WO2020233523A1 - 植入式器械及其制备方法 - Google Patents

植入式器械及其制备方法 Download PDF

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Publication number
WO2020233523A1
WO2020233523A1 PCT/CN2020/090544 CN2020090544W WO2020233523A1 WO 2020233523 A1 WO2020233523 A1 WO 2020233523A1 CN 2020090544 W CN2020090544 W CN 2020090544W WO 2020233523 A1 WO2020233523 A1 WO 2020233523A1
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WO
WIPO (PCT)
Prior art keywords
markers
frame
medical imaging
marker
distal
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PCT/CN2020/090544
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English (en)
French (fr)
Inventor
陈贤淼
刘琮
李博宁
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先健科技(深圳)有限公司
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Publication of WO2020233523A1 publication Critical patent/WO2020233523A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements 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
    • A61B2017/00575—Implements 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
    • A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2051—Electromagnetic tracking systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2068—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis using pointers, e.g. pointers having reference marks for determining coordinates of body points

Definitions

  • the invention relates to the field of medical devices, in particular to an implantable device and a preparation method thereof.
  • the minimally invasive treatment method of implanting implantable devices into the human body through a catheter has become an increasingly important method.
  • DSA Digital Subtraction Angiography
  • other medical imaging equipment to determine the shape and position of implantable devices.
  • Visibility under X-ray is related to the materials that make up the implantable device.
  • materials with high atomic coefficient, high density, and large size have good radiopacity under X-ray, such as common nickel titanium alloys and stainless steel.
  • Etc. because of its good radiopacity under X-rays, it has good visibility.
  • polymer materials are usually composed of elements such as C, H, O, etc., and their density is low, resulting in poor visibility of devices made of polymer materials under X-rays.
  • An implantable device includes a frame, the frame includes a plurality of silk threads that are staggered to form a plurality of network nodes, the implantable device further includes a plurality of markers, the plurality of markers are arranged on At least part of the plurality of network nodes, and among the plurality of markers and at least part of the plurality of network nodes, each marker corresponds to each network node, and each of the markers is included in a medical imaging device Visual material.
  • At least part of the multiple network nodes of the above-mentioned implantable device are provided with multiple markers, and each marker includes a material that is visible under the medical imaging device, so that the implantable device has visibility under the medical imaging device. better.
  • Figure 1 is a schematic view of the structure of an occlusion device according to an embodiment
  • Figure 2 is a schematic diagram of the weaving mode of the occluder shown in Figure 1;
  • Figure 3 is a top view of the occluder shown in Figure 1;
  • FIG. 4 is a schematic diagram of the structure of a marker according to an embodiment
  • Fig. 5 is a schematic diagram of the structure of a marker according to another embodiment
  • Figure 6 is a schematic diagram of the distribution of markers according to an embodiment
  • Figure 7 is a schematic diagram of the distribution of markers in another embodiment
  • Figure 8 is a partial enlarged view of Figure 7;
  • Fig. 9 is a schematic structural diagram of a stent according to an embodiment
  • Figure 10 is an image diagram of the occlusion device of Example 1 under the DSA device.
  • distal and proximal are used as orientation words, which are commonly used terms in the field of interventional medical devices, where “distal” means the end far away from the operator during the operation.
  • Proximal refers to the end close to the operator during the operation.
  • the medical imaging equipment may be X-ray imaging equipment, fluorescent imaging equipment, and other medical imaging equipment that can be used to determine the position of the implantable device in a living body and recognize the shape of the implantable device.
  • an occlusion device 100 of an embodiment includes a frame 20.
  • the frame 20 is a net-like structure woven by a plurality of wires.
  • the material of the wire can be a metal that is not corrosive in the living body.
  • the wire can be a nickel-titanium alloy wire, a cobalt-chromium alloy wire, or a stainless steel wire.
  • the material of the silk thread may also be a biodegradable material.
  • the biodegradable material may be polyracemic lactic acid (PDLLA), poly D-lactic acid (PDLA), poly L-lactic acid (PLLA), polyglycolic acid (PGA), polylactic acid-glycolic acid copolymer (PLGA), Polyhydroxy fatty acid ester (PHA), polydioxanone (PDO) or polycaprolactone (PCL), etc.
  • the frame 20 includes a first blocking unit 22, a second blocking unit 24 and a waist 26. The two ends of the waist 26 are respectively connected to the first blocking unit 22 and the second blocking unit 24 to form a two-disc and one-waist structure with two large ends and a small middle.
  • the first sealing unit 22, the second sealing unit 24 and the waist 26 are of an integrated structure.
  • the structure of the frame 20 is not limited to a two-plate and one-waist structure with large ends at both ends and a small middle.
  • the number of plugging units in the frame 20 is one.
  • the plugging unit and the waist are connected to form a plugging frame with a substantially T-shaped cross section.
  • the frame 20 is woven from a plurality of silk threads.
  • the frame 20 is formed by weaving two or more sets of silk threads with different directions. Referring to FIG. 2, taking two sets of silk threads as an example, the frame 20 is formed by weaving a set of longitude threads 210 and a set of latitude threads 220 up and down. The intersecting parts of the longitude thread 210 and the latitude thread 220 form a plurality of network nodes 230.
  • the occluder 100 further includes a plurality of markers 40, the plurality of markers 40 are arranged on at least a part of the plurality of network nodes 230 of the frame 20, and each marker 40 corresponds to each network Node 230. That is, among all the network nodes 230 of the framework 20, a marker 40 is set on each network node 230. Alternatively, in a part of the network nodes 230 of the framework 20, each network node 230 is provided with a marker 40.
  • Each marker 40 includes a material that is visible under the medical imaging equipment, so that the occluder 100 has better visibility under the medical imaging equipment, so that the operator can accurately determine the occluder 100 during intervention. Shape and location.
  • the material visible under the medical imaging equipment is a radiopaque material, so that each marker 40 is visible under the X-ray medical imaging equipment.
  • the radiopaque material of the marker 40 is a radiopaque material with adhesion properties, so that each marker 40 can be reliably fixed on the frame 20 by relying on the radiopaque material.
  • the radiopaque material with adhesion properties is a polymer material containing iodine.
  • the radiopaque material is selected from iodinated polylactic acid, iodinated polycarbonate, iodinated cellulose, and iodinated At least one of methacrylate, iodinated polyurethane, and iodinated poly ⁇ -caprolactone.
  • Radiopaque materials with adhesion properties on the one hand, enables the marker 40 to be visible under X-ray medical imaging equipment; on the other hand, enables the marker 40 to be placed on the frame 20 more reliably;
  • the object 40 can fix the longitude thread 210 and the latitude thread 220 at the network node 230 to form a fixed network node, thereby improving the stability of the frame 20.
  • the radiopaque material of the marker 40 is a radiopaque material that does not have adhesion properties.
  • the marker 40 further includes an adhesion agent.
  • the radiopaque material without adhesion properties is selected from at least one of metals, inorganic salts and organic materials.
  • the metal is selected from at least one of gold, platinum, tungsten, iridium, osmium, rhenium, rhodium and tantalum.
  • the inorganic salt is selected from at least one of barium sulfate, sodium iodide, and bismuth subcarbonate.
  • the organic material is selected from at least one of iopamidol, ioverol, diatrizoate meglumine and iopromide.
  • the material of the adhesion agent is selected from polyethylene terephthalate, polypropylene, polyethylene, polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, polyhydroxy fatty acid ester, polydioxanone and polyhexanone At least one of lactones.
  • polylactic acid is poly-L-lactic acid, poly-D-lactic acid or poly-racemic lactic acid.
  • the adhesive helps the marker 40 to be reliably arranged on the frame 20, and on the other hand, the marker 40 can fix the longitude thread 210 and the latitude thread 220 at the network node 230 to form a fixed network node, thereby improving the frame 20 stability.
  • the marker 40 has a single-layer structure, and the radiopaque material is dispersed in the adhesive (the small dots at 40 in FIG. 4 represent the radiopaque material).
  • the higher the content of the radiopaque material the better the visual effect of the marker 40 under the X-ray medical imaging equipment.
  • the higher the content of the radiopaque material the lower the content of the adhesive, so that the binding force between the marker 40 and the longitude thread 210 and the latitude thread 220 at the network node 230 decreases, and it is easy to fall off. Therefore, in one embodiment, the mass ratio of the adhesion agent to the radiopaque material in each marker 40 is 0.1-2:1.
  • the mass of the radiopaque material in each marker 40 is 0.01-2 mg.
  • the mass ratio of the adhesive to the radiopaque material is 0.125-2:1, and the mass of the radiopaque material is 0.1-2 mg.
  • the marker 40 has a multilayer structure, and the multilayer structure includes an innermost layer 42, an outermost layer 44, and at least one middle layer located between the innermost layer 42 and the outermost layer 44.
  • Layer 46 the materials of the innermost layer 42 and the outermost layer 44 are adhesives, and the material of at least one intermediate layer 46 is a radiopaque material or a mixed material of a radiopaque material and an adhesive.
  • the material of the at least one intermediate layer 46 is a radiopaque material
  • the material is a radiopaque material with adhesion properties or a radiopaque material without adhesion properties.
  • the materials of the innermost layer 42 and the outermost layer 44 may be the same or different.
  • the material of the at least one intermediate layer 46 is a mixed material of a radiopaque material and an adhesive
  • the material of the adhesive in the intermediate layer 46 and the innermost layer 42 and the outermost layer 44 can be the same or different.
  • the number of the intermediate layers 46 is greater than 1, the materials of different intermediate layers 46 may be the same or different.
  • the material of the intermediate layer 46 is a radiopaque material with adhesion properties or any kind of radiopaque material (including radiopaque materials with adhesion properties and radiopaque materials without adhesion properties). Permeable material) and the adhering agent. In this way, the adhesion performance between the middle layer 46 and the innermost layer 42 and the outermost layer 46 is better, which is beneficial to avoid the delamination of the marker 40 and cause agglomeration of the radiopaque material The phenomenon.
  • the marker 40 is Contains 3-7 layers of multilayer structure.
  • the mass ratio of the adhesion agent to the radiopaque material is 0.1-2:1, and the mass of the radiopaque material is 0.01-2 mg.
  • the mass ratio of the adhesive to the radiopaque material is 0.125-2:1, and the mass of the radiopaque material is 0.1-2 mg.
  • the first blocking unit 22 is a network disk structure.
  • the first blocking unit 22 includes a first distal blocking disk 222, a first proximal blocking disk 224, and a first ridge 226 connecting the first distal blocking disk 222 and the first proximal blocking disk 224.
  • the second blocking unit 24 also has a network disk structure.
  • the second blocking unit 24 includes a second distal blocking disk 242, a second proximal blocking disk 244, and a second ridge 246 connecting the second distal blocking disk 242 and the second proximal blocking disk 244.
  • all the markers 40 of the occluder 100 are provided on the first occlusion unit 22. In an embodiment, all the markers 40 of the occluder 100 are arranged on the first distal end occluding disc 222 of the first occluding unit 22. Please refer to FIG. 6, in an embodiment, the number of markers 40 provided on the first distal end blocking disk 222 is two, and two markers 40 are provided on both ends of the first distal end blocking disk 222. The connecting line of the two markers 40 passes through the geometric center of the first distal blocking disc 222. In addition, the distance from the edge of each marker 40 to the edge of the first distal blocking disk 222 is 0-2 mm.
  • the width of the first distal blocking disc 222 is D1
  • the length of the line connecting the edges of the two markers 40 and passing through the geometric centers of the two markers 40 is D2
  • D1 is greater than or equal to D2
  • D1 The difference with D2 is 0 to 4 mm.
  • the width D1 of the first distal end occluding disc 222 refers to the length of a line passing through the geometric center of the first distal occluding disc 222 and extending to the edge of the first distal end occluding disc 222 at both ends. This line is parallel to the line connecting the edges of the two markers 40 and passing through the geometric centers of the two markers 40.
  • the above D1 refers to the diameter of the first distal occluding disk 222, and two markers 40 are provided on the first distal occluding disk 222.
  • the number of markers 40 provided on the first distal end blocking disk 222 is three, two of the markers 40 are set in the above-mentioned manner.
  • the other marker 40 can be arranged at any other position on the first distal end blocking disc 222.
  • the number of the markers 40 is 3, and the three markers 40 are evenly arranged on the first distal blocking disc 222, that is, the angle between any two adjacent markers 40 is 120 degrees.
  • the above-mentioned included angle refers to the included angle between the marker 30 and the straight line determined by the geometric center of the first distal blocking disc 222.
  • the number of markers 40 is 3, two markers 40 are provided on the first distal blocking disc 222 in the above-mentioned manner, and the other marker 30 is disposed on the first proximal blocking disc 224 , And define a plane perpendicular to the longitudinal center axis II of the occluder 100, and the three markers 40 on the first distal occlusion disc 222 and the first proximal occlusion disc 224 are projected on this plane , The angle between any two adjacent markers 40 is 120 degrees.
  • the above-mentioned included angle refers to the included angle between the projection of the marker 30 and the straight line determined by the geometric center of the projection of the first distal occlusion disk 222 or the first proximal occlusion disk 224 (the two overlap).
  • the circumscribed patterns of the plurality of markers 40 on the first distal sealing disc 222 and the first The shape of a distal blocking disk 222 is the same, and the geometric center of the circumscribed figure of the plurality of markers 40 coincides with the geometric center of the first distal blocking disk 222.
  • the distance from the circumscribed figure of the plurality of markers 40 on the first distal blocking disk 222 to the edge of the first distal blocking disk 222 is 0-2 mm.
  • the distribution track of the plurality of markers 40 on the first distal blocking disc 222 that is, the circumscribed figure of the plurality of markers 40 is It is circular, and the center of the distribution track of the plurality of markers 40 on the first distal blocking disk 22 coincides with the center of the first distal blocking disk 222.
  • the distance between the circumscribed circle R of the plurality of markers 40 and the edge of the first distal end blocking disk 222 is L, and the size of L ranges from 0 to 2 mm.
  • the shape of the first distal occluding disk 222 is not limited to a circular shape, and may be other shapes, for example, oval, square, etc., accordingly, the plurality of markers 40 on the first distal occluding disk 222
  • the circumscribed figure of is the same as the shape of the first distal end blocking disc 222, and can be oval, square, and so on.
  • all the markers 40 of the occlusion device 100 are arranged on the first proximal occlusion disc 224 of the first occlusion unit 22.
  • the arrangement of the multiple markers 40 on the first proximal blocking disc 224 is the same as the arrangement on the first distal blocking disc 222 described above, and will not be repeated here.
  • first release the first occlusion unit 22 of the occluder 100 After confirming that the first occlusion unit 22 is positioned accurately, that is, after confirming that the first occlusion unit 22 adheres to the defect site, release the second occlusion unit 22.
  • the plugging unit 24 is used to make the first plugging unit 22 and the second plugging unit 24 adhere well to the defect site to obtain a better plugging effect.
  • a plurality of markers 40 are set in the above manner.
  • the overall outline of the first occlusion unit 22 can be determined with the help of medical imaging equipment, and it is confirmed that the first occlusion unit 22 is in good shape and adheres to the defect site.
  • the second occlusion unit 24 is released again, which facilitates accurate positioning of the occluder 100.
  • the edges of the first distal end occlusion disc 222 and the first proximal end occlusion disc 224 of the first occlusion unit 22 will overlap each other, for example, as shown in FIG. 6, points a and d
  • the marker 40 at will overlap to form a point, indicating a limit position of the first blocking unit 22, and the markers 40 at point b and c will overlap to form a point, indicating another limit of the first blocking unit 22 position. Therefore, setting a plurality of markers 40 on one of the first distal end occluding disc 222 and the first proximal end occluding disc 224 can ensure the visibility of the first occlusion unit 22 under the medical imaging equipment.
  • the distance from the circumscribed pattern of the plurality of markers 40 on the first distal blocking disk 222 to the edge of the first distal blocking disk 222 is 0-2 mm. That is, the edges of the plurality of markers 40 located on the first distal blocking disk 222 away from the geometric center of the first distal blocking disk 222 are all aligned with the edges of the first distal blocking disk 222.
  • the multiple markers 40 on the first distal occluding disk 222 are all closer to the geometric center of the first distal occluding disk 222 than the edge of the first distal occluding disk 222, and each marker 40 The distance from the edge away from the geometric center of the first distal plugging disc 222 to the edge of the first distal plugging disc 222 is less than or equal to 2 mm. Or, the distance from the circumscribed figure of the plurality of markers 40 on the second distal blocking disk 242 to the edge of the second distal blocking disk 242 is 0-2 mm, where 0-2 mm means the same as The above is the same and will not be repeated here.
  • the distance from the circumscribed pattern of the plurality of markers 40 on the first distal occluding disk 222 to the edge of the first distal occluding disk 222 is 0 to 2 mm or more than that on the second distal occluding disk 242.
  • the distance from the circumscribed figure of each marker 40 to the edge of the second distal occluding disc 242 is 0-2 mm, which facilitates the identification of the limit position of the first occluder unit 22, thereby facilitating the accurate positioning of the occluder 100.
  • a plurality of markers 40 on each disc are evenly distributed, that is, adjacent The distance between every two markers 40 is equal. It can be understood that in other embodiments, the multiple markers 40 on each disk are not uniformly distributed. Alternatively, the plurality of markers 40 of one of the first distal end occlusion disk 222 and the first proximal end occlusion disk 224 are evenly distributed, and the plurality of markers 40 of the other are not uniformly distributed.
  • some of all the markers 40 of the occluder 100 are arranged on the first distal occluding disc 222 and the other part is arranged on the first proximal occluding disc 224.
  • the distribution mode of the plurality of markers 40 provided on the first distal blocking disc 222 and the plurality of markers 40 disposed on the first proximal disc 224 is the same as the above-mentioned distribution mode.
  • some of all the markers 40 of the occluder 100 are provided on the first occluding unit 22 and the other part is provided on the second occluding unit 24.
  • the multiple markers 40 provided on the first occluding unit 22 are arranged in the same manner as described above, and can be all set on the first distal occluding disc 222, or all set on the first proximal seal.
  • the multiple markers 40 provided on the second occluding unit 24 are set in the same manner as described above.
  • Multiple markers 40 are simultaneously arranged on the first occlusion unit 22 and the second occlusion unit 24.
  • the plurality of markers 40 are only arranged on the first blocking unit 22, or only on the second blocking unit 24, or the first blocking unit 22 and the second blocking unit
  • a plurality of markers 40 are provided on each 24.
  • the number of markers 40 on each blocking disk is 2 to 36. That is, the number of the plurality of markers 40 on the first blocking unit 22 is 2 to 36; and/or, the number of the plurality of markers 40 on the second blocking unit 24 is 2 to 36.
  • the number of markers on each occluding disc is 2 to 36, which takes into account the visibility of the occluder 100 and the flexibility of delivery.
  • At least a part of the plurality of markers 40 is provided on the waist 26 of the occluder 100. After the occluder 100 is implanted in the defect site, the waist 26 is located at the opening of the defect site and blocks the opening. A marker 40 is provided on the waist 26 to facilitate the identification of the position and shape of the waist 26 and smooth the interventional operation.
  • the number of markers 40 provided on the waist 26 is two, and the two markers 40 are respectively located on two opposite edges of the waist 26 to indicate the extreme position of the waist 26.
  • the two opposite edges of the waist 26 refer to a certain cross section of the waist 26 perpendicular to the longitudinal center axis II and parallel to the first blocking unit 22 or the second blocking unit 24 Two opposing edges.
  • two markers 40 are respectively located at two ends of a diameter of the cross-section of the waist.
  • the number of markers 40 provided on the waist 26 is greater than two, and the plurality of markers 40 with the number greater than two are distributed along the circumference of the waist 26, and the plurality of markers 40 are located on the same plane.
  • the plane is perpendicular to the longitudinal center axis I-I of the occluder 100.
  • multiple circles of markers 40 are arranged along the circumference of the waist 26, and the multiple markers 40 of each circle are located on the same plane, and the plane and the seal
  • the longitudinal center axis II of the occluder 100 is vertical, and the plane where the multiple markers 40 of each circle are located is parallel to the plane where the multiple markers 40 of other circles are located.
  • the multiple markers 40 located on the same plane may be distributed at equal intervals or at unequal intervals.
  • the distance between multiple markers 40 on the same plane (referring to the distance between any two adjacent markers in the same plane) is the same as that of multiple markers on other planes.
  • the distance between the objects 40 (referring to the distance between any two adjacent markers in the same plane) may be equal or unequal.
  • the number of the multiple markers 40 on the same plane and the number of the multiple markers 40 on other planes may be equal or different.
  • the occluder 100 further includes a distal end cap 60 and a proximal end plug 80.
  • the distal end cap 60 is connected to the first distal end blocking disc 222 for converging and fixing one end of the silk thread
  • the proximal plug head 80 is connected to the second proximal end blocking disc 244 for converging and fixing the other end of the silk thread .
  • the proximal plug 80 is detachably connected to the delivery system, so that after the occluder 100 is delivered to the diseased site through the delivery system and released, the connection with the delivery system can be disconnected.
  • At least one of the distal end cap 60 and the proximal end plug 80 is provided with an end marking structure 90 to indicate the two extreme positions of the extension direction of the longitudinal central axis I-I of the occluder 100.
  • the occlusion device 100 shown in FIG. 1 is provided with two end marking structures 90, and the two end marking structures 90 are respectively embedded in the distal end cap 60 and the proximal end plug 80.
  • the end marking structure 90 may be provided on the distal end cap 60 and/or the proximal plug 80 in other ways, for example, the end marking structure 90 covers the distal end cap 60 and/or Or the surface of the proximal plug 80.
  • the end marking structure 90 is a material under the medical imaging equipment.
  • the above-mentioned radiopaque material or fluorescent material may be in the form of powder, for example, gold solid powder is filled in the inner cavity of the distal end cap 60 to form the end marking structure 90.
  • the end marking structure 90 may exist in the form of a band or a film, for example, a band of gold is wound on the outer surface of the distal end cap 60.
  • Membranous iodinated poly ⁇ -caprolactone covers the outer surface of the distal end cap.
  • At least some of the multiple network nodes of the occluder 100 are provided with a plurality of markers 40, and each marker 40 includes a material that is visible under the medical imaging equipment, so that the occluder 100 is protected under the light of the medical imaging equipment. The visibility is better.
  • the material visible under the medical imaging device is a fluorescent material, so that the occluder 100 is visible under the fluorescent medical imaging device.
  • the implantable device is a stent 200.
  • the stent 200 is a lumen stent, and specifically may be an aortic stent, a coronary stent, a peripheral vascular stent, an airway stent, a urethral stent, an esophagus stent, an intestinal stent, a biliary stent, and the like.
  • the bracket 200 includes a frame 220.
  • a frame is formed by weaving a plurality of braided threads, and the plurality of braided threads are staggered to form a plurality of network nodes 210, and then a plurality of markers 240 are formed on the frame 220 according to the method of forming markers 40 on the frame 20 of the occluder 100. .
  • each network node 210 of the frame 220 is provided with a marker 240, so that the stent 200 has better visibility under the medical imaging equipment. Moreover, since the frame 220 is woven by interlacing multiple wires up and down into a grid-like woven net, the wires in the upper and lower layers of the woven net are only interlaced, and the wires are not fixedly connected to the wires. As a result, the stability of the woven net is poor.
  • the marker 240 fixes the upper and lower silk threads at the network node 210 to form a fixed network node, so that the stent 200 has better stability and is beneficial to resist the impact of body fluids without deformation and displacement. .
  • a plurality of markers 240 are provided on part of the network nodes 210 of the frame 220, and each network node 210 corresponds to each marker 240 one-to-one. There is no marker 240 on another part of the network node 210 of the frame 220.
  • markers 240 are provided on part of the network nodes 210 at both ends of the frame 220, which is beneficial to accurately determine the position of the stent 200 in the vessel, and is beneficial to maintain the stent 200 Suppleness.
  • the methods of fixing the thread at the network node 210 by an adhesive to form a fixed network node is also the same as the method of forming a fixed network node with an adhesive in the occluder 100, such as leaching and/or spraying. Repeat it again.
  • the implantable device is described above by taking the occluder 100 and the stent 200 as an example. It can be understood that the implantable device is not limited to the occluder 100 and the stent 200, and any frame that includes multiple wires It is applicable to devices in which multiple wires are staggered to form multiple network nodes.
  • the markers for example, the marker 40, the marker 240
  • the frame for example, the frame 20, the frame 220
  • the visibility under medical imaging equipment especially the visibility of implantable devices woven from polymer material wires, is improved.
  • the above solution does not limit the specific material of the wires, which are made of pure metal wires or alloy wires. Implantable devices formed by braiding are also suitable.
  • an occluder made of Nitinol wire braided although the Nitinol itself has certain visibility under medical imaging equipment, two markers are set on both ends of a diameter of the first distal occlusion disc , The two markers are used to further enhance the visibility of the two extreme positions of the occluder, which is further conducive to judging the shape of the occluder and the accurate positioning of the occluder.
  • a method for preparing an implantable device which includes the following steps:
  • Step 110 Provide a frame.
  • the frame includes a plurality of wires, and the plurality of wires are staggered to form a plurality of network nodes.
  • the structure of the frame is different.
  • the frame when the implantable device is an occluder, the frame is a frame used for occlusion. It can be a two-disc and one-waist structure including a first occlusion unit, a second occlusion unit and a waist, or it can include A occlusion disc and a waist section are roughly T-shaped structures and so on.
  • the implantable device is a vascular stent
  • the frame is a lumen structure.
  • Step 120 Set a plurality of markers on at least part of the network nodes respectively, and the plurality of markers and at least part of the plurality of network nodes, each marker corresponding to each network node, and each marker included in the medical imaging equipment Under the visible material.
  • the materials visible under the medical imaging equipment are radiopaque materials or fluorescent materials that are visible under the medical imaging equipment.
  • the material visible under the medical imaging equipment is in contact with at least part of the network nodes of the frame, so that the material visible under the medical imaging equipment is attached to at least part of the network nodes of the frame.
  • a plurality of markers are formed on the surface, and among the plurality of markers and at least part of the plurality of network nodes, each marker corresponds to each network node.
  • the material visible under the medical imaging equipment is in contact with at least part of the network nodes of the frame, so that the material visible under the medical imaging equipment is attached to at least part of the network nodes of the frame.
  • the step of forming the plurality of markers, and at least part of the plurality of markers and at least part of the plurality of network nodes, each marker corresponding to each network node includes:
  • the visible material under the medical imaging device is attached to at least part of the network nodes of the frame, thereby forming multiple markers on at least part of the network nodes, and multiple Among the markers and at least part of the plurality of network nodes, each marker corresponds to each network node.
  • the material visible under the medical imaging equipment is a radio-opaque material with adhesion properties
  • dissolve the radio-opaque material with adhesion properties in a solvent and after being fully dissolved, it is formulated to contain the radio-opaque material visible under the medical imaging equipment Solutions or suspensions of materials.
  • the visible material under the medical imaging equipment is a radiopaque material with no adhesion properties and the formed marker also contains an adhesion agent
  • the adhesion agent is dissolved in a solvent to prepare a solution, and then it will not have adhesion properties
  • the radio-opaque material of the compound is added to the solution and mixed evenly to prepare a solution or suspension containing the material visible under the medical imaging equipment.
  • the non-adhesive radiopaque material is insoluble in the above solution, continuous stirring is required to prevent the non-adhesive radiopaque material from agglomerating to form a precipitate.
  • the material visible under the medical imaging device is brought into contact with at least part of the network nodes of the frame by the extraction method, so that the material visible under the medical imaging device is attached to at least part of the network nodes of the frame.
  • At least part of the frame is immersed in the solution or suspension containing the material visible under the medical imaging equipment, and then the frame is lifted from the solution or suspension containing the material visible under the medical imaging equipment.
  • the remaining solution or suspension will form a liquid film on the frame. Due to the rapid volatilization of the solvent, the The concentration is higher and higher, and the liquid is less and less.
  • the liquid film ruptures, and the remaining solutes and or particles are enriched in at least part of the network nodes of the frame, and finally precipitated in the medical imaging equipment at the network nodes.
  • the visible material and adhesive are the markers attached to the network node.
  • the solution or suspension containing the material visible under the medical imaging equipment after the step of contacting the solution or suspension containing the material visible under the medical imaging equipment with at least part of the network nodes of the frame, the solution or suspension containing the material visible under the medical imaging equipment after the solvent of the liquid volatilizes, before the step of attaching the visible material under the medical imaging device to at least part of the network nodes of the frame, it also includes the step of air jet processing. Air-jet processing is performed to force the liquid film to be blown through, and only the materials visible under the medical imaging equipment are deposited on the network nodes to form markers attached to the network nodes.
  • the time for immersing at least part of the frame in the solution or suspension containing the material visible under the medical imaging device is greater than or equal to 5 seconds, so that the material that is visible under the medical imaging device is contained
  • the solution or suspension is fully infiltrated into the frame to increase the adhesion of the visible material under the medical imaging equipment to the frame.
  • the speed at which the frame is lifted from the solution or suspension containing the material visible under the medical imaging equipment is 0.01 to 0.5 meters per second.
  • the frame is then lifted from the solution or suspension containing the material visible under the medical imaging device.
  • the immersion time should be shorter for the second time or after repeated operations, and should not exceed 5s. This is because when the operation is repeated, the solvent in the solution or suspension will re-dissolve at least part of the solute precipitated the first time.
  • the lifting speed is also required to be faster during repeated operations. In one embodiment, the lifting speed during repeated operations is 0.05-1 meter per second (m/s).
  • the method of spraying or dripping is used to contact the solution or suspension containing the material visible under the medical imaging equipment with at least part of the network nodes of the frame, and the solvent volatilizes, and the visible under the medical imaging equipment
  • the material is deposited and attached to at least part of the network nodes of the frame.
  • spraying or dripping is used to sequentially form the innermost layer, the middle layer, and the outermost layer of the marker. Instillation can be performed with infusion equipment, such as infusion sets, syringes, etc.
  • At least one method of dipping, spraying and dripping is used to form the marker.
  • the innermost layer of the marker is formed by leaching, and then the middle layer covering the innermost layer and the outermost layer covering the middle layer are sequentially formed by spraying or dripping.
  • the specific part of the frame can be immersed in the solution or suspension containing the material visible under the medical imaging equipment according to the actual part to be attached with the marker, and after a certain period of time, it is slowly raised until the frame leaves the A solution or suspension of materials visible under medical imaging equipment.
  • the frame is immersed in a solution or suspension containing a material visible under the medical imaging equipment to form the marker at the required part.
  • part of the frame is immersed in a solution or suspension containing a material that is visible under medical imaging equipment, and after a marker is formed on the frame, a solvent is sprayed on the marker at certain parts to remove the marker.
  • the implantable device is an occluder and the occluder also includes a distal end cap and a proximal end plug
  • a method of leaching or spraying can be used to apply at least one of the distal end cap and the proximal end plug.
  • a film-like end marking structure is formed on it.
  • a heat treatment step is further included. Heat treatment is performed to improve the strength of the connection between the marker and the frame, which helps prevent the marker from falling off the frame.
  • the step of heat treatment includes: placing the frame with multiple markers at a temperature of 45-110°C for 5-60 minutes.
  • the temperature range of 45 ⁇ 110°C is 10 ⁇ 60°C higher than the glass transition temperature of absorbable polymers. Therefore, keep the temperature at 45 ⁇ 110°C 5 to 60 minutes, on the one hand, it is beneficial to improve the connection strength between the marker and the frame, and on the other hand, to ensure that the heat treatment temperature does not exceed the melting point or softening point temperature of the polymer, thereby ensuring the stability of the overall structure and performance of the frame.
  • concentration of the material and adhesive that is visible under the medical imaging device there is no requirement for the concentration of the material and adhesive that is visible under the medical imaging device.
  • concentration of the visible material and the adhesive under the medical imaging equipment can be lower or higher or reach saturation, and it is only necessary to ensure that the quality of the visible material under the medical imaging equipment meets the requirements. It should be pointed out that when the concentration of solute or particulate matter is low, the quality of the material visible under the medical imaging equipment precipitated in a single time is limited, and multiple operations are required to achieve the desired effect. The quality of the visible materials under the medical imaging equipment meets the requirements of visualization.
  • the concentration of the adhesive solution may be 30 mg/mL, 15 mg/mL, 50 mg/mL, 20 mg/mL, 10 mg/mL, or the like.
  • the adhesive solution is a saturated solution.
  • the dissolution performance of the concentration of the material visible under the medical imaging equipment varies greatly, and the concentration can be different.
  • insoluble substances such as gold, platinum, barium sulfate, etc.
  • the content can be 1%, 5%, or 10%.
  • Inorganic iodides, such as sodium iodide have a solubility of 158.7 g in 100 g of water at 0°C due to their good solubility, and the prepared concentration can be 20%, 40%, 50% or a saturated solution.
  • Organic iodides such as iopamidol
  • iopamidol have a solubility greater than 8.2 mg/mL in water, and the prepared solubility can be 2 mg/mL, 4 mg/mL, 6 mg/mL or a saturated solution.
  • the concentration of visible materials and adhesives under the medical imaging equipment can be increased during the extraction process to facilitate the deposition of more visible materials and adhesives under the medical imaging equipment Improve visibility and adhesion at network nodes.
  • the leaching step is repeated multiple times, so that the more visible materials and adhesives are deposited at the network nodes under the medical imaging equipment, and the visibility and adhesion are improved.
  • the preparation method of the above-mentioned implantable device has a simple process, and can form a firm and reliable marker on the frame, thereby improving the visibility of the occluder under the medical imaging equipment.
  • the frame includes a first plugging unit, a second plugging unit, and waists respectively connecting the first plugging unit and the second plugging unit.
  • the frame includes multiple networks.
  • the structures of the node, the first plugging unit and the second plugging unit are the same as the above structure, and will not be repeated here. Wherein, in this embodiment, the first plugging unit and the second plugging unit are both circular.
  • PLLA polyracemic lactic acid
  • solid barium sulfate powder particle size less than 0.1mm
  • the entire frame (including the first plugging unit, the second plugging unit and the waist) is immersed in the suspension containing polyracemic lactic acid and barium sulfate for 5 seconds (the dipping process continues to stir the suspension to prevent the barium sulfate particles from agglomerating Precipitation), the frame is taken out of the suspension at a speed of 0.5m/s, polyracemic lactic acid and barium sulfate are deposited on all network nodes of the frame, and after drying, a mark attached to all network nodes of the frame is formed Wherein, each marker corresponds to each network node, and the marker fixes the thread at the network node to form a fixed network node.
  • the mass of barium sulfate in each marker is 0.1 mg.
  • the frame forming the marker was heat-treated at 70° C. for 5 min to obtain an occluder.
  • the occluder was implanted into the atrial septum of Bama pigs, and the implantation process was smooth.
  • the image of the implanted occluder under the DSA device is shown in Figure 10.
  • the multiple small black dots are multiple markers. With the help of multiple markers, the visibility of the occluder under the DSA device is better. .
  • the frame includes a first plugging unit, a second plugging unit, and waists respectively connecting the first plugging unit and the second plugging unit.
  • the frame includes multiple networks.
  • the structures of the node, the first plugging unit and the second plugging unit are the same as the above structure, and will not be repeated here. Wherein, in this embodiment, the first plugging unit and the second plugging unit are both circular.
  • PLLA Polyracemic lactic acid
  • the frame forming the marker was heat-treated at 60° C. for 30 min to obtain an occluder.
  • the occluder was implanted into the atrial septum of Bama pigs, the visibility of the occluder under the DSA device was better, and the implantation process was smooth.
  • the glycol ester thread is used as the latitude thread to be interlaced up and down to form a woven net, and the woven net is heat-set to form a frame.
  • the frame includes a first plugging unit, a second plugging unit and respectively connecting the first and second plugging units.
  • the waist of the unit and the frame include a plurality of network nodes, and the structures of the first plugging unit and the second plugging unit are the same as the above structure, and will not be repeated here.
  • the occluder also includes a distal end cap connected to the first distal end occlusion disk and a proximal end plug connected to the second proximal end occlusion disk.
  • the first occlusion unit and the second The plugging units are all round.
  • An end marking structure is embedded in the distal bolt head, and the material of the end marking structure is gold.
  • each marker corresponds to each network node, and the marker fixes the thread at the network node to form a fixed network node.
  • the mass of gold in each marker is 2 mg.
  • the frame forming the marker was heat-treated at 70° C. for 20 min to obtain an occluder.
  • the occluder was implanted into the atrial septum of Bama pigs, the visibility of the occluder under the DSA device was better, and the implantation process was smooth.
  • a set of 30 parallel-arranged polyethylene terephthalate (PET) threads with a wire diameter of 0.30 mm as longitude threads and a set of 30 parallel-arranged polyethylene terephthalate (PET) threads with a wire diameter of 0.30 mm Ester (PET) threads are interlaced up and down as the latitude threads to form a woven mesh, and the woven mesh is heat-set to form a frame.
  • the frame includes a first plugging unit, a second plugging unit and connecting the first and second plugging units respectively.
  • the waist of the blocking unit, the frame includes a plurality of network nodes, and the structures of the first blocking unit and the second blocking unit are the same as the above structure, and will not be repeated here.
  • the first plugging unit and the second plugging unit are both circular.
  • polyhydroxybutyrate and iopamidol are deposited on all network nodes of the first remote plugging disk, and after drying, they form markers attached to all network nodes of the first remote plugging disk.
  • Spray chloroform on part of the markers to make part of the markers fall off, so that 15 markers distributed in a circle are formed only on the first distal end blocking disc.
  • the circumscribed circle of the 15 markers reaches the first distal end seal.
  • the distance between the edges of the blocking plate is 1 mm.
  • each marker corresponds to each network node, and the marker fixes the thread at the network node to form a fixed network node.
  • the mass of iopamidol in each marker is 1 mg.
  • the second proximal plugging disc of the second plugging unit was immersed in the suspension containing polyhydroxybutyrate and iopamidol for 30 seconds, the second proximal plugging disc was removed from the suspension at a speed of 0.1 m/s. It is proposed in the suspension that polyhydroxybutyrate and iopamidol are deposited on all network nodes of the second proximal blocking disk, and after drying, a mark attached to all network nodes of the second proximal blocking disk is formed Spray chloroform on part of the markers to make part of the markers fall off, so that 15 markers distributed in a circle are formed only on the second proximal blocking disc.
  • each marker corresponds to each network node, and the marker fixes the thread at the network node to form a fixed network node.
  • the mass of iopamidol in each marker is 1 mg.
  • the frame forming the marker was heat-treated at 45°C for 15 min to obtain an occluder.
  • the occluder was implanted into the atrial septum of Bama pigs, the visibility of the occluder under the DSA device was better, and the implantation process was smooth.
  • the frame includes a first plugging unit, a second plugging unit, and waists respectively connecting the first plugging unit and the second plugging unit.
  • the frame includes multiple networks.
  • the structure of the node, the first plugging unit and the second plugging unit are the same as the above structure, and will not be repeated here. Among them, in this embodiment, both the first plugging unit and the second plugging unit are circular.
  • the polyracemic lactic acid (PDLLA) was dissolved in ethyl acetate to prepare a polyracemic lactic acid solution with a concentration of 20 mg/mL; iopamidol was dissolved in ethanol to prepare a 50 mg/mL iopamidol solution; the polylactic acid -Glycolic acid copolymer (PLGA) is dissolved in dichloroethane to prepare a polylactic acid-glycolic acid copolymer solution with a concentration of 20mg/mL. Spray the polyracemic lactic acid solution on the two network nodes of the first remote blocking disk.
  • the two markers are located at both ends of a diameter of the first distal occluded disk, and the distance between the edges of the two markers and the edge of the first distal occluded disk is 0 mm.
  • the mass of iopamidol in each marker is 2 mg, and the mass ratio of polyracemic lactic acid, iopamidol and polylactic acid-glycolic acid copolymer is 2:5:2.
  • the frame forming the marker was heat-treated at 55°C for 15 min to obtain an occluder.
  • the occluder was implanted into the atrial septum of Bama pigs, the visibility of the occluder under the DSA device was better, and the implantation process was smooth.
  • a set of 14 parallel-arranged polyethylene terephthalate (PET) threads with a wire diameter of 0.30 mm is used as the longitude thread and a set of 14 parallel-arranged polyethylene terephthalate threads with a wire diameter of 0.30 mm
  • the glycol ester thread is used as the latitude thread to be interlaced up and down to form a woven net, and the woven net is heat-set to form a frame.
  • the frame includes a first plugging unit, a second plugging unit and respectively connecting the first and second plugging units.
  • the waist of the unit and the frame include a plurality of network nodes, and the structures of the first plugging unit and the second plugging unit are the same as the above structure, and will not be repeated here. Wherein, in this embodiment, the first plugging unit and the second plugging unit are both circular.
  • the first distal plugging disc of the first plugging unit is immersed in the suspension containing polydioxanone and bismuth subcarbonate for 5 seconds (the dipping process continues to stir the suspension to prevent bismuth subcarbonate particles Agglomeration precipitation), the first distal plugging disk is lifted out of the suspension at a speed of 0.5m/s, and polyracemic lactic acid and bismuth subcarbonate are deposited on all network nodes of the first distal plugging disk Because the concentration is small, repeat the extraction operation twice. For the second and third times, the first distal plugging disc was immersed in the suspension containing polydioxanone and bismuth subcarbonate for 3s and 2s, respectively, at 0.2m/s and 1.0m respectively.
  • the number of markers is 25.
  • Each marker corresponds to each network node.
  • the marker fixes the thread at the network node to form a fixed network node.
  • the mass of bismuth subcarbonate in each marker is about 0.2 mg.
  • the frame forming the marker was heat-treated at 55°C for 15 min to obtain an occluder.
  • the occluder is implanted into the atrial septum of Bama pigs, so that the visibility of the occluder under the DSA device is better.
  • the diester (PET) wire is used as the latitude wire to be interlaced up and down to form a woven mesh.
  • the woven mesh is heat-set to form a frame.
  • the frame includes a first plugging unit, a second plugging unit and connecting the first and second plugging units respectively.
  • the frame of the waist of the plugging unit includes a plurality of network nodes, and the structures of the first plugging unit and the second plugging unit are the same as the above structure, and will not be repeated here. Wherein, in this embodiment, the first plugging unit and the second plugging unit are both circular.
  • the iodinated poly ⁇ -caprolactone (I-PCL, I content is 11wt.%) was dissolved in chloroform to prepare a 10mg/mL iodinated poly ⁇ -caprolactone solution, and the iodinated poly ⁇ -caprolactone was used with a syringe.
  • the caprolactone solution is dropped dropwise on all network nodes of the first remote blocking disk, and after drying, it forms markers attached to all network nodes of the first remote blocking disk.
  • the number of markers is 36. Among them, each marker corresponds to each network node, and the marker fixes the silk thread at the network node to form a fixed network node to obtain an occluder.
  • the mass of each marker is 0.2 mg.
  • the occluder was implanted into the atrial septum of Bama pigs, the visibility of the occluder under the DSA device was better, and the implantation process was smooth.
  • PDO polydioxanone
  • Poly-L-lactic acid (PLLA) was dissolved in chloroform to prepare a saturated poly-L-lactic acid solution, platinum powder was added to the poly-L-lactic acid solution, and stirred evenly to obtain a suspension containing poly-L-lactic acid and platinum powder.
  • the mass ratio of lactic acid and platinum powder is 1:2.
  • the mass of platinum powder in each marker is 1.5mg.
  • the frame forming the marker was heat-treated at 110° C. for 5 min to obtain a lumen implantation device.
  • the lumen implantation device was implanted into the peripheral blood vessels of Bama pigs.
  • the visibility of the lumen implantation device under the DSA device was better, and the implantation process was smooth.

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Abstract

一种植入式器械（100, 200）及其制备方法，植入式器械（100, 200）包括框架（20, 220），框架（20, 220）包括多根丝线，多根丝线交错形成多个网络节点（230, 210），植入式器械（100, 200）还包括多个标记物（40, 240），多个标记物（40, 240）设置于至少部分多个网络节点（230, 210）上，且多个标记物（40, 240）和至少部分多个网络节点（230, 210）中，每个标记物（40, 240）对应每个网络节点（230, 210），每个标记物（40, 240）包括在医学影像设备下可视的材料。植入式器械（100, 200）在医学影像设备下的可视性较好。

Description

植入式器械及其制备方法 技术领域
本发明涉及医疗器械领域，特别是涉及一种植入式器械及其制备方法。
背景技术
经导管将植入式器械植入人体的微创治疗方法成为当前越来越重要的方法。例如，植入血管支架治疗血管狭窄、动脉瘤等；植入封堵器治疗房间隔缺损(ASD)、室间隔缺损(VSD)、动脉导管未闭(PDA)和卵圆孔未闭(PFO)先天性心脏病等等。
目前，血管支架、封堵器等植入式器械大都采用金属丝或高分子丝制成。在使用过程中，医生通常会借助数字减影血管造影(Digital Subtraction Angiography,简称DSA)等医学影像设备来判断植入式器械的形态和位置。DSA利用的是植入式器械和组织在X光下的辐射不透性不同实现植入式器械可视。X光下的可视性与组成植入式器械的材料有关，一般原子系数高、密度大、尺寸大的材料在X光下的辐射不透性较好，比如，常见的镍钛合金、不锈钢等，由于在X光下的辐射不透性较好，因而具有良好的可视性。然而，高分子材料通常由C、H、O等元素组成，密度小，导致高分子材料制成的器械在X光下的可视性较差。
发明内容
基于此，有必要提供一种在医学影像设备下的可视性较好的植入式器械。
一种植入式器械，包括框架，所述框架包括多根丝线，所述多根丝线交错形成多个网络节点，所述植入式器械还包括多个标记物，所述多个标记物设置于至少部分所述多个网络节点上，且所述多个标记物和至少部分所述多个网络节点中，每个标记物对应每个网络节点，每个所述标记物包括在医学影像设备下可视的材料。
上述植入式器械的至少部分多个网络节点上设置有多个标记物，每个标记 物包括在医学影像设备下可视的材料，使得该植入式器械在医学影像设备下的可视性较好。
附图说明
图1为一实施方式的封堵器的结构示意图；
图2为图1所示的封堵器的编织方式示意图；
图3为图1所示的封堵器的俯视图；
图4为一实施方式的标记物的结构示意图；
图5为另一实施方式的标记物的结构示意图；
图6为一实施方式的标记物的分布示意图；
图7为另一实施方式的标记物的分布示意图；
图8为图7的局部放大图；
图9为一实施方式的支架的结构示意图；
图10为实施例1的封堵器在DSA设备下的影像图。
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。
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例的目的，不是旨在于限制本发明。
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。
提供一种在医学影像设备下的可视性较好的植入式器械，以在介入式手术 中，操作者能够判断植入式器械的形态和位置。医学影像设备可以为X光影像设备、荧光影像设备等可用于判断生物体内植入式器械的位置和识别植入式器械的形态的医学影像设备。以下以封堵器为例，对该植入式器械进行说明。
请参阅图1，一实施方式的封堵器100，包括框架20。框架20为由多根丝线编织而成的网状结构。丝线的材质可以为在生物体内不可腐蚀的金属，例如，丝线可以为镍钛合金丝、钴铬合金丝或不锈钢丝等。或者，丝线的材质也可以为生物可降解材料。例如，生物可降解材料可以为聚消旋乳酸(PDLLA)、聚D-乳酸(PDLA)、聚L-乳酸(PLLA)、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。本实施方式中，框架20包括第一封堵单元22、第二封堵单元24和腰部26。腰部26的两端分别与第一封堵单元22和第二封堵单元24连接，形成两端大中间小的两盘一腰结构。第一封堵单元22、第二封堵单元24和腰部26为一体式结构。
可以理解，在其他实施方式中，框架20的结构不限于两端大中间小的两盘一腰结构。例如，框架20中的封堵单元的个数为一个，此时，封堵单元和腰部相连形成截面大致呈T形的封堵框架。
框架20由多根丝线编织而成。例如，框架20由两组或多组方向不一的丝线编织后定型而成。请参阅图2，以两组丝线为例，框架20由一组经度丝线210和一组纬度丝线220上下交错编织形成。经度丝线210和纬度丝线220交错的部位形成多个网络节点230。
请一并参阅图2和图3，封堵器100还包括多个标记物40，多个标记物40设置于框架20的至少部分多个网络节点230上，每个标记物40对应每个网络节点230。即框架20的所有网络节点230中，每个网络节点230上设置一个标记物40。或者，框架20的一部分网络节点230中，每个网络节点230上设置一个标记物40。
每个标记物40包括在医学影像设备下可视的材料，使得封堵器100在医学影像设备下的可视性较好，以在介入术中，操作者能够准确地判断封堵器100的形态和位置。
在一实施方式中，在医学影像设备下可视的材料为辐射不透性材料，使得每个标记物40在X光医学影像设备下可视。
在一实施方式中，标记物40的辐射不透性材料为具有粘连性能的辐射不透性材料，使得每个标记物40依靠该辐射不透性材料即能够可靠地固定于框架20上。在一实施方式中，具有粘连性能的辐射不透性材料为含碘的高分子材料，例如，辐射不透性材料选自碘化聚乳酸、碘化聚碳酸酯、碘化纤维素、碘化甲基丙烯酸酯、碘化聚氨酯及碘化聚ε-己内酯中的至少一种。
选用具有粘连性能的辐射不透性材料，一方面使标记物40能够在X光医学影像设备下可视；另一方面能够使标记物40较为可靠地设置于框架20上；再一方面使标记物40能够将网络节点230处的经度丝线210和纬度丝线220固定而形成固定网络节点，从而提高框架20的稳定性。
在一实施方式中，标记物40的辐射不透性材料为不具有粘连性能的辐射不透性材料。在该实施方式中，标记物40还包括粘连剂。在一实施例中，不具有粘连性能的辐射不透性材料选自金属、无机盐和有机材料中的至少一种。其中，金属选自黄金、铂金、钨、铱、锇、铼、铑及钽中的至少一种。无机盐选自硫酸钡、碘化钠及碱式碳酸铋中的至少一种。有机材料选自碘帕醇、碘佛醇、泛影葡胺及碘普罗胺中的至少一种。粘连剂的材料选自聚对苯二甲酸乙二酯、聚丙烯、聚乙烯、聚乳酸、聚乙醇酸、聚乳酸-羟基乙酸共聚物、聚羟基脂肪酸脂、聚二氧环己酮和聚己内酯中的至少一种。其中，聚乳酸为聚左旋乳酸、聚右旋乳酸或聚消旋乳酸。
粘连剂一方面有利于标记物40可靠地设置于框架20上，另一方面使标记物40能够将网络节点230处的经度丝线210和纬度丝线220固定而形成固定网络节点，从而提高框架20的稳定性。
请参阅图4，在一实施例中，标记物40为单层结构，辐射不透性材料分散于粘连剂中(用图4中的标号40处的小点表示辐射不透性材料)。在标记物40中，辐射不透性材料的含量越高，标记物40在X光医学影像设备下的可视效果越好。然而，辐射不透性材料的含量越高，则粘连剂的含量越低，使得标记物40与网络节点230处的经度丝线210和纬度丝线220的结合力降低，容易发生 脱落。因此，在一实施例中，每个标记物40中，粘连剂与辐射不透性材料的质量比为0.1～2:1。当辐射不透性材料的质量越高，标记物40在X光医学影像设备下的可视效果越好，但当辐射不透性材料的质量过高时，可能会导致标记物40的体积过大，会影响封堵器100的输送性能。因此，在一实施例中，兼顾可视性和体积大小，每个标记物40中，辐射不透性材料的质量为0.01～2毫克。在一实施例中，粘连剂与辐射不透性材料的质量比为0.125～2:1，辐射不透性材料的质量为0.1～2毫克。
请参阅图5，在另一实施例中，标记物40为多层结构，多层结构包括最内层42、最外层44及位于最内层42和最外层44之间的至少一个中间层46。其中，最内层42和最外层44的材料均为粘连剂，至少一个中间层46的材料为辐射不透性材料或为辐射不透性材料与粘连剂的混合材料。当至少一个中间层46的材料为辐射不透性材料时，该材料为具有粘连性能的辐射不透性材料或不具有粘连性能的辐射不透性材料。最内层42和最外层44的材料可以相同，也可以不同。当至少一个中间层46的材料为辐射不透性材料与粘连剂的混合材料时，中间层46中的粘连剂的材料与最内层42和最外层44的材料可以相同，也可以不同。当中间层46的数量大于1时，不同的中间层46的材料可以相同，也可以不同。
在一实施例中，中间层46的材料为具有粘连性能的辐射不透性材料或为任意一种辐射不透性材料(包括具有粘连性能的辐射不透性材料和不具有粘连性能的辐射不透性材料)与粘连剂的混合物，如此，中间层46与最内层42及最外层46之间的粘连性能较好，有利于避免标记物40出现分层而导致辐射不透性材料团聚的现象。
当标记物40的层数过多时，会导致标记物40的体积过大，从而导致封堵器100的压缩体积过大，使得难以将封堵器100装载于输送鞘管中进行输送。为保证标记物40的可视性及标记物40可靠地与网络节点230处的经度丝线210和纬度丝线220相连，同时综合封堵器100的压缩体积，在一实施例中，标记物40为含有3～7层的多层结构。在一实施例中，每个多层结构的标记物40中，粘连剂与辐射不透性材料的质量比为0.1～2:1，辐射不透性材料的质量为0.01～2 毫克。在一实施例中，粘连剂与辐射不透性材料的质量比为0.125～2:1，辐射不透性材料的质量为0.1～2毫克。
请再次参阅图1，第一封堵单元22为网盘结构。第一封堵单元22包括第一远端封堵盘222、第一近端封堵盘224及连接第一远端封堵盘222和第一近端封堵盘224的第一脊部226。第二封堵单元24也为网盘结构。第二封堵单元24包括第二远端封堵盘242、第二近端封堵盘244及连接第二远端封堵盘242和第二近端封堵盘244的第二脊部246。
在一实施例中，封堵器100的所有标记物40均设置于第一封堵单元22上。在一实施例中，封堵器100的所有标记物40均设置于第一封堵单元22的第一远端封堵盘222上。请参阅图6，在一实施例中，设于第一远端封堵盘222上的标记物40的数量为2，两个标记物40设置于第一远端封堵盘222的两端，两个标记物40的连线穿过第一远端封堵盘222的几何中心。并且，每个标记物40的边缘至第一远端封堵盘222的边缘的距离为0～2毫米。即，当第一远端封堵盘222的宽度为D1，连接两个标记物40的边缘且穿过两个标记物40的几何中心的线的长度为D2时，D1大于或等于D2，D1与D2的差值为0～4毫米。其中，上述第一远端封堵盘222的宽度D1是指穿过第一远端封堵盘222的几何中心，且两端延伸至第一远端封堵盘222的边缘的线的长度，该线与连接两个标记物40的边缘且穿过两个标记物40的几何中心的线平行。例如，在其中一个实施例中，当第一远端封堵盘222为圆形时，上述D1是指第一远端封堵盘222的直径，两个标记物40设置于第一远端封堵盘222的一直径的两端；当第一远端封堵盘222为椭圆形时，上述D1是指椭圆形的长轴的长度或短轴的长度，两个标记物40设置于第一远端封堵盘222的长轴或短轴的两端。
在一实施例中，当设于第一远端封堵盘222上的标记物40的数量为3个时，其中的两个标记物40按上述设置方式设置。另一个标记物40可以设置于第一远端封堵盘222上的其他任意位置。
在一实施例中，标记物40的数量为3，3个标记物40均匀设于第一远端封堵盘222上，即任意相邻的两个标记物40之间的夹角为120度。上述夹角是指标记物30与第一远端封堵盘222的几何中心所确定的直线之间的夹角。
在一实施例中，标记物40的数量为3，2个标记物40按上述方式设于第一远端封堵盘222上，另一个标记物30设于第一近端封堵盘224上，并且，定义一个与封堵器100的纵向中心轴线I-I垂直的平面，第一远端封堵盘222及第一近端封堵盘224上的3个标记物40在该平面上的投影中，任意相邻的两个标记物40之间的夹角为120度。上述夹角是指标记物30的投影与第一远端封堵盘222或第一近端封堵盘224的投影的几何中心(两者重合)所确定的直线之间的夹角。
在一实施例中，当设于第一远端封堵盘222上的标记物40的数量大于或等于4时，第一远端封堵盘222上的多个标记物40的外接图形与第一远端封堵盘222的形状相同，且多个标记物40的外接图形的几何中心与第一远端封堵盘222的几何中心重合。
在一实施例中，位于第一远端封堵盘222上的多个标记物40的外接图形至第一远端封堵盘222的边缘的距离为0～2毫米。
例如，请参阅图7，当第一远端封堵盘222为圆形时，多个标记物40在第一远端封堵盘222上的分布轨迹，即多个标记物40的外接图形为圆形，且多个标记物40在第一远端封堵盘22上的分布轨迹的圆心与第一远端封堵盘222的圆心重合。请一并参阅图8，多个标记物40的外接圆R与第一远端封堵盘222的边缘的距离为L，L的大小范围为0～2毫米。
可以理解，第一远端封堵盘222的形状不限于圆形，可以为其他形状，例如，椭圆形、方形等等，相应地，第一远端封堵盘222上的多个标记物40的外接图形与第一远端封堵盘222的形状相同，可以为椭圆形、方形等等。
在另一实施例中，封堵器100的所有标记物40均设置于第一封堵单元22的第一近端封堵盘224上。多个标记物40在第一近端封堵盘224上的设置方式与上述在第一远端封堵盘222上的设置方式相同，此处不再赘述。
在植入过程中，首先释放封堵器100的第一封堵单元22，确认第一封堵单元22定位准确后，即确认第一封堵单元22与缺损部位贴壁后，再释放第二封堵单元24，以使第一封堵单元22和第二封堵单元24与缺损部位贴壁良好，以获得较好的封堵效果。按上述方式设置多个标记物40，在植入后，能够借助医 学影像设备判断第一封堵单元22的整体轮廓，确认第一封堵单元22的形态良好，且与缺损部位贴壁后，再释放第二封堵单元24，从而有利于准确定位封堵器100。
由于在植入后，第一封堵单元22的第一远端封堵盘222和第一近端封堵盘224的边缘会重叠在一起，例如，如图6所示，a点和d点处的标记物40会重叠成一个点，指示第一封堵单元22的一个极限位置，b点和c点处的标记物40会重叠成一个点，指示第一封堵单元22的另一个极限位置。因此，在第一远端封堵盘222和第一近端封堵盘224之一设置多个标记物40，即可保证第一封堵单元22在医学影像设备下的可视性。
在一更具体的实施例中，位于第一远端封堵盘222上的多个标记物40的外接图形至第一远端封堵盘222的边缘的距离为0～2毫米。即，位于第一远端封堵盘222上的多个标记物40的远离第一远端封堵盘222的几何中心的边缘均与第一远端封堵盘222的边缘对齐。或者，位于第一远端封堵盘222上的多个标记物40均比第一远端封堵盘222的边缘更靠近第一远端封堵盘222的几何中心，且每个标记物40的远离第一远端封堵盘222的几何中心的边缘至第一远端封堵盘222的边缘的距离小于或等于2毫米。或者，位于第二远端封堵盘242上的多个标记物40的外接图形至第二远端封堵盘242的边缘的距离为0～2毫米，此处的0～2毫米的意思与上文相同，不再赘述。
在植入过程中，当第一封堵单元22释放后与缺损部位逐渐靠近并贴壁的过程中，第一封堵单元22的边缘首先与缺损部位接触。因此，识别第一封堵单元22的极限位置有利于封堵器100准确定位。位于第一远端封堵盘222上的多个标记物40的外接图形至第一远端封堵盘222的边缘的距离为0～2毫米或者位于第二远端封堵盘242上的多个标记物40的外接图形至第二远端封堵盘242的边缘的距离为0～2毫米，有利于识别第一封堵单元22的极限位置，从而有利于封堵器100的准确定位。
在一更具体的实施例中，无论多个标记物40都分布于第一远端封堵盘222上，还是多个标记物40都分布于第一近端封堵盘224上，或者，部分标记物40设置于第一远端封堵盘222上，另一边部分标记物40设置于第一近端封堵盘224 上，每个盘上的多个标记物40均匀分布，即相邻的每两个标记物40之间的距离是相等的。可以理解，在另外的实施例中，每个盘上的多个标记物40不均匀分布。或者，第一远端封堵盘222和第一近端封堵盘224之一的多个标记物40均匀分布，另一个的多个标记物40不均匀分布。
在一更具体的实施例中，封堵器100的所有标记物40中，有部分设置于第一远端封堵盘222上，另一部分设置于第一近端封堵盘224上。设置于第一远端封堵盘222上的多个标记物40和设置于第一近端盘224上的多个标记物40的分布方式与上述的分布方式相同。
或者，在一实施例中，封堵器100的所有标记物40中，有部分设置于第一封堵单元22上，另一部分设置于第二封堵单元24上。设置于第一封堵单元22上的多个标记物40的设置方式与上文描述的方式相同，可以全部设置于第一远端封堵盘222上，也可以全部设置于第一近端封堵盘224上，或者，部分设置于第一远端封堵盘222上，另一部分设置于第一近端封堵盘224上。设置于第二封堵单元24上的多个标记物40的设置方式与上文描述的方式相同，可以全部设置于第二远端封堵盘242上，也可以全部设置于第二近端封堵盘244上，或者，部分设置于第二远端封堵盘242上，另一部分设置于第二近端封堵盘244上。
多个标记物40同时设置于第一封堵单元22和第二封堵单元24上，一方面，有利于封堵器100的准确定位，另一方面，有利于判断封堵器100的整体形态，以确认封堵器100的释放形态良好，满足封堵需求。
在一实施例中，无论多个标记物40仅设置于第一封堵单元22上，还是仅设置于第二封堵单元24上，亦或是第一封堵单元22和第二封堵单元24上均设置有多个标记物40。在每个封堵盘上的标记物40的数量为2～36个。即第一封堵单元22上的多个标记物40的数量为2～36；和/或，第二封堵单元24上的多个标记物40的数量为2～36个。每个封堵盘上的标记物的数量为2～36个，兼顾了封堵器100的可视性和输送的柔顺性要求。
在一实施例中，多个标记物40中，至少有部分设置于封堵器100的腰部26上。封堵器100植入缺损部位后，腰部26位于缺损部位的开口处并阻塞开口， 在腰部26上设置标记物40，有利于识别腰部26的位置和形态，使介入手术顺利进行。
在一实施例中，设于腰部26的标记物40的数量为2，且两个标记物40分别位于腰部26的相对的两个边缘，以指示腰部26的极限位置。请再次参阅图1，上述腰部26的相对的两个边缘是指，腰部26的垂直于纵向中心轴线I-I、且与第一封堵单元22或第二封堵单元24平行的某个横截面的两个相对的边缘。例如，当腰部26的上述横截面的形状为圆形时，两个标记物40分别位于腰部的横截面的一直径的两端。
在一实施例中，设于腰部26的标记物40的数量大于2个，且数量大于2的多个标记物40沿腰部26的周向分布，且该多个标记物40位于同一平面上。该平面与封堵器100的纵向中心轴线I-I垂直。
在另一实施例中，当腰部26的轴向长度较大时，在沿腰部26的周向设置多圈标记物40，每一圈的多个标记物40位于同一平面上，该平面与封堵器100的纵向中心轴线I-I垂直，并且，每一圈的的多个标记物40所在的平面与其他圈的多个标记物40所在的平面平行。
需要说明的是，在上述两个实施例中，位于同一平面的多个标记物40可以等间距分布也可以不等间距分布。
进一步需要说明的是，当设有多圈标记物40时，同一平面的多个标记物40的间距(指同一平面内任意相邻的两个标记物的间距)与其他平面上的多个标记物40的间距(指同一平面内任意相邻的两个标记物的间距)可以相等，也可以不等。同一平面的多个标记物40的数量与其他平面上的多个标记物40的数量可以相等，也可以不等。
请再次参阅图1，在一实施例中，封堵器100还包括远端封头60和近端栓头80。远端封头60与第一远端封堵盘222相连，用于汇聚和固定丝线的一端，近端栓头80与第二近端封堵盘244相连，用于汇聚和固定丝线的另一端。并且，近端栓头80与输送系统可拆卸连接，以通过输送系统将封堵器100输送至病变部位并释放后，能够断开与输送系统的连接。远端封头60和近端栓头80中的至少一个上设置有端部标记结构90，以指示封堵器100的纵向中心轴轴线I-I 延伸方向的两个极限位置。图1所示的封堵器100设有两个端部标记结构90，并且，两个端部标记结构90分别嵌设于远端封头60和近端栓头80中。在另外的实施例中，端部标记结构90可以以其他的方式设置于远端封头60和/或近端栓头80上，例如，端部标记结构90覆盖于远端封头60和/或近端栓头80的表面。
可以理解，端部标记结构90的为在医学影像设备下的材料。例如为上述的辐射不透性材料或荧光材料等。端部标记结构90可以以粉末状的形式存在，例如，黄金固体粉末填充于远端封头60的内腔中形成端部标记结构90。或者，端部标记结构90可以带状或膜状的形式存在，例如，带状的黄金缠绕于远端封头60的外表面。膜状的碘化聚ε-己内酯包覆远端封头的外表面。
上述封堵器100的至少部分多个网络节点上设置有多个标记物40，每个标记物40包括在医学影像设备下可视的材料，使得该封堵器100在医学影像设备光下的可视性较好。
可以理解，在其他实施方式中，在医学影像设备下可视的材料为荧光材料，使得封堵器100在荧光医学影像设备下可视。
进一步，以支架为例，对上述植入式器械进行说明。
请参阅图9，在一实施方式中，植入式器械为支架200。支架200为管腔支架，具体可以为主动脉支架、冠脉支架、外周血管支架、气道支架、尿道支架、食道支架、肠道支架、胆道支架等等。支架200包括框架220。用多根编织丝线编织形成框架，多根编织丝线交错形成多个网络节点210，然后按照上述在封堵器100的框架20上形成标记物40的方法在该框架220上形成多个标记物240。
在一实施例中，框架220的每一个网络节点210上均设置一个标记物240，使得支架200在医学影像设备下的可视性较好。并且，由于框架220的编织是将多根丝线上下交错编成网格状的编织网，编织网中位于上下层的丝线之间仅仅是交错设置，丝线与丝线之间并不是固定连接，这会导致编织网的稳定性较差，标记物240在网络节点210处将上下层的丝线固定而形成固定网络节点，使得支架200的稳定性较好，有利于抵抗体液的冲击而不变形和移位。
在另一实施例中，框架220的部分网络节点210上设置有多个标记物240， 且每个网络节点210与每个标记物240一一对应。框架220的另一部分网络节点210上不设有标记物240。例如，在图9所示的实施例中，仅在框架220两端的部分网络节点210上设置有标记物240，有利于准确地判断支架200在脉管中的位置，且有利于保持支架200的柔顺性。
需要说明是，在医学影像设备下可视的材料的种类、粘连剂与上述封堵器100所用的种类相同。通过粘连剂将网络节点210处的丝线固定形成固定网络节点的方法也与上述封堵器100的用粘连剂形成固定网络节点的方法相同，如采用浸提和/或喷涂等方法，此处不再赘述。
需要说明的是，上述以封堵器100和支架200为例对植入式器械进行了说明，可以理解，植入式器械不限于封堵器100和支架200，任何具有包括多根丝线的框架，且多根丝线交错形成多个网络节点的器械均适用。
进一步需要说明的是，按上述方式将标记物(例如，标记物40、标记物240)设置于植入式器械的框架(例如，框架20、框架220)上，有利于提高植入式器械在医学影像设备下的可视性，特别是提高了由高分子材料丝线编织成的植入式器械的可视性，但是，上述方案并不限制丝线的具体材料，由纯金属丝线或由合金丝线编织形成的植入式器械同样适用。例如，由镍钛合金丝线编织形成的封堵器，虽然镍钛合金自身在医学影像设备下具有一定的可视性，在第一远端封堵盘的一直径的两端设置两个标记物，两个标记物用于进一步增强封堵器的两个极限位置的可视性，进一步有利于判断封堵器的形态和有利于封堵器的准确定位。
进一步，提供一种植入式器械的制备方法，包括如下步骤：
步骤110：提供框架，框架包括多根丝线，多根丝线交错形成多个网络节点。
根据植入式器械的种类不同，框架的结构不同。例如，当植入式器械为封堵器时，该框架为用于封堵的框架，可以为包括第一封堵单元、第二封堵单元和腰部的两盘一腰结构，也可以为包括一个封堵盘和一个腰部的截面大致呈T形的结构等等。当植入式器械为脉管支架时，框架为管腔结构。
步骤120：分别将多个标记物设置于至少部分网络节点上，且多个标记物和至少部分多个网络节点中，每个标记物对应每个网络节点，每个标记物包括在 医学影像设备下可视的材料。
在医学影像设备下可视的材料为辐射不透性材料或荧光材料等在医学影像设备下可视的材料。
在一实施例中，将在医学影像设备下可视的材料与框架的至少部分网络节点接触，使在医学影像设备下可视的材料附着于框架的至少部分网络节点上，在至少部分网络节点上形成多个标记物，且多个标记物和至少部分多个网络节点中，每个标记物对应每个网络节点。
在一实施例中，将在医学影像设备下可视的材料与框架的至少部分网络节点接触，使在医学影像设备下可视的材料附着于框架的至少部分网络节点上，在至少部分网络节点上形成所述多个标记物，且多个标记物和至少部分多个网络节点中，每个标记物对应每个网络节点的步骤包括：
配制含有在医学影像设备下可视的材料的溶液或混悬液，将含有在医学影像设备下可视的材料的溶液或混悬液与框架的至少部分网络节点接触，含有在医学影像设备下可视的材料的溶液或混悬液的溶剂挥发后，在医学影像设备下可视的材料附着于框架的至少部分网络节点上，从而在至少部分网络节点上形成多个标记物，且多个标记物和至少部分多个网络节点中，每个标记物对应每个网络节点。
当在医学影像设备下可视的材料为具有粘连性能的辐射不透性材料时，将具有粘连性能的辐射不透性材料溶于溶剂中，充分溶解后配制成含有在医学影像设备下可视的材料的溶液或混悬液。
当在医学影像设备下可视的材料为不具有粘连性能的辐射不透性材料且所形成的标记物还含有粘连剂时，将粘连剂溶于溶剂中配制成溶液，然后将不具有粘连性能的辐射不透性材料加入该溶液中，混合均匀后，配制成含有医学影像设备下可视的材料的溶液或混悬液。当不具有粘连性能的辐射不透性材料不溶于上述溶液时，需要持续搅拌，以防止不具有粘连性能的辐射不透性材料团聚形成沉淀。
在一实施例中，采用浸提法将在医学影像设备下可视的材料与框架的至少部分网络节点接触，使在医学影像设备下可视的材料附着于框架的至少部分网 络节点上。将框架的至少部分部位浸渍于含有在医学影像设备下可视的材料的溶液或混悬液中，然后将框架从含有在医学影像设备下可视的材料的溶液或混悬液中提起。将框架从含有在医学影像设备下可视的材料的溶液或混悬液中缓慢提起的过程中，残留的溶液或混悬液会在框架上形成一层液体膜，由于溶剂快速挥发，溶液的浓度越来越高，液体越来越少，在表面张力的作用下，液体膜破裂，剩余的溶质和或颗粒物富集在框架的至少部分网络节点处，最终在网络节点处析出在医学影像设备下可视的材料和粘连剂(如有)，即为附着于网络节点上的标记物。
在一实施例中，将含有在医学影像设备下可视的材料的溶液或混悬液与框架的至少部分网络节点接触的步骤之后，含有在医学影像设备下可视的材料的溶液或混悬液的溶剂挥发后，在医学影像设备下可视的材料附着于框架的至少部分网络节点上的步骤之前，还包括进行喷气处理的步骤。进行喷气处理，以强制把液体膜吹破，以仅在网络节点上沉积在医学影像设备下可视的材料而形成附着于网络节点的标记物。
在一实施例中，将框架的至少部分部位浸渍于含有在医学影像设备下可视的材料的溶液或混悬液中的时间大于或等于5秒，使得含有在医学影像设备下可视的材料的溶液或混悬液充分浸润框架，以提高在医学影像设备下可视的材料在框架上的附着量。
在一实施例中，将框架从含有在医学影像设备下可视的材料的溶液或混悬液中提起的速度为0.01～0.5米每秒。
在一实施方式中，如一次浸提后析出的在医学影像设备下可视的材料量不够，可进行多次操作，即重复浸提的过程，将框架的至少部分部位浸渍于含有在医学影像设备下可视的材料的溶液或混悬液中，然后将框架从含有在医学影像设备下可视的材料的溶液或混悬液中提起。按上述工艺进行第一次浸提操作后，第二次或之后重复操作时浸渍时间要较短，不宜超过5s。这是由于重复操作时，溶液或混悬液中的溶剂会将第一次析出的至少部分溶质重新溶解。重复操作时要求提升速度也较快，在一实施例中，重复操作中的提升速度为0.05～1米每秒(m/s)。
在一实施例中，采用喷涂或滴注的方法将含有在医学影像设备下可视的材料的溶液或混悬液与框架的至少部分网络节点接触，溶剂挥发，在医学影像设备下可视的材料析出并附着于框架的至少部分网络节点上。例如，当标记物为多层结构时，采用喷涂或滴注的方法依次形成标记物的最内层、中间层和最外层。滴注可以采用滴注设备进行，如输液器、注射器等。
在一实施例中，采用浸提及喷涂和滴注中的至少一种方法形成标记物。例如，首先采用浸提的方法形成标记物的最内层，然后在采用喷涂或滴注的方法依次形成包覆最内层的中间层及包覆中间层的最外层。
可以理解，可以根据实际要附着有标记物的部位将框架的具体部位浸渍于含有在医学影像设备下可视的材料的溶液或混悬液中，保留一定时间后再缓慢提升至框架离开含有在医学影像设备下可视的材料的溶液或混悬液。例如，将不需要附着有标记物的部位进行隔离保护后，再将框架浸渍于含有在医学影像设备下可视的材料的溶液或混悬液中，以在需要的部位形成标记物。或者，将部分框架浸渍于含有在医学影像设备下可视的材料的溶液或混悬液中，在框架上形成标记物后，再向某些部位的标记物喷涂溶剂，以将该标记物移除，从而在特定部位留下标记物。或者，将不需要附着有标记物的部位进行隔离保护后，仅在需要附着有标记物的部位喷涂含有在医学影像设备下可视的材料的溶液或混悬液，以在需要的部位形成标记物。或者，采用喷涂的方法，在在框架上形成标记物后，再向某些部位的标记物喷涂溶剂，以将该标记物移除，从而在特定部位留下标记物。
当植入式器械为封堵器，且封堵器还包括远端封头和近端栓头时，可以采用浸提或喷涂的方法，在远端封头和近端栓头中的至少一个上形成膜状的端部标记结构。
在一实施例中，分别将多个标记物设置于至少部分网络节点上后，还包括热处理的步骤。进行热处理，以提高标记物与框架上的连接强度，有利于避免标记物从框架上脱落。
在一实施例中，热处理的步骤包括：将附着有多个标记物的框架置于45～110℃的温度下保温5～60min。
对于大多数可吸收的高分子聚合物而言，45～110℃的温度范围比可吸收的高分子聚合物的玻璃化转变温度高10～60℃，因此，在45～110℃的温度下保温5～60min，一方面有利于提高标记物与框架的连接强度，另一方面保证热处理的温度不超过高分子聚合物熔点或软化点温度，从而保证框架整体结构和性能的稳定性。
需要说明的是，含有在医学影像设备下可视的材料的溶液或混悬液中，在医学影像设备下可视的材料和粘连剂的浓度没有要求。在医学影像设备下可视的材料和粘连剂的浓度可以较低或较高或者达到饱和，只需保证在医学影像设备下可视的材料的质量满足要求即可。需要指出的是，当溶质或颗粒物的浓度较低时，单次析出的在医学影像设备下可视的材料的质量有限，需要多次操作才能达到理想的效果，使得附着于网络节点上的在医学影像设备下可视的材料的质量满足可视的要求。
在具体的实施方式中，粘连剂溶液的浓度可以为30mg/mL、15mg/mL、50mg/mL、20mg/mL或10mg/mL等。或者，粘连剂溶液为饱和溶液。在医学影像设备下可视的材料的浓度的溶解性能差异较大，浓度可以有所不同。比如不可溶物质，如金，铂，硫酸钡等，含量可以为1％、5％或10％等。无机碘化物，如碘化钠，由于其溶解度较好，0℃时在100g水中的溶解度为158.7g，配制的浓度可以为20％、40％、50％或者饱和溶液。有机碘化物，如碘帕醇，在水中的溶解度大于8.2mg/mL，配制的溶度可以为2mg/mL、4mg/mL、6mg/mL或者饱和溶液。
当丝线的丝径越大，在浸提的过程中，可以提高在医学影像设备下可视的材料和粘连剂的浓度，以利于较多的在医学影像设备下可视的材料和粘连剂沉积于网络节点处而提高可视性和粘连性。或者，浸提的步骤重复多次，使在医学影像设备下可视的材料和粘连剂沉积于网络节点处的量越多，提高可视性和粘连性。
上述植入式器械的制备方法工艺简单，能够在框架上形成牢固可靠的标记物，从而提高封堵器在医学影像设备下的可视性。
以下进一步通过具体实施例对上述植入式器械及其制备方法进一步阐述。
实施例1
将一组包括丝径0.40mm的18根平行排列的聚左旋乳酸(PLLA)丝线作为经度丝线和一组包括丝径0.40mm的18根平行排列的聚左旋乳酸(PLLA)丝线作为纬度丝线上下交错编织形成编织网，将该编织网进行热定型形成框架，框架包括第一封堵单元、第二封堵单元及分别连接第一封堵单元和第二封堵单元的腰部，框架包括多个网络节点，第一封堵单元和第二封堵单元的结构与上文的结构相同，此处不再赘述。其中，本实施例中，第一封堵单元和第二封堵单元均为圆形。
将聚消旋乳酸(PDLLA)溶于乙腈中配制浓度为30mg/mL聚消旋乳酸溶液，向该聚消旋乳酸溶液中加入硫酸钡固体粉末(粒径小于0.1mm)，搅拌均匀，得到含有聚消旋乳酸和硫酸钡的混悬液，其中，聚消旋乳酸和硫酸钡的质量比为2:1。将整个框架(包括第一封堵单元，第二封堵单元和腰部)浸渍于含有聚消旋乳酸和硫酸钡的混悬液5s后(浸渍的过程持续搅拌混悬液，防止硫酸钡颗粒团聚沉淀)，将框架以0.5m/s的速度从该混悬液中提出，聚消旋乳酸和硫酸钡沉积于框架的所有网络节点上，干燥后，形成附着于框架的所有网络节点上的标记物，其中，每个标记物对应每个网络节点，标记物将网络节点处的丝线固定，形成固定网络节点。每个标记物中硫酸钡的质量为0.1mg。
将形成标记物的框架于70℃下热处理5min，得到封堵器。
将该封堵器植入巴马猪的房间隔处，植入过程顺利。植入后的封堵器在DSA设备下的影像如图10所示，多个小黑点为多个标记物，借助多个标记物，使得封堵器在DSA设备下的可视性较好。
实施例2
将一组包括丝径0.10mm的30根平行排列的聚左旋乳酸(PLLA)丝线作为经度丝线和一组包括丝径0.10mm的30根平行排列的聚左旋乳酸(PLLA)丝线作为纬度丝线上下交错编织形成编织网，将该编织网进行热定型形成框架，框架包括第一封堵单元、第二封堵单元及分别连接第一封堵单元和第二封堵单元的腰部，框架包括多个网络节点，第一封堵单元和第二封堵单元的结构与上文 的结构相同，此处不再赘述。其中，本实施例中，第一封堵单元和第二封堵单元均为圆形。
将聚消旋乳酸(PDLLA)溶于丙酮中配制饱和的聚消旋乳酸溶液，向该聚消旋乳酸溶液中加入碘化钠固体粉末(粒径小于0.1mm)，搅拌均匀，得到含有聚消旋乳酸和碘化钠的溶液，其中，聚消旋乳酸和碘化钠的质量比为1:1。将第一封堵单元的第一远端封堵盘浸渍于含有聚消旋乳酸和碘化钠的溶液1min后，将第一远端封堵盘以0.1m/s的速度从该溶液中提出，聚消旋乳酸和碘化钠沉积于第一远端封堵盘的所有网络节点上，干燥后，形成附着于第一远端封堵盘的所有网络节点上的标记物，标记物的数量为18个，其中，每个标记物对应每个网络节点，标记物将网络节点处的丝线固定，形成固定网络节点。每个标记物中碘化钠的质量为0.5mg。
将第二封堵单元的第二近端封堵盘浸渍于含有聚消旋乳酸和碘化钠的溶液1min后，将第二近端封堵盘以0.1m/s的速度从该溶液中提出，聚消旋乳酸和碘化钠沉积于第二近端封堵盘的所有网络节点上，干燥后，形成附着于第二近端封堵盘的所有网络节点上的标记物，标记物的数量为18个，其中，每个标记物对应每个网络节点，标记物将网络节点处的丝线固定，形成固定网络节点。每个标记物中碘化钠的质量为0.5mg。
将形成标记物的框架于60℃下热处理30min，得到封堵器。
将该封堵器植入巴马猪的房间隔处，封堵器的在DSA设备下的可视性较好，植入过程顺利。
实施例3
将一组包括丝径0.10mm的50根平行排列的聚对苯二甲酸乙二醇酯(PET)丝线作为经度丝线和一组包括丝径0.10mm的50根平行排列的聚对苯二甲酸乙二醇酯丝线作为纬度丝线上下交错编织形成编织网，将该编织网进行热定型形成框架，框架包括第一封堵单元、第二封堵单元及分别连接第一封堵单元和第二封堵单元的腰部，框架包括多个网络节点，第一封堵单元和第二封堵单元的结构与上文的结构相同，此处不再赘述。封堵器还包括与第一远端封堵盘相连 的远端封头和与第二近端封堵盘相连的近端栓头，其中，本实施例中，第一封堵单元和第二封堵单元均为圆形。远端栓头中嵌设有端部标记结构，端部标记结构的材料为黄金。
将聚消旋乳酸(PDLLA)溶于丙酮中配制浓度为30mg/mL聚消旋乳酸溶液，向该聚消旋乳酸溶液中加入金固体粉末(粒径小于0.1mm)，搅拌均匀，得到含有聚消旋乳酸和金粉的混悬液，其中，聚消旋乳酸和金粉的质量比为1:8。将第一封堵单元的第一远端封堵盘浸渍于含有聚消旋乳酸和金粉的混悬液1min后，将第一远端封堵盘以0.01m/s的速度从该溶液中提出，聚消旋乳酸和金粉沉积于第一远端封堵盘的所有网络节点上，干燥后，形成附着于第一远端封堵盘的所有网络节点上的标记物，将能够溶解聚消旋乳酸的溶剂喷洒在部分标记物上，使部分标记物脱落，从而仅在第一远端封堵盘上形成呈圆周分布的20个标记物，该20个标记物的外接圆至第一远端封堵盘的边缘的距离为2mm。20个标记物中，每个标记物对应每个网络节点，标记物将网络节点处的丝线固定，形成固定网络节点。每个标记物中金的质量为2mg。
将形成标记物的框架于70℃下热处理20min，得到封堵器。
将该封堵器植入巴马猪的房间隔处，封堵器的在DSA设备下的可视性较好，植入过程顺利。
实施例4
将一组包括丝径0.30mm的30根平行排列的聚对苯二甲酸乙二酯(PET)丝线作为经度丝线和一组包括丝径0.30mm的30根平行排列的聚对苯二甲酸乙二酯(PET)丝线作为纬度丝线上下交错编织形成编织网，将该编织网进行热定型形成框架，框架包括第一封堵单元、第二封堵单元及分别连接第一封堵单元和第二封堵单元的腰部，框架包括多个网络节点，第一封堵单元和第二封堵单元的结构与上文的结构相同，此处不再赘述。其中，本实施例中，第一封堵单元和第二封堵单元均为圆形。
将聚羟基丁酸酯(PHB)溶于氯仿中配制浓度为50mg/mL聚羟基丁酸酯溶液，向该聚羟基丁酸酯溶液中加入碘帕醇固体粉末(粒径小于0.1mm)，搅拌均 匀，得到含有聚羟基丁酸酯和碘帕醇的混悬液，其中，聚羟基丁酸酯和碘帕醇的质量比为0.5:1。将第一封堵单元的第一远端封堵盘浸渍于含有聚羟基丁酸酯和碘帕醇的混悬液30s后，将第一远端封堵盘以0.1m/s的速度从该溶液中提出，聚羟基丁酸酯和碘帕醇沉积于第一远端封堵盘的所有网络节点上，干燥后，形成附着于第一远端封堵盘的所有网络节点上的标记物，将氯仿喷洒在部分标记物上，使部分标记物脱落，从而仅在第一远端封堵盘上形成呈圆周分布的15个标记物，该15个标记物的外接圆至第一远端封堵盘的边缘的距离为1mm。15个标记物中，每个标记物对应每个网络节点，标记物将网络节点处的丝线固定，形成固定网络节点。每个标记物中碘帕醇的质量为1mg。
将第二封堵单元的第二近端封堵盘浸渍于含有聚羟基丁酸酯和碘帕醇的混悬液30s后，将第二近端封堵盘以0.1m/s的速度从该混悬液中提出，聚羟基丁酸酯和碘帕醇沉积于第二近端封堵盘的所有网络节点上，干燥后，形成附着于第二近端封堵盘的所有网络节点上的标记物，将氯仿喷洒在部分标记物上，使部分标记物脱落，从而仅在第二近端封堵盘上形成呈圆周分布的15个标记物，该15个标记物的外接圆至第二近端封堵盘的边缘的距离为1mm。15个标记物中，每个标记物对应每个网络节点，标记物将网络节点处的丝线固定，形成固定网络节点。每个标记物中碘帕醇的质量为1mg。
将形成标记物的框架于45℃下热处理15min，得到封堵器。
将该封堵器植入巴马猪的房间隔处，封堵器的在DSA设备下的可视性较好，植入过程顺利。
实施例5
将一组包括丝径0.40mm的20根平行排列的聚左旋乳酸(PLLA)丝线作为经度丝线和一组包括丝径0.40mm的20根平行排列的聚左旋乳酸(PLLA)丝线作为纬度丝线上下交错编织形成编织网，将该编织网进行热定型形成框架，框架包括第一封堵单元、第二封堵单元及分别连接第一封堵单元和第二封堵单元的腰部，框架包括多个网络节点，第一封堵单元和第二封堵单元的结构与上文的结构相同，此处不再赘述。其中，本实施例中，第一封堵单元和第二封堵单 元均为圆形。
将聚消旋乳酸(PDLLA)溶于乙酸乙酯中配制浓度为20mg/mL聚消旋乳酸溶液；将碘帕醇溶于乙醇中，配制浓度为50mg/mL的碘帕醇溶液；将聚乳酸-羟基乙酸共聚物(PLGA)溶于二氯乙烷中，配制浓度为20mg/mL的聚乳酸-羟基乙酸共聚物溶液。将聚消旋乳酸溶液喷涂在第一远端封堵盘的两个网络节点上，充分干燥后，重复喷涂和干燥的操作5次，形成PDLLA层；在PDLLA层外面喷涂碘帕醇溶液，充分干燥后，重复喷涂和干燥的操作5次，形成包覆PDLLA层的碘帕醇层；最后再在碘帕醇层外面再喷涂聚乳酸-羟基乙酸共聚物溶液溶液，充分干燥后，重复喷涂和干燥的操作5次，形成包覆碘帕醇层的PLGA层，在第一远端封堵盘上形成两个标记物。该两个标记物位于第一远端封堵盘的一直径的两端，且两个标记物的边缘至第一远端封堵盘的边缘的距离为0mm。每个标记物中碘帕醇的质量为2mg，聚消旋乳酸、碘帕醇和聚乳酸-羟基乙酸共聚物的质量比为2:5:2。
将形成标记物的框架于55℃下热处理15min，得到封堵器。
将该封堵器植入巴马猪的房间隔处，封堵器的在DSA设备下的可视性较好，植入过程顺利。
实施例6
将一组包括丝径0.30mm的14根平行排列的聚对苯二甲酸乙二醇酯(PET)丝线作为经度丝线和一组包括丝径0.30mm的14根平行排列的聚对苯二甲酸乙二醇酯丝线作为纬度丝线上下交错编织形成编织网，将该编织网进行热定型形成框架，框架包括第一封堵单元、第二封堵单元及分别连接第一封堵单元和第二封堵单元的腰部，框架包括多个网络节点，第一封堵单元和第二封堵单元的结构与上文的结构相同，此处不再赘述。其中，本实施例中，第一封堵单元和第二封堵单元均为圆形。
将聚二氧环己酮(PDO)溶于四氯乙烷中配制浓度为10mg/mL的聚二氧环己酮(PDO)溶液，向该聚二氧环己酮溶液中加入碱式碳酸铋，搅拌均匀，得到含有聚二氧环己酮和碱式碳酸铋的混悬液，其中，聚二氧环己酮和碱式碳酸 铋的质量比为1.5:1。将第一封堵单元的第一远端封堵盘浸渍于含有聚二氧环己酮和碱式碳酸铋的混悬液5s后(浸渍的过程持续搅拌混悬液，防止碱式碳酸铋颗粒团聚沉淀)，将第一远端封堵盘以0.5m/s的速度从该混悬液中提出，聚消旋乳酸和碱式碳酸铋沉积于第一远端封堵盘的所有网络节点上，由于浓度较小，重复浸提的操作2次。第二和第三次都将第一远端封堵盘分别浸渍于含有聚二氧环己酮和碱式碳酸铋的混悬液中浸泡3s和2s后，分别以0.2m/s和1.0m/s的速度快速提起，干燥后，形成附着于第一远端封堵盘的所有网络节点上的标记物，标记物物的数量为25个，其中，每个标记物对应每个网络节点，标记物将网络节点处的丝线固定，形成固定网络节点。每个标记物中碱式碳酸铋的质量约为0.2mg。
将形成标记物的框架于55℃下热处理15min，得到封堵器。
将该封堵器植入巴马猪的房间隔处，使得封堵器的在DSA设备下的可视性较好。
实施例7
将一组包括丝径0.30mm的30根平行排列的聚对苯二甲酸乙二酯(PET)丝线作为经度丝线和一组包括丝径0.30mm的30根平行排列的聚聚对苯二甲酸乙二酯(PET)丝线作为纬度丝线上下交错编织形成编织网，将该编织网进行热定型形成框架，框架包括第一封堵单元、第二封堵单元及分别连接第一封堵单元和第二封堵单元的腰部，框架包括多个网络节点，第一封堵单元和第二封堵单元的结构与上文的结构相同，此处不再赘述。其中，本实施例中，第一封堵单元和第二封堵单元均为圆形。
将碘化聚ε-己内酯(I-PCL，I含量为11wt.％)溶于氯仿中配制浓度为10mg/mL的碘化聚ε-己内酯溶液，采用注射器将碘化聚ε-己内酯溶液逐滴滴在第一远端封堵盘的所有网络节点上，干燥后形成附着于第一远端封堵盘的所有网络节点上的标记物，标记物的数量为36个，其中，每个标记物对应每个网络节点，标记物将网络节点处的丝线固定，形成固定网络节点，得到封堵器。每个标记物的质量为0.2mg。
将该封堵器植入巴马猪的房间隔处，封堵器的在DSA设备下的可视性较好，植入过程顺利。
实施例8
将一组丝径为0.40mm的20根聚对二氧环己酮(PDO)丝作为经度丝线和一组包括丝径0.40mm的20根平行排列的聚对二氧环己酮丝作为纬度丝线上下交错编织形成管腔状的框架，管腔编织框架包括多个网络节点。
将聚左旋乳酸(PLLA)溶于氯仿中配制饱和的聚左旋乳酸溶液，向该聚左旋乳酸溶液中加入铂金粉，搅拌均匀，得到含有聚左旋乳酸和铂金粉的混悬液，其中，聚左旋乳酸和铂金粉的质量比为1:2。将整个框架浸渍于含有聚左旋乳酸和铂金粉的混悬液中30s，然后以0.3m/s的速度提升离开混悬液后，进行喷气处理，干燥后，形成附着于框架的所有网络节点上的标记物，每个标记物中铂金粉的质量为1.5mg。
将形成标记物的框架于110℃下热处理5min，得到管腔植入器械。
将该管腔植入器械植入巴马猪的外周血管，管腔植入器械的在DSA设备下的可视性较好，植入过程顺利。
以上所述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。
以上所述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 (20)

  1. 一种植入式器械，包括框架，所述框架包括多根丝线，所述多根丝线交错形成多个网络节点，其特征在于，所述植入式器械还包括多个标记物，所述多个标记物设置于至少部分所述多个网络节点上，且所述多个标记物和至少部分所述多个网络节点中，每个标记物对应每个网络节点，每个所述标记物包括在医学影像设备下可视的材料。
  2. 根据权利要求1所述的植入式器械，其特征在于，每个标记物将对应的每个网络节点粘连形成固定网络节点。
  3. 根据权利要求1或2所述的植入式器械，其特征在于，所述在医学影像设备下可视的材料为辐射不透性材料。
  4. 根据权利要求3所述的植入式器械，其特征在于，所述标记物还包括粘连剂。
  5. 根据权利要求4所述的植入式器械，其特征在于，所述标记物为单层结构，所述辐射不透性材料分散于所述粘连剂中；或者，
    所述标记物为多层结构，所述多层结构包括最内层、最外层及位于所述最内层和最外层之间的至少一个中间层，所述最内层和最外层的材料均为粘连剂，所述至少一个中间层的材料为辐射不透性材料或为辐射不透性材料与粘连剂的混合材料。
  6. 根据权利要求4所述的植入式器械，其特征在于，所述粘连剂与所述辐射不透性材料的质量比为0.1～2:1。
  7. 根据权利要求3所述的植入式器械，其特征在于，每个标记物中，所述辐射不透性材料的质量为0.01～2mg。
  8. 根据权利要求4所述的植入式器械，其特征在于，所述粘连剂的材料选自聚对苯二甲酸乙二酯、聚丙烯、聚乙烯、聚乳酸、聚乙醇酸、聚乳酸-羟基乙酸共聚物、聚羟基脂肪酸脂、聚二氧环己酮和聚己内酯中的至少一种。
  9. 根据权利要求3所述的植入式器械，其特征在于，所述辐射不透性材料选自金属、无机盐和有机材料中的至少一种；其中，所述金属选自黄金、铂金、钨、铱、锇、铼、铑及钽中的至少一种，所述无机盐选自硫酸钡、碘化钠及碱式碳酸铋中的至少一种，所述有机材料选自碘帕醇、碘佛醇、泛影葡胺、碘普 罗胺及含碘的高分子材料中的至少一种。
  10. 根据权利要求1所述的植入式器械，其特征在于，所述植入式器械为封堵器，所述封堵器包括所述框架，且所述框架包括第一封堵单元、第二封堵单元和腰部，所述腰部的两端分别连接所述第一封堵单元和所述第二封堵单元，所述第一封堵单元包括第一远端封堵盘、第一近端封堵盘及连接所述第一远端封堵盘和所述第一近端封堵盘的第一脊部，所述第二封堵单元包括第二远端封堵盘、第二近端封堵盘及连接所述第二远端封堵盘和所述第二近端封堵盘的第二脊部，所述多个标记物中至少有部分设置于所述第一远端封堵盘和/或所述第一近端封堵盘上。
  11. 根据权利要求10所述的植入式器械，其特征在于，所述多个标记物中，有部分设置于所述第一远端封堵盘和/或所述第一近端封堵盘上，另一部分设置于所述第二远端封堵盘和/或所述第二近端封堵盘上。
  12. 根据权利要求10所述的植入式器械，其特征在于，所述多个标记物中，至少有两个设置于所述第一远端封堵盘或所述第一近端封堵盘上；
    位于所述第一远端封堵盘上的所述至少两个标记物中，有两个标记物的连线穿过所述第一远端封堵盘的几何中心，且所述两个标记物中，每个标记物的边缘至所述第一远端封堵盘的边缘的距离为0～2毫米；或者，
    或位于所述第一近端封堵盘上的所述至少两个标记物中，有两个标记物的连线穿过所述第一近端封堵盘的几何中心，且所述两个标记物中，每个标记物的边缘至所述第一近端封堵盘的边缘的距离为0～2毫米。
  13. 根据权利要求10或11所述的植入式器械，其特征在于，位于所述第一远端封堵盘上的多个标记物的外接图形与所述第一远端封堵盘的形状相同，且所述多个标记物的外接图形的几何中心与所述第一远端封堵盘的几何中心重合；或者，位于所述第一近端封堵盘上的多个标记物的外接图形与所述第一近端封堵盘的形状相同，且所述多个标记物的外接图形的几何中心与所述第一近端封堵盘的几何中心重合。
  14. 根据权利要求13所述的植入式器械，其特征在于，位于所述第一远端封堵盘上的所述多个标记物的外接图形至所述第一远端封堵盘的边缘的距离为 0～2毫米；或者，位于所述第一近端封堵盘上的所述多个标记物的外接图形的边缘至所述第一近端封堵盘的边缘的距离为0～2毫米。
  15. 根据权利要求10所述的植入式器械，其特征在于，所述多个标记物中，至少有部分设置于所述腰部上。
  16. 根据权利要求10所述的植入式器械，其特征在于，所述封堵器还包括与所述第一远端封堵盘相连的远端封头和与所述第二近端封堵盘相连的近端栓头，所述远端封头和近端栓头中的至少一个上设置有端部标记结构。
  17. 一种植入式器械的制备方法，其特征在于，包括如下步骤：
    提供框架，所述框架包括多根丝线，所述多根丝线交错形成多个网络节点；
    分别将多个标记物设置于至少部分所述网络节点上，且所述多个标记物和至少部分所述多个网络节点中，每个标记物对应每个网络节点，每个所述标记物包括在医学影像设备下可视的材料。
  18. 根据权利要求17所述的植入式器械的制备方法，其特征在于，所述分别将多个标记物设置于至少部分所述网络节点上，且所述多个标记物和至少部分所述多个网络节点中，每个标记物对应每个网络节点，每个所述标记物包括在医学影像设备下可视的材料的步骤包括：
    配制含有在医学影像设备下可视的材料的溶液或混悬液，将所述含有在医学影像设备下可视的材料的溶液或混悬液与所述框架的至少部分网络节点接触，所述含有在医学影像设备下可视的材料的溶液或混悬液的溶剂挥发后，所述在医学影像设备下可视的材料附着于所述框架的至少部分网络节点上，在所述至少部分网络节点上形成所述多个标记物，且所述多个标记物和至少部分所述多个网络节点中，每个标记物对应每个网络节点；
    其中，所述将所述含有在医学影像设备下可视的材料的溶液或混悬液与所述框架的至少部分网络节点接触的步骤包括：
    将所述框架的至少部分部位浸渍于所述含有在医学影像设备下可视的材料的溶液或混悬液中，然后将所述框架从所述含有在医学影像设备下可视的材料的溶液或混悬液中提起；或者，
    采用喷涂或滴注的方法将所述含有在医学影像设备下可视的材料的溶液或 混悬液与所述框架的至少部分网络节点接触；或者，
    将所述框架的至少部分部位浸渍于所述含有在医学影像设备下可视的材料的溶液或混悬液中，然后将所述框架从所述含有在医学影像设备下可视的材料的溶液或混悬液中提起及采用喷涂和滴注中的至少一种方法将所述含有在医学影像设备下可视的材料的溶液或混悬液与所述框架的至少部分网络节点接触。
  19. 根据权利要求18所述的植入式器械的制备方法，其特征在于，所述将所述框架的至少部分部位浸渍于所述含有在医学影像设备下可视的材料的溶液或混悬液中的时间大于或等于5秒，所述将所述框架从所述含有在医学影像设备下可视的材料的溶液或混悬液中提起的速度为0.01～0.5米每秒。
  20. 根据权利要求18或19所述的植入式器械的制备方法，其特征在于，所述将所述含有在医学影像设备下可视的材料的溶液或混悬液与所述框架的至少部分网络节点接触，所述含有在医学影像设备下可视的材料的溶液或混悬液的溶剂挥发后，所述在医学影像设备下可视的材料附着于所述框架的至少部分网络节点上的步骤之后，还包括对热处理的步骤，所述热处理的步骤包括：
    将附着有所述多个标记物的所述框架置于45～110℃的温度下保温5～60min。
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