WO2020093925A1 - 封堵器 - Google Patents

封堵器 Download PDF

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Publication number
WO2020093925A1
WO2020093925A1 PCT/CN2019/114703 CN2019114703W WO2020093925A1 WO 2020093925 A1 WO2020093925 A1 WO 2020093925A1 CN 2019114703 W CN2019114703 W CN 2019114703W WO 2020093925 A1 WO2020093925 A1 WO 2020093925A1
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WO
WIPO (PCT)
Prior art keywords
markers
occluder
film
marker
distance
Prior art date
Application number
PCT/CN2019/114703
Other languages
English (en)
French (fr)
Inventor
陈贤淼
Original Assignee
先健科技(深圳)有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 先健科技(深圳)有限公司 filed Critical 先健科技(深圳)有限公司
Priority to CA3117408A priority Critical patent/CA3117408A1/en
Priority to EP19882103.5A priority patent/EP3878374A4/en
Priority to US17/289,427 priority patent/US20210353273A1/en
Publication of WO2020093925A1 publication Critical patent/WO2020093925A1/zh

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004(bio)absorbable, (bio)resorbable, resorptive
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00592Elastic or resilient implements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00597Implements comprising a membrane
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00606Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966Radiopaque markers visible in an X-ray image

Definitions

  • the invention relates to the field of medical equipment, in particular to an occluder.
  • the degradable occluder made of degradable materials is the latest development direction in the field of interventional therapy occluders.
  • the degradable occluder can complete the effect of occlude the defect.
  • the material that constitutes the occluder degrades in the body, and finally is metabolized by the body into CO2 and water to be eliminated from the body, so as to avoid long-term foreign body exposure influences.
  • Biodegradable materials used in the field of interventional therapy include but are not limited to polylactic acid (PLA), polyglycolic acid (PGA), polylactic acid-glycolic acid copolymer (PLGA), polyhydroxy fatty acid lipid (PHA), polydioxane Hexanone (PDO) or polycaprolactone (PCL) etc.
  • PLA polylactic acid
  • PGA polyglycolic acid
  • PLGA polylactic acid-glycolic acid copolymer
  • PHA polyhydroxy fatty acid lipid
  • PDO polydioxane Hexanone
  • PCL polycaprolactone
  • Interventional occlusion surgery usually needs to be performed under the guidance of X-ray imaging equipment such as DSA (Digital Subtraction Angiography), so the occlusion device is required to be radiopaque under X-ray Can be identified under the ray.
  • X-ray imaging equipment such as DSA (Digital Subtraction Angiography)
  • An occluder made of degradable materials has poor developability under X-rays, and it is difficult to judge its exact position and release state under DSA, resulting in a decrease in the success rate of implant surgery.
  • An occluder includes an occluder unit and a head connected to the occluder unit.
  • the occluder unit has a central axis, and the central axis passes through the distal and proximal ends of the occluder.
  • the occluder also includes a marking structure
  • the marking structure includes a distal marker and at least two first markers.
  • the distal marker is provided on the head, each first marker is connected to the blocking unit, and each first marker is located in the same placement plane.
  • the placement plane is perpendicular to the central axis, and the distal markers are outside the placement plane.
  • the projection point of each first marker in a projection plane perpendicular to the placement plane is on a straight line segment. In the natural state of the occluder, the The connection between the end marker and the two ends of the straight line segment is a triangle.
  • the plugging unit includes a first subunit, the first subunit includes a first mesh disk and a first spoiler film provided in the first mesh disk, the central axis passes through the geometric center of the first mesh disk, and The central axis is perpendicular to the plane where the first screen disk is located, the central axis passes through the geometric center of the first choke film, and the central axis is perpendicular to the plane where the first choke film is located, each first marker is connected to the first screen disk Connected, or, each first marker is connected to the first blocking film.
  • each first marker is fixed on the first screen, and in the natural state of the occluder, the distance between each first marker and the central axis is equal to or less than the edge of the first screen The distance from the geometric center of the first network disk.
  • each first marker is fixed on the first baffle film.
  • the distance between at least one of the first markers and the central axis is equal to that of the first baffle film.
  • the distance from the edge to the geometric center of the first choke film, or the distance between each first marker and the central axis is less than the distance from the edge of the first choke film to the geometric center of the first choke film.
  • the distance between each first marker and the central axis is less than the distance from the edge of the first choke film to the geometric center of the first choke film, each first mark
  • the objects are distributed along the first circumference, and the first circumference is arranged concentrically with the first flow blocking film.
  • each first marker is distributed at equal intervals along the first circumference, and the number of first markers ranges from 2 to 12.
  • the plugging unit further includes a second subunit connected to the first subunit.
  • the second subunit includes a second mesh disk and a second spoiler film provided in the second mesh disk.
  • the central axis passes through the first The geometric center of the two mesh discs, and the central axis is perpendicular to the plane where the second mesh disc is located, the central axis passes through the geometric center of the second choke film, and the central axis is perpendicular to the plane where the second choke film is, the marking structure is also At least two second markers are included, and each second marker is connected to the second screen, or each second marker is connected to the second blocking film.
  • each second marker is fixed on the second screen, and in the natural state of the occluder, the distance between each second marker and the central axis is equal to or less than the edge of the second screen The distance from the geometric center of the second network disk.
  • each second marker is fixed on the second baffle film.
  • the distance between at least one of the second markers and the central axis is equal to that of the second baffle film.
  • the distance from the edge to the geometric center of the second choke film, or the distance between each second marker and the central axis is less than the distance from the edge of the second choke film to the geometric center of the second choke film.
  • each second marker is less than the distance from the edge of the second choke film to the geometric center of the second choke film, each second mark
  • the objects are distributed along the second circumference, and the second circumference is arranged concentrically with the second flow blocking film.
  • each second marker is distributed at equal intervals along the second circumference, and the number of second markers ranges from 2 to 12.
  • the plugging unit further includes a waist and a third choke film, both ends of the waist are respectively connected to the first mesh disk and the second mesh disk, the third choke film is disposed in the waist, and the central axis passes through the third The geometric center of the baffle film, and the center axis is perpendicular to the plane where the third baffle film is located, the marking structure further includes at least two third markers, each third marker is connected to the waist, or each third marker Both are connected to the third blocking film.
  • each third marker is connected to the third baffle film, and in the natural state of the occluder, the distance between at least one of each third marker and the central axis is equal to the edge of the third baffle film.
  • the distance from the geometric center of the third choke film, or the distance between each third marker and the central axis is less than the distance from the edge of the third choke film to the geometric center of the third choke film.
  • the number of the first marker, the second marker, and the third marker are two, and in the natural state of the occluder, the two first markers are located at two of the same diameter of the first baffle film.
  • two second markers are located at both ends of the same diameter of the second choke film
  • two third markers are located at both ends of the same diameter of the third choke film
  • two first markers and two second markers Coplanar with two third markers.
  • the marking structure of the above-mentioned occluder includes a distal marker and at least two first markers.
  • the distal marker is provided on the head, each first marker is connected to the sealing unit, and each first marker is located In the same placement plane, the placement plane is perpendicular to the central axis, the distal markers are set outside the placement plane, and the projection point of each first marker in a projection plane perpendicular to the placement plane is located on a straight line segment, in the occluder In the natural state, the connection between the distal marker and the two ends of the straight line is triangular.
  • the marking structure can be developed under the DSA to guide the release of the occluder.
  • the accurate position and release state of the occlusion unit can be accurately judged, thereby improving the success rate of the operation.
  • FIG. 1 is a schematic structural diagram of an occluder in an embodiment.
  • Fig. 2 is a schematic structural diagram of the cooperation between the occluder and the interatrial septum in an embodiment.
  • FIG. 3 is a schematic structural diagram of the cooperation between the occluder and the sheath tube in an embodiment.
  • Fig. 4a is a first state diagram of the occluder in an embodiment.
  • Fig. 4b is a second state diagram of the occluder in an embodiment.
  • 4c is a third state diagram of the occluder in an embodiment.
  • Fig. 4d is a fourth state diagram of the occluder in an embodiment.
  • FIG. 5 is a schematic diagram of the structure of the first blocking film and the first marker in an embodiment.
  • FIG. 6 is a schematic structural diagram of a head, a plugging unit, and a marking structure in an embodiment.
  • FIG. 7 is a top view of the plugging unit in an embodiment.
  • distal and proximal are used as azimuth words, which is a common term in the field of interventional medical devices, where “distal” refers to the end away from the operator during surgery, "Proximal” means the end near the operator during the procedure.
  • this embodiment provides an occluder 100, which includes an occluder unit 10 and a head 141 connected to the occluder unit 10.
  • the occluder unit 10 has a central axis AA, and the central axis AA passes through the occluder The distal and proximal ends of the occluder 100.
  • the occluder 100 further includes a marking structure 20.
  • the marking structure 20 includes a distal marker 211 and at least two first markers 212.
  • the distal marker 211 is disposed on the head 141
  • Each first marker 212 is connected to the blocking unit 10, each first marker 212 is located in the same placement plane, the placement plane is perpendicular to the central axis AA, and the distal marker 211 is located outside the placement plane, each first The projection point of the marker 212 in a projection plane perpendicular to the placement plane is on a straight line segment. In the natural state of the occluder 100, the line connecting the distal marker 211 and the two ends of the straight line segment is triangular.
  • the occluder 100 of this embodiment is used to occlude the defect of the interatrial septum 300, as shown in FIG. 2. Please also refer to FIG. 3, the occluder 100 needs to be loaded into the conveyor before use.
  • the conveyor includes a sheath 400 with an inner diameter of 2-5 mm.
  • the occluder 100 When the occluder 100 is implanted, it needs to be in the DSA (Digital Subtraction Angiography, digital subtraction angiography technology) and other X-ray imaging equipment under the guidance of the surgical operation, so that the occluder 100 is delivered to the distal end along the sheath 400, after delivery to the relevant lesion site, the occluder 100 A force is applied to release the occluder 100 from the sheath 400 to the interatrial septum 300 to seal the defect of the interatrial septum 300.
  • DSA Digital Subtraction Angiography, digital subtraction angiography technology
  • a force is applied to the occluder 100 to move the occluder unit 10 out of the sheath tube 400, and the occluder unit 10 acts on its own elastic force Unfold it to block the defect.
  • the marking structure 20 of the occluder 100 includes a distal marker 211 and at least two first markers 212.
  • the distal marker 211 is provided on the head 141, and each first marker 212 is connected to the sealing unit 10.
  • Each first marker 212 is located in the same placement plane, the placement plane is perpendicular to the central axis AA, the distal marker 211 is located outside the placement plane, and each first marker 212 is in a projection plane perpendicular to the placement plane
  • the projection point is located on a straight line segment. In the natural state of the occluder 100, the connection between the distal marker 211 and the two ends of the straight line segment is triangular.
  • the marking structure 20 can be in the DSA Lower development to guide the release of the occluder 100.
  • the occluder 100 applies a force to the occluder 100 to make it in the left atrium (here only the occluder 100 is deployed in the left atrium as an example for illustration, but not limited to this)
  • the surgeon can apply a force to the occluder 100 to make it reciprocate. By observing whether the triangle is deformed during the reciprocation, if in this process, If the triangle is not deformed, it can be determined that the sealing unit 10 is not attached to the interatrial septum 300.
  • each first marker 212 is attached to the interatrial septum 300.
  • the morphology guides the surgeon to perform the operation and assists the surgeon in understanding the positional relationship between the occlusion unit 10 and the interatrial septum 300, so as to operate the occlusion device 100 later.
  • the movement of each first marker 212 is restricted, and the distal marker 211 can move freely.
  • the distal marker 211 continues to The room partition 300 is close to the first marker 212, and the triangle will be deformed. At this time, it can be determined that the sealing unit 10 has been attached to the room partition 300.
  • the distal marker 211 continues to approach the atrial septum 300, when the projection of the distal marker 211 When it is collinear with the straight line segment, if further force is applied to the occluder 100 to make the distal marker 211 continue to move closer to the interatrial septum 300, as shown in FIG.
  • the distal marker 211 may cross the defect location of the interatrial septum 300 , Causing the occluder 100 to fall off, so that when the projection of the distal marker 211 is collinear with the straight line segment, it can serve as an early warning to the surgeon to prevent the distal marker 211 from crossing the defect location of the atrial septum 300, and then To avoid causing the occluder 100 to fall off, therefore, the occluder 100 in this embodiment can determine its accurate position and release status under DSA, improving the success rate of the operation.
  • the plugging unit 10 includes a first subunit 11, and the first subunit 11 includes a first screen 111 and a first spoiler film 112 provided in the first screen 111, and a central axis AA passes through the geometric center of the first screen 111, and the central axis AA is perpendicular to the plane where the first screen 111 is located, the central axis AA passes through the geometric center of the first spoiler film 112, and the central axis AA is perpendicular to the first In the plane where the flow blocking film 112 is located, each first marker 212 is connected to the first screen 111. Or, as shown in FIG. 5, in another embodiment, each first marker 212 is connected to the first blocking film 112.
  • the central axis AA passes through the geometric center of the first network disk 111, and the central axis AA is perpendicular to the plane where the first network disk 111 is located, so that the plane where the first network disk 111 is located is perpendicular to the projection plane, each A marker 212 is connected to the first network disk 111, so that the projection of each first marker 212 in the projection plane is on the same straight line segment, and the projection of the remote marker 211 is connected to the two ends of the straight line segment The line is triangular.
  • the central axis AA passes through the geometric center of the first choke film 112, and the central axis AA is perpendicular to the plane of the first choke film 112, so that the plane of the first choke film 112 is perpendicular to the projection plane ,
  • Each first marker 212 is connected to the first blocking film 112, so that the projection of each first marker 212 in the projection plane is located on the same straight line segment, further making the projection of the distal marker 211 and the straight line segment
  • the lines at both ends of the are triangular.
  • applying force to the occluder 100 causes the first subunit 11 to expand in the left atrium, and by adjusting parameters such as the probe angle of the DSA, each first mark in the screen detected by the DSA
  • the projection point of the object 212 in the projection plane is located on a straight line segment, and the connection between the distal marker 211 and the two ends of the straight line segment is triangular, and the surgeon can apply a force to the occluder 100 to make it reciprocate.
  • the surgeon can apply a force to the occluder 100 to make it reciprocate.
  • the distal marker 211 may cross the defect of the interatrial septum 300 Position, causing the occluder 100 to fall off, so that when the projection of the distal marker 211 is collinear with the straight line segment, it can serve as an early warning to the surgeon to avoid the distal marker 211 crossing the defect location of the interatrial septum 300, Furthermore, the occluder 100 can be prevented from falling off, and the operation success rate can be improved.
  • the first screen 111 and the first flow blocking film 112 are transported to the defect of the interatrial septum 300 for sealing the defect of the interatrial septum 300.
  • the first screen 111 is made of a material with elastic memory.
  • the first screen 111 can be unfolded and recovered under its own elastic force To the natural state, and when the first screen 111 returns to the natural state, it can drive the first flow blocking film 112 to expand, so that the first screen 111 and the first flow blocking film 112 close the defect of the interatrial septum 300.
  • each first marker 212 is fixed on the first screen 111.
  • the distance between each first marker 212 and the central axis AA Both are equal to the distance from the edge of the first network disk 111 to the geometric center of the first network disk 111.
  • each first marker 212 is fixed on the first mesh 111, and each first marker 212 is connected to the central axis
  • the distance between AA is equal to the distance from the edge of the first network disk 111 to the geometric center of the first network disk 111, which can ensure that each first marker 212 fits the interatrial septum 300, and can increase the distance between the distal marker 211 and The accuracy of the guided surgery used in conjunction with the first marker 212.
  • the first screen 111 is circular, the central axis AA passes through the center of the first screen 111 (that is, the geometric center of the first screen 111), and each first marker 212 is fixed to the first screen On the circumference of the disk 111, the distance between each first marker 212 and the center of the circle of the first screen 111 is equal to the radius of the first screen 111.
  • the distance between each first marker 212 and the central axis AA may also be less than the edge of the first screen 111 to the first screen 111
  • the distance of the geometric center For example, the first screen 111 is circular, the central axis AA passes through the center of the first screen 111 (that is, the geometric center of the first screen 111), and each first marker 212 is fixed to the first screen along a circumference Above 111, the distance between each first marker 212 and the center of the first screen 111 is equal to the radius of the first screen 111, specifically, the diameter of the circumference of each first marker 212 is larger than that of the first screen 111 1-8mm smaller diameter.
  • the distance between each first marker 212 and the central axis AA may also be less than the distance from the edge of the first screen 111 to the geometric center of the first screen 111 to facilitate processing, and When the occluder 100 is transported outward from the sheath 400, it can also avoid friction between the first marker 212 and the inner wall of the sheath 400, thereby preventing the first marker 212 from falling off.
  • each first marker 212 is fixed on the first flow blocking film 112.
  • the distance between at least one of each first marker 212 and the central axis AA is equal to the first The distance from the edge of a flow blocking film 112 to the geometric center of the first flow blocking film 112.
  • the distance between each first marker 212 and the central axis A-A is less than the distance from the edge of the first choke film 112 to the geometric center of the first choke film 112.
  • the distance between the first marker 212 and the central axis AA is equal to the distance from the edge of the first choke film 112 to the geometric center of the first choke film 112, for example, the first choke film 112 is Round, the central axis AA passes through the center of the first choke film 112 (that is, the geometric center of the first choke film 112), each first marker 212 is fixed to the edge of the first choke film 112, each first mark The distance between the object 212 and the center of the first baffle film 112 is equal to the radius of the first baffle film. In the operation, the accuracy of the guided surgery in which the distal marker 211 and the first marker 212 are used together can be improved.
  • each first marker 212 and the central axis AA When the distance between each first marker 212 and the central axis AA is less than the distance from the edge of the first choke film 112 to the geometric center of the first choke film 112, the distance between each first marker 212 and the sheath can be avoided
  • the inner wall of 400 is rubbed, which can prevent the first marker 212 from falling off.
  • each first marker 212 in the natural state of the occluder 100, is less than the edge of the first choke film 112 to the first choke film 112 With respect to the distance of the geometric center, each first marker 212 is distributed along a first circumference, and the first circumference is concentrically arranged with the first flow blocking film 112.
  • the distance between each first marker 212 and the central axis AA is less than the distance from the edge of the first choke film 112 to the geometric center of the first choke film 112, for example, the first choke film 112
  • the center axis AA passes through the center of the first choke film 112 (that is, the geometric center of the first choke film 112), and each first marker 212 is fixed on the first choke film 112 along the first circumference.
  • the diameter of the first circumference is smaller than the diameter of the first flow blocking film by 1-8 mm. It is possible to avoid friction between each first marker 212 and the inner wall of the sheath tube 400, and thus to prevent the first marker 212 from falling off.
  • the first markers 212 are equally spaced along the first circumference, and the number of the first markers 212 ranges from 2 to 12.
  • the marking structure 20 includes six first markers 212, and the six first markers 212 are equally spaced along the first circumference.
  • the blocking unit 10 further includes a second subunit 12 connected to the first subunit 11.
  • the second subunit 12 includes a second network disk 121 and is disposed in the second network disk 121 Of the second choke film 122, the central axis AA passes through the geometric center of the second screen 121, and the central axis AA is perpendicular to the plane where the second screen 121 is located, and the central axis AA passes through the geometry of the second choke film 122
  • the marking structure 20 further includes at least two second markers 213, and each second marker 213 is connected to the second screen 121, or, each The second markers 213 are all connected to the second blocking film 122.
  • the central axis AA passes through the geometric center of the second network disk 121, and the central axis AA is perpendicular to the plane where the second network disk 121 is located, so that the plane where the second network disk 121 is located is perpendicular to the projection plane.
  • Both the two markers 213 are connected to the second network disk 121, so that the projection of each second marker 213 in the projection plane is on the same straight line segment.
  • the central axis AA passes through the geometric center of the second choke film 122, and the central axis AA is perpendicular to the plane of the second choke film 122, so that the plane of the second choke film 122 is perpendicular to the projection plane
  • Each second marker 213 is connected to the second blocking film 122, so that the projection of each second marker 213 in the projection plane is on the same straight line segment.
  • each second marker 213 is fixed on the second screen 121.
  • the distance between each second marker 213 and the central axis AA Both are equal to the distance from the edge of the second network disk 121 to the geometric center of the second network disk 121.
  • the distance between each second marker 213 and the central axis AA is equal to the distance from the edge of the second screen 121 to the geometric center of the second screen 121, During the operation, when the edge of the second mesh disk 121 is attached to the interatrial septum 300, it can be ensured that each second marker 213 is attached to the interatrial septum 300, and the accuracy of guiding the second marker 213 can be improved.
  • the central axis AA passes through the geometric center of the second screen 121, and the central axis AA is perpendicular to the plane where the second screen 121 is located, and each second marker 213 is fixed on the second screen 121.
  • the distance between each second marker 213 and the central axis AA is less than the distance from the edge of the second screen 121 to the geometric center of the second screen 121.
  • the distance between each second marker 213 and the central axis AA is less than the distance from the edge of the second screen 121 to the geometric center of the second screen 121
  • friction between the second marker 213 and the inner wall of the sheath 400 can be avoided, thereby preventing the second marker 213 from falling off.
  • each second marker 213 is fixed on the second blocking film 122.
  • the distance between at least one of each second marker 213 and the central axis AA is equal to the The distance from the edge of the second choke film 122 to the geometric center of the second choke film 122, or the distance between each second marker 213 and the central axis AA is less than the edge of the second choke film 122 to the second resistance The distance of the geometric center of the flow film 122.
  • each second marker 213 and the central axis AA is less than the distance from the edge of the second choke film 122 to the geometric center of the second choke film 122,
  • Each second marker 213 is distributed along a second circumference, and the second circumference is disposed concentrically with the second blocking film 122.
  • each second marker 213 and the central axis AA is less than the distance from the edge of the second choke film 122 to the geometric center of the second choke film 122, and each second marker 213 is located at On a second circumference, when the second blocking film 122 is located in the sheath 400, friction between the second marker 213 and the inner wall of the sheath 400 can be avoided, thereby preventing the second marker 213 from falling off.
  • each second marker 213 is distributed at equal intervals along the second circumference, and the number of second markers 213 ranges from 2 to 12.
  • the plugging unit 10 further includes a waist 131 and a third flow blocking film 132. Both ends of the waist 131 are connected to the first mesh plate 111 and the second mesh plate 121 respectively.
  • the film 132 is disposed in the waist 131
  • the marking structure 20 further includes at least two third markers 214, the central axis AA passes through the geometric center of the third flow blocking film 132, and the center axis AA is perpendicular to the third flow blocking film 132
  • each third marker 214 is connected to the waist 131, or each third marker 214 is connected to the third blocking film 132.
  • the central axis AA passes through the geometric center of the third choke film 132, and the central axis AA is perpendicular to the plane of the third choke film 132, so that the plane of the third choke film 132 is perpendicular to the projection
  • each third marker 214 is connected to the third blocking film 132, so that the projection of each second marker 213 in the projection plane is on the same straight line segment.
  • the third marker 214 is formed in the projection plane
  • the straight line formed by the first marker 212 and the straight line formed by the first marker 212 are parallel to each other. The surgeon can determine the relative position of the third marker 214 and the interatrial septum 300 by the distance between the two straight lines, and then determine the waist 131 and the third baffle membrane 132 relative position to the interatrial septum 300.
  • each third marker 214 is connected to the third blocking film 132, and in the natural state of the occluder 100, the distance between at least one of each third marker 214 and the central axis AA is equal to the third The distance from the edge of the choke film 132 to the geometric center of the third choke film 132, or the distance between each third marker 214 and the central axis AA is less than the edge of the third choke film 132 to the third choke The distance of the geometric center of the membrane 132.
  • the distance between the third marker 214 and the central axis AA when the distance between the third marker 214 and the central axis AA is equal to the distance from the edge of the third choke film 132 to the geometric center of the third choke film 132, it helps to improve the third marker
  • the accuracy of the guided surgery of 214 is released at the waist 131 when the distance between the third marker 214 and the central axis AA is less than the distance from the edge of the third choke film 132 to the geometric center of the third choke film 132 During the process, friction between the third marker 214 and the inner wall of the sheath 400 can be avoided, and the third marker 214 can be prevented from falling off.
  • the third spoiler film 132 is circular, the central axis AA passes through the center of the third spoiler film 132 (that is, the central axis AA passes through the geometric center of the third spoiler film 132), and the central axis AA Perpendicular to the plane of the third choke film 132, each third marker 214 is fixed on the third choke film 132 along a circumference, and the diameter of the circumference of each third marker 214 is smaller than the diameter of the third choke film 132 1-8mm. During the release of the waist 131, friction between the third marker 214 and the inner wall of the sheath 400 can be avoided, and the third marker 214 can be prevented from falling off.
  • the waist 131 is round, the central axis AA passes through the center of the waist 131 (that is, the central axis AA passes through the geometric center of the waist 131), and each third marker 214 is fixed to the waist along a circle On 131, the diameter of the circumference of each third marker 214 is smaller than the diameter of the waist 131 by 1-8 mm.
  • friction between the third marker 214 and the inner wall of the sheath 400 can be avoided, and the third marker 214 can be prevented from falling off.
  • the number of the first marker 212, the second marker 213, and the third marker 214 are two.
  • the two One marker 212 is located at both ends of the same diameter of the first flow blocking film 112
  • two second markers 213 are located at both ends of the same diameter of the second flow blocking film 122
  • two third markers 214 are located at the third flow blocking film Both ends of the same diameter of 132, and two first markers 212, two second markers 213 and two third markers 214 are coplanar.
  • the two first markers 212, the two second markers 213, and the two third markers 214 are coplanar, which helps to improve the judgment of the first screen 111, the second screen 121, and the waist 131. Morphological accuracy.
  • the occluder 100 further includes a plug head 151 fixed to the proximal end of the occluder unit 10, and the conveyor further includes a transport head made of a developing material, the transport head and the plug head 151 Threaded connection.
  • the occluder 100 further includes a locking pin 161, which is connected between the head 141 and the plug 151, and the marking structure 20 further includes For the end marker, whether the occluder 100 and the conveyor are smoothly separated can be judged by the relative position between the proximal marker and the delivery head.
  • the first spoiler film 112 is released along with the first screen 111.
  • the second spoiler 122 also When the second mesh disk 121 is released and the waist 131 is released, the third blocking film 132 is released together with the waist 131.
  • the first mesh disc 111, the second mesh disc 121 and the waist 131 can all be prepared by braiding, cutting, etc.
  • the material of the braided wire may be NiTi alloy, Co-Cr alloy, stainless steel, etc.
  • Non-degradable metal materials can also use biodegradable materials.
  • the biodegradable materials include but are not limited to polylactic acid (PLA), polyracemic lactic acid (PDLLA), polyglycolic acid (PGA), Polylactic acid-glycolic acid copolymer (PLGA), polyhydroxy fatty acid lipid (PHA), polydioxanone (PDO), polycaprolactone (PCL), etc.
  • PLA polylactic acid
  • PDLLA polyracemic lactic acid
  • PGA polyglycolic acid
  • PLGA Polylactic acid-glycolic acid copolymer
  • PHA polyhydroxy fatty acid lipid
  • PDO polydioxanone
  • PCL polycaprolactone
  • the material of the marking structure 20 may be a metallic substance, such as gold, platinum, barium sulfate, etc., or a non-metallic substance, such as sodium bromide, sodium iodide, iohexol, iodide, etc.
  • the first marker 212 is fixed to the first mesh 111, or is wound on the woven monofilament, or welded on the woven monofilament, or painted Covering the surface of woven monofilament.
  • the arrangement of the above-mentioned marking structure 20 has a simple structure, is firm and reliable, and does not affect the overall structure of the occluder 100 itself.
  • the above-mentioned fixing method can also be referred to, which will not be repeated here.
  • the fixing method may be embedding, bonding, and stitching.

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Abstract

一种封堵器(100),包括封堵单元(10)和与封堵单元(10)相连的封头(141),封堵单元(10)具有一中心轴(A-A),中心轴(A-A)穿过封堵器(100)的远端和近端,封堵器(100)还包括标记结构(20),标记结构(20)包括远端标记物(211)和至少两个第一标记物(212),远端标记物(211)设于封头(141)上,各第一标记物(212)均与封堵单元(10)相连,各第一标记物(212)均位于同一放置平面内,放置平面垂直于中心轴(A-A),远端标记物(211)位于放置平面之外,各第一标记物(212)在一垂直于放置平面的投影平面内的投影点位于一直线段上,在封堵器(100)的自然状态下,远端标记物(211)与直线段的两端点的连线呈三角形。该封堵器(100)可以提高植入手术的成功率。

Description

封堵器 技术领域
本发明涉及医疗器械领域,特别是涉及一种封堵器。
背景技术
1974年,King和Mills首次完成了经导管介入治疗继发孔型房间隔缺损(atrial septal defect,ASD),此后随着封堵器械的不断改进,尤其是1997年以来,随着Amplatzer镍钛合金编织封堵器的面世,镍钛合金编织封堵器广泛应用于房间隔缺损(ASD)、室间隔缺损(VSD)、动脉导管未闭(PDA)和卵圆孔未闭(PFO)等先天性心脏病的介入治疗。目前经导管介入封堵器微创治疗房间隔缺损ASD、VSD、PDA和PFO等先天性心脏病成为重要方法。封堵器心脏缺损部位后,缺损周围的组织向内生长并完成内皮化。不可降解的封堵器在完成内皮化后依然长期存在于缺损部位,易产生远期并发症和不利影响,包括房室传导阻滞、瓣膜损伤、残余分流、心脏磨穿、镍过敏等。因此,由可降解材料制成的可降解封堵器是目前介入治疗封堵领域的最新发展方向。可降解封堵器在植入人体后可完成封堵缺损的效果,封堵完成后,组成封堵器的材料在体内发生降解,最终被肌体代谢成CO2和水排除体外,避免人体长期受到异物影响。
应用于介入治疗领域的生物可降解材料包括但不限于聚乳酸(PLA),聚乙醇酸(PGA)、聚乳酸-羟基乙酸共聚物(PLGA)、聚羟基脂肪酸脂(PHA)、聚二氧环己酮(PDO)或聚己内酯(PCL)等。
介入封堵术通常需要在DSA(Digital Subtraction Angiography,数字减影血管造影技术)等X射线影像设备的引导下进行手术操作,因此要求封堵器在X射线下具有辐射不透性,以在X射线下可被识别。可降解材料制成的封堵器在X光下的显影性较差,在DSA下难以判断其准确位置和释放状态,导致植入手术的成功率下降。
发明内容
基于此,有必要提供一种封堵器,以解决现有的封堵器在X射线影像设备下难以判断植入产品的准确位置和释放状态的问题。
一种封堵器,包括封堵单元和与封堵单元相连的封头,封堵单元具有一中心轴,中心轴穿过封堵器的远端和近端,封堵器还包括标记结构,标记结构包括远端标记物和至少两个第一标记物,远端标记物设于封头上,各第一标记物均与封堵单元相连,各第一标记物均位于同一放置平面内,放置平面垂直于中心轴,远端标记物位于放置平面之外,各第一标记物在一垂直于放置平面的投影平面内的投影点位于一直线段上,在封堵器的自然状态下,远端标记物与直线段的两端点的连线呈三角形。
可以理解地,封堵单元包括第一子单元,第一子单元包括第一网盘和设于第一网盘中的第一阻流膜,中心轴穿过第一网盘的几何中心,且中心轴垂直于第一网盘所在的平面,中心轴穿过第一阻流膜的几何中心,且中心轴垂直于第一阻流膜所在的平面,各第一标记物均与第一网盘相连,或,各第一标记物均与第一阻流膜相连。
可以理解地,各第一标记物均固定于第一网盘上,在封堵器的自然状态下,各第一标记物与中心轴之间的距离均等于或均小于第一网盘的边缘到第一网盘的几何中心的距离。
可以理解地,各第一标记物均固定于第一阻流膜上,在封堵器的自然状态下,各第一标记物中至少一个与中心轴之间的距离等于第一阻流膜的边缘到第一阻流膜的几何中心的距离,或,各第一标记物与中心轴之间的距离均小于第一阻流膜的边缘到第一阻流膜的几何中心的距离。
可以理解地,在封堵器的自然状态下,各第一标记物与中心轴之间的距离均小于第一阻流膜的边缘到第一阻流膜的几何中心的距离,各第一标记物沿第一圆周分布,第一圆周与第一阻流膜同心设置。
可以理解地,各第一标记物沿第一圆周等间距分布,第一标记物的数量的范围是2至12个。
可以理解地,封堵单元还包括与第一子单元相连的第二子单元,第二子单 元包括第二网盘和设于第二网盘中的第二阻流膜,中心轴穿过第二网盘的几何中心,且中心轴垂直于第二网盘所在的平面,中心轴穿过第二阻流膜的几何中心,且中心轴垂直于第二阻流膜所在的平面,标记结构还包括至少两个第二标记物,各第二标记物均与第二网盘相连,或,各第二标记物均与第二阻流膜相连。
可以理解地,各第二标记物均固定于第二网盘上,在封堵器的自然状态下,各第二标记物与中心轴之间的距离均等于或均小于第二网盘的边缘到第二网盘的几何中心的距离。
可以理解地,各第二标记物均固定于第二阻流膜上,在封堵器的自然状态下,各第二标记物中至少一个与中心轴之间的距离等于第二阻流膜的边缘到第二阻流膜的几何中心的距离,或,各第二标记物与中心轴之间的距离均小于第二阻流膜的边缘到第二阻流膜的几何中心的距离。
可以理解地,在封堵器的自然状态下,各第二标记物与中心轴之间的距离均小于第二阻流膜的边缘到第二阻流膜的几何中心的距离,各第二标记物沿第二圆周分布,第二圆周与第二阻流膜同心设置。
可以理解地,各第二标记物沿第二圆周等间距分布,第二标记物的数量的范围是2至12个。
可以理解地,封堵单元还包括腰部和第三阻流膜,腰部的两端分别与第一网盘和第二网盘相连,第三阻流膜设于腰部中,中心轴穿过第三阻流膜的几何中心,且中心轴垂直于第三阻流膜所在的平面,标记结构还包括至少两个第三标记物,各第三标记物均与腰部相连,或,各第三标记物均与第三阻流膜相连。
可以理解地,各第三标记物均与第三阻流膜相连,在封堵器的自然状态下,各第三标记物中至少一个与中心轴之间的距离等于第三阻流膜的边缘到第三阻流膜的几何中心的距离,或,各第三标记物与中心轴之间的距离均小于第三阻流膜的边缘到第三阻流膜的几何中心的距离。
可以理解地,第一标记物、第二标记物和第三标记物的数量均为2个,在封堵器的自然状态下,两第一标记物位于第一阻流膜的同一直径的两端,两第二标记物位于第二阻流膜的同一直径的两端,两第三标记物位于第三阻流膜的 同一直径的两端,且两第一标记物、两第二标记物和两第三标记物共面。
上述封堵器的标记结构包括远端标记物和至少两个第一标记物,远端标记物设于封头上,各第一标记物均与封堵单元相连,各第一标记物均位于同一放置平面内,放置平面垂直于中心轴,远端标记物设于放置平面之外,各第一标记物在一垂直于放置平面的投影平面内的投影点位于一直线段上,在封堵器的自然状态下,远端标记物与直线段的两端点的连线呈三角形,在封堵器的释放过程中,标记结构可在DSA下显影以引导封堵器的释放,在手术中,可通过远端标记物与直线段的两端点的连线所形成的三角形的形态变化,精确地判断封堵单元的准确位置和释放状态,进而提高手术的成功率。
附图说明
图1为一实施例中封堵器的结构示意图。
图2为一实施例中封堵器与房间隔配合的结构示意图。
图3为一实施例中封堵器与鞘管配合的结构示意图。
图4a为一实施例中封堵器的第一状态图。
图4b为一实施例中封堵器的第二状态图。
图4c为一实施例中封堵器的第三状态图。
图4d为一实施例中封堵器的第四状态图。
图5为一施例中第一阻流膜和第一标记物的结构示意图。
图6为一实施例中封头、封堵单元、标记结构的结构示意图。
图7为一实施例中封堵单元的俯视图。
具体实施方式
为使本发明的上述目的、特征和优点能够更加明显易懂,下面结合附图对本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施,本领域技术人员可以在不违背本发明内涵的情况下做类似改进,因此本发明不受下面公开的具体实施的限制。
需要说明的是,当元件被称为“固定于”或“设置于”另一个元件,它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件,它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“垂直的”、“水平的”、“左”、“右”以及类似的表述只是为了说明的目的,并不表示是唯一的实施方式。
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。本文中在本发明的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。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。
为了更加清楚地描述本发明的结构,采用“远端”、“近端”作为方位词,该方位词为介入医疗器械领域惯用术语,其中“远端”表示手术过程中远离操作者的一端,“近端”表示手术过程中靠近操作者的一端。
如图1所示,本实施例提供一种封堵器100,包括封堵单元10和与封堵单元10相连的封头141,封堵单元10具有一中心轴A-A,中心轴A-A穿过封堵器100的远端和近端,封堵器100还包括标记结构20,标记结构20包括远端标记物211和至少两个第一标记物212,远端标记物211设于封头141上,各第一标记物212均与封堵单元10相连,各第一标记物212均位于同一放置平面内,放置平面垂直于中心轴A-A,远端标记物211位于放置平面之外,各第一标记物212在一垂直于放置平面的投影平面内的投影点位于一直线段上,在封堵器100的自然状态下,远端标记物211与该直线段的两端点的连线呈三角形。
本实施例的封堵器100用于封堵房间隔300的缺损,如图2所示。请一并参阅图3所示,封堵器100在使用前,需要装入输送器中,输送器包括一个内径为2-5mm的鞘管400,封堵器100在植入时,需要在DSA(Digital Subtraction Angiography,数字减影血管造影技术)等X射线影像设备的引导下进行手术操作,使得封堵器100沿鞘管400向远端输送,输送至相关病灶部位后,对封堵器100施加作用力,以将封堵器100从鞘管400中释放至房间隔300处以封堵房间隔300的缺损。具体地,装载有封堵器100的鞘管400穿过房间隔300后,对封堵器100施加作用力使得封堵单元10运动至鞘管400外,封堵单元10在 自身的弹性力作用下展开,从而封堵缺损。
封堵器100的标记结构20包括远端标记物211和至少两个第一标记物212,远端标记物211设于封头141上,各第一标记物212均与封堵单元10相连,各第一标记物212均位于同一放置平面内,放置平面垂直于中心轴A-A,远端标记物211设于放置平面之外,各第一标记物212在一垂直于放置平面的投影平面内的投影点位于一直线段上,在封堵器100的自然状态下,远端标记物211与直线段的两端点的连线呈三角形,在封堵器100的释放过程中,标记结构20可在DSA下显影以引导封堵器100的释放。
具体地,如图4a所示,对封堵器100施加作用力使其在左心房(在此仅以封堵器100在左心房内展开为例进行说明,但并不以此为限)内展开,通过调整DSA的探头角度等参数,使得DSA探测到的画面中各第一标记物212在一垂直于放置平面的投影平面内的投影点位于一直线段上,且远端标记物211与该直线段的两端点的连线呈三角形,此时,术者可通对封堵器100施加作用力使其往复运动,通过观察该三角形在往复运动过程中是否发生变形,若在此过程中,三角形未发生变形,则可判断为封堵单元10未与房间隔300相贴。
如图4b所示,继续对封堵单元10施加作用力,使封堵单元10向近端移动至各第一标记物212与房间隔300相贴,在此过程中,可通过观察三角形的几何形态引导术者进行手术,辅助术者了解封堵单元10与房间隔300的位置关系,以便后续操作封堵器100。具体地,当各第一标记物212与房间隔300相贴后,各第一标记物212的运动受到限制,而远端标记物211的可自由运动,此时,远端标记物211继续向房间隔300和第一标记物212靠近,三角形会发生变形,此时可判断为封堵单元10已与房间隔300相贴。
如图4c所示,当封堵单元10与房间隔300相贴后,若继续向近端拉拽封堵器100,远端标记物211继续靠近房间隔300,当远端标记物211的投影与直线段共线时,若再继续对封堵器100施加作用力使远端标记物211继续靠近房间隔300运动,如图4d所示,远端标记物211可能越过房间隔300的缺损位置,造成封堵器100脱落,如此,当远端标记物211的投影与直线段共线时可对术者起到预警提示的作用,避免远端标记物211越过房间隔300的缺损位置,进 而避免造成封堵器100脱落,因此,本实施例中的封堵器100在DSA下可以判断其准确位置和释放状态,提高手术的成功率。
进一步地,如图1所示,封堵单元10包括第一子单元11,第一子单元11包括第一网盘111和设于第一网盘111中的第一阻流膜112,中心轴A-A穿过第一网盘111的几何中心,且中心轴A-A垂直于第一网盘111所在的平面,中心轴A-A穿过第一阻流膜112的几何中心,且中心轴A-A垂直于第一阻流膜112所在的平面,各第一标记物212均与第一网盘111相连。或,如图5所示,在另一实施方式中,各第一标记物212均与第一阻流膜112相连。
本实施例中,中心轴A-A穿过第一网盘111的几何中心,且中心轴A-A垂直于第一网盘111所在的平面,使得第一网盘111所在的平面垂直于投影平面,各第一标记物212均与第一网盘111相连,可使得各第一标记物212在投影平面内的投影位于同一直线段上,且使得远端标记物211的投影与该直线段的两端的连线呈三角形。同理可知,中心轴A-A穿过第一阻流膜112的几何中心,且中心轴A-A垂直于第一阻流膜112所在的平面,可使得第一阻流膜112所在的平面垂直于投影平面,各第一标记物212均与第一阻流膜112相连,可使得各第一标记物212在投影平面内的投影位于同一直线段上,进一步地使得远端标记物211的投影与直线段的两端的连线呈三角形。
如图4a所示,在手术中,对封堵器100施加作用力使得第一子单元11在左心房内展开,通过调整DSA的探头角度等参数,使得DSA探测到的画面中各第一标记物212在投影平面内的投影点位于一直线段上,且使得远端标记物211与直线段的两端点的连线呈三角形,术者可通对封堵器100施加作用力使其往复运动,通过观察该三角形在往复运动过程中是否发生变形,若在此过程中,三角形未发生变形,则可判断为封堵单元10未与房间隔300相贴。
如图4b所示,继续对封堵单元10施加作用力,使封堵单元10向近端移动至第一网盘111或第一阻流膜112与房间隔300相贴,在此过程中,可通过观察三角形的几何形态辅助术者了解第一网盘111与房间隔300的位置关系,以便操作封堵器100后续的释放。具体地,当第一网盘111或第一阻流膜112与房间隔300相贴后,各第一标记物212的运动均受到限制,而远端标记物211的可 自由运动,此时,远端标记物211继续向房间隔300和第一标记物212靠近,三角形会发生变形,此时可判断为第一子单元11已与房间隔300相贴。
如图4c所示,当第一子单元11与房间隔300相贴后,若继续向近端拉拽封堵器100,远端标记物211继续靠近房间隔300,当远端标记物211的投影与直线段共线时,若再继续对封堵器100施加作用力使远端标记物211继续靠近房间隔300运动,如图4d所示,远端标记物211可能越过房间隔300的缺损位置,造成封堵器100脱落,如此,当远端标记物211的投影与直线段共线时可对术者起到预警提示的作用,避免远端标记物211越过房间隔300的缺损位置,进而可以避免造成封堵器100脱落,提高手术成功率。
本实施例中,在封堵器100的使用中,第一网盘111和第一阻流膜112被输送至房间隔300的缺损处,用于封堵该房间隔300的缺损。第一网盘111由具有弹性记忆的材料制成,当第一网盘111被输送至预期位置并运动至鞘管400外时,第一网盘111可在自身的弹性力作用下展开并恢复至自然状态,并且第一网盘111在恢复至自然状态时可带动第一阻流膜112展开,使得第一网盘111和第一阻流膜112封堵房间隔300的缺损。
可以理解地,如图1所示,各第一标记物212均固定于第一网盘111上,在封堵器100的自然状态下,各第一标记物212与中心轴A-A之间的距离均等于第一网盘111的边缘到第一网盘111的几何中心的距离。
本实施例中,在手术中,当第一网盘111的边缘与房间隔300贴合时,各第一标记物212均固定于第一网盘111上,各第一标记物212与中心轴A-A之间的距离均等于第一网盘111的边缘到第一网盘111的几何中心的距离,可保证各第一标记物212均与房间隔300贴合,可以提高远端标记物211与第一标记物212配合使用的引导手术的准确性。
一实施例中,第一网盘111呈圆形,中心轴A-A穿过第一网盘111的圆心(即第一网盘111的几何中心),各第一标记物212均固定于第一网盘111的圆周上,各第一标记物212与第一网盘111的圆心之间距离等于第一网盘111的半径。
当然,在其他实施例中,在封堵器100的自然状态下,各第一标记物212 与中心轴A-A之间的距离亦可均小于第一网盘111的边缘到第一网盘111的几何中心的距离。例如,第一网盘111呈圆形,中心轴A-A穿过第一网盘111的圆心(即第一网盘111的几何中心),各第一标记物212沿一圆周固定于第一网盘111的上,各第一标记物212与第一网盘111的圆心之间距离等于第一网盘111的半径,具体地,各第一标记物212所在圆周的直径比第一网盘111的直径小1-8mm。本实施例中,各第一标记物212与中心轴A-A之间的距离亦可均小于第一网盘111的边缘到第一网盘111的几何中心的距离,以方便加工,并且,将封堵器100由鞘管400内向外输送时,还可以避免第一标记物212与鞘管400内壁发生摩擦,进而避免第一标记物212脱落。
可以理解地,各第一标记物212均固定于第一阻流膜112上,在封堵器100的自然状态下,各第一标记物212中至少一个与中心轴A-A之间的距离等于第一阻流膜112的边缘到第一阻流膜112的几何中心的距离。或,如图6所示,各第一标记物212与中心轴A-A之间的距离均小于第一阻流膜112的边缘到第一阻流膜112的几何中心的距离。
本实施例中,第一标记物212与中心轴A-A之间的间距等于第一阻流膜112的边缘到第一阻流膜112的几何中心的距离时,例如,第一阻流膜112呈圆形,中心轴A-A穿过第一阻流膜112的圆心(即第一阻流膜112的几何中心),各第一标记物212固定于第一阻流膜112的边缘,各第一标记物212到第一阻流膜112的圆心的距离等于第一阻流膜的半径,在手术中,可以提高远端标记物211与第一标记物212配合使用的引导手术的准确性。各第一标记物212与中心轴A-A之间的距离均小于第一阻流膜112的边缘到第一阻流膜112的几何中心的距离时,可以避免与各第一标记物212与鞘管400的内壁发生摩擦,进而可以避免造成第一标记物212脱落。
优选地,一实施例中,在封堵器100的自然状态下,各第一标记物212与中心轴A-A之间的距离均小于第一阻流膜112的边缘到第一阻流膜112的几何中心的距离,各第一标记物212沿第一圆周分布,第一圆周与第一阻流膜112同心设置。
本实施例中,各第一标记物212与中心轴A-A之间的距离均小于第一阻流 膜112的边缘到第一阻流膜112的几何中心的距离,例如,第一阻流膜112呈圆形,中心轴A-A穿过第一阻流膜112的圆心(即第一阻流膜112的几何中心),各第一标记物212沿第一圆周固定于第一阻流膜112上,第一圆周的直径小于第一阻流膜的直径1-8mm。可以避免各第一标记物212与鞘管400的内壁发生摩擦,进而可以避免造成第一标记物212脱落。
可以理解地,各第一标记物212沿第一圆周等间距分布,第一标记物212的数量的范围是2至12个。
优选地,如图5所示,一实施例中,标记结构20包括6个第一标记物212,6个第一标记物212沿第一圆周等间距分布。
可以理解地,如图1所示,封堵单元10还包括与第一子单元11相连的第二子单元12,第二子单元12包括第二网盘121和设于第二网盘121中的第二阻流膜122,中心轴A-A穿过第二网盘121的几何中心,且中心轴A-A垂直于第二网盘121所在的平面,中心轴A-A穿过第二阻流膜122的几何中心,且中心轴A-A垂直于第二阻流膜122所在的平面,标记结构20还包括至少两个第二标记物213,各第二标记物213均与第二网盘121相连,或,各第二标记物213均与第二阻流膜122相连。
本实施例中,中心轴A-A穿过第二网盘121的几何中心,且中心轴A-A垂直于第二网盘121所在的平面,使得第二网盘121所在的平面垂直于投影平面,各第二标记物213均与第二网盘121相连,可使得各第二标记物213在投影平面内的投影位于同一直线段上。同理可知,中心轴A-A穿过第二阻流膜122的几何中心,且中心轴A-A垂直于第二阻流膜122所在的平面,可使得第二阻流膜122所在的平面垂直于投影平面,各第二标记物213均与第二阻流膜122相连,可使得各第二标记物213在投影平面内的投影位于同一直线段上。
可以理解地,各第二标记物213均固定于第二网盘121上,在封堵器100的自然状态下,如图1所示,各第二标记物213与中心轴A-A之间的距离均等于第二网盘121的边缘到第二网盘121的几何中心的距离。本实施例中,在封堵器100的自然状态下,各第二标记物213与中心轴A-A之间的距离均等于第二网盘121的边缘到第二网盘121的几何中心的距离,在手术中,当第二网盘 121的边缘与房间隔300贴合时,可保证各第二标记物213均与房间隔300贴合,可以提高第二标记物213引导的准确性。
可以理解地,中心轴A-A穿过第二网盘121的几何中心,且中心轴A-A垂直于第二网盘121所在的平面,各第二标记物213均固定于第二网盘121上,在封堵器100的自然状态下,各第二标记物213与中心轴A-A之间的距离均小于第二网盘121的边缘到第二网盘121的几何中心的距离。在本实施例中,在封堵器100的自然状态下,各第二标记物213与中心轴A-A之间的距离均小于第二网盘121的边缘到第二网盘121的几何中心的距离,当第二网盘121位于鞘管400中时,可以避免第二标记物213与鞘管400的内壁发生摩擦,进而避免第二标记物213脱落。
可以理解地,各第二标记物213均固定于第二阻流膜122上,在封堵器100的自然状态下,各第二标记物213中至少一个与中心轴A-A之间的距离等于第二阻流膜122的边缘到第二阻流膜122的几何中心的距离,或,各第二标记物213与中心轴A-A之间的距离均小于第二阻流膜122的边缘到第二阻流膜122的几何中心的距离。
优选地,在封堵器100的自然状态下,各第二标记物213与中心轴A-A之间的距离均小于第二阻流膜122的边缘到第二阻流膜122的几何中心的距离,各第二标记物213沿第二圆周分布,第二圆周与第二阻流膜122同心设置。本实施例中,各第二标记物213与中心轴A-A之间的距离均小于第二阻流膜122的边缘到第二阻流膜122的几何中心的距离,各第二标记物213均位于一第二圆周上,当第二阻流膜122位于鞘管400中时,可以避免第二标记物213与鞘管400的内壁发生摩擦,进而避免第二标记物213脱落。
优选地,各第二标记物213沿第二圆周等间距分布,第二标记物213的数量的范围是2至12个。
可以理解地,如图1所示,封堵单元10还包括腰部131和第三阻流膜132,腰部131的两端分别与第一网盘111和第二网盘121相连,第三阻流膜132设于腰部131中,标记结构20还包括至少两个第三标记物214,中心轴A-A穿过第三阻流膜132的几何中心,且中心轴A-A垂直于第三阻流膜132所在的平面, 各第三标记物214均与腰部131相连,或,各第三标记物214均与第三阻流膜132相连。
本实施例中,中心轴A-A穿过第三阻流膜132的几何中心,且中心轴A-A垂直于第三阻流膜132所在的平面,可使得第三阻流膜132所在的平面垂直于投影平面,各第三标记物214均与第三阻流膜132相连,可使得各第二标记物213在投影平面内的投影位于同一直线段上。在手术中,当第一子单元11达到预期的位置时(即第一子单元11与房间隔300相贴),通过调整DSA探头的角度等参数,使得在投影平面内第三标记物214形成的直线与第一标记物212形成的直线相互平行,术者可通过两直线之间的间距的大小判断第三标记物214与房间隔300的相对位置,进而判断腰部131和第三阻流膜132与房间隔300的相对位置。
可以理解地,各第三标记物214均与第三阻流膜132相连,在封堵器100的自然状态下,各第三标记物214中至少一个与中心轴A-A之间的距离等于第三阻流膜132的边缘到第三阻流膜132的几何中心的距离,或,各第三标记物214与中心轴A-A之间的距离均小于第三阻流膜132的边缘到第三阻流膜132的几何中心的距离。
本实施例中,当第三标记物214与中心轴A-A之间的距离等于第三阻流膜132的边缘到第三阻流膜132的几何中心的距离时,有助于提高第三标记物214的引导手术的准确性,当第三标记物214与中心轴A-A之间的距离小于第三阻流膜132的边缘到第三阻流膜132的几何中心的距离时,在腰部131的释放过程中,可以避免第三标记物214与鞘管400的内壁发生摩擦,可以防止第三标记物214脱落。
一实施例中,第三阻流膜132呈圆形,中心轴A-A穿过第三阻流膜132的圆心(即中心轴A-A穿过第三阻流膜132的几何中心),且中心轴A-A垂直于第三阻流膜132所在的平面,各第三标记物214沿一圆周固定于第三阻流膜132上,各第三标记物214所在圆周的直径小于第三阻流膜132的直径1-8mm。在腰部131的释放过程中,可以避免第三标记物214与鞘管400的内壁发生摩擦,可以防止第三标记物214脱落。
当然,在另一实施例中,腰部131呈圆形,中心轴A-A穿过腰部131的圆心(即中心轴A-A穿过腰部131的几何中心),各第三标记物214沿一圆周固定于腰部131上,各第三标记物214所在圆周的直径小于腰部131的直径1-8mm。在腰部131的释放过程中,可以避免第三标记物214与鞘管400的内壁发生摩擦,可以防止第三标记物214脱落。
优选地,如图7所示,一实施例中,第一标记物212、第二标记物213和第三标记物214的数量均为2个,在封堵器100的自然状态下,两第一标记物212位于第一阻流膜112的同一直径的两端,两第二标记物213位于第二阻流膜122的同一直径的两端,两第三标记物214位于第三阻流膜132的同一直径的两端,且两第一标记物212、两第二标记物213和两第三标记物214共面。
在本实施例中,两第一标记物212、两第二标记物213和两第三标记物214共面,有助于提高可以判断第一网盘111、第二网盘121和腰部131的形态的精确度。
如图1所示,封堵器100还包括栓头151,栓头151固定于封堵单元10的近端,输送器还包括由显影材料制成的输送头,输送头与所述栓头151螺纹连接。
可以理解地,如图1和图4a所示,封堵器100还包括锁定销161,锁定销161连接封头141与栓头151之间,标记结构20还包括设置于栓头151内的近端标记物,可以通过近端标记物与输送头之间的相对位置判断封堵器100与输送器是否顺利分离。
可以理解地,在第一网盘111释放的过程中,第一阻流膜112跟随第一网盘111一起释放,同理,在第二网盘121释放过程中,第二阻流膜122亦跟随第二网盘121一起释放,腰部131释放时,第三阻流膜132跟随腰部131一起释放。
可以理解地,第一网盘111、第二网盘121和腰部131均可以采用编织,切割等方式进行制备,以编织为例,编织丝的材质可以是NiTi合金,Co-Cr合金,不锈钢等不可降解的金属材料,也可以采用生物可降解材料。
第一网盘111、第二网盘121和腰部131为生物可降解材料时,生物可降解材料包括但不限于聚乳酸(PLA)、聚消旋乳酸(PDLLA)、聚乙醇酸(PGA)、聚 乳酸-羟基乙酸共聚物(PLGA)、聚羟基脂肪酸脂(PHA)、聚二氧环己酮(PDO)、或聚己内酯(PCL)等。编织后的第一网盘111、第二网盘121和腰部131通过模具热处理定型成预定的形状。
标记结构20的材料可以为金属物质,例如金、铂、硫酸钡等,也可以为非金属物质,例如溴化钠、碘化钠,碘海醇、碘代物等。当第一标记物212固定于第一网盘111时,第一标记物212固定于第一网盘111的网格交点,或缠绕在编织单丝上,或焊接在编织单丝上,或涂覆于编织单丝表面。上述的标记结构20的设置方式,其结构简单,牢固可靠,且不会影响封堵器100本身的整体结构。
可以理解地,当第二标记物213固定于第二网盘121或可参照上述固定方式,第三标记物214固定于腰部131上时,亦可参照上述固定方式,在此不再赘述。
可以理解地,当第一标记物212固定于第一阻流膜112上时,其固定方式可以为包埋、粘接以及缝合等方式。
以上实施例的各技术特征可以进行任意的组合,为使描述简洁,未对上述实施例中的各个技术特征所有可能的组合都进行描述,然而,只要这些技术特征的组合不存在矛盾,都应当认为是本说明书记载的范围。
以上实施例仅表达了本发明的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明专利的保护范围应以所附权利要求为准。

Claims (14)

  1. 一种封堵器,包括封堵单元和与所述封堵单元相连的封头,所述封堵单元具有一中心轴,所述中心轴穿过所述封堵器的远端和近端,其特征在于,所述封堵器还包括标记结构,所述标记结构包括远端标记物和至少两个第一标记物,所述远端标记物设于所述封头上,各所述第一标记物均与所述封堵单元相连,各所述第一标记物均位于同一放置平面内,所述放置平面垂直于所述中心轴,所述远端标记物位于所述放置平面之外,各所述第一标记物在一垂直于所述放置平面的投影平面内的投影点位于一直线段上,在所述封堵器的自然状态下,所述远端标记物与所述直线段的两端点的连线呈三角形。
  2. 如权利要求1所述的封堵器,其特征在于,所述封堵单元包括第一子单元,所述第一子单元包括第一网盘和设于所述第一网盘中的第一阻流膜,所述中心轴穿过所述第一网盘的几何中心,且所述中心轴垂直于所述第一网盘所在的平面,所述中心轴穿过所述第一阻流膜的几何中心,且所述中心轴垂直于所述第一阻流膜所在的平面,各所述第一标记物均与所述第一网盘相连,或,各所述第一标记物均与所述第一阻流膜相连。
  3. 如权利要求2所述的封堵器,其特征在于,各所述第一标记物均固定于所述第一网盘上,在所述封堵器的自然状态下,各所述第一标记物与所述中心轴之间的距离均等于或均小于所述第一网盘的边缘到所述第一网盘的几何中心的距离。
  4. 如权利要求2所述的封堵器,其特征在于,各所述第一标记物均固定于所述第一阻流膜上,在所述封堵器的自然状态下,各所述第一标记物中至少一个与所述中心轴之间的距离等于所述第一阻流膜的边缘到所述第一阻流膜的几何中心的距离,或,各所述第一标记物与所述中心轴之间的距离均小于所述第一阻流膜的边缘到所述第一阻流膜的几何中心的距离。
  5. 如权利要求4所述的封堵器,其特征在于,在所述封堵器的自然状态下,各所述第一标记物与所述中心轴之间的距离均小于所述第一阻流膜的边缘到所述第一阻流膜的几何中心的距离,各所述第一标记物沿第一圆周分布,所述第一圆周与所述第一阻流膜同心设置。
  6. 如权利要求5所述的封堵器,其特征在于,各所述第一标记物沿所述第一圆周等间距分布,所述第一标记物的数量的范围是2至12个。
  7. 如权利要求2所述的封堵器,其特征在于,所述封堵单元还包括与所述第一子单元相连的第二子单元,所述第二子单元包括第二网盘和设于所述第二网盘中的第二阻流膜,所述中心轴穿过所述第二网盘的几何中心,且所述中心轴垂直于所述第二网盘所在的平面,所述中心轴穿过所述第二阻流膜的几何中心,且所述中心轴垂直于所述第二阻流膜所在的平面,所述标记结构还包括至少两个第二标记物,各所述第二标记物均与所述第二网盘相连,或,各所述第二标记物均与所述第二阻流膜相连。
  8. 如权利要求7所述的封堵器,其特征在于,各所述第二标记物均固定于所述第二网盘上,在所述封堵器的自然状态下,各所述第二标记物与所述中心轴之间的距离均等于或均小于所述第二网盘的边缘到所述第二网盘的几何中心的距离。
  9. 如权利要求7所述的封堵器,其特征在于,各所述第二标记物均固定于所述第二阻流膜上,在所述封堵器的自然状态下,各所述第二标记物中至少一个与所述中心轴之间的距离等于所述第二阻流膜的边缘到所述第二阻流膜的几何中心的距离,或,各所述第二标记物与所述中心轴之间的距离均小于所述第二阻流膜的边缘到所述第二阻流膜的几何中心的距离。
  10. 如权利要求9所述的封堵器,其特征在于,在所述封堵器的自然状态下,各所述第二标记物与所述中心轴之间的距离均小于所述第二阻流膜的边缘到所述第二阻流膜的几何中心的距离,各所述第二标记物沿第二圆周分布,所述第二圆周与所述第二阻流膜同心设置。
  11. 如权利要求10所述的封堵器,其特征在于,各所述第二标记物沿所述第二圆周等间距分布,所述第二标记物的数量的范围是2至12个。
  12. 如权利要求7所述的封堵器,其特征在于,所述封堵单元还包括腰部和第三阻流膜,所述腰部的两端分别与所述第一网盘和所述第二网盘相连,所述第三阻流膜设于所述腰部中,所述中心轴穿过所述第三阻流膜的几何中心,且所述中心轴垂直于所述第三阻流膜所在的平面,所述标记结构还包括至少两个 第三标记物,各所述第三标记物均与所述腰部相连,或,各所述第三标记物均与所述第三阻流膜相连。
  13. 如权利要求12所述的封堵器,其特征在于,各所述第三标记物均与所述第三阻流膜相连,在所述封堵器的自然状态下,各所述第三标记物中至少一个与所述中心轴之间的距离等于所述第三阻流膜的边缘到所述第三阻流膜的几何中心的距离,或,各所述第三标记物与所述中心轴之间的距离均小于所述第三阻流膜的边缘到所述第三阻流膜的几何中心的距离。
  14. 如权利要求12所述的封堵器,其特征在于,所述第一标记物、第二标记物和所述第三标记物的数量均为2个,在所述封堵器的自然状态下,两所述第一标记物位于所述第一阻流膜的同一直径的两端,两所述第二标记物位于所述第二阻流膜的同一直径的两端,两所述第三标记物位于所述第三阻流膜的同一直径的两端,且两所述第一标记物、两所述第二标记物和两所述第三标记物共面。
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