WO2024083064A1 - 血管植入物 - Google Patents

血管植入物 Download PDF

Info

Publication number
WO2024083064A1
WO2024083064A1 PCT/CN2023/124676 CN2023124676W WO2024083064A1 WO 2024083064 A1 WO2024083064 A1 WO 2024083064A1 CN 2023124676 W CN2023124676 W CN 2023124676W WO 2024083064 A1 WO2024083064 A1 WO 2024083064A1
Authority
WO
WIPO (PCT)
Prior art keywords
developing
mark
implant
development
braided
Prior art date
Application number
PCT/CN2023/124676
Other languages
English (en)
French (fr)
Inventor
刘子昂
�田�浩
燕阳阳
王亦群
Original Assignee
微创神通医疗科技（上海）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 微创神通医疗科技（上海）有限公司 filed Critical 微创神通医疗科技（上海）有限公司
Publication of WO2024083064A1 publication Critical patent/WO2024083064A1/zh

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—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
    • A61F2/02—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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

  • the present invention relates to the technical field of medical devices, and in particular to a vascular implant.
  • Minimally invasive intervention is a treatment for vascular aneurysms, which usually involves delivering vascular implants, such as but not limited to stents, coils, aneurysm occlusion devices, etc., to the diseased location in the blood vessel through a delivery device. Subsequently, the delivery rod maintains the implant design structure while releasing the vascular implant to achieve therapeutic effects such as dilating the blood vessels and occluding aneurysms.
  • vascular implants such as but not limited to stents, coils, aneurysm occlusion devices, etc.
  • Self-expanding braided stent is a form of vascular implant, which is widely used due to its good delivery performance.
  • the self-expanding braided stent is developed only by the developing structures at both ends of the stent and/or the developing wires inserted in the stent, which is not conducive to judging the opening and wall adhesion status of the stent in a curved blood vessel.
  • the recognition of the developing structures at both ends is generally poor, and it is not easy to judge the opening and wall adhesion status of the two ends of the stent, thereby reducing the safety and accuracy of the surgical operation and increasing the operation time.
  • the object of the present invention is to provide a vascular implant, wherein both ends and a middle section of the vascular implant are developable under X-ray, and the developability of the two ends of the vascular implant under X-ray is better than that of the middle section, so that an operator can judge the position and posture of the two ends of the vascular implant, thereby improving the safety and accuracy of surgical operation.
  • the present invention provides a vascular implant, comprising a tubular implant body and a first end and a second end located at two axial ends of the implant body;
  • the implant body is formed by interlacing at least two braided wires, at least one of the at least two braided wires has a developing property, the braided wire with a developing property comprises a developing core wire and a sleeve covering the developing core wire, and the cross-sectional area of the developing core wire accounts for 20% to 35% of the total cross-sectional area of the braided wire;
  • the first end is provided with at least one first end development mark, the first end development mark is 0.1 mm to 0.9 mm away from the farthest end of the first end, and the second end is provided with at least one second end development mark.
  • the ratio of the first end development mark, the implant body and the second end development mark in recognizability under X-ray is 0.99:(0.32-0.66):1.0, the material relative density of the vascular implant is 15-25, and the thickness of the vascular implant in the X-ray irradiation direction is 0.015mm-0.2mm.
  • the first end development mark and the implant body are configured to be different in at least one of the following aspects: the selected radiopaque material and the thickness in the X-ray irradiation direction;
  • the second end development mark and the implant body are configured to be different in at least one of the following aspects: the selected radiopaque material and the thickness in the X-ray irradiation direction.
  • the radiopaque material in the first end development mark is the same as the radiopaque material in the braided wire, and the thickness of the first end development mark in the X-ray irradiation direction is greater than the thickness of the implant body in the X-ray irradiation direction, or,
  • the radiopaque material in the first end development mark is different from the radiopaque material in the braided wire, and the thickness of the first end development mark in the X-ray irradiation direction is greater than, equal to or less than the thickness of the implant body in the X-ray irradiation direction.
  • the radiopaque material in the second end development mark is the same as the radiopaque material in the braided wire, and the thickness of the second end development mark in the X-ray irradiation direction is greater than the thickness of the implant body in the X-ray irradiation direction, or,
  • the radiopaque material in the second end development mark is different from the radiopaque material in the braided wire, and the thickness of the second end development mark in the X-ray irradiation direction is greater than, equal to or less than the thickness of the implant body in the X-ray irradiation direction.
  • the first end development mark and the second end development mark are configured to be different in at least one of the following aspects: the selected radiopaque material and the thickness in the X-ray irradiation direction.
  • the ratio of the recognizability of the first-end development mark under X-ray to the recognizability of the implant body under X-ray is 1.80 to 2.30; and/or the ratio of the recognizability of the second-end development mark under X-ray to the recognizability of the implant body under X-ray is 1.82 to 2.33.
  • the first end developing mark and/or the second end developing mark is a developing spring or a developing sleeve
  • the outer diameter of the developing spring or the developing sleeve is 0.003 inches to 0.007 inches.
  • the spring wire of the developing spring includes a core wire and a sleeve wrapped around the core wire, the sleeve of the developing spring has a non-developing property, and the core wire of the developing spring has a developing property, wherein: The cross-sectional area of the core wire in the spring wire accounts for 20% to 35% of the total cross-sectional area of the spring wire.
  • the first end is the distal end of the vascular implant
  • the second end is the proximal end of the vascular implant
  • the number of the first end development marks is at least two, and at least two of the first end development marks are evenly arranged in the circumferential direction of the vascular implant
  • the number of the second end development marks is at least two, and at least two of the second end development marks are evenly arranged in the same circumferential direction of the vascular implant.
  • At least two of the first end development marks are arranged on different circumferences of the vascular implant.
  • the number of the first end development marks is different from the number of the second end development marks.
  • the vascular implant comprises a tubular implant body and a first end and a second end located at two axial ends of the implant body, the implant body is formed by interlacing at least two braided wires, and at least one of the at least two braided wires has a developing property, that is, the vascular implant is woven with braided wires having a developable core wire, so that the vascular implant as a whole achieves good development, which is convenient for the operator to accurately judge the opening and wall-attaching state of the vascular implant in the curved blood vessel, and at the same time, the proportion (cross-sectional area) of the developable core wire in the braided wire in the braided wire is limited to take into account the radial support force of the braided stent; in addition, the first end developing mark on the first end of the axial direction of the vascular implant and the second end developing mark on the second end are both more recognizable under X-ray than the implant body under X-ray,
  • the positions of the first end developing mark and the second end developing mark at the first end and the second end of the implant body are respectively limited, and the distance between the first end developing mark and the farthest end of the first end and the second end of the second end is controlled to be 0.1mm-0.9mm, and the distance between the second end developing mark and the end face of the second end is controlled to be 0.5mm-4.0mm.
  • the first end developing mark and the second end developing mark are prevented from interfering with the implant body during the delivery process, thereby reducing the pushing resistance of the vascular implant, and on the other hand, the axial ends of the implant body are prevented from being too long, thereby reducing the instability of the vascular implant in the curved blood vessel after release.
  • the vascular implant of the present invention has good overall visualization, the visualization marks at both ends can be accurately identified, while also taking into account radial support, reducing the pushing resistance of the vascular implant, and ensuring the opening and wall adhesion performance of the vascular implant.
  • the first end developing mark on the first end of the vascular implant has a different degree of recognition under X-ray from the second end developing mark on the second end.
  • the ratio of the degree of recognition under X-ray of the first end developing mark to the degree of recognition of the implant body under X-ray is 1.80-2.30
  • the ratio of the degree of recognition under X-ray of the second end developing mark to the degree of recognition of the implant body under X-ray is 1.82-2.33, that is, there is a difference in the developing performance at the two axial ends of the vascular implant, which facilitates the doctor to accurately and quickly distinguish the distal and proximal ends of the vascular implant, making the surgical operation more flexible and convenient.
  • FIG1 is a front view of a vascular implant according to a preferred embodiment of the present invention.
  • FIG. 2 is a diagram showing the transport state of the first end development mark and the implant body when the first end development mark on the axial first end of the vascular implant body of the comparative embodiment is 0.95 mm away from the most distal end of the first end;
  • FIG. 3 is a diagram showing the delivery state of the second end developing mark and the implant body when the second end developing mark on the axial second end of the vascular implant body of the comparative embodiment is 0.4 mm away from the end surface formed by the first intersection of the braided wires at the end of the second end;
  • FIG4 is a release diagram of the vascular implant in a curved blood vessel when the second end development mark on the axial second end of the vascular implant body of the comparative embodiment is 4.5 mm away from the end surface of the second end, and the release diagram is a simulated release of the stent adhered to the wall of the in vitro blood vessel;
  • FIG5 is an X-ray image of the first end development mark and the implant body according to a preferred embodiment of the present invention.
  • FIG. 6 is an X-ray image of the second end development mark and the implant body according to the preferred embodiment of the present invention.
  • distal end and proximal end are used; the end close to the heart is called the “proximal end”, that is, the proximal end; the end far from the heart is called the “distal end”, that is, the “distal end”.
  • proximal end that is, the proximal end
  • distal end that is, the distal end
  • the core idea of the present invention is to provide a vascular implant, in particular a braided stent for treating intracranial vascular diseases, which is delivered to a target location through a delivery device and can be used to treat vascular diseases such as intracranial aneurysms. It is understandable that the vascular implant can also be used to treat intracranial or non-intracranial vascular aneurysms, vascular dilatation, vascular embolism capture or other luminal lesions.
  • the vascular implant provided by the present invention comprises a tubular implant body, wherein the implant body is formed by interlacing and weaving at least two braided wires, and the implant body has a first end and a second end located at both ends of the implant body in the axial direction. At least one of the at least two braided wires has a developing property, that is, at least one braided wire contains a radiopaque material.
  • At least one of the at least two braided wires comprises a developable core wire and a sleeve wrapped outside the developable core wire
  • the material of the developable core wire in the braided wire includes but is not limited to one of platinum, iridium, gold, silver, tantalum and tungsten or an alloy thereof
  • the material of the sleeve in the braided wire includes but is not limited to one or more combinations of nickel-titanium alloy, nitinol, stainless steel, cobalt-chromium alloy, and nickel-cobalt alloy.
  • the cross-sectional area of the developable core wire in the braided wire accounts for 20% to 35% of the total cross-sectional area of the braided wire, and the outer diameter of the sleeve is preferably 0.0010 inches to 0.0030 inches (0.0254mm to 0.0762mm).
  • the vascular implant is configured such that the X-ray imaging performance at the two ends is better than that in the middle section. Performance, that is, the vascular implant is configured such that the first end and the second end are more recognizable under X-ray than the implant body under X-ray.
  • recognition can be understood as the imaging clarity under X-ray with human soft tissue blocking. The greater the recognition, the better the imaging clarity, that is, the better the imaging performance.
  • the developing performance can be understood as the recognition of two substances under X-ray (i.e. contrast).
  • SC is the contrast of material A in material B under X-ray, such as the contrast of the braided stent (i.e. material A) in human tissue (i.e. material B) is the recognition of the braided stent under X-ray;
  • c is the thickness of material A in the X-ray direction;
  • ⁇ is the difference in attenuation coefficients between material A and material B.
  • e is a natural constant
  • ⁇ 0 is the X-ray attenuation coefficient of human soft tissues such as muscle and blood
  • c is the thickness of the vascular implant in the X-ray direction
  • ⁇ k is the relative density of the vascular implant material, which is equal to the ratio of the material density of the vascular implant to the density of human tissue
  • k is an empirical coefficient related to the atomic number of the material of the vascular implant, which can be obtained through experiments, specifically:
  • Z is the atomic number of the material of the vascular implant.
  • the X-ray attenuation coefficient of human soft tissues such as muscle and blood is about 0.22
  • the X-ray attenuation coefficient of human bones is about 0.63
  • the difference in attenuation coefficient is 0.41
  • the thickness of the human skull is usually about 10mm.
  • the recognition of a 10mm thick skull in human soft tissue is about 0.33. Therefore, in order to make the vascular implant have good recognition under X-ray, its recognition in the blood vessel should also be not less than 0.33.
  • the relative density of the material of each part of the vascular implant is about 15 ⁇ k ⁇ 25, and the thickness of each part of the vascular implant in the X-ray direction is about 0.015mm ⁇ c ⁇ 0.2mm. In this way, the vascular implant has good recognition under X-ray.
  • vascular implant of the present invention is further described below with reference to the accompanying drawings and several embodiments.
  • a preferred embodiment of the present invention provides a vascular implant, which may be a braided stent.
  • the braided stent includes a tubular implant body 110, and the implant body 110 is formed by interlacing at least two braided wires 140.
  • at least one braided wire of the at least two braided wires 140 includes a developable core wire and a sleeve wrapped outside the developable core wire.
  • the developable core wire has developability under X-ray
  • the material of the developable core wire includes but is not limited to one of the radiopaque materials such as platinum, iridium, gold, silver, tantalum and tungsten or its alloy
  • the sleeve has no developability
  • the material of the sleeve includes but is not limited to one or more combinations of nickel-titanium alloy, nitinol, stainless steel, cobalt-chromium alloy, and nickel-cobalt alloy.
  • the braided stent uses a developing material as a braided wire, which can make the overall X-ray developability of the braided stent better, which is convenient for the operator to accurately judge the opening and wall-attaching state of the vascular implant in the curved blood vessel, and improve the safety and accuracy of the surgical operation.
  • all the braided wires 140 in the implant body 110 are double-layer braided wires (i.e., DFT materials) of a developable core wire and a sleeve coated outside the developable core wire, and the wire diameter of the braided wire is 0.001 inches to 0.003 inches.
  • the cross-sectional area of the developable core wire accounts for 20% to 35% of the total cross-sectional area of the braided wire.
  • part of the braided wires 140 in the implant body 110 are double-layer braided wires of a developable core wire and a sleeve coated outside the developable core wire, and the other parts can be made of different materials and/or braided wires of different sizes, for example, double-layer braided wires of other wire diameter ranges, or braided wires made of one or more materials of nickel-titanium alloy, nitinol, stainless steel, cobalt-chromium alloy, and nickel-cobalt alloy.
  • Using braided wires of different materials and/or different sizes can reduce costs and increase the use occasions and scope of the stent.
  • the implant body 110 is interlaced and woven into a diamond mesh structure by 12 to 32 braided wires 140, and the number of intersections formed by these braided wires in the axial direction is 10 to 75 per inch. It is understandable that when the braided stent is in a natural state (i.e., a non-compressed state), the number of intersections formed by these braided wires in the axial direction can be 10 to 75 per inch depending on the design size of the stent; when the braided stent is in a compressed state, the number of intersections formed by these braided wires in the axial direction can be as low as 10 per inch depending on the size/position of the blood vessel (i.e., different compression degrees).
  • the implant body 110 is interlaced and woven into a diamond mesh structure by 16 to 24 braided wires 140, for example, 16, 20, or 24.
  • the number of intersections formed by these braided wires in the axial direction is 30 to 55 per inch.
  • the implant body 110 preferably has a higher number of braided wires and a braiding density. More preferably, the metal coverage rate (i.e., the braiding density) of the braided wires 140 formed on the implant body 110 is 8% to 25%, so that the development effect of the middle section of the braided stent is good. It should be understood that the "middle section" described herein refers to the braided portion located between the first end and the second end of the vascular implant.
  • the implant body 110 its material should first meet the various properties of the vascular implant, such as pushing force, radial support force, compatibility, biocompatibility, etc. Under the premise of meeting the performance of the vascular implant, a material with a higher density can be selected as much as possible to enhance the developing property. In order to maximize the performance and developing property of the vascular implant, DFT material can be used, and a structure of a developable core wire plus a sleeve can be adopted. The material of the sleeve mainly meets the various properties of the vascular implant, such as the radial support force, and the material of the developable core wire meets the developing property.
  • the outer sleeve material of the DFT is nickel-titanium alloy (Ni-Ti), and the material of the developable core wire is platinum.
  • the outer diameter of the sleeve and the outer diameter of the core wire of the braided wire will also affect the various properties of the vascular implant, such as the radial support force, and the developing property.
  • a smaller sleeve outer diameter and a larger core wire outer diameter should be selected; in order to make the vascular implant have better radial support force, a larger sleeve outer diameter and a smaller core wire outer diameter should be selected; in order to make the vascular implant have better developing property, a larger sleeve outer diameter and a larger core wire outer diameter should be selected.
  • the braided wires 140 in the implant body 110 are all made of double-layer braided wires (i.e., DFT materials), i.e., they include a developable core wire and a sleeve coated on the outside of the developable core wire.
  • the sleeve is a nickel-titanium alloy
  • the material of the developable core wire is platinum
  • the outer diameter of the sleeve is 0.0533 mm (0.0021 inches)
  • the cross-sectional area of the developable core wire accounts for 20% of the total cross-sectional area of the braided wire, i.e., the outer diameter of the developable core wire is approximately 0.0238 mm.
  • the radial force of the stent measured by the local anti-extrusion method is 0.052 N, and the experiment proves that the radial support of the entire vascular implant is good.
  • the braided wires in the implant body 110 are all made of DFT material
  • the sleeve is nickel-titanium alloy
  • the material of the developable core wire is platinum
  • the outer diameter of the sleeve is 0.0533 mm (0.0021 inches)
  • the cross-sectional area of the developable core wire accounts for 30% of the total cross-sectional area of the braided wire, that is, the outer diameter of the developable core wire is about 0.0292 mm.
  • the relative density ⁇ k 20.4
  • the recognizability SC 0.52.
  • the radial force of the stent measured by the local anti-extrusion method is 0.059 N, which also proves that the radial support of the entire vascular implant is good.
  • the braided wire in the implant body 110 is made of DFT material
  • the sleeve is nickel-titanium alloy
  • the developable core wire is made of platinum
  • the outer diameter of the sleeve is 0.0533 mm
  • the cross-sectional area of the developable core wire accounts for 63% of the total cross-sectional area of the braided wire, that is, the outer diameter of the developable core wire is about 0.042 mm.
  • the radial force of the stent measured by the local anti-extrusion method is 0.045N. At this time, due to the increase in the proportion of the developable core wire, the radial support force of the vascular implant is reduced.
  • the braided wire in the implant body 110 is made of DFT material
  • the sleeve is nickel-titanium alloy
  • the developable core wire is made of platinum
  • the outer diameter of the sleeve is 0.0533 mm
  • the cross-sectional area of the developable core wire accounts for 9% of the total cross-sectional area of the braided wire, that is, the outer diameter of the developable core wire is about 0.016 mm.
  • the relative density ⁇ k 20.4
  • the recognizability SC 0.34.
  • the radial force of the stent measured by the local anti-extrusion method is 0.043N, so the reduction in the proportion of the developable core wire will also affect the radial support, resulting in a reduction in the radial support force, and it is also difficult to take into account good developability.
  • the braided wire in the implant body 110 is made of DFT material
  • the sleeve is nickel-titanium alloy
  • the developable core wire is made of platinum
  • the outer diameter of the sleeve is 0.0533 mm
  • the cross-sectional area of the developable core wire accounts for 34% of the total cross-sectional area of the braided wire, that is, the outer diameter of the developable core wire is about 0.031 mm.
  • the radial force of the stent measured by the local anti-extrusion method is 0.056N, which ensures the radial support force of the entire vascular implant and takes into account the developability.
  • the material of the braided wire in the implant body 110 is selected from DFT material.
  • the sleeve is made of nickel-titanium alloy
  • the material of the developable core wire is platinum
  • the outer diameter of the sleeve is 0.0533 mm
  • the cross-sectional area of the developable core wire accounts for 17% of the total cross-sectional area of the braided wire, that is, the outer diameter of the developable core wire is about 0.022 mm.
  • the radial force of the stent measured by the local anti-extrusion method is 0.049 N, and the radial support force can be reduced.
  • the material of the braided wire in the implant body 110 is DFT material
  • the sleeve is nickel-titanium alloy
  • the material of the developable core wire is platinum
  • the outer diameter of the sleeve is 0.0533 mm
  • the cross-sectional area of the developable core wire accounts for 8% of the total cross-sectional area of the braided wire, that is, the outer diameter of the developable core wire is about 0.015 mm.
  • the thickness of the developable core wire in the X-ray direction c 0.015 mm
  • the radial force of the stent measured by the local anti-extrusion method is 0.041N.
  • the proportion of the developable core wire is low, the developability is insufficient, and the radial support is also insufficient.
  • the recognition of the implant body 110 under X-ray is related to the stent material, the wire diameter of the braided wire and the outer diameter of the developable core wire.
  • the radial support performance of the implant changes with the change of the outer diameter of the developable core wire.
  • the cross-sectional area of the developable core wire in the braided wire of the vascular implant accounts for 20% to 35% of the total cross-sectional area of the braided wire.
  • a radiopaque material with a higher density is selected to prepare the development mark, as well as a larger size of the development mark, such as a development ring or a development spring with a larger outer diameter.
  • the vascular implant further includes a first end 111 and a second end 112 located at two axial ends of the implant body 110.
  • the first end 111 is the distal end of the vascular implant
  • the second end 112 is the proximal end of the vascular implant.
  • at least one first end development mark 120 is set on the first end 111
  • at least one second end development mark 130 is set on the second end 112.
  • the setting of the first end development mark 120 and the second end development mark 130 can make the braided stent have better development performance during the operation, facilitate the operator to accurately judge the position and posture of the two ends of the vascular implant, and timely adjust the vascular implant to achieve good positioning, opening, anchoring, wall adhesion and other effects, thereby improving the safety and accuracy of the surgical operation.
  • the first end 111 includes a plurality of back-wrap braided loops 1111.
  • the weaving rings 1111 are arranged at intervals in the circumferential direction.
  • At least one first end developing mark 120 is set on the circumference of at least one of the multiple rewinding weaving rings 1111.
  • the farthest end of the first end 111 is defined by the vertex of each rewinding weaving ring 111, and D is the distance from the end of the first end developing mark 120 away from the implant body 110 to the vertex of the weaving ring.
  • the above 0.1 mm to 0.9 mm is set by the applicant based on the size of the vascular implant in the intracranial blood vessel and a large amount of experimental data, so that the vascular implant of the present invention can ensure the developability and radial support force while taking into account the influence of the first end developable mark 120 on the pushing performance and opening and adhering performance of the vascular implant. It should be noted that if D is less than 0.1 mm, the vascular implant cannot be compressed to match the 0.017-inch microcatheter for pushing, and the applicant unexpectedly found in the research process that if D is greater than 0.9 mm, the pushing resistance is very large.
  • the first end developable mark 120 will interfere with the braided stent body, increasing the compressed state size of the braided stent. Therefore, setting D within the range of 0.1 mm to 0.9 mm can reduce the influence of the first end developable mark 120 on the pushing performance, and prevent the first end developable mark 120 from interfering with the braided stent (i.e., the implant body 110) as much as possible, and prevent the increase of the compressed state size of the braided stent.
  • first end development markers 120 there are three or four first end development markers 120, which are respectively arranged on different rewinding braided rings 1111.
  • the use of three or four first end development markers 120 is to minimize the radial size of the stent after compression while ensuring the X-ray development performance, so that the stent can be delivered in a small-sized delivery system.
  • the number of first end development markers 120 (distal end) is four, and the maximum outer diameter of a single first end development marker 120 that can be accommodated is about 0.0055 inches.
  • the outer diameter of the first end development marker 120 is smaller than the size of the second end development marker 130. If the outer diameter of the first end development marker 120 is large, it will make it difficult for the vascular implant to be delivered through the 0.017-inch catheter lumen, or increase the delivery resistance.
  • the braided wires in the implant body 110 are all made of DFT material
  • the sleeve is made of nickel-titanium alloy
  • the material of the developable core wire is platinum
  • the outer diameter of the sleeve is 0.0533 mm (0.0021 inches)
  • the cross-sectional area of the developable core wire accounts for 30% of the total cross-sectional area of the braided wire
  • the outer surface of the first end developable marker 120 is 0.0533 mm (0.0021 inches).
  • the diameter is 0.0055 inches, and there are 4 of them.
  • a 0.017-inch microcatheter is used for pushing. Experiments have shown that the pushing resistance of the vascular implant is 125gf.
  • the braided wires in the implant body 110 are all made of DFT material
  • the sleeve is nickel-titanium alloy
  • the material of the developable core wire is platinum
  • the outer diameter of the sleeve is 0.0533 mm (0.0021 inches)
  • the cross-sectional area of the developable core wire accounts for 30% of the total cross-sectional area of the braided wire
  • the outer diameter of the first end developing mark 120 is 0.0055 inches
  • the pushing resistance of the vascular implant is 121gf.
  • the braided wires in the implant body 110 are all made of DFT material
  • the sleeve is nickel-titanium alloy
  • the material of the developable core wire is platinum
  • the outer diameter of the sleeve is 0.0533 mm (0.0021 inches)
  • the cross-sectional area of the developable core wire accounts for 30% of the total cross-sectional area of the braided wire
  • the outer diameter of the first end developing mark 120 is 0.0055 inches
  • the pushing resistance of the vascular implant is 115 gf.
  • the braided wires in the implant body 110 are all made of DFT material
  • the sleeve is nickel-titanium alloy
  • the material of the developable core wire is platinum
  • the outer diameter of the sleeve is 0.0533 mm (0.0021 inches)
  • the cross-sectional area of the developable core wire accounts for 30% of the total cross-sectional area of the braided wire
  • the outer diameter of the first end developing mark 120 is 0.0055 inches
  • the pushing resistance of the vascular implant is 109 gf.
  • the braided wires in the implant body 110 are all made of DFT material
  • the sleeve is nickel-titanium alloy
  • the material of the developable core wire is platinum
  • the outer diameter of the sleeve is 0.0533 mm (0.0021 inches)
  • the cross-sectional area of the developable core wire accounts for 30% of the total cross-sectional area of the braided wire
  • the outer diameter of the first end developing mark 120 is 0.0055 inches
  • the pushing resistance of the vascular implant is 111 gf.
  • the braided wires in the implant body 110 are all made of DFT material
  • the sleeve is made of nickel-titanium alloy
  • the material of the developable core wire is platinum
  • the outer diameter of the sleeve is 0.0533 mm (0.0021 inches).
  • the cross-sectional area of the developable core wire accounts for 30% of the total cross-sectional area of the braided wire.
  • the outer diameter of the first end developing mark 120 is 0.0055 inches.
  • a 0.017-inch microcatheter is used for pushing. Experiments have shown that the pushing resistance of the vascular implant is 118 gf.
  • the braided wires in the implant body 110 are all made of DFT material
  • the sleeve is nickel-titanium alloy
  • the material of the developable core wire is platinum
  • the outer diameter of the sleeve is 0.0533 mm (0.0021 inches)
  • the cross-sectional area of the developable core wire accounts for 30% of the total cross-sectional area of the braided wire
  • the outer diameter of the first end developing mark 120 is 0.0055 inches
  • the pushing resistance is 238 gf, which is much larger than 125 gf, 121 gf, 115 gf, 109 gf, 111 gf, and 118 gf. Therefore, when D exceeds 0.9 mm, the first end development mark 120 and the implant body 110 interfere with each other during the delivery process, which increases the size of the vascular implant in a compressed state and increases the push resistance, as shown in Figure 2. The area circled by the black line frame in Figure 2 interferes.
  • the first end developing mark 120 is set at other positions other than the vertex of the winding braiding ring 1111.
  • the distance D between the first end developing mark 120 and the farthest end of the first end can also be within any of the following ranges: 0.1 ⁇ 0.15mm, 0.1 ⁇ 0.3mm, 0.1 ⁇ 0.5mm, 0.1 ⁇ 0.8mm, 0.15 ⁇ 0.3mm, 0.15 ⁇ 0.5mm, 0.15 ⁇ 0.8mm, 0.15 ⁇ 0.9mm, 0.3 ⁇ 0.5mm, 0.3 ⁇ 0.8mm, 0.3 ⁇ 0.9mm, 0.5 ⁇ 0.8mm, 0.5 ⁇ 0.9mm, 0.8 ⁇ 0.9mm.
  • the rewinding braiding ring 1111 is a circular arc formed by rewinding a braided wire, and the circular arc is semicircular, semi-elliptical or quasi-semicircular, or the rewinding braiding ring 1111 is a braided wire that is rewoven and bonded or welded to another braided wire, wherein the end of the braided wire after rewinding is wound into a spring-shaped first end developing mark 120 and then connected to another braided wire by bonding or welding, or the rewinding braiding ring 1111 is a braided wire that is rewoven and bonded or welded to another braided wire, wherein the braided wire is bonded or welded to another braided wire through the first end developing mark 120 after rewinding, wherein the first end developing mark 120 can be a developing spring or a developing sleeve.
  • the outer diameter of the first end developing mark 120 is 0.0055 inches, which is convenient for adapting to the 0.017-inch catheter lumen.
  • the material of the first end developing mark 120 includes platinum (Pt), which has a high material density and good recognizability.
  • the material of the first end developing mark 120 can be selected from platinum tungsten alloy (Pt-W) or platinum iridium alloy (Pt-Ir), the pushing resistance of the vascular implant is small, the recognizability of the first end developing mark 120 is good, and the connection strength is high.
  • the second end 112 includes a plurality of first connection parts 1121, and the first connection part 1121 is a non-invasive connection part formed by connecting at least two braided wires 140 together.
  • the connection method of the braided wires 140 can be adopted but not limited to twisting, gluing, welding, etc.
  • the first connection part 1121 is that two braided wires are wound together and connected together, and then bonded or welded together through the second end development mark 130, and at the same time, the end of the second end development mark 130 is laser welded by end face spheroidizing welding to form a smooth closed end, that is, a non-invasive connection part is formed.
  • the second end development mark 130 can be a development spring or a development sleeve.
  • the first connection part 1121 is that two braided wires are parallelly welded together, and after parallel welding, the second end development mark 130 is used to cover the outside, and the end of the second end development mark 130 is laser welded by end face spheroidizing welding to form a smooth closed end, that is, a non-invasive connection part is formed, and at this time, the second end development mark 130 can also be a development spring or a development sleeve.
  • the 0.5 mm to 4.0 mm is set by the inventor based on the size of the vascular implant in the intracranial blood vessel and a large amount of experimental data, so that the vascular implant of the present invention can ensure the overall development and radial support force while taking into account the influence of the second end development mark 130 on the pushing performance and opening and adhesion performance of the vascular implant.
  • the inventors found that when the braided stent (vascular implant) is released into a curved blood vessel with a radius of curvature of, for example, 4.5 mm, the second end developing mark 130 will not adhere to the wall.
  • the inventors have tried a variety of solutions to improve the opening and wall adhesion performance, such as mixing nickel-titanium braided wire with DFT composite braided wire, or reducing the braiding density, or cutting the short wave A between two adjacent second end developing marks 130 in Figure 1 or Figure 4, etc.
  • the applicant unexpectedly found that when the distance between the second end developing mark 130 and the end face of the second end 112 is set within the above range, it is possible to prevent the vascular implant from not adhering to the wall after opening. Therefore, when d is 0.5 mm to 4.0 mm, when the braided stent is released into a curved blood vessel with a radius of curvature of, for example, 4.5 mm, the second end developing mark 130 It can adhere to the wall, ensuring the wall-adherence performance of the vascular implant after opening, thereby achieving unexpected technical effects.
  • the applicant also found in the research process that if d is greater than 4.0 mm, the second end development mark 130 will still not adhere to the wall when the braided stent is released into a curved blood vessel with a curvature radius of 4.5 mm. After further analyzing the cause of this problem, it was found that since the second end 112 adopts a flared design, when the curved section cannot conform to the curvature of the blood vessel, the second end development mark 130 will be lifted and not adhere to the wall. In addition, if d is less than 0.5 mm, the push resistance will be very large, and the second end development mark 130 will interfere with the braided stent, increasing the size of the braided stent in a compressed state.
  • the end of the second end 112 is the end surface formed by the first intersection of the second end braided wire, that is, the vertex of the short wave A is the end of the second end, and d is the distance from the distal end of the second end development mark 130 close to the implant body 110 to the end of the second end 112.
  • the braided wires in the implant body 110 are all made of DFT material
  • the sleeve is nickel-titanium alloy
  • the material of the developable core wire is platinum
  • the outer diameter of the sleeve is 0.0533 mm (0.0021 inches)
  • the cross-sectional area of the developable core wire accounts for 30% of the total cross-sectional area of the braided wire
  • the outer diameter of the second end developable mark 120 is 0.0063 inches
  • a 0.017-inch microcatheter is used for pushing.
  • the pushing resistance of the vascular implant is 246 gf, and it is observed that the second end developable mark 130 interferes with the implant body 110 during the delivery process, increasing the size of the vascular implant in the compressed state, as shown in Figure 3. It can be understood that the part circled by the black line frame in Figure 3 interferes.
  • the braided wires in the implant body 110 are all made of DFT material
  • the sleeve is nickel-titanium alloy
  • the material of the developable core wire is platinum
  • the outer diameter of the sleeve is 0.0533 mm (0.0021 inches)
  • the cross-sectional area of the developable core wire accounts for 30% of the total cross-sectional area of the braided wire
  • the outer diameter of the second end developable mark 120 is 0.0063 inches
  • there are 4 second end developable marks 130, which are arranged at intervals along the circumference of the second end 112, and the second end developable mark 130 is 4.5 mm away from the end face of the second end 112, that is, d 4.5 mm, and a 0.017-inch microcatheter is used for pushing.
  • the braided wires in the implant body 110 are all made of DFT material
  • the sleeve is nickel-titanium alloy
  • the material of the developable core wire is platinum
  • the outer diameter of the sleeve is 0.0533 mm (0.0021 inches)
  • the cross-sectional area of the developable core wire accounts for 30% of the total cross-sectional area of the braided wire
  • the outer diameter of the second end developing mark 120 is 0.0063 inches
  • a 0.017-inch microcatheter is used for pushing. Experiments have shown that the pushing resistance of the vascular implant is 112 gf.
  • the braided wires in the implant body 110 are all made of DFT material
  • the sleeve is nickel-titanium alloy
  • the material of the developable core wire is platinum
  • the outer diameter of the sleeve is 0.0533 mm (0.0021 inches)
  • the cross-sectional area of the developable core wire accounts for 30% of the total cross-sectional area of the braided wire
  • the outer diameter of the second end developing mark 120 is 0.0063 inches
  • a 0.017-inch microcatheter is used for pushing. Experiments have shown that the pushing resistance of the vascular implant is 109 gf.
  • the braided wires in the implant body 110 are all made of DFT material
  • the sleeve is nickel-titanium alloy
  • the material of the developable core wire is platinum
  • the outer diameter of the sleeve is 0.0533 mm (0.0021 inches)
  • the cross-sectional area of the developable core wire accounts for 30% of the total cross-sectional area of the braided wire
  • the outer diameter of the second end developing mark 120 is 0.0063 inches
  • a 0.017-inch microcatheter is used for pushing. Experiments have shown that the pushing resistance of the vascular implant is 113 gf.
  • the braided wires in the implant body 110 are all made of DFT material
  • the sleeve is nickel-titanium alloy
  • the material of the developable core wire is platinum
  • the outer diameter of the sleeve is 0.0533 mm (0.0021 inches)
  • the cross-sectional area of the developable core wire accounts for 30% of the total cross-sectional area of the braided wire
  • the outer diameter of the second end developing mark 120 is 0.0063 inches
  • a 0.017-inch microcatheter is used for pushing. Experiments have shown that the pushing resistance of the vascular implant is 119 gf.
  • the distance d between the second end developing mark 130 on the second end 112 and the end face of the second end 112 is closely related to the pushing resistance of the vascular implant during the delivery process and the wall adhesion after release.
  • the larger d is, the smaller the pushing resistance is and reaches the lowest value, while the wall adhesion of the second end developing mark 130 is worse; the smaller d is, the wall adhesion of the second end developing mark 130 is improved, while the pushing resistance gradually increases. Therefore, in order to balance the pushing resistance and wall adhesion, it is preferred that the second end developing mark 130 on the second end 112 is 0.5mm to 4.0mm away from the farthest end of the second end 112, that is, d 0.5mm to 4.0mm.
  • the distance d between the second end developing mark 130 on the second end 112 and the farthest end of the second end 112 can also be in any of the following ranges: 0.5 to 1.5mm, 0.5 to 3.0mm, 1.5 to 3.0mm, 1.5 to 4.0mm, 3.0 to 4.0mm.
  • the number of second end developing markers 130 (proximal end) is 4, and the maximum outer diameter of a single second end developing marker 130 that can be accommodated is about 0.0063 inches.
  • the outer diameter of the second end developing marker 130 is 0.0063 inches, which is convenient for adapting to the 0.017-inch catheter lumen.
  • the material of the second end developing marker 130 includes platinum (Pt), and the material density of platinum is large and the recognizability is good.
  • the material of the second end developing marker 130 can be selected from platinum tungsten alloy (Pt-W) or platinum iridium alloy (Pt-Ir), the pushing resistance of the vascular implant is small, and the recognizability of the second end developing marker 130 is good, and the connection strength is high.
  • the recognition of each part of the vascular implant under X-ray is different, especially the development performance of one end or both ends of the braided stent is better than the development performance of the middle section of the stent, and more preferably the development performance of the two ends of the braided stent is also different.
  • the recognition of the three under X-ray can be adjusted by adjusting the materials of the first end development mark 120, the implant body 110 and the second end development mark 130, and the thickness (or outer diameter) in the X-ray direction. If the development mark adopts a development spring or a development sleeve, the material and proportion, outer diameter and wall thickness of the development spring or the development sleeve can be adjusted to adjust the recognition of the development mark.
  • the material and proportion of the braided stent, the diameter of the braided wire, and the diameter of the core wire can be adjusted to adjust the recognition of the implant body and the two ends.
  • the first end development mark 120 has a greater recognition degree under X-ray than the implant body 110, so as to distinguish the opening and wall-attached state of the first end 111 of the braided stent in the blood vessel, thereby enhancing the development performance of the first end 111 under X-ray, making the first end 111
  • the recognition is relatively high compared to human tissue and the implant body 110, and the image is clear in the blood vessel and can be effectively distinguished from other parts of the braided stent, so as to facilitate the determination of the position and shape of the first end 111 of the stent.
  • the ratio of the recognition of the first end image mark 120 under X-ray to the recognition of the implant body 110 under X-ray is preferably 1.5 to 3.1, and more preferably, the ratio of the recognition of the first end image mark 120 under X-ray to the recognition of the implant body 110 under X-ray is 1.8 to 2.3, such as the recognition ratio is 1.5, 1.8, 1.91, 2.11, 2.3, 2.91 or 3.09. The larger the recognition value, the better the image development performance.
  • the recognition degree of the second end development mark 130 under X-ray is greater than that of the implant body 110 under X-ray, so as to judge the opening and wall-attached state of the second end 112 of the braided stent in the blood vessel, thereby enhancing the development performance of the second end 112 under X-ray, making the recognition degree of the second end 112 higher than that of the human tissue and the braided implant body 110, clearly developing in the blood vessel and being able to be effectively distinguished from other parts of the braided stent, and facilitating the determination of the position and shape of the second end 112 of the stent.
  • the ratio of the recognition degree of the second end development mark 130 under X-ray to the recognition degree of the implant body 110 under X-ray is preferably 1.5 to 3.2, and more preferably, the ratio of the recognition degree of the second end development mark 130 under X-ray to the recognition degree of the implant body 110 under X-ray is preferably 1.82 to 2.33, such as the recognition ratio is 1.52, 1.82, 2.13, 2.33, 2.94 or 3.13.
  • the recognition degree of the first end development mark 120 and the second end development mark 130 under X-ray are both greater than the recognition degree of the implant body 110 under X-ray, so that the recognition degree of the development marks at both ends of the braided stent is relatively high relative to the human tissue and the braided implant body 110, and the development in the blood vessel is clear and can be effectively distinguished from other parts of the braided stent, which is convenient for judging the position and shape of the two ends of the stent.
  • the recognition degree of the development marks at both ends of the braided stent is high, which is convenient for judging the shape of the two ends of the braided stent, achieving good positioning, opening, anchoring and wall adhesion effects, and improving the safety of surgical operations.
  • the recognition of the first end development mark 120 under X-ray is different from the recognition of the second end development mark 130 under X-ray, so that there is a significant difference in the development performance of the two ends of the braided stent, so as to achieve a development effect that is convenient for doctors to operate.
  • the ratio of the recognition of the first end development mark 120 to the recognition of the second end development mark 130 is preferably 0.8 to 1.2, and more preferably, the ratio of the recognition of the first end development mark 120 to the recognition of the second end development mark 130 is 0.9 or 0.99.
  • the recognition ratio of the first end development mark 120 to the implant body 110 is 0.88/0.46 ⁇ 1.91 ⁇ k
  • the recognition ratio of the second end development mark 130 to the implant body 110 is 0.98/0.46 ⁇ 2.13
  • the recognition ratio of the first end development mark 120, the implant body 110 and the second end development mark 130 is approximately 1.91:1:2.13
  • the recognition ratio of the first end development mark 120 to the second end development mark 130 is 0.88/0.98 ⁇ 0.9.
  • the wire diameter of the braided wire 140 selected for the implant body 110 is 0.0533 mm, and the braided wire is made of DFT material.
  • the sleeve in the DFT material is nickel-titanium alloy, and the developable core wire is platinum material.
  • the material of the braided wire in the implant body 110 is DFT material, the sleeve is nickel-titanium alloy, the material of the developable core wire is platinum, the outer diameter of the sleeve is 0.0533 mm, and the cross-sectional area of the developable core wire accounts for 63% of the total cross-sectional area
  • the ratio of the recognizability of the first end development mark 120 to the recognizability of the implant body 110 is 1.5
  • the ratio of the recognizability of the second end development mark 130 to the recognizability of the implant body 110 is 1.52
  • the ratio of the recognizability of the first end development mark 120, the recognizability of the implant body 110, and the recognizability of the second end development mark 130 is 0.99:0.66:1.0.
  • the material of the braided wire in the implant body 110 is DFT material, the sleeve is nickel-titanium alloy, the material of the developable core wire is platinum, the outer diameter of the sleeve is 0.0533 mm, and the cross-sectional area of the developable core wire accounts for 9% of the total cross-sectional area
  • the ratio of the recognizability of the first end development mark 120 to the recognizability of the implant body 110 is 2.91
  • the ratio of the recognizability of the second end development mark 130 to the recognizability of the implant body 110 is 2.94
  • the ratio of the recognizability of the first end development mark 120, the recognizability of the implant body 110, and the recognizability of the second end development mark 130 is 0.99:0.34:1.0.
  • the material of the braided wire in the implant body 110 is DFT material, the sleeve is nickel-titanium alloy, the material of the developable core wire is platinum, the outer diameter of the sleeve is 0.0533 mm, and the cross-sectional area of the developable core wire accounts for 34% of the total cross-sectional area of the
  • the ratio of the recognizability of the first end development mark 120 to the recognizability of the implant body 110 is 1.8
  • the ratio of the recognizability of the second end development mark 130 to the recognizability of the implant body 110 is 1.82
  • the ratio of the first end development mark 120 to the recognizability of the implant body 110 is 1.82.
  • the ratio of the recognition degree of the implant body 110 to the recognition degree of the second end development mark 130 is 0.99:0.55:1.0.
  • the material of the braided wire in the implant body 110 is DFT material, the sleeve is nickel-titanium alloy, the material of the developable core wire is platinum, the outer diameter of the sleeve is 0.0533 mm, and the cross-sectional area of the developable core wire accounts for 17% of the total cross-sectional area
  • the ratio of the recognizability of the first end development mark 120 to the recognizability of the implant body 110 is 2.3
  • the ratio of the recognizability of the second end development mark 130 to the recognizability of the implant body 110 is 2.33
  • the ratio of the recognizability of the first end development mark 120, the recognizability of the implant body 110, and the recognizability of the second end development mark 130 is 0.99:0.43:1.0.
  • the material of the braided wire in the implant body 110 is DFT material
  • the sleeve is nickel-titanium alloy
  • the material of the developable core wire is platinum
  • the outer diameter of the sleeve is 0.0533 mm
  • the cross-sectional area of the developable core wire accounts for 8% of the total cross-sectional area of the braided wire, that
  • the ratio of the recognizability of the first end development mark 120 to the recognizability of the implant body 110 is 3.09
  • the ratio of the recognizability of the second end development mark 130 to the recognizability of the implant body 110 is 3.13
  • the ratio of the recognizability of the first end development mark 120, the recognizability of the implant body 110, and the recognizability of the second end development mark 130 is 0.99:0.32:1.0.
  • the first end development mark 120, the implant body 110 and the second end development mark The ratio of the recognition of 130 under X-ray is preferably 0.99:(0.32 ⁇ 0.66):1.0.
  • the ratio of the recognition degrees of the first end development mark 120 and the second end development mark 130 is 0.88/0.98 ⁇ 0.90. At this time, the development performance of the second end development mark 130 is better than that of the first end development mark 120.
  • the development mark can be made by a development spring or a development sleeve.
  • the material of the development spring or the development sleeve includes one or more combinations of nickel-titanium alloy, nitinol, stainless steel, cobalt-chromium alloy, nickel-cobalt alloy, and of course also includes radiopaque development materials, and the development materials include but are not limited to one of platinum, iridium, gold, silver, tantalum and tungsten or alloys thereof.
  • the diameter of the spring wire of the developing spring is 0.0010 inches to 0.0020 inches (0.0254 mm to 0.0508 mm), the outer diameter of the developing spring is 0.0030 inches to 0.0070 inches (0.0762 mm to 0.1778 mm), and the axial length of the developing spring is 0.4 mm to 1.5 mm.
  • the wall thickness of the developing sleeve is 0.0010 inches to 0.0020 inches, the outer diameter of the developing sleeve is 0.0030 inches to 0.0070 inches, and the axial length of the developing sleeve is 0.4 mm to 0.8 mm.
  • the spring wire of the development spring may include a core wire and a sleeve wrapped around the core wire, wherein the core wire material in the spring wire includes but is not limited to one of platinum, iridium, gold, silver, tantalum and tungsten or their alloys, and the sleeve material in the spring wire includes but is not limited to one or more combinations of nickel-titanium alloy, nitinol, stainless steel, cobalt-chromium alloy, and nickel-cobalt alloy.
  • the cross section of the core wire in the development spring is The area accounts for 20% to 35% of the total cross-sectional area of the spring wire, and the outer diameter of the sleeve in the developing spring is 0.0010 inch to 0.0020 inch. It should be understood that, in terms of the developing mark, the outer diameter of the developing spring or the developing sleeve is the thickness c of the developing mark in the X-ray direction.
  • the present application has no special requirements for the number of the first end development marks 120.
  • the number of the first end development marks 120 is 1 to 6.
  • the number of the first end development marks 120 is preferably 3 or 4, and they are evenly arranged in the circumferential direction. Further, the first end development marks 120 are distributed on different circumferences of the vascular implant, that is, they are arranged in layers on the axis to reduce the compression size of the stent and reduce the push resistance.
  • the present application has no special requirements on the number of the second end development marks 130.
  • the number of the second end development marks 130 is 1 to 6.
  • the number of the second end development marks 130 is preferably 4 or 6, and they are evenly arranged in the same circumferential direction.
  • the number of the first end developing mark 120 and the second end developing mark 130 is different, so as to distinguish the head and tail of the stent, making the surgical operation more convenient.
  • the thickness of the development material (i.e., the radiopaque material) and the vascular implant in the X-ray direction is mainly adjusted to adjust the recognition of the corresponding parts under X-ray.
  • the recognition degree of the first-end development mark 120 when the recognition degree of the first-end development mark 120 is greater than the recognition degree of the implant body 110, the first-end development mark 120 and the implant body 110 use different radiopaque materials, or the thicknesses of the two in the X-ray direction are different, or the radiopaque material and the thickness in the X-ray direction are both different; for example, when the recognition degree of the second-end development mark 130 is greater than the recognition degree of the implant body 110, the second-end development mark 130 and the implant body 110 use different radiopaque materials, or the thicknesses of the two in the X-ray direction are different, or the radiopaque material and the thickness in the X-ray direction are both different.
  • the radiopaque material in the first end developing mark 120 and the radiopaque material in the braided wire of the implant body 110 are mutually connected.
  • the radiopaque materials can be the same, in which case the thickness of the first end development mark 120 in the X-ray direction is greater than the thickness of the implant body 110 in the X-ray direction, or the radiopaque material in the first end development mark 120 is different from the radiopaque material in the braided wire of the implant body 110, in which case the thickness of the first end development mark 120 in the X-ray direction can be greater than, equal to or less than the thickness of the implant body 110 in the X-ray direction.
  • the radiopaque material in the second-end development mark 130 may be the same as the radiopaque material in the braided wire of the implant body 110, and the thickness of the second-end development mark 130 in the X-ray direction is greater than the thickness of the implant body 110 in the X-ray direction, or, the radiopaque material in the second-end development mark 130 is different from the radiopaque material in the braided wire of the implant body 110, and the thickness of the second-end development mark 130 in the X-ray direction is greater than, equal to or less than the thickness of the implant body 110 in the X-ray direction.
  • the thickness of the development mark in the X-ray direction is mainly determined by the outer diameter and wall thickness of the development spring or the outer diameter and wall thickness of the development sleeve
  • the thickness of the implant body in the X-ray direction is mainly determined by the wire diameter of the braiding wire or the diameter of the core wire.
  • different development materials have different material densities, so the relative density of the material can be adjusted by selecting the corresponding development material.
  • the braiding density i.e., the metal coverage
  • the braiding density will also affect the development performance to a certain extent, so the braiding density can be further adjusted to adjust the development performance of the implant body.
  • the technical solution provided by the present invention has outstanding substantial characteristics.
  • In order to accurately determine the positions of the two ends of the vascular implant there are many methods to improve the recognition of the two ends, such as increasing the development density of the two ends or increasing the development thickness of the material, but this will bring about problems such as push resistance and difficulty in sticking to the wall.
  • it is conceivable to set the development intensity of the two ends to be higher than that of the middle section of the implant it also requires consideration from multiple angles.
  • it is necessary to match the implant with the size, developability, number, and push resistance of the development mark which requires a large amount of clinical experimental data to achieve.
  • vascular implant provided by the present invention
  • different parts of the vascular implant provided by the present invention have different X-ray development performances, which is convenient for meeting the needs of different doctors' operating conditions and facilitating the judgment of the opening and wall adhesion status of the stent in a curved blood vessel.
  • the development marks at one or both ends have high recognition, which makes it easy for doctors to judge the opening and wall adhesion status of one or both ends of the stent, thereby improving the safety and accuracy of surgical operations. It can shorten the operation time and improve the operation efficiency and treatment effect.

Landscapes

  • Health & Medical Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Prostheses (AREA)

Abstract

一种血管植入物，植入物主体（110）由至少两根编织丝（140）交错编织而成，至少一根编织丝（140）包括芯丝和包覆在芯丝外的套管，芯丝的截面积占编织丝（140）的总截面积的20％～35％；植入物主体（110）第一端（111）上的第一端显影标记（120）距第一端最远端部0.1mm～0.9mm，第二端（112）上的第二端显影标记（130）距第二端端部0.5mm～4.0mm；第一端显影标记（120）、植入物主体（110）和第二端显影标记（130）在X光下的辨识度的比值为0.99：(0.32～0.66):1.0，血管植入物的材料相对密度为15～25，且在X光方向上的厚度为0.015mm～0.2mm；使得血管植入物的两端在X光下的显影性能优于中段的显影性能，还可兼顾血管植入物的径向支撑性以及推送、打开贴壁性。

Description

血管植入物 技术领域
本发明涉及医疗器械技术领域，特别涉及一种血管植入物。
背景技术
微创伤介入是血管动脉瘤的一种治疗手段，通常涉及将血管植入物，例如但不仅限于支架、弹簧圈、动脉瘤封堵装置等，通过输送装置输送至血管中的病变位置，随后，输送杆在实现血管植入物的释放的同时保持植入物设计结构，以起到扩张血管，封堵动脉瘤等治疗作用。
自膨编织支架是血管植入物的一种形式，由于其良好的输送性能被广泛使用。在现有技术中，自膨编织支架仅靠支架两端的显影结构和/或穿插在支架中的显影丝显影，不利于判断支架在弯曲血管内的打开和贴壁状态，同时两端显影结构辨识度一般，也不易判断支架两端打开和贴壁状态，因而降低了手术操作的安全性和准确性，也会增加手术时间。
发明内容
本发明的目的在于提供一种血管植入物，该血管植入物的两端以及中段在X光下均具有显影性，且血管植入物的两端在X光下的显影性能优于中段的显影性能，以便于操作者判断血管植入物两端的位置和姿态，从而提高手术操作安全性和准确性。
为实现上述目的，本发明提供的一种血管植入物，包括管状的植入物主体以及位于所述植入物主体轴向两端的第一端和第二端；
所述植入物主体由至少两根编织丝交错编织而成，至少两根所述编织丝中的至少一根编织丝具有显影性，具有显影性的所述编织丝包括可显影芯丝和包覆在所述可显影芯丝外的套管，所述可显影芯丝的截面积占所述编织丝的总截面积的20％～35％；
所述第一端上设置有至少一个第一端显影标记，所述第一端显影标记距所述第一端的最远端部0.1mm～0.9mm，所述第二端上设置有至少一个第二端 显影标记，所述第二端显影标记距所述第二端的端部端面0.5mm～4.0mm；
所述第一端显影标记、所述植入物主体和所述第二端显影标记在X光下的辨识度的比值为0.99：(0.32～0.66):1.0，所述血管植入物的材料相对密度为15～25，所述血管植入物在X光照射方向上的厚度为0.015mm～0.2mm。
可选的，所述第一端显影标记和所述植入物主体在以下方面中的至少一种设置为不相同：所选用的不透射线材料以及在X光照射方向上的厚度；
所述第二端显影标记和所述植入物主体在以下方面中的至少一种设置为不相同：所选用的不透射线材料以及在X光照射方向上的厚度。
可选的，所述第一端显影标记中的不透射线材料与所述编织丝中的不透射线材料相同，所述第一端显影标记在X光照射方向上的厚度大于所述植入物主体在X光照射方向上的厚度，或者，
所述第一端显影标记中的不透射线材料与所述编织丝中的不透射线材料不相同，所述第一端显影标记在X光照射方向上的厚度大于、等于或小于所述植入物主体在X光照射方向上的厚度。
可选的，所述第二端显影标记中的不透射线材料与所述编织丝中的不透射线材料相同，所述第二端显影标记在X光照射方向上的厚度大于所述植入物主体在X光照射方向上的厚度，或者，
所述第二端显影标记中的不透射线材料与所述编织丝中的不透射线材料不相同，所述第二端显影标记在X光照射方向上的厚度大于、等于或小于所述植入物主体在X光照射方向上的厚度。
可选的，所述第一端显影标记和所述第二端显影标记在以下方面中的至少一种设置为不相同：所选用的不透射线材料以及在X光照射方向上的厚度。
可选的，所述第一端显影标记在X光下的辨识度与所述植入物主体在X光下的辨识度的比值为1.80～2.30；和/或，所述第二端显影标记在X光下的辨识度与所述植入物主体在X光下的辨识度的比值为1.82～2.33。
可选的，所述第一端显影标记和/或所述第二端显影标记为显影弹簧或显影套管，所述显影弹簧或显影套管的外径为0.003英寸～0.007英寸。
可选的，所述显影弹簧的簧丝包括芯丝和包覆在所述芯丝外的套管，所述显影弹簧的套管具有非显影性，所述显影弹簧的芯丝具有显影性，其中， 所述簧丝中的所述芯丝的截面积占所述簧丝的总截面积的20％～35％。
可选的，所述第一端为血管植入物的远端，所述第二端为血管植入物的近端，所述第一端显影标记的数量为至少两个，至少两个所述第一端显影标记在所述血管植入物的圆周方向上均匀排布，所述第二端显影标记的数量为至少两个，至少两个所述第二端显影标记在所述血管植入物的同一圆周方向上均匀排布。
可选的，至少两个所述第一端显影标记在所述血管植入物的不同圆周上排布。
可选的，所述第一端显影标记的数量与所述第二端显影标记的数量不相同。
在本发明提供的血管植入物中，所述血管植入物包括管状的植入物主体以及位于所述植入物主体轴向两端的第一端和第二端，所述植入物主体由至少两根编织丝交错编织而成，至少两根所述编织丝中的至少一根编织丝具有显影性，即，血管植入物采用具有可显影芯丝的编织丝编织而成，使得血管植入物整体达到良好显影，方便操作者准确判断血管植入物在弯曲血管内的打开和贴壁状态，同时限定了编织丝中的可显影芯丝在该编织丝中的所占比例(截面积)以兼顾编织支架的径向支撑力；此外，血管植入物轴向的第一端上的第一端显影标记和第二端上的第二端显影标记在X光下的辨识度均要大于植入物主体在X光下的辨识度，从而使得血管植入物的两端的显影性能优于植入物中段的显影性能，以方便操作者准确判断血管植入物两端的位置和姿态，及时调整植入物以达到良好的定位、打开、锚定、贴壁等效果，提高手术操作的安全性和准确性；另外，在确保植入物主体、第一端显影标记与第二端显影标记的显影性能的前提下，还兼顾了血管植入物的输送性能和贴壁性，为此，限定了第一端显影标记与第二端显影标记分别在植入物主体轴向第一端与第二端的位置，将第一端显影标记距所述第一端的最远端部控制在0.1mm～0.9mm，并将第二端显影标记距所述第二端的端部端面控制在0.5mm～4.0mm，这样设置，一方面防止第一端显影标记和第二端显影标记与植入物主体在输送过程中发生干涉，减小了血管植入物的推送阻力，另一方面避免植入物主体轴向两端过长，降低了血管植入物释放后在弯曲血管中不 贴壁的风险。如此一来，使得本发明的血管植入物具备良好的整体显影性，两端显影标记可准确辨识，同时还兼顾了径向支撑性，也减小了血管植入物的推送阻力，又确保了血管植入物的打开贴壁性能。
在本发明提供的血管植入物中，优选血管植入物的第一端上的第一端显影标记在X光下的辨识度与第二端上的第二端显影标记在X光下的辨识度不相同，如所述第一端显影标记在X光下的辨识度与所述植入物主体在X光下的辨识度的比值为1.80～2.30，所述第二端显影标记在X光下的辨识度与所述植入物主体在X光下的辨识度的比值为1.82～2.33，即血管植入物轴向两端的显影性能存在差异，便于医生准确快速地判别血管植入物的远近端，使手术操作更为灵活和方便。
附图说明
图1是本发明优选实施例的血管植入物的主视图；
图2是对比实施例的血管植入物主体轴向第一端上的第一端显影标记距第一端的最远端部0.95mm时，第一端显影标记与植入物主体输送状态图；
图3是对比实施例的血管植入物主体轴向第二端上的第二端显影标记距第二端的端部的所述编织丝的第一个交点形成的端面0.4mm时，第二端显影标记与植入物主体输送状态图；
图4是对比实施例的血管植入物主体轴向第二端上的第二端显影标记距第二端的端部端面4.5mm时，血管植入物在弯曲血管内的释放图，该释放图为体外血管模拟释放后支架贴壁的情况；
图5是本发明优选实施例的第一端显影标记与植入物主体在X光下的成像图；
图6是本发明优选实施例的第二端显影标记与植入物主体在X光下的成像图。
具体实施方式
为使本发明的目的、优点和特征更加清楚，以下结合附图对本发明作进一步详细说明。需说明的是，附图均采用非常简化的形式且均使用非精准的 比例，仅用以方便、明晰地辅助说明本发明实施例的目的。
如在本说明书中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，除非内容另外明确指出外。如在本说明书中所使用的，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外。术语“多个”通常是以包括两个或两个以上的含义而进行使用的，除非内容另外明确指出外。术语“若干”以包括一个或多个的含义而进行使用的，除非内容另外明确指出外。
此外，在以下说明中，为了便于描述，使用了“远端”和“近端”；离心脏近的一端称为“近端”，即近心端；离心脏远的一端称为“远端”，即“远心端”。另外，在下文的描述中，给出了大量具体的细节以便提供对本发明更为彻底的理解。然而，对于本领域技术人员而言显而易见的是，本发明可以无需一个或多个这些细节而得以实施。在其他的例子中，为了避免与本发明发生混淆，对于本领域公知的一些技术特征未进行描述。
本发明的核心思想在于提供一种血管植入物，尤其是一种应用于颅内血管疾病治疗的编织支架，该血管植入物通过输送装置递送至目标位置，可用于治疗颅内动脉瘤等血管疾病。可以理解的是，该血管植入物也可以应用于颅内或非颅内的血管动脉瘤、血管扩张、血管栓塞捕获或其他管腔病变的治疗。
本发明提供的血管植入物，包括管状的植入物主体，所述植入物主体由至少两根编织丝交错编织而成，所述植入物主体具有位于所述植入物主体轴向两端的第一端和第二端。其中至少两根所述编织丝中的至少一根编织丝具有显影性，即至少一根编织丝包含不透射线材料。进一步的，至少两根所述编织丝中的至少一根编织丝包括可显影芯丝和包覆在所述可显影芯丝外面的套管，所述编织丝中的可显影芯丝的材料包括但不限于为铂、铱、金、银、钽和钨中的一种或其合金，所述编织丝中的套管的材料包括但不限于为镍钛合金、镍钛诺、不锈钢、钴铬合金、镍钴合金的一种或多种组合。进一步的，所述编织丝中的可显影芯丝的截面积占所述编织丝的总截面积的20％～35％，且所述套管的外径优选为0.0010英寸～0.0030英寸(0.0254mm～0.0762mm)。
其中所述血管植入物被配置为两端的X光显影性能优于中段的X光显影 性能，也就是说，所述血管植入物被配置为第一端和第二端在X光下的辨识度大于植入物主体在X光下的辨识度。本文中，“辨识度”可以理解为在X光下有人体软组织遮挡下的成像清晰度，辨识度越大，成像清晰度越好，也即显影性能越好。
对于显影性能，可以理解为，两种物质在X光下的辨识度(即对比度)，在X光下的辨识度的计算公式为：
SC＝1-ecAμ    (1)
其中:SC为在X光下，物质A在物质B中的对比度，如编织支架(即物质A)在人体组织(即物质B)中的对比度即为编织支架在X光下的辨识度；c为物质A在X光方向上的厚度；Δμ为物质A和物质B的衰减系数的差值。
由上式(1)可以得到，血管植入物在血管中的辨识度的计算公式为：
其中：e为自然常数；μ0为人体软组织如肌肉、血液的X光衰减系数；c为血管植入物在X光方向上的厚度；ρk为血管植入物的材料相对密度，等于血管植入物的材料密度与人体组织密度的比值；k为与血管植入物的材料原子序数有关的经验系数，可通过实验获取，具体为：
其中：Z为血管植入物的材料原子序数。
根据式(2)和式(3)可知，当血管植入物的材料相对密度ρk越大或血管植入物的材料在X光方向上的厚度c越大时，血管植入物在X光下的辨识度越好，显影性能越好。
因此，已知60kev的光强下，人体软组织如肌肉、血液的X光衰减系数约0.22，人体骨骼的X光衰减系数约0.63，则衰减系数的差值为0.41，而人体颅骨的厚度通常约为10mm，此时，根据公式(1)可知10mm厚的颅骨在人体软组织中的辨识度约为0.33。故，为了使血管植入物在X光下具有良好的辨识度，其在血管中的辨识度也应不小于0.33。为此，血管植入物中各部分的材料相对密度约为15≤ρk≤25，血管植入物的各部分在X光方向上的厚度约为0.015mm≤c≤0.2mm。以此方式，使血管植入物在X光下具有良好的辨识度。
以下结合附图和若干实施例对本发明提出的血管植入物作进一步的说明。
如图1所示，本发明一优选实施例提供一种血管植入物，该血管植入物可为编织支架，该编织支架包括管状的植入物主体110，植入物主体110为由至少两根编织丝140交错编织而成。其中，至少两根所述编织丝140中的至少一根编织丝包括可显影芯丝和包覆在可显影芯丝外面的套管。其中，所述可显影芯丝在X光下具有显影性，所述可显影芯丝的材料包括但不限于为铂、铱、金、银、钽和钨等不透射线材料中的一种或其合金，套管不具有显影性，套管的材料包括但不限于为镍钛合金、镍钛诺、不锈钢、钴铬合金、镍钴合金的一种或多种组合。该编织支架采用显影材料作为编织丝，可以使得编织支架整体的X光显影性更好，方便操作者准确判断血管植入物在弯曲血管内的打开和贴壁状态，提高手术操作安全性和准确性。
在一些实施方式中，植入物主体110中所有的编织丝140都采用可显影芯丝和包覆在可显影芯丝外面的套管的双层编织丝(即DFT材料)，该编织丝的丝径为0.001英寸～0.003英寸。所述可显影芯丝的截面积占编织丝的总截面积的20％～35％。在其他一些实施例中，植入物主体110中的部分编织丝140采用可显影芯丝和包覆在可显影芯丝外面的套管的双层编织丝，其他部分可采用不同的材料和/或不同尺寸的编织丝，例如采用其他丝径范围的双层编织丝，或采用材料为镍钛合金、镍钛诺、不锈钢、钴铬合金、镍钴合金的一种或多种制成的编织丝。采用不同材料和/或不同尺寸的编织丝可以降低成本、增加支架的使用场合和使用范围。
在一些实施方式中，植入物主体110由12～32根编织丝140交错编织成菱形网状结构，这些编织丝在轴向形成的交点个数为每英寸10～75个。可以理解的是，编织支架在自然状态(即非压缩状态)，这些编织丝在轴向形成的交点个数根据支架设计尺寸的不同可以为每英寸10～75个；编织支架在压缩状态，根据处于血管尺寸/位置不同(即压缩度不同)，这些编织丝在轴向形成的交点个数可以低至每英寸10个。在较优的实施方式中，植入物主体110为由16～24根编织丝140交错编织成菱形网状结构，例如，16根，20根，24根。这些编织丝在轴向形成的交点个数为每英寸30～55个。
为使植入物主体110的边缘具有理想的显影效果，植入物主体110优选具有较高的编织丝数和编织密度，更优选的，编织丝140形成在植入物主体110的金属覆盖率(即编织密度)为8％～25％，使编织支架中段的显影效果好。应理解，本文中所述“中段”指的是位于血管植入物的第一端和第二端之间的编织部分。
需说明的是，对于植入物主体110，其材料应首先满足血管植入物的各项性能如推送力、径向支撑力、兼容性、生物相容性等。在满足血管植入物性能的前提下，可尽量选用密度较大的材料以加强显影性。为了最大化优化血管植入物的性能和显影性，可使用DFT材料，采用可显影芯丝加套管的构造，套管的材料主要满足血管植入物的径向支撑力等各项性能，可显影芯丝的材料满足显影性。在一种较优的实施例中，DFT的外层套管材料选择镍钛合金(Ni-Ti)，可显影芯丝的材料选择铂金。除了材料外，编织丝的套管外径和芯丝外径也会影响血管植入物的径向支撑力等各项性能以及显影性。例如：为了使血管植入物有较好的推送性和兼容性，应选择较小的套管外径和较大的芯丝外径；为了使血管植入物有较好的径向支撑力，应选择较大的套管外径和较小的芯丝外径；为了使血管植入物有较好的显影性，应选择较大的套管外径和较大的芯丝外径。
在一些实施方式中，植入物主体110采用钽材料的编织丝140编织而成，其中编织丝140的丝径为0.027mm，ρk＝15.9，c＝0.027mm，SC＝0.34。
在另一些实施方式中，植入物主体110采用铂金材料的编织丝140编织而成，其中编织丝140的丝径为0.16mm，其ρk＝20.4，c＝0.16mm，SC＝1.00。
在另一些实施方式中，植入物主体110中的编织丝140均采用双层编织丝(即DFT材料)，即包括可显影芯丝和包覆在可显影芯丝外面的套管，在这种情况下，套管为镍钛合金，可显影芯丝的材料为铂金，套管外径为0.0533mm(0.0021英寸)，可显影芯丝的截面积占编织丝的总截面积的20％，即可显影芯丝的外径约为0.0238mm，此时，可显影芯丝在X光方向上的厚度c＝0.0238mm，相对密度ρk＝20.4，可辨识度SC＝0.46。此时，采用局部抗挤压方式测得的支架径向力为0.052N，实验证明了整个血管植入物的径向支撑性较好。应理解，当编织丝包括可显影芯丝时，在X光方向的厚度即为可显影 芯丝的外径。而当编织丝不包括可显影芯丝时，在X光方向的厚度即为编织丝的丝径。
在另一些实施方式中，植入物主体110中的编织丝均选用DFT材料，套管为镍钛合金，可显影芯丝的材料为铂金，套管外径为0.0533mm(0.0021英寸)，可显影芯丝的截面积占编织丝的总截面积的30％，即可显影芯丝的外径约为0.0292mm，此时，可显影芯丝在X光方向上的厚度c＝0.0292mm，相对密度ρk＝20.4，可辨识度SC＝0.52。此时，采用局部抗挤压方式测得的支架径向力为0.059N，同样证明了整个血管植入物的径向支撑性较好。
在一对比实施例中，植入物主体110中的编织丝的材料选用DFT材料，套管为镍钛合金，可显影芯丝的材料为铂金，套管外径为0.0533mm，可显影芯丝的截面积占编织丝的总截面积的63％，即可显影芯丝的外径约为0.042mm，此时，可显影芯丝在X光方向上的厚度c＝0.042mm，相对密度ρk＝20.4，可辨识度SC＝0.66。采用局部抗挤压方式测得的支架径向力为0.045N，此时，由于可显影芯丝的占比提高，导致血管植入物的径向支撑力有所降低。
在另一对比实施例中，植入物主体110中的编织丝的材料选用DFT材料，套管为镍钛合金，可显影芯丝的材料为铂金，套管外径为0.0533mm，可显影芯丝的截面积占编织丝的总截面积的9％，即可显影芯丝的外径约为0.016mm，此时，可显影芯丝在X光方向上的厚度c＝0.016mm，相对密度ρk＝20.4，可辨识度SC＝0.34。此时，采用局部抗挤压方式测得的支架径向力为0.043N，那么，可显影芯丝的占比降低也会对径向支撑性造成影响，导致径向支撑力减小，而且也难以兼顾良好的显影性。
在一些实施例中，植入物主体110中的编织丝的材料选用DFT材料，套管为镍钛合金，可显影芯丝的材料为铂金，套管外径为0.0533mm，可显影芯丝的截面积占编织丝的总截面积的34％，即可显影芯丝的外径约为0.031mm，此时，可显影芯丝在X光方向上的厚度c＝0.031mm，相对密度ρk＝20.4，可辨识度SC＝0.55。此时，采用局部抗挤压方式测得的支架径向力为0.056N，确保了整个血管植入物的径向支撑力，还兼顾了显影性。
在一对比实施例中，植入物主体110中的编织丝的材料选用DFT材料， 套管为镍钛合金，可显影芯丝的材料为铂金，套管外径为0.0533mm，可显影芯丝的截面积占编织丝的总截面积的17％，即可显影芯丝的外径约为0.022mm，此时，可显影芯丝在X光方向上的厚度c＝0.022mm，相对密度ρk＝20.4，可辨识度SC＝0.43。此时，采用局部抗挤压方式测得的支架径向力为0.049N，径向支撑力能有所下降。
在一对比实施例中，植入物主体110中的编织丝的材料选用DFT材料，套管为镍钛合金，可显影芯丝的材料为铂金，套管外径为0.0533mm，可显影芯丝的截面积占编织丝的总截面积的8％，即可显影芯丝的外径约为0.015mm，此时，可显影芯丝在X光方向上的厚度c＝0.015mm，相对密度＝20.4，可辨识度SC＝0.32。此时，采用局部抗挤压方式测得的支架径向力为0.041N，显然可显影芯丝的占比较低，显影性不足，而且径向支撑也不足。
由以上可见，植入物主体110在X光下的辨识度与支架材料、编织丝的丝径以及可显影芯丝的外径相关。通常，编织丝的丝径或可显影芯丝的外径越大，在X光下的辨识度越好，或者所选用的显影材料的材料相对密度越大，辨识度也越好。而植入物的径向支撑性能则随着可显影芯丝的外径的变化而变化，因此，基于上述实验验证，为了获得良好的显影性的同时兼顾足够的径向支撑力，血管植入物编织丝中的可显影芯丝的截面积占编织丝的总截面积的20％～35％。此外，为方便分辨血管植入物的远端和近端位置，两端在X光下的可辨识度应越高越好，选择密度较大的不透射线材料制备显影标记，以及较大尺寸的显影标记，如较大外径的显影环或显影弹簧。
继续参阅图1，血管植入物还包括位于植入物主体110轴向两端的第一端111和第二端112。在一些实施方式中，第一端111为血管植入物的远端，第二端112为血管植入物的近端。其中，第一端111上至少设置一个第一端显影标记120，第二端112上至少设置一个第二端显影标记130。第一端显影标记120和第二端显影标记130的设置可以使得编织支架在手术过程中的显影性能更好，方便操作者准确判断血管植入物两端的位置和姿态，及时调整血管植入物以达到良好的定位、打开、锚定、贴壁等效果，提高手术操作的安全性和准确性。
在一些实施方式中，第一端111包括多个回绕编织环1111，多个回绕编 织环1111周向间隔排布。多个回绕编织环1111中的至少一个的圆周上设置至少一个第一端显影标记120。为避免增大编织支架的轴向尺寸或挫伤血管以及增大血管植入物输送过程的推送阻力，该第一端显影标记120设置在回绕编织环1111非顶点的其他位置，且第一端显影标记120距第一端111的最远端部0.1mm～0.9mm，即D＝0.1mm～0.9mm。第一端111的最远端部由各回绕编织环111的顶点限定，D为第一端显影标记120远离植入物主体110的一端到编织环的顶点的距离。
需特别说明的是，以上0.1mm～0.9mm是申请人根据血管植入物在颅内血管内的尺寸以及大量的实验数据进行设定的，以使得本发明的血管植入物在确保显影性和径向支撑力的同时，还能兼顾第一端显影标记120对血管植入物的推送性能和打开贴壁性能的影响。需特别说明的是，如果D小于0.1mm，则血管植入物无法压缩到匹配0.017英寸微导管进行推送，且申请人在研究过程中意外地发现如果D大于0.9mm，则推送阻力很大，此时，第一端显影标记120会与编织支架主体相互干涉，增大编织支架的压缩状态尺寸。因此，将D设置在0.1mm～0.9mm的范围内，可减小第一端显影标记120对推送性能的影响，而且尽可能地防止了第一端显影标记120与编织支架(即植入物主体110)的干涉，防止增大编织支架的压缩状态尺寸。
优选的，第一端显影标记120为3个或4个，分别设置在不同的回绕编织环1111上。同时，使用3个或4个第一端显影标记120是在保证X光显影性能的同时，尽可能减小压缩后的支架径向尺寸，使得支架可以在小尺寸的输送系统中进行输送。优选的，对于适配0.017英寸的导管管腔，第一端显影标记120(远端)的数量为4个，且可容纳的单个第一端显影标记120的最大外径约为0.0055英寸，此时考虑到第一端显影标记120的周围存在编织丝，故第一端显影标记120的外径比第二端显影标记130的尺寸更小，如果第一端显影标记120的外径大，将使血管植入物难以通过0.017英寸的导管管腔进行输送，或增大输送阻力。
在一些实施例中，植入物主体110中的编织丝均选用DFT材料，套管为镍钛合金，可显影芯丝的材料为铂金，套管外径为0.0533mm(0.0021英寸)，可显影芯丝的截面积占编织丝的总截面积的30％，第一端显影标记120的外 径为0.0055英寸，设置为4个，4个第一端显影标记120分别设置在不同的回绕编织环1111上，距第一端111的最远端部0.1mm，即D＝0.1mm，采用0.017英寸微导管推送，实验证明，血管植入物的推送阻力为125gf。
在一些实施例中，植入物主体110中的编织丝均选用DFT材料，套管为镍钛合金，可显影芯丝的材料为铂金，套管外径为0.0533mm(0.0021英寸)，可显影芯丝的截面积占编织丝的总截面积的30％，第一端显影标记120的外径为0.0055英寸，设置为4个，4个第一端显影标记120分别设置在不同的回绕编织环1111上，距第一端111的最远端部0.15mm，即D＝0.15mm，采用0.017英寸微导管推送，实验证明，血管植入物的推送阻力为121gf。
在一些实施例中，植入物主体110中的编织丝均选用DFT材料，套管为镍钛合金，可显影芯丝的材料为铂金，套管外径为0.0533mm(0.0021英寸)，可显影芯丝的截面积占编织丝的总截面积的30％，第一端显影标记120的外径为0.0055英寸，设置为4个，4个第一端显影标记120分别设置在不同的回绕编织环1111上，距第一端111的最远端部0.3mm，即D＝0.3mm，采用0.017英寸微导管推送，实验证明，血管植入物的推送阻力为115gf。
在一些实施例中，植入物主体110中的编织丝均选用DFT材料，套管为镍钛合金，可显影芯丝的材料为铂金，套管外径为0.0533mm(0.0021英寸)，可显影芯丝的截面积占编织丝的总截面积的30％，第一端显影标记120的外径为0.0055英寸，设置为4个，4个第一端显影标记120分别设置在不同的回绕编织环1111上，距第一端111的最远端部0.5mm，即D＝0.5mm，采用0.017英寸微导管推送，实验证明，血管植入物的推送阻力为109gf。
在一些实施例中，植入物主体110中的编织丝均选用DFT材料，套管为镍钛合金，可显影芯丝的材料为铂金，套管外径为0.0533mm(0.0021英寸)，可显影芯丝的截面积占编织丝的总截面积的30％，第一端显影标记120的外径为0.0055英寸，设置为4个，4个第一端显影标记120分别设置在不同的回绕编织环1111上，距第一端111的最远端部0.8mm，即D＝0.8mm，采用0.017英寸微导管推送，实验证明，血管植入物的推送阻力为111gf。
在一些实施例中，植入物主体110中的编织丝均选用DFT材料，套管为镍钛合金，可显影芯丝的材料为铂金，套管外径为0.0533mm(0.0021英寸)， 可显影芯丝的截面积占编织丝的总截面积的30％，第一端显影标记120的外径为0.0055英寸，设置为4个，4个第一端显影标记120分别设置在不同的回绕编织环1111上，距第一端111的最远端部0.9mm，即D＝0.9mm，采用0.017英寸微导管推送，实验证明，血管植入物的推送阻力为118gf。
在一对比实施例中，植入物主体110中的编织丝均选用DFT材料，套管为镍钛合金，可显影芯丝的材料为铂金，套管外径为0.0533mm(0.0021英寸)，可显影芯丝的截面积占编织丝的总截面积的30％，第一端显影标记120的外径为0.0055英寸，设置为4个，4个第一端显影标记120分别设置在不同的回绕编织环1111上，距第一端111的最远端部0.95mm，即D＝0.95mm，采用0.017英寸微导管推送，实验证明该推送阻力为238gf，远大于125gf、121gf、115gf、109gf、111gf、118gf。故而，D超过0.9mm后，第一端显影标记120与植入物主体110在输送过程中发生干涉，会增大血管植入物压缩状态的尺寸，增大推送阻力，如图2所示。图2中黑色线框所圈示的部位发生干涉。
由以上可见，为避免增大编织支架的轴向尺寸或挫伤血管，第一端显影标记120设置在回绕编织环1111非顶点的其他位置，为防止显影标记与植入物主体在输送过程中发生干涉，降低植入物输送过程的推送阻力，优选该第一端显影标记120距第一端最远端部0.1～0.9mm，即D＝0.1～0.9mm。当然，该第一端显影标记120距第一端最远端部的距离D也可在以下任意一个范围内取值：0.1～0.15mm，0.1～0.3mm，0.1～0.5mm，0.1～0.8mm，0.15～0.3mm，0.15～0.5mm，0.15～0.8mm，0.15～0.9mm，0.3～0.5mm，0.3～0.8mm，0.3～0.9mm，0.5～0.8mm，0.5～0.9mm，0.8～0.9mm。
回绕编织环1111为一根编织丝回编而成的圆弧，圆弧为半圆形、半椭圆形或类半圆形，或者，回绕编织环1111为一根编织丝回编后与另一根编织丝粘接或焊接在一起，其中，编织丝回编后的端部绕制成弹簧状的第一端显影标记120后通过粘接或焊接的形式与另一根编织丝连接在一起，又或者，回绕编织环1111为一根编织丝回编后与另一根编织丝粘接或焊接在一起，其中编织丝回编后通过第一端显影标记120与另一根编织丝粘接或焊接在一起，其中第一端显影标记120可以为显影弹簧或显影套管。在一优选的实施例中，第一端显影标记120的外径为0.0055英寸，便于适配0.017英寸的导管管腔， 第一端显影标记120的材料包括铂金(Pt)，铂金的材料密度大，可辨识度好。为了进一步降低加工难度，第一端显影标记120的材料可选铂钨合金(Pt-W)或铂铱合金(Pt-Ir)，血管植入物的推送阻力小，而且第一端显影标记120的可辨识度好，同时连接强度高。
继续参阅图1，第二端112包括多个第一连接部1121，第一连接部1121是由至少两根编织丝140连接在一起形成的无创连接部，编织丝140的连接方式可采用但不限于拧结、胶结、焊接等方式。第一连接部1121为两根编织丝相互缠绕连接在一起后，通过第二端显影标记130粘接或焊接在一起，同时第二端显影标记130的端部使用端面球化焊接的方式进行激光焊接，形成圆滑的封闭端，即形成无创连接部。其中第二端显影标记130可以为显影弹簧或显影套管。在其他实施方式中，第一连接部1121为两根编织丝相互并丝焊接在一起，并丝焊接后，使用第二端显影标记130套在外侧，并在第二端显影标记130的端部使用端面球化焊接的方式进行激光焊接，形成圆滑的封闭端，即形成无创连接部，此时第二端显影标记130亦可为显影弹簧或显影套管。
特别地，第二端显影标记130距第二端112的端部的编织丝的第一个交点形成的端面0.5mm～4.0mm，即d＝0.5mm～4.0mm。该0.5mm～4.0mm是发明人根据血管植入物在颅内血管内的尺寸以及大量的实验数据进行设定的，以使得本发明的血管植入物在确保整体显影性和径向支撑力的同时，还能兼顾第二端显影标记130对血管植入物的推送性能和打开贴壁性能的影响。
发明人在研究过程中发现，编织支架(血管植入物)释放到曲率半径例如为4.5mm的弯曲血管中，第二端显影标记130会产生不贴壁现象。为了解决该问题，发明人曾尝试多种方案来改善打开贴壁性能，如将镍钛编织丝与DFT复合编织丝混合编织，或降低编织密度，或将图1或图4中的两个相邻第二端显影标记130之间的短波A剪开等，这些方式虽然理论上可行，但是实验结果证明，血管植入物还是打开后不贴壁。进一步地，申请人在研究过程中意外地发现，将第二端显影标记130距第二端112的端部端面设定在上述范围内时，能够防止血管植入物打开后不贴壁。因此，当d为0.5mm～4.0mm时，编织支架释放到曲率半径如为4.5mm的弯曲血管中，第二端显影标记130 可以贴壁，确保了血管植入物打开后的贴壁性能，由此取得了预料不到的技术效果。申请人在研究过程中还发现，如果d大于4.0mm，编织支架释放到曲率半径为4.5mm的弯曲血管中，第二端显影标记130还是会不贴壁，进而分析造成该问题的原因后发现，由于第二端112采用喇叭口设计，在弯曲段无法顺应血管的曲率时，第二端显影标记130就会翘起不贴壁。此外，如果d小于0.5mm，则推送阻力会很大，第二端显影标记130会与编织支架相互干涉，增大编织支架的压缩状态尺寸。
最终经过大量的实验证明，将d设置在0.5mm～4.0mm时，会改善血管植入物的顺应性，确保血管植入物的打开贴壁性能。本申请文件中，第二端112的端部为第二端编织丝的第一个交点形成的端面，也即，短波A的顶点为第二端端部，d为第二端显影标记130靠近植入物主体110的远端到第二端112的端部的距离。
在一对比实施例中，植入物主体110中的编织丝均选用DFT材料，套管为镍钛合金，可显影芯丝的材料为铂金，套管外径为0.0533mm(0.0021英寸)，可显影芯丝的截面积占编织丝的总截面积的30％，第二端显影标记120的外径为0.0063英寸，设置为4个，4个第二端显影标记130沿第二端112的周向间隔设置，第二端显影标记130距第二端112的端部端面0.4mm，即d＝0.4mm，采用0.017英寸微导管推送，实验证明，血管植入物的推送阻力为246gf，并且观察发现第二端显影标记130在输送过程中与植入物主体110发生干涉，增大了血管植入物压缩状态的尺寸，如图3所示。可以理解，图3中黑色线框所圈示的部位发生干涉。
在一对比实施例中，植入物主体110中的编织丝均选用DFT材料，套管为镍钛合金，可显影芯丝的材料为铂金，套管外径为0.0533mm(0.0021英寸)，可显影芯丝的截面积占编织丝的总截面积的30％，第二端显影标记120的外径为0.0063英寸，设置为4个，4个第二端显影标记130沿第二端112的周向间隔设置，第二端显影标记130距第二端112的端部端面4.5mm，即d＝4.5mm，采用0.017英寸微导管推送，实验证明，该血管植入物的推送阻力为104gf，且观察发现释放在弯曲血管中部分第二端显影标记130存在贴壁不良，如图4所示。需理解，图4中两个黑色线框所圈出的部位存在贴壁不良 的情形。
在一些实施例中，植入物主体110中的编织丝均选用DFT材料，套管为镍钛合金，可显影芯丝的材料为铂金，套管外径为0.0533mm(0.0021英寸)，可显影芯丝的截面积占编织丝的总截面积的30％，第二端显影标记120的外径为0.0063英寸，设置为4个，4个第二端显影标记130沿第二端112的周向间隔设置，第二端显影标记130距第二端112的端部端面0.5mm，即d＝0.5mm，采用0.017英寸微导管推送，经由实验证明，血管植入物的推送阻力为112gf。
在一些实施例中，植入物主体110中的编织丝均选用DFT材料，套管为镍钛合金，可显影芯丝的材料为铂金，套管外径为0.0533mm(0.0021英寸)，可显影芯丝的截面积占编织丝的总截面积的30％，第二端显影标记120的外径为0.0063英寸，设置为4个，4个第二端显影标记130沿第二端112的周向间隔设置，第二端显影标记130距第二端112的端部端面1.5mm，即d＝1.5mm，采用0.017英寸微导管推送，经由实验证明，血管植入物的推送阻力为109gf。
在一些实施例中，植入物主体110中的编织丝均选用DFT材料，套管为镍钛合金，可显影芯丝的材料为铂金，套管外径为0.0533mm(0.0021英寸)，可显影芯丝的截面积占编织丝的总截面积的30％，第二端显影标记120的外径为0.0063英寸，设置为4个，4个第二端显影标记130沿第二端112的周向间隔设置，第二端显影标记130距第二端112的端部端面3.0mm，即d＝3.0mm，采用0.017英寸微导管推送，经由实验证明，血管植入物的推送阻力为113gf。
在一些实施例中，植入物主体110中的编织丝均选用DFT材料，套管为镍钛合金，可显影芯丝的材料为铂金，套管外径为0.0533mm(0.0021英寸)，可显影芯丝的截面积占编织丝的总截面积的30％，第二端显影标记120的外径为0.0063英寸，设置为4个，4个第二端显影标记130沿第二端112的周向间隔设置，第二端显影标记130距第二端112的端部端面4.0mm，即d＝4.0mm，采用0.017英寸微导管推送，经由实验证明，血管植入物的推送阻力为119gf。
由以上可见，第二端112上的第二端显影标记130距第二端112的端部端面的距离d与血管植入物在输送过程中的推送阻力以及释放后的贴壁性密切相关。d越大，推送阻力较小且达到最低值，而第二端显影标记130的贴壁性越差；d越小，第二端显影标记130的贴壁性改善，而推送阻力逐渐升高。因此，为了平衡推送阻力和贴壁性，优选第二端112上的第二端显影标记130距第二端112的最远端部0.5mm～4.0mm，即d＝0.5mm～4.0mm。当然，该第二端112上的第二端显影标记130距第二端112的最远端部的距离d也可在以下任意一个范围内取值：0.5～1.5mm，0.5～3.0mm，1.5～3.0mm，1.5～4.0mm，3.0～4.0mm。
优选的，对于适配0.017英寸的导管管腔，第二端显影标记130(近端)的数量为4个，且可容纳的单个第二端显影标记130的最大外径约为0.0063英寸，此时如果第二端显影标记130的外径大，将使血管植入物难以通过0.017英寸的导管管腔进行输送，或增大输送阻力。在一优选的实施例中，第二端显影标记130的外径为0.0063英寸，便于适配0.017英寸的导管管腔，第二端显影标记130的材料包括铂金(Pt)，铂金的材料密度大，可辨识度好。为了进一步降低加工难度，第二端显影标记130的材料可选铂钨合金(Pt-W)或铂铱合金(Pt-Ir)，血管植入物的推送阻力小，而且第二端显影标记130的可辨识度好，同时连接强度高。
本实施例中，所述血管植入物的各部分的在X光下的辨识度不同，尤其是编织支架一端或两端的显影性能优于与支架中段的显影性能，更优选编织支架两端的显影性能也不同。具体地，可通过调整第一端显影标记120、植入物主体110以及第二端显影标记130，该三者的材料、在X光方向上的厚度(或外径)，来调整三者在X光下的辨识度。如显影标记采用显影弹簧或显影套管时，可调整显影弹簧或显影套管的材料及比例、外径及壁厚，调整显影标记的辨识度。而对于编织支架，可调整编织支架的材料及比例、编织丝丝径、芯丝的直径，调整植入物主体和两端的辨识度。
在一些实施方式中，第一端显影标记120在X光下的辨识度大于植入物主体110在X光下的辨识度，以便判别编织支架的第一端111在血管中的打开和贴壁状态，从而增强第一端111在X光下的显影性能，使第一端111的 辨识度相对于人体组织和植入物主体110较高，在血管中显影清晰且能有效的区别于编织支架的其他部位，方便判断支架的第一端111的位置和形态。第一端显影标记120在X光下的辨识度与植入物主体110在X光下的辨识度的比值优选为1.5～3.1，更优选的，第一端显影标记120在X光下的辨识度与植入物主体110在X光下的辨识度的比值为1.8～2.3，如辨识度比值为1.5、1.8、1.91、2.11、2.3、2.91或3.09。辨识度值越大，显影性能越好。
在一些实施方式中，第二端显影标记130在X光下的辨识度大于植入物主体110在X光下的辨识度，以便判断编织支架的第二端112在血管中的打开和贴壁状态，从而增强第二端112在X光下的显影性能，使第二端112的辨识度相对于人体组织和编织植入物主体110较高，在血管中显影清晰且能有效的区别于编织支架的其他部位，方便判断支架的第二端112的位置和形态。第二端显影标记130在X光下的辨识度与植入物主体110在X光下的辨识度的比值优选为1.5～3.2，更优选的，第二端显影标记130在X光下的辨识度与植入物主体110在X光下的辨识度的比值优选为1.82～2.33，如辨识度比值为1.52、1.82、2.13、2.33、2.94或3.13。
在一优选实施方式中，第一端显影标记120在X光下的辨识度和第二端显影标记130在X光下的辨识度均大于植入物主体110在X光下的辨识度，使得编织支架的两端显影标记的辨识度相对于人体组织和编织植入物主体110均较高，在血管中显影清晰且能有效的区别于编织支架的其他部位，方便判断支架的两端位置和形态。因此，编织支架两端显影标记的辨识度较高，方便判断编织支架两端形态，达到良好的定位、打开、锚定和贴壁效果，提高手术操作安全性。
进一步的，为了便于判别支架的头尾，优选第一端显影标记120在X光下的辨识度与第二端显影标记130在X光下的辨识度不相同，使编织支架的两端的显影性能存在显著差异，以达到便于医生操作的显影效果。第一端显影标记120的辨识度和第二端显影标记130的辨识度的比值优选为0.8～1.2，更优选的，第一端显影标记120的辨识度和第二端显影标记130的辨识度的比值为0.9或0.99。
在一些实施方式中，植入物主体110所选用的编织丝140的丝径为 0.0533mm，且编织丝选用DFT材料，DFT材料中套管为镍钛合金，可显影芯丝为铂金材料，可显影芯丝的截面积占比为20％，则ρk＝20.4，c＝0.024mm，辨识度SC＝0.46，同时第一端显影标记120的材料为钽，材料相对密度ρk＝15.9，其在X光方向上的厚度c＝0.14mm(0.0055英寸)，辨识度SC＝0.88；同时第二端显影标记130的材料为铂金，材料相对密度ρk＝20.4，其在X光方向上的厚度c＝0.16mm，辨识度SC＝0.98。因此，第一端显影标记120与植入物主体110的辨识度比值0.88/0.46≈1.91ρk，第二端显影标记130与植入物主体110的辨识度之比0.98/0.46≈2.13，且第一端显影标记120、植入物主体110和第二端显影标记130的辨识度比值约为1.91:1:2.13，以及第一端显影标记120和第二端显影标记130的辨识度比值为0.88/0.98≈0.9。
在另一些实施方式中，植入物主体110所选用的编织丝140的丝径为0.0533mm，且编织丝选用DFT材料，DFT材料中套管为镍钛合金，可显影芯丝为铂金材料，可显影芯丝的截面积占比为20％，则ρk＝20.4，c＝0.024mm，SC＝0.46，同时第一端显影标记120的材料为铂金，材料相对密度ρk＝20.4，第一端显影标记120在X光方向上的厚度c＝0.14mm，辨识度SC＝0.97，同时第二端显影标记130的材料为铂金，相对密度ρk＝20.4，其在X光方向上的厚度c＝0.16mm，辨识度SC＝0.98。因此，第一端显影标记120与植入物主体110的辨识度比值0.97/0.46≈2.11，第二端显影标记130与植入物主体110的辨识度0.98/0.46≈2.13，且第一端显影标记120、植入物主体110和第二端显影标记130的辨识度比值约为2.11:1:2.13，以及第一端显影标记120与第二端显影标记130的辨识度比值0.97/0.98≈0.99。
在一对比实施例中，第一端显影标记120的材料为铂钨合金或铂铱合金，外径为0.0055英寸，第一端显影标记120在X光方向上的厚度c＝0.14mm，相对密度ρk＝20.4，可辨识度SC＝0.99；第二端显影标记130的材料为铂钨合金或铂铱合金，外径为0.0063英寸，第二端显影标记130在X光方向上的厚度c＝0.016mm，相对密度ρk＝20.4，可辨识度SC＝1.0；同时植入物主体110中的编织丝的材料选用DFT材料，套管为镍钛合金，可显影芯丝的材料为铂金，套管外径为0.0533mm，可显影芯丝的截面积占编织丝的总截面积的63％，即可显影芯丝的外径约为0.042mm，此时，可显影芯丝在X光方向上的厚度 c＝0.042mm，相对密度ρk＝20.4，可辨识度SC＝0.66。该方案中，第一端显影标记120的辨识度与植入物主体110的辨识度的比值为1.5，第二端显影标记130的辨识度与植入物主体110的辨识度的比值为1.52，第一端显影标记120的辨识度、植入物主体110的辨识度以及第二端显影标记130的辨识度的比值为0.99:0.66:1.0。
在一对比实施例中，第一端显影标记120的材料为铂钨合金或铂铱合金，外径为0.0055英寸，第一端显影标记120在X光方向上的厚度c＝0.14mm，相对密度ρk＝20.4，可辨识度SC＝0.99；第二端显影标记130的材料为铂钨合金或铂铱合金，外径为0.0063英寸，第二端显影标记130在X光方向上的厚度c＝0.016mm，相对密度ρk＝20.4，可辨识度SC＝1.0；同时植入物主体110中的编织丝的材料选用DFT材料，套管为镍钛合金，可显影芯丝的材料为铂金，套管外径为0.0533mm，可显影芯丝的截面积占编织丝的总截面积的9％，即可显影芯丝的外径约为0.016mm，此时，可显影芯丝在X光方向上的厚度c＝0.016mm，相对密度ρk＝20.4，可辨识度SC＝0.34。该方案中，第一端显影标记120的辨识度与植入物主体110的辨识度的比值为2.91，第二端显影标记130的辨识度与植入物主体110的辨识度的比值为2.94，第一端显影标记120的辨识度、植入物主体110的辨识度以及第二端显影标记130的辨识度的比值为0.99:0.34:1.0。
在一些实施方式中，第一端显影标记120的材料为铂钨合金或铂铱合金，外径为0.0055英寸，第一端显影标记120在X光方向上的厚度c＝0.14mm，相对密度ρk＝20.4，可辨识度SC＝0.99；第二端显影标记130的材料为铂钨合金或铂铱合金，外径为0.0063英寸，第二端显影标记130在X光方向上的厚度c＝0.016mm，相对密度ρk＝20.4，可辨识度SC＝1.0；同时植入物主体110中的编织丝的材料选用DFT材料，套管为镍钛合金，可显影芯丝的材料为铂金，套管外径为0.0533mm，可显影芯丝的截面积占编织丝的总截面积的34％，即可显影芯丝的外径约为0.031mm，此时，可显影芯丝在X光方向上的厚度c＝0.031mm，相对密度ρk＝20.4，可辨识度SC＝0.55。该方案中，第一端显影标记120的辨识度与植入物主体110的辨识度的比值为1.8，第二端显影标记130的辨识度与植入物主体110的辨识度的比值为1.82，第一端显影标记120的 辨识度、植入物主体110的辨识度以及第二端显影标记130的辨识度的比值为0.99:0.55:1.0。
在一对比实施例中，第一端显影标记120的材料为铂钨合金或铂铱合金，外径为0.0055英寸，第一端显影标记120在X光方向上的厚度c＝0.14mm，相对密度ρk＝20.4，可辨识度SC＝0.99；第二端显影标记130的材料为铂钨合金或铂铱合金，外径为0.0063英寸，第二端显影标记130在X光方向上的厚度c＝0.016mm，相对密度ρk＝20.4，可辨识度SC＝1.0；同时植入物主体110中的编织丝的材料选用DFT材料，套管为镍钛合金，可显影芯丝的材料为铂金，套管外径为0.0533mm，可显影芯丝的截面积占编织丝的总截面积的17％，即可显影芯丝的外径约为0.022mm，此时，可显影芯丝在X光方向上的厚度c＝0.022mm，相对密度ρk＝20.4，可辨识度SC＝0.43。该方案中，第一端显影标记120的辨识度与植入物主体110的辨识度的比值为2.3，第二端显影标记130的辨识度与植入物主体110的辨识度的比值为2.33，第一端显影标记120的辨识度、植入物主体110的辨识度以及第二端显影标记130的辨识度的比值为0.99:0.43:1.0。
在一对比实施方式中，第一端显影标记120的材料为铂钨合金或铂铱合金，外径为0.0055英寸，第一端显影标记120在X光方向上的厚度c＝0.14mm，相对密度＝20.4，可辨识度SC＝0.99；第二端显影标记130的材料为铂钨合金或铂铱合金，外径为0.0063英寸，第二端显影标记130在X光方向上的厚度c＝0.016mm，相对密度＝20.4，可辨识度SC＝1.0；同时植入物主体110中的编织丝的材料选用DFT材料，套管为镍钛合金，可显影芯丝的材料为铂金，套管外径为0.0533mm，可显影芯丝的截面积占编织丝的总截面积的8％，即可显影芯丝的外径约为0.015mm，此时，可显影芯丝在X光方向上的厚度c＝0.015mm，相对密度ρk＝20.4，可辨识度SC＝0.32。该方案中，第一端显影标记120的辨识度与植入物主体110的辨识度的比值为3.09，第二端显影标记130的辨识度与植入物主体110的辨识度的比值为3.13，第一端显影标记120的辨识度、植入物主体110的辨识度以及第二端显影标记130的辨识度的比值为0.99:0.32:1.0。
本实施例中，第一端显影标记120、植入物主体110和第二端显影标记 130在X光下的辨识度的比值优选为0.99：(0.32～0.66):1.0。
在一实施方式中，第一端显影标记120的材料为钽，相对密度ρk＝15.9，其在X光方向上的厚度c＝0.14mm，辨识度SC＝0.88，同时第二端显影标记130的材料为铂金，相对密度ρk＝20.4，其在X光方向上的厚度c＝0.16mm，辨识度SC＝0.98，第一端显影标记120和第二端显影标记130的辨识度之比0.88/0.98≈0.90，此时，第二端显影标记130的显影性能优于第一端显影标记120的显影性能。
请参考图5，当第一端显影标记120的辨识度高于植入物主体110的辨识度时，通过成像设备所显示的图像中，第一端显影标记120在X光下的成像清晰度显然高于植入物主体110在X光下的成像清晰度，因此，第一端111的辨识度高，使得医生可以方便的判别支架的第一端111的位置和形态。
请参考图6，当第二端显影标记130的辨识度高于植入物主体110的辨识度时，通过成像设备所显示的图像中，第二端显影标记130在X光下的成像清晰度显然高于植入物主体110在X光下的成像清晰度，因此，第二端112的辨识度高，使得医生可以方便的判别支架的第二端112的位置和形态。
本实施例中，可通过显影弹簧或显影套管制作显影标记。显影弹簧或显影套管的材料包括镍钛合金、镍钛诺、不锈钢、钴铬合金、镍钴合金的一种或多种组合，当然还包括不透射线的显影材料，显影材料包括但不限于为铂、铱、金、银、钽和钨中的一种或其合金。
在一些实施例中，显影弹簧的簧丝丝径为0.0010英寸～0.0020英寸(0.0254mm～0.0508mm)，显影弹簧的外径为0.0030英寸～0.0070英寸(0.0762mm～0.1778mm)，显影弹簧的轴向长度为0.4mm～1.5mm。在一些实施例中，显影套管的壁厚为0.0010英寸～0.0020英寸，显影套管的外径为0.0030英寸～0.0070英寸，显影套管的轴向长度为0.4mm～0.8mm。
显影标记不能过长和过短，过长会影响支架的性能，过短则显影效果不好。其中显影弹簧的簧丝可以包括芯丝和包覆在芯丝外面的套管，其中所述簧丝中的芯丝材料包括但不限于为铂、铱、金、银、钽和钨中的一种或其合金，所述簧丝中套管的材料包括但不限于为镍钛合金、镍钛诺、不锈钢、钴铬合金、镍钴合金的一种或多种组合。优选的，所述显影弹簧中的芯丝的截 面积占簧丝的总截面积的20％～35％，显影弹簧中套管的外径为0.0010英寸～0.0020英寸。应理解，就显影标记来说，显影弹簧或显影套管的外径就是显影标记在X光方向上的厚度c。
本申请对第一端显影标记120的数量没有特别的要求。在一实施例中，所述第一端显影标记120的数量为1～6个，为了方便判断支架端部的形态，第一端显影标记120的数量优选为3个或4个，并在圆周方向上均匀排布。进一步的，第一端显影标记120在血管植入物的不同圆周上分布，即在轴上错落分层排布，以减小支架压缩尺寸，降低推送阻力。
本申请对第二端显影标记130的数量也没有特别的要求。在一实施例中，所述第二端显影标记130的数量为1～6个。为了方便判断支架端部的形态，第二端显影标记130的数量优选为4个或6个，并在同一圆周方向上均匀排布。
优选的，第一端显影标记120和第二端显影标记130的数量不同，以便区分支架头尾，使手术操作更为方便。在一些实施方式中，第一端显影标记120为3个，第二端显影标记130为4个，在另一些实施方式中，第一端显影标记120为3个，第二端显影标记130为6个。
根据本发明实施例提供的技术方案，为了使血管植入物的一端或两端的显影性能优于支架中段的显影性能，在实际加工时，主要调整显影材料(即不透射线材料)和血管植入物在X光方向上的厚度，以此调整相应部分在X光下的辨识度。
如，当所述第一端显影标记120的辨识度大于植入物主体110的辨识度时，第一端显影标记120和植入物主体110所选用的不透射线材料不相同，或者两者在X光方向上的厚度不相同，又或者不透射线材料和在X光方向上的厚度都不相同；如当所述第二端显影标记130的辨识度大于植入物主体110的辨识度时，第二端显影标记130和植入物主体110所选用的不透射线材料不相同，或者两者在X光方向上的厚度不相同，又或者不透射线材料和在X光方向上的厚度都不相同。
当所述第一端显影标记120的辨识度大于植入物主体110的辨识度时，所述第一端显影标记120中的不透射线材料与植入物主体110的编织丝中的 不透射线材料可以相同，此时，所述第一端显影标记120在X光方向上的厚度大于植入物主体110在X光方向上的厚度，或者，所述第一端显影标记120中的不透射线材料与植入物主体110的编织丝中的不透射线材料不相同，此时，所述第一端显影标记120在X光方向上的厚度大于、等于或小于植入物主体110在X光方向上的厚度都可。
同样的，当所述第二端显影标记130的辨识度大于植入物主体110的辨识度时，所述第二端显影标记130中的不透射线材料与植入物主体110的编织丝中的不透射线材料可以相同，所述第二端显影标记130在X光方向上的厚度大于植入物主体110在X光方向上的厚度，或者，所述第二端显影标记130中的不透射线材料与植入物主体110的编织丝中的不透射线材料不相同，所述第二端显影标记130在X光方向上的厚度大于、等于或小于植入物主体110在X光方向上的厚度。
应理解，显影标记在X光方向上的厚度主要由显影弹簧的外径、壁厚或显影套管的外径及壁厚确定，而植入物主体在X光方向上的厚度主要由编织丝的丝径或芯丝的直径确定。此外，所应理解，不同的显影材料具有不同的材料密度，因此，通过选择相应的显影材料可调整材料相对密度，另外，编织密度(即金属覆盖率)在一定程度上也会影响显影性能，因此，还可进一步调整编织密度来调整植入物主体的显影性能。
需特别强调的是，本发明提供的技术方案具有突出的实质性特点，为了达到准确判断血管植入物两端位置的目的，有众多方法提高两端的辨识度，例如提高两端的显影密度或者增加材料显影厚度，但这又会带来推送阻力、打开难以贴壁等问题，另外从技术上来讲，也是较难实现的，尽管可以想到将两端的显影强度设置为高于植入物中段，也需要多角度的考量，同时做到与植入物匹配，需要进行显影标记的尺寸、显影性、个数、推送阻力的验证，这需要大量的临床实验数据才能实现。
与现有技术相比，本发明提供的血管植入物的不同部分在X光下的显影性能不同，便于满足不同医生操作条件的需求，便于判断支架在弯曲血管内的打开和贴壁状态，同时一端或两端的显影标记的辨识度高，易于医生判断支架一端或两端的打开和贴壁状态，提高手术操作安全性和手术操作的准确 性，并缩短手术时间，提高手术效率和治疗效果。
虽然本发明披露如上，但并不局限于此。本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样，倘若本发明的这些修改和变型属于本发明及其等同技术的范围之内，则本发明也意图包含这些改动和变型在内。

Claims (11)

  1. 一种血管植入物，包括管状的植入物主体以及位于所述植入物主体的轴向两端的第一端和第二端；
    所述植入物主体由至少两根编织丝交错编织而成，至少两根所述编织丝中的至少一根编织丝具有显影性，具有显影性的所述编织丝包括可显影芯丝和包覆在所述可显影芯丝外的套管，所述可显影芯丝的截面积占所述编织丝的总截面积的20％～35％；
    所述第一端上设置有至少一个第一端显影标记，所述第一端显影标记距所述第一端的最远端部0.1mm～0.9mm，所述第二端上设置有至少一个第二端显影标记，所述第二端显影标记距所述第二端的端部端面0.5mm～4.0mm；
    所述第一端显影标记、所述植入物主体和所述第二端显影标记在X光下的辨识度的比值为0.99：(0.32～0.66):1.0，所述血管植入物的材料相对密度为15～25，所述血管植入物在X光照射方向上的厚度为0.015mm～0.2mm。
  2. 如权利要求1所述的血管植入物，其特征在于，所述第一端显影标记和所述植入物主体在以下方面中的至少一种设置为不相同：所选用的不透射线材料以及在X光照射方向上的厚度；
    所述第二端显影标记和所述植入物主体在以下方面中的至少一种设置为不相同：所选用的不透射线材料以及在X光照射方向上的厚度。
  3. 如权利要求2所述的血管植入物，其特征在于，所述第一端显影标记中的不透射线材料与所述编织丝中的不透射线材料相同，所述第一端显影标记在X光照射方向上的厚度大于所述植入物主体在X光照射方向上的厚度，或者，
    所述第一端显影标记中的不透射线材料与所述编织丝中的不透射线材料不相同，所述第一端显影标记在X光照射方向上的厚度大于、等于或小于所述植入物主体在X光照射方向上的厚度。
  4. 如权利要求2所述的血管植入物，其特征在于，所述第二端显影标记中的不透射线材料与所述编织丝中的不透射线材料相同，所述第二端显影标记在X光照射方向上的厚度大于所述植入物主体在X光照射方向上的厚度，或 者，
    所述第二端显影标记中的不透射线材料与所述编织丝中的不透射线材料不相同，所述第二端显影标记在X光照射方向上的厚度大于、等于或小于所述植入物主体在X光照射方向上的厚度。
  5. 如权利要求1所述的血管植入物，其特征在于，所述第一端显影标记和所述第二端显影标记在以下方面中的至少一种设置为不相同：所选用的不透射线材料以及在X光照射方向上的厚度。
  6. 如权利要求1所述的血管植入物，其特征在于，所述第一端显影标记在X光下的辨识度与所述植入物主体在X光下的辨识度的比值为1.80～2.30；和/或，所述第二端显影标记在X光下的辨识度与所述植入物主体在X光下的辨识度的比值为1.82～2.33。
  7. 如权利要求1所述的血管植入物，其特征在于，所述第一端显影标记和/或所述第二端显影标记为显影弹簧或显影套管，所述显影弹簧或显影套管的外径为0.003英寸～0.007英寸。
  8. 如权利要求7所述的血管植入物，其特征在于，所述显影弹簧的簧丝包括芯丝和包覆在所述芯丝外的套管，所述显影弹簧的套管具有非显影性，所述显影弹簧的芯丝具有显影性，其中，所述簧丝中的所述芯丝的截面积占所述簧丝的总截面积的20％～35％。
  9. 如权利要求1所述的血管植入物，其特征在于，所述第一端为血管植入物的远端，所述第二端为血管植入物的近端，所述第一端显影标记的数量为至少两个，至少两个所述第一端显影标记在所述血管植入物的圆周方向上均匀排布，所述第二端显影标记的数量为至少两个，至少两个所述第二端显影标记在所述血管植入物的同一圆周方向上均匀排布。
  10. 如权利要求9所述的血管植入物，其特征在于，至少两个所述第一端显影标记在所述血管植入物的不同圆周上排布。
  11. 如权利要求1所述的血管植入物，其特征在于，所述第一端显影标记的数量与所述第二端显影标记的数量不相同。
PCT/CN2023/124676 2021-10-15 2023-10-16 血管植入物 WO2024083064A1 (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN202111200666.8A CN113633433A (zh) 2021-10-15 2021-10-15 血管植入物
CN202211284816.2 2022-10-17
CN202211284816.2A CN115969592A (zh) 2021-10-15 2022-10-17 血管植入物

Publications (1)

Publication Number Publication Date
WO2024083064A1 true WO2024083064A1 (zh) 2024-04-25

Family

ID=78426974

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2023/124676 WO2024083064A1 (zh) 2021-10-15 2023-10-16 血管植入物

Country Status (2)

Country Link
CN (2) CN113633433A (zh)
WO (1) WO2024083064A1 (zh)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113288314A (zh) * 2021-01-06 2021-08-24 微创神通医疗科技（上海）有限公司 一种血管植入物及医疗设备
CN113633433A (zh) * 2021-10-15 2021-11-12 微创神通医疗科技（上海）有限公司 血管植入物

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080288046A1 (en) * 2007-05-16 2008-11-20 Boston Scientific Scimed, Inc. Method of Attaching Radiopaque Markers to Intraluminal Medical Devices, and Devices Formed Using the Same
CN104487024A (zh) * 2012-03-16 2015-04-01 麦克柔文绅有限公司 支架和支架送递装置
CN109498210A (zh) * 2018-11-08 2019-03-22 东莞先健畅通医疗有限公司 管腔支架
CN212234823U (zh) * 2020-06-30 2020-12-29 微创神通医疗科技（上海）有限公司 一种血管支架
CN112754584A (zh) * 2021-01-06 2021-05-07 微创神通医疗科技（上海）有限公司 一种血管植入物及医疗设备
CN113633433A (zh) * 2021-10-15 2021-11-12 微创神通医疗科技（上海）有限公司 血管植入物
CN113967116A (zh) * 2021-11-04 2022-01-25 北京泰杰伟业科技有限公司 一种颅内支架及颅内支架输送系统
CN114287989A (zh) * 2021-12-24 2022-04-08 珠海通桥医疗科技有限公司 一种血流导向装置支架

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6699278B2 (en) * 2000-09-22 2004-03-02 Cordis Corporation Stent with optimal strength and radiopacity characteristics
EP3296413A1 (en) * 2007-12-21 2018-03-21 Cook Medical Technologies LLC Radiopaque alloy and medical device made of this alloy
CN102655824B (zh) * 2010-03-26 2014-10-29 奥林巴斯医疗株式会社 医疗用支架
KR101845115B1 (ko) * 2010-12-13 2018-04-03 마이크로벤션, 인코포레이티드 스텐트
CN202724037U (zh) * 2012-08-01 2013-02-13 吕文峰 一种治疗动脉瘤用的支架及其输送系统
US20140277397A1 (en) * 2013-03-12 2014-09-18 DePuy Synthes Products, LLC Variable porosity intravascular implant and manufacturing method
CN106132356B (zh) * 2014-01-29 2018-06-12 同心医疗公司 血管及体内导管治疗装置和方法
CN203885667U (zh) * 2014-06-06 2014-10-22 微创神通医疗科技（上海）有限公司 一种支架
JP6549717B2 (ja) * 2015-01-12 2019-07-24 マイクロベンション インコーポレイテッドＭｉｃｒｏｖｅｎｔｉｏｎ， Ｉｎｃ． ステント
CN105486703A (zh) * 2015-12-17 2016-04-13 南车戚墅堰机车车辆工艺研究所有限公司 一种双x光底片射线照相方法
CN107029306B (zh) * 2016-02-04 2020-05-15 中国科学院金属研究所 一种能使降解支架在x光下显影的标记及其制备方法
US10850073B2 (en) * 2017-05-22 2020-12-01 Boston Scientific Scimed, Inc. Devices and methods of use with devices having a radiopaque filament
CN209548046U (zh) * 2018-02-11 2019-10-29 南京普微森医疗科技有限公司 一种编织支架系统
JP2022509934A (ja) * 2018-11-16 2022-01-25 マイクロベンション インコーポレイテッド 放射線不透過性血管プロテーゼ

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080288046A1 (en) * 2007-05-16 2008-11-20 Boston Scientific Scimed, Inc. Method of Attaching Radiopaque Markers to Intraluminal Medical Devices, and Devices Formed Using the Same
CN104487024A (zh) * 2012-03-16 2015-04-01 麦克柔文绅有限公司 支架和支架送递装置
CN109498210A (zh) * 2018-11-08 2019-03-22 东莞先健畅通医疗有限公司 管腔支架
CN212234823U (zh) * 2020-06-30 2020-12-29 微创神通医疗科技（上海）有限公司 一种血管支架
CN112754584A (zh) * 2021-01-06 2021-05-07 微创神通医疗科技（上海）有限公司 一种血管植入物及医疗设备
CN113633433A (zh) * 2021-10-15 2021-11-12 微创神通医疗科技（上海）有限公司 血管植入物
CN115969592A (zh) * 2021-10-15 2023-04-18 微创神通医疗科技（上海）有限公司 血管植入物
CN113967116A (zh) * 2021-11-04 2022-01-25 北京泰杰伟业科技有限公司 一种颅内支架及颅内支架输送系统
CN114287989A (zh) * 2021-12-24 2022-04-08 珠海通桥医疗科技有限公司 一种血流导向装置支架

Also Published As

Publication number Publication date
CN115969592A (zh) 2023-04-18
CN113633433A (zh) 2021-11-12

Similar Documents

Publication Publication Date Title
WO2024083064A1 (zh) 血管植入物
EP2543345B1 (en) Surgical apparatus for aneurysms
JP6441297B2 (ja) ステント及びステントグラフト
US20230218300A1 (en) Detachable implantable devices
JP3343684B2 (ja) 改良された肺塞栓症防止フィルタおよび付属位置決め装着キット
JP6543367B2 (ja) トルク緩和気道内肺容量減少圧縮型インプラント構造体
CA2806462C (en) Stent graft having a marker and a reinforcing and marker ring
JP5610542B2 (ja) ブレードボール塞栓装置および送達システム
EP2836165B1 (en) Intracorporeal imaging aid (ima)
JP2007503923A (ja) ステントグラフト、ステントグラフトデリバリー（送入）システムおよびキット、およびステントグラフトを留置する方法
JPH09506005A (ja) 回収可能なシールドされた放射線治療インプラント
RU2521351C2 (ru) Маркер и стент
JP2023144097A (ja) 改良された縮径部被覆を伴う塞栓デバイス
CN212415821U (zh) 血管瘤封堵装置、血管瘤封堵治疗装置及血管瘤封堵系统
JP2017517339A (ja) 肺容積減少弾性インプラント及び器械
JP2022511824A (ja) 血管閉塞デバイス
EP3363408B1 (en) Lung-volume-reduction elastic implant and lung-volume-reduction instrument
WO2022042345A1 (zh) 血管瘤封堵装置、血管瘤封堵治疗装置及血管瘤封堵系统
JPH07227429A (ja) 医療用ガイドワイヤ
US20230346382A1 (en) Intravascular device
WO2022042346A1 (zh) 血管瘤封堵装置、血管瘤封堵治疗装置及血管瘤封堵系统
EP4197458A1 (en) Hemangioma occlusion apparatus, hemangioma occlusion and treatment apparatus, and hemangioma occlusion system
US11266415B2 (en) Lung volume reduction elastic implant and lung volume reduction instrument
CN114209379A (zh) 一种用于动脉瘤治疗的装置
Lim et al. Successful Application of the Newly Developed Vascular Occluder for Patent Ductus Arteriosus (PDA) Treatment in Two Dogs