述第四网线远离所述远心端的端部均与所述近心端过滤网相连。
  6. 根据权利要求5所述的滤器，其特征在于，在所述滤器自然释放的状态下，任一所述第二Y型单元中的所述第三网线与第四网线的连接点到所述滤器的纵向中心轴的距离与所述滤器自然释放后所述滤器在垂直于所述滤器的纵向中心轴方向上的外径最大处的尺寸的比值范围为1:10至7:16。
  7. 根据权利要求1所述的滤器，其特征在于，所述远心端过滤网包括多条直线型的第五网线，所述多条第五网线靠近所述远心端的端部在所述远心端处汇聚，每条所述第五网线的远离所述远心端的端部均与所述近心端过滤网相连。
  8. 根据权利要求1所述的滤器，其特征在于，所述主体部还包括连接于所述近心端过滤网及远心端过滤网之间的支撑段，所述支撑段包括多根直杆，所述直杆大致平行于所述滤器的纵向中心轴。
  9. 根据权利要求8所述的滤器，其特征在于，所述直杆的数量为多根，且多根所述直杆的长度相同。
  10. 根据权利要求8所述的滤器，其特征在于，所述直杆沿所述滤器的周向方向的宽度大于所述近心端过滤网和所述远心端过滤网的任一网线沿所述滤器的周向方向的宽度。
  11. 根据权利要求8所述的滤器，其特征在于，所述支撑段还包括至少一根曲线型杆，所述曲线型杆的一端与所述近心端过滤网相连，另一端与所述远心端过滤网相连。
  12. 根据权利要求11所述的滤器，其特征在于，所述直杆和所述曲线型杆间隔分布于所述滤器的圆周方向。
  13. 根据权利要求11所述的滤器，其特征在于，所述直杆和所述曲线型杆不间隔分布于所述滤器的圆周方向。
  14. 根据权利要求8所述的滤器，其特征在于，至少一根所述直杆上设有至少一个用于固定所述滤器的固定锚，所述固定锚的一端固定于所述直杆上，所述固定锚的另一端为自由端且向所述近心端的方向延伸。
  15. 根据权利要求14所述的滤器，其特征在于，所述固定锚与与其直接相连的所述直杆之间的夹角小于90度。
  16. 根据权利要求14所述的滤器，其特征在于，所述固定锚的自由端至与其所在的所述固定锚直接相连的所述直杆的垂直距离小于或者等于3毫米。
  17. 根据权利要求1所述的滤器，其特征在于，所述滤器还包括回收钩，所述回收钩设置于所述主体部的远心端或近心端；所述回收钩为具有一开口的管状结构，所述回收钩的开口方向沿所述滤器的径向方向向外延伸且朝所述主体部偏移；所述回收钩的开口在垂直于所述开口方向上的宽度大于或等于所述回收钩的管状结构外径尺寸的1/5，所述回收钩的开口在垂直于所述滤器的纵向中心轴方向上的深度小于或等于所述回收钩的管状结构外径尺寸的19/20。
  18. 根据权利要求1所述的滤器，其特征在于，所述滤器的材料为镍钛合金，所述滤器通过在镍钛管上切割形成所述近心端过滤网和所述远心端过滤网的网线，并进行定型而成。
PCT/CN2016/086117 2015-12-29 2016-06-17 滤器 Ceased WO2017113633A1 (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201511024970.6A CN105662646A (zh) 2015-12-29 2015-12-29 滤器
CN201511024970.6 2015-12-29

Publications (1)

Publication Number Publication Date
WO2017113633A1 true WO2017113633A1 (zh) 2017-07-06

Family

ID=56189866

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2016/086117 Ceased WO2017113633A1 (zh) 2015-12-29 2016-06-17 滤器

Country Status (2)

Country Link
CN (1) CN105662646A (zh)
WO (1) WO2017113633A1 (zh)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113633431A (zh) * 2020-05-11 2021-11-12 上海蓝脉医疗科技有限公司 滤器
CN113940783A (zh) * 2020-07-15 2022-01-18 先健科技(深圳)有限公司 血栓拦截器械
CN113940784A (zh) * 2020-07-15 2022-01-18 先健科技(深圳)有限公司 血栓拦截器械

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105662646A (zh) * 2015-12-29 2016-06-15 先健科技(深圳)有限公司 滤器
CN108013951B (zh) * 2016-11-02 2021-06-04 先健科技(深圳)有限公司 滤器
CN108125729B (zh) * 2016-12-01 2020-10-27 先健科技(深圳)有限公司 滤器
CN108143518B (zh) * 2016-12-06 2020-10-27 先健科技(深圳)有限公司 滤器
CN108143517B (zh) * 2016-12-06 2024-07-05 先健科技(深圳)有限公司 滤器
CN107374777A (zh) * 2017-08-25 2017-11-24 重庆医科大学附属第二医院 一种易于回收且安全的临时腔静脉滤网
CN111412498B (zh) * 2019-01-04 2022-05-17 宁波方太厨具有限公司 一种用于吸油烟机的折叠式滤网
CN110226989B (zh) * 2019-06-24 2024-04-02 内蒙古工业大学 一种涡流式腔静脉过滤器及滤器系统

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN2569770Y (zh) * 2002-09-28 2003-09-03 维科医疗器械(苏州)有限公司 一种可回收式血栓过滤器
US20150073470A1 (en) * 2013-09-09 2015-03-12 Cook Medical Technologies Llc Vena cava filter
CN104970900A (zh) * 2015-06-26 2015-10-14 深圳市科奕顿生物医疗科技有限公司 可回收血栓过滤器
CN204709071U (zh) * 2014-12-30 2015-10-21 先健科技(深圳)有限公司 滤器
CN105662646A (zh) * 2015-12-29 2016-06-15 先健科技(深圳)有限公司 滤器
CN205494083U (zh) * 2015-12-29 2016-08-24 先健科技(深圳)有限公司 滤器

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN2710575Y (zh) * 2004-04-23 2005-07-20 深圳市先健科技股份有限公司 可控释放的血栓过滤器
CN202568530U (zh) * 2012-04-30 2012-12-05 王志伟 双放双取腔静脉滤器及其释放系统的组合结构
US9308007B2 (en) * 2012-08-14 2016-04-12 W. L. Gore & Associates, Inc. Devices and systems for thrombus treatment
CN204181741U (zh) * 2014-10-13 2015-03-04 陈奕龙 腔静脉过滤器
CN205494080U (zh) * 2015-11-30 2016-08-24 先健科技(深圳)有限公司 滤器
CN205494082U (zh) * 2015-12-28 2016-08-24 先健科技(深圳)有限公司 滤器
CN205494081U (zh) * 2015-12-28 2016-08-24 先健科技(深圳)有限公司 滤器

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN2569770Y (zh) * 2002-09-28 2003-09-03 维科医疗器械(苏州)有限公司 一种可回收式血栓过滤器
US20150073470A1 (en) * 2013-09-09 2015-03-12 Cook Medical Technologies Llc Vena cava filter
CN204709071U (zh) * 2014-12-30 2015-10-21 先健科技(深圳)有限公司 滤器
CN104970900A (zh) * 2015-06-26 2015-10-14 深圳市科奕顿生物医疗科技有限公司 可回收血栓过滤器
CN105662646A (zh) * 2015-12-29 2016-06-15 先健科技(深圳)有限公司 滤器
CN205494083U (zh) * 2015-12-29 2016-08-24 先健科技(深圳)有限公司 滤器

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113633431A (zh) * 2020-05-11 2021-11-12 上海蓝脉医疗科技有限公司 滤器
CN113940783A (zh) * 2020-07-15 2022-01-18 先健科技(深圳)有限公司 血栓拦截器械
CN113940784A (zh) * 2020-07-15 2022-01-18 先健科技(深圳)有限公司 血栓拦截器械

Also Published As

Publication number Publication date
CN105662646A (zh) 2016-06-15

Similar Documents

Publication Publication Date Title
WO2017113633A1 (zh) 滤器
CN106037863B (zh) 左心耳封堵器及其制造方法
EP0942767B1 (en) Atraumatic anchoring and disengagement mechanism for permanent implant device
JP6873233B2 (ja) 虚血性脳卒中治療のための血餅回収装置
CA3022010C (en) An inferior vena cava filter
US8246650B2 (en) Removable vena cava filter
CA2580124C (en) Vein filter
JP2008532621A (ja) 血管内フィルタアセンブリ
WO2017063371A1 (zh) 滤器
WO2019033977A1 (zh) 滤器装置
US9987117B2 (en) Thromboembolic protection device
CN106913392A (zh) 滤器
Greenfield Evolution of venous interruption for pulmonary thromboembolism
CN219579135U (zh) 可回收的下腔静脉滤器
CN205494080U (zh) 滤器
CN205494083U (zh) 滤器
CN205729436U (zh) 左心耳封堵器
CN205494082U (zh) 滤器
CN108143518B (zh) 滤器
CN205198208U (zh) 滤器
CN105726158B (zh) 一种编织型腔静脉滤器及编织方法
CN205758765U (zh) 一种编织型腔静脉滤器
CN112120828A (zh) 一种腔静脉滤器
US11337789B2 (en) Inferior Vena Cava (IVC) filter and related methods
CN115337074A (zh) 一种具有血流导通功能的肺动脉栓塞取栓装置

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 16880441

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 16880441

Country of ref document: EP

Kind code of ref document: A1