WO2017113628A1 - 滤器 - Google Patents

滤器 Download PDF

Info

Publication number
WO2017113628A1
WO2017113628A1 PCT/CN2016/085741 CN2016085741W WO2017113628A1 WO 2017113628 A1 WO2017113628 A1 WO 2017113628A1 CN 2016085741 W CN2016085741 W CN 2016085741W WO 2017113628 A1 WO2017113628 A1 WO 2017113628A1
Authority
WO
WIPO (PCT)
Prior art keywords
filter
mesh
equal
wire
shaped
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/CN2016/085741
Other languages
English (en)
French (fr)
Inventor
李安宁
陈卓
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 WO2017113628A1 publication Critical patent/WO2017113628A1/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
    • 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

Definitions

  • the present invention relates to an implantable medical device, and more particularly to a filter.
  • Pulmonary embolism is a common disease with high mortality. According to statistics, the untreated pulmonary embolism mortality rate is 20%-30%, and the annual new cases account for about 0.2% of the population. With a population of 1.35 billion, China has about 2.7 million new patients each year.
  • Various thrombosis of the systemic circulation can cause pulmonary embolism. Trauma or fracture, trauma, large surgery, extensive burns, pregnancy, childbirth, long-term bed rest, long-distance ride or long-term sit-in, long-term meditation and squatting can make venous blood flow slow, blood Stasis, or increased platelets and clotting factors, increased blood adhesion, and thrombosis. These thrombi are generally slightly adhered to the wall of the tube and tend to fall off. Free emboli can cause serious diseases such as pulmonary embolism. Vena cava filters (hereinafter referred to as filters) have been clinically proven to be a safe and effective means of preventing pulmonary embolism, which can reduce the incidence of pulmonary embolism.
  • the thrombus should not easily leak out of the filter mesh after implantation into the inferior vena cava to prevent the filter from catching the thrombus; and the large and small blood clots must not be trapped outside the filter and difficult to enter the filter, resulting in the next The vena cava is blocked.
  • a filter comprising a body portion having a proximal end and a distal end, the body portion including a first filter between the proximal end and the telecentric end adjacent the proximal end, and the first a support segment connected by the filter and located between the first filter and the telecentric end;
  • the first filter comprises a plurality of Y-shaped units, each of the Y-shaped units comprising a first network cable And two second network lines connected to one end of the first network cable, the ends of the plurality of first network lines away from the second network line converge at the near-center end, each of the Y-shaped units being far away
  • the ends of the proximal ends are each connected to the support segment;
  • the number of the plurality of Y-shaped cells is 2n, n is a natural number and 2 ⁇ n ⁇ 6, the first of any of the Y-shaped cells
  • a distance between a connection point of the first wire and the second wire in the plurality of Y-shaped cells of the first filter to a longitudinal central axis of the filter is equal.
  • the filter further includes a second filter mesh between the telecentric end and the support segment and connected to the support segment, the second filter mesh comprising a plurality of mesh wires.
  • the second filter network includes a plurality of Y-shaped units, each of the Y-shaped units including a third network cable and two fourth network cables connected to one end of the third network cable.
  • the ends of the plurality of third network lines away from the fourth network line converge at the telecentric end, and the ends of each of the second filter nets away from the telecentric end are
  • the support segments are connected, the distance between the connection point of the third wire and the fourth wire in any of the Y-shaped units to the longitudinal central axis of the filter and the outside of the support segment after the filter is naturally released
  • the ratio of the diameter dimensions is greater than or equal to 1/10 and less than or equal to 7/16.
  • the number of the plurality of Y-shaped cells of the second filter mesh is half of the number of the plurality of Y-shaped cells of the first filter mesh.
  • a distance between a connection point of the third network line and the fourth network line of the plurality of Y-shaped units of the second filter to a longitudinal central axis of the filter is equal.
  • the support section includes a plurality of support rods, and the main body portion and/or the second filter mesh is formed by cutting the same nickel-titanium tube; the support rod is along the circumference of the filter The width in the direction of the direction is greater than the width of the mesh of the first filter and/or the second filter in the circumferential direction of the filter.
  • the filter further includes a recovery hook disposed at a telecentric end or a proximal end of the body portion; the recovery hook is a tubular structure having an opening, the recovery hook An opening direction extending outward in a radial direction of the filter and biased toward the main body portion; a width of the opening of the recycling hook in a direction perpendicular to the opening is greater than or equal to an outer diameter of the tubular structure of the recovery hook 1/5, the opening of the recovery hook has a depth in a direction perpendicular to the longitudinal central axis of the filter that is less than or equal to 19/20 of the outer diameter of the tubular structure of the recovery hook.
  • At least one of the support rods is provided with a fixed anchor, one end of the fixed anchor is fixed on the support rod, and the other end of the fixed anchor is a suspended end and is away from the recovery hook.
  • the direction extends and hangs; the angle between the fixed anchor and the support section is less than 90°, and the distance from the suspended end of the fixed anchor to the support section is less than 3 mm.
  • the distance between the connection point of the first wire and the second wire in the Y-shaped unit to the longitudinal central axis of the filter and the support segment after the filter is naturally released
  • the ratio of the outer diameter dimensions is greater than or equal to 1/10 and less than or equal to 7/16, whereby the filter pores formed by the filter are appropriately sized after the filter is released in the blood vessel, thereby preventing large thrombus leakage.
  • the patency rate of the blood vessels is ensured at the same time.
  • FIGS. 1a-1b are schematic diagrams showing the overall structure of a filter according to Embodiment 1 of the present invention, the filter comprising a main body portion, the main body portion including a first filter net, a second filter net, and a connection of the first filter net and the second a support section of the filter; wherein, Figure 1a is a front view, and Figure 1b is a perspective view;
  • Figure 2a - Figure 2b is a partial structural view of the main body of the filter of Figure 1a - Figure 1b, wherein Figure 2a is a front view and Figure 2b is a perspective view;
  • Figure 3 is a schematic view showing the structure of the first filter of the filter of Figures 1a - 1b along the longitudinal central axis of the filter;
  • Figure 4 is a schematic view showing the structure of the second filter of the filter of Figures 1a - 1b along the longitudinal central axis of the filter;
  • Figure 5 is a schematic illustration of the distance from the connection point in the first filter and the second filter of Figures 1a - 1b to the longitudinal central axis of the filter;
  • Figure 6 is a schematic view showing the structure of the recovery hook of the filter of Figures 1a - 1b;
  • Figure 7 is a schematic view showing the structure of the anchor of the filter of Figures 1a - 1b;
  • Figure 8 is a front elevational view of a filter according to Embodiment 2 of the present invention.
  • FIG. 9a-9b are schematic diagrams showing the overall structure of a filter according to Embodiment 3 of the present invention, wherein FIG. 9a is a front view and FIG. 9b is a perspective view;
  • FIG. 10a-10b are schematic structural views of a filter according to Embodiment 4 of the present invention, wherein FIG. 10a is a front view and FIG. 10b is a perspective view.
  • Figure 11a is a schematic view showing the structure of the first filter of the filter of Figures 10a - 10b along the longitudinal central axis of the filter;
  • Figure 11b is a schematic view showing the structure of the second filter of the filter of Figures 10a-10b along the longitudinal central axis of the filter;
  • FIG. 12a-12b are schematic structural views of a filter according to Embodiment 5 of the present invention, wherein FIG. 12a is a front view and FIG. 12b is a perspective view.
  • Figure 13a is a schematic view showing the structure of the first filter of the filter of Figures 12a - 12b along the longitudinal central axis of the filter;
  • Figure 13b is a schematic view of the second filter of the filter of Figures 12a-12b along the longitudinal central axis of the filter.
  • the end closer to the heart after the filter is implanted in the body is called the proximal end, and the end farther from the heart is called the telecentric end.
  • the filter provided by the invention 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 includes a body portion 10 having a proximal end 101 and a telecentric end 102.
  • the body portion 10 includes a proximal end 101 and a distal end 102 and is adjacent to the proximal end.
  • the second filter screen 12 is used for primary filtration of the thrombus
  • the first filter screen 11 is used for secondary filtration of the thrombus
  • the support section 13 is used for supporting the blood vessel wall to make the filter 100 After release, it can be stably and reliably located in the blood vessel, preventing the filter 100 from tilting in the blood vessel.
  • the support section 13 includes a plurality of support rods 131 equally spaced along the circumferential direction of the filter 100, and each of the support rods 131 is substantially parallel to the longitudinal central axis of the filter 100.
  • the support rod 131 can be a straight rod or a rod of other shapes, such as an irregular shape rod, a corrugated rod or the like combined with a straight line segment and a straight line segment, as long as the support rod 131 is substantially parallel to the filter 100.
  • the longitudinal center axis is sufficient.
  • the first filter screen 11 includes a plurality of Y-shaped units 111 each formed by a first mesh line 1111 and two second network lines 1112 connected to one end of the first network line 1111.
  • the ends of the plurality of first network lines 1111 of the plurality of Y-shaped units 111 away from the second network line 1112 converge at the proximal end 101, and the adjacent two second network lines 1112 of the adjacent two Y-shaped units 111 are distant from each other.
  • the ends of the ends 101 are each connected to the same support rod 131 of the support section 13.
  • ends of the adjacent two second mesh lines 1112 adjacent to the proximal end 101 of the adjacent two Y-shaped units 111 may be connected to the same point of the same support rod 131, or may be respectively connected to the same support rod 131. The different points are connected.
  • each of the first network cable 1111 and the second network cable 1112 can be linear, or curved, and partially curved, and the remaining portions are linear.
  • the first filter hole 113 is formed by the cooperation of two first mesh wires 1111 of two adjacent Y-shaped units 111 and two adjacent second mesh wires 1112.
  • the second filter hole is formed by the two second mesh wires 1112 of a Y-shaped unit 111 and the blood vessel wall. Both the first filter hole 113 and the second filter hole can capture a thrombus.
  • the second filter screen 12 includes a plurality of Y-shaped units 121 each formed by a third network cable 1211 and two fourth network wires 1212 connected to one end of the third network cable 1211.
  • the ends of the plurality of third mesh wires 1211 of the plurality of Y-shaped units 121 away from the fourth mesh wires 1212 converge at the telecentric end 102, and the ends of each of the fourth mesh wires 1212 away from the telecentric end 102 are connected to the support segments 13 The support bars 131 are connected.
  • the second filter mesh 12 has a tapered mesh structure, and the two fourth mesh wires 1212 of each Y-shaped unit 121 form a third filter hole with the blood vessel wall (Fig. Not shown), two third mesh lines 1211 and two adjacent fourth mesh wires 1212 and adjacent blood vessel walls of each adjacent two Y-shaped cells 121 form a fourth filter hole (not shown).
  • Each of the third wire 1211 and the fourth wire 1212 may be linear, or curved, and may be partially curved, and the remaining portions are linear. Therefore, the third filter hole is substantially triangular, and the fourth filter hole is substantially pentagonal. Both the third filter hole and the fourth filter hole can capture a thrombus.
  • the number of the plurality of Y-shaped cells 111 of the first filter 11 is 2n, n is a natural number and 2 ⁇ n ⁇ 6.
  • the number of the plurality of Y-shaped cells 121 of the second filter screen 12 is half of the number of the plurality of Y-shaped cells 111 of the first filter mesh 11, so that the density of the mesh structure of the first filter mesh 11 is greater than that of the second filter mesh 12 The density of the mesh structure.
  • the number of the plurality of support bars 131 of the support section 13 is equal to the number of the plurality of Y-shaped cells 111 of the first filter screen 11.
  • the first filter net 11 includes six Y-shaped units 111.
  • the lengths of the first network lines 1111 of the six Y-shaped units 111 are equal, and the lengths of the second network lines 1112 are equal, and each adjacent two
  • the angle formed by a wire 1111 at the proximal end 101 is equal.
  • the second filter 12 includes three Y-shaped units 121, the third network lines 1211 of the three Y-shaped units 121 are equal in length, the fourth network lines 1212 are all equal in length, and each adjacent two third network lines 1211 are far away.
  • the angle formed at the heart end 102 is equal.
  • the support section 13 includes six support rods 131.
  • the six Y-shaped units 111 of the first filter screen 11 form six first filter holes 113, and the six Y-shaped units 111 and the blood vessel walls form six of the second filter holes.
  • the three Y-shaped cells 121 of the second filter screen 12 and the blood vessel wall form three of the third filter holes and three of the fourth filter holes.
  • the maximum outer diameter of the cylinder formed by the plurality of support rods 131 of the support section 13 is the outer diameter dimension D of the support section 13.
  • the distance between the connection point of the first wire 1111 and the second wire 1112 in each of the Y-shaped cells 111 of the first filter 11 to the longitudinal central axis of the filter 100 is H1, and each Y-shaped unit 121 of the second filter 12
  • the distance between the connection point of the third wire 1211 and the fourth wire 1212 to the longitudinal center axis of the filter 100 is H2.
  • the size of the first filter hole 113 and the second filter hole may be adjusted by changing the size of H1; by changing the size of H2, the size of the third filter hole may be adjusted.
  • the filter hole is too large, the thrombus will directly pass through the filter hole, so that the trapping of the thrombus cannot be achieved; when the filter hole is too small, the size of the thrombus is intercepted by the filter hole and it is difficult to enter the filter, which is easy to cause vascular blockage. .
  • the distance H1 between the connection point of the first wire 1111 and the second wire 1112 in each Y-shaped unit 111 of the first filter 11 to the longitudinal central axis of the filter 100 and the support segment 13 in the natural release state of the filter 100 The ratio of the outer diameter dimension D is greater than or equal to 1/10 and less than or equal to 7/16, so that the first filter hole 113 and the second filter hole have an appropriate size, thereby preventing a large thrombus from leaking while ensuring a blood vessel.
  • the patency rate is greater than or equal to 1/10 and less than or equal to 7/16, so that the first filter hole 113 and the second filter hole have an appropriate size, thereby preventing a large thrombus from leaking while ensuring a blood vessel.
  • the distance H2 of the connection point of the third wire 1211 and the fourth wire 1212 of each of the Y-shaped cells 121 of the second filter 12 to the longitudinal central axis of the filter 100 and the outer diameter dimension D of the support section 13 in the natural release state of the filter 100 The ratio is greater than or equal to 1/10 and less than or equal to 7/16, thereby ensuring that the third filter hole and the fourth filter hole have an appropriate size, thereby preventing large thrombus leakage and simultaneously ensuring patency of the blood vessel. rate.
  • the ratio of the distance H2 between the connection point of the third wire 1211 and the fourth wire 1212 in the shaped unit 111 to the longitudinal central axis of the filter 100 and the outer diameter dimension D of the support section 13 in the natural release state of the filter 100 are both 1/4.
  • the filter 100 of the present embodiment is implanted into the inferior vena cava of the human body for one month, no thrombus enters the pulmonary artery to generate pulmonary embolism; and the blood flow signal is present at the implantation site of the filter 100 by Doppler ultrasound detection, that is, no vascular occlusion is caused. .
  • the ratio of the diameter dimension D may be equal, partially equal, or unequal, as long as the ratio satisfies greater than or equal to 1/10 and less than or equal to 7/16.
  • the distance H2 of the connection point of the third wire 1211 and the fourth wire 1212 of each of the Y-shaped cells 121 of the second filter 12 to the longitudinal central axis of the filter 100 and the outer diameter dimension D of the support section 13 in the natural release state of the filter 100 may all be equal, partially equal, or unequal, as long as the ratios satisfy greater than or equal to 1/10 and less than or equal to 7/16.
  • the number of the plurality of Y-shaped units of the first filter net 11 and the second filter net 12 may also be equal.
  • the connection manner of the first filter net 11 and the support section 13 and the second filter net 12 and the support section 13 are The connection is the same.
  • the distance H1 between the connection point of the first wire 1111 and the second wire 1112 in each of the Y-shaped units 111 of the first filter 11 to the longitudinal central axis of the filter 100 and each Y-shape of the second filter 12 are also understood.
  • the ratio of the distance H2 of the connection point of the third network line 1211 and the fourth network line 1212 to the longitudinal central axis of the filter 100 in the unit 121 and the outer diameter dimension D of the support section 13 in the natural release state of the filter 100 may be equal, partially equal or They are not equal.
  • the support section 13 can also be composed not only by the support rod 131, for example, the support section 13 can also include a circular arc section, and the support section 13 can support the peripheral wall of the blood vessel only after the filter 100 is released in the blood vessel. And it will not stab the blood vessel wall.
  • the filter 100 when the filter 100 is cut and shaped by a nickel-titanium tube having an outer diameter d, that is, the plurality of the first filter 11 and/or the second filter 12 are cut on the same nickel-titanium tube.
  • the plurality of support rods 131 of the wire and the support section 13 have a width in the circumferential direction of the filter 100 that is greater than a circumferential direction of the filter 100 constituting the first filter 11 and/or the second filter 12 in the circumferential direction of the filter 100. width.
  • the filter 100 may also utilize other superelastic materials, stainless steel wire, cobalt-chromium-nickel-molybdenum-iron alloy, cobalt-chromium alloy, polymer or may be formed of any other suitable material having self-expansion.
  • the filter 100 may further include a recovery hook 103 disposed at one end of the main body portion 10.
  • the recovery hook 103 is disposed at the distal end 102 of the main body portion 10, and the filter 100 implanted in the blood vessel can be recovered from the blood vessel to the outside of the body by the recovery hook 103.
  • the recovery hook 103 can also be disposed at the proximal end 101 of the main body portion 10, and only the recovery device for recovering the filter 100 is connected to the recovery hook 103 from the proximal end 101, and the filter 100 is recovered from the proximal end 101. And return to the blood vessels.
  • the recovery hook 103 is integrally formed with the main body of the filter 100, that is, the recovery hook 103 is directly on the nickel-titanium tube. The end is cut and opened.
  • the recovery hook 103 may be a near-center end of a main body portion of the filter having a nickel-titanium tube having an opening and an outer diameter d Or the end structures of the telecentric ends are connected.
  • the opening direction of the recovery hook 103 extends outward in the radial direction of the filter 100 and is biased toward the main body portion 10, that is, the angle ⁇ between the opening direction of the recovery hook 103 and the longitudinal central axis of the filter 100 is less than 90 degrees.
  • the opening of the recovery hook 103 has a width H perpendicular to the opening direction, and the opening of the recovery hook 103 also has a depth S perpendicular to the longitudinal central axis of the filter 100.
  • the width H of the opening of the recovery hook 103 is greater than or equal to 1/5 of the outer diameter dimension d of the nickel-titanium tube, so that the recovery device can conveniently catch the recovery hook 103.
  • the depth S of the opening of the recovery hook 103 is less than or equal to 19/20 of the outer diameter dimension d of the nitinol tube, so that the recovery device can pull the recovery hook 103 into after the recovery device catches the recovery hook 103 Recycle the sheath.
  • the filter 100 can further include a fixed anchor 104 that is disposed on the support rod 131 of the support section 13 at an acute angle to the longitudinal center axis of the filter 100.
  • the fixed anchor 104 has a sheet shape, and one end of the fixed anchor 104 is fixed on the support rod 131, and the other end of the fixed anchor 104 is a suspended end, and the suspended end of the fixed anchor 104 extends away from the recovery hook 103 and is suspended.
  • the angle ⁇ between the fixed anchor 104 and the support rod 131 is less than 90°, and the distance h from the suspended end of the fixed anchor 104 to the support rod 131 is less than 3 mm.
  • the structure of the filter 100a of Embodiment 2 is substantially the same as that of the filter 100 of Embodiment 1, and the filter 100a includes a first filter between the proximal end 101a and the telecentric end 102a and adjacent to the proximal end 101a.
  • the only difference is that the mesh shape of the second filter 12a is different from the mesh shape of the second filter 12 in the first embodiment.
  • the first filter net 11a is composed of six Y-shaped units 111a
  • the second filter net 12a is composed of six linear network lines 121a. Therefore, there is no connection point between the third network line and the fourth network line in the second filter net 12a, and there is no The distance of the connection point to the longitudinal central axis of the filter 100a.
  • the ratio of the outer diameter dimension D is 1/4.
  • the filter 100a of the present embodiment is implanted into the inferior vena cava of the human body for one month, no thrombus enters the pulmonary artery to generate pulmonary embolism; and the blood flow signal is present at the implantation site of the filter 100a by Doppler ultrasound detection, that is, no vascular occlusion is caused. .
  • the network cable of the second filter net 12a may also be an irregular curved mesh line, a linear mesh line or a network line composed of an arc segment and a straight segment.
  • the mesh of the first filter 11a may be composed of an irregular curved mesh line, a linear mesh line or a network line composed of an arc segment and a straight segment, and the second filter mesh 12a is composed of a Y-shaped unit.
  • the structure of the filter 100b of the embodiment 3 is the same as that of the filter 100 of the embodiment 1, except that the main body 10b of the filter 100b includes only the proximal end 101b and the telecentric end 102b.
  • the first filter 11b between and adjacent to the proximal end 101b and the support section 13b connecting the first filter 11b and adjacent to the telecentric end 102b, the filter 100b does not include the second filter, that is, the filter 100b is open in one direction structure.
  • the first filter 11b is composed of six Y-shaped units 111b. It can be understood that the first filter 11b can be composed of 2n Y-shaped units 111, n being a natural number and 2 ⁇ n ⁇ 6.
  • the ratio of the outer diameter dimension D is 1/4.
  • the filter 100a of the present embodiment is implanted into the inferior vena cava of the human body for one month, no thrombus enters the pulmonary artery to generate pulmonary embolism; and the blood flow signal is present at the implantation site of the filter 100a by Doppler ultrasound detection, that is, no vascular occlusion is caused. .
  • the structure of the filter 100c of the embodiment 4 is substantially the same as that of the filter 100 of the embodiment 1, and the filter 100c is disposed between the proximal end 101c and the telecentric end 102c.
  • the difference is that the number of Y-shaped units of the first filter 11c and the second filter 12c is different from the number of Y-shaped units of the first filter 11 and the second filter 12 in Embodiment 1.
  • the first filter net 11c includes four Y-shaped units 111c formed by the cooperation of the first net line 1111c and the second net line 1112c, and the four Y-shaped units 111c form four.
  • the first filter hole 113c, the four Y-shaped units 111c and the blood vessel wall form four second filter holes.
  • the second filter 12c includes two Y-shaped units 121c formed by the cooperation of the third mesh line 1211c and the fourth mesh line 1212c.
  • the two Y-shaped units 121c and the blood vessel wall form two third filter holes and two fourth filter holes.
  • the distance H1 between the connection point of the first network line 1111c and the second network line 1112c in each Y-shaped unit 111c of the first filter net 11c to the longitudinal central axis of the filter 100c and each Y of the second filter net 12c The ratio of the distance H2 between the connection point of the third wire 1211c and the fourth wire 1212c in the shape unit 111c to the longitudinal center axis of the filter 100c and the outer diameter dimension D of the support segment 13c in the natural release state of the filter 100c are both 7/16.
  • the filter 100c of the present embodiment After the filter 100c of the present embodiment is implanted into the inferior vena cava of the human body for one month, no thrombus enters the pulmonary artery to generate pulmonary embolism; and the blood flow signal is present at the implantation site of the filter 100c by Doppler ultrasound detection, that is, no vascular occlusion is caused. .
  • the structure of the filter 100d of the embodiment 5 is substantially the same as that of the filter 100 of the embodiment 1, and the filter 100d is disposed between the proximal end 101d and the telecentric end 102d.
  • the difference is that the number of Y-shaped units of the first filter 11d and the second filter 12d is different from the number of Y-shaped units of the first filter 11 and the second filter 12 in Embodiment 1.
  • the first filter 11d includes twelve Y-shaped units 111d formed by the cooperation of the first mesh line 1111d and the second mesh line 1112d, and twelve Y-shaped units 111d are formed. Twelve first filter holes 113d, twelve Y-shaped units 111d and blood vessel walls form twelve second filter holes.
  • the second filter web 12d includes six Y-shaped units 121d formed by the cooperation of the third mesh wires 1211d and the fourth mesh wires 1212d, and the six Y-shaped cells 121d and the blood vessel walls form six third filter holes and six fourth filter holes.
  • the distance H1 between the connection point of the first network line 1111d and the second network line 1112d in each Y-shaped unit 111d of the first filter net 11d to the longitudinal central axis of the filter 100d and each Y of the second filter net 12d The ratio of the distance H2 between the connection point of the third wire 1211d and the fourth wire 1212d in the shaped unit 111d to the longitudinal central axis of the filter 100d and the outer diameter dimension D of the support segment 13d in the natural release state of the filter 100d are both 1/10.
  • the filter 100d of the present embodiment was implanted into the inferior vena cava of the human body for one month, no thrombus entered the pulmonary artery to generate pulmonary embolism; and the blood flow signal was present at the implantation site of the filter 100d by Doppler ultrasound detection, that is, no vascular occlusion was caused. .

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)
  • Surgical Instruments (AREA)

Abstract

提供一种滤器，包括位于近心端的第一过滤网和与第一过滤网相连的支撑段；第一过滤网包括多个Y形单元组合形成的网状结构，每个Y形单元均包括一条第一网线和与第一网线的一端相连的两条第二网线，多条第一网线远离第二网线的端部在近心端处汇聚，每个Y形单元远离近心端的端部均与支撑段相连；多个Y形单元的数量为2n，n为自然数且2≤n≤6，在滤器自然释放状态下，任一Y形单元中的第一网线和第二网线的连接点到滤器的纵向中心轴的距离与滤器支撑段的外径尺寸的比值大于或等于1/10，且小于或等于7/16。提供的滤器过滤血栓效率高，且具有长期安全性和血管通畅率。

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】
肺栓塞是一种常见疾病，病死率高，有资料统计，不经治疗的肺栓塞死亡率为20%-30%，每年新增病例约占人口的0.2%。我国以13.5亿人口计算，每年约有270万新增患者。
体循环的各种血栓脱落均可引起肺栓塞。外伤或骨折、创伤、较大的手术、大面积烧伤、妊娠、分娩、久病卧床、长途乘车或飞机久坐不动、长时间的静坐及下蹲等均可使静脉血流缓慢，血液瘀滞，或血小板和凝血因子增多，血液黏附性增强，形成血栓。这些血栓一般与管壁轻度粘连，容易脱落，脱落的游离栓子可引起肺栓塞等严重病变。腔静脉滤器（以下简称滤器）在临床上被证实为预防肺栓塞安全有效的手段，可降低肺栓塞的发生率。
对于临时滤器，临床上要求其植入下腔静脉后血栓不得易于从过滤网孔中漏出，以避免滤器无法捕捉血栓；并且，大小血栓不得均被拦截在滤器之外而难以进入滤器，造成下腔静脉堵塞。
【发明内容】
基于此，有必要提供一种滤器，以使所述滤器在植入血管中释放后，具有合适大小的过滤孔，以使所述滤器过滤血栓效率高，且具有长期安全性和血管通畅率。
本发明解决其技术问题所采用的技术方案是：
一种滤器，包括具有近心端和远心端的主体部，所述主体部包括位于所述近心端及远心端之间且邻近所述近心端的第一过滤网，和与所述第一过滤网相连且位于所述第一过滤网和所述远心端之间的支撑段；所述第一过滤网包括多个Y形单元，每个所述Y形单元均包括一条第一网线和与所述第一网线的一端相连的两条第二网线，所述多条第一网线远离所述第二网线的端部在所述近心端处汇聚，每个所述Y形单元远离所述近心端的端部均与所述支撑段相连；所述多个Y形单元的数量为2n，n为自然数且2≤n≤6，任一所述Y形单元中的所述第一网线与所述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自然释放后所述支撑段的外径尺寸的比值大于或等于1/10，且小于或等于7/16。
在其中一个实施例中，所述第一过滤网的所述多个Y形单元中所述第一网线和所述第二网线的连接点到所述滤器的纵向中心轴的距离相等。
在其中一个实施例中，所述滤器还包括位于所述远心端与所述支撑段之间且与所述支撑段相连的第二过滤网，所述第二过滤网包括多条网线。
在其中一个实施例中，所述第二过滤网包括多个Y形单元，每个所述Y形单元均包括一条第三网线和与所述第三网线的一端相连的两条第四网线，所述多条第三网线远离所述第四网线的端部在所述远心端处汇聚，所述第二过滤网的每个所述Y形单元远离所述远心端的端部均与所述支撑段相连，任一所述Y形单元中所述第三网线和所述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支撑段的外径尺寸的比值大于或等于1/10，且小于或等于7/16。
在其中一个实施例中，所述第二过滤网的多个Y形单元的数量为所述第一过滤网的多个Y形单元的数量的一半。
在其中一个实施例中，所述第二过滤网的所述多个Y形单元中所述第三网线和所述第四网线的连接点到所述滤器的纵向中心轴的距离相等。
在其中一个实施例中，所述支撑段包括多根支撑杆，所述主体部和/或所述第二过滤网由切割同一根镍钛管而成；所述支撑杆沿所述滤器的周向方向的宽度大于所述第一过滤网和/或所述第二过滤网的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偏向所述主体部；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，至少一个所述支撑杆上设置有固定锚，所述固定锚的一端固定于所述支撑杆上，所述固定锚的另一端为悬空端且向远离所述回收钩的方向延伸并悬空；所述固定锚与所述支撑段之间的夹角小于90°，所述固定锚的悬空端至所述支撑段的距离小于3mm。
本发明的滤器中，任一所述Y形单元中所述第一网线和所述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自然释放后所述支撑段的外径尺寸的比值大于或等于1/10，且小于或等于7/16，由此当所述滤器在血管中释放后，所述滤器形成的过滤孔均具有合适大小，从而防止大的血栓漏过，且同时保证了血管的通畅率。
【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1a-图1b为本发明实施例1的滤器的整体结构示意图，所述滤器包括主体部，所述主体部包括第一过滤网、第二过滤网和连接所述第一过滤网和第二过滤网的支撑段；其中，图1a为主视图，图1b为立体图；
图2a-图2b为图1a-图1b中所述滤器的主体部的局部结构示意图，其中，图2a为主视图，图2b为立体图；
图3为图1a-图1b中所述滤器的第一过滤网沿所述滤器的纵向中心轴方向的结构示意图；
图4为图1a-图1b中所述滤器的第二过滤网沿所述滤器的纵向中心轴方向的结构示意图；
图5为图1a-图1b中所述第一过滤网和第二过滤网中的连接点至所述滤器的纵向中心轴的距离的示意图；
图6为图1a-图1b中所述滤器的回收钩的结构示意图；
图7为图1a-图1b中所述滤器的固定锚的结构示意图；
图8为本发明实施例2的滤器的主视图；
图9a-图9b为本发明实施例3的滤器的整体结构示意图，其中，图9a为主视图，图9b为立体图；
图10a-图10b为本发明实施例4的滤器的结构示意图，其中，图10a为主视图，图10b为立体图
图11a为图10a-图10b中所述滤器的第一过滤网沿所述滤器的纵向中心轴方向的结构示意图；
图11b为图10a-图10b中所述滤器的第二过滤网沿所述滤器的纵向中心轴方向的结构示意图；
图12a-图12b为本发明实施例5的滤器的结构示意图，其中，图12a为主视图，图12b为立体图
图13a为图12a-图12b中所述滤器的第一过滤网沿所述滤器的纵向中心轴方向的结构示意图；
图13b为图12a-图12b中所述滤器的第二过滤网沿所述滤器的纵向中心轴方向的结构示意图。
【具体实施方式】
为了对本发明的技术特征、目的和效果有更加清楚的理解，现对照附图详细说明本发明的具体实施方式。
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方式的目的，不是旨在于限制本发明。
在滤器领域，将滤器植入体内后相对心脏较近的一端称为近心端，相对心脏较远的一端称为远心端。
本发明提供的滤器采用外径尺寸为0.2-4mm的镍钛管切割、定型而成。可以理解，所述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。
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1
请参阅图1a和图1b，滤器100包括主体部10，主体部10具有近心端101和远心端102，主体部10包括位于近心端101及远心端102之间且邻近近心端101的第一过滤网11、邻近远心端102的第二过滤网12和位于第一、第二过滤网11、12之间的支撑段13。当滤器100在血管中自然释放后，第二过滤网12用于对血栓进行一级过滤，第一过滤网11用于对血栓进行二级过滤，支撑段13用于支撑血管壁，使滤器100释放后能稳定地、可靠地位于血管中，防止滤器100在血管中发生倾斜。
支撑段13包括多根沿滤器100的圆周方向等间隔分布的支撑杆131，且每根支撑杆131均大致平行于滤器100的纵向中心轴。可以理解，支撑杆131可为直形杆，也可为其他形状的杆状物，如圆弧段与直线段组合成的不规则形状杆、波形杆等，只要支撑杆131大致平行于滤器100的纵向中心轴即可。
第一过滤网11包括多个Y形单元111，每个Y形单元111由一条第一网线1111和与第一网线1111的一端相连的两条第二网线1112配合形成。多个Y形单元111的多条第一网线1111远离第二网线1112的端部在近心端101处汇聚，相邻两个Y形单元111的相邻两条第二网线1112的远离近心端101的端部均与支撑段13的同一根支撑杆131相连。可以理解，相邻两个Y形单元111的相邻两条第二网线1112的远离近心端101的端部可以与同一根支撑杆131的同一点相连，也可以分别与同一根支撑杆131的不同点相连。
请同时参阅图2a和图2b，每条第一网线1111和第二网线1112均可分别呈直线型，也可呈现曲线型，还可部分呈曲线型，其余部分呈直线型。第一过滤孔113由两个相邻Y形单元111的两条第一网线1111和相邻两条第二网线1112配合形成。所述第二过滤孔由一个Y形单元111的两条第二网线1112与所述血管壁形成。第一过滤孔113和所述第二过滤孔均可捕捉血栓。
第二过滤网12包括多个Y形单元121，每个Y形单元121由一条第三网线1211和与第三网线1211的一端相连的两条第四网线1212配合形成。多个Y形单元121的多条第三网线1211远离第四网线1212的端部在远心端102处汇聚，每条第四网线1212的远离远心端102的端部均与支撑段13的支撑杆131相连。由此，当滤器100在血管中释放后，第二过滤网12具有锥形网状结构，每个Y形单元121的两条第四网线1212与所述血管壁形成一个第三过滤孔（图未示），每相邻两个Y形单元121的两条第三网线1211和相邻两条第四网线1212和血管壁形成一个第四过滤孔（图未示）。
每条第三网线1211和第四网线1212均可分别呈直线型，也可呈现曲线型，还可部分呈曲线型，其余部分呈直线型。因此，所述第三过滤孔大致为三角形，所述第四过滤孔大致为五边形。所述第三过滤孔和所述第四过滤孔均可捕捉血栓。
第一过滤网11的多个Y形单元111的数量为2n，n为自然数且2≤n≤6。第二过滤网12的多个Y形单元121的数量为第一过滤网11的多条Y形单元111的数量的一半，因此第一过滤网11的网状结构的密度大于第二过滤网12的网状结构的密度。支撑段13的多根支撑杆131的数量与第一过滤网11的多条Y形单元111的数量相等。本实施例中，第一过滤网11包括六个Y形单元111，六个Y形单元111的第一网线1111的长度均相等，第二网线1112的长度均相等，且每相邻两条第一网线1111在近心端101处形成的夹角相等。第二过滤网12包括三个Y形单元121，三个Y形单元121的第三网线1211的长度均相等，第四网线1212的长度均相等，且每相邻两条第三网线1211在远心端102处形成的夹角相等。支撑段13包括六根支撑杆131。
请参阅图3和图4，第一过滤网11的六个Y形单元111形成六个第一过滤孔113，六个Y形单元111和所述血管壁形成六个所述第二过滤孔。第二过滤网12的三个Y形单元121和所述血管壁形成三个所述第三过滤孔和三个所述第四过滤孔。
请参阅图5，滤器100在自然释放且无压缩状态下，支撑段13的多根支撑杆131围合形成的柱面的最大外径尺寸为支撑段13对应的外径尺寸D。第一过滤网11的每个Y形单元111中第一网线1111和第二网线1112的连接点到滤器100的纵向中心轴的距离为H1，第二过滤网12的每个Y形单元121中第三网线1211和第四网线1212的连接点到滤器100的纵向中心轴的距离为H2。
当支撑段13的外径尺寸D为定值时，改变H1的大小，可调节第一过滤孔113和所述第二过滤孔的大小；改变H2的大小，可调节第三过滤孔的大小。当过滤孔过大时，血栓会直接穿过所述过滤孔，从而无法实现对血栓的捕捉；当过滤孔过小时，大小血栓均被所述过滤孔拦截而难以进入滤器，极易造成血管堵塞。
本发明中，第一过滤网11的每个Y形单元111中第一网线1111和第二网线1112的连接点到滤器100的纵向中心轴的距离H1与滤器100自然释放状态下支撑段13的外径尺寸D的比值大于或等于1/10，且小于或等于7/16，使得第一过滤孔113和所述第二过滤孔具有合适大小，从而防止大的血栓漏过且同时保证了血管的通畅率。第二过滤网12的每个Y形单元121中第三网线1211和第四网线1212的连接点到滤器100的纵向中心轴的距离H2与滤器100自然释放状态下支撑段13的外径尺寸D的比值大于或等于1/10，且小于或等于7/16，从而保证所述第三过滤孔和所述第四过滤孔具有合适大小，从而防止大的血栓漏过且同时保证了血管的通畅率。
本实施例中，第一过滤网11的每个Y形单元111中第一网线1111和第二网线1112的连接点到滤器100的纵向中心轴的距离H1和第二过滤网12的每个Y形单元111中第三网线1211和第四网线1212的连接点到滤器100的纵向中心轴的距离H2与滤器100自然释放状态下支撑段13的外径尺寸D的比值均为1/4。
将本实施例的滤器100植入人体下腔静脉中一个月后，没有血栓进入肺动脉以产生肺栓塞；且通过多普勒超声检测得到滤器100植入处存在血流信号，即没有造成血管闭塞。
可以理解，第一过滤网11的每个Y形单元111中第一网线1111和第二网线1112的连接点到滤器100的纵向中心轴的距离H1与滤器100自然释放状态下支撑段13的外径尺寸D的比值可以均相等、部分相等或均不相等，只需所述比值均满足大于或等于1/10，且小于或等于7/16即可。第二过滤网12的每个Y形单元121中第三网线1211和第四网线1212的连接点到滤器100的纵向中心轴的距离H2与滤器100自然释放状态下支撑段13的外径尺寸D的比值可以均相等、部分相等或均不相等，只需所述比值均满足大于或等于1/10，且小于或等于7/16即可。
可以理解，第一过滤网11和第二过滤网12的多条Y形单元的数量也可以相等，此时第一过滤网11与支撑段13的连接方式与第二过滤网12与支撑段13的连接方式相同。同样可以理解，第一过滤网11的每个Y形单元111中第一网线1111和第二网线1112的连接点到滤器100的纵向中心轴的距离H1和第二过滤网12的每个Y形单元121中第三网线1211和第四网线1212的连接点到滤器100的纵向中心轴的距离H2分别与滤器100自然释放状态下支撑段13的外径尺寸D的比值可以均相等、部分相等或均不相等。
可以理解，支撑段13也可以不仅由支撑杆131组成，如支撑段13还可以包括圆弧段，只需滤器100在血管中释放后，支撑段13可以对所述血管的周壁起到支撑作用且不会刺伤血管壁即可。
可以理解，当滤器100采用外径尺寸为d的镍钛管切割、定型制备时，即在同一所述镍钛管上切割形成第一过滤网11和/或第二过滤网12的所述多条网线和支撑段13的多根支撑杆131，支撑杆131沿滤器100的周向方向的宽度大于组成第一过滤网11和/或第二过滤网12的网线沿滤器100的周向方向的宽度。从而当滤器100在血管中释放后，保证支撑杆131对血管壁具有更加稳定的支撑力。
可以理解，滤器100还可以采用其他超弹性材料、不锈钢丝、钴-铬-镍-钼-铁合金、钴-铬合金、聚合物或可以由具有自膨胀的任何其它合适材料形成。
请继续参阅图1a和图1b，滤器100还可以包括设置于主体部10一端的回收钩103。本实施例中，回收钩103设置于主体部10的远心端102处，利用回收钩103可以将植入血管中的滤器100从血管中回收至体外。可以理解，回收钩103也可以设置于主体部10的近心端101处，只需要回收滤器100的回收装置从近心端101处连接回收钩103，并从近心端101处将滤器100回收并退回血管即可。
请同时参阅图6，当滤器100采用外径尺寸为d的镍钛管切割、定型而成时，回收钩103与滤器100的主体部一体成型，即回收钩103直接在所述镍钛管的端部切割一开口而成。当滤器100采用镍钛丝或镍钛扁带通过编织、定型而成时，回收钩103可以为将一具有开口且外径尺寸为d的镍钛管与所述滤器的主体部的近心端或远心端的端部结构连接而成。
回收钩103的开口方向沿滤器100的径向方向向外延伸且偏向主体部10，即回收钩103的开口方向与滤器100的纵向中心轴的夹角β小于90度。回收钩103的开口具有一垂直于所述开口方向上的宽度H，回收钩103的开口还具有一垂直于滤器100的纵向中心轴方向上的深度S。本实施例中，回收钩103的开口的宽度H大于或等于所述镍钛管的外径尺寸d的1/5，从而回收装置可以方便地抓捕回收钩103。回收钩103的开口的深度S小于或等于所述镍钛管的外径尺寸d的19/20,从而当所述回收装置抓捕回收钩103后，所述回收装置可以将回收钩103拉进回收鞘管。
请再参阅图1a、图1b和图7，滤器100还可以包括固定锚104，固定锚104与滤器100的纵向中心轴成锐角地设置于支撑段13的支撑杆131上。固定锚104呈片状，固定锚104的一端固定在支撑杆131上，固定锚104的另一端为悬空端，且固定锚104的悬空端向远离回收钩103的方向延伸并悬空。固定锚104与支撑杆131的的夹角α小于90°，固定锚104的悬空端到支撑杆131的距离h小于3mm。当滤器100在血管内释放后，支撑段13的支撑杆131支撑着血管壁，固定锚104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。
实施例2
请参阅图8，实施例2的滤器100a的结构与实施例1的滤器100的结构大致相同，滤器100a包括位于近心端101a和远心端102a之间且邻近近心端101a的第一过滤网11a、邻近远心端102a的第二过滤网12a和位于第一过滤网11a和第二过滤网12a之间的支撑段13a。区别仅在于第二过滤网12a的网线形状与实施例1中的第二过滤网12的网线形状不同。
第一过滤网11a由六个Y形单元111a组成，第二过滤网12a由六条直线形网线121a组成，因此第二过滤网12a中不存在第三网线和第四网线的连接点，也不存在所述连接点到滤器100a的纵向中心轴的距离。
本实施例中，第一过滤网11a的每个Y形单元111a中第一网线1111a和第二网线1112a的连接点到滤器100a的纵向中心轴的距离H1与滤器100a自然释放状态下支撑段13a的外径尺寸D的比值为1/4。
将本实施例的滤器100a植入人体下腔静脉中一个月后，没有血栓进入肺动脉以产生肺栓塞；且通过多普勒超声检测得到滤器100a植入处存在血流信号，即没有造成血管闭塞。
可以理解，第二过滤网12a的网线还可以为不规则弧形网线、直线形网线或者由弧形段与直线段组成的网线。
可以理解，也可以是第一过滤网11a的网线由不规则弧形网线、直线形网线或由弧形段与直线段组成的网线，第二过滤网12a由Y形单元组成。
实施例3
请参阅图9a和图9b，实施例3的滤器100b的结构与实施例1的滤器100的结构部分相同，区别之处在于，滤器100b的主体10b只包括位于近心端101b和远心端102b之间且邻近近心端101b的第一过滤网11b和连接第一过滤网11b且邻近远心端102b的支撑段13b,滤器100b不包括所述第二过滤网，即滤器100b为单向开放结构。
第一过滤网11b由六条Y形单元111b组成。可以理解，第一过滤网11b可以由2n个Y形单元111组成，n为自然数且2≤n≤6。
本实施例中，第一过滤网11b的每个Y形单元111b中第一网线1111b和第二网线1112b的连接点到滤器100b的纵向中心轴的距离H1与滤器100b自然释放状态下支撑段13b的外径尺寸D的比值为1/4。
将本实施例的滤器100a植入人体下腔静脉中一个月后，没有血栓进入肺动脉以产生肺栓塞；且通过多普勒超声检测得到滤器100a植入处存在血流信号，即没有造成血管闭塞。
实施例4
请参阅图10（a）和图10（b），实施例4的滤器100c的结构与实施例1的滤器100的结构大致相同，滤器100c包括位于近心端101c和远心端102c之间且邻近近心端101c的第一过滤网11c、邻近远心端102c的第二过滤网12c和位于第一、第二过滤网11c、12c之间的支撑段13c。区别之处在于，第一过滤网11c和第二过滤网12c的Y形单元的数量与实施例1中第一过滤网11和第二过滤网12的Y形单元的数量不同。
请同时参阅图11（a）和图11（b），第一过滤网11c包括四根由第一网线1111c和第二网线1112c配合形成的Y形单元111c，且四个Y形单元111c形成四个第一过滤孔113c，四个Y形单元111c和血管壁形成四个第二过滤孔。第二过滤网12c包括二根由第三网线1211c和第四网线1212c配合形成的Y形单元121c，二个Y形单元121c和血管壁形成二个第三过滤孔和二个第四过滤孔。
本实施例中，第一过滤网11c的每个Y形单元111c中第一网线1111c和第二网线1112c的连接点到滤器100c的纵向中心轴的距离H1和第二过滤网12c的每个Y形单元111c中第三网线1211c和第四网线1212c的连接点到滤器100c的纵向中心轴的距离H2与滤器100c自然释放状态下支撑段13c的外径尺寸D的比值均为7/16。
将本实施例的滤器100c植入人体下腔静脉中一个月后，没有血栓进入肺动脉以产生肺栓塞；且通过多普勒超声检测得到滤器100c植入处存在血流信号，即没有造成血管闭塞。
实施例5
请参阅图12（a）和图12（b），实施例5的滤器100d的结构与实施例1的滤器100的结构大致相同，滤器100d包括位于近心端101d和远心端102d之间且邻近近心端101d的第一过滤网11d、邻近远心端102d的第二过滤网12d和位于第一、第二过滤网11d、12d之间的支撑段13d。区别之处在于，第一过滤网11d和第二过滤网12d的Y形单元的数量与实施例1中第一过滤网11和第二过滤网12的Y形单元的数量不同。
请同时参阅图13（a）和图13（b），第一过滤网11d包括十二根由第一网线1111d和第二网线1112d配合形成的Y形单元111d，且十二个Y形单元111d形成十二个第一过滤孔113d，十二个Y形单元111d和血管壁形成十二个第二过滤孔。第二过滤网12d包括六根由第三网线1211d和第四网线1212d配合形成的Y形单元121d，六个Y形单元121d和血管壁形成六个第三过滤孔和六个第四过滤孔。
本实施例中，第一过滤网11d的每个Y形单元111d中第一网线1111d和第二网线1112d的连接点到滤器100d的纵向中心轴的距离H1和第二过滤网12d的每个Y形单元111d中第三网线1211d和第四网线1212d的连接点到滤器100d的纵向中心轴的距离H2与滤器100d自然释放状态下支撑段13d的外径尺寸D的比值均为1/10。
将本实施例的滤器100d植入人体下腔静脉中一个月后，没有血栓进入肺动脉以产生肺栓塞；且通过多普勒超声检测得到滤器100d植入处存在血流信号，即没有造成血管闭塞。
上面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例，上述的具体实施例仅仅是示意性的，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 (9)

  1. 一种滤器，包括具有近心端和远心端的主体部，所述主体部包括位于所述近心端及远心端之间且邻近所述近心端的第一过滤网，和与所述第一过滤网相连且位于所述第一过滤网和所述远心端之间的支撑段；所述第一过滤网包括多个Y形单元，每个所述Y形单元均包括一条第一网线和与所述第一网线的一端相连的两条第二网线，所述多条第一网线远离所述第二网线的端部在所述近心端处汇聚，每个所述Y形单元远离所述近心端的端部均与所述支撑段相连；所述多个Y形单元的数量为2n，n为自然数且2≤n≤6，其特征在于，在所述滤器自然释放状态下，任一所述Y形单元中的所述第一网线与所述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支撑段对应的外径尺寸的比值大于或等于1/10，且小于或等于7/16。
  2. 根据权利要求1所述的滤器，其特征在于，所述第一过滤网的所述多个Y形单元中所述第一网线和所述第二网线的连接点到所述滤器的纵向中心轴的距离相等。
  3. 根据权利要求1所述的滤器，其特征在于，所述滤器还包括位于所述远心端与所述支撑段之间且与所述支撑段相连的第二过滤网，所述第二过滤网包括多条网线。
  4. 根据权利要求3所述的滤器，其特征在于，所述第二过滤网包括多个Y形单元，每个所述Y形单元均包括一条第三网线和与所述第三网线的一端相连的两条第四网线，所述多条第三网线远离所述第四网线的端部在所述远心端处汇聚，所述第二过滤网的每个所述Y形单元远离所述远心端的端部均与所述支撑段相连，在所述滤器自然释放状态下，任一所述Y形单元中所述第三网线和所述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支撑段的外径尺寸的比值大于或等于1/10，且小于或等于7/16。
  5. 根据权利要求4所述的滤器，其特征在于，所述第二过滤网的多个Y形单元的数量为所述第一过滤网的多个Y形单元的数量的一半。
  6. 根据权利要求4所述的滤器，其特征在于，所述第二过滤网的所述多个Y形单元中所述第三网线和所述第四网线的连接点到所述滤器的纵向中心轴的距离相等。
  7. 根据权利要求3所述的滤器，其特征在于，所述支撑段包括多根支撑杆，所述主体部和/或所述第二过滤网由切割同一根镍钛管而成；所述支撑杆沿所述滤器的周向方向的宽度大于所述第一过滤网和/或所述第二过滤网的网线沿所述滤器的周向方向的宽度。
  8. 根据权利要求1至7任一项所述的滤器，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偏向所述主体部；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。
  9. 根据权利要求8所述的滤器，其特征在于，至少一个所述支撑杆上设置有固定锚，所述固定锚的一端固定于所述支撑杆上，所述固定锚的另一端为悬空端且向远离所述回收钩的方向延伸并悬空；所述固定锚与所述支撑段之间的夹角小于90°，所述固定锚的悬空端至所述支撑段的距离小于或等于3mm。
PCT/CN2016/085741 2015-12-28 2016-06-14 滤器 Ceased WO2017113628A1 (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201511004971.4 2015-12-28
CN201511004971.4A CN106913391B (zh) 2015-12-28 2015-12-28 滤器

Publications (1)

Publication Number Publication Date
WO2017113628A1 true WO2017113628A1 (zh) 2017-07-06

Family

ID=59224402

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2016/085741 Ceased WO2017113628A1 (zh) 2015-12-28 2016-06-14 滤器

Country Status (2)

Country Link
CN (1) CN106913391B (zh)
WO (1) WO2017113628A1 (zh)

Citations (4)

* 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
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
CN101147705A (zh) * 2006-09-18 2008-03-26 深圳市先健科技股份有限公司 可控释放的生物陶瓷血栓过滤器及其制作方法
WO2014016359A1 (en) * 2012-07-25 2014-01-30 Novate Medical Limited A vascular filter device

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1739466A (zh) * 2004-08-28 2006-03-01 深圳市先健科技股份有限公司 可控释放的血栓过滤器及其制作方法
CN205494081U (zh) * 2015-12-28 2016-08-24 先健科技(深圳)有限公司 滤器

Patent Citations (4)

* 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
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
CN101147705A (zh) * 2006-09-18 2008-03-26 深圳市先健科技股份有限公司 可控释放的生物陶瓷血栓过滤器及其制作方法
WO2014016359A1 (en) * 2012-07-25 2014-01-30 Novate Medical Limited A vascular filter device

Also Published As

Publication number Publication date
CN106913391A (zh) 2017-07-04
CN106913391B (zh) 2018-12-21

Similar Documents

Publication Publication Date Title
WO2017113627A1 (zh) 滤器
CA2636419C (en) Removable blood conduit filter
CN108348320B (zh) 管腔内装置
AU2017255547A1 (en) Inferior vena cava filter
CN109248006B (zh) 一种腔静脉滤器
CN105662646A (zh) 滤器
CN107280807A (zh) 一种半封闭双支撑可回收型腔静脉滤器
CN206621451U (zh) 腔静脉滤器、双回收腔静脉滤器
CN117771015A (zh) 栓塞保护装置及医疗器械
CN102824229A (zh) 一种免取出的临时型腔静脉滤器及其制作方法
WO2017113628A1 (zh) 滤器
WO2018110736A1 (ko) 단부의 저항력이 강화된 의료용 스텐트 제조 방법 및 그 스텐트
CN205494081U (zh) 滤器
CN107174375B (zh) 可减少贴壁的笼形滤器
WO2017092278A1 (zh) 滤器
WO2018103376A1 (zh) 滤器
CN205494080U (zh) 滤器
CN106725997A (zh) 腔静脉滤器及其生产方法
WO2014030982A1 (ko) 와이어형 스텐트
CN205494082U (zh) 滤器
CN205494083U (zh) 滤器
CN105726158B (zh) 一种编织型腔静脉滤器及编织方法
WO2020096298A1 (ko) 인공심장판막 및 이를 포함하는 인공심장판막 세트
CN205433998U (zh) 可转化型腔静脉滤器
CN207949945U (zh) 滤器

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: 16880436

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: 16880436

Country of ref document: EP

Kind code of ref document: A1