WO2020238168A1 - 一种腔内支架及其制备方法 - Google Patents

一种腔内支架及其制备方法 Download PDF

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Publication number
WO2020238168A1
WO2020238168A1 PCT/CN2019/126080 CN2019126080W WO2020238168A1 WO 2020238168 A1 WO2020238168 A1 WO 2020238168A1 CN 2019126080 W CN2019126080 W CN 2019126080W WO 2020238168 A1 WO2020238168 A1 WO 2020238168A1
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WIPO (PCT)
Prior art keywords
stent
sub
covered
wire
intraluminal
Prior art date
Application number
PCT/CN2019/126080
Other languages
English (en)
French (fr)
Inventor
冷德嵘
李玉茜
徐念慈
赵永雪
潘长网
李宁
刘春俊
唐志
金鸿雁
张晨
Original Assignee
南微医学科技股份有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by 南微医学科技股份有限公司 filed Critical 南微医学科技股份有限公司
Priority to CA3132998A priority Critical patent/CA3132998A1/en
Priority to ES202190022U priority patent/ES1285733Y/es
Priority to DE212019000506.3U priority patent/DE212019000506U1/de
Publication of WO2020238168A1 publication Critical patent/WO2020238168A1/zh
Priority to AU2021106843A priority patent/AU2021106843A4/en
Priority to US17/503,700 priority patent/US20220031481A1/en

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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61F2/852—Two or more distinct overlapping stents
    • 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
    • A61F2/88—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 formed as helical or spiral coils
    • A61F2/885—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 formed as helical or spiral coils comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis
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    • 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
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    • 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
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    • 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
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    • 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
    • A61F2210/0066—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof shrinkable
    • A—HUMAN NECESSITIES
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    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
    • A—HUMAN NECESSITIES
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    • 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
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    • 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
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Definitions

  • the application relates to an intracavitary stent used in the human body cavity, belonging to a medical device used in the human body.
  • the existing braiding methods of stents are mainly divided into manual braiding and machine braiding.
  • the manual braiding is difficult and the production capacity is limited.
  • the machine braided stent head end is difficult to handle, and it is usually impossible to achieve a good fit between the end of the thin wire and the main body of the stent.
  • the ground is fixed together, causing the bracket connection part to be easily disconnected.
  • a stent prepared by a woven method on the one hand, the end connecting portion formed by the re-knitting area of the wire end is close to the edges of the two ends of the stent. During the pulling-off process, the connecting portion yields due to the force.
  • connection part The deformability and tensile resistance are poor, and it is easy to damage the tissues in the cavity, and it is easy to break, making it difficult to remove the stent.
  • the welding process used in the connection part makes the surface of the connection point rough and easy to damage the cavity The structure, and the welding point area is too small, the tensile strength is poor, and the welding area is too large, which will cause the connection part to be too rigid, and the environmental adaptability in the cavity will be reduced.
  • the end of the wire head is still fixedly connected, that is, the two ends of the wire head are fixedly connected to the outer sleeve structure.
  • the biggest defect of the head connection method is that the research and development personnel found that during the pulling process, when the radial or axial pull-out force exceeds the tolerance limit of the wire head connection part, the shape mutation of the bracket at the moment the wire head is disconnected will cause The stent has a greater impact on the tissue and brings greater damage to the tissue.
  • the wire head connecting section is also arranged at the edge of the stent, and sharp corners are formed during the break of the wire head, which increases damage to human tissues. The odds.
  • an intraluminal stent with less damage to intraluminal tissues and strong tensile resistance including: an intraluminal stent, the intraluminal stent includes at least one sub-stent, so The sub-stent has a radially compressed form and a radially expanded form. The sub-stent has end regions at both ends and an intermediate region extending between the end regions in the axial direction. The sub-stent includes at least a first The first wire extending in the spiral direction and the second wire extending in at least the second spiral direction, and the extension directions of the two are different to form a plurality of wire intersections.
  • the intraluminal stent has a plurality of covered parts to connect the corresponding two A wire end is wrapped in it, the outer periphery of the covered part is provided with a covered connector, two ends of the covered connector form a stable connection with the regions corresponding to both ends of the covered part, and the covered part
  • the covering part is spaced apart from the edge of at least one end of the sub-bracket.
  • the arrangement in this application makes the wire head
  • the degree of freedom of the connection part is limited by the braided mesh of the stent, and it is not easy to deform and fail, which improves its radial compression resistance and pull-off force, so that the mechanical properties of the stent can be significantly improved.
  • the distance between the coated portion and the edge of at least one end of the stent is a, and the length of the sub-stent in the axial direction is L, where a/L is greater than 1/20.
  • the two wire ends of the covered part are covered in a manner of being close to or in contact with each other by the covering connecting piece.
  • the two wire ends of the covered part are covered by the covering connector in such a way that the two ends are relatively movable.
  • the radial compression resistance of the corresponding part of the cladding connector is not less than 10N.
  • the covered connecting member is a coating and/or heat shrinkable tube with elasticity.
  • the length of the covered connector at least completely covers the covered part, and two corresponding wire ends in the covered part are in butt contact or have overlapping areas.
  • the at least one end region is radially contracted when transitioning to the middle region, and the connecting part is located in the radial contraction region.
  • cross section of the sub-support is circular, D-shaped or elliptical.
  • the intraluminal stent is an L-shaped or Y-shaped stent.
  • the end of the first wire extending in the first spiral direction is folded back to the middle area at the end area of at least one end of the sub-stent to form a bent portion, and is corresponding to the corresponding one extending in the second spiral direction.
  • the end of the second wire approaches to form a covered part.
  • the wire end of one sub-stent extends to the corresponding wire end of the other sub-stent and forms a covered part.
  • This application also provides a method for preparing an endoluminal stent, which includes the following steps:
  • an intraluminal stent including at least one sub-stent
  • a covering connector is provided on the outer periphery of the covered part, and the two ends of the covering connector and the areas corresponding to the two ends of the covered part form a stable connection.
  • the two wire ends of the covering part are wrapped in it, and the covered part is spaced from the edge of at least one end of the sub-stent.
  • the two ends of the silk thread are inserted into the thread grid formed by the first thread extending in the first spiral direction and the second thread extending at least in the second spiral direction to form the The covered part.
  • step (2) through a coating process or a heat shrinking process, the areas corresponding to the two ends of the covered connector and the two ends of the covered part are fixed to form a stable connection.
  • the stent in this application uses a multi-filament stent braided by a machine with higher productivity as the body, and uses a non-welded wire end (wire end) connection method, so that the end portions of the two ends of the stent are the same as the traditional hand-woven single-wire braided stent Smooth, less irritating to the tube wall, reducing the risk of hyperplasia, perforation and displacement, and reducing the risk of the connector falling off when the stent is adjusted and recovered.
  • the tensile strength of the connection position of the wire head is improved to ensure that it is not easy to break during use and improve the safety performance of the stent.
  • Figures 1a to 1b are side views of the cladding connector part of the intraluminal stent extending in different spiral directions;
  • Figure 2 is a schematic diagram of the axial force on one end of the intraluminal stent
  • Figure 3 is a schematic diagram of the radial force on the intraluminal stent shown in Figure 2;
  • 4a to 4c are enlarged schematic diagrams of different approaches to the corresponding areas of the stent-covered connector in the cavity shown in FIG. 3;
  • Figure 5 is a schematic diagram of a radial cross-section of the intraluminal stent
  • Figure 6 is a schematic diagram of a radial cross-section of the intraluminal stent
  • Figure 7 is a schematic diagram of a radial cross-section of the intraluminal stent
  • Figures 8a to 8f are schematic diagrams of an L-shaped stent composed of two sub-stents, in which Figures 8a to 8f illustrate the arrangement of the sheathing connector on the intraluminal stent on different sub-stents;
  • Figures 9a to 91 are schematic diagrams of a Y-shaped stent composed of three sub-stents, in which Figures 9a to 91 exemplify the arrangement of the sheathing connectors on the intraluminal stent on different sub-stents.
  • the compressed form refers to the state when the stent is compressed in the radial direction during the delivery of the stent;
  • the expanded form refers to the form after the stent is released and expanded due to its own radial tension;
  • first thread and the second thread will be further explained.
  • the first thread extending in the first spiral direction represents the collective name of all the threads extending in the first spiral direction in each sub-stent in the intraluminal stent, and is not limited to one
  • the second thread extending in the second spiral direction represents the collective term for all the threads extending in the second spiral direction in the sub-stents in the intraluminal stent.
  • the sub-stents in the intraluminal stent are formed according to the machine.
  • the specific form of the stent, the first wire and the second wire extending in different spiral directions can be relatively independent and separate wire braided bodies, that is, both ends of the sub-stents in the stent in the cavity after the machine-knitting have both ends extending in the first spiral direction.
  • the thread ends (thread heads) of the first and second threads extending in the second spiral direction; the first thread and the second thread extending in different spiral directions may also be a wire braid formed by integrally bending the same thread , That is, only one end of the sub-stent in the intraluminal stent after machine-knitting has the silk ends (thread ends) of the first and second threads extending in the first spiral direction and the second spiral direction, while the other end does not exist Silk head.
  • Fig. 1a, Fig. 2 and Fig. 3 show an embodiment in this application, which shows that at least one sub-stent in the intraluminal stent includes a corresponding area in the covering connector.
  • the sub-stent is used in the human body cavity, which can be pancreatic duct, bile duct, intestine, esophagus or trachea.
  • the sub-stent has a radially compressed form and a radially expanded form.
  • the sub-stent includes a plurality of The first thread 4 extending in a spiral direction and the second thread 5 extending in the second spiral direction corresponding to the number of the first thread 4, wherein the first spiral direction and the second spiral direction intersect and are symmetrical with respect to the central axis of the stent Set up.
  • the first wire 4 and the second wire 5 extend to intersect and form a plurality of grid shapes with a plurality of wire intersection points.
  • the extension mode of the covering connector can also extend in the first spiral direction, that is, the extension direction of the covering connector can extend in different spiral directions according to the actual weaving mode.
  • the end of the first thread 4 extending in the first spiral direction is folded back at the end region 11 to the middle region 12 to form a bent portion, and is aligned with the corresponding first thread extending in the second spiral direction.
  • the ends of the thread 5 overlap and overlap to form the covered part 2.
  • a tubular covered connector 3 is provided on the outer periphery of the covered part. The two ends of the covered connector 3 are formed in areas corresponding to both ends of the covered part 2.
  • the ends of the first wire 4 and the second wire 5 of the covered portion 2 are both wrapped in the covering connecting piece 3 by the covering connecting piece 3.
  • a heat-shrinkable tube is preferably used to cover the covered part 2 at the end of the wire, and the length of the heat-shrinkable tube as a covered connector at least covers the entire length of the covered part.
  • the length of the heat-shrinkable tube is preferably along the length of the covered part.
  • the ends of both sides of the covering portion 2 are extended by at least 1 mm to ensure that the end of the thread will not be pulled out of the pipe during the stretching process, and the stability of the covering connector is improved.
  • an elastic coating formed on the outside of the return portion can be used to cover the end of the thread.
  • FIG. 4a an enlarged schematic view of the corresponding area of the covering connector 3, in this embodiment, the covering connector 3 completely covers the covered portion 2, and the length of the covered portion along the extending direction of the wire is greater than 3mm, where One end of the covering connecting piece 3 is stably joined with the first wire at the first joining point, and the other end of the covering connecting piece 3 is stably joined with the second wire at the second joining point.
  • the covering connecting piece 3 has certain elasticity, so When the stent is dragged in the axial direction, when the coated portion 2 receives an axial tensile force, the first and second wires move away from each other in the second spiral direction, that is, the ends of the first and second wires can move relatively (two The thread ends are close but not fixedly connected), the research and development personnel of this application innovatively try to change the traditional fixed connection method between the thread ends into a relatively movable method.
  • the two wire ends (wire ends) in the covered portion 2 have overlapping areas as shown in Figure 4a, as shown in Figure 4b and Figure 4c, the two wire ends can also be arbitrarily close to each other
  • the two wire heads can be non-overlapping, only the wire heads are partially in contact (as shown in Figure 4b) or not in contact (as shown in Figure 4c), as long as they are covered
  • the covering part 2 can be stably connected together by the covering connector 3.
  • the radial compression resistance of the corresponding part of the cladding connector 3 in the intraluminal stent is not less than 10N.
  • the radial compression resistance refers to making the corresponding part of the cladding connector radial
  • the edge of the end region of each sub-stent in the intraluminal stent has a circumferentially surrounding bending part, and the axial pull-off force of the inflection point of a single bend is not less than 30N, where the axial pull-off force is defined as: the axial force of the stent body , The pulling force to separate the connecting part from the end of the wire.
  • the intraluminal stent can meet the above-mentioned compression resistance and pull-off performance requirements during the use and removal of the intraluminal stent, and the support formed by the stent on the cavity wall can ensure that it is not damaged. In the case of tissue, the stent is pulled out of the human cavity.
  • the covered part and the edge of the sub-stent to the end are separated by at least 3 wire crossing points, and the covered part is preferably separated from the edge of the sub-stent to the end by 5 or more.
  • Silk thread intersection Through this special weaving method of keeping the covering connector 3 away from the bending part, the yield deformation performance of the stent is greatly improved.
  • connection point is easily broken due to the stress concentration of the connection point during the pull-off process
  • the other is
  • the way of offsetting the connection point to the middle area of the stent can effectively reduce the damage to the channel tissue of the wire connection part during the pull-off process.
  • test cases are used to verify the pull-off performance of the stent in this application.
  • Test equipment Tensile testing machine, corresponding tooling for different tests.
  • Axial pull-off force test conditions Fix the auxiliary tooling on the fixture of the tensile testing machine, hang the auxiliary wire on one end of the cavity bracket to the auxiliary tooling, and fix the other end of the cavity bracket to the other fixture of the tensile testing machine, test During the process, record the maximum tensile force F max (the maximum tensile force that can be withstood when the connection part of the wire head is broken (to separate the covered connector from the end of the wire)); the test is carried out at a speed of 200mm/min, and the gauge length is based on the test of different samples The total length of the sample in the free state is determined, and the principle of selecting parameters refers to GB/T15812.1-2005 Appendix B.
  • Radial compression resistance test conditions Fix the sample to be tested on the opening with a cylindrical fixing tool at room temperature, and pass a probe with a rectangular probe through the sample until the connecting piece is separated from the connected piece, and record the test process
  • the operation steps are: adjust the fixed mold or probe so that the annular opening and the probe are in concentric positions, place the test part of the sample at the opening of the cylindrical fixed mold, fix the sample, and slowly lower the probe to the sample Contact, and then move the probe at a speed of 50mm/min until the wire head connection part on the intraluminal stent breaks (to make the covering connector separate from the wire end), and record the maximum load at the break.
  • At least one end region of the intraluminal stent or any sub-stent is radially contracted when transitioning to the middle region, and the covered part 2 is located at the radially contracted part and is covered accordingly
  • the connector 3 is located in the radial contraction area.
  • the radial cross-section of the sub-stent body is preferably circular, D-shaped or elliptical to adapt to different tissue cavities, and different cross-sectional shapes meet the requirements of strength in different directions.
  • the cross-sectional shape of each sub-stent may be the same or different, and the corresponding selection can be made according to needs.
  • each sub-stent when the intraluminal stent is composed of multiple sub-stents, an L-shaped stent formed by two sub-stents can be formed (as shown in Figures 8a to 8f) ), or a Y-shaped stent formed by three sub-stents (as shown in FIG. 9a to FIG. 91), the radial cross-section of each sub-stent may be circular, D-shaped or elliptical.
  • the covering connector 3 can be located on any one of the different sub-supports (as shown in Figure 8a, Figure 8b, Figure 8d and Figure 8f) or multiple (as shown in Figure 8c and Figure 8e), and on one sub-support Corresponding weaving methods can be adopted according to the position and quantity of the wire ends to form one or more wire end connection areas (each wire end connection area contains several covered parts 2 arranged in the same direction).
  • connection area can be located at any position in the axial direction of the intraluminal stent and can extend along any spiral direction, as shown in Figure 9a, Figure 9d, Figure 9e, Figure 9f, Figure 9h, Figure 9i, Figure 9k and Figure 91, one sub Only one wire-end connection area can be provided on the bracket, and as shown in Figs. 9b, 9c, 9g, and 9j, multiple wire-end connection areas can be provided on one sub-bracket.
  • the weaving and forming method of the covered portion 2 on the intraluminal stent based on the difference of the machine-knitting method, it can be adjusted accordingly according to the difference in the actual forming position and the number of filament ends.
  • one end or both ends of the sub-stent may have a first silk thread head extending in the first spiral direction and a second silk thread head extending in the second spiral direction.
  • the first wire end (wire head) extending in the first spiral direction can be folded back to the middle region of the above-mentioned end region of the sub-stent to form a bent portion, and the corresponding The end of the second thread extending in the second spiral direction is approached to form the covered part 2, and the sheathing connector 3 is correspondingly arranged, so that only one end has a thread connection area (each thread connection area contains the same direction).
  • Each thread connection area contains the same direction
  • the arranged intraluminal stents of the several covered parts 2) or the intraluminal stents with wire head connection areas (each wire head connection area includes several covered parts 2 arranged in the same direction) at both ends.
  • the entire intraluminal stent has 2-4 wire head connection areas (each A number of covered parts 2) arranged in the same direction are included in the connecting area of each thread head.
  • radiopaque marks such as tantalum marks, etc.
  • a recovery line may be provided at the end area of at least one end of the stent to facilitate recovery of the stent.
  • the recovery line may be a separate structure or an integrated structure woven with the stent.
  • the stent is covered with a stent membrane at least in the middle area, and the membrane material is preferably a degradable material to reduce irritation to the human body.
  • the method for preparing the above-mentioned intraluminal stent in this application includes the following steps:
  • an intraluminal stent including at least one sub-stent
  • a covering connector is provided on the outer periphery of the covered part, and the two ends of the covering connector and the areas corresponding to the two ends of the covered part form a stable connection.
  • the two wire ends of the covering part are wrapped in it, and the covered part is spaced from the edge of at least one end of the sub-stent.
  • the two ends of the silk thread are inserted into the thread grid formed by the first thread extending in the first spiral direction and the second thread extending at least in the second spiral direction to form the The covered part.
  • step (2) through a coating process or a heat shrinking process, the areas corresponding to the two ends of the covered connector and the two ends of the covered part are fixed to form a stable connection.

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Abstract

一种腔内支架（1）及其制备方法。该腔内支架（1）包括至少一个子支架。子支架包括至少沿第一螺旋方向延伸的第一丝线（4）和至少沿第二螺旋方向延伸的第二丝线（5），且两者延伸方向不同以形成若干丝线交叉点。腔内支架（1）具有若干被包覆部（2），以将对应的两个丝线末端包覆其中。被包覆部（2）外周设有包覆连接件（3），包覆连接件（3）两端部与被包覆部（2）两端对应的区域形成稳定连接，通过包覆连接件（3）将被包覆部（2）的两个丝线末端包覆其中。该支架（1）具有对腔内组织伤害较小，以及较强的抗拉伸能力。

Description

一种腔内支架及其制备方法
相关申请的交叉引用
本申请要求于2019年05月28日提交中国专利局的申请号为201910453118.2、名称为“一种腔内支架及其制备方法”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本申请涉及一种用于人体腔道内的腔内支架，属于人体内使用的医疗装置。
背景技术
现有支架的编织方法主要分为人工编织和机器编织，而人工编织的编织难度大且产能受限制，而机器编织支架头端处理困难，通常无法实现将细线的端头与支架主体部分良好地固定在一起，导致支架连接部分容易断开。例如现有技术CN105873547A中，采用机织方式制备的支架，一方面，丝线端部回编区域形成的端头连接部靠近支架两端的边缘处，在拉脱过程中，连接部受力屈服过程，形变能力和抗拉伸性能较差，容易对腔道内组织形成伤害，且极易断开，造成支架取出困难；另一方面，连接部采用的焊接工艺，使得连接点表面粗糙，容易伤害腔道组织，且焊接点面积过小时抗拉脱强度差，焊接面积过大又会导致连接部分刚性过大，腔道内环境适应性形变能力降低。此外，从专利US20050256563A1和US20170231746A1等均可以看出，在支架编织过程中，现有技术通常采用的回编方式中，连接部的处理方式均与CN105873547A相近，因此，也均存在上述难以克服的对腔内组织伤害大以及连接部抗拉伸性能差等技术问题。
此外，如现有技术CN107595448A中，丝头外部虽然采用了套管结构，但由于丝头末端处仍然是固定连接，即两个丝头末端是固定连接后套接外部套管结构，这种丝头连接方式最大的缺陷在于，研发人员发现在拉脱过程中，在施加径向或轴向的拉脱力超过丝头连接部的耐受极限时，丝头断开的瞬间支架产生形状突变会导致支架对组织产生较大的冲击，对组织带来较大伤害，此外，该现有技术中丝头连接段同样设置在支架边缘部，在丝头断裂过程中会形成尖角，增加损伤人体组织的几率。
有鉴于此，特提出本申请。
发明内容
基于现有技术存在的技术问题，提出一种具有对腔内组织伤害小以及抗拉伸能力强的腔内支架，包括：一种腔内支架，所述腔内支架包括至少一个子支架，所述子支架具有径向压缩形态和径向扩张形态，所述子支架在轴向方向上具有位于两端的端部区域和在端部区域间延伸的中间区域，所述子支架包括至少沿第一螺旋方向延伸的第一丝线和至少沿第 二螺旋方向延伸的第二丝线，且两者延伸方向不同以形成若干丝线交叉点，所述腔内支架具有若干被包覆部，以将对应的两个丝线末端包覆在其中，所述被包覆部外周设有包覆连接件，所述包覆连接件两端部与所述被包覆部两端对应的区域形成稳定连接，所述被包覆部与所述子支架至少一个端部的边缘间隔设置。通过将被包覆部远离腔内支架(子支架)端部边缘间隔一段距离设置，相对于丝头连接部直接设置在边缘或紧邻边缘设置的现有方式，本申请中的设置方式使得丝头连接部分的自由度受到支架编织网格的限制，不易变形失效，提高了其径向耐压缩力和拉脱力，使得支架的力学性能得以明显提升。
进一步，所述被包覆部与所述支架至少一个端部的边缘间隔距离为a，所述子支架沿轴向方向的长度为L，其中a/L大于1/20。
进一步，通过所述包覆连接件将被包覆部的两个丝线末端以相互接近或接触的方式包覆在其中。
进一步，通过所述包覆连接件将被包覆部的两个丝线末端以所述两个末端间可相对移动的方式包覆在其中。
进一步，所述包覆连接件对应部分径向耐压缩力不小于10N。
进一步，所述包覆连接件为具有弹性的涂层和/或热缩管材。
进一步，所述包覆连接件的长度至少完全覆盖所述被包覆部，且被包覆部中两个对应丝线末端为对接接触或者具有重叠区域。
进一步，所述至少一端部区域向中间区域过渡时径向收缩，所述连接部位于径向收缩区域。
进一步，所述子支架的横截面为圆形、D形或椭圆形。
进一步，所述腔内支架为L型或Y型支架。
进一步，所述沿第一螺旋方向延伸的第一丝线末端在所述子支架的至少一端的端部区域向中间区域回折以形成弯折部，并与对应的所述沿第二螺旋方向延伸的第二丝线末端接近以形成被包覆部。
进一步，两个所述子支架间，一个子支架的丝线末端向另一子支架的对应丝线末端延伸，并形成被包覆部。
本申请还提供一种内腔支架的制备方法，包括如下步骤：
(1)提供包括至少一个子支架的腔内支架；
(2)将所述子支架中对应的两个丝线末端接近以形成被包覆部，所述子支架上形成若干被包覆部；
(3)所述被包覆部外周设置包覆连接件，并使得包覆连接件两端部与所述被包覆部两端对应的区域形成稳定连接，通过所述包覆连接件将被包覆部的两个丝线末端包覆在其中， 并使得所述被包覆部与所述子支架至少一个端部的边缘间隔设置。
进一步，所述步骤(3)中，将两个所述丝线末端穿入至第一螺旋方向延伸的第一丝线和至少沿第二螺旋方向延伸的第二丝线形成的丝线网格中以形成所述被包覆部。
进一步，所述步骤(2)中，通过涂覆工艺或热缩工艺，将包覆连接件两端部与所述被包覆部两端对应的区域固定，形成稳定连接。
基于上述技术方案，本申请具有如下优点：
本申请中支架采用产能更高的机器编织的多丝线支架作为本体，采用非焊接的丝线端部(丝头)连接方式，使得支架两端端头部分同传统手工编织的一根丝编织支架一样圆滑，对管壁刺激小，减少了增生、穿孔及移位的风险，又降低了支架位置调整及回收时连接件脱落的风险。
此外，通过优化被包覆部在支架上的设置位置，在确保支架的拉脱性能的前提下，提高了丝头连接位置的抗拉能力，确保在使用中不易断裂，提高支架使用的安全性能。
附图说明
图1a至图1b为腔内支架中包覆连接件部分沿不同螺旋方向延伸时的侧视图；
图2为腔内支架一端受轴向力的示意图；
图3为图2所示腔内支架受径向力的示意图；
图4a至图4c为图3所示腔内支架包覆连接件对应区域不同接近方式的放大示意图；
图5为腔内支架径向截面的示意图；
图6为腔内支架径向截面的示意图；
图7为腔内支架径向截面的示意图；
图8a至图8f为由两个子支架组成的L型支架的示意图，其中图8a至图8f例举了腔内支架上包覆连接件在不同子支架上的排布方式；
图9a至图9l为由三个子支架组成的Y型支架示意图，其中图9a至图9l例举了腔内支架上包覆连接件在不同子支架上的排布方式。
附图标记说明：
1-支架；11-端部区域；12-中间区域；2-支架的被包覆部；3-包覆连接件；4-第一丝线；41-第一结合点；5-第二丝线；51-第二结合点。
具体实施方式
结合附图和具体实施例对本申请的技术内容作详细说明。
下面将结合实施例对本申请的实施方案进行详细描述，但是本领域技术人员将会理解，下列实施例仅用于说明本申请，而不应视为限制本申请的范围。
对本申请中涉及的一些名词进行说明。压缩形态是指在传输支架过程中，支架被径向 压缩时的状态；扩张形态是指支架被释放后，由于自身径向张力而扩张后的形态；轴向是指腔内支架中的各子支架中心轴的延伸方向；径向是指垂直于轴向的径向延伸方向。此外，对第一丝线和第二丝线作进一步解释，沿第一螺旋方向延伸的第一丝线代表腔内支架中的各子支架中所有沿第一螺旋方向延伸的丝线统称，并不限于某一丝线，同理，沿第二螺旋方向延伸的第二丝线，代表腔内支架中的各子支架中所有沿第二螺旋方向延伸的丝线统称，其中，根据机编形成腔内支架中的各子支架的具体形态，沿不同螺旋方向延伸的第一丝线和第二丝线可以为相对独立分离的丝线编织体，即机编后腔内支架中的子支架两端均具有沿第一螺旋方向延伸和沿第二螺旋方向延伸的第一和第二丝线的丝线端部(丝头)；沿不同螺旋方向延伸的第一丝线和第二丝线也可以为由同一丝线整体弯折后形成的丝线编织体，即机编后腔内支架中的子支架仅有一端具有沿第一螺旋方向延伸和沿第二螺旋方向延伸的第一和第二丝线的丝线端部(丝头)，而另一端不存在丝头。
图1a、图2和图3所示的为本申请中的一实施例，其所示的是腔内支架中的至少一个子支架中包含包覆连接件中的对应区域。该子支架用于人体腔道内，人体腔道可以为胰管、胆管、肠道、食道或气管等。该子支架具有径向压缩形态和径向扩张形态，在子支架的轴向方向上具有位于两端的端部区域11和在端部区域11间延伸的中间区域12，子支架包括多条沿第一螺旋方向延伸的第一丝线4和与第一丝线4数量对应的沿第二螺旋方向延伸的第二丝线5，其中，第一螺旋方向和第二螺旋方向相交，且相对于支架中心轴对称设置。第一丝线4和第二丝线5延伸相交并形成具有若干丝线交叉点的若干网格形态。图1b所示的另一种实施方式，包覆连接件的延伸方式也可以沿第一螺旋方向延伸，即包覆连接件的延伸方向可以根据实际编制方式的需要沿不同的螺旋方向延伸。
如图2和图3所示，沿第一螺旋方向延伸的第一丝线4末端在端部区域11向中间区域12回折以形成弯折部，并与对应的沿第二螺旋方向延伸的第一丝线5末端重合并交叠形成被包覆部2，在被包覆部外周设有管型包覆连接件3，包覆连接件3两端部与被包覆部2两端对应的区域形成稳定连接，通过包覆连接件3将被包覆部2的第一丝线4和第二丝线5的末端均包覆在包覆连接件3中。本实施例优选采用热缩管材包覆住丝线末端的被包覆部2，且作为包覆连接件的热缩管材长度至少覆盖住被包覆部的全部长度，热缩管材长度优选沿被包覆部2两侧端部至少多延伸1mm，以确保在拉伸过程中，丝线末端不会从管材中拉脱出，提高包覆连接件的稳定性。当然除热缩管材外，可以采用在重回部外部形成弹性的涂层，以包覆住丝线的末端。
如图4a所示包覆连接件3对应区域的放大示意图，本实施例中，包覆连接件3完全覆盖被包覆部2，且被包覆部沿丝线延伸方向上的长度大于3mm，其中包覆连接件3一端与第一丝线在第一结合点稳定接合，包覆连接件3的另一端与第二丝线在第二结合点稳定接 合，所述包覆连接件3具有一定弹性，故当沿轴向拖拽支架时，被包覆部2受到轴向拉伸力时，第一和第二丝线沿第二螺旋方向彼此远离，即第一和第二丝线的末端可以相对移动(两个丝头相接近但不固定连接)，本申请研发人员创新性地尝试将丝头间传统的固定连接方式变为可相对移动方式，相对于现有技术中丝头间固定连接的方式，本申请中两丝头末端可相对移动的设置方式能够极大地增加丝线连接点的抗拉伸挠性，提高支架整体的形变性能，在支架扩张和拉伸等形变过程中，支架的抗拉伸性能得以显著提高。更显著的是，有别于现有技术中焊接等固定连接方式，采用热缩管材或涂层方式使两个丝头末端间形成相对稳定的包覆连接件形式，一方面确保连接点外表面更为平滑，对管壁刺激小，减少了增生、穿孔及移位的风险，另一方面又降低了支架位置调整及回收时连接件断裂时产生的瞬时突变对人体组织带来的损伤风险。当然，除了如图4a中所示的被包覆部2中两个丝线末端(丝头)具有重合区域的情况外，如图4b和图4c所示，两个丝线末端也可以以任意相互接近的方式包覆于包覆连接件3中，例如，两个丝头可以为不重叠，仅丝头部分接触(如图4b所示)或者不接触(如图4c所示)，只要确保被包覆部2被包覆连接件3稳定连接在一起即可。
进一步，如图2和图3所示，腔内支架中的包覆连接件3对应部分径向耐压缩力不小于10N，其中径向耐压缩力是指，使包覆连接件对应部分径向压缩至极限状态下(使包覆连接件与丝线末端脱离)所需的压缩力。腔内支架中每个子支架端部区域的边缘部位具有周向环绕的折弯部，单个折弯部拐点的轴向拉脱力不小于30N，其中轴向拉脱力定义为：支架主体轴向受力，使连接部件与丝线末端脱离的拉力。支架主体轴向部折弯拐点的轴向拉脱力总和不小于200N。基于本申请中改进的丝线连接方式，腔内支架在使用和取出过程中，腔内支架能够达到上述耐压缩和拉脱性能要求，且支架对腔壁形成的支撑作用，又能确保在不损伤组织的情况下将支架脱出人体腔道。
如图2、图8a至图8f以及图9a至图9l所示，腔内支架中的被包覆部2与子支架至少一个端部区域的边缘间具有一定间隔，有别于现有技术中丝头连接点位于支架端部边缘的常规设计，本申请优选使得丝头连接点对应的被包覆部2远离支架端部边缘，设定丝头连接点(包覆连接件)朝向边缘的一侧与支架端部边缘间的距离为a，子支架沿轴向方向的整体长度为L，则本申请优选a/L大于1/20，经过多次反复验证，当a/L大于1/20时，丝头连接部分与边缘区确保有足够的间距，在拉脱过程中被包覆部被拉脱破坏的几率明显降低，拉脱形变性能也得以提升。从丝线交叉点角度考虑，优选使得被包覆部与子支架至端部的边缘间隔至少3个丝线交叉点，优选被包覆部与子支架至端部的边缘间隔5个或5个以上的丝线交叉点。通过这一将包覆连接件3远离折弯部的特殊编织方式，极大地提高了支架的屈服形变性能，一方面能够避免拉脱过程中连接点应力集中导致的连接点易断裂的缺陷， 另一方面，通过反复试验和临床使用反馈，连接点向支架中间区域偏移编织的方式可以有效降低拉脱过程中丝头连接部分对腔道组织的损伤。
通过如下测试例以验证本申请中支架的拉脱性能。
测试例：
测试设备：拉伸试验机，不同测试采用相应工装。
轴向拉脱力测试条件：将辅助工装固定在拉伸试验机夹具上，将腔内支架一端上辅助线挂到辅助工装上，腔内支架另一端固定到拉伸试验机另一个夹具上，测试过程中记录最大拉力F max(使丝头连接部位断裂(使包覆连接件与丝线末端脱离)时能够承受的最大拉力)；以200mm/min的速度进行测试，标距根据不同试样的测试样品自由状态下总长度而定，选定参数原则参照GB/T15812.1-2005附录B。
径向耐压缩力测试条件：在室温下用圆柱形固定工装将被测试样品固定在开口上，将一个带长方形探头的探针穿过样品，直到连接件与被连接件分离，记录测试过程中的最大载荷；操作步骤为：调整固定模具或探针，使环形开口和探针在同心位置，将样品的测试部位置于圆柱形固定模具的开口处，固定样品，缓慢降低探针到与样品接触，随后以50mm/min的速度移动探针直到腔内支架上丝头连接部位断裂(使包覆连接件与丝线末端脱离)，记录断裂时的最大载荷。
测试结果如表1和表2所示：
表1丝头连接部分位置不同的对比试验结果
Figure PCTCN2019126080-appb-000001
(备注：表1中，设定丝头连接点(包覆连接件)朝向边缘的一侧与支架端部边缘间的距离为a(如图3所示)，子支架沿轴向方向的整体长度为L。)
基于上述表1所示的试验结果可以看出，将丝头连接部分与支架边缘间隔一段距离设置后，支架整体的力学性能得到较大提升，相比于现有技术中丝头连接部分直接位于支架边缘或紧邻支架边缘的设置方式，本申请中的径向耐压缩力均达到10N以上，极大地提升了支架在拉脱取出过程中的安全性能，通过临床试验证明，相比于现有技术，本申请的支架具有更加优异的安全性。
表2丝头连接方式不同的对比试验结果
Figure PCTCN2019126080-appb-000002
Figure PCTCN2019126080-appb-000003
(备注：表2中，设定丝头连接点(包覆连接件)朝向边缘的一侧与支架端部边缘间的距离为a(如图3所示)，子支架沿轴向方向的整体长度为L，a/L＝1/20。)
基于上述表2所示的试验结果可以看出，采用丝头间可相对移动的方式，支架的径向耐压缩力明显提高，且相对于丝头连接部分设置在支架端部边缘位置，将丝头连接部分与边缘间隔设置后，无论是径向耐压缩性能还是轴向拉脱性能均得到显著提高。
此外，作为另外的优选方式，如图2所示，腔内支架或任意子支架的至少一端部区域向中间区域过渡时径向收缩，被包覆部2位于径向收缩部位，相应地包覆连接件3位于径向收缩区域，这种设计方式一方面有效提高支架端部径向扩张强度，同时在满足径向抗压强度的要求下，包覆连接件编织位置靠近径向宽度较小的中间区域，有效减少连接点与人体腔道组织接触几率，降低对组织造成损伤的几率。
如图5至图7所示，所述子支架主体的径向横截面优选为圆形、D形或椭圆形，以适应不同的组织腔道，不同的截面形状适应不同方向强度的要求。腔内支架中包含多个子支架的情况下，各个子支架的截面形状可以相同，也可以不同，根据需要进行相应的选择。
此外，如图8a至图8f以及图9a至图9l所示，当所述腔内支架由多个子支架组成时，可以形成由两个子支架形成的L型支架(如图8a至图8f所示)，或由三个子支架形成的Y型支架(如图9a至图9l所示)，每个子支架的径向横截面可以呈圆形、D形或椭圆形中的一种。包覆连接件3可以位于不同子支架中的任意一个(如图8a、图8b、图8d和图8f所示)或多个(如图8c和图8e所示)上，且一个子支架上可以根据丝头形成位置和数量，采用相应的编制方法，以形成一个或多个丝头连接区域(每个丝头连接区域中包含同向排布的若干被包覆部2)，这些丝头连接区域可以位于腔内支架轴向方向上任意位置并可沿任意螺旋方向延伸，如图9a、图9d、图9e、图9f、图9h、图9i、图9k和图9l所示，一个子支架上可以仅设置一个丝头连接区域，另外如图9b、图9c、图9g和图9j所示，一个子支架上可以设置多个丝头连接区域。此外，本申请中优选与支架端部边缘之间间隔设置，以确保支架整体外部圆滑的同时，支架拉脱性能符合不同腔道内使用时的要求。
具体地说，对于腔内支架上被包覆部2的编织形成方式而言，基于机编方式的差异，可以根据实际丝头形成位置和数量的差异而进行相应调整。例如，当腔内支架中仅有一个子支架时，子支架可以为一端或者两端具有沿第一螺旋方向延伸的第一丝线丝头和沿第二螺旋方向延伸的第二丝线丝头时，为了形成闭合的支架端部区域，则可以使得沿第一螺旋方向延伸的第一丝线末端(丝头)在子支架的上述端部区域向中间区域回折以形成弯折部，并与对应的所述沿第二螺旋方向延伸的第二丝线末端接近以形成被包覆部2，并相应设置包覆连接件3，进而得到仅一端具有丝头连接区域(每个丝头连接区域中包含同向排布的若干被包覆部2)的腔内支架或者两端均具有丝头连接区域(每个丝头连接区域中包含同 向排布的若干被包覆部2)的腔内支架。当腔内支架由多个子支架连接编织而成时，两个所述子支架间，一个子支架的丝线末端向另一子支架的对应丝线末端延伸以形成被包覆部，并采用包覆连接件3稳固连接，如图8a至图8f所示的L型腔内支架中，基于机编后形成的丝头分布情况，整个腔内支架上具有1-2个丝头连接区域(每个丝头连接区域中包含同向排布的若干被包覆部2)，如图9a至图9l所示的Y型腔内支架中，整个腔内支架上具有2-4个丝头连接区域(每个丝头连接区域中包含同向排布的若干被包覆部2)。
此外，本申请中支架上可以根据实际需要及特定的使用要求，设置不透射线标记，例如钽标记等，以在使用中便于定位。另外，可以在支架的至少一端的端部区域设置回收线，以便于回收支架，回收线可以是单独的结构也可以与支架一体结构编织而成。支架至少中间区域被覆有支架覆膜，优选覆膜材料为可降解材料，减少对人体的刺激。
本申请中的上述内腔支架的制备方法，包括如下步骤：
(1)提供包括至少一个子支架的腔内支架；
(2)将所述子支架中对应的两个丝线末端接近以形成被包覆部，所述子支架上形成若干被包覆部；
(3)所述被包覆部外周设置包覆连接件，并使得包覆连接件两端部与所述被包覆部两端对应的区域形成稳定连接，通过所述包覆连接件将被包覆部的两个丝线末端包覆在其中，并使得所述被包覆部与所述子支架至少一个端部的边缘间隔设置。
进一步，所述步骤(3)中，将两个所述丝线末端穿入至第一螺旋方向延伸的第一丝线和至少沿第二螺旋方向延伸的第二丝线形成的丝线网格中以形成所述被包覆部。
进一步，所述步骤(2)中，通过涂覆工艺或热缩工艺，将包覆连接件两端部与所述被包覆部两端对应的区域固定，形成稳定连接。
最后应说明的是：以上各实施例仅用以说明本申请的技术方案，而非对其限制；尽管参照前述各实施例对本申请进行了详细的说明，但本领域的普通技术人员应当理解：其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分或者全部技术特征进行等同替换；而这些修改或者替换，并不使相应技术方案的本质脱离本申请各实施例技术方案的范围。

Claims (15)

  1. 一种腔内支架，所述腔内支架包括至少一个子支架，所述子支架具有径向压缩形态和径向扩张形态，所述子支架在轴向方向上具有位于两端的端部区域和在端部区域间延伸的中间区域，所述子支架包括至少沿第一螺旋方向延伸的第一丝线和至少沿第二螺旋方向延伸的第二丝线，且两者延伸方向不同以形成若干丝线交叉点，其特征在于：
    所述腔内支架具有若干被包覆部，以将对应的两个丝线末端包覆在其中，所述被包覆部外周设有包覆连接件，所述包覆连接件两端部与所述被包覆部两端对应的区域形成稳定连接，所述被包覆部与所述子支架至少一个端部的边缘间隔设置。
  2. 如权利要求1所述的腔内支架，其特征在于：所述被包覆部与所述支架至少一个端部的边缘间隔距离为a，所述子支架沿轴向方向的长度为L，其中a/L大于1/20。
  3. 如权利要求1所述的腔内支架，其特征在于：通过所述包覆连接件将被包覆部的两个丝线末端以相互接近或接触的方式包覆在其中。
  4. 如权利要求3所述的腔内支架，其特征在于：通过所述包覆连接件将被包覆部的两个丝线末端以所述两个末端间能相对移动的方式包覆在其中。
  5. 如权利要求1所述的腔内支架，其特征在于：所述包覆连接件对应部分径向耐压缩力不小于10N。
  6. 如权利要求1-5任一项所述的腔内支架，其特征在于：所述包覆连接件为具有弹性的涂层和/或热缩管材。
  7. 如权利要求1-5任一项所述的腔内支架，其特征在于：所述包覆连接件的长度至少完全覆盖所述被包覆部，且被包覆部中两个对应丝线末端为对接接触或者具有重叠区域。
  8. 如权利要求1-5任一项所述的腔内支架，其特征在于：所述至少一端部区域向中间区域过渡时径向收缩，所述连接部位于径向收缩区域。
  9. 如权利要求1-5任一项所述的腔内支架，其特征在于：所述子支架的横截面为圆形、D形或椭圆形。
  10. 如权利要求1-5任一项所述的腔内支架，其特征在于：所述腔内支架为L型或Y型支架。
  11. 如权利要求1-5任一项所述的腔内支架，其特征在于：所述沿第一螺旋方向延伸的第一丝线末端在所述子支架的至少一端的端部区域向中间区域回折以形成弯折部，并与对应的所述沿第二螺旋方向延伸的第二丝线末端接近以形成被包覆部。
  12. 如权利要求1-5任一项所述的腔内支架，其特征在于：两个所述子支架间，一个子支架的丝线末端向另一子支架的对应丝线末端延伸，并形成被包覆部。
  13. 一种制备权利要求1-12任一项所述内腔支架的制备方法，包括如下步骤：
    (1)提供包括至少一个子支架的腔内支架；
    (2)将所述子支架中对应的两个丝线末端接近以形成被包覆部，所述子支架上形成若干被包覆部；
    (3)所述被包覆部外周设置包覆连接件，并使得包覆连接件两端部与所述被包覆部两端对应的区域形成稳定连接，通过所述包覆连接件将被包覆部的两个丝线末端包覆在其中，并使得所述被包覆部与所述子支架至少一个端部的边缘间隔设置。
  14. 如权利要求13所述内腔支架的制备方法，其特征在于：所述步骤(3)中，将两个所述丝线末端穿入至第一螺旋方向延伸的第一丝线和至少沿第二螺旋方向延伸的第二丝线形成的丝线网格中以形成所述被包覆部。
  15. 如权利要求13所述内腔支架的制备方法，其特征在于：所述步骤(2)中，通过涂覆工艺或热缩工艺，将包覆连接件两端部与所述被包覆部两端对应的区域固定，形成稳定连接。
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