WO2022267890A1 - 一种支架与一种载药支架 - Google Patents

一种支架与一种载药支架 Download PDF

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Publication number
WO2022267890A1
WO2022267890A1 PCT/CN2022/097719 CN2022097719W WO2022267890A1 WO 2022267890 A1 WO2022267890 A1 WO 2022267890A1 CN 2022097719 W CN2022097719 W CN 2022097719W WO 2022267890 A1 WO2022267890 A1 WO 2022267890A1
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WO
WIPO (PCT)
Prior art keywords
stent
bracket
rod
opening
section
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PCT/CN2022/097719
Other languages
English (en)
French (fr)
Inventor
候娟
宋志浩
�田�浩
雷文斌
Original Assignee
微创神通医疗科技（上海）有限公司
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Priority to EP22827386.8A priority Critical patent/EP4338714A1/en
Publication of WO2022267890A1 publication Critical patent/WO2022267890A1/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
    • A61F2/90—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
    • 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
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91575—Adjacent bands being connected to each other connected peak to trough
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0054—V-shaped
    • 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
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • 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
    • A61F2250/0036—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 thickness
    • 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
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • 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
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • A61F2250/0068—Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir
    • 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 invention belongs to the technical field of medical devices, and in particular relates to a bracket and a drug-loaded bracket.
  • Intracranial atherosclerotic stenosis (hereinafter referred to as ICAS) is an important reason for the occurrence, development and recurrence of ischemic stroke.
  • symptomatic ICAS is the focus of clinical intervention, and the main treatment measures include: antiplatelet drug therapy, angioplasty, and traditional surgical treatment.
  • Antiplatelet drug therapy is the classic treatment for symptomatic intracranial arterial stenosis, but the incidence of stroke is high, and traditional surgical treatment is seldom used due to its high risk.
  • angioplasty is currently an important method for the treatment of symptomatic intracranial atherosclerotic stenosis.
  • Angioplasty includes the use of bare metal stents, simple balloon dilatation, and application of coronary drug stents.
  • bare metal stents and simple balloon expansion have the problem of restenosis
  • coronary drug stents are basically balloon-expandable drug stents.
  • This type of stent has a large outer diameter in the delivery system, and the stent delivery is poor, especially for tortuous For vascular sites and complex lesions, the self-expandable stent delivered by microcatheter has a smaller outer diameter in the delivery system, and the stent delivery is more advantageous.
  • intracranial arteries Compared with extracranial arteries, the physiological structure of intracranial arteries has the following characteristics: 1) The physiological curvature is large, and intracranial artery stenosis is often accompanied by arteriosclerosis, which exacerbates the degree of physiological tortuosity; 2) Extracranial arteries The membrane is thin and lacks elasticity, the lumen soaked in the subarachnoid space lacks tissue support, and the ability to resist mechanical damage is poor. Once the blood vessel ruptures or the drug extravasates, it is easy to spread to the whole brain and even the spinal cord with the cerebrospinal fluid. Therefore, stents used for intracranial arteries need to have a reasonable radial support force.
  • a higher radial support force will cause the stent to be difficult to place or damage the blood vessel during use, while a lower radial support force will cause the stent to fail. Very good at supporting plaque in blood vessels.
  • Good flexibility and compliance enable the stent to be placed in place smoothly and conform to the intracranial curved blood vessels.
  • the stent needs to have good metal coverage, but for the weak and inelastic intracranial blood vessels, the high metal coverage of the stent often brings too high radial support force, poor Flexibility, high radial support force can lead to intracranial vascular injury, triggering in-stent restenosis.
  • the purpose of the present invention is to provide a bracket to solve the problem of poor overall effect of the metal coverage and bending ability of the bracket in the prior art.
  • the present invention provides a bracket, the bracket includes at least one bracket net, and the bracket net includes a plurality of bracket rods sequentially connected along the circumference of the bracket net, a plurality of the bracket rods connected end to end in sequence, and form a plurality of connection parts between the head and tail of the adjacent stent rods; the stent net is used to realize expansion or contraction by changing the opening and closing angles of the connection parts;
  • the bracket bar includes at least one main body section and at least one wide bar section, the main body section and the wide bar section are sequentially arranged at intervals, and the width of the main body section is smaller than the width of the wide bar section;
  • the wide bar sections of the adjacent stent bars are arranged staggered along the axial direction of the stent net; There is a gap in the axial direction between them.
  • the length of the gap accounts for 0-90% of the total length of the stent rod.
  • the length of the gap accounts for 10-75% of the total length of the stent rod.
  • the length of the gap accounts for 20-50% of the total length of the stent rod.
  • the length of the gap is 0.1-0.3 mm.
  • the opening and closing angle of the connecting portion ranges from 0° to 140°.
  • the metal coverage of a single stent mesh is 30%-99%.
  • the metal coverage of a single stent mesh is 5%-90%.
  • the metal coverage of a single stent mesh is 4%-15%.
  • the metal coverage of a single stent mesh is 8%-15%.
  • connection part when the opening and closing angle of the connection part is 90°-140°, the metal coverage of a single stent mesh is 3%-12%.
  • the metal coverage of the stent is 20%-60%.
  • the metal coverage of the stent is 5%-45%.
  • the metal coverage of the stent is 3%-15%.
  • the metal coverage of the stent is 2%-15%.
  • the radial support force of the stent is 1-300kPa.
  • the support rod includes two main body segments and one wide rod segment, and the wide rod segment is located between the two main body segments.
  • a single stent net includes 8 to 24 stent rods.
  • said at least one said wide bar section includes a groove.
  • the number of the grooves in a single wide bar section is 1-10.
  • the longitudinal cross-sectional shape of the groove is at least one of arc, quadrangle and triangle.
  • the cross-sectional shape of a single groove is at least one of circle, strip, polygon, wave, ring and irregular figure.
  • the grooves are used for loading medicine or filling developing substances.
  • the wide segment of the support rod connecting the connecting portion does not overlap with the main body segment of the adjacent support rod.
  • the two sides of the wide rod section along the length direction of the bracket rod have the same or different dimensions beyond the main body section.
  • one side of the wide rod section along the length direction of the support rod is flush with the main body section.
  • a V-shaped structure is formed between the two stent rods connected by the connecting portion, and the adjacent stent rods are located on the side flush with the main body section at the same time.
  • the inside or outside of the V-shaped structure is formed between the two stent rods connected by the connecting portion, and the adjacent stent rods are located on the side flush with the main body section at the same time.
  • the stent includes at least two stent nets, and at least two stent nets are axially connected.
  • the bracket includes a connecting rod, and the connecting parts of the adjacent bracket nets are connected through the connecting rod.
  • the shape of the connecting rod is at least one of straight rod, wave shape, zigzag shape, circle shape, ring shape, " ⁇ " shape and "S" shape.
  • the present invention also provides a drug-loaded stent, the drug-loaded stent includes at least one stent net, and the stent net includes a plurality of stent rods sequentially connected along the circumference of the stent net, and a plurality of the stent rods connected end to end in sequence, and form a plurality of connection parts between the head and tail of the adjacent stent rods; the stent net is used to realize expansion or contraction by changing the opening and closing angles of the connection parts;
  • the bracket bar includes at least one main body section and at least one wide bar section, the main body section and the wide bar section are sequentially arranged at intervals, and the width of the main body section is smaller than the width of the wide bar section;
  • the wide bar sections of the adjacent stent bars are staggered along the axial direction of the stent net; grooves are provided on the wide bar sections, and the grooves are used for drug loading; the connection When the opening and closing angle of the upper portion is the smallest, there is a gap in the axial direction between the wide rod sections of the adjacent support rods.
  • the bracket includes at least one bracket net, and the bracket net includes a plurality of bracket rods sequentially connected along the circumference of the bracket net, and a plurality of the bracket rods are sequentially connected end to end to form a plurality of connecting parts
  • the stent net is used to realize expansion or contraction through the change of the opening and closing angle of the connecting part; wherein, the stent rod includes a main body segment and a wide rod segment, and the width of the main body segment is smaller than the wide rod segment The width of the adjacent stent rods is staggered along the axial direction of the stent net.
  • the technical solution of the present invention has at least one of the following beneficial effects:
  • a gap in the axial direction is provided between the wide rod sections of adjacent stent rods, which improves the compliance of the stent, enables the stent to better conform to the blood vessel in the blood vessel, and prevents stretching and damage of the blood vessel.
  • the staggered arrangement of the wide rod sections makes the overall size of the stent smaller when it shrinks, which improves the ability of the stent to pass through the lesion.
  • the wide rod section has a larger surface area, which can be used to set grooves, and the grooves can be used to load drugs or fill with developing substances, so as to improve the drug-loading capacity of the stent or improve the developing capacity of the stent.
  • Fig. 1a is a schematic structural view of a part of a stent network according to an embodiment of the present invention
  • Figure 1b is a schematic structural view of the scaffold network shown in Figure 1a when it shrinks;
  • Fig. 2 is a schematic structural view of a part of a stent net in another embodiment of the present invention.
  • Fig. 3 a is a schematic structural view of a part of a stent net according to another embodiment of the present invention.
  • Figure 3b is a schematic structural view of the scaffold network shown in Figure 3a when it shrinks;
  • Fig. 4a is a schematic structural view of a wide bar section according to an embodiment of the present invention.
  • Fig. 4b is a schematic structural view of a wide bar section according to another embodiment of the present invention.
  • Fig. 4c is a structural schematic diagram of a wide pole section according to another embodiment of the present invention.
  • Fig. 5a is a schematic diagram of Alternative 1 of the groove pattern of the present invention.
  • Fig. 5b is a schematic diagram of the second option of the groove pattern of the present invention.
  • Fig. 5c is a schematic diagram of the third option of the groove pattern of the present invention.
  • Fig. 5d is a schematic diagram of option 4 of the groove pattern of the present invention.
  • Fig. 5e is a schematic diagram of option five of the groove pattern of the present invention.
  • Fig. 6 is a schematic structural view of a part of a stent according to an embodiment of the present invention.
  • Fig. 7a is a schematic structural view of a part of the stent network used to illustrate an embodiment of the connecting portion in the present invention
  • Figure 7b is a schematic structural view of the scaffold network shown in Figure 7a when it shrinks;
  • Fig. 8a is a structural schematic diagram of a part of the stent net for showing yet another embodiment of the connecting part in the present invention.
  • Figure 8b is a schematic structural view of the scaffold network shown in Figure 8a when it shrinks;
  • Fig. 9a is a structural schematic diagram of a part of the stent net for showing yet another embodiment of the connecting part of the present invention.
  • Fig. 9b is a schematic diagram of the structure of the stent net shown in Fig. 9a when it is contracted.
  • the singular forms “a”, “an” and “the” include plural objects, the term “or” is usually used in the sense of including “and/or”, and the term “several” Usually, the term “at least one” is used in the meaning of “at least one”, and the term “at least two” is usually used in the meaning of "two or more”.
  • the terms “first”, “second “Two” and “third” are used for descriptive purposes only, and should not be understood as indicating or implying relative importance or implicitly indicating the quantity of the indicated technical features.
  • proximal end is usually the end close to the operator
  • distal end is usually the end close to the patient
  • one end and “other end” and “proximal end” and “distal end” usually refer to the corresponding two parts, which not only include the end point
  • installation should be understood in a broad sense, for example, it can be a fixed connection, or a detachable connection, or integrated; it can be a mechanical connection, or an electrical connection; it can be a direct connection or an indirect connection through an intermediary To be connected can be the internal communication of two elements or the interaction relationship between two elements.
  • an element is arranged on another element, usually only means that there is a connection, coupling, cooperation or transmission relationship between the two elements, and the relationship between the two elements can be direct or indirect through an intermediate element.
  • connection, coupling, fit or transmission but should not be understood as indicating or implying the spatial positional relationship between two elements, that is, one element can be in any orientation such as inside, outside, above, below or on one side of another element, unless the content Also clearly point out.
  • the core idea of the present invention is to provide a bracket to solve the problem of poor overall effect of the metal coverage and bending ability of the bracket in the prior art.
  • FIG. 1a is a schematic structural view of a part of the stent net according to an embodiment of the present invention
  • Fig. 1b is a schematic structural view of the contracted stent net shown in Fig. 1a
  • FIG. 3a is a schematic structural view of a part of the stent net of another embodiment of the present invention
  • FIG. 3b is a schematic structural view of the contracted stent net shown in FIG. 3a
  • Fig. 4b is a structural schematic view of the wide bar section of another embodiment of the present invention
  • Fig. 1a is a schematic structural view of a part of the stent net according to an embodiment of the present invention
  • Fig. 1b is a schematic structural view of the contracted stent net shown in Fig. 1a
  • FIG. 3a is a schematic structural
  • FIG. 4c is a structural schematic view of the wide bar section of another embodiment of the present invention
  • Fig. 5a is a schematic structural view of the wide bar section of the present invention
  • Fig. 5b is a schematic diagram of an option two of the groove pattern of the present invention
  • Fig. 5c is a schematic diagram of an option three of the groove pattern of the present invention
  • FIG. 5d is a schematic diagram of the groove pattern of the present invention
  • Figure 5e is a schematic diagram of optional solution 4 of the graphic
  • Figure 5e is a schematic diagram of optional solution 5 of the groove graphic of the present invention
  • Figure 6 is a schematic structural diagram of a part of the bracket of an embodiment of the present invention
  • Figure 7a is a schematic diagram of the present invention for showing the connection
  • Figure 7b is a schematic structural view of a part of the stent net shown in Figure 7a when it shrinks
  • Figure 8a is a part of the stent net used to show another embodiment of the connecting part of the present invention
  • Fig. 8b is a schematic diagram of the structure of the stent network shown in Fig. 8a when it shrinks
  • FIG. 9a is a schematic structural diagram of a part of the stent network used to show another embodiment of the connecting portion of the present invention
  • Fig. 9b is a schematic diagram of the structure shown in Fig. 9a Schematic diagram of the structure of the scaffold network shown in contraction.
  • an embodiment provides a kind of support, and described support comprises a plurality of support nets 100, and described support net 100 comprises a plurality of support rods that are sequentially connected along the circumferential direction of described support nets 100 110, a plurality of support rods 110 are connected end to end in sequence, and a plurality of connection parts 120 are formed between the head and tail of adjacent support rods; Changes to achieve expansion or contraction; wherein, the stent rod 110 includes at least one main body segment 101 and at least one wide rod segment 102, the width of the main body segment 101 is smaller than the width of the wide rod segment 102; The wide rod sections 102 of the support rods 110 are arranged in a staggered manner along the axial direction of the support net 100; There is a gap 140 in the direction.
  • the measurement direction of the length is parallel to the axis direction of the support rod; ;
  • the length direction of the gap 140 is parallel to the measurement direction of the length of the bracket, and parallel to the axis direction of the bracket rod.
  • the measurement direction of the width is perpendicular to the axis of the measured object and the line of sight of the reader.
  • the width direction 200 and the length direction 300 are shown in FIG. 1a, and the gap 140 is shown in FIGS. 1b and 3b.
  • the width, length and gaps appearing in the subsequent content of this specification should also be understood according to the above-mentioned thinking.
  • the number of the stent net 100 is multiple, and Fig. 1a and Fig. 1b only show a part of the stent net 100 (subsequent Figs. 3a-3b , Figs. 6 to 9b only show a part of the stent or the stent net 100), the complete stent net 100 is formed by overlapping and connecting multiple parts as shown in Fig. 1a and Fig. 1b.
  • the single support net 100 includes 8-24 support rods 110, further, the number of the support rods 110 is preferably 12-18.
  • the stent includes a plurality of stent nets 100, and the stent may be composed of 2 to 18 stent nets.
  • the support rods 110 are connected end to end to form a ring structure, the ring structure is the support net 100, and the support net 100 is sequentially connected in the axial direction to form a support.
  • the stent net 100 expands, the stent forms a structure as shown in Figure 1a for supporting human tissues such as blood vessels; when the stent net 100 shrinks, the stent forms a structure as shown in Figure 1b, For passing through narrow areas such as blood vessels.
  • the bracket rod 110 saves the occupied space of the whole bracket by setting the main body section 101, and at the same time ensures the metal coverage of the bracket by setting the wide rod section 102, and the higher metal coverage can ensure that the bracket can be more durable. Good enough to cover the plaque; by setting different widths of the wide rod segment 102 and the main body segment 101, and the staggered arrangement of the wide rod segment 102, the radial support force of the stent can be in an appropriate range, suitable The radial support force can ensure that the stent can support the narrow position without damaging the blood vessel.
  • the bracket provided by the present invention may not include a groove structure.
  • the existing self-expandable stent drug-loading technology is mostly a layer of drug coating on the surface of the stent, or the coating on the outside of the stent contains drugs.
  • the drug loading method is to spray polymer nanofibers on the surface of the stent to form a polymer film, wherein the nanofibers contain drugs.
  • grooves can be provided on the wide rod section, and the grooves provided are used for drug loading to improve the drug-loading capacity of the metal.
  • the drug-loading capacity is reflected in two aspects.
  • the first aspect is that the wide rod section 102 has a larger width and a larger surface area, thus ensuring the basic space required for drug loading; the second is through the groove. Instead of smearing on the surface, it avoids the problem of drug wear and peeling during the process of compressing the stent into the sheath and delivering it.
  • the radial size of the stent after contraction can be less than or equal to 0.0165 inches, and can cooperate with the current smallest delivery microcatheter.
  • the outer diameter of the stent in the contracted state is 0.3-0.7mm, which can match the microcatheter with the inner diameter of 0.013inch-0.027inch.
  • the gap 140 accounts for 0-90% of the total length of the support rod 110; in a preferred embodiment, when the opening and closing angle of the connecting portion 120 When the opening and closing angle of the connecting part 120 is the smallest, the gap 140 accounts for 10% to 75% of the total length of the support rod 110; 20% to 50% of the length; in some specific embodiments, when the opening and closing angle of the connecting portion 120 is the smallest, the gap 140 accounts for 1%, 2%, 5%, 10%, or 1% of the total length of the support rod 110 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, etc.
  • the gap 140 accounts for 2.5% of the total length of the stent rod 110 ⁇ 12.5%.
  • the length of the support rod 110 may range from 1 to 2.5 mm. In a preferred embodiment, the length of the support rod 110 may range from 1.2 to 1.5 mm. In different embodiments, the length of the gap 140 may range from 0.1 to 0.3 mm. In a preferred embodiment, the length of the gap 140 may range from 0.15 to 0.25 mm. In some specific embodiments, the length of the gap 140 may be 0.1 mm, 0.12 mm, 0.15 mm, 0.18 mm, 0.2 mm, 0.22 mm, 0.25 mm, 0.27 mm, 0.3 mm, and so on.
  • the width of the support rod 110 can be 20-150 mm; in different embodiments, the width of the main body section 101 can be 30-50 ⁇ m; in different embodiments, the width of the wide rod section 102 can be 90-150 mm 120 ⁇ m.
  • the shrinkage outer diameter of all test brackets was 0.53mm, and the total length of the bracket in the contracted state was 9.68mm.
  • the thickness of the bracket rod 0.07mm, and the number of stent nets is 6. Under the condition that the size of the stent is the same when it shrinks, when the stent is expanded to a radial dimension of 3mm, its radial support force and metal coverage are tested. The test results are shown in Table 1 shown.
  • Table 1 The relationship between the proportion of wide bar section, radial support force and metal coverage
  • the total length of the wide rod section 102 accounts for 15% to 75% of the total length of the bracket rod 110 is a better solution, and the total length of the wide rod section 102 accounts for 15% to 75% of the total length of the bracket rod 110. 20%-50% of the total length of the rod 110 is a more optimal solution.
  • the total length of the wide rod section 102 can be 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45% of the total length of the bracket rod 110 , 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, etc.
  • the ratio of the sum of the lengths of the wide bar sections 102 of the two adjacent support bars 110 to the length of a single support bar 110 does not exceed 100%.
  • the ratio of the total length of the wide rod section 102 in the adjacent support rods 110 to the total length of the support rods 110 can be the same or different.
  • the radial support force of the stent is 1-300kpa.
  • the length of the support rod 110 may range from 1 to 2.5 mm. In a preferred embodiment, the length of the support rod 110 may range from 1.2 to 1.5 mm.
  • the support rod 110 may have a linear or curved overall outline, but its shape extends along the length direction as a whole.
  • the width of the support rod 110 can be 20-150 mm; in different embodiments, the width of the main body section 101 can be 30-50 ⁇ m; in different embodiments, the width of the wide rod section 102 can be 90-150 mm 120 ⁇ m.
  • the metal coverage of the bracket is determined by the structure of the bracket and the opening and closing angle of the connecting portion 120.
  • the opening and closing angle of the connecting portion 120 is the angle between the two bracket rods 110 connected by the connecting portion 120.
  • the opening and closing angle of the connecting portion 120 is 0°
  • the angle between the two bracket rods 110 connected by the connecting portion 120 is 0°
  • the bracket is in a contracted state. In this state, the metal coverage of the bracket is relatively large; when When the opening and closing angle of the connection part is 30°-120°, the stent is in an expanded state, and in this state, the metal coverage of the stent is small.
  • a larger metal coverage means a smaller stent outer diameter, and a smaller stent outer diameter enables the stent to pass through the blood vessel better.
  • the ability to reach farther or thinner blood vessels; in the expanded state, the higher metal coverage can better cover the lesion plaque position and achieve better therapeutic effect.
  • Using the design of alternating wide and narrow rods can effectively improve the metal coverage while maintaining a moderate radial support force.
  • the metal coverage of different stent nets 100 at different opening and closing angles of the connection is shown in Table 2:
  • the opening and closing angle of the connecting portion 120 ranges from 0° to 120°, and in some other embodiments, the opening and closing angle of the connecting portion 120 may range from 0° to 140°.
  • the opening and closing angle of the connecting portion 120 when the opening and closing angle of the connecting portion 120 is 0° or near 0°, the stent is in a contracted state, and the stent is bound by an introduction sheath outside before entering the microcatheter, so it is in a contracted state. It is also in a contracted state during transportation.
  • the stent is in a contracted state not only when the opening and closing angle of the connecting portion 120 is 0°, and the opening and closing angle of the connecting portion 120 may be different when the inner diameter of the entering microcatheter is different.
  • the opening and closing angle of the connecting portion 120 is relatively large.
  • the opening and closing angle of the connecting portion 120 may be 0° ⁇ 5°.
  • the opening and closing angle of the connecting part 120 is 30°-120°
  • the stent is in the expanded state, wherein, in some embodiments, when the stent is expanded to an outer diameter of 2mm-3mm, the opening and closing angle of the connecting part 120 is 30° ° ⁇ 90°.
  • the expanded state refers to the state when the stent is expanded to a certain outer diameter, and does not mean that the stent is in a fully expanded natural state.
  • the stent when the stent is placed in a tube with an inner diameter of 2 mm to 3 mm, the stent can be expanded.
  • the opening and closing angle of the connecting part 120 is greater than the opening and closing angle of the stent in the contracted state.
  • the stent can be further expanded.
  • the opening and closing angle of the connecting portion 120 can also be further increased.
  • the metal coverage of a single stent mesh 100 is 5%-90%.
  • the metal coverage of a single stent mesh 100 is 3%-12%.
  • the metal coverage of the whole support is not only affected by the metal coverage of the support nets 100, but also by the connecting rods 130 between the support nets.
  • the length of the connecting rods 130 is longer, the distance between the support nets 100 is large.
  • the metal coverage of the entire stent is lower than that of a single stent net 100; when the length of the connecting rods 130 is the same and the structure is consistent, the more connecting rods between the stent nets 100, the higher the metal coverage of the stent; , the metal coverage of the stent is also affected by the shape of the connecting rods.
  • the overall metal coverage of the stent when the opening and closing angle of the connecting part is 0°-5°, the overall metal coverage of the stent is 20%-60%, preferably 35-60%; when the connecting part When the opening and closing angle of the stent is 5° to 30°, the overall metal coverage of the stent is 5% to 45%, preferably 8% to 40%; when the opening and closing angle of the connecting portion is 30° to 90°, the stent The overall metal coverage rate is 3% to 15%, preferably 8% to 15%; when the opening and closing angle of the connecting portion is 90° to 140°, the overall metal coverage rate of the stent is 2% to 15%, preferably 5% to 15%.
  • the number of the wide rod segments 102 on one support rod 110 can be 1 to 10, preferably 1, so as to maximize the use of space and ensure greater metal coverage and/or drug loading.
  • the number of the main body segments 101 may be 1-11, preferably 2.
  • the main body section 101 and the wide rod section 102 are sequentially arranged at intervals.
  • the ratio of the width of the main body section 101 to the width of the wide bar section 102 may be 1/4 ⁇ 2/3, preferably 1/3, so as to maximize the use of space.
  • the number of wide bar sections 102 on adjacent bracket bars 110 can be the same or different, and the number of wide bar sections 102 can be one or more. Please refer to FIG.
  • one of the bracket rods 110 includes three of the main body segments 101 and two of the wide rod segments 102, the main body segments 101 and the wide rod segments 102 are arranged at intervals, A single wide bar section is located between two main body sections, but adjacent support bars on the same support net 100 include two main body sections 101 and one wide bar section 102, the wide bar Segment is positioned between two described main body sections; Continue to refer to Fig. Rod segment 102, the wide rod segment is located between the two main body segments.
  • the stent net 100 also includes a bent section 121, which is used to form the connection between the stent rods 110.
  • the width of the main body section 101 and the bent section 121 may be 1/2 ⁇ 3/4, preferably 3/5, so as to prevent the connecting portion 120 from breaking and keep the supporting force of the bracket at a low level.
  • the ratio of the total length of the support rod 110 to the length of the shortest body section 101 may be greater than or equal to 10/3, preferably 6/1.
  • the ratio of the total length of the support rod 110 to the length of the bent section 121 may be greater than or equal to 8, preferably 12, so as to prevent the breakage of the connecting part 120 and make the The support force of the stand is kept low.
  • the wide rod segment 102 of the bracket rod 110 connected to the connecting portion 120 does not overlap with the main body segment 101 of the adjacent bracket rod 110 .
  • the smallest radial distance between the main body sections 101 of the two adjacent bracket rods 110 is obtained, and then the above-mentioned radial distance
  • the spacing inversely drives the dimensions of the wide bar section 102 .
  • the space can be further utilized, and the overall size of the bracket is smaller.
  • the radial spacing between different connecting parts 120 may be different between the main body sections 101 when the opening and closing angle is the smallest.
  • Design to maximize the use of space, can also be uniformly designed.
  • the design standard is the smallest one of the smallest radial distances between the main body sections 101 of all adjacent bracket rods 110.
  • the above-mentioned scheme The design cost is lower.
  • the above solution is the preferred solution.
  • the main body sections 101 of the two bracket rods 110 connecting the connecting part 120 may also be smaller than the width of the wide rod section 102 beyond the width of the main body section 101 .
  • Such a solution can also make better use of space.
  • the two sides of the wide rod section 102 along the length direction of the bracket rod have the same dimension beyond the main body section 101 .
  • the axis of the wide rod section 102 coincides with the axis of the support rod 110 or coincides within the scope of engineering.
  • the dimensions of the two sides of the wide rod section 102 along the length direction of the support rod beyond the main body section 101 may also be different.
  • one side of the wide rod segment 102 along the radial direction is flush with the main body segment 101 .
  • a V-shaped structure is formed between the two stent rods 110 connected by the connecting portion 120 , and the adjacent stent rods 110 are parallel to the main body section 101 .
  • the aligned side is located on the inner side or the outer side of the V-shaped structure at the same time.
  • the side of the adjacent wide bar section 102 of the stent bar 110 that is flush with the main body section 101 can also be arranged on the same side, that is, when the stent is in an expanded state, the connection A V-shaped structure is formed between the two support rods 110 connected by the part 120, and the side of the adjacent support rods 110 that is flush with the main body section 101 is not on the inside or outside of the V-shaped structure at the same time, one of them
  • the side of the support rod 110 that is flush with the main body section 101 is located inside the V-shaped structure, and the side of the other support rod 110 that is flush with the main body section 101 is located outside the V-shaped structure.
  • the wide bar section 102 includes a wide bar section main body 103 and a transition section 104 , and the transition section 104 is used to connect the wide bar section main body 103 and the main body section 101 .
  • the specific shape of the transition section 104 can have various schemes, for example, in one embodiment, the width of the transition section 104 gradually shrinks along the direction in which the wide rod section main body 103 points to the main body section 101 (that is, as shown in FIG. scheme shown in 4a).
  • the transition section 104 includes two transition grooves opened outward, the transition grooves are arranged on both sides of the main body section 101, the width of the transition section 104 and the The width of the wide bar section main body 103 is equal, and the opening width of the transition groove gradually decreases along the direction from the wide bar section main body 103 to the main body section 101 (that is, the scheme shown in FIG. 4b ).
  • at least a part of all the transition sections 104 adopts at least one of the above two solutions (ie the solutions shown in Fig. 4a, Fig. 4b and Fig. 4c).
  • the transition section 104 can also be set in other forms. In some other embodiments, such as the embodiment shown in FIG.
  • the wide rod section 102 may only include the wide rod section main body 103, and the wide rod section main body 103 is directly connected to the main body section 101.
  • the wide bar section 102 includes the transition section 104
  • the length of the gap at different positions may be different, but as long as the opening and closing angle of the connecting part 120 is the smallest, the support bar
  • There is a gap 140 at any circumferential position of 110 which can provide deformation space for the bracket, thereby improving the bending performance of the bracket.
  • the opening and closing angle of the connecting portion 120 is the smallest, the length of the gap 140 at any circumferential position satisfies 0-90% of the total length of the stent rod.
  • the wide rod section has a larger surface area, which can be used to set grooves, and the grooves can be used to load drugs or fill developing substances, so as to improve the drug-loading ability of the stent or the developing ability of the stent.
  • the wide rod section 102 includes a groove 105, the groove 105 is formed by extending the groove pattern, and the groove pattern is a solid pattern, a hollow pattern, a continuous pattern and a discontinuous pattern. at least one.
  • the shape of the groove is at least one of cylinder, cuboid and triangular prism, and the cross-sectional shape of a single groove is circular, strip-shaped, polygonal, wavy, ring-shaped and irregular. at least one.
  • the longitudinal section shape of a single groove is at least one of arc, quadrilateral and triangle.
  • the cross section refers to a section parallel to the outer surface of the wide bar section 102
  • the longitudinal section refers to a section perpendicular to the outer surface of the wide bar section 102 and perpendicular to the length direction of the wide bar section 102. section.
  • the groove 105 is used for loading medicine or filling developing substance.
  • the groove 105 may be a penetrating groove that runs through the entire thickness of the support rod 110 , and in other embodiments, the groove 105 may be a non-penetrating groove that runs through a part of the thickness of the support rod 110 .
  • the ratio of the maximum width of the groove pattern to the width of the wide bar segment 102 may be 1/3-4/5, preferably 1/2, to maximize the use of space, Guaranteed a large drug load.
  • the measurement direction of the width of the groove pattern is the same as the width direction of the wide bar segment 102 .
  • the stent includes at least two stent nets 100 , and at least two stent nets 100 are connected along the axial direction.
  • the number of support nets 100 can be 4-18, preferably 6-10.
  • the length of a single stent mesh can be 1-1.8mm.
  • the connection mode between the stent net and the stent net can be arbitrary.
  • the preferred solution is, please refer to FIG. And connected by the connecting rod 130 .
  • the connecting portions 120 of the adjacent stent nets 100 are aligned, forming a mirror-symmetrical effect of the adjacent stent nets 100 with respect to the joints.
  • the connecting rods 130 are connected to the connecting parts 120 at intervals along the circumferential direction of the bracket. Such an arrangement facilitates the opening and closing of the angle of the connecting portion and further utilizes the space.
  • the connecting parts 120 may not be aligned, and the connecting rod may not be located on the connecting part 120; when the connecting parts 120 are aligned and connected by the connecting rod 130 , the connecting rods 130 can also be connected in other ways, for example, the connecting rods 130 connect each group of aligned connecting parts 120, or the connecting rods 130 are aligned at intervals of two groups along the circumferential direction of the bracket The connectors 120 of the third set of aligned connectors 120 are connected, and so on.
  • the ratio of the width of the main body section 101 to the width of the connecting rod 130 may be 1/2 to 1, preferably 1/2, so as to prevent the connecting rod 130 from fracture.
  • the shape of the connecting rod 130 is at least one of straight rod, wave shape, zigzag shape, circle shape, ring shape, " ⁇ " shape and "S" shape.
  • the shape of the connecting rod 130 is a non-straight rod shape, such as a wave shape, an " ⁇ " shape or an "S" shape, it is beneficial to the contraction and expansion process of the whole stent, which is a better solution. It should be understood that the solution of the connecting rod 130 can be combined with the solutions of the groove 105 , the transition section 104 and the wide bar section 102 arbitrarily.
  • grooves may also be provided on the connecting rod 130 .
  • a better solution is not to provide grooves.
  • the material of the stent can be one or more of cobalt-based alloys, magnesium alloys, nickel-titanium alloys, stainless steel, and other materials.
  • This embodiment also provides a drug-loaded stent, the main difference between the drug-loaded stent and the above-mentioned stent is that a groove 105 is provided on the drug-loaded stent, and the groove 105 is used for drug loading or filling and developing substance.
  • the support provided in this embodiment includes at least one support net 100, the support net 100 includes a plurality of support rods 110 sequentially connected along the circumference of the support net 100, a plurality of the support rods 110 are connected end to end in sequence, and A plurality of connection parts 120 are formed between the head and the tail of the adjacent stent rods 110; the stent mesh 100 is used to realize expansion or contraction through the change of the opening and closing angle of the connection parts 120; wherein, the stent The rod 110 includes at least one main body segment 101 and at least one wide rod segment 102, the main body segment 101 and the wide rod segment 102 are sequentially arranged at intervals, the width of the main body segment 101 is smaller than the width of the wide rod segment 102; In one stent net 100 , the wide rod segments 102 of adjacent stent rods 110 are arranged in a staggered manner along the axial direction of the stent net 100 .
  • the drug-loaded stent provided in this embodiment also has a similar structure.
  • the space is reasonably used, and the metal coverage and radial support capacity are taken into account, so that the When the stent shrinks, the overall size is small, which improves the ability of the stent to pass through the lesion, and a gap is provided between the wide rod segments 102 in the adjacent stent rods 110, which improves the bending ability of the stent, so that the stent can pass through the blood vessel.
  • the middle is better bent so that it can be put in place smoothly, and at the same time, the stent can better conform to the blood vessel and prevent the blood vessel from being stretched and damaged.
  • the problem that the comprehensive effect of metal coverage and bending ability of the bracket in the prior art is not good is solved.

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Abstract

本发明提供了一种支架及载药支架，所述支架包括至少一个支架网，所述支架网包括沿所述支架网的周向依次连接的多个支架杆，多个所述支架杆依次首尾连接，并在相邻的所述支架杆的首尾之间形成多个连接部；所述支架网用于通过所述连接部的开合角的变化来实现扩张或收缩；其中，所述支架杆包括至少一个主体段和至少一个宽杆段，所述主体段的宽度小于所述宽杆段的宽度；在一个所述支架网中，相邻的所述支架杆的宽杆段沿所述支架网的轴向交错布置。所述载药支架也具有类似的结构。通过所述宽杆段和所述主体段的不同宽度的设置，以及所述宽杆段的交错排布，合理地利用了空间，提高了所述支架的金属覆盖率和弯曲能力的综合效果。

Description

一种支架与一种载药支架 技术领域
本发明属于医疗器械技术领域，具体涉及一种支架与一种载药支架。
背景技术
颅内动脉粥样硬化性狭窄(以下简称ICAS)是缺血性卒中发生、发展和复发的重要原因。其中有症状的ICAS是临床干预的重点，主要治疗措施包括：抗血小板药物治疗、血管成形术、传统外科手术治疗。抗血小板药物治疗是症状性颅内动脉狭窄的经典治疗手段，但卒中发生率较高，传统外科手术治疗由于风险极大而较少采用。
随着颅内介入治疗发展，血管成形术是目前治疗症状性颅内动脉粥样硬化狭窄的重要手段，血管成形术包括用金属裸支架、单纯球囊扩张、应用冠脉药物支架等治疗方案。其中金属裸支架和单纯球囊扩张存在再狭窄问题，而冠脉药物支架基本为球囊扩张式药物支架，该类支架在输送系统中外径尺寸较大，支架输送到位性较差，尤其对于迂曲血管部位和复杂病变，微导管输送的自膨式支架在输送系统中外径尺寸更小，支架输送到位性更具优势。
与颅外动脉相比，颅内动脉的生理结构具有以下特点：1)生理弯曲度大，且颅内动脉狭窄多伴有动脉硬化，更加剧了生理性的迂曲程度；2)颅内血管外膜较薄，缺乏弹性，管腔浸泡在蛛网膜下腔中缺乏组织依托，抗机械损伤能力差。一旦血管破裂或药物外渗，易于随脑脊液播散至全脑甚至脊髓。因此，用于颅内动脉的支架需要有合理的径向支撑力，较高的径向支撑力会导致支架在使用过程中难以到位或损伤血管，而较低的径向支撑力会导致支架无法很好支撑血管中的斑块。另外，因为颅内动脉的生理弯曲度大，弯曲性能不好的支架通常难以到达病变位置，且到位展开后的支架如果不能很好顺应血管往往会造成血管的拉伸和损伤，因此需要支架有良好的弯曲性和顺应性使支架能顺利到位且顺应颅内弯曲血管。同时，为了更好得覆盖斑块，支架需要有良好的金属覆盖率，但是对于薄弱而缺乏弹性的颅内血管，支架的高金属覆盖率往往带来过高的径向支撑力、较差的弯曲性，高径向支撑力会 导致颅内血管损伤，引发支架内再狭窄。
综上所述，现有技术中的支架的金属覆盖率和弯曲能力的综合效果不佳。
发明内容
本发明的目的在于提供一种支架，以解决现有技术中的支架的金属覆盖率和弯曲能力综合效果不佳的问题。
为了解决上述技术问题，本发明提供了一种支架，所述支架包括至少一个支架网，所述支架网包括沿所述支架网的周向依次连接的多个支架杆，多个所述支架杆依次首尾连接，并在相邻的所述支架杆的首尾之间形成多个连接部；所述支架网用于通过所述连接部的开合角的变化来实现扩张或收缩；
其中，所述支架杆包括至少一个主体段和至少一个宽杆段，所述主体段和所述宽杆段依次间隔设置，所述主体段的宽度小于所述宽杆段的宽度；在一个所述支架网中，相邻的所述支架杆的宽杆段沿所述支架网的轴向交错布置；所述连接部的开合角度最小时，相邻的所述支架杆的宽杆段之间在轴向方向上存在间隙。
可选的，所述连接部的开合角度最小时，所述间隙的长度占支架杆总长度的0～90％。
可选的，所述连接部的开合角度最小时，所述间隙的长度占支架杆总长度的10～75％。
可选的，所述连接部的开合角度最小时，所述间隙的长度占支架杆总长度的20～50％。
可选的，所述连接部的开合角度最小时，所述间隙的长度为0.1～0.3mm。
可选的，所述连接部的开合角范围为0°～140°。
可选的，当所述连接部的开合角为0°～5°时，单个所述支架网的金属覆盖率为30％～99％。
可选的，当所述连接部的开合角为5°～30°时，单个所述支架网的金属覆盖率为5％～90％。
可选的，当所述连接部的开合角为30°～90°时，单个所述支架网的金属覆 盖率为4％～15％。
可选的，当所述连接部的开合角为30°～90°时，单个所述支架网的金属覆盖率为8％～15％。
可选的，当所述连接部的开合角为90°～140°时，单个所述支架网的金属覆盖率为3％～12％。
可选的，当所述连接部的开合角为0°～5°时，所述支架的金属覆盖率为20％～60％。
可选的，当所述连接部的开合角为5°～30°时，所述支架的金属覆盖率为5％～45％。
可选的，当所述连接部的开合角为30°～90°时，所述支架的金属覆盖率为3％～15％。
可选的，当所述连接部的开合角为90°～140°时，所述支架的金属覆盖率为2％～15％。
可选的，所述支架的径向支撑力为1～300kpa。
可选的，所述支架杆包括两个所述主体段和一个所述宽杆段，所述宽杆段位于两个所述主体段之间。
可选的，单个所述支架网包括8～24个支架杆。
可选的，所述至少一个所述宽杆段包括凹槽。
可选的，单个所述宽杆段的所述凹槽的数量为1～10个。
可选的，所述凹槽的纵截面形状为弧形、四边形与三角形中的至少一者。
可选的，单个所述凹槽的横截面形状为圆形、长条形、多边形、波浪形、环形和不规则图形中的至少一者。
可选的，所述凹槽用于载药或者填充显影物质。
可选的，所述连接部的开合角度最小时，连接所述连接部的所述支架杆中的宽杆段与相邻支架杆中的主体段不交叠。
可选的，所述宽杆段沿所述支架杆的长度方向的两边超出所述主体段的尺寸相同或不同。
可选的，所述宽杆段沿所述支架杆的长度方向的其中一边与所述主体段 平齐。
可选的，在所述支架为扩张状态下时，所述连接部连接的两个所述支架杆之间形成V形结构，相邻的所述支架杆与所述主体段平齐的一边同时位于所述V形结构的内侧或外侧。
可选的，所述支架包括至少两个所述支架网，至少两个所述支架网沿轴向连接。
可选的，所述支架包括连接杆，相邻的所述支架网的所述连接部通过所述连接杆连接。
可选的，所述连接杆的形状为直杆、波浪形、锯齿形、圆形、环形、“Ω”形和“S”形中的至少一者。
此外，本发明还提供一种载药支架，所述载药支架包括至少一个支架网，所述支架网包括沿所述支架网的周向依次连接的多个支架杆，多个所述支架杆依次首尾连接，并在相邻的所述支架杆的首尾之间形成多个连接部；所述支架网用于通过所述连接部的开合角的变化来实现扩张或收缩；
其中，所述支架杆包括至少一个主体段和至少一个宽杆段，所述主体段和所述宽杆段依次间隔设置，所述主体段的宽度小于所述宽杆段的宽度；在一个所述支架网中，相邻的所述支架杆的宽杆段沿所述支架网的轴向交错布置；所述宽杆段上设有凹槽，所述凹槽用于载药；所述连接部的开合角度最小时，相邻的所述支架杆的宽杆段之间在轴向方向上存在间隙。
本发明的支架，所述支架包括至少一个支架网，所述支架网包括沿所述支架网的周向依次连接的多个支架杆，多个所述支架杆依次首尾连接，形成多个连接部；所述支架网用于通过所述连接部的开合角的变化来实现扩张或收缩；其中，所述支架杆包括主体段和宽杆段，所述主体段的宽度小于所述宽杆段的宽度；相邻的所述支架杆的宽杆段沿所述支架网的轴向交错布置。通过所述宽杆段和所述主体段不同宽度的设置，所述宽杆段的交错排布，以及所述相邻的支架杆的宽杆段之间的间隙，与现有技术相比，本发明技术方案至少具有如下有益效果之一：
1、在支架杆上设置宽杆段，同时在相邻的支架杆的宽杆段之间设置轴向 方向的间隙，使支架在弯曲时，宽杆段之间不会相互影响，提高了支架的弯曲性能，兼顾了金属覆盖率和弯曲性能的需求，解决了现有技术中的支架的金属覆盖率和弯曲能力的综合效果不佳的问题。
2、在相邻的支架杆的宽杆段之间设置轴向方向的间隙，提高了支架的顺应性，使支架在血管中能更好顺应血管，防止造成血管的拉伸和损伤。
3、合理地利用了空间，兼顾了金属覆盖率和径向支撑能力的需求。
4、宽杆段交错排布使得所述支架在收缩时，整体尺寸较小，提高了所述支架的通过病变能力。
5、宽杆段上具有较大的表面积，可以用于设置凹槽，凹槽可以用于载药或者填充显影物质，提高支架的载药能力或者提高支架的显影能力。
附图说明
本领域的普通技术人员将会理解，提供的附图用于更好地理解本发明，而不对本发明的范围构成任何限定。其中：
图1a是本发明一实施例的支架网的一部分的结构示意图；
图1b是图1a所示的支架网收缩时的结构示意图；
图2是本发明又一实施例的支架网的一部分的结构示意图；
图3a是本发明再一实施例的支架网的一部分的结构示意图；
图3b是图3a所示的支架网收缩时的结构示意图；
图4a是本发明一实施例的宽杆段的结构示意图；
图4b是本发明另一实施例的宽杆段的结构示意图；
图4c是本发明又一实施例的宽杆段的结构示意图；
图5a是本发明凹槽图形的可选方案一的示意图；
图5b是本发明凹槽图形的可选方案二的示意图；
图5c是本发明凹槽图形的可选方案三的示意图；
图5d是本发明凹槽图形的可选方案四的示意图；
图5e是本发明凹槽图形的可选方案五的示意图；
图6是本发明一实施例的支架的一部分的结构示意图；
图7a是本发明用于展示连接部的一实施例的支架网的一部分的结构示意图；
图7b是图7a所示的支架网收缩时的结构示意图；
图8a是本发明用于展示连接部的又一实施例的支架网的一部分的结构示意图；
图8b是图8a所示的支架网收缩时的结构示意图；
图9a是本发明用于展示连接部的再一实施例的支架网的一部分的结构示意图；
图9b是图9a所示的支架网收缩时的结构示意图。
附图中：
100-支架网；110-支架杆；120-连接部；130-连接杆；101-主体段；102-宽杆段；103-宽杆段主体；104-过渡段；105-凹槽；121-折弯段；140-间隙；200-宽度方向；300-长度方向。
具体实施方式
为使本发明的目的、优点和特征更加清楚，以下结合附图和具体实施例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未按比例绘制，仅用以方便、明晰地辅助说明本发明实施例的目的。此外，附图所展示的结构往往是实际结构的一部分。特别的，各附图需要展示的侧重点不同，有时会采用不同的比例。
如在本发明中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，术语“或”通常是以包括“和/或”的含义而进行使用的，术语“若干”通常是以包括“至少一个”的含义而进行使用的，术语“至少两个”通常是以包括“两个或两个以上”的含义而进行使用的，此外，术语“第一”、“第二”、“第三”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”、“第三”的特征可以明示或者隐含地包括一个或者至少两个该特征，术语“近端”通常是靠近操作者的一端，术语“远端”通常是靠近患者的一端，“一端”与“另一端”以及“近端”与“远端”通常是指 相对应的两部分，其不仅包括端点，术语“安装”、“相连”、“连接”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；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。此外，如在本发明中所使用的，一元件设置于另一元件，通常仅表示两元件之间存在连接、耦合、配合或传动关系，且两元件之间可以是直接的或通过中间元件间接的连接、耦合、配合或传动，而不能理解为指示或暗示两元件之间的空间位置关系，即一元件可以在另一元件的内部、外部、上方、下方或一侧等任意方位，除非内容另外明确指出外。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中的具体含义。
本发明的核心思想在于提供一种支架，以解决现有技术中的支架的金属覆盖率和弯曲能力的综合效果不佳的问题。
以下参考附图进行描述。
请参考图1a至图9b，其中，图1a是本发明一实施例的支架网的一部分的结构示意图；图1b是图1a所示的支架网收缩时的结构示意图；图2是本发明又一实施例的支架网的一部分的结构示意图；图3a是本发明再一实施例的支架网的一部分的结构示意图；图3b是图3a所示的支架网收缩时的结构示意图；图4a是本发明一实施例的宽杆段的结构示意图；图4b是本发明另一实施例的宽杆段的结构示意图；图4c是本发明又一实施例的宽杆段的结构示意图；图5a是本发明凹槽图形的可选方案一的示意图；图5b是本发明凹槽图形的可选方案二的示意图；图5c是本发明凹槽图形的可选方案三的示意图；图5d是本发明凹槽图形的可选方案四的示意图；图5e是本发明凹槽图形的可选方案五的示意图；图6是本发明一实施例的支架的一部分的结构示意图；图7a是本发明用于展示连接部的一实施例的支架网的一部分的结构示意图；图7b是图7a所示的支架网收缩时的结构示意图；图8a是本发明用于展示连接部的又一实施例的支架网的一部分的结构示意图；图8b是图8a所示的支架网收缩时的结构示意图；图9a是本发明用于展示连接部的再一实施例的支架网的一部分的结构示意图；图9b是图9a所示的支架网收缩时的结 构示意图。
如图1a和图1b所示，一实施例提供了一种支架，所述支架包括多个支架网100，所述支架网100包括沿所述支架网100的周向依次连接的多个支架杆110，多个所述支架杆110依次首尾连接，并在相邻的所述支架杆的首尾之间形成多个连接部120；所述支架网100用于通过所述连接部120的开合角的变化来实现扩张或收缩；其中，所述支架杆110包括至少一个主体段101和至少一个宽杆段102，所述主体段101的宽度小于所述宽杆段102的宽度；相邻的所述支架杆110的宽杆段102沿所述支架网100的轴向交错布置；所述连接部120的开合角度最小时，相邻的所述支架杆110的宽杆段102之间在轴向方向上存在间隙140。在本实施例中，长度的测量方向与支架杆的轴线方向平行；在本实施例中，宽度的测量方向与被测对象的轴线方向垂直，且朝向所述支架网100的外周面的切向；在本实施例中，间隙140的长度方向平行于支架长度的测量方向，同时平行于支架杆的轴线方向。在图1a～9b中，所述宽度的测量方向同时与被测对象的轴线以及读者的视线垂直。在图1a中示出了宽度方向200和长度方向300，在图1b和图3b中示出了间隙140。本说明书后续内容中出现的宽度、长度和间隙，也应当按照上述思路进行理解。
当所述连接部的开合角为0°～5°时，单个所述支架网的金属覆盖率为30％～99％。支架的金属覆盖率指的是支架植入血管后，支架金属部分的外表面面积占所覆盖管段的总面积的比率。具体地，金属覆盖率＝Ss/πDL×100％。其中，Ss代表支架金属部分的外表面积；D代表覆盖管段的外径；L代表覆盖管段的长度。需理解，金属覆盖率与支架的具体结构存在联系，只有设计了特定的支架结构，才能使得支架的金属覆盖率提高，或者使得支架在特定扩张状态和收缩状态下的金属覆盖率提高。
需理解，在图1a和图1b所示的所述支架中，所述支架网100的数量为多个，图1a和图1b仅仅展示了所述支架网100的一部分(后续的图3a～3b、图6～图9b也仅仅展示了所述支架或者所述支架网100的一部分)，完整的所述支架网100由多个如图1a和图1b所示的部分重复叠加并连接而成。在不同的实施例中，单个所述支架网100包括8～24个支架杆110，进一步的，所 述支架杆110的数量优选为12～18个。同理，所述支架包括多个支架网100，所述支架可以由2～18个支架网组成。所述支架杆110首尾连接，形成一环状结构，环状结构即支架网100，支架网100在轴向上依次连接形成支架。当所述支架网100扩张时，所述支架形成如图1a所示的结构，用于支撑血管等人体组织；当所述支架网100收缩时，所述支架形成如图1b所示的结构，用于通过血管等狭小区域。所述支架杆110通过设置所述主体段101节约了整个所述支架的占据空间，同时又通过设置所述宽杆段102保证了支架的金属覆盖率，金属覆盖率较高可以保证支架能较好得覆盖斑块；通过宽杆段102和所述主体段101不同宽度的设置，以及所述宽杆段102的交错排布，可以使支架的径向支撑力处于一个合适的范围，合适的径向支撑力能保证支架可以起到支撑狭窄位置的同时，又不会损伤血管。
请参考图2，在一些实施例中，本发明所提供的支架，可以不包括凹槽结构。但是，基于发明人对于载药支架的分析，如下：现有的自膨式支架载药技术，多为支架表面附一层药物涂层，或者支架外面覆膜中含有药物。现有技术中存在一种自膨胀支架，其载药方式为在支架表面喷射聚合物纳米纤维形成聚合物薄膜，其中纳米纤维中含有药物。现有技术中还存在一种自膨式管腔支架，其载药方式为支架进行部分或全部覆膜，其中覆膜上附有药物。现有技术中还存在一种支架，其载药方式为覆盖在记忆金属网上的覆膜以及涂覆在覆膜上的药物层。这些技术不可避免存在自膨支架压缩入鞘、输送过程中存在药物层的磨损、剥脱问题。针对这些问题，在支架上开设槽，将药物填充入槽是比较好的解决方式，这种方式在用于治疗颅外动脉狭窄的支架上已经有所应用，例如冠脉药物洗脱支架。因此在一些实施例中，宽杆段上可以开设凹槽，开设的凹槽用于载药以提高金属的载药能力。载药能力从两方面体现，第一个方面是所述宽杆段102具有较大的宽度和较大的表面积，因此保证了载药所需的基本空间；第二个是通过凹槽的方式而不是通过表面涂抹的方式，避免了支架压缩入鞘、输送过程中存在药物的磨损、剥脱问题。如此配置，合理地利用了空间，通过兼顾了载药能力和径向支撑能力，使得所述支架在收缩时，整体尺寸较小，提高了所述支架的通过病变能力，同时 满足了支架的通过病变能力、载药能力和径向支撑能力的综合效果。
通过上述设置，所述支架在收缩后的径向尺寸可以小于或者等于0.0165英寸，可与目前尺寸最小的输送微导管配合工作。在所有实施例中，支架在收缩状态下的外径为0.3～0.7mm，可以匹配内径为0.013inch～0.027inch的微导管。
如图1a-3b所示，所述连接部120的开合角度最小时，相邻的所述支架杆110的宽杆段之间在轴向方向上存在间隙140，设置宽杆段102能提高支架的金属覆盖率，而设置轴向方向的间隙140，使支架在弯曲时，宽杆段102之间不会相互影响，提高了支架的弯曲性能，使支架兼顾了金属覆盖率和弯曲性能的需求，解决了现有技术中的支架的金属覆盖率和弯曲能力的综合效果不佳的问题。同时，间隙140的存在提高了支架的顺应性，使支架在血管中能更好顺应血管，防止造成血管的拉伸和损伤。
在一实施例中，当所述连接部120的开合角度最小时，所述间隙140占支架杆110总长度的0～90％；在一优选实施例中，当所述连接部120的开合角度最小时，所述间隙140占支架杆110总长度的10～75％；在一优选实施例中，当所述连接部120的开合角度最小时，所述间隙140占支架杆110总长度的20～50％；在一些具体实施例中，当所述连接部120的开合角度最小时，所述间隙140占支架杆110总长度的1％、2％、5％、10％、15％、20％、25％、30％、35％、40％、45％、50％、55％、60％、65％、70％、75％、80％、85％、90％等。考虑到使支架的金属覆盖率和弯曲性能的综合效果最佳，在一更优实施例中，所述连接部120的开合角度最小时，所述间隙140占支架杆110总长度的2.5％～12.5％。
在不同实施例中，支架杆110的长度范围可以为1～2.5mm，在一优选实施例中，支架杆110的长度范围可以为1.2～1.5mm。在不同实施例中，间隙140的长度范围可以为0.1～0.3mm，在一优选实施例中，间隙140的长度范围可以为0.15～0.25mm。在一些具体实施例中，间隙140的长度可以为0.1mm、0.12mm、0.15mm、0.18mm、0.2mm、0.22mm、0.25mm、0.27mm、0.3mm等。
在不同实施例中，支架杆110的宽度可以为20～150mm；在不同实施例中， 主体段101的宽度可以为30～50μm；在不同实施例中，宽杆段102的宽度可以为90～120μm。
发明人对所述宽杆段102的总长度占所述支架杆110总长度的比例进行了试验，所有试验支架的收缩外径为0.53mm，收缩状态下支架总长为9.68mm，支架杆的厚度为0.07mm，支架网的个数为6，在所述支架收缩时的尺寸相同的条件下，扩张至径向尺寸为3mm时，测试其径向支撑力和金属覆盖率，试验结果如表1所示。
表1 宽杆段比例与径向支撑力、金属覆盖率的关系
Figure PCTCN2022097719-appb-000001
由表1的内容可知，与对照用的第1组试验的结果相比，当所述宽杆段102的总长度占所述支架杆110总长度的5％～95％时，所述支架有合适的径向支撑力，且具有较高的金属覆盖率。
根据表1的内容进一步可知，所述宽杆段102的总长度占所述支架杆110总长度的15％～75％是较优的方案，所述宽杆段102的总长度占所述支架杆110总长度的20％～50％是更优的方案。在一些具体实施例中，宽杆段102的总长度占所述支架杆110总长度可以为5％、10％、15％、20％、25％、30％、35％、40％、45％、50％、55％、60％、65％、70％、75％、80％、85％、90％、95％等。
进一步地，所述相邻两个支架杆110的所述宽杆段102的长度之和与单个所述支架杆110长度的比值不超过100％。同时，基于表1，相邻所述支架 杆110中宽杆段102的总长度占所述支架杆110总长度的比值可以相同也可以不同。
同时，基于表1，所述支架的径向支撑力为1～300kpa。
在不同实施例中，支架杆110的长度范围可以为1～2.5mm，在一优选实施例中，支架杆110的长度范围可以为1.2～1.5mm。所述支架杆110可以整体外轮廓为直线型的，也可以带曲线，但其形状在整体上沿长度方向延伸。
在不同实施例中，支架杆110的宽度可以为20～150mm；在不同实施例中，主体段101的宽度可以为30～50μm；在不同实施例中，宽杆段102的宽度可以为90～120μm。
支架的金属覆盖率由支架的结构和连接部120的开合角度决定，在支架的结构相同时，连接部120的开合角度即连接部120连接的两根支架杆110之间的夹角。当连接部120的开合角为0°时，连接部120连接的两根支架杆110之间的夹角为0°，支架处于收缩状态，该状态下，支架的金属覆盖率较大；当连接部的开合角为30°～120°时，支架处于扩张状态，该状态下，支架的金属覆盖率较小。在收缩状态下，在支架的金属总面积和支架杆的厚度相同的条件下，较大的金属覆盖率意味着较小的支架外径，较小的支架外径使支架具有较好的通过血管的能力，且能到位到更远或更细的血管；在扩张状态下，较高的金属覆盖率可以更好覆盖病变斑块位置，起到更好的治疗效果。使用宽窄杆交替的设计，可以在保持径向支撑力适中的前提小，有效提高金属覆盖率，不同支架网100在不同的连接部开合角下的金属覆盖率见表2：
表2 不同支架网在不同开合角下的金属覆盖率
Figure PCTCN2022097719-appb-000002
由表2的内容可知，支架处于连接部的开合角为0°～5°的状态下时，单个所述支架网100的金属覆盖率为30％～99％；根据表2的内容进一步可知，支架处于连接部的开合角为0°～5°的状态下时，单个所述支架网100的金属覆盖率为80％～99％是较优的方案。
由表2的内容可知，所述连接部120的开合角范围为0°～120°，在其他一些实施例中，连接部120的开合角范围可以为0°～140°。其中，当连接部120的开合角为0°或者0°附近时，支架为收缩状态，支架在进入微导管前外部有导入鞘束缚因此处于收缩状态，支架在进入微导管后，在微导管中输送时也处于收缩状态。需要说明的是，并非只有连接部120的开合角为0°时，支架才处于收缩状态，进入的微导管的内径不同时，连接部120的开合角可能不同，当微导管的内径较大时，连接部120的开合角较大，例如，支架处于收缩状态下时，连接部120的开合角可能为0°～5°。当连接部120的开合角为30°～120°时，支架处于扩张状态，其中，在一些实施例中，当支架扩张至外径为2mm～3mm时，连接部120的开合角为30°～90°。需要说明的是，所述扩张状态指的是支架扩张至一定外径时的状态，并非指支架处于完全扩张的自然 状态，例如将支架放置在内径为2mm～3mm的管中时，支架可以扩张至2mm～3mm，这时连接部120的开合角大于支架处于收缩状态下的开合角，当支架从2mm～3mm的管中取出或者进入内径更大的管中时，支架可以进一步扩张，连接部120的开合角也可以进一步变大。
当所述连接部120的开合角为5°～30°时，单个所述支架网100的金属覆盖率为5％～90％。
由表2的内容可知，当所述连接部120的开合角为30°～90°时，单个所述支架网100的金属覆盖率为4％～15％；根据表2的内容进一步可知，支架处于连接部的开合角为30°～90°的状态下时，单个所述支架网100的金属覆盖率为8％～15％是较优的方案。
当所述连接部120的开合角为90°～140°时，单个所述支架网100的金属覆盖率为3％～12％。
整个支架的金属覆盖率除了受到支架网100的金属覆盖率的影响，还受到支架网之间的连接杆130的影响，当连接杆130的长度较长时，支架网100之间的距离大，使得整个支架的金属覆盖率比单个支架网100的金属覆盖率低；当连接杆130的长度相同且结构一致时，支架网100之间的连接杆越多，支架的金属覆盖率越高；此外，支架的金属覆盖率还受到连接杆的形状的影响。在本发明提供的实施例中，当所述连接部的开合角为0°～5°时，支架整体的金属覆盖率为20％～60％，优选35～60％；当所述连接部的开合角为5°～30°时，支架整体的金属覆盖率为5％～45％，优选8％～40％；当所述连接部的开合角为30°～90°时，支架整体的金属覆盖率为3％～15％，优选8％～15％；当所述连接部的开合角为90°～140°时，支架整体的金属覆盖率为2％～15％，优选5％～15％。
在不同的实施例中，一个所述支架杆110上的所述宽杆段102的数量可以是1～10个，优选为1个，以较大限度地利用空间，保证较大的金属覆盖率和/或载药量。所述主体段101的数量可以是1～11个，优选为2个。所述主体段101和所述宽杆段102依次间隔设置。且所述主体段101的宽度和所述宽杆段102的宽度之比可以是1/4～2/3，优选为1/3，以较大限度地利用空间。相 邻支架杆110上的宽杆段102的数量可以相同也可以不同，宽杆段102的数量可以为1个也可以为多个。请参考图1a，在一个实施例中，一个所述支架杆110包括三个所述主体段101和两个所述宽杆段102，所述主体段101与所述宽杆段102间隔设置，单个所述宽杆段位于两个所述主体段之间，但是同一个支架网100上的相邻的支架杆包括两个所述主体段101和一个所述宽杆段102，所述宽杆段位于两个所述主体段之间；继续参考图2，在一个较优的实施例中，一个支架网100上的所述支架杆110都包括两个所述主体段101和一个所述宽杆段102，所述宽杆段位于两个所述主体段之间。
所述支架网100还包括折弯段121，所述折弯段121用于形成所述支架杆110之间的连接，在不同的实施例中，所述主体段101的宽度和所述折弯段121的宽度之比可以是1/2～3/4，优选为3/5，以防止所述连接部120断裂又可以使所述支架的支撑力保持较低的水平。
在不同的实施例中，所述支架杆110的总长度和所述最短的主体段101的长度之比可以是大于或者等于10/3，优选为6/1。
在不同的实施例中，所述支架杆110的总长度和所述折弯段121的长度之比可以是大于或者等于8，优选为12，以防止所述连接部120断裂又可以使所述支架的支撑力保持较低的水平。
较优地，所述连接部120的开合角度最小时，连接所述连接部120的所述支架杆110中的宽杆段102与相邻支架杆110中的主体段101不交叠。在设计时，应当反向考虑，在保证结构整体强度和使用寿命的前提下，得到最小的两个相邻所述支架杆110的主体段101之间的径向间距，再以上述的径向间距反推所述宽杆段102的尺寸。如此配置，能够进一步地利用空间，实现所述支架整体尺寸较小的效果。在一些实施例中，可能不同的所述连接部120在开合角度最小时的主体段101之间的径向间距不同，此时，各支架杆110的所述宽杆段102的宽度可以单独设计，以较大限度地利用空间，也可以统一设计，此时，设计标准为所有相邻的所述支架杆110的主体段101之间的最小径向间距中最小的那一个，上述方案的设计成本较低。
需理解，上述方案为优选方案，在特殊情况下，在一些实施例中，所述 连接部120的开合角度最小时，连接所述连接部120的两个所述支架杆110的主体段101之间的径向间距也可以是小于所述宽杆段102的超出所述主体段101的宽度。这样的方案也能较优地利用空间。
如图2所示，在一实施例中，所述宽杆段102的沿支架杆的长度方向的两边的超出所述主体段101的尺寸相等。所述宽杆段102的轴线和所述支架杆110的轴线重合或者在工程范畴内重合。
在其他的一些实施例中，所述宽杆段102的沿支架杆的长度方向的两边的超出所述主体段101的尺寸也可以不同。例如，如图3a和图3b所示，在一实施例中，所述宽杆段102沿径向的一边与所述主体段101平齐。较优地，在所述支架为扩张状态下时，所述连接部120连接的两个所述支架杆110之间形成V形结构，相邻的所述支架杆110与所述主体段101平齐的一边同时位于所述V形结构的内侧或外侧。
在其他的实施例中，相邻的所述支架杆110的宽杆段102与所述主体段101平齐的一边也可以同侧布置，即，在所述支架为扩张状态下，所述连接部120连接的的两个所述支架杆110之间形成V形结构，相邻的所述支架杆110与所述主体段101平齐的一边不同时在V形结构的内侧或外侧，其中一个所述支架杆110与所述主体段101平齐的一边位于V形结构的内侧，另一个所述支架杆110与所述主体段101平齐的一边位于V形结构的外侧。
请参考图4a至4c，所述宽杆段102包括宽杆段主体103和过渡段104，所述过渡段104用于连接所述宽杆段主体103和所述主体段101。所述过渡段104的具体形状可以有多种方案，例如，在一实施例中，所述过渡段104的宽度沿所述宽杆段主体103指向所述主体段101的方向逐渐缩小(即图4a所示的方案)。或者，在另一个实施例中，所述过渡段104包括两个向外开设的过渡凹槽，所述过渡凹槽设置于所述主体段101的两侧，所述过渡段104的宽度和所述宽杆段主体103的宽度相等，所述过渡凹槽的开口宽度沿所述宽杆段主体103指向所述主体段101的方向逐渐缩小(即图4b所示的方案)。又或者，所有所述过渡段104中的至少一部分采用上述两个方案中的至少一个(即图4a、图4b和图4c所示的方案)。需理解，所述过渡段104还可以采用 其他的形式进行设置。在其他的一些实施例中，例如图3a所示的实施例中，所述宽杆段102可以仅包括所述宽杆段主体103，所述宽杆段主体103与所述主体段101直接连接。需要说明的是，如图4a-图4c所示，当宽杆段102包括过渡段104时，不同位置的间隙长度可能不同，但是只要当所述连接部120的开合角度最小时，支架杆110的任意周向位置存在间隙140，就能给支架提供形变空间，从而起到提高支架弯曲性能的作用。在一优选实施例中，当所述连接部120的开合角度最小时，间隙140在任意周向位置上的长度都满足占支架杆总长度的0～90％。
宽杆段上具有较大的表面积，可以用于设置凹槽，凹槽可以用于载药或者填充显影物质，提高支架的载药能力或者提高支架的显影能力。请参考图5a至5e，所述宽杆段102包括凹槽105，所述凹槽105通过凹槽图案延伸而成，所述凹槽图案为实心图案、中空图案、连续图案和间断图案中的至少一者。所述凹槽的形状为圆柱形、长方体和三棱柱形中的至少一者，单个所述凹槽的横截面形状为圆形、长条形、多边形、波浪形、环形和不规则图形中的至少一者。单个所述凹槽的纵截面形状为弧形、四边形与三角形中的至少一者。需要说明的是，所述横截面指的是平行于宽杆段102的外表面的截面，所述纵截面指的是垂直于宽杆段102的外表面且垂直于宽杆段102的长度方向的截面。所述凹槽105用于载药或者填充显影物质。在一些实施例中，凹槽105可以是穿透性槽，贯穿支架杆110整个厚度，在另外一些实施例中，凹槽105可以是非穿透性槽，贯穿支架杆110的部分厚度。需理解，图4a至4c的展示重点在于所述过渡段104，图5a至5e的展示重点在于所述凹槽105，并非当过渡段104选择如图4a至4c所示的方案时，所述凹槽105只能选择如图4a至4c所示的方案；也并非当所述凹槽105选择如图5a至5e所示的方案时，所述过渡段104只能选择如图5a至5e所示的方案。两者的方案可以任意的组合。
在不同的实施例中，所述凹槽图案的最大宽度与所述宽杆段102的宽度之比可以是1/3～4/5，优选为1/2，以较大限度地利用空间，保证较大的载药量。所述凹槽图案的宽度的测量方向和所述宽杆段102的宽度方向相同。
请参考图1a，在一实施例中，所述支架包括至少两个所述支架网100，至少两个所述支架网100沿轴向连接。支架网100的个数可以为4～18，优选6～10个。在支架扩张至外径为2mm～3mm状态下时，单个所示支架网的长度可以为1～1.8mm。支架网与支架网之间的连接方式可以是任意的，较优的方案是，请参考图6，所述支架包括连接杆130，相邻的所述支架网100的所述连接部120对齐，并通过所述连接杆130连接。在图6所示的实施例中，相邻的所述支架网100的所述连接部120对齐，形成了相邻的所述支架网100关于连接处镜像对称的效果。进一步地，请参考图6，所述连接杆130沿所述支架的周向间隔地连接所述连接部120。如此配置，有利于所述连接部的角度的开合，进一步利用空间。需理解，在其他的实施例中，所述连接部120可以不对齐，连接杆的设置位置可以不在所述连接部120上；当所述连接部120对齐，并通过所述连接杆130连接时，所述连接杆130也可以是其他的方式连接，例如，所述连接杆130连接每一组对齐的连接部120，又或者所述连接杆130沿所述支架的周向每间隔两组对齐的连接部120连接第三组对齐的连接部120，等等。
在不同的实施例中，所述主体段101的宽度与所述连接杆130的宽度之比可以是1/2～1，优选为1/2，以较大程度的防止所述连接杆130发生断裂。
请参考图1a至1b、图7a至9b，所述连接杆130的形状为直杆、波浪形、锯齿形、圆形、环形、“Ω”形和“S”形中的至少一者。所述连接杆130的形状为非直杆的形状，例如波浪形、“Ω”形或“S”形时，有利于所述支架整体的收缩和扩张过程，是较优的方案。需理解，所述连接杆130的方案也可以和前述的所述凹槽105、所述过渡段104的方案以及所述宽杆段102的方案进行任意地组合。
在其他的实施例中，所述连接杆130上也可以设置凹槽。但是出于保持整体结构的可靠性的考虑，较优的方案是不设置凹槽。
在一些实施例中，支架的材料可以为钴基合金、镁合金、镍钛合金、不锈钢等材料中的一种或几种组成。
本实施例还提供了一种载药支架，所述载药支架与上述的支架的主要区 别在于，所述载药支架上设置有凹槽105，所述凹槽105用于载药或者填充显影物质。
所述载药支架的其他结构可以参考本说明书前述内容中关于所述支架的相关说明进行理解。
本实施例所提供的支架包括至少一个支架网100，所述支架网100包括沿所述支架网100的周向依次连接的多个支架杆110，多个所述支架杆110依次首尾连接，并在相邻的所述支架杆110的首尾之间形成多个连接部120；所述支架网100用于通过所述连接部120的开合角的变化来实现扩张或收缩；其中，所述支架杆110包括至少一个主体段101和至少一个宽杆段102，所述主体段101和所述宽杆段102依次间隔设置，所述主体段101的宽度小于所述宽杆段102的宽度；在一个所述支架网100中，相邻的所述支架杆110的宽杆段102沿所述支架网100的轴向交错布置。本实施例提供的载药支架也具有类似的结构。通过所述宽杆段102和所述主体段101不同宽度的设置，以及所述宽杆段102的交错排布，合理地利用了空间，兼顾了金属覆盖率和径向支撑能力，使得所述支架在收缩时，整体尺寸较小，提高了所述支架的通过病变能力，且在相邻的支架杆110中的宽杆段102之间设置间隙，提高了支架的弯曲能力，使支架在血管中较好弯曲从而能顺利到位，同时使支架能更好地顺应血管，防止血管拉伸和损伤。解决了现有技术中的支架的金属覆盖率和弯曲能力的综合效果不佳的问题。
上述描述仅是对本发明较佳实施例的描述，并非对本发明范围的任何限定，本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰，均属于本发明技术方案的保护范围。

Claims (31)

  1. 一种支架，其特征在于，所述支架包括至少一个支架网，所述支架网包括沿所述支架网的周向依次连接的多个支架杆，多个所述支架杆依次首尾连接，并在相邻的所述支架杆的首尾之间形成多个连接部；所述支架网用于通过所述连接部的开合角的变化来实现扩张或收缩；
    其中，所述支架杆包括至少一个主体段和至少一个宽杆段，所述主体段和所述宽杆段依次间隔设置，所述主体段的宽度小于所述宽杆段的宽度；在一个所述支架网中，相邻的所述支架杆的宽杆段沿所述支架网的轴向交错布置；所述连接部的开合角度最小时，相邻的所述支架杆的宽杆段之间在轴向方向上存在间隙。
  2. 根据权利要求1所述的支架，其特征在于，所述连接部的开合角度最小时，所述间隙的长度占支架杆总长度的0～90％。
  3. 根据权利要求2所述的支架，其特征在于，所述连接部的开合角度最小时，所述间隙的长度占支架杆总长度的10～75％。
  4. 根据权利要求3所述的支架，其特征在于，所述连接部的开合角度最小时，所述间隙的长度占支架杆总长度的20～50％。
  5. 根据权利要求1所述的支架，其特征在于，所述连接部的开合角度最小时，所述间隙的长度为0.1～0.3mm。
  6. 根据权利要求1所述的支架，其特征在于，所述连接部的开合角范围为0°～140°。
  7. 根据权利要求1所述的支架，其特征在于，当所述连接部的开合角为0°～5°时，单个所述支架网的金属覆盖率为30％～99％。
  8. 根据权利要求1所述的支架，其特征在于，当所述连接部的开合角为5°～30°时，单个所述支架网的金属覆盖率为5％～90％。
  9. 根据权利要求1所述的支架，其特征在于，当所述连接部的开合角为30°～90°时，单个所述支架网的金属覆盖率为4％～15％。
  10. 根据权利要求9所述的支架，其特征在于，当所述连接部的开合角为30°～90°时，单个所述支架网的金属覆盖率为8％～15％。
  11. 根据权利要求1所述的支架，其特征在于，当所述连接部的开合角为90°～140°时，单个所述支架网的金属覆盖率为3％～12％。
  12. 根据权利要求1所述的支架，其特征在于，当所述连接部的开合角为0°～5°时，所述支架的金属覆盖率为20％～60％。
  13. 根据权利要求1所述的支架，其特征在于，当所述连接部的开合角为5°～30°时，所述支架的金属覆盖率为5％～45％。
  14. 根据权利要求1所述的支架，其特征在于，当所述连接部的开合角为30°～90°时，所述支架的金属覆盖率为3％～15％。
  15. 根据权利要求1所述的支架，其特征在于，当所述连接部的开合角为90°～140°时，所述支架的金属覆盖率为2％～15％。
  16. 根据权利要求1所述的支架，其特征在于，所述支架的径向支撑力为1～300kpa。
  17. 根据权利要求1所述的支架，其特征在于，所述支架杆包括两个所述主体段和一个所述宽杆段，所述宽杆段位于两个所述主体段之间。
  18. 根据权利要求1所述的支架，其特征在于，单个所述支架网包括8～24个支架杆。
  19. 根据权利要求1所述的支架，其特征在于，至少一个所述宽杆段包括凹槽。
  20. 根据权利要求19所述的支架，其特征在于，单个所述宽杆段的所述凹槽的数量为1～10个。
  21. 根据权利要求19所述的支架，其特征在于，所述凹槽的纵截面形状为弧形、四边形与三角形中的至少一者。
  22. 根据权利要求19所述的支架，其特征在于，单个所述凹槽的横截面形状为圆形、长条形、多边形、波浪形、环形和不规则图形中的至少一者。
  23. 根据权利要求19所述的支架，其特征在于，所述凹槽用于载药或者填充显影物质。
  24. 根据权利要求1所述的支架，其特征在于，所述连接部的开合角度最小时，连接所述连接部的所述支架杆中的宽杆段与相邻的所述支架杆中的 主体段不交叠。
  25. 根据权利要求1所述的支架，其特征在于，所述宽杆段的沿所述支架杆的长度方向的两边的超出所述主体段的尺寸相同或不同。
  26. 根据权利要求1所述的支架，其特征在于，所述宽杆段的沿所述支架杆的长度方向的其中一边与所述主体段平齐。
  27. 根据权利要求26所述的支架，其特征在于，在所述支架为扩张状态下时，所述连接部连接的两个所述支架杆之间形成V形结构，相邻的所述支架杆与所述主体段平齐的一边同时位于所述V形结构的内侧或外侧。
  28. 根据权利要求1～27中任一项所述的支架，其特征在于，所述支架包括至少两个所述支架网，至少两个所述支架网沿轴向连接。
  29. 根据权利要求28所述的支架，其特征在于，所述支架包括连接杆，相邻的所述支架网的所述连接部通过所述连接杆连接。
  30. 根据权利要求29所述的支架，其特征在于，所述连接杆的形状为直杆、波浪形、锯齿形、圆形、环形、“Ω”形和“S”形中的至少一者。
  31. 一种载药支架，其特征在于，所述载药支架包括至少一个支架网，所述支架网包括沿所述支架网的周向依次连接的多个支架杆，多个所述支架杆依次首尾连接，并在相邻的所述支架杆的首尾之间形成多个连接部；所述支架网用于通过所述连接部的开合角的变化来实现扩张或收缩；
    其中，所述支架杆包括至少一个主体段和至少一个宽杆段，所述主体段和所述宽杆段依次间隔设置，所述主体段的宽度小于所述宽杆段的宽度；在一个所述支架网中，相邻的所述支架杆的宽杆段沿所述支架网的轴向交错布置；所述宽杆段上设有凹槽，所述凹槽用于载药；所述连接部的开合角度最小时，相邻的所述支架杆的宽杆段之间在轴向方向上存在间隙。
PCT/CN2022/097719 2021-06-22 2022-06-08 一种支架与一种载药支架 WO2022267890A1 (zh)

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CN103221002A (zh) * 2010-09-24 2013-07-24 威尼蒂公司 具有支撑架的支架

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US20020188347A1 (en) * 2001-06-08 2002-12-12 Mark Mathis Stent with interlocking elements
US20030105511A1 (en) * 2001-11-30 2003-06-05 Welsh Greg P. Stent designed for the delivery of therapeutic substance or other agents
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