WO2023125387A1 - 覆膜支架 - Google Patents

覆膜支架 Download PDF

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Publication number
WO2023125387A1
WO2023125387A1 PCT/CN2022/141844 CN2022141844W WO2023125387A1 WO 2023125387 A1 WO2023125387 A1 WO 2023125387A1 CN 2022141844 W CN2022141844 W CN 2022141844W WO 2023125387 A1 WO2023125387 A1 WO 2023125387A1
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WO
WIPO (PCT)
Prior art keywords
wave
trough
coil
stent
proximal
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PCT/CN2022/141844
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English (en)
French (fr)
Inventor
吴少聪
刘奎
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先健科技(深圳)有限公司
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Publication of WO2023125387A1 publication Critical patent/WO2023125387A1/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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • 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
    • A61F2002/91558—Adjacent bands being connected to each other connected peak to peak
    • 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
    • A61F2002/91566—Adjacent bands being connected to each other connected trough to trough

Definitions

  • the invention relates to the technical field of interventional medical devices, in particular to a covered stent.
  • aneurysm disease Due to various lesions or injuries of the human aorta, it is easy to cause damage to the intima of the aortic vessel or the vessel wall, forming an aneurysm disease. Once the aneurysm ruptures, blood gushes out of the blood vessel, resulting in insufficient blood supply to the human body, resulting in shock or death of the human body.
  • aneurysm disease the treatment of aneurysms in different parts is different, and surgical treatment, aneurysm embolization and endovascular repair of aneurysm are commonly used.
  • the main principles of surgical treatment are aneurysm resection and arterial reconstruction; for some visceral aneurysms, coil embolization can be used to form a thrombus in the aneurysm to avoid further expansion of the aneurysm and bleeding; Endovascular repair of aneurysm with vascular stent has less trauma and obvious curative effect.
  • Endovascular repair has become the mainstream in the treatment of cardiovascular diseases in recent years. With the continuous improvement of interventional technology, the advantages of endovascular repair have become increasingly prominent.
  • the use of covered stents needs to be transported to the lesion for treatment using a conveyor. Before delivery, the stent graft needs to be compressed into the sheath of the delivery device.
  • the blood vessel is punctured at the position of the femoral artery or the iliac artery, and a guide wire is used to establish a track, and the delivery device is passed through the iliac artery-abdominal aorta-thoracic aorta-aortic arch —The ascending aorta establishes a transport path, and then transports to the designated location of the lesion, releases the covered stent, the stent expands and clings to the wall of the aneurysm, and the film covered on the stent isolates the blood flow from the lesion, eliminating the blood flow The impact on the aneurysm wall of the diseased part re-establishes the normal channel of blood circulation, and finally withdraws the guide wire and delivery device, so as to realize the interventional treatment of aneurysm and arterial dissection.
  • the covering film is generally made of polymer materials such as PTFE, and the stent is mainly braided with nickel-tit
  • the two anchoring single waves (high waves 111) on the first wave circle 11 at the proximal end of the stent can be hooked by using the specific U-shaped anchor structure of the conveyor to achieve stable release, or Avoid stent shortening or endoleaks due to unanchored structures.
  • the first wave coil 11 at the proximal end can be designed as a wave coil of high and low waves, as shown in Figure 1-3, using the high wave 111 of the wave coil (the proximal end of the low wave 112 is close to On the proximal end face of the coating 20, the part of the high wave 111 higher than the low wave 112 is exposed from the proximal end to the coating to form a bare section 1112) as an anchor wave to cooperate with the U-shaped anchor to realize the stable release of the stent.
  • the traction force F only acts on the crests of the two high waves, and at this time the trough of the high waves is mainly affected by the component force F1 along the axial direction towards the proximal end (and the smaller component force F1).
  • the technical problem to be solved by the present invention is that the anchoring wave in the first wave circle used to hook the U-shaped anchor in the prior art is likely to cause damage to the coating, so that the coating cannot isolate the blood flow and the lesion, or even It is a defect that may cause the first wave circle to fall off and the film to deform and shrink, and a film-grafted stent is provided.
  • An embodiment of the present invention provides a stent graft, comprising a stent and a membrane coated on the stent, the stent includes a plurality of corrugated coils arranged in the axial direction, and the corrugated coils include a first corrugated coil and a A second corrugated coil, the first corrugated coil is located at the proximal end of the stent-graft, the second corrugated coil is located at the distal side of the first corrugated coil, and the first corrugated coil includes a first single corrugated coil and a first corrugated coil.
  • the first single wave is at least partially not covered by the covering film, and the first single wave is fixed to the second wave coil.
  • the proximal end of the first single wave protrudes from the proximal end surface of the coating, and the second single wave is located in the area of the coating and is surrounded by the coating. Overlapping, the trough formed between the first single wave and the adjacent single wave on the same wave circle is fixed to the nearest wave trough or peak on the second wave circle.
  • the second wave circle includes a proximal second wave circle and a distal second wave circle, and the trough of the first single wave is not along the peak of the proximal second wave circle. on the same axis.
  • the trough of the first single wave and the trough of the second proximal wave are on the same axial line, and are fixed or integrally formed by knotting polymer wires.
  • one of the first single waves includes a first wave trough and a second wave trough on both sides along the axial direction
  • the polymer wire includes at least one first axial section
  • the first axial A segment is located between the first trough or/and the second trough and the trough of the proximal second coil.
  • a middle second wave coil is further included between the proximal second wave coil and the distal second wave coil, and the polymer wire is located between the first wave trough and the proximal wave coil.
  • the polymer wire includes a plurality of overlapping first axial segments between the end second wave coils, and the polymer wire includes a plurality of overlapping second axis segments between the proximal second wave coil and the middle second wave coil.
  • the second axial segment is located between each of the second wave rings.
  • the trough of the first single wave and the two peaks closest to the second wave circle at the proximal end are respectively fixed by knotting with polymer wires.
  • one of the first single waves includes troughs on both sides of the axial direction
  • the polymer wire includes at least one oblique section, and the oblique section is located at the trough of the first single wave. and between the crests of the second wave circle.
  • the second corrugation includes a proximal second corrugation and a distal second corrugation
  • the trough of the first single wave is along the same edge as the crest of the proximal second corrugation.
  • the trough of the first single wave and the second wave coil at the proximal end are fixed or integrally formed by knotting polymer wires.
  • the first single wave includes a first trough and a second trough
  • the second near-end wave circle further includes a first crest and a second crest
  • the first crest and the second crest are A trough is on the same axis
  • the second peak and the second trough are on the same axis
  • the polymer wire includes at least one first axial segment
  • the first axial segment is located at the first trough and the first peak or/and between the second valley and the second peak.
  • the nodes between the polymer wires and the corrugations include starting and ending points and intermediate points, and the starting and ending points are doubled.
  • knot the middle point is tied with a single knot.
  • the above covered stent can increase the connection strength between the first single wave and the second wave circle by fixing the first single wave and the second wave circle, disperse the force of the first single wave, and avoid the first single wave and the second wave coil.
  • the second single wave is deformed due to excessive force and damages the coating, or avoids the phenomenon that the first wave coil falls off and the coating film is unsupported, and avoids the problem of radial shrinkage of the coating film caused by the pulling deformation of the first wave coil , thereby improving the stability of the stent graft.
  • Fig. 1 is a schematic structural view of a stent graft with high and low corrugations in the prior art
  • Fig. 2 is a structural schematic diagram of high and low corrugations in the prior art
  • Fig. 3 is a schematic diagram of the structure of the tiling after cutting in Fig. 2;
  • Fig. 4 is a force analysis diagram when the high-wave hook in Fig. 1 is hung on a U-shaped anchor;
  • FIG. 5 is a schematic structural view of a stent graft according to an embodiment of the present invention.
  • FIG. 6 is a schematic structural view of a stent graft according to another embodiment of the present invention.
  • Fig. 7 is a schematic structural view of a stent graft according to another embodiment of the present invention.
  • Fig. 8 is a structural schematic diagram of a single knot of a polymer wire and a corrugated coil in the present invention.
  • Fig. 9 is a structural schematic diagram of a double knot between a polymer wire and a corrugated coil in the present invention.
  • Fig. 10 is a schematic structural view of a stent graft according to another embodiment of the present invention.
  • Fig. 11 is a schematic structural view of a stent graft according to another embodiment of the present invention.
  • Fig. 12 is a schematic structural view of a stent graft according to another embodiment of the present invention.
  • Fig. 13 is a schematic structural view of a stent graft according to another embodiment of the present invention.
  • Fig. 14 is a schematic structural view of a stent graft according to another embodiment of the present invention.
  • a blood vessel is used as an example to illustrate the lumen, and the blood vessel may be the aortic arch, thoracic aorta, or abdominal aorta.
  • the orientation can be defined according to the direction of blood flow.
  • the blood flow is defined as flowing from the proximal end to the distal end.
  • the upper part is the proximal end
  • the lower part is the distal end.
  • stent-graft refers to the structure after the surface of the bare stent is covered with a thin film
  • axial refers to the direction along the tubular central axis of the stent-graft
  • circumferential refers to the direction around the axial direction.
  • the first axial section is defined as the polymer wire that connects the trough of the first single wave and the trough or crest of the second wave circle in the axial direction, and is knotted and fixed on the two troughs to form a polymer wire part;
  • the first circumferential segment is the polymer wire part formed by axially connecting and knotting the two adjacent troughs of the second wave ring;
  • the second axial segment the polymer wire is axially connected
  • the troughs of the two second wave circles are knotted and fixed on the two troughs to form the part of the polymer line; when the polymer line is defined to connect the crests or troughs, knots are fixed on the crests and troughs to form nodes.
  • Example 1 provides a covered stent, including a stent 10 and a film 20 coated on the stent 10. Fitting to wrap the stent 10 in the membrane.
  • the stent 10 includes a plurality of wave rings arranged in the axial direction, so as to support the membrane 20.
  • the stent 10 and the membrane 20 together form a tubular structure with openings at both ends.
  • the wave ring is composed of a plurality of periodic waves (defined from the valley to A periodic wave of the trough is a closed wave ring formed by a single wave) connection, and the wave ring is made of a material with good biocompatibility and good elasticity. For example: nickel-titanium alloy, stainless steel, etc.
  • the stent 10 sequentially includes a first wave coil 11 and a plurality of second wave coils 12 from the proximal end to the distal end, wherein the first wave coil 11 includes The first single wave 111 and the second single wave 112 of the same cycle, wherein the first single wave 111 is used to hook and cooperate with the U-shaped anchor to realize the release of the stent graft, so as to increase the stability of the release of the stent graft .
  • the first single wave 111 forms a periodic wave (high wave) by two high wave poles 1111
  • the second single wave 112 forms a periodic wave (low wave) by two short wave poles 1121
  • the first The single wave 111 includes at least part of the bare section 1112 that is not covered by the coating film.
  • the bare section 1112 protrudes from the proximal end of the first single wave 111 to the proximal end surface of the coating.
  • the bare section 1112 is the high pole 1111 beyond the short pole.
  • the part of 1121, the part of the same height of the first single wave 111 and the second single wave 112 is the coated section, and the coated section and the bare section 1112 together form the first single wave 111, as shown in Fig. 5 and Fig. 2-3.
  • the second single wave 112 is entirely located in the area of the coating 20 and is covered by the coating 20 .
  • the first single wave 111 and one or more second single waves 112 are arranged at intervals to form a high-low wave ring wave structure.
  • the trough formed between the first single wave 111 and the adjacent single wave on the same wave circle is fixed to the nearest trough or peak of the second wave circle 12, wherein the first single wave 111 (high wave) can be used for hooking on the conveyor on the U-shaped anchors.
  • the first corrugated circle includes two first single waves 111, and the bare section can also be that the entire first single wave is not covered by the coating, but the first single wave is located in the coated area in a natural state The inside is attached to the coating but not fixed to the coating, and the second single wave is covered and fixed by the coating, as long as the first single wave can be used for hooking on the anchoring structure of the conveyor.
  • all single waves of the first corrugation 11 and the second corrugation 12 are waves of the same period, and the difference between the first corrugation 11 and the second corrugation 12 is that , the first wave circle 11 has two high waves (the first single wave) and four low waves (the second single wave), and the interval between the high wave and the two low waves is set to surround the synthetic waveform ring, and the two high waves are relatively to the center of the circle Symmetrical; the second wave ring 12 is a wave ring with equal height, and the trough of the second wave ring 12 is on the same axis as the wave trough of the first wave ring 11 .
  • the second corrugation 12 includes a proximal second corrugation 121 and a distal second corrugation 122
  • the proximal second corrugation 121 is the second corrugation closest to the first corrugation 11.
  • the distal second corrugation 122 is the second corrugation farthest from the first corrugation 11
  • the middle second corrugation is also included between the proximal second corrugation 121 and the distal second corrugation 122 .
  • the first single wave 111 includes two troughs on both sides of the axial direction, which are respectively the first trough 1113 and the second trough 1114, and the second wave ring 121 at the proximal end includes two troughs on both sides of the axial direction.
  • the troughs are respectively the third trough 1211 and the fourth trough 1212
  • the first trough 1113 and the third trough 1211 are on the same axis
  • the second trough 1114 and the fourth trough 1212 are on the same axis.
  • first trough 1113 uses a polymer wire to tie a knot on the first trough 1113 and then connect it to the third trough 1211 in the axial direction, and tie a knot on the third trough 1211 to form a first axial segment, and then connect with the fourth trough 1212 in the circumferential direction, and tie a knot on the fourth trough 1212 to form the first circumferential segment 34, and then connect with the second trough 1114 axially toward the proximal end, And tie a knot on the second trough 1114 to form another first circumferential segment 34 .
  • the first trough 1113 and the second trough 1114 are the starting and ending points, and the other nodes are the middle points, and the starting and ending points are fixed with double knots, as shown in Figure 9 in combination with Figure 5, and the middle points are tied with a single knot Fixed, as shown in Figure 8 combined with Figure 5, and in each illustration, two dots are used together to refer to the double knot, and one dot is used to refer to the single knot. Prevent the polymer wire from slipping off the wave ring due to force.
  • increasing the arrangement of the circumferential section can make the winding of the polymer wire integrally formed, reduce the knotting process, and at the same time increase the constraint of the polymer wire on the second coil without affecting the flexibility of the stent graft.
  • the stent graft When the stent graft is loaded or released, due to the large traction force on the first single wave, it is easy to cause deformation between the first single wave and the second single wave, thereby destroying the membrane; Deformation or even falling off reduces the anchoring strength at the proximal end of the stent graft; it is also easy to cause the deformation of the PTFE membrane to extend and deform in the axial direction, resulting in serious shrinkage of the membrane in the radial direction; by using polymer wires to tie and fix Make the two troughs of the first single wave 111 fixedly connected with the nearest trough on the adjacent second wave circle 12 along the axial direction, so that the first single wave 111 can be dispersed or even offset as a high wave hook on the U-shaped anchor When it goes up, the axially proximal traction can prevent deformation between the first single wave 111 and the second single wave 112 or cause the first wave coil 111 to fall off, thereby avoiding damage to the
  • polymer wires can also be used to connect the first trough 1113 and the third trough 1211 in the axial direction, and connect the second trough 1114 and the fourth trough 1212 in the axial direction, and each node is double-knotted , to increase the fixing reliability of the polymer wire and the wave coil.
  • Polymer wires are generally flexible wires made of biocompatible polymer materials such as polytetrafluoroethylene (PTFE) and polyethylene terephthalate (PET), so that the first single wave and While improving the connection strength of other wave coils, it reduces the impact on the flexibility of the proximal end of the stent graft.
  • PTFE polytetrafluoroethylene
  • PET polyethylene terephthalate
  • each second wave ring 12 is a wave ring, and the wave ring includes a plurality of single waves with the same period, and the troughs and troughs of each second wave ring are along the axial direction. corresponding to the above.
  • the second wave circle 122 at the far end also includes a fifth wave trough 1221 and a sixth wave trough 1222, the fifth wave trough 1221 is on the same axis as the first wave trough 1113 and the third wave trough 1211, the sixth wave trough 1222 is connected to the second wave trough 1114 and the The four troughs 1212 are all on the same axis.
  • first trough 1113 uses a polymer wire to tie a knot in the first trough 1113 and fix it, and connect it to the third trough 1211 in the axial direction.
  • the upper part is knotted and fixed to form a first axial section 31, which continues to be connected with the middle second corrugated coil in the axial direction and knotted and fixed until it is knotted and fixed with the fifth wave trough 1221 of the distal second corrugated coil 122 to form a first axial section 31.
  • a plurality of second axial segments 32 are formed, and then connected to the sixth trough 1222 in the circumferential direction, and fixed by knotting on the sixth trough 1222 to form the first circumferential segment 34, and then axially toward the proximal end in sequence Pass through the second wave ring 12 in the middle and tie it until it is knotted and fixed at the fourth wave valley 1212 to form a plurality of second axial segments 32, and finally continue to connect axially to the proximal end with the second wave valley 1114, and The second trough 1114 is knotted and fixed to form another first axial segment 31 .
  • Increasing the nodes between the troughs coaxial with the first trough 1113 and the second trough 1114 can further disperse the axial traction force received when the first single wave 111 is hung on the U-shaped anchor as a high wave hook, and the force Dispersed to each corrugation of the bracket 10, thereby increasing the connection strength between the first corrugation 11 and the second corrugation 12, improving the overall stability and structural strength of the stent 10, preventing the film from being pulled and damaged, the first wave
  • the knotting and fixing of the polymer wire can also reduce the influence of the axial connection between the coils on the overall flexibility of the stent graft.
  • the first trough 1113 and the second trough 1114 are the starting and ending points respectively, and the other troughs are the middle points, and the polymer wire 30 is used to tie a single knot on the wave circle at the middle point, as shown in Fig. 8 in combination with Fig. 6 .
  • the starting and ending points are fixed with double knots on the corrugated coils with polymer wire 30, as shown in Fig. 9 combined with Fig. 6, and in each illustration, two points are used together to refer to double knots, and one point is used to refer to single knots.
  • trough is used as the starting and ending point, it only needs to meet the requirements of connecting and fixing the first trough and the second trough to the trough of the second wave ring in the axial direction so as to achieve the purpose of connecting the U-shaped anchor to the first unit.
  • the traction force caused by the wave is for the purpose of dispersion and counteracting.
  • the axial section formed by the polymer wire makes the first wave circle and the most distal second wave circle at the farthest end
  • the two corrugated coils are connected, which can also limit the distance between the corrugated coils at the first and last ends of the stent graft as a whole, and tie knots at each corrugated coil to disperse the axial force in each axial section, which is also beneficial to limit the overall stent graft. elongated.
  • double knots can also be made starting from the seventh trough 1231 coaxial with the first trough 1113 (or coaxial with the second trough) on the second wave circle in the middle, toward The proximal end passes through the third wave trough 1211 and the first wave trough 1113 in sequence and is knotted, and then wraps around the distal end and is tied in sequence until the fifth wave trough 1221 on the second wave circle 122 at the far end and extends to the sixth wave trough along the circumferential direction 1222, after knotting, extend toward the proximal end and tie knots until the second trough 1114 is knotted, and then wrap around the far end to the eighth trough 1232 that is the same as the starting point and tie a double knot to terminate, so that the first trough can be further increased 1113, the stability of the connection between the second wave trough 1114 and the proximal second wave coil 121 ensures the reliability of the connection between the first single
  • Example 2 proposes another stent graft.
  • the features of the stent graft in Example 2 that are the same as those in Example 1 or that can be appropriated will not be repeated here.
  • the main difference is that in the stent graft in Example 2, as shown in Figures 10-11, the first The trough of a single wave 111 and the crest of the second near-end wave ring 121 are not on the same axis, that is, the trough of the first single wave 111 and the wave trough of the near-end second wave ring 121 may be on the same axis, or Not on the same axis, as long as the trough of the first single wave 111 and the crest of the proximal second wave coil 121 are not on the same axis.
  • each single wave of the first wave ring 11 and each second wave ring 12 has the same period, and the troughs correspond to the troughs along the axial direction, that is, the first wave trough 1113, the third wave trough 1211, the third wave trough
  • the five troughs 1221 are on the same axis
  • the second trough 1114, the fourth trough 1212, and the sixth trough 1222 are on the same axis, as shown in Figure 11;
  • the third peak 1215 , the first peak 1213 and the second peak 1214 are respectively located on both sides of the third trough 1211 along the axial direction, and the second peak 1214 and the third peak 1215 are respectively located on both sides of the fourth trough 1212 along the axial direction.
  • first crest 1213 uses a polymer wire to tie and fix it, then connect it obliquely to the proximal end and the first trough 1113, and tie a knot on the first trough 1113, and then move along the oblique direction.
  • the first peak 1213 and the third peak 1215 are the starting and ending points, and the rest of the knotting points that the oblique polymer line passes through are the middle points, where the starting and ending points are double knotted, and the middle point is single knotted.
  • Oblique fixation makes the second wave ring 12 provide an oblique force to the trough of the high wave of the first wave ring 11, and each oblique force can form a force component toward the distal end in the axial direction, thereby canceling the first single wave 111 Due to the axially super-proximal traction force received when hooked on the U-shaped anchor, it is prevented that the deformation between the first single wave 111 and the second single wave 112 is caused by excessive traction force, and then there is a gap between the first single wave 111 and the second single wave 112, and then there is a gap between the first single wave 111 and the second single wave 112.
  • the polymer wire is used to tie knots to fix the flexible connection
  • the method can also reduce the influence of axial connection between the first wave ring 11 and the second wave ring 12 on the flexibility of the proximal end of the stent graft.
  • the high poles of the single wave 111 deviate from each other, so it also has a counteracting effect on the component force of the traction force along the vertical axis (such as F2 in Figure 4), so that the first single wave is more balanced when the traction force is applied, and the first wave circle is more stable. In this way, it is possible to prevent the film from being damaged, the first wave ring falling off, or even the problem of shrinking in the radial direction caused by excessive stretching of the film.
  • first wave valley 1113 and the first wave peak 1213, the first wave valley 1113 and the second wave peak 1214, the second wave valley 1114 and the The second crest 1214 , the second trough 1114 and the third crest 1215 are respectively fixed with double knots at each crest and trough to form four separate oblique segments.
  • the polymer wire fixation also includes connecting the third wave trough 1211 with the middle second wave ring in the axial direction and then knotting and fixing it until it is tied with the fifth wave trough 1221 of the second wave ring 122 at the distal end.
  • the knot is fixed so as to form a plurality of second axial segments 32, and then is connected with the sixth trough 1222 in the circumferential direction, and is knotted and fixed on the sixth trough 1222 to form the first circumferential segment 34, and then axially toward
  • the proximal end sequentially passes through the middle second wave ring 12 and is knotted until reaching the fourth wave trough 1212 to be knotted and fixed to form a plurality of second axial segments 32 .
  • the third wave valley 1211 and the fourth wave valley 1212 are the starting and ending points, and the remaining nodes are intermediate points, increasing the distance between the wave valleys between the second wave circles 12
  • the nodes along the axial direction between them can further disperse the axial traction force received by the first single wave 111 when it is hung on the U-shaped anchor as a high wave hook, and distribute the force to each wave circle of the whole bracket, thereby increasing the first single wave 111.
  • connection strength between a single wave 111 and the second wave coil improves the overall stability and structural strength of the stent 10, prevents the first wave coil from deforming and falling off, thereby reducing the anchoring strength at the proximal end, and prevents the coating from being pulled and damaged Or axial excessive stretching deformation leads to radial shrinkage.
  • the use of polymer wire knotting for fixation can also reduce the influence of the axial connection between the coils on the overall flexibility of the stent graft.
  • Example 3 proposes another stent graft.
  • the features of the stent graft in Example 3 that are the same as those in Example 1 or that can be appropriated will not be repeated here.
  • the main difference is that in the stent graft in Example 3, as shown in Figures 12-13, the first The trough of a single wave 111 is on the same axis as the crest of the proximal second wave ring 121 , and the troughs of all the second wave rings 12 are axially opposite to each other, and the wave crests are axially opposite to each other.
  • the first single wave 111 includes a first wave trough 1113 and a second wave trough 1114
  • the proximal second wave circle 121 includes a first wave peak 1213 and a second wave peak 1214, wherein the first wave trough 1113 and the first wave peak 1213 are on the same axis and
  • the second wave trough 1114 and the second wave peak 1214 are arranged at intervals along the axial direction on the same axis.
  • the proximal second wave ring 121 includes a third wave trough 1211 and a fourth wave trough 1212.
  • the second wave circle 122 at the far end includes a fifth trough 1221 and a sixth trough 1222, the fifth trough 1221 is on the same axis as the third trough 1211, and the sixth trough 1222 On the same axis as the fourth trough 1212 .
  • the first wave trough 1113 and the first wave crest 1213 are connected axially by a polymer wire and fixed by knotting to form a first axial section 31, and both are double-knotted; the second wave trough 1114 and the second wave peak 1214 are axially passed through Molecular wires are connected and knotted to form another first axial section 31, and all of them are double-knotted.
  • the first axial section 31 increases the winding strength between the first single wave 111 and the proximal second wave 121. , which reduces the risk that the first single wave 111 will be peeled off relative to the covering film due to the large traction force.
  • the two troughs of the first single wave 111 and the crests of the coaxial line on the proximal second wave ring 121 are fixedly connected in the axial direction by using a knotted and fixed polymer wire, so that the first wave can be dispersed or even offset.
  • the single wave 111 When the single wave 111 is used as a high-wave hook on the U-shaped anchor, it is subjected to axially upward and proximal traction to prevent excessive traction from causing deformation or first wave circles between the first single wave 111 and the second single wave 112 Relative to the displacement of the second wave coil, the film 20 is pulled, so as to avoid the displacement of the first single wave 111 or the falling off of the first wave coil, so as to avoid the damage of the film or the radial shrinkage caused by excessive stretching and deformation in the axial direction.
  • the molecular wire is knotted and fixed, which can preserve the distance between the wave coils and ensure the flexibility of the stent graft; compared with the traditional rigid connection, it not only retains the connection strength between the first wave circle 11 and the second wave circle 12 , and avoid the impact on the flexibility of the proximal end of the stent graft.
  • the polymer connecting wire also includes a third wave trough 1211 that is sequentially connected with the middle second wave ring 12 in the axial direction and fixed by knotting until it is connected with the fifth wave trough 1221 of the distal second wave ring 122 .
  • the third wave valley 1211 and the fourth wave valley 1212 are the start and end points, and the rest of the nodes are intermediate points, increasing the distance between the wave valleys between the second wave circles 12 along the axial direction.
  • the nodes can further disperse the axial traction force received by the first single wave 111 as a high-wave hook when it is hung on the U-shaped anchor, and distribute the force to each wave circle of the bracket 10, thereby increasing the first wave circle 11 and the first wave circle 11.
  • the connection strength between the second wave coils 12 improves the overall stability and structural strength of the stent 10, prevents damage to the covering film, and prevents radial shrinkage caused by excessive stretching and deformation along the axial direction.
  • polymer wires can also be used to tie knots only along the troughs of the second trough 12 between the third trough 1211 and the fifth trough 1221, and the axis where the fourth trough 1212 and the sixth trough 1222 are located
  • the trough of the upward second wave circle 12 is not fixedly connected by knotting.
  • the third wave trough 1211 is between the first wave peak 1213 and the second wave peak 1214, and is facing the peak position of the first single wave 111.
  • the traction force on the crest of the first single wave 111 can be distributed to each of the second wave coils 12 .
  • symmetrically setting the high wave can make the first wave circle 11 more symmetrical and symmetrical under the traction force of the U-shaped anchor.
  • the other side of the polymer wire is symmetrically arranged in the same manner, and the two symmetrical first single waves 111 are respectively offset by the traction force of the U-shaped anchor.
  • Example 4 proposes another stent graft.
  • the features of the stent graft in Example 4 that are the same as those in Example 1 or that can be appropriated will not be repeated here.
  • the main difference is that in the stent graft in Example 4, as shown in FIG. 14 , the first unit The trough of the wave 111 is on the same axis as the crest of the second wave ring 121 at the proximal end, and is connected by the first connecting rod 102 along the axial direction.
  • the crests face each other along the axial direction, wherein the first wave ring 11 , the first connecting rod 102 and the second wave ring 121 at the proximal end are integrally formed.
  • the first wave coil 11 and the proximal second wave coil 121 can be formed by laser cutting an alloy tube with shape memory (such as a nickel-titanium alloy tube) to form an integral structure, and then processed by heat setting and other processes.
  • the first single wave 111 includes a first wave trough 1113 and a second wave trough 1114
  • the near-end second wave circle 121 includes a first wave peak 1213 and a second wave peak 1214
  • the first wave trough 1113 and the first wave peak 1213 are on the same axis and connected by the first connecting rod 102 along the axial direction
  • the second wave trough 1114 is on the same axis as the second peak 1214 and are connected by the first connecting rod 102 along the axial direction
  • the second wave ring at the proximal end 121 includes a third trough 1211 and a fourth trough 1212
  • the third trough 1211 and the fourth trough 1212 are on the axial sides of the second crest 1214
  • the second wave circle 122 at the far end includes a fifth trough 1221 and a sixth trough 1222
  • the fifth trough 1221 is on the same axis as the third trough 1211
  • the polymer connection line also includes connecting and fixing with the second wave circle in the middle sequentially from the third wave trough 1211 in the axial direction until it is knotted and fixed with the fifth wave valley 1221 of the second wave circle 122 at the distal end to form multiple
  • the second axial segment 32 is then connected to the sixth trough 1222 in the circumferential direction, and is knotted and fixed on the sixth trough 1222 to form the first circumferential segment 34, and then passes through the middle in the proximal direction in the axial direction.
  • the second wave ring 12 is knotted until the fourth wave trough 1212 is knotted and fixed to form a plurality of second axial segments 32 .
  • the third wave valley 1211 and the fourth wave valley 1212 are the starting and ending points, and the remaining nodes are intermediate points, increasing the distance between the wave valleys between the second wave circles 12
  • the nodes along the axial direction can further disperse the axial traction force received by the first single wave 111 as a high wave hook on the U-shaped anchor, and distribute the force to each wave circle of the bracket 10, thereby increasing the first single wave 111.
  • the overall connection strength between the corrugated coil 11 and the second proximal corrugated coil 121 and other second corrugated coils improves the overall stability and structural strength of the stent 10 and prevents the membrane from being damaged. Knotting and fixing with polymer wire can also reduce the influence of axial connection between the corrugations on the flexibility of the stent graft.
  • Another high wave is provided on the other side which is 180° symmetric to the high wave as shown in Figure 14. Symmetrically setting the high wave can make the first wave circle 11 more symmetrical and symmetrical under the traction force of the U-shaped anchor.
  • the other side uses polymer wires to be symmetrically arranged between the second wave circles in the same way, respectively offsetting the traction force of the two symmetrical first single waves by the U-shaped anchor.
  • each single wave of the second wave coil 12 may not have the same period as the first single wave 111 of the first wave coil 11 .

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Abstract

一种覆膜支架，包括支架(10)和包覆于支架(10)上的覆膜(20)，支架(10)包括多个沿轴向排列的波圈，波圈包括第一波圈(11)和第二波圈(12)，第一波圈(11)位于覆膜支架近端，第二波圈(12)位于第一波圈(11)的远端侧，第一波圈(11)包括第一单波(111)和第二单波(112)，第一单波(111)至少部分未被覆膜(20)包覆，且第一单波(111)与第二波圈(12)固定。覆膜支架增大第一单波(111)与第二波圈(12)之间的连接强度，分散第一单波(111)的受力，避免第一单波(111)与第二单波(112)之间因受力过大变形后破坏覆膜(20)，或避免导致第一波圈(11)脱落覆膜(20)无支撑的现象，以及避免覆膜(20)受第一波圈(11)拉扯变形导致径向缩口的问题，从而提高覆膜支架的使用稳定性。

Description

覆膜支架 技术领域
本发明涉及介入医疗器械技术领域，特别是涉及一种覆膜支架。
背景技术
人体主动脉由于各种病变或损伤，容易导致主动脉血管内膜或血管壁损伤，形成动脉瘤疾病，一旦动脉瘤破裂，血液涌出血管造成人体血液供应不足，从而造成人体休克或死亡。对于动脉瘤疾病，不同部位的动脉瘤治疗上有所差异，常见以手术治疗、动脉瘤栓塞及动脉瘤腔内修复术。手术治疗主要原则是动脉瘤的切除以及动脉重建；对于一些内脏动脉瘤可使用弹簧圈栓塞的方式，使得动脉瘤体内形成血栓，避免瘤体进一步扩大破裂出血；腔内修复术采用覆膜型人工血管支架进行动脉瘤腔内修复术，创伤小，疗效明显。
腔内修复术近年来已经成为治疗心血管疾病的主流，随着介入技术不断提高，腔内修复术的优势日益突出，而覆膜支架的使用，需要使用输送器输送到病变部位进行治疗。输送之前需要先将覆膜支架压缩进输送器的鞘管内，一般选择在股动脉或髂动脉位置穿刺血管，利用导丝建立轨道，将输送器经髂动脉—腹主动脉—胸主动脉—主动脉弓—升主动脉建立输送路径，进而输送到病变指定位置后，释放覆膜支架，支架展开并紧贴动脉瘤管壁，支架上所覆的膜从而将血流和病变部位隔绝，消除了血流对病变部位动脉瘤壁的冲击，重新建立起血液循环的正常通道，最后撤出导丝和输送器，从而实现对动脉瘤和动脉夹层的介入治疗。覆膜一般由PTFE等高分子材料制成，支架主要使用镍钛合金丝编织而成。
对于现有的一些覆膜支架，利用输送器设计特定的U型锚定件结构来钩挂支架近端第一波圈11上的两个锚定单波(高波111)，可以实现稳定释放，或避免因无锚定结构导致的支架短缩现象或内漏。匹配U型锚定结构的覆膜支架，可以将近端的第一波圈11设计成高低波型的波圈，如图1-3所示，利用波圈的高波111(低波112的近端靠近覆膜20的近端端面，高波111高出低波112的 部分从近端裸露出覆膜形成裸段1112)作为锚定波与U型锚定件配合，实现支架的稳定释放。
但是，因与U型锚定件配合的上述高低波型的波圈结构的特殊性，利用波圈的其中两个锚定波钩挂于U型锚结构上，锚定波受U型锚相应的牵引力F，在牵引力的作用下，完成覆膜支架的装配以及支架的释放，如图4所示。以高低波圈为例，从结构受力上分析，该牵引力F只作用于两个高波的波峰处，此时高波的波谷主要受到沿轴向朝近端的分力F1(以及较小的分力F2，F2如图4所示)，如图4结合图1所示，而高低波圈(第一波圈11)与其余波圈之间的连接，仅仅依靠覆膜20(PTFE膜)相连接，当牵引力F过大时，高波111受牵引力F朝向近端拉伸，低波112未受牵引力，高波(锚定波)与低波(非锚定波)之间在覆膜支架装载和释放的过程中，一方面，由于第一波圈受力不均容易导致第一波圈11在高低波连接处(高波的波谷处)变形而拉扯覆膜，从而导致高波111相对覆膜会产生位移，覆膜20会被破坏，使覆膜无法起到隔绝血流和病变部位的作用，甚至是第一波圈严重变形导致脱落降低了覆膜支架近端处的锚定强度(覆膜支架两端的锚定强度由两端的几个波圈段与血管尺寸匹配来提供)；另一方面，由于覆膜为高分子材料，当受第一波圈牵引力较大还可能导致高分子材料变形后沿轴向过度拉伸延长进而导致覆膜沿径向严重缩口，使得第一波圈与对应处的覆膜失效，降低了覆膜支架近端处的锚定强度，从而影响整个覆膜支架的使用性能。
发明内容
本发明要解决的技术问题在于，针对现有技术中用于钩挂U型锚的第一波圈中的锚定波容易造成破坏覆膜导致覆膜无法起到隔绝血流和病变部位、甚至是可能导致第一波圈脱落以及覆膜变形缩口的缺陷，提供一种覆膜支架。
本发明解决其技术问题所采用的技术方案是：
本发明一实施例提供一种覆膜支架，包括支架和包覆于所述支架上的覆膜，所述支架包括多个沿轴向排列的波圈，所述波圈包括第一波圈和第二波圈，所述第一波圈位于所述覆膜支架近端，所述第二波圈位于所述第一波圈的远端侧， 所述第一波圈包括第一单波和第二单波，所述第一单波至少部分未被所述覆膜包覆，且所述第一单波与所述第二波圈固定。
在本发明一实施例中，所述第一单波的近端凸出于所述覆膜的近端端面，所述第二单波位于所述覆膜的区域内且被所述覆膜包覆，所述第一单波与同一波圈上相邻的单波之间形成的波谷与所述第二波圈上最近的波谷或波峰固定。
在本发明一实施例中，所述第二波圈包括近端第二波圈和远端第二波圈，所述第一单波的波谷与所述近端第二波圈的波峰不沿同一轴线上。
在本发明一实施例中，所述第一单波的波谷与所述近端第二波圈的波谷在同一轴向线上，且通过高分子线打结固定或一体成型。
在本发明一实施例中，一个所述第一单波包括沿轴向两侧的第一波谷和第二波谷，所述高分子线至少包括一个第一轴向段，所述第一轴向段位于所述第一波谷或/和所述第二波谷与所述近端第二波圈的波谷之间。
在本发明一实施例中，所述近端第二波圈与所述远端第二波圈之间还包括中间第二波圈，所述高分子线在所述第一波谷与所述近端第二波圈之间包括多个重叠的第一轴向段，所述高分子线在所述近端第二波圈与所述中间第二波圈之间包括多个重叠的第二轴向段，所述第二轴向段位于各所述第二波圈之间。
在本发明一实施例中，所述第一单波的波谷与所述近端第二波圈最近的两个波峰分别通过高分子线打结固定。
在本发明一实施例中，一个所述第一单波包括沿轴向两侧的波谷，所述高分子线至少包括一个斜向段，所述斜向段位于所述第一单波的波谷与所述第二波圈的波峰之间。
在本发明一实施例中，所述第二波圈包括近端第二波圈和远端第二波圈，所述第一单波的波谷与所述近端第二波圈的波峰沿同一轴线上，且所述第一单波的波谷与所述近端第二波圈之间通过高分子线打结固定或一体成型。
在本发明一实施例中，所述第一单波包括第一波谷和第二波谷，所述近端第二波圈还包括第一波峰和第二波峰，所述第一波峰与所述第一波谷在同一轴线上，所述第二波峰与所述第二波谷位于同一轴线上，所述高分子线至少包括一个第一轴向段，所述第一轴向段位于所述第一波谷与所述第一波峰之间或/和 所述第二波谷与所述第二波峰之间。
在本发明一实施例中，当各波圈之间通过高分子线打结固定时，所述高分子线与各波圈之间的结点包括起止点和中间点，所述起止点打双结，所述中间点打单结。
上述覆膜支架通过将第一单波与第二波圈固定，可以增大第一单波与第二波圈之间的连接强度，分散第一单波的受力，避免第一单波与第二单波之间因受力过大变形后破坏覆膜，或避免导致第一波圈脱落覆膜无支撑的现象，以及避免覆膜受第一波圈拉扯变形导致径向缩口的问题，从而提高覆膜支架的使用稳定性。
附图说明
下面将结合附图及实施例对本发明作进一步说明，附图中：
图1是现有技术中的具有高低波圈的覆膜支架的结构示意图；
图2是现有技术中高低波圈的结构示意图；
图3是图2剪开后平铺的结构示意图；
图4是图1中的高波钩挂于U型锚定件时的受力分析图；
图5是本发明一实施例的覆膜支架的结构示意图；
图6是本发明另一实施例的覆膜支架的结构示意图；
图7是本发明另一实施例的覆膜支架的结构示意图；
图8是本发明中高分子线与波圈打单结的结构示意图；
图9是本发明中高分子线与波圈打双结的结构示意图；
图10是本发明另一实施例的覆膜支架的结构示意图；
图11是本发明另一实施例的覆膜支架的结构示意图；
图12是本发明另一实施例的覆膜支架的结构示意图；
图13是本发明另一实施例的覆膜支架的结构示意图；
图14是本发明另一实施例的覆膜支架的结构示意图。
具体实施方式
为使本发明的上述目的、特征和优点能够更加明显易懂，下面结合附图对本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施，本领域技术人员可以在不违背本发明内涵的情况下做类似改进，因此本发明不受下面公开的具体实施的限制。
需要说明的是，当元件被称为“固定于”或“设置于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“垂直的”、“水平的”、“左”、“右”以及类似的表述只是为了说明的目的，并不表示是唯一的实施方式。
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施方式的目的，不是旨在于限制本发明。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。
为方便描述，以血管为例来阐述管腔，该血管可以是主动脉弓，或胸主动脉，或腹主动脉等。本领域的普通技术人员应当知晓，采用血管来阐述仅用作举例，并不是对本发明的限制，本发明的方案适用于各种人体管腔，例如消化道管腔等，基于本发明教导的各种改进和变形均在本发明的保护范围之内。另外，在阐述血管中，可按照血流方向定义方位，本发明中定义血流从近端流向远端。在各实施例的示意图中，上方为近端，下方为远端。
本申请中“覆膜支架”是指裸支架表面覆盖有薄膜后的结构，“轴向”，是指沿覆膜支架管状中心轴的方向，“周向”是指围绕轴向的方向。
在本申请中，定义第一轴向段为高分子线沿轴向连接第一单波的波谷与第二波圈的波谷或波峰，并在两个波谷上打结固定，形成的高分子线部分；第一周向段为高分子线在第二波圈相邻的两个波谷沿轴向连接并打结固定形成的高分子线部分；第二轴向段：高分子线沿轴向连接两个第二波圈的波谷，并在两个波谷上打结固定，形成的高分子线部分；定义高分子线连接波峰或波谷时，在波峰和波谷上打结固定形成结点。
实施例1
请参阅图5-8所示，实施例1提供了一种覆膜支架，包括支架10和包覆于支架10上的覆膜20，在本实施方式中，支架10经内外两侧的覆膜贴合从而将支架10包覆于覆膜内。
支架10包括多个沿轴向排列的波圈，从而起支撑覆膜20的作用，支架10与覆膜20一起形成两端开口的管状结构，波圈是由多个周期波(定义从波谷到波谷的一个周期波为一个单波)连接形成的闭合的波形环状物，波形环状物由具有良好生物相容性和良好弹性的材料制成。例如：镍钛合金、不锈钢等。
如图5-6结合图2所示，在本实施方式中，支架10自近端至远端依次包括一个第一波圈11和多个第二波圈12，其中，第一波圈11包括同周期的第一单波111和第二单波112，其中，第一单波111用于与U型锚定件钩挂配合实现对覆膜支架的释放，以增加覆膜支架释放的稳定性。
如图5-6所示，第一单波111由两个高波杆1111形成一个周期波(高波)，第二单波112由两个矮波杆1121形成一个周期波(低波)，第一单波111包括至少部分未被覆膜包覆裸段1112，裸段1112自第一单波111的近端凸出于覆膜的近端端面，裸段1112即为高波杆1111超出矮波杆1121的部分，第一单波111与第二单波112等高的部分为覆膜段，覆膜段与裸段1112一起形成第一单波111，如图5结合图2-3所示。第二单波112整体位于覆膜20的区域内，且被覆膜20包覆，第一单波111与一个或多个第二单波112间隔设置从而形成高低波型的环形波圈结构。第一单波111与同一波圈上相邻的单波之间形成的波谷与第二波圈12最近的波谷或波峰固定，其中，第一单波111(高波)可用于钩挂于输送器的U型锚定件上。
在其他的实施方式中，第一波圈包括两个第一单波111，裸段也可以为整个第一单波均不被覆膜包覆，但是第一单波自然状态下位于覆膜区域内与覆膜相贴合但与覆膜不固定，第二单波被覆膜包覆固定，只要能实现第一单波用于钩挂在输送器的锚定结构上即可。
如图5-6所示，在本实施方式中，第一波圈11与第二波圈12的所有单波均为同周期的波，第一波圈11与第二波圈12的区别在于，第一波圈11有两个 高波(第一单波)和四个低波(第二单波)，且高波和两个低波间隔设置围合成波形环状物，两个高波相对圆周中心对称；而第二波圈12为等高的波形环状物，且第二波圈12的波谷与第一波圈11的波谷在同一轴线上。
如图5-6所示，第二波圈12包括近端第二波圈121和远端第二波圈122，近端第二波圈121为最靠近第一波圈11的第二波圈，远端第二波圈122为离第一波圈11最远的第二波圈，近端第二波圈121和远端第二波圈122之间还包括中间第二波圈。
如图5所示，第一单波111包括沿轴向两侧的两个波谷，分别为第一波谷1113和第二波谷1114，近端第二波圈121包括沿轴向两侧的两个波谷，分别为第三波谷1211和第四波谷1212，第一波谷1113与第三波谷1211在同一轴线上，第二波谷1114与第四波谷1212在同一轴线上。自第一波谷1113开始，使用高分子线在第一波谷1113上打结固定后沿轴向与第三波谷1211之间连接，并在第三波谷1211上打结固定从而形成一个第一轴向段，再沿周向与第四波谷1212之间连接，并在第四波谷1212上打结固定从而形成第一周向段34，然后沿轴向朝近端与第二波谷1114之间连接，并在第二波谷1114上打结固定从而形成另一个第一周向段34。此时，第一波谷1113和第二波谷1114为起止点，其他结点为中间点，在起止点使用双结打结固定，如图9结合图5所示，在中间点使用单结打结固定，如图8结合图5所示，且各图示中，使用两个圆点一起代指双结，一个圆点代指单结，双结设置在起止点，受力时，不易散开防止高分子线因受力从波圈上滑脱。在本实施方式中，增加周向段的设置可以使高分子线绕线一体形成，减少打结工序，同时增加高分子线对第二波圈的约束，但不影响覆膜支架的柔顺性。
在覆膜支架装载或释放时，由于第一单波所受的牵引力较大，容易导致第一单波与第二单波之间变形，从而破坏覆膜；或是容易导致第一波圈严重变形甚至是脱落，降低覆膜支架近端处的锚定强度；还容易导致PTFE膜变形后沿轴向延长变形进而导致覆膜沿径向严重缩口；通过使用高分子线打结固定的方式使第一单波111的两个波谷与相邻的第二波圈12上最近的波谷之间沿轴向固定连接，从而可以分散甚至是抵消第一单波111作为高波钩挂在U型锚上时，受 到的沿轴向朝近端的牵引力，可以防止第一单波111与第二单波112之间产生变形或导致第一波圈111脱落，从而避免覆膜受损以及保持覆膜支架近端处的锚定强度，同时避免覆膜沿轴向变形以及沿径向缩口，避免影响覆膜支架10的使用性能；同时使用高分子线打结固定不仅可以加强各个波圈间的连接强度，保证覆膜支架10可以有稳定的有效长度，还可以减少第一波圈11与第二波圈12之间沿轴向连接对覆膜支架近端柔顺性的影响(相比传统的刚性连接)，防止因固定造成柔顺性降低导致覆膜支架的近端无法紧贴血管壁。在其他的实施方式中，还可以仅用高分子线沿轴向连接第一波谷1113和第三波谷1211，沿轴向连接第二波谷1114与第四波谷1212，且各结点均打双结，以增加高分子线与波圈的固定可靠性。
高分子线一般选用聚四氟乙烯(PTFE)、聚对苯二甲酸乙二醇酯(PET)等生物相容性较好的高分子材料制成的柔性线，使得在增加第一单波与其他波圈的连接强度的同时，减少对覆膜支架近端的柔顺性的影响。
在本实施方式中，如图6所示，各个第二波圈12均波形环状物，波形环状物包括多个同周期的单波，且各个第二波圈的波谷与波谷沿轴向上相对应。远端第二波圈122还包括第五波谷1221和第六波谷1222，第五波谷1221与第一波谷1113和第三波谷1211均在同一轴线上，第六波谷1222与第二波谷1114和第四波谷1212均在同一轴线上，自第一波谷1113开始，使用高分子线在第一波谷1113打结固定后沿轴向朝远端与第三波谷1211之间连接，并在第三波谷1211上打结固定从而形成一个第一轴向段31，继续沿轴向依次与中间的第二波圈连接并打结固定，直至与远端第二波圈122的第五波谷1221打结固定从而形成多个第二轴向段32，再沿周向与第六波谷1222之间连接，并在第六波谷1222上打结固定从而形成第一周向段34，然后沿轴向朝近端依次经过中间的第二波圈12并打结直至于第四波谷1212打结固定从而形成多个第二轴向段32，最后再继续沿轴向朝近端与第二波谷1114之间连接，并在第二波谷1114上打结固定从而形成另一个第一轴向段31。增加与第一波谷1113和第二波谷1114同轴的波谷之间的结点，可以进一步分散第一单波111作为高波钩挂在U型锚上时受到的沿轴向上的牵引力，将力分散至支架10的各个波圈上，从而增加第 一波圈11与第二波圈12之间的连接强度，提高支架10整体的稳定性和结构强度，防止造成覆膜拉扯损坏、第一波圈移位或脱落，同时使用高分子线打结固定还可以减少各波圈之间沿轴向连接对覆膜支架整体柔顺性的影响。此时，第一波谷1113和第二波谷1114分别为起止点，其他波谷为中间点，在中间点使用高分子线30在波圈上打单结固定，如图8结合图6所示，在起止点使用高分子线30在波圈上打双结固定，如图9结合图6所示，且各图示中，使用两个点一起代指双结，一个点代指单结。可以理解的是，以哪个波谷为起止点不做限定，只需满足将第一波谷和第二波谷沿轴向与第二波圈的波谷连接固定从而达到将U型锚定件对第一单波引起的牵引力进行分散和抵消的目的即可。同时，由于高分子线沿着覆膜支架近端至覆膜支架最远端的远端第二波圈，利用高分子线形成的轴向段使得第一波圈和最远端的远端第二波圈相连，在整体上还可以限制覆膜支架首尾两端的波圈的距离，在各个波圈打结，使各轴向段分别分散轴向作用力，还有利于限制覆膜支架整体被拉长。
在其他的实施方式中，如图7所示，也可以从中间的第二波圈上与第一波谷1113同轴的(或与第二波谷同轴)第七波谷1231开始打双结，朝近端依次经过第三波谷1211和第一波谷1113并打结后再朝远端回绕并依次打结，直至远端第二波圈122上的第五波谷1221并沿周向延伸至第六波谷1222，打结后朝近端依次延伸打结直至第二波谷1114打结后，再朝远端回绕至与起点同一波圈的第八波谷1232上打双结终止，这样可以进一步增加第一波谷1113和第二波谷1114与近端第二波圈121之间的连接稳固性，确保第一单波111与第二波圈的连接可靠性，降低第一波圈11移位、脱落以及覆膜因撕扯破损或沿轴向过度拉伸变形导致径向缩口的风险。进一步地，还可以在近端第二波圈上设置倒钩结构40，增加覆膜支架近端的锚定性。
可以理解的是，在与如图5-6所示的高波呈周向180°对称的另一侧还设有一个高波，对称设置的两个高波可以使第一波圈11受U型锚的牵引力更对称，且对称的另一侧使用高分子线以同样的方式对称设置，分别抵消对称的两个第一单波111受U型锚的牵引力。
实施例2
实施例2提出另一种覆膜支架。实施例2的覆膜支架与实施例1中相同或可以挪用的特征部分在此不再赘述，主要的不同之处在于，实施例2的覆膜支架中，如图10-11所示，第一单波111的波谷与近端第二波圈121的波峰不沿同一轴线上，即，第一单波111的波谷与近端第二波圈121的波谷可以在同一轴向上，也可以不在同一轴线上，只要第一单波111的波谷与近端第二波圈121的波峰不在沿同一轴线即可。在本实施方式中，第一波圈11与各个第二波圈12的各个单波均为同周期，且波谷与波谷沿轴向上相对应，即第一波谷1113、第三波谷1211、第五波谷1221在同一轴线上，第二波谷1114、第四波谷1212、第六波谷1222在同一轴线上，如图11所示；近端第二波圈121包括第一波峰1213、第二波峰1214和第三波峰1215，第一波峰1213和第二波峰1214分别位于第三波谷1211沿轴向的两侧，第二波峰1214和第三波峰1215分别位于第四波谷1212沿轴向的两侧。在本实施方式中，自第一波峰1213开始，使用高分子线打结固定后沿斜向朝近端与第一波谷1113之间连接，并在第一波谷1113上打结固定，再沿斜向朝远端与第二波峰1214之间连接，并在第二波峰1214上打结固定，然后沿斜向朝近端与第二波谷1114之间连接，并在第二波谷1114上打结固定，最后沿斜向朝远端与第三波峰1215之间连接，并在第三波峰1215上打结固定，以使第一单波111的两个波谷与第二波圈12相固定，且在受到沿轴向的牵引力时，高分子线不易从固定点滑脱。此种打结路径中，第一波峰1213和第三波峰1215为起止点，斜向的高分子线经过的其余打结点为中间点，起止点打双结，中间点打单结。斜向固定使第二波圈12对第一波圈11的高波的波谷提供沿斜向的力，每个斜向的力可以沿轴向朝向远端形成分力，从而抵消第一单波111因钩挂在U型锚上时受到的沿轴向超朝近端的牵引力，防止牵引力过大导致第一单波111与第二单波112之间产生变形，进而与覆膜20之间产生相对位移，从而避免第一波圈11脱离或移位、以及波圈间覆膜因撕扯而破损或轴向过度拉伸变形导致径向缩口的问题，同时使用高分子线打结固定柔性连接的方式还可以减少第一波圈11与第二波圈12之间沿轴向连接对覆膜支架近端柔顺性的影响。另一方面，第一波峰1213与第一波谷1113之间的斜向段、第三波峰1215与第二波谷1114之间的斜向段，由于这两个斜向段分别与各自连 接的第一单波111的高波杆相背离，所以，对于牵引力沿垂直轴向的分力(例如图4中的F2)也有抵消作用，使第一单波受牵引力时更均衡，第一波圈更稳定，从而防止覆膜破损、第一波圈脱落、甚至是覆膜过度拉伸导致沿径向缩口的问题。
在其他的实施方式中，高波的波谷与第二波圈12之间可以通过高分子线分别连接第一波谷1113与第一波峰1213、第一波谷1113与第二波峰1214、第二波谷1114与第二波峰1214、第二波谷1114与第三波峰1215，并分别在各波峰波谷处打双结固定，从而形成四个单独的斜向段。
如图11所示，高分子线固定还包括自第三波谷1211沿轴向上依次与中间的第二波圈连接并打结固定，直至与远端第二波圈122的第五波谷1221打结固定从而形成多个第二轴向段32，再沿周向与第六波谷1222之间连接，并在第六波谷1222上打结固定从而形成第一周向段34，然后沿轴向朝近端依次经过中间的第二波圈12并打结直至于第四波谷1212打结固定从而形成多个第二轴向段32。此时，在各个第二波圈12之间的结点中，第三波谷1211和第四波谷1212为起止点，其余的结点为中间点，增加各个第二波圈12之间的波谷之间沿轴向的结点，可以进一步分散第一单波111作为高波钩挂在U型锚上时受到的沿轴向上的牵引力，将力分散至整个支架的各个波圈上，从而增加第一单波111与第二波圈之间的连接强度，提高支架10整体的稳定性和结构强度，防止造成第一波圈变形、脱落从而降低近端的锚定强度，防止覆膜被拉扯损坏或轴向过度拉伸变形导致径向缩口。同时，相比传统的刚性连接，使用高分子线打结固定还可以减少各波圈之间沿轴向连接对覆膜支架整体柔顺性的影响。
可以理解的是，在与如图10-11所示高波呈周向180°对称的另一侧还设有一个高波，对称设置高波可以使第一波圈11受U型锚的牵引力对称，且对称的另一侧使用高分子线以同样的方式对称设置，分别抵消两个第一单波111受U型锚的牵引力。
实施例3
实施例3提出另一种覆膜支架。实施例3的覆膜支架与实施例1中相同或可以挪用的特征部分在此不再赘述，主要的不同之处在于，实施例3的覆膜支 架中，如图12-13所示，第一单波111的波谷与近端第二波圈121的波峰在同一轴线上，且所有的第二波圈12的波谷与波谷沿轴向相对，波峰与波峰沿轴向相对。第一单波111包括第一波谷1113和第二波谷1114，近端第二波圈121包括第一波峰1213和第二波峰1214，其中，第一波谷1113与第一波峰1213在同一轴线上且沿轴向间隔设置，第二波谷1114与第二波峰1214在同一轴线上且沿轴向间隔设置，近端第二波圈121包括第三波谷1211和第四波谷1212，第三波谷1211和第四波谷1212在第二波峰1214的轴向两侧，远端第二波圈122包括第五波谷1221和第六波谷1222，第五波谷1221与第三波谷1211在同一轴线上，第六波谷1222与第四波谷1212在同一轴线上。
第一波谷1113与第一波峰1213沿轴向通过高分子线连接并打结固定形成一个第一轴向段31，且均打双结；第二波谷1114与第二波峰1214沿轴向通过高分子线连接并打结固定形成另一个第一轴向段31，且均打双结，第一轴向段31在第一单波111与近端第二波圈121之间增加了绕线强度，降低了第一单波111因牵引力较大而相对覆膜发生剥离的风险。通过使用高分子线打结固定的方式使第一单波111的两个波谷与近端第二波圈121上同轴线的波峰之间沿轴向固定连接，从而可以分散甚至是抵消第一单波111作为高波钩挂在U型锚上时受到的沿轴向上朝近端的牵引力，防止牵引力过大导致第一单波111与第二单波112之间产生形变或第一波圈相对第二波圈位移，而拉扯覆膜20，从而避免第一单波111移位或第一波圈脱落，从而避免覆膜破损或轴向过度拉伸变形导致径向缩口，同时使用高分子线打结固定，既可以保留波圈间的间距，保证了覆膜支架的柔顺性；相比传统的刚性连接，既保留了第一波圈11与第二波圈12之间的连接强度，又避免了对覆膜支架近端柔顺性的影响。
如图13所示，高分子连接线还包括自第三波谷1211沿轴向上依次与中间的第二波圈12连接并打结固定，直至与远端第二波圈122的第五波谷1221打结固定从而形成多个第二轴向段32，再沿周向与第六波谷1222之间连接，并在第六波谷1222上打结固定从而形成第一周向段34，然后沿轴向朝近端依次经过中间的第二波圈12并打结直至于第四波谷1212打结固定从而形成多个第二轴向段32。此时，在各个第二波圈12中，第三波谷1211和第四波谷1212为起止 点，其余的结点为中间点，增加各个第二波圈12之间的波谷之间沿轴向的结点，可以进一步分散第一单波111作为高波钩挂在U型锚上时受到的沿轴向上的牵引力，将力分散至支架10的各个波圈上，从而增加第一波圈11与第二波圈12之间的连接强度，提高支架10整体的稳定性和结构强度，防止造成覆膜破损、沿轴向过度拉伸变形导致径向缩口，同时使用高分子线打结固定还可以减少各波圈之间沿轴向连接对覆膜支架整体柔顺性的影响。在其他的实施方式中，还可以使用高分子线只沿第三波谷1211与第五波谷1221之间的第二波圈12的各波谷打结固定，第四波谷1212和第六波谷1222所在轴向上的第二波圈12的波谷不进行打结固定连接，此时，第三波谷1211在第一波峰1213和第二波峰1214之间，且对着第一单波111的波峰位置，同样可以将第一单波111的波峰所受的牵引力分散至各个第二波圈12中。
可以理解的是，在与如图12-13所示高波呈周向180°对称的另一侧的一个高波，对称设置高波可以使第一波圈11受U型锚的牵引力更对称，且对称的另一侧使用高分子线以同样的方式对称设置，分别抵消对称的两个第一单波111受U型锚的牵引力。
实施例4
实施例4提出另一种覆膜支架。实施例4的覆膜支架与实施例1中相同或可以挪用的特征部分在此不再赘述，主要的不同之处在于，实施例4的覆膜支架中，如图14所示，第一单波111的波谷与近端第二波圈121的波峰在同一轴线上，且通过沿轴向的第一连接杆102连接，所有的第二波圈12的波谷与波谷沿轴向相对，波峰与波峰沿轴向相对，其中第一波圈11、第一连接杆102和近端第二波圈121之间一体成型。第一波圈11与近端第二波圈121可以通过对具有形状记忆的合金管材(例如镍钛合金管)进行激光切割，从而呈一体成型的结构，再采用热定型等工艺进行处理。
如图14所示，第一单波111包括第一波谷1113和第二波谷1114，近端第二波圈121包括第一波峰1213和第二波峰1214，其中，第一波谷1113与第一波峰1213在同一轴线上且通过沿轴向的第一连接杆102连接，第二波谷1114与第二波峰1214在同一轴线上且通过沿轴向的第一连接杆102连接，近端第二 波圈121包括第三波谷1211和第四波谷1212，第三波谷1211和第四波谷1212在第二波峰1214的轴向两侧，远端第二波圈122包括第五波谷1221和第六波谷1222，第五波谷1221与第三波谷1211在同一轴线上，第六波谷1222与第四波谷1212在同一轴线上。在其他的实施方式中，第一波圈11和近端第二波圈121之间一体成型，但波谷与波峰不沿轴向相对时，第一连接杆也可以不沿轴向设置。
高分子连接线还包括自第三波谷1211沿轴向上依次与中间的第二波圈连接并打结固定，直至与远端第二波圈122的第五波谷1221打结固定从而形成多个第二轴向段32，再沿周向与第六波谷1222之间连接，并在第六波谷1222上打结固定从而形成第一周向段34，然后沿轴向朝近端依次经过中间的第二波圈12并打结直至于第四波谷1212打结固定从而形成多个第二轴向段32。此时，在各个第二波圈之间的结点中，第三波谷1211和第四波谷1212为起止点，其余的结点为中间点，增加各个第二波圈12之间的波谷之间沿轴向的结点，可以进一步分散第一单波111作为高波钩挂在U型锚上时受到的沿轴向上的牵引力，将力分散至支架10的各个波圈上，从而增加第一波圈11和近端第二波圈121整体与其他的第二波圈之间的连接强度，提高支架10整体的稳定性和结构强度，防止造成覆膜破损，同时各第二波圈之间使用高分子线打结固定还可以减少各波圈之间沿轴向连接对覆膜支架柔顺性的影响。
可以理解的是，在与如图14所示高波呈周向180°对称的另一侧设有另一个高波，对称设置高波可以使第一波圈11受U型锚的牵引力更对称，且对称的另一侧使用高分子线以同样的方式在各个第二波圈之间对称设置，分别抵消对称的两个第一单波受U型锚的牵引力。
可以理解的是，在其他的实施方式中，第二波圈12的各个单波也可以不与第一波圈11的第一单波111同周期。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细， 但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (11)

  1. 一种覆膜支架，包括支架和包覆于所述支架上的覆膜，所述支架包括多个沿轴向排列的波圈，其特征在于，所述波圈包括第一波圈和第二波圈，所述第一波圈位于所述覆膜支架近端，所述第二波圈位于所述第一波圈的远端侧，所述第一波圈包括第一单波和第二单波，所述第一单波至少部分未被所述覆膜包覆，且所述第一单波与所述第二波圈固定。
  2. 根据权利要求1所述的覆膜支架，其特征在于，所述第一单波的近端凸出于所述覆膜的近端端面，所述第二单波位于所述覆膜的区域内且被所述覆膜包覆，所述第一单波与同一波圈上相邻的单波之间形成的波谷与所述第二波圈上最近的波谷或波峰固定。
  3. 根据权利要求2所述的覆膜支架，其特征在于，所述第二波圈包括近端第二波圈和远端第二波圈，所述第一单波的波谷与所述近端第二波圈的波峰不沿同一轴线上。
  4. 根据权利要求3所述的覆膜支架，其特征在于，所述第一单波的波谷与所述近端第二波圈的波谷在同一轴向线上，且通过高分子线打结固定或一体成型。
  5. 根据权利要求4所述的覆膜支架，其特征在于，一个所述第一单波包括沿轴向两侧的第一波谷和第二波谷，所述高分子线至少包括一个第一轴向段，所述第一轴向段位于所述第一波谷或/和所述第二波谷与所述近端第二波圈的波谷之间。
  6. 根据权利要求5所述的覆膜支架，其特征在于，所述近端第二波圈与所述远端第二波圈之间还包括中间第二波圈，所述高分子线在所述第一波谷与所述近端第二波圈之间包括多个重叠的第一轴向段，所述高分子线在所述近端第二波圈与所述中间第二波圈之间包括多个重叠的第二轴向段，所述第二轴向段位于各所述第二波圈之间。
  7. 根据权利要求3所述的覆膜支架，其特征在于，所述第一单波的波谷与所述近端第二波圈最近的两个波峰分别通过高分子线打结固定。
  8. 根据权利要求7所述的覆膜支架，其特征在于，一个所述第一单波包括沿轴向两侧的波谷，所述高分子线至少包括一个斜向段，所述斜向段位于所述 第一单波的波谷与所述第二波圈的波峰之间。
  9. 根据权利要求2所述的覆膜支架，其特征在于，所述第二波圈包括近端第二波圈和远端第二波圈，所述第一单波的波谷与所述近端第二波圈的波峰沿同一轴线上，且所述第一单波的波谷与所述近端第二波圈之间通过高分子线打结固定或一体成型。
  10. 根据权利要求8所述的覆膜支架，其特征在于，所述第一单波包括第一波谷和第二波谷，所述近端第二波圈还包括第一波峰和第二波峰，所述第一波峰与所述第一波谷在同一轴线上，所述第二波峰与所述第二波谷位于同一轴线上，所述高分子线至少包括一个第一轴向段，所述第一轴向段位于所述第一波谷与所述第一波峰之间或/和所述第二波谷与所述第二波峰之间。
  11. 根据权利要求4-10任意一项所述的覆膜支架，其特征在于，当各波圈之间通过高分子线打结固定时，所述高分子线与各波圈之间的结点包括起止点和中间点，所述起止点打双结，所述中间点打单结。
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