WO2022178740A1 - 一种外周血管支架及其制备方法和应用 - Google Patents

一种外周血管支架及其制备方法和应用 Download PDF

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Publication number
WO2022178740A1
WO2022178740A1 PCT/CN2021/077792 CN2021077792W WO2022178740A1 WO 2022178740 A1 WO2022178740 A1 WO 2022178740A1 CN 2021077792 W CN2021077792 W CN 2021077792W WO 2022178740 A1 WO2022178740 A1 WO 2022178740A1
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Prior art keywords
membrane
vascular stent
peripheral vascular
wall
stent according
Prior art date
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PCT/CN2021/077792
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English (en)
French (fr)
Inventor
陆信武
唐烈
仇鹏
叶开创
秦金保
王瑞华
高成
谢鹏
Original Assignee
普利瑞医疗科技（苏州）有限公司
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Application filed by 普利瑞医疗科技（苏州）有限公司 filed Critical 普利瑞医疗科技（苏州）有限公司
Priority to PCT/CN2021/077792 priority Critical patent/WO2022178740A1/zh
Priority to US17/616,694 priority patent/US20230172731A1/en
Priority to EP21927184.8A priority patent/EP4248918A4/en
Publication of WO2022178740A1 publication Critical patent/WO2022178740A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • 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
    • A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/828—Means for connecting a plurality of stents allowing flexibility of the whole structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91533—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
    • A61F2002/91541—Adjacent bands are arranged out of phase
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
    • 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
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0018—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in elasticity, stiffness or compressibility

Definitions

  • the invention belongs to the technical field of medical devices, and in particular relates to a peripheral blood vessel stent and a preparation method and application thereof.
  • Atherosclerosis-induced lower extremity arteriosclerosis obliteration is the third atherosclerotic cardiovascular disease after coronary heart disease and stroke. More than 300 million people worldwide suffer from PAD. The evolution of the disease can cause lameness, rest pain, and amputation, which seriously affects the quality of life of patients.
  • the main treatment methods for PAD are drugs, open surgery and endovascular intervention. With the development of interventional therapy for PAD, interventional therapy has been proved to be less invasive and more effective, thus it has become the main way to treat PAD.
  • the two most common methods of endoluminal intervention are percutaneous intraluminal balloon dilation and intraluminal stenting. The disadvantage of the former is that the 1-year patency rate is only 28%-37%, while the appearance of the latter significantly improves the short- and long-term patency rate of diseased blood vessels.
  • the commonly used vascular stents are mainly divided into two categories: cutting type and braiding type.
  • the braided stent is mainly made of metal wire
  • the cutting type stent includes a plurality of closed rings distributed along the axial direction and made of metal material.
  • the braided stent has certain flexibility and fatigue resistance, but the axial shortening rate is very high and the radial support force is relatively weak; while the cut stent has better radial support force and smaller axial support force. Shortening rate, but its flexibility is poor.
  • the lower extremity arteries of the human body have unique physiological characteristics, pathological characteristics, kinematics characteristics, hydrodynamic characteristics, etc., but the existing peripheral arterial stents cannot fully meet the unique requirements of the lower extremity arteries, and the lower extremity arterial disease after stent treatment, about More than 40% of patients will induce in-stent restenosis due to chronic stent expansion and low in-stent shear force.
  • Peripheral artery stents need to overcome mechanical factors such as chronic external expansion force and low shear force under the condition of ensuring a certain radial support force, but the existing peripheral artery stents cannot meet this requirement, which leads to the implantation of peripheral artery stents. The main reason for the high reintervention rate after surgery.
  • a technical problem to be solved by the present invention is to provide a vascular stent with sufficient radial support force and good flexibility, which can be applied to peripheral blood vessels.
  • the second technical problem to be solved by the present invention is to provide a preparation method of the above-mentioned vascular stent.
  • the third technical problem to be solved by the present invention is to provide an application of the above-mentioned vascular stent in intravascular treatment.
  • the technical scheme adopted in the present invention is:
  • One aspect of the present invention provides a peripheral vascular stent, which has an expanded state and a contracted state, and the inner diameter of the peripheral vascular stent in the expanded state is greater than the inner diameter of the peripheral vascular stent when it is in the contracted state;
  • the peripheral vascular stent includes:
  • the supporting units are a plurality of the supporting units arranged at intervals along the axial direction of the peripheral vascular stent, each of the supporting units is formed by a wire and is a closed ring shape, and each of the supporting units includes a plurality of supporting units The peaks and valleys arranged periodically along the circumferential direction, the two adjacent peaks are one cycle;
  • a film the film is covered on a plurality of the support units, the flexibility of the film is greater than the flexibility of the support units, between the wires of the same support unit and/or two adjacent support units
  • a plurality of hollow areas are opened on the film between them, and two adjacent supporting units are connected only through the film outside the hollow area.
  • the lower extremity arteries are different from other non-moving arteries (such as coronary arteries, carotid arteries, and aorta), they are in various deformation states under long-term lower extremity activities, such as the popliteal artery after squatting: the shortening rate is 13%-25 %, the curvature radius after bending is 8-17mm, and the twist degree is 14-26°/cm.
  • the arterial deformation after these movements will cause radial compression, torsion, buckling, axial stretching and compression of the stent, while the existing peripheral vascular stents are limited by the homogeneous design, so the flexibility of the material and the supporting force It is impossible to take both into account, so it is impossible to meet the characteristics of the lower extremity arteries at the same time.
  • the vascular stent of the present invention transcends the limitation of homogeneous design. There is no metal connection between the multiple support units in the stent, and only a flexible membrane with a hollow area is used for connection. In the first aspect, the flexible structural connection has no metal connection.
  • the flexible structure is less irritating to endothelial cells during the shortening process, thereby reducing vascular damage, and can adapt to the shortening rate of the artery under various deformation states;
  • the blood vessel of the structure of the present invention The stent can satisfy the deformation of the peripheral blood vessel in the twisted state, and the flexible structure is less irritating to endothelial cells during the twisting process, thereby reducing the damage to the blood vessel;
  • the vascular stent of the present invention has no metal stent in the flexed state.
  • the present invention can realize bending under a small radius of curvature without damaging the vascular endothelium;
  • the vascular stent of the present invention adopts a plurality of closed annular support units arranged at intervals in the axial direction, so it can provide Sufficient radial support force can withstand the radial force and crushing or pinch load of peripheral blood vessels, effectively support the artery and provide sufficient blood flow.
  • one supporting unit and the other supporting unit are staggered on the circumferential surface, and the staggered distance is less than one half cycle, so that the blood vessels
  • the stent has better flexion, torsion, axial compression and tensile properties.
  • the staggered distance is less than or equal to a quarter period.
  • each of the supporting units is staggered from an adjacent one of the supporting units on the circumferential surface and is staggered by the same distance, so that the supporting units can form a spiral-like shape as a whole. Therefore, the vascular stent can better maintain the circular cross-section of the vascular stent in the state of bending, twisting, etc., and avoid the vascular stent from collapsing.
  • the axis line of each of the supporting units coincides with the axis line of the peripheral blood vessel stent.
  • the axis line of each of the support units coincides with the axis line of the peripheral vascular stent, which means that when the peripheral vascular stent includes a main stent and a sub-stent connected to the main stent, The axis line of the support unit located in the main bracket part coincides with the axis line of the main bracket, and the axis line of the support unit located in the sub bracket part and the axis line of the sub bracket Coincidence; when the peripheral vascular stent has no branches, the axis line of each of the supporting units coincides with the axis line of the peripheral vascular stent.
  • the hollow area includes
  • a plurality of third hollow parts are located between two adjacent supporting units and communicated with the first hollow part and the second hollow part respectively; so that the blood vessel stent has better flexibility and can be more flexible. Good as the blood vessels undergo flexion, torsion, etc.
  • parts of the plurality of third hollow parts between two adjacent supporting units may be communicated with each other, but cannot be all communicated with each other, resulting in separation between two adjacent supporting units without membrane connection.
  • each of the third hollow parts is only communicated with the nearest first hollow part and the second hollow part, so that there are more connection positions between the two adjacent supporting units, and thus the two adjacent supporting units are connected. The connection between the units is stronger.
  • the valley bottom of one support unit and the nearest peak of the other support unit are only connected by a strip-shaped film.
  • the first hollow portion is surrounded by a first wall and a second wall connected by upper ends
  • the second hollow portion is formed by a third wall and a second wall connected by lower ends. surrounded by four walls
  • the third hollow part is composed of a fifth wall connected to the lower end of the first wall and the upper end of the fourth wall respectively, and a sixth wall connected to the lower end of the second wall and the upper end of the third wall respectively. surrounded by.
  • first hollow part and the second hollow part are as large as possible, and it is only necessary to ensure that the film covers the supporting unit.
  • the first hollow part and the second hollow part are also staggered, so that the hollow area forms two staggered and inverted triangles, so that the blood vessel stent has better flexibility, and can better flex and flex with the blood vessel. twist, etc.
  • the two nearest first walls in the two adjacent supporting units are on a first straight line, and the first straight line
  • the lines are arranged obliquely, so that the vascular stent can form a similar helical structure, so that the vascular stent can better maintain a circular shape in cross-section when the vascular stent is bent, twisted, etc., so as to avoid the vascular stent from collapsing.
  • the included angle between the first wall and the second wall is an acute angle.
  • first wall and the third wall are parallel
  • second wall and the fourth wall are parallel
  • a plurality of the second walls are parallel.
  • the membrane is coated on the outer side or/and the inner side of the support unit, so that the vascular stent of the present invention has less influence on the blood flow in the blood vessel, thereby reducing the blood flow after stent implantation.
  • the present invention effectively increases the sticking area between the vascular stent and the blood vessel by covering the support unit with a relatively soft film, thereby increasing the pull-out force of the vascular stent to the blood vessel, so as to maintain sufficient radial support force and good performance.
  • the flexibility of the vascular stent further reduces the chronic external expansion force of the vascular stent.
  • the covering design can seal the dissection rupture of peripheral blood vessels to a certain extent; on the other hand, the hollow area on the film can avoid completely covering the branch blood vessels compared with the full covering design, so it is suitable for patients with many branch blood vessels.
  • peripheral blood vessels such as the popliteal artery.
  • the membrane includes an inner membrane located inside the support unit and an outer membrane located outside the support unit, the inner membrane and the outer membrane are fixedly connected, and the support unit Coated between the inner membrane and the outer membrane.
  • the inner film and the outer film in contact are heat-fused to form the film integrally.
  • the inner diameter of the peripheral vascular stent in the unfolded state gradually decreases from one end to the other end, so as to meet the physiological characteristics of a tapered reduction in the diameter of the lower extremity artery of the human body, and effectively improve the application of the vascular stent to the blood vessel. area, and reduce the chronic external expansion force of the stent, thereby avoiding the probability of in-stent restenosis.
  • the film is coated with drugs, thereby greatly increasing the drug adhesion area and providing more drug adhesion methods.
  • the drugs that can be coated on the surface of the film include but are not limited to drug polymers
  • a carrier or active agent eg, a biologically active agent
  • administered locally to the therapeutic substance achieves anti-angiogenesis and anti-endothelialization.
  • the material of the support unit is one of stainless steel, memory alloy, titanium alloy, tantalum alloy, cobalt-chromium alloy, biodegradable metal, biodegradable polymer, magnesium alloy, and pure iron or more, preferably Nitinol.
  • the material of the film is one or more of polytetrafluoroethylene, block polyetheramide, polyimide, and bioabsorbable medical materials.
  • the film is made of Polytetrafluoroethylene microporous membrane.
  • the peripheral blood vessel stent of the present invention is suitable for endovascular treatment of various peripheral blood vessels including superficial femoral artery, iliac artery, carotid artery, radial artery, lower extremity artery and the like.
  • the peripheral blood vessel stent of the present invention is particularly suitable for blood vessels that are subject to large deformation.
  • the support unit in the present invention may be a self-expanding or balloon-expandable support unit.
  • the second aspect of the present invention is to provide a method for preparing the peripheral blood vessel stent.
  • the membrane is fixed with the support unit, and then a plurality of hollow areas are formed on the membrane.
  • the third aspect of the present invention is to provide a method for preparing the peripheral blood vessel stent, wherein a plurality of hollow areas are formed on the membrane, and then the membrane is fixed to the supporting unit.
  • the fourth aspect of the present invention is to provide a method for preparing the peripheral vascular stent, wherein the intima and the adventitia are respectively arranged on the inner side and the outer side of the supporting unit, and the supporting unit is covered by heating the intima and the adventitia. Between the inner membrane and the outer membrane, the inner membrane and the outer membrane other than the support unit are thermally fused to form a membrane integrally, and then a plurality of hollow areas are formed on the membrane.
  • a fifth aspect of the present invention is to provide a method for preparing the peripheral vascular stent, wherein a plurality of hollow areas are opened on the intima and the adventitia respectively, and then the intima and the adventitia are respectively arranged on the supporting unit
  • the inner and outer sides of the inner membrane are aligned, and the hollow area on the inner membrane and the outer membrane are aligned, and the supporting unit is wrapped between the inner membrane and the outer membrane by heating,
  • the inner film and the outer film other than the support unit are thermally fused to form a film integrally.
  • the sixth aspect of the present invention is to provide an application of the peripheral vascular stent in endovascular treatment.
  • the present invention has the following advantages compared with the prior art:
  • the peripheral blood vessel stent of the present invention can meet the mechanical performance requirements of the peripheral blood vessel in various deformation states, the peripheral blood vessel stent of the present invention can take into account suitable radial support force and good flexibility, and can well reduce the internal volume of the peripheral blood vessel stent.
  • the peripheral vascular stent of the present invention has the advantages of little influence on blood flow, little damage to the inner wall of the blood vessel, and is not easy to cause secondary thrombosis.
  • FIG. 1 is a perspective view of a blood vessel stent provided in Embodiment 1 of the present invention.
  • FIG. 2 is a schematic structural diagram of the vascular stent according to Embodiment 1 of the present invention, which is cut along the axial direction and unfolded into a plane;
  • Example 3 is a partial enlarged view of the vascular stent provided in Example 1 of the present invention.
  • Fig. 4 is the A-A sectional view of Fig. 3;
  • Fig. 5 is a partial enlarged view of Fig. 4;
  • Fig. 6 is the B-B sectional view of Fig. 3;
  • Fig. 7 is a partial enlarged view of Fig. 6;
  • FIG. 8 is a schematic diagram of the preparation process of the blood vessel stent of Example 1.
  • FIG. 8 is a schematic diagram of the preparation process of the blood vessel stent of Example 1.
  • first and second are only used for descriptive purposes, and should not be construed as indicating or implying relative importance or implying the number of indicated technical features. Thus, a feature defined as “first” or “second” may expressly or implicitly include one or more of that feature.
  • “plurality” means two or more, unless otherwise expressly and specifically defined.
  • the first feature "on” or “under” the second feature may include the first and second features in direct contact, or may include the first and second features The two features are not in direct contact but through another feature between them.
  • the first feature being “above”, “over” and “above” the second feature includes the first feature being directly above and obliquely above the second feature, or simply means that the first feature is level higher than the second feature.
  • the first feature is “below”, “below” and “beneath” the second feature includes the first feature being directly above and obliquely above the second feature, or simply means that the first feature is level less than the second feature.
  • this embodiment provides a peripheral vascular stent, which includes A plurality of support units 1 and membranes 2 .
  • Each support unit 1 is formed of a wire and is a closed loop, wherein the wire can be a single wire that is cut and shaped from a pipe or made in other forms, or a wire that is twisted and braided by multiple wires.
  • the material of the wire includes but is not limited to one or more of stainless steel, memory alloy, titanium alloy, tantalum alloy, cobalt-chromium alloy, biodegradable metal, biodegradable polymer, magnesium alloy, pure iron, formed by wire
  • the support unit 1 can be a self-expanding support unit, or a support unit that needs to be expanded by means of a balloon or the like; preferably, the wire is made of nickel-titanium alloy, which can realize self-expansion, thereby providing better support force.
  • Each support unit 1 includes a plurality of peaks 11 and valleys 12 periodically arranged along the circumferential direction with the axis of the peripheral blood vessel stent as the axis, and two adjacent peaks are one cycle.
  • the shape of the filaments constituting one cycle may be any shape as long as it has peaks and valleys, including but not limited to V-shape, U-shape, and the like.
  • the axis of each support unit 1 coincides with the axis of the peripheral vascular stent.
  • the inner diameters of the plurality of support units 1 in the unfolded state gradually decrease from one end to the other end, so as to meet the physiological characteristics of the lower extremity artery diameter of the human body decreasing in a tapered shape, and effectively improve the vascular stents.
  • the inner diameters of the plurality of support units 1 in the unfolded state gradually decrease from one end to the other end, so as to meet the physiological characteristics of the lower extremity artery diameter of the human body decreasing in a tapered shape, and effectively improve the vascular stents.
  • For the application area of the blood vessel and reduce the chronic external expansion force of the stent, thereby significantly reducing the probability of in-stent restenosis.
  • a plurality of supporting units 1 are connected by a membrane 2 covered on the supporting unit 1.
  • the flexibility of the membrane 2 is greater than that of the supporting unit 1, so that the peripheral blood vessel stent adopts a flexible connection without metal
  • the fatigue damage of the connecting structure, and the flexible structure in the process of shortening, torsion, buckling, stretching, etc., is less irritating to endothelial cells, thereby reducing vascular damage and meeting the shortening rate of arteries under various deformation states.
  • the material of the membrane 2 includes, but is not limited to, polytetrafluoroethylene, block polyetheramide, polyimide, and bioabsorbable medical materials.
  • the membrane 2 is a polytetrafluoroethylene microporous membrane (ePTFE).
  • the film 2 may be a single-layer film or a double-layer film.
  • the membrane 2 When the membrane 2 is a single-layer membrane, the membrane 2 can be arranged on the inner side of the support unit 1 to minimize the influence of the peripheral vascular stent on blood flow; The contact area of the blood vessel wall reduces the damage of the peripheral blood vessel stent to the blood vessel wall.
  • the membrane 2 is a double-layer membrane, that is, as shown in FIG. 8 , the membrane 2 includes an intima 21 located inside the support unit 1 and an adventitia 22 located outside the support unit 1 , which can reduce the impact of the peripheral vascular stent on the The influence of blood flow can also reduce the damage of the peripheral vascular stent to the vascular wall.
  • a plurality of hollow areas 23 are opened between the wires of the same support unit 1 and/or between the two adjacent support units 1, so that when the blood vessel is When the bracket is bent or twisted, the hollow area 23 can provide an escape space.
  • the hollow area 23 is provided on the membrane 2 between the wires of the same support unit 1 and between two adjacent support units 1 .
  • the support unit 1 is wrapped inside the membrane 2, and the support unit 1 without the support unit 1 protrudes to the hollow area 23 and the support unit 1 does not directly contact the blood vessel wall.
  • the area of the hollow area 23 is set as large as possible.
  • one supporting unit 1 and the other supporting unit 1 are staggered (staggered) on the circumferential surface, and the staggered distance d is less than one half of the period, preferably staggered The distance d is less than or equal to a quarter period. In this embodiment, as shown in FIG. 2 , the staggered distance d is a quarter period.
  • the clockwise direction is consistent with the clockwise rotation direction; in the clockwise direction , each support unit 1 is staggered from the adjacent one of the support units 1 on the circumferential surface and by the same distance.
  • each support unit 1 in the counterclockwise direction, each support unit 1 The same effect can be obtained with the vascular stent obtained by the solution in which the adjacent one supporting unit 1 is staggered on the circumferential surface and staggered by the same distance.
  • FIG. 2 when the peripheral vascular stent is cut along its axial direction and expanded into a plane, the next supporting unit 1 is relatively opposite to the previous one.
  • the support unit 1 is always staggered to the left by the same distance, so that the peaks and peaks, valleys and valleys, and peaks and valleys in two adjacent support units are not aligned in the axial direction.
  • each hollow area 23 in this embodiment includes a first hollow part 231 located in the peak 11 of each support unit 1 , and a second hollow part 231 located in the valley 12 of each support unit 1 .
  • the hollow part 232 and the third hollow part 233 are located between the two adjacent supporting units 1 and communicate with the first hollow part 231 and the second hollow part 232 respectively.
  • each third hollow portion 233 is only communicated with its nearest first hollow portion 231 and the second hollow portion 232, and the hollow regions 23 are not connected to each other independently, so that in two adjacent supporting units 1, The valley bottom of one support unit 1 and the nearest peak of the other support unit 1 are connected only by the strip-shaped membrane 2 .
  • first hollow portion 231 is surrounded by the first wall 211 and the second wall 212 connected by the upper ends
  • second hollow portion 232 is surrounded by the third wall 213 and the fourth wall 214 connected by the lower ends
  • the third hollow portion 233 consists of a fifth wall 215 connected to the lower end of the first wall 211 and the upper end of the fourth wall 214 respectively, and a sixth wall 216 connected to the lower end of the second wall 212 and the upper end of the third wall 213 respectively. surrounded by.
  • the first wall 211 is parallel to the third wall 213, the second wall 212 is parallel to the fourth wall 214; the plurality of first walls 211 are parallel to each other, the plurality of second walls 212 are parallel to each other, and the first The included angle between the wall 211 and the second wall 212 is an acute angle.
  • FIG. 2 when the peripheral vascular stent is cut along its axial direction and expanded into a plane, the two nearest first walls 211 in the two adjacent supporting units 1 are on the first straight line L, and the first straight line The line L is arranged obliquely, that is, the first straight line L intersects the length direction of the peripheral blood vessel stent.
  • the staggered arrangement of the support unit 1 and the structural design of the hollow area 23 enable the peripheral vascular stent to form a similar helical structure, so that the peripheral vascular stent can better maintain a circular shape in cross-section when it is bent, twisted, etc.
  • the vascular stent collapses; and the structural design enables the peripheral vascular stent to have better flexion, torsion, axial compression and tensile properties, as well as better compliance and radial support properties.
  • the inner membrane 21 and the outer membrane 22 are arranged on the inner and outer sides of the support unit 1 respectively, and the inner membrane 21 and the outer membrane 22 are heated so that the supporting unit 1 is wrapped between the inner membrane 21 and the outer membrane 22 , the inner membrane 21 and the outer membrane 22 outside the support unit 1 are thermally fused to form a membrane 2, and then a plurality of hollow areas 23 are opened on the membrane 2; or, the inner membrane 21 and the outer membrane 22 are respectively A plurality of hollow areas 23 are opened on the inner film 21, and then the inner film 21 and the outer film 22 are respectively arranged on the inner side and the outer side of the support unit 1, and the hollow areas 23 on the inner film 21 and the outer film 22 are respectively arranged.
  • the hollow areas 23 are aligned, and the support unit 1 is wrapped between the inner membrane 21 and the outer membrane 22 by heating, and the inner membrane 21 and the outer membrane outside the support unit 1 22 is thermally fused to form the film 2 integrally.
  • Coated drugs include, but are not limited to, drug polymer carriers or active agents (eg, bioactive agents), topical administration of therapeutic substances, and anti-angiogenesis and anti-endothelialization.
  • the two examples are basically the same as Example 1, the only difference is that the film 2 of Example 2 is a single-layer film arranged on the inner side of the support unit 1, and the film 2 of Example 3 is a film 2 arranged on the support unit 1. Outer monolayer.
  • the film 2 and the support unit 1 are fixed by means of heat fusion, sewing, etc., and then a plurality of hollow areas 23 are opened on the film 2; or, a plurality of hollow areas 23 are formed on the film 2, and then the film 2 and the support unit 1 It is fixed by heat fusion, stitching, etc.
  • the peripheral blood vessel stent has an expanded state and a contracted state, and the inner diameter of the expanded state is larger than the inner diameter of the contracted state.
  • the structures of the peripheral vascular stents of the above-mentioned Embodiments 1 to 3 are described when the peripheral vascular stent is in a deployed state.
  • peripheral vascular stent of the three embodiments When the peripheral vascular stent of the three embodiments is transported into the blood vessel, it is stored in the delivery mechanism and is in a contracted state. When the peripheral vascular stent is transported to the desired part of the blood vessel, after the delivery mechanism is retracted, the peripheral vascular stent is automatically expanded to The deployed state supports the vessel.
  • the plurality of mutually independent support units 1 in the vascular stent of the present invention are connected by a flexible membrane 2 with a hollow area 23.
  • the flexible structure is connected without the fatigue damage of the metal connection structure, and the shortening process is shortened.
  • the medium-flexible structure is less irritating to endothelial cells, thereby reducing vascular damage, and can adapt to the shortening rate of the artery under various deformation states;
  • the arrangement of the hollow area 23 enables the vascular stent of the present invention to adapt to peripheral blood vessels Deformation in the torsion state, and the flexible structure is less irritating to endothelial cells during the torsion process, thereby reducing vascular damage;
  • the vascular stent of the present invention does not have the "fish scale phenomenon" and fatigue damage of the metal stent in the flexed state.
  • the present invention can realize bending under a small radius of curvature without damaging the vascular endothelium; fourthly, the flexible connection arrangement enables the vascular stent of the present invention to have sufficient axial tension
  • a plurality of closed annular support units 1 arranged at intervals along the axial direction can provide sufficient radial support force and can withstand the radial force and pressure of the peripheral blood vessels. Collapsing or pinch load, effectively supporting the artery to provide adequate blood flow.

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Abstract

一种外周血管支架及其制备方法和应用，外周血管支架包括多个支撑单元（1）和膜（2），每个支撑单元（1）由丝线形成且为封闭的环状，每个支撑单元（1）包括多个沿圆周方向周期排列的峰、谷，相邻的两个峰顶为一个周期；膜（2）覆设在多个支撑单元（1）上，膜（2）的柔性大于支撑单元（1）的柔性，同一个支撑单元（1）的丝线之间和/或相邻两个支撑单元（1）之间的膜（2）上开设有多个镂空区域（23），相邻两个支撑单元（1）仅通过镂空区域（23）以外的膜（2）相连接。血管支架能够满足下肢动脉各种变形状态下的机械性能要求，具有合适的径向支撑力和良好的柔顺性，能够很好的减小血管支架内的慢性外扩力；血管支架对血流的影响小，对血管内壁的损伤小，具有不易引起继发血栓形成的优点。

Description

一种外周血管支架及其制备方法和应用 技术领域
本发明属于医疗器械技术领域，具体涉及一种外周血管支架及其制备方法和应用。
背景技术
动脉粥样硬化导致的下肢动脉硬化闭塞症(peripheral artery disease，PAD)是仅次于冠心病、脑卒中的第三位粥样硬化性心血管疾病。全球有超过3亿人患有PAD，该病的演进会造成跛行、静息痛、截肢，严重影响患者的生活质量。PAD的治疗方法主要有药物、开放手术和腔内介入治疗方式。随着介入治疗PAD的发展，介入治疗被证明创伤更小且疗效更好，从而已成为治疗PAD的主要方式。腔内介入最常见的两种方式是经皮腔内球囊扩张和腔内支架置入术。前者的不足之处是1年通畅率仅为28％-37％，而后者的出现明显提高了病变血管的近远期通畅率。
目前常用的血管支架主要有切割型和编织型两大类，其中编织型支架主要通过金属丝编织而成，而切割型支架包括沿轴向间隔分布且为金属材质的多个封闭环、以及用于将相邻两个封闭环连接的金属材质的连接件。其中编织型支架有一定的柔顺性和抗疲劳性能，但轴向短缩率非常高并且径向支撑力相对较弱；而切割型支架通过具有较好的径向支撑力以及较小的轴向短缩率，但是其柔顺性较差。
另外人体的下肢动脉具有独特的生理特点、病理特点、运动力学特点、流体力学特点等，但现有的外周动脉支架均无法完全满足下肢动脉的独特要求，并且下肢动脉疾病在支架治疗后，约40％以上患者会因支架慢性外扩力、支架内低剪切力诱发支架内再狭窄。外周动脉支架需在保证一定径向支撑力的情况下，克服慢性外扩力和低剪切力等力学因素，但现有外周动脉支架均无法达到这一要求，这是导致外周动脉支架植入手术后再干预率居高不下的最主要原因。
发明内容
本发明所要解决的一个技术问题是提供一种具有足够的径向支撑力和良好的柔顺性，可以适用于外周血管的血管支架。
本发明所要解决的第二个技术问题是提供一种上述血管支架的制备方法。
本发明所要解决的第三个技术问题是提供一种上述血管支架在血管内治疗中的应用。
为达到上述目的，本发明采用的技术方案是：
本发明一方面提供一种外周血管支架，其具有展开状态和收缩状态，所述外周血管支架处于展开状态时的内径大于其处于收缩状态时的内径；所述外周血管支架包括：
支撑单元，所述支撑单元为沿着所述外周血管支架的轴向依次间隔设置的多个，每个所述支撑单元由丝线形成且为封闭的环状，每个所述支撑单元包括多个沿圆周方向周期排列的峰、谷，相邻的两个峰顶为一个周期；
膜，所述膜覆设在多个所述支撑单元上，所述膜的柔性大于所述支撑单元的柔性，同一个所述支撑单元的丝线之间和/或相邻两个所述支撑单元之间的所述膜上开设有多个镂空区域，相邻两个所述支撑单元仅通过所述镂空区域以外的所述膜相连接。
由于下肢动脉不同与其他非运动的动脉血管(如冠状动脉、颈动脉、主动脉)，其长期在下肢活动下处于各种变形状态，如下蹲后的腘动脉：短缩率为13％-25％，弯曲后曲率半径为8-17mm，扭曲度为14-26°/cm。这些运动后的动脉变形对于支架会造成径向压缩、扭转、屈曲、轴向拉伸和压缩等作用，而现有的外周血管支架受限于均质性设计，因此材料的柔顺性和支撑力无法同时兼顾，故而无法同时满足上述下肢动脉的特点。本发明的血管支架超越均质性设计的局限，支架中的多个支撑单元之间没有金属连接，仅通过柔性的且开设有镂空区域的膜进行连接，第一方面，柔性结构连接无金属连接结构存在的疲劳损伤，并且短缩过程中柔性结构对内皮细胞刺激性小，从而减少了血管损伤，并且可以适应动脉在各种变形状态下的短缩率；第二方面，本发明结构的血管支架可以满足外周血管扭转状态下的变形，并且扭转过程中柔性结构对内皮细胞刺激性小，从而减少了血管损伤；第三方面，本发明结构的血管支架在屈曲状态下无金属支架存在的“鱼鳞现象”、疲劳损伤，尤其在胯关节的外周血管中(如腘动脉等)，本发明可实现小曲率半径下弯曲且不损伤血管内皮；第四方面，本发明结构的血管支架由于采用柔性连接，因此存在足够轴向拉伸率，可满足外周血管轴向拉伸变形；第五方面，本发明的血管支架的轴向上采用间隔设置的多个封闭环状的支撑单元，因此可提供足够的径向支撑力，可以承受外周血管的径向力和压溃或箍缩负荷，有效支撑动脉，提供足够血流。
根据一些具体且优选实施方式，在相邻的两个所述支撑单元中，一个支撑单元和另一个支撑单元在圆周面上错开设置，错开的距离为小于二分之一个周期，从而使得血管支架具有更好的屈曲、扭转、轴向压缩和拉伸性能。
进一步优选地，所述的错开的距离为小于等于四分之一个周期。
进一步优选地，在沿着顺时针方向上，每个所述支撑单元都与相邻的一个支撑单元在所述 圆周面上错开设置并且错开的距离相同，从而支撑单元总体上能够形成类似螺旋的结构，从而使得血管支架在弯曲、扭转等状态下，能够更好的维持血管支架的横截面呈圆形，避免血管支架塌陷。
需要说明的是，文中的顺时针方向，仅是为了便于描述，而不构成对本申请保护范围的限定，当沿着逆时针方向时，能够实现相同的技术效果，也在本申请的保护范围之内。
根据一些具体且优选实施方式，每个所述支撑单元的轴心线与所述外周血管支架的轴心线重合。本申请中每个所述支撑单元的轴心线与所述外周血管支架的轴心线重合的意思是：当所述外周血管支架包括主支架以及与所述主支架相连接的分支架时，位于所述主支架部分的所述支撑单元的轴心线与所述主支架的轴心线重合，位于所述分支架部分的所述支撑单元的轴心线与所述分支架的轴心线重合；当所述外周血管支架无分支时，每个所述支撑单元的轴心线与所述外周血管支架的轴心线重合。
根据一些具体且优选实施方式，所述镂空区域包括
位于每个所述支撑单元的峰内的第一镂空部、
位于每个所述支撑单元的谷内的第二镂空部、
位于相邻两个所述支撑单元之间且分别与所述第一镂空部和所述第二镂空部相连通的多个第三镂空部；从而使得血管支架具有更好的柔顺性，能够更好的随着血管进行屈曲、扭转等。
在一些实施方式中，相邻两个所述支撑单元之间的多个第三镂空部中的部分可以相互连通，但不能全部连通而导致相邻两个支撑单元之间没有膜连接而分离。
进一步地，每个所述第三镂空部仅与其最近的第一镂空部和第二镂空部相连通，从而使得相邻两个支撑单元之间的连接位置较多，进而使得相邻两个支撑单元之间的连接更加牢固。
根据一些具体且优选实施方式，在相邻的两个所述支撑单元中，一个支撑单元的谷底与另一个支撑单元的最近的一个峰顶之间仅通过条状的膜相连接。
根据一些更加具体且优选实施方式，所述第一镂空部由上端部相连接的第一壁和第二壁围设而成，所述第二镂空部由下端部相连接的第三壁和第四壁围设而成，
所述第三镂空部由分别与所述第一壁下端和所述第四壁上端相连接的第五壁、分别与所述第二壁下端和所述第三壁上端相连接的第六壁围设而成。
进一步优选地，所述第一镂空部和所述第二镂空部尽可能大，只需要保证膜将所述支撑单元包覆即可，另外，由于相邻两个所述支撑单元错开设置，因此，所述第一镂空部和第二镂空部也错开设置，从而使镂空区域形成两个错开且倒置的三角形，从而使得血管支架具有更好的 柔顺性，能够更好的随着血管进行屈曲、扭转等。
进一步优选地，当所述外周血管支架沿着其轴向剖开并展开成平面状时，相邻的两支撑单元中最近的两个第一壁在第一直线上，所述第一直线倾斜设置，从而使得血管支架能够形成类似螺旋结构，从而使得血管支架在弯曲、扭转等状态下，能够更好的维持横截面上呈圆形，避免血管支架塌陷。
进一步优选地，所述第一壁与所述第二壁的夹角为锐角。
进一步优选地，所述第一壁和所述第三壁相平行，所述第二壁和所述第四壁相平行，多个所述第二壁相平行。
根据一些具体且优选实施方式，所述膜包覆在所述支撑单元的外侧或/和内侧，从而使得本发明的血管支架对血管内血流的影响较小，从而降低支架植入术后血流紊乱及切应力/切变率异常的发生概率，从而降低血管内一系列炎症和血管损伤的发生概率。并且本发明通过在支撑单元外覆设较为柔软的膜，有效增加了血管支架与血管的贴敷面积，从而增加了血管支架对于血管的拔出力，从而在保持足够的径向支撑力和良好的柔顺性的同时更加降低了血管支架的慢性外扩力。并且，一方面覆膜设计在一定程度上封闭外周血管的夹层破口；另一方面膜上开设镂空区域，相比全覆膜设计，可避免完全覆盖分支血管，从而适用于分支血管较多的外周血管中，如腘动脉。
根据一些具体且优选实施方式，所述膜包括位于所述支撑单元内侧的内膜以及位于所述支撑单元外侧的外膜，所述内膜和所述外膜相固定连接，并且所述支撑单元被包覆于所述内膜和所述外膜之间。
进一步地，相接触的所述内膜和所述外膜被热熔成一体形成所述膜。
根据一些优选实施方式，所述外周血管支架在展开状态时的内径自一端向另一端逐渐减小，从而满足人体下肢动脉直径呈锥形减小的生理特点，有效提高血管支架对于血管的贴敷面积，并减小支架的慢性外扩力，从而避免支架内再狭窄的发生概率。
根据一些具体且优选实施方式，所述膜上涂覆有药物，从而大大增加了药物附着面积以及提供了更多的药物附着方式，可在膜的表面涂覆的药物包括但不限于药物聚合物载体或活性剂(例如生物活性剂)，局部给予治疗物质，实现抗血管增生和抗内皮化。
根据一些具体且优选实施方式，所述支撑单元的材质为不锈钢、记忆合金、钛合金、钽合金、钴铬合金、生物可降解金属、生物可降解聚合物、镁合金、纯铁中的一种或多种，优选为镍钛合金。
根据一些具体且优选实施方式，所述膜的材质为聚四氟乙烯、嵌段聚醚酰胺、聚酰亚胺、生物可吸收医用材料中的一种或多种，优选地，所述膜为聚四氟乙烯多微孔膜。
本发明的外周血管支架适用于包括股浅动脉、髂动脉、颈动脉、桡动脉、下肢动脉等各种外周血管进行血管内治疗。其中，本发明的外周血管支架特别适用于会发生较大形变的血管。
本发明中的支撑单元可以是自扩张或球囊扩张的支撑单元。
本发明的第二方面是提供一种所述的外周血管支架的制备方法，将膜与支撑单元相固定，然后在所述膜上开设多个镂空区域。
本发明的第三方面是提供一种所述的外周血管支架的制备方法，在膜上开设多个镂空区域，然后将膜与支撑单元相固定。
本发明的第四方面是提供一种所述的外周血管支架的制备方法，将内膜和外膜分别设置在支撑单元的内侧和外侧，通过对内膜和外膜加热使得支撑单元被包覆在所述内膜和所述外膜之间，支撑单元之外的所述内膜和所述外膜被热熔为一体形成膜，再在膜上开设多个镂空区域。
本发明的第五方面是提供一种所述的外周血管支架的制备方法，分别在内膜和外膜上开设多个镂空区域，然后将所述内膜和所述外膜分别设置在支撑单元的内侧和外侧，并使所述内膜上的镂空区域和所述外膜上的镂空区域相对齐，通过加热使得所述支撑单元被包覆在所述内膜和所述外膜之间，支撑单元之外的所述内膜和所述外膜被热熔为一体形成膜。
本发明的第六方面是提供一种所述外周血管支架在血管内治疗中的应用。
由于上述技术方案运用，本发明与现有技术相比具有下列优点：
本发明的外周血管支架能够满足外周血管各种变形状态下的机械性能要求，本发明的外周血管支架可以兼顾合适的径向支撑力和良好的柔顺性，能够很好的减小外周血管支架内的慢性外扩力，减小外周血管支架内再狭窄的发生率，并且，本发明的外周血管支架对血流的影响小，对血管内壁的损伤小，不易引起继发血栓形成的优点。
附图说明
为了更清楚地说明本申请实施例技术方案，下面将对实施例描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1为本发明实施例1提供的血管支架的立体图；
图2为本发明实施例1的血管支架沿轴向剖开并展开成平面的结构示意图；
图3为本发明实施例1提供的血管支架的局部放大图；
图4为图3的A-A剖面图；
图5为图4的局部放大图；
图6为图3的B-B剖面图；
图7为图6的局部放大图；
图8为实施例1的血管支架制备过程中的示意图。
具体实施方式
在下文中，仅简单地描述了某些示例性实施例。正如本领域技术人员可认识到的那样，在不脱离本发明实施例的精神或范围的情况下，可通过各种不同方式修改所描述的实施例。因此，附图和描述被认为本质上是示例性的而非限制性的。
在本发明实施例的描述中，需要理解的是，术语“长度”、“内”、“上”等指示的方位或位置关系为基于附图1所示的方位或位置关系，仅是为了便于描述本发明实施例和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明实施例的限制。
此外，术语“第一”、“第二”仅用于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”的特征可以明示或者隐含地包括一个或者更多个该特征。在本发明实施例的描述中，“多个”的含义是两个或两个以上，除非另有明确具体的限定。
在本发明实施例中，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”、“固定”等术语应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或成一体；可以是机械连接，也可以是电连接，还可以是通信；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本发明实施例中的具体含义。
在本发明实施例中，除非另有明确的规定和限定，第一特征在第二特征之“上”或之“下”可以包括第一和第二特征直接接触，也可以包括第一和第二特征不是直接接触而是通过它们之间的另外的特征接触。而且，第一特征在第二特征“之上”、“上方”和“上面”包括第一特征在第二特征正上方和斜上方，或仅仅表示第一特征水平高度高于第二特征。第一特征在第二特征“之下”、“下方”和“下面”包括第一特征在第二特征正上方和斜上方，或仅仅表示第一特征水平高度小于第二特征。
下文的公开提供了许多不同的实施方式或例子用来实现本发明实施例的不同结构。为了简 化本发明实施例的公开，下文中对特定例子的部件和设置进行描述。当然，它们仅仅为示例，并且目的不在于限制本发明实施例。此外，本发明实施例可以在不同例子中重复参考数字和/或参考字母，这种重复是为了简化和清楚的目的，其本身不指示所讨论各种实施方式和/或设置之间的关系。
下面结合附图对本发明的实施例进行详细说明。
实施例1
请参照图1-图8，为了解决现有的血管支架不能够很好的适应在运动过程中具有较大变形的血管，例如下肢动脉的要求，本实施例提供一种外周血管支架，其包括多个支撑单元1和膜2。
如图1和图2所示，多个支撑单元1沿着外周血管支架的轴向依次间隔设置。每个支撑单元1由丝线形成且为封闭的环状，其中丝线可以是管材经切割定型而成或其他形式制成的单丝，也可以是采用多根丝线绞合编织而成的一根丝线，丝线的材质包括但不限于不锈钢、记忆合金、钛合金、钽合金、钴铬合金、生物可降解金属、生物可降解聚合物、镁合金、纯铁中的一种或多种，由丝线形成的支撑单元1可以是自扩张的支撑单元，也可以需要借助球囊等进行扩张的支撑单元；优选地，丝线采用镍钛合金，其能够实现自扩张，从而能够提供更好的支撑力。
每个支撑单元1包括多个以外周血管支架的轴心线为轴心并沿圆周方向周期排列的峰11、谷12，并且相邻的两个峰顶为一个周期。其中，构成一个周期的丝线的形状只要是具有峰和谷的形状即可，包括但不限于V型、U型等。每个支撑单元1的轴心线与外周血管支架的轴心线重合。为了适应下肢动脉逐渐呈锥形的结构，多个支撑单元1在展开状态时的内径自一端向另一端逐渐变小，从而满足人体下肢动脉直径呈锥形减小的生理特点，有效提高血管支架对于血管的贴敷面积，并减小支架的慢性外扩力，从而显著降低支架内再狭窄的发生概率。
如图1和图2所示，多个支撑单元1通过覆设在支撑单元1上的膜2进行连接，膜2的柔性大于支撑单元1的柔性，从而使得外周血管支架采用柔性连接，无金属连接结构存在的疲劳损伤，并且短缩、扭转、屈曲、拉伸等过程中柔性结构对内皮细胞刺激性小，从而减少了血管损伤，并且可以满足动脉在各种变形状态下的短缩率。膜2的材质包括但不限于聚四氟乙烯、嵌段聚醚酰胺、聚酰亚胺、生物可吸收医用材料，优选膜2为聚四氟乙烯多微孔膜(ePTFE)。
其中，膜2可以是单层膜或者是双层膜。当膜2为单层膜时，膜2可以设置在支撑单元1的内侧从而尽可能减小外周血管支架对血流的影响；膜2也可以设置在支撑单元1的外侧从而 增加外周血管支架与血管壁的接触面积，减小外周血管支架对血管壁的损伤。本实施例中，膜2为双层膜，即如图8所示，膜2包括位于支撑单元1内侧的内膜21以及位于支撑单元1外侧的外膜22，既可以减小外周血管支架对血流的影响，又可以减小外周血管支架对血管壁的损伤。
为了使得外周血管支架能够更好的进行弯曲和扭转，同一个支撑单元1的丝线之间和/或相邻两个支撑单元1之间的膜2上开设有多个镂空区域23，从而当血管支架弯曲或扭转时，镂空区域23可以提供避让空间。本实施例如图1至3所示，镂空区域23开设在同一个支撑单元1的丝线之间和相邻两个支撑单元1之间的膜2上。支撑单元1被包覆于膜2的内部，而无支撑单元1伸出至镂空区域23且支撑单元1不直接与血管壁接触，较为优选地，镂空区域23的面积设置为尽可能大。
具体地，在相邻的两个支撑单元1中，一个支撑单元1和另一个支撑单元1在圆周面上错开(错峰)设置，错开的距离d为小于二分之一个周期，优选错开的距离d为小于等于四分之一个周期。本实施例如图2所示，错开的距离d为四分之一个周期。并且，以如图1所示的血管支架的横截面为圆周面，并且按照图1中的方位向下观察该圆周面时，与时针转动方向一致为顺时针方向；在沿着顺时针方向上，每个支撑单元1都与相邻的一个支撑单元1在圆周面上错开设置并且错开的距离相同，当然，本领域技术人员可以预期“在沿着逆时针方向上，每个支撑单元1都与相邻的一个支撑单元1在圆周面上错开设置并且错开的距离相同”的方案所得到的血管支架可以获得相同的效果。为了更清楚的阐述相邻两个支撑单元1之间错开设置的结构，如图2所示，当外周血管支架沿着其轴向剖开并展开成平面时，下一个支撑单元1相对上一个支撑单元1总是向着左侧错开相同的距离，从而使得相邻两个支撑单元中的峰顶和峰顶、谷底和谷底、峰顶和谷底在轴线方向上均不对齐。
具体地，如图2所示，本实施例中的每个镂空区域23包括位于每个支撑单元1的峰11内的第一镂空部231、位于每个支撑单元1的谷12内的第二镂空部232、位于相邻两个支撑单元1之间且分别与第一镂空部231和第二镂空部232相连通的第三镂空部233。并且，每个第三镂空部233仅与其最近的第一镂空部231和第二镂空部232相连通，各个镂空区域23之间相互独立不连通，使得在相邻的两个支撑单元1中，一个支撑单元1的谷底与另一个支撑单元1的最近的一个峰顶之间仅通过条状的膜2相连接。
进一步地，第一镂空部231由上端部相连接的第一壁211和第二壁212围设而成，第二镂空部232由下端部相连接的第三壁213和第四壁214围设而成，第三镂空部233由分别与第一 壁211下端和第四壁214上端相连接的第五壁215、分别与第二壁212下端和第三壁213上端相连接的第六壁216围设而成。第一壁211和第三壁213相平行，第二壁212和第四壁214相平行；多个第一壁211之间相互平行，多个第二壁212之间相互平行，并且，第一壁211和第二壁212之间的夹角为锐角。如图2所示，当外周血管支架沿着其轴向剖开并展开成平面时，相邻的两支撑单元1中最近的两个第一壁211在第一直线L上，第一直线L倾斜设置，即第一直线L与外周血管支架的长度方向相交。支撑单元1的错开设置以及镂空区域23的结构设计，使得外周血管支架能够形成类似螺旋结构，从而使得外周血管支架在弯曲、扭转等状态下，能够更好的维持横截面上呈圆形，避免血管支架塌陷；并且，该结构设计使得外周血管支架具有更好的屈曲、扭转、轴向压缩和拉伸性能的同时，具有更好的柔顺性和径向支撑性能。
该实施例的外周血管支架的制备方法为：
将内膜21和外膜22分别设置在支撑单元1的内侧和外侧，通过对内膜21和外膜22加热使得支撑单元1被包覆在所述内膜21和所述外膜22之间，支撑单元1之外的所述内膜21和所述外膜22被热熔为一体形成膜2，再在膜2上开设多个镂空区域23；或者，分别在内膜21和外膜22上开设多个镂空区域23，然后将所述内膜21和所述外膜22分别设置在支撑单元1的内侧和外侧，并使所述内膜21上的镂空区域23和所述外膜22上的镂空区域23相对齐，通过加热使得所述支撑单元1被包覆在所述内膜21和所述外膜22之间，支撑单元1之外的所述内膜21和所述外膜22被热熔为一体形成膜2。
该实施例中，内膜21的外表面、外膜22的外表面以及内膜21和外膜22之间的面上可以选择性地涂覆有药物，从而大大增加了药物附着面积和方式，涂覆的药物包括但不限于药物聚合物载体或活性剂(例如生物活性剂)，局部给予治疗物质，实现抗血管增生和抗内皮化。
实施例2和实施例3
该两个实施例与实施例1基本相同，不同之处仅在于：实施例2的膜2为设置在支撑单元1的内侧的单层膜，实施例3的膜2为设置在支撑单元1的外侧的单层膜。
该两个实施例的外周血管支架的制备方法为：
将膜2与支撑单元1通过热熔、缝合等方式相固定，然后在膜2上开设多个镂空区域23；或者，在膜2上开设多个镂空区域23，然后将膜2与支撑单元1通过热熔、缝合等方式相固定。
外周血管支架具有展开状态和收缩状态，且展开状态时的内径大于收缩状态时的内径。上 述实施例1至3的外周血管支架的结构是以外周血管支架处于展开状态时进行描述的。
该3个实施例的外周血管支架在输送进入血管的过程中，收纳于输送机构中且处于收缩状态，当输送至血管的所需部位时，回撤输送机构后，该外周血管支架自动展开至展开状态以对血管进行支撑。
本发明的血管支架中的多个相互独立的支撑单元1通过柔性的且开设有镂空区域23的膜2进行连接，第一方面，柔性结构连接无金属连接结构存在的疲劳损伤，并且短缩过程中柔性结构对内皮细胞刺激性小，从而减少了血管损伤，并且可以适应动脉在各种变形状态下的短缩率；第二方面，镂空区域23的设置使得本发明的血管支架可以适应外周血管扭转状态下的变形，并且扭转过程中柔性结构对内皮细胞刺激性小，从而减少了血管损伤；第三方面，本发明的血管支架在屈曲状态下无金属支架存在的“鱼鳞现象”、疲劳损伤，尤其在胯关节的外周血管中(如腘动脉等)，本发明可实现小曲率半径下弯曲而不损伤血管内皮；第四方面，柔性连接的设置使得本发明的血管支架存在足够轴向拉伸率，可满足外周血管轴向拉伸变形；第五方面，沿轴向间隔设置的多个封闭环形的支撑单元1可提供足够的径向支撑力，可以承受外周血管的径向力和压溃或箍缩负荷，有效支撑动脉提供足够血流。
上述实施例只为说明本发明的技术构思及特点，其目的在于让熟悉此项技术的人士能够了解本发明的内容并据以实施，并不能以此限制本发明的保护范围。凡根据本发明精神实质所作的等效变化或修饰，都应涵盖在本发明的保护范围之内。

Claims (23)

  1. 一种外周血管支架，其具有展开状态和收缩状态，所述外周血管支架处于展开状态时的内径大于其处于收缩状态时的内径；其特征在于，所述外周血管支架包括：
    支撑单元，所述支撑单元为沿着所述外周血管支架的轴向依次间隔设置的多个，每个所述支撑单元由丝线形成且为封闭的环状，每个所述支撑单元包括多个沿圆周方向周期排列的峰、谷，相邻的两个峰顶为一个周期；
    膜，所述膜覆设在多个所述支撑单元上，所述膜的柔性大于所述支撑单元的柔性，同一个所述支撑单元的丝线之间和/或相邻两个所述支撑单元之间的所述膜上开设有多个镂空区域，相邻两个所述支撑单元仅通过所述镂空区域以外的所述膜相连接。
  2. 根据权利要求1所述的外周血管支架，其特征在于，在相邻的两个所述支撑单元中，一个支撑单元和另一个支撑单元在圆周面上错开设置，错开的距离为小于二分之一个周期。
  3. 根据权利要求2所述的外周血管支架，其特征在于，所述的错开的距离为小于等于四分之一个周期。
  4. 根据权利要求2或3所述的外周血管支架，其特征在于，在沿着顺时针方向上，每个所述支撑单元都与相邻的一个支撑单元在所述圆周面上错开设置并且错开的距离相同。
  5. 根据权利要求1所述的外周血管支架，其特征在于，每个所述支撑单元的轴心线与所述外周血管支架的轴心线重合。
  6. 根据权利要求1所述的外周血管支架，其特征在于，所述镂空区域包括：
    位于每个所述支撑单元的峰内的第一镂空部、
    位于每个所述支撑单元的谷内的第二镂空部；
    位于相邻两个所述支撑单元之间且分别与所述第一镂空部和所述第二镂空部相连通的多个第三镂空部。
  7. 根据权利要求6所述的外周血管支架，其特征在于，在相邻的两个所述支撑单元中，一个支撑单元的谷底与另一个支撑单元的最近的一个峰顶之间仅通过条状的膜相连接。
  8. 根据权利要求6所述的外周血管支架，其特征在于，所述第一镂空部由上端部相连接的第一壁和第二壁围设而成，所述第二镂空部由下端部相连接的第 三壁和第四壁围设而成，
    所述第三镂空部由分别与所述第一壁下端和所述第四壁上端相连接的第五壁、分别与所述第二壁下端和所述第三壁上端相连接的第六壁围设而成。
  9. 根据权利要求8所述的外周血管支架，其特征在于，当所述外周血管支架沿着其轴向剖开并展开成平面状时，相邻的两支撑单元中最近的两个第一壁在第一直线上。
  10. 根据权利要求8所述的外周血管支架，其特征在于，所述第一壁与所述第二壁的夹角为锐角。
  11. 根据权利要求8所述的外周血管支架，其特征在于，所述第一壁和所述第三壁相平行，所述第二壁和所述第四壁相平行，多个所述第二壁相平行。
  12. 根据权利要求1所述的外周血管支架，其特征在于，所述膜包覆在所述支撑单元的外侧或/和内侧。
  13. 根据权利要求1所述的外周血管支架，其特征在于，所述膜包括位于所述支撑单元内侧的内膜以及位于所述支撑单元外侧的外膜，所述内膜和所述外膜相固定连接，并且所述支撑单元被包覆于所述内膜和所述外膜之间。
  14. 根据权利要求13所述的外周血管支架，其特征在于，相接触的所述内膜和所述外膜被热熔成一体形成所述膜。
  15. 根据权利要求1所述的外周血管支架，其特征在于，所述外周血管支架在展开状态时的内径自一端向另一端逐渐减小。
  16. 根据权利要求1所述的外周血管支架，其特征在于，所述膜上涂覆有药物。
  17. 根据权利要求1所述的外周血管支架，其特征在于，所述支撑单元的材质为不锈钢、记忆合金、钛合金、钽合金、钴铬合金、生物可降解金属、生物可降解聚合物、镁合金、纯铁中的一种或多种，优选为镍钛合金。
  18. 根据权利要求1所述的外周血管支架，其特征在于，所述膜的材质为聚四氟乙烯、嵌段聚醚酰胺、聚酰亚胺、生物可吸收医用材料中的一种或多种，优选地，所述膜为聚四氟乙烯多微孔膜。
  19. 一种如权利要求1至18的外周血管支架的制备方法，其特征在于，将膜与支撑单元相固定，然后在所述膜上开设多个镂空区域。
  20. 一种如权利要求1至18的外周血管支架的制备方法，其特征在于，在膜上开设多个镂空区域，然后将膜与支撑单元相固定。
  21. 一种如权利要求1至18的外周血管支架的制备方法，其特征在于，将内膜和外膜分别设置在支撑单元的内侧和外侧，通过对内膜和外膜加热使得支撑单元被包覆在所述内膜和所述外膜之间，支撑单元之外的所述内膜和所述外膜被热熔为一体形成膜，再在膜上开设多个镂空区域。
  22. 一种如权利要求1至18的外周血管支架的制备方法，其特征在于，分别在内膜和外膜上开设多个镂空区域，然后将所述内膜和所述外膜分别设置在支撑单元的内侧和外侧，并使所述内膜上的镂空区域和所述外膜上的镂空区域相对齐，通过加热使得所述支撑单元被包覆在所述内膜和所述外膜之间，支撑单元之外的所述内膜和所述外膜被热熔为一体形成膜。
  23. 一种所述外周血管支架在血管内治疗中的应用。
PCT/CN2021/077792 2021-02-25 2021-02-25 一种外周血管支架及其制备方法和应用 WO2022178740A1 (zh)

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