WO2019042302A1 - Covered stent and preparation method therefor - Google Patents

Covered stent and preparation method therefor Download PDF

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Publication number
WO2019042302A1
WO2019042302A1 PCT/CN2018/102827 CN2018102827W WO2019042302A1 WO 2019042302 A1 WO2019042302 A1 WO 2019042302A1 CN 2018102827 W CN2018102827 W CN 2018102827W WO 2019042302 A1 WO2019042302 A1 WO 2019042302A1
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WO
WIPO (PCT)
Prior art keywords
diaphragm
stent
film
connector
membrane
Prior art date
Application number
PCT/CN2018/102827
Other languages
French (fr)
Chinese (zh)
Inventor
肖本好
王逸斐
Original Assignee
先健科技(深圳)有限公司
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Publication date
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Publication of WO2019042302A1 publication Critical patent/WO2019042302A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • A61F2002/072Encapsulated stents, e.g. wire or whole stent embedded in lining
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/005Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2240/00Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001Designing or manufacturing processes

Definitions

  • the invention relates to the field of medical instruments, in particular to a stent graft and a preparation method thereof.
  • the existing endoluminal graft stent is divided into a bare stent composed of a metal stent and a stent graft composed of a coating material and a metal stent according to the structural morphological type, wherein the stent graft adopts a leak-proof coating material to carry out the stent.
  • the wrapper when it is released at the lesion site, acts as a barrier to blood flow.
  • the stent graft generally covers the metal stent by heat treatment and suturing the single layer or multiple layers of the coating material.
  • a conventional stent graft using a polyethylene terephthalate (PET) film is generally fixed to one or both sides of the metal stent by stitching.
  • PET polyethylene terephthalate
  • FIG. 1 to FIG. 3 when the film 240 made of expanded polytetrafluoroethylene (ePTFE) is used, the film 240 has a high elongation and is easily deformed, and is not suitable for the metal stent 210 by a stitching process.
  • the ePTFE is melted at a high temperature (for example, 327 ° C), and the films are bonded to each other after cooling.
  • the inner membrane 241 of ePTFE and the outer membrane 243 of ePTFE are completely or partially wrapped with the metal stent 210, and heat-treated. The portions in contact with the inner and outer films are bonded together to fix the metal bracket 210 between the inner film 241 and the outer film 243.
  • the lower inner membrane 241 and the outer membrane 243 are gradually separated because the ePTFE loses viscosity at normal temperature, so the separation is irreversible, and the inner membrane 241 and the outer membrane 243 may be partially detached, and even the metal stent may be detached from the coating 240. The risk of failure.
  • a stent graft comprising a stent body and a coating, the stent having a first surface and a second surface opposite the first surface, the coating comprising a first membrane and a second membrane, a first diaphragm is disposed on the first surface, the second diaphragm is disposed on the second surface and bonded to the first diaphragm, and the coating further includes a fixed body attached to the bracket body a connector, the connector being located between the first diaphragm and the second diaphragm, the connector being bonded to at least one of the first diaphragm and the second diaphragm.
  • the stent body under the action of an external force, the stent body is fixed to one of the first membrane and the second membrane by the connecting member, so that it is not easy to be in the first membrane and the second membrane. Loosening occurs, which increases the connection strength between the film and the stent body, and reduces the risk of failure of the stent graft caused by the displacement of the stent body when the stent is stressed or deformed.
  • the connector is an envelope encasing the stent body.
  • the ratio of the sum of the thicknesses of the first diaphragm and the second diaphragm to the thickness of the envelope is 4:1 to 20:1.
  • the stent body includes a wave ring including a crest, a trough, and a side bar, the side bar connecting the crests and troughs, the crests and the envelope of the trough surface The thickness is less than the thickness of the envelope of the side bar surface.
  • At least one of the first surface and the second surface is recessed inwardly to form a groove, and the connecting member is received in and fixed to the groove.
  • the material of the connector is the same as the material of the first diaphragm and/or the second diaphragm.
  • the preparation method of the above-mentioned stent graft comprises the following steps:
  • the first diaphragm is disposed on the first surface of the bracket body, and the second diaphragm is disposed on the second surface of the bracket body, the first diaphragm and the second diaphragm
  • the first film, the second film, and the connecting member are bonded and fixed by heat treatment.
  • the step of forming a connector covering the stent body on the stent body is specifically: winding the connector around the stent body to form a coating covering the stent body.
  • the step of forming a connector covering the bracket body on the bracket body is specifically: forming a coating on the surface of the bracket body to obtain the connector.
  • Another preparation method of the above-mentioned stent graft includes the following steps:
  • bracket body at least one of the first surface and the second surface of the bracket body is recessed inward to form a groove
  • the first diaphragm is disposed on the first surface of the bracket body, and the second diaphragm is disposed on the second surface of the bracket body, the first diaphragm and the second diaphragm Performing a heat treatment to bond the first film to the second film, and at least one of the first film and the second film is filled with the groove after heat treatment to be received and fixed to the concave The connector of the slot.
  • FIG. 1 is a schematic structural view of a conventional stent graft
  • FIG. 2 is a partial structural schematic view of the stent graft shown in FIG. 1;
  • Figure 3 is a partial cross-sectional view of the stent graft of Figure 2;
  • Figure 4 is a partial enlarged view of Figure 3;
  • Figure 5 is a schematic view showing the structure of the stent graft of Figure 3 in a state of use
  • Figure 6 is a schematic view showing the structure of the stent graft of Figure 3 in another state of use
  • Figure 7 is a partial cross-sectional view showing a stent graft of an embodiment
  • Figure 8 is a schematic structural view of a wave ring of the stent graft of Figure 7;
  • Figure 9 is a partial enlarged view of the wave ring of Figure 8.
  • Figure 10 is a partial enlarged view of the side bar of the wave ring of Figure 8.
  • Figure 11 is a cross-sectional view of the side bar of Figure 10;
  • Figure 12 is a partial enlarged view of the stent graft of Figure 7;
  • Figure 13 is a partial cross-sectional view showing a stent graft of another embodiment
  • Figure 14 is a schematic view showing the structure of the stent body of the stent graft of Figure 13;
  • FIG. 15 is a schematic structural view of a stent graft according to still another embodiment.
  • Figure 16 is a schematic view showing the structure of the coil of the stent graft of Figure 15;
  • Figure 17 is a cross-sectional view of the wave coil of Figure 16.
  • Figure 18 is a schematic view showing the structure of the coil and the connecting member of the stent graft of Figure 15;
  • the stent graft 300 of one embodiment includes a stent body 310 and a coating 340 .
  • the bracket body 310 includes a wave ring 312.
  • the wave ring 312 is an alloy wire braided wave ring or a cut metal wave ring.
  • the coil 312 is woven from a titanium-nickel alloy wire.
  • the cross section of the wave ring 312 is circular.
  • the bracket body 310 is substantially cylindrical, and the plurality of coils 312 are spaced apart in the axial direction of the bracket body 310.
  • the structure of the bracket body 310 is not limited thereto.
  • the bracket body 310 further includes a connecting rod (not shown) connected between the adjacent two coils 312.
  • the two adjacent coils 312 are connected by at least one connecting rod.
  • the spacing between the turns 312 is equal.
  • the spacing between the turns 312 may also be unequal.
  • the coil 312 is a Z-shaped coil.
  • the wave circle 312 includes a peak 3121, a trough 3123, and a side bar 3125.
  • the side bars 3125 connect adjacent peaks 3123 and troughs 3125.
  • the bracket body 310 has a first surface and a second surface opposite the first surface.
  • the first surface refers to the outer surface of the stent body 310 and the second surface refers to the inner surface of the stent body 310.
  • the film 340 includes a first diaphragm 341, a second diaphragm 343, and a connector 345.
  • the material of the film 340 is expanded polytetrafluoroethylene.
  • the materials of the first diaphragm 341, the second diaphragm 343 and the connecting member 345 are the same material, which facilitates the hot melt bonding of the coating 340.
  • the materials of the first diaphragm 341, the second diaphragm 343, and the connecting member 345 can be fused and bonded to each other with a similar melting point.
  • the connecting member 345 can also be an envelope formed by an adhesive coated on the bracket body 310 to increase the bonding strength of the bracket body 310 and the coating film 340.
  • the material of the connector 345 is polyperfluoroethylene propylene (FEP).
  • the first diaphragm 341 is disposed on the first surface of the bracket body 310, and the second diaphragm 343 is disposed on the second surface of the bracket body 310, thereby clamping the bracket body 310 and the connecting member 345 to the first diaphragm 341 and the second Between the diaphragms 343.
  • the first diaphragm 341 and the second diaphragm 343 have the same thickness.
  • the connector 345 is a wrap that wraps the coil 312 .
  • the connector 345 forms an envelope around the wire of the coil 312.
  • the wire of the connecting member 345 spirally wound around the coil 312 forms an envelope to be fixed to the coil 312.
  • the spirally wound strips 3451 are flush, non-overlapping, and free of gaps, thereby ensuring that the formed envelope is smooth and free of protrusions.
  • the connector 345 can be bonded to the first diaphragm 341 and the second diaphragm 343 by heat fusion, and the connector 345 is thermally fused to form a coating covering the coil 312.
  • the number of the connecting members 345 is not limited, and the envelope 345 may be wound by one connecting member 345 to form a coating film, or the plurality of connecting members 345 may be wound around the wave ring 312 to form a coating film. It will be appreciated that in other embodiments, the wire may be inserted into the expanded polytetrafluoroethylene hose to re-wrap the coil.
  • the thickness of the envelope formed by the connecting member 345 wound with the wave ring 312 affects the bonding strength between the bracket body 310 and the first diaphragm 341 and the second diaphragm 343.
  • the ratio of the sum of the thicknesses of the first diaphragm 341 and the second diaphragm 343 to the thickness of the envelope is 4:1 to 20:1.
  • the thickness of the envelope on the surface of the peak 3121 and the trough 3123 is smaller than the thickness of the envelope on the surface of the side bar 3125, thereby ensuring the bonding strength of the envelope to the first diaphragm 341 and the second diaphragm 343 while reducing The effect of the envelope on the compressive strength of the stent body 310.
  • the ratio of the sum of the thicknesses of the first diaphragm 341 and the second diaphragm 343 to the thickness of the envelope of the peaks 3121 and the valleys 3123 is greater than 8:1, and the sum of the thicknesses of the first diaphragm 341 and the second diaphragm 343 is the sidebar
  • the thickness ratio of the envelope of the 3125 surface is 2:1 to 6:1.
  • the ratio of the thickness of the envelope at the crests and troughs to the thickness of the envelope at the side bars is 1:1.5 to 1:3. It can be understood that, in an embodiment, the envelope may be provided only at the side bars of the coil, and there is no envelope at the crests and troughs of the coils.
  • envelopes of different thicknesses may be disposed in the axial direction of the surface of the wire of the coil 312, depending on the particular requirements for the performance of the stent graft 300. It will also be appreciated that different envelope thicknesses may also be provided in the circumferential direction of the wire of the coil 312.
  • the thickness of the envelope at both sides of the wire of the coil 312 is greater than the thickness at the first surface and the second surface.
  • the two sides refer to a surface perpendicular to the first surface and the second surface.
  • the ratio of the thickness of the envelope at the two sides of the wire of the coil 312 to the distance between the first surface and the second surface of the wire is from 2:1 to 4:1 to further increase the wire. The strength of the connection to the film.
  • the connecting member 345 is spirally wound around the wire of the wave ring 312 to form a coating, and a gap formed by the spiral winding is formed with a gap, and the connecting member 345 wraps the wave ring.
  • the formed envelope covers the surface of the coil portion.
  • the gap can also be large under certain conditions, and the connecting member 345 can also form a discontinuous envelope on the surface of the wire.
  • the connecting member 345 is hot-melted and coated on the surface of the bracket body 310 to form a coating.
  • 345 fills the gap between the first diaphragm 341 and the second diaphragm 343, so that the bracket body 310 is fully fixed in the coating 340, and the connection strength between the bracket body 310 and the coating 340 is greatly improved, and the stent graft 300 is ensured. Stability and safety.
  • the stent body 300 is bonded and fixed to the first diaphragm 341 and the second diaphragm 343 by the connecting member 345 under the action of an external force, so that the first diaphragm 341 and the second diaphragm 343 are not easily adhered. Loosening occurs between them, reducing the risk of failure of the stent graft 300 due to displacement of the stent body 310 when the stent graft 300 is stressed or deformed.
  • the structure of the stent graft 400 of another embodiment is substantially the same as that of the stent graft 300 .
  • the difference is that the stent body 410 of the stent graft 400 is a cut metal stent, and the connecting member 445 is An envelope formed by a coating applied to the surface of the stent body 410.
  • the stent graft 400 is a stainless steel ball expanded membrane stent
  • the coil 412 of the stent body 410 is a cut metal coil prepared by metal laser engraving.
  • the cross section of the wave ring 412 is rectangular. Preferably, the four corners of the rectangle are rounded.
  • the connector 445 is a coating formed by spraying, and the coating adheres to the surface of the coil 412 to form a coating.
  • the material of the connecting member 445 is preferably expanded polytetrafluoroethylene.
  • the thickness of the first film 441 and the second film 445 is 4:1 to 20:1.
  • the thickness of the envelope of the surface of the peak 4121 and the valley 4123 is less than the thickness of the envelope of the surface of the sidebar 3125.
  • the ratio of the sum of the thicknesses of the first diaphragm 341 and the second diaphragm 443 to the thickness of the envelope of the peaks 4121 and the valleys 4123 is greater than 8:1, and the thicknesses of the first diaphragm 441 and the second diaphragm 443 are The thickness ratio of the envelope on the surface of the side bar 4125 is 2:1 to 6:1.
  • a coating is prepared on the surface of the stent body 410 to obtain a connecting member 445, and the first diaphragm 441, the second diaphragm 443 and the connecting member 445 are thermally fusion-bonded by a laminating process, and the connecting member is connected.
  • the 445 hot-melt coating forms a coating on the surface of the bracket body 410, and the connecting member 445 fills the gap between the first diaphragm 441 and the second diaphragm 443, so that the bracket body 410 is sufficiently fixed in the coating 440.
  • the bracket body 410 The connection strength with the film 440 is greatly improved, and the stability and safety of the film stent 400 are ensured.
  • the stent graft 400 is bonded and fixed to the first diaphragm 441 and the second diaphragm 443 by the connecting member 445 under the action of an external force, so that the first diaphragm 441 and the second diaphragm 443 are not easily attached. Loosening occurs between them, reducing the risk of failure of the stent graft 400 due to displacement of the stent body 410 when the stent graft 400 is stressed or deformed.
  • the structure of the stent graft 500 of another embodiment is substantially the same as that of the stent graft 400 , except that the surface of the coil 512 of the stent graft 500 is formed with a groove 521.
  • the recess 5121 is recessed inwardly from the first surface of the coil 512.
  • the recess 5121 may also be recessed inward from the second surface of the coil 512, or
  • the first surface and the second surface of the wave ring 512 are each formed with a groove.
  • the recess 5121 is a blind slot.
  • the recess 5121 can also be a through slot, and the recess 5121 extends through the first surface and the second surface.
  • the material of the coating fills the groove 5121 , so that the connecting member 545 can be added.
  • the adhesive force between the wave ring 512, the portion received in the groove 5121 becomes an anchor point connecting the connecting member 545 and the wave ring 512, and the connecting member 545 and the first diaphragm 541 and the second diaphragm 543 are thermally melt-bonded.
  • the connection between the bracket body and the first diaphragm 541 and the second diaphragm 543 is more stable.
  • the connecting member 545 is not limited to the envelope of the coated wave ring 512 formed by spraying. In other embodiments, the connecting member 545 may also be spirally wound around the envelope of the wave ring 512. After the hot pressing process, the connecting member 545, the first diaphragm 541 and the second diaphragm 543 are hot-melted to fill the recess 5121. Of course, it can be understood that the coating applied to the wave ring 512 can also be omitted. After the hot pressing treatment of the coating film, the first film piece 541 and the second film piece 543 are melted and filled into the groove 5121 to be received in the concave shape.
  • the protrusion of the groove serves as a connecting member, and the connecting member is received and fixed to the groove at this time, and becomes an anchor point connecting the film and the coil 512.
  • the bracket body 510 is adhered and fixed to the first diaphragm 541 and the second diaphragm 543 through the connecting member 545, so that loosening between the first diaphragm 541 and the second diaphragm 543 is not easy, and the reduction is reduced.
  • the displacement of the stent body 510 when the stent graft 500 is stressed or deformed poses a risk of failure of the stent graft 500.
  • the method for preparing the above-mentioned stent graft comprises the following steps:
  • Step S710 providing a stent body.
  • the bracket body has a first surface and a second surface opposite the first surface.
  • the bracket body includes a wave ring.
  • At least one of the first surface and the second surface of the stent body is recessed inwardly to form a groove.
  • Step S720 forming a connector for wrapping the bracket body on the bracket body.
  • the connector is wrapped around the stent body to form a wrap that surrounds the stent body.
  • the connector is spirally wound around the coil.
  • the strips formed by the connectors wound by the coils are flush, non-overlapping, and free of gaps to ensure smooth formation of the envelope without protrusions.
  • a gap is formed between the stripes formed by the connectors spirally wound around the coil.
  • the thickness of the connector of the peak and trough surface is less than the thickness of the connector of the side bar surface. It will be appreciated that in one embodiment it is also possible to wrap the connector only at the side bars of the coil, not at the crests and troughs of the wave ring.
  • a coating is formed on the surface of the stent body to obtain a connector.
  • the coating is obtained by spraying, spin coating or knife coating to form a coating.
  • the thickness of the coating of the crest and trough surface is less than the thickness of the coating of the side bar surface. It will be appreciated that in one embodiment, it is also possible to apply the coating only at the side bars of the coils, without coating at the crests and troughs of the coils. It will also be appreciated that different coating thicknesses may also be provided in the circumferential direction of the coil. For example, the thickness at both sides of the wire of the coil is greater than the thickness of the coating at the first and second surfaces.
  • the thickness of the coating at both sides of the coiled wire is a ratio of the distance between the first surface of the wire and the second surface of from 2:1 to 4:1.
  • the connector is a hose that is sleeved over the coil of the stent.
  • the material of the connector is expanded polytetrafluoroethylene.
  • the material of the connector may also be an adhesive such as polyperfluoroethylene propylene (FEP).
  • Step S730 the first diaphragm is disposed on the first surface of the bracket body, the second diaphragm is disposed on the second surface of the bracket body, and the first diaphragm and the second diaphragm are heat treated to make the first diaphragm and the first diaphragm
  • the two membranes are adhesively fixed.
  • the material of the first diaphragm and the second diaphragm is expanded polytetrafluoroethylene, and the materials of the first diaphragm, the second diaphragm and the connecting member are the same.
  • at least one of the first diaphragm and the second diaphragm may be the same material as the connector. It can be understood that when the material of the connecting member is an adhesive, the material of the connecting member may be different from the materials of the first diaphragm and the second diaphragm.
  • the first film and the second film are heat-treated to thermally bond the first film and the second film, and the first film and the second film are thermally bonded to the connecting member.
  • the connector wound around the stent body is thermally melted to fill the groove.
  • the preparation method of the above-mentioned stent graft is simple in operation, and the prepared stent graft can improve the joint strength between the membrane and the stent.
  • Step S720 can be omitted.
  • the first diaphragm is directly disposed on the first surface of the bracket body having the groove on the surface
  • the second diaphragm is disposed on the second surface of the bracket body to heat treat the first diaphragm and the second diaphragm.
  • the first film and the second film are bonded and fixed, and at least one of the first film and the second film covering the surface of the groove is filled and fixed in the groove. Connector.
  • the surface of at least one of the first diaphragm and the second diaphragm may be disposed on the corresponding protrusion of the groove. After the heat fusion, the protrusion is received and fixed to the groove to form a connection. Pieces.
  • the groove may be a through groove, penetrate the first surface and the second surface of the wave ring, and the first film and the second film are hot-melted and filled into the groove to obtain the first film and the second film simultaneously Membrane-attached connector.

Abstract

The present invention relates to a covered stent and a preparation method therefor. The covered stent comprises a stent body and a covering membrane. The stent body has a first surface and a second surface opposite the first surface. The covering membrane comprises a first membrane and a second membrane. The first membrane is arranged on the first surface. The second membrane is arranged on the second surface and is bonded with the first membrane. The covering membrane further comprises a connector fixedly connected to the stent body. The connector is located between the first membrane and the second membrane. The connector is bonded with at least one of the first membrane and the second membrane. The covered stent can improve the connection strength between the covering membrane and the stent body.

Description

覆膜支架及其制备方法Covered stent and preparation method thereof 技术领域Technical field
本发明涉及医疗器械领域,尤其涉及覆膜支架及其制备方法。The invention relates to the field of medical instruments, in particular to a stent graft and a preparation method thereof.
背景技术Background technique
现有腔内移植物支架根据结构形态类型分为由金属支架构成的裸支架和由覆膜材料与金属支架构成的覆膜支架,其中覆膜支架采用了防渗漏的覆膜材料将支架进行包裹,当它在病变位置释放后,覆膜材料起到隔绝血流的作用。The existing endoluminal graft stent is divided into a bare stent composed of a metal stent and a stent graft composed of a coating material and a metal stent according to the structural morphological type, wherein the stent graft adopts a leak-proof coating material to carry out the stent. The wrapper, when it is released at the lesion site, acts as a barrier to blood flow.
覆膜支架一般采用将单层或多层覆膜材料通过热处理、缝合的方式将金属支架覆盖包裹。现有的一种覆膜支架,使用聚对苯二甲酸乙二醇酯(PET)材质的覆膜,一般采用缝合的方式固定在金属支架的一侧或两侧。请参阅图1至图3,当使用膨体聚四氟乙烯(ePTFE)材质的覆膜240时,覆膜240延伸率高易变形,并不适合采用缝合的工艺连接金属支架210,此时需要利用ePTFE在高温(比如327℃)会融化,冷却后薄膜之间将会相互粘合的特性,将ePTFE材质的内膜241及ePTFE材质的外膜243将金属支架210完全或部分包裹,经过热处理,内外膜接触的部分会粘合成一体,从而将金属支架210固定在内膜241及外膜243之间。The stent graft generally covers the metal stent by heat treatment and suturing the single layer or multiple layers of the coating material. A conventional stent graft using a polyethylene terephthalate (PET) film is generally fixed to one or both sides of the metal stent by stitching. Referring to FIG. 1 to FIG. 3, when the film 240 made of expanded polytetrafluoroethylene (ePTFE) is used, the film 240 has a high elongation and is easily deformed, and is not suitable for the metal stent 210 by a stitching process. The ePTFE is melted at a high temperature (for example, 327 ° C), and the films are bonded to each other after cooling. The inner membrane 241 of ePTFE and the outer membrane 243 of ePTFE are completely or partially wrapped with the metal stent 210, and heat-treated. The portions in contact with the inner and outer films are bonded together to fix the metal bracket 210 between the inner film 241 and the outer film 243.
请参阅图4至图6,ePTFE材料本身与金属支架210之间没有粘性,且内膜241与外膜243与金属支架210的金属丝汇合时仍会有一定的空隙260存在,导致覆膜支架在受到外力的作用下,金属支架210容易在内膜241及外膜243之间发生松动,并对内膜241及外膜243粘合的接触面产生撕裂的力,在这种力的作用下内膜241及外膜243会逐渐分离,因为在常温下ePTFE失去粘性,所以这种分离是不可逆的,可能造成内膜241及外膜243部分脱落,甚至有金属支架从覆膜240中脱离失效的风险。Referring to FIG. 4 to FIG. 6 , there is no adhesive between the ePTFE material itself and the metal bracket 210 , and there is still a certain gap 260 when the inner film 241 and the outer film 243 meet the metal wire of the metal bracket 210 , resulting in a stent graft. Under the action of an external force, the metal stent 210 is liable to loosen between the inner membrane 241 and the outer membrane 243, and a tearing force is generated on the contact surface where the inner membrane 241 and the outer membrane 243 are bonded. The lower inner membrane 241 and the outer membrane 243 are gradually separated because the ePTFE loses viscosity at normal temperature, so the separation is irreversible, and the inner membrane 241 and the outer membrane 243 may be partially detached, and even the metal stent may be detached from the coating 240. The risk of failure.
发明内容Summary of the invention
基于此,有必要提供一种能提高覆膜与支架之间连接强度的覆膜支架及其制备方法。Based on this, it is necessary to provide a stent graft capable of improving the joint strength between the membrane and the stent and a preparation method thereof.
一种覆膜支架,包括支架本体及覆膜,所述支架具有第一表面及与所述第一表面相对的第二表面,所述覆膜包括第一膜片及第二膜片,所述第一膜片设于所述第一表面,所述第二膜片设于所述第二表面且与所述第一膜片粘合,所述覆膜还包括与所述支架本体固接的连接件,所述连接件位于所述第一膜片及所述第二膜片之间,所述连接件与所述第一膜片及所述第二膜片中的至少一个粘合。A stent graft comprising a stent body and a coating, the stent having a first surface and a second surface opposite the first surface, the coating comprising a first membrane and a second membrane, a first diaphragm is disposed on the first surface, the second diaphragm is disposed on the second surface and bonded to the first diaphragm, and the coating further includes a fixed body attached to the bracket body a connector, the connector being located between the first diaphragm and the second diaphragm, the connector being bonded to at least one of the first diaphragm and the second diaphragm.
上述覆膜支架,覆膜支架在受到外力的作用下,支架本体通过连接件与第一膜片及第二膜片中的一个固定在一起,从而不易在第一膜片及第二膜片之间发生松动,从而增加了覆膜与支架本体的连接强度,降低了覆膜支架在受力或变形时支架本体的移位造成覆膜支架失效的风险。In the above-mentioned film-covered stent, under the action of an external force, the stent body is fixed to one of the first membrane and the second membrane by the connecting member, so that it is not easy to be in the first membrane and the second membrane. Loosening occurs, which increases the connection strength between the film and the stent body, and reduces the risk of failure of the stent graft caused by the displacement of the stent body when the stent is stressed or deformed.
在其中一个实施例中,所述连接件为包裹所述支架本体的包膜。In one embodiment, the connector is an envelope encasing the stent body.
在其中一个实施例中,所述第一膜片及所述第二膜片的厚度之和与所述包膜的厚度比为4:1~20:1。In one embodiment, the ratio of the sum of the thicknesses of the first diaphragm and the second diaphragm to the thickness of the envelope is 4:1 to 20:1.
在其中一个实施例中,所述支架本体包括波圈,所述波圈包括波峰、波谷及侧杆,所述侧杆连接所述波峰及波谷,所述波峰及所述波谷表面的包膜的厚度小于所述侧杆表面的包膜的厚度。In one embodiment, the stent body includes a wave ring including a crest, a trough, and a side bar, the side bar connecting the crests and troughs, the crests and the envelope of the trough surface The thickness is less than the thickness of the envelope of the side bar surface.
在其中一个实施例中,所述第一表面及所述第二表面中的至少一个向内凹陷形成凹槽,所述连接件收容于并固定于所述凹槽。In one embodiment, at least one of the first surface and the second surface is recessed inwardly to form a groove, and the connecting member is received in and fixed to the groove.
在其中一个实施例中,所述连接件的材料与所述第一膜片和/或所述第二膜片的材料相同。In one embodiment, the material of the connector is the same as the material of the first diaphragm and/or the second diaphragm.
上述覆膜支架的制备方法,包括以下步骤:The preparation method of the above-mentioned stent graft comprises the following steps:
在所述支架本体上形成包裹所述支架本体的连接件;及Forming a connector covering the bracket body on the bracket body; and
将所述第一膜片设于所述支架本体的第一表面,将所述第二膜片设于所述支架本体的第二表面,对所述第一膜片及所述第二膜片进行热处理使所述第一膜片、第二膜片及所述连接件粘合固定。The first diaphragm is disposed on the first surface of the bracket body, and the second diaphragm is disposed on the second surface of the bracket body, the first diaphragm and the second diaphragm The first film, the second film, and the connecting member are bonded and fixed by heat treatment.
在其中一个实施例中,所述在所述支架本体上形成包裹所述支架本体的连 接件的步骤具体为:将所述连接件缠绕于所述支架本体形成包裹所述支架本体的包膜。In one embodiment, the step of forming a connector covering the stent body on the stent body is specifically: winding the connector around the stent body to form a coating covering the stent body.
在其中一个实施例中,所述在所述支架本体上形成包裹所述支架本体的连接件的步骤具体为:在所述支架本体表面形成涂层得到所述连接件。In one embodiment, the step of forming a connector covering the bracket body on the bracket body is specifically: forming a coating on the surface of the bracket body to obtain the connector.
上述覆膜支架的另一种制备方法,包括以下步骤:Another preparation method of the above-mentioned stent graft includes the following steps:
提供所述支架本体,所述支架本体的所述第一表面及所述第二表面中的至少一个向内凹陷形成凹槽;Providing the bracket body, at least one of the first surface and the second surface of the bracket body is recessed inward to form a groove;
将所述第一膜片设于所述支架本体的第一表面,将所述第二膜片设于所述支架本体的第二表面,对所述第一膜片及所述第二膜片进行热处理使所述第一膜片与第二膜片粘合固定,所述第一膜片及所述第二膜片中的至少一个热处理后填充所述凹槽得到收容并固定于所述凹槽的连接件。The first diaphragm is disposed on the first surface of the bracket body, and the second diaphragm is disposed on the second surface of the bracket body, the first diaphragm and the second diaphragm Performing a heat treatment to bond the first film to the second film, and at least one of the first film and the second film is filled with the groove after heat treatment to be received and fixed to the concave The connector of the slot.
附图说明DRAWINGS
图1为现有的一种覆膜支架的结构示意图;1 is a schematic structural view of a conventional stent graft;
图2为图1所示覆膜支架的局部结构示意图;2 is a partial structural schematic view of the stent graft shown in FIG. 1;
图3为图2的覆膜支架的部分剖面图;Figure 3 is a partial cross-sectional view of the stent graft of Figure 2;
图4为图3的局部放大图;Figure 4 is a partial enlarged view of Figure 3;
图5为图3的覆膜支架处于一种使用状态的结构示意图;Figure 5 is a schematic view showing the structure of the stent graft of Figure 3 in a state of use;
图6为图3的覆膜支架处于另一种使用状态的结构示意图;Figure 6 is a schematic view showing the structure of the stent graft of Figure 3 in another state of use;
图7为一实施方式的覆膜支架的局部剖面图;Figure 7 is a partial cross-sectional view showing a stent graft of an embodiment;
图8为图7的覆膜支架的波圈的结构示意图;Figure 8 is a schematic structural view of a wave ring of the stent graft of Figure 7;
图9为图8的波圈的部分放大图;Figure 9 is a partial enlarged view of the wave ring of Figure 8;
图10为图8的波圈的侧杆的部分放大图;Figure 10 is a partial enlarged view of the side bar of the wave ring of Figure 8;
图11为图10的侧杆的剖面图;Figure 11 is a cross-sectional view of the side bar of Figure 10;
图12为图7的覆膜支架的局部放大图;Figure 12 is a partial enlarged view of the stent graft of Figure 7;
图13为另一实施方式的覆膜支架的局部剖面图;Figure 13 is a partial cross-sectional view showing a stent graft of another embodiment;
图14为图13的覆膜支架的支架本体的结构示意图;Figure 14 is a schematic view showing the structure of the stent body of the stent graft of Figure 13;
图15为又一实施方式的覆膜支架的结构示意图15 is a schematic structural view of a stent graft according to still another embodiment.
图16为图15的覆膜支架的波圈的结构示意图;Figure 16 is a schematic view showing the structure of the coil of the stent graft of Figure 15;
图17为图16的波圈的剖面图;Figure 17 is a cross-sectional view of the wave coil of Figure 16;
图18为图15的覆膜支架的波圈与连接件的结构示意图。Figure 18 is a schematic view showing the structure of the coil and the connecting member of the stent graft of Figure 15;
具体实施方式Detailed ways
为了便于理解本发明,下面将参照相关附图对本发明进行更全面的描述。附图中给出了本发明的较佳的实施例。但是,本发明可以以许多不同的形式来实现,并不限于本文所描述的实施例。相反地,提供这些实施例的目的是使对本发明的公开内容的理解更加透彻全面。In order to facilitate the understanding of the present invention, the present invention will be described more fully hereinafter with reference to the accompanying drawings. Preferred embodiments of the invention are shown in the drawings. However, the invention may be embodied in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided so that the understanding of the present disclosure will be more fully understood.
需要说明的是,当元件被称为“固定于”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”、“上”、“下”、“远”、“近”以及类似的表述只是为了说明的目的。It should be noted that when an element is referred to as being "fixed" to another element, it can be directly on the other element or the element can be present. When an element is considered to be "connected" to another element, it can be directly connected to the other element or. The terms "vertical," "horizontal," "left," "right," "upper," "lower," "far," "near," and the like, as used herein, are for illustrative purposes only.
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例的目的,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。All technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs, unless otherwise defined. The terminology used in the description of the present invention is for the purpose of describing particular embodiments and is not intended to limit the invention. The term "and/or" used herein includes any and all combinations of one or more of the associated listed items.
请参阅图7及图8,一实施方式的覆膜支架300包括支架本体310及覆膜340。Referring to FIGS. 7 and 8 , the stent graft 300 of one embodiment includes a stent body 310 and a coating 340 .
支架本体310包括波圈312。波圈312为合金丝编织波圈或切割金属波圈。在图示的实施方式中,波圈312由钛镍合金丝编织定型而成。波圈312的横截面为圆形。The bracket body 310 includes a wave ring 312. The wave ring 312 is an alloy wire braided wave ring or a cut metal wave ring. In the illustrated embodiment, the coil 312 is woven from a titanium-nickel alloy wire. The cross section of the wave ring 312 is circular.
在其中一个实施例中,支架本体310大致呈圆筒形,多个波圈312沿支架本体310的轴向方向间隔设置。当然,在其他实施方式中,支架本体310的结构并不局限于此。例如,支架本体310还包括及连接相邻两个波圈312之间的连接杆(图未示),两个相邻波圈312之间通过至少一个连接杆连接。波圈312之间的间距相等,当然,波圈312之间的间距也可以不相等。In one of the embodiments, the bracket body 310 is substantially cylindrical, and the plurality of coils 312 are spaced apart in the axial direction of the bracket body 310. Of course, in other embodiments, the structure of the bracket body 310 is not limited thereto. For example, the bracket body 310 further includes a connecting rod (not shown) connected between the adjacent two coils 312. The two adjacent coils 312 are connected by at least one connecting rod. The spacing between the turns 312 is equal. Of course, the spacing between the turns 312 may also be unequal.
在图示的实施方式中,波圈312为Z型波圈。波圈312包括波峰3121、波谷3123及侧杆3125。侧杆3125连接相邻的波峰3123及波谷3125。In the illustrated embodiment, the coil 312 is a Z-shaped coil. The wave circle 312 includes a peak 3121, a trough 3123, and a side bar 3125. The side bars 3125 connect adjacent peaks 3123 and troughs 3125.
支架本体310具有第一表面及与第一表面相对的第二表面。在图示的实施方式中,第一表面指的是支架本体310的外表面,第二表面指的是支架本体310的内表面。The bracket body 310 has a first surface and a second surface opposite the first surface. In the illustrated embodiment, the first surface refers to the outer surface of the stent body 310 and the second surface refers to the inner surface of the stent body 310.
覆膜340包括第一膜片341、第二膜片343及连接件345。覆膜340的材料为膨胀聚四氟乙烯。优选的,第一膜片341、第二膜片343及连接件345的材料为同种材料,这样方便实现覆膜340的热熔粘合。当然,在其他实施例中,第一膜片341、第二膜片343及连接件345的材料能够相互融合粘结且熔点相近即可。可以理解的是,连接件345还可以为涂覆在支架本体310上的胶黏剂形成的包膜,以增加支架本体310与覆膜340的结合强度。例如,连接件345的材料为聚全氟乙丙烯(FEP)。The film 340 includes a first diaphragm 341, a second diaphragm 343, and a connector 345. The material of the film 340 is expanded polytetrafluoroethylene. Preferably, the materials of the first diaphragm 341, the second diaphragm 343 and the connecting member 345 are the same material, which facilitates the hot melt bonding of the coating 340. Of course, in other embodiments, the materials of the first diaphragm 341, the second diaphragm 343, and the connecting member 345 can be fused and bonded to each other with a similar melting point. It can be understood that the connecting member 345 can also be an envelope formed by an adhesive coated on the bracket body 310 to increase the bonding strength of the bracket body 310 and the coating film 340. For example, the material of the connector 345 is polyperfluoroethylene propylene (FEP).
第一膜片341设于支架本体310的第一表面,第二膜片343设于支架本体310的第二表面,从而将支架本体310及连接件345夹持于第一膜片341及第二膜片343之间。在图示的实施方式中,第一膜片341及第二膜片343的厚度相同。The first diaphragm 341 is disposed on the first surface of the bracket body 310, and the second diaphragm 343 is disposed on the second surface of the bracket body 310, thereby clamping the bracket body 310 and the connecting member 345 to the first diaphragm 341 and the second Between the diaphragms 343. In the illustrated embodiment, the first diaphragm 341 and the second diaphragm 343 have the same thickness.
请同时参阅图9,连接件345为包裹波圈312的包膜。在图示的实施方式中,连接件345绕设于波圈312的金属丝形成包膜。连接件345螺旋缠绕于波圈312的金属丝形成包膜从而固定至波圈312。在图示的实施方式中,螺旋缠绕的条纹3451之间平齐、无交叠且无间隙,从而保证形成的包膜平滑无突起。从而,通过热熔可以将连接件345与第一膜片341及第二膜片343粘合在一起,连接件345热熔形成包裹波圈312的包膜。需要说明的是,连接件345的数量没有限定,可以通过一个连接件345缠绕波圈312形成包膜,也可以使用多个连接件345缠绕波圈312形成包膜。可以理解的是,在其他实施例中,也可以将金属丝插入膨体聚四氟乙烯软管中再编织波圈。Referring also to FIG. 9 , the connector 345 is a wrap that wraps the coil 312 . In the illustrated embodiment, the connector 345 forms an envelope around the wire of the coil 312. The wire of the connecting member 345 spirally wound around the coil 312 forms an envelope to be fixed to the coil 312. In the illustrated embodiment, the spirally wound strips 3451 are flush, non-overlapping, and free of gaps, thereby ensuring that the formed envelope is smooth and free of protrusions. Thus, the connector 345 can be bonded to the first diaphragm 341 and the second diaphragm 343 by heat fusion, and the connector 345 is thermally fused to form a coating covering the coil 312. It should be noted that the number of the connecting members 345 is not limited, and the envelope 345 may be wound by one connecting member 345 to form a coating film, or the plurality of connecting members 345 may be wound around the wave ring 312 to form a coating film. It will be appreciated that in other embodiments, the wire may be inserted into the expanded polytetrafluoroethylene hose to re-wrap the coil.
连接件345缠绕波圈312形成的包膜的厚度会影响支架本体310与第一膜片341及第二膜片343的结合强度,包膜厚度越大,包膜与第一膜片341及第二膜片343的结合强度越好。优选的,第一膜片341及第二膜片343的厚度之 和与包膜的厚度比为4:1~20:1。The thickness of the envelope formed by the connecting member 345 wound with the wave ring 312 affects the bonding strength between the bracket body 310 and the first diaphragm 341 and the second diaphragm 343. The larger the coating thickness, the larger the envelope and the first diaphragm 341 and the The bonding strength of the two sheets 343 is better. Preferably, the ratio of the sum of the thicknesses of the first diaphragm 341 and the second diaphragm 343 to the thickness of the envelope is 4:1 to 20:1.
需要特别说明的是,较厚的包膜将会影响支架本体310的抗压强度。因此,优选的,波峰3121及波谷3123表面的包膜的厚度小于侧杆3125表面的包膜的厚度,从而保证包膜与第一膜片341及第二膜片343的结合强度的同时,减少包膜对支架本体310的抗压强度的影响。第一膜片341及第二膜片343的厚度之和与波峰3121及波谷3123表面的包膜的厚度比大于8:1,第一膜片341及第二膜片343的厚度之和侧杆3125表面的包膜的厚度比为2:1~6:1。在其中一个实施例中,波峰及波谷处的包膜的厚度与侧杆处的包膜的厚度的比为1:1.5~1:3。可以理解的是,在一实施方式中,也可以仅在波圈的侧杆处设置有包膜,在波圈的波峰和波谷处无包膜。还可以理解的是,可以根据对覆膜支架300的性能的特殊要求,在波圈312的金属丝表面的轴向设置不同厚度的包膜。还可以理解的是,还可以在波圈312的金属丝周向方向设置不同的包膜厚度。例如,波圈312的金属丝的两个侧面处的包膜的厚度大于第一表面与第二表面处的厚度。需要说明的是,两个侧面是指与第一表面及第二表面垂直的面。优选的,波圈312的金属丝的两个侧面处的包膜的厚度与金属丝的第一表面与第二表面之间的距离的比值为2:1~4:1,以进一步增加金属丝与覆膜的连接强度。It should be particularly noted that a thicker envelope will affect the compressive strength of the stent body 310. Therefore, it is preferable that the thickness of the envelope on the surface of the peak 3121 and the trough 3123 is smaller than the thickness of the envelope on the surface of the side bar 3125, thereby ensuring the bonding strength of the envelope to the first diaphragm 341 and the second diaphragm 343 while reducing The effect of the envelope on the compressive strength of the stent body 310. The ratio of the sum of the thicknesses of the first diaphragm 341 and the second diaphragm 343 to the thickness of the envelope of the peaks 3121 and the valleys 3123 is greater than 8:1, and the sum of the thicknesses of the first diaphragm 341 and the second diaphragm 343 is the sidebar The thickness ratio of the envelope of the 3125 surface is 2:1 to 6:1. In one of the embodiments, the ratio of the thickness of the envelope at the crests and troughs to the thickness of the envelope at the side bars is 1:1.5 to 1:3. It can be understood that, in an embodiment, the envelope may be provided only at the side bars of the coil, and there is no envelope at the crests and troughs of the coils. It will also be appreciated that envelopes of different thicknesses may be disposed in the axial direction of the surface of the wire of the coil 312, depending on the particular requirements for the performance of the stent graft 300. It will also be appreciated that different envelope thicknesses may also be provided in the circumferential direction of the wire of the coil 312. For example, the thickness of the envelope at both sides of the wire of the coil 312 is greater than the thickness at the first surface and the second surface. It should be noted that the two sides refer to a surface perpendicular to the first surface and the second surface. Preferably, the ratio of the thickness of the envelope at the two sides of the wire of the coil 312 to the distance between the first surface and the second surface of the wire is from 2:1 to 4:1 to further increase the wire. The strength of the connection to the film.
请同时参阅图10及图11,在图示的实施方式中,连接件345螺旋缠绕于波圈312的金属丝形成包膜,且螺旋缠绕形成的条纹之间形成有间隙,连接件345包裹波圈形成的包膜覆盖波圈部分表面,当然,当间隙较小时,连接件345热熔后形成的包膜也可以完全覆盖波圈312的表面。当然,在满足一定条件下,间隙也可以较大,连接件345也可以在金属丝表面形成不连续的包膜。Referring to FIG. 10 and FIG. 11 simultaneously, in the illustrated embodiment, the connecting member 345 is spirally wound around the wire of the wave ring 312 to form a coating, and a gap formed by the spiral winding is formed with a gap, and the connecting member 345 wraps the wave ring. The formed envelope covers the surface of the coil portion. Of course, when the gap is small, the envelope formed by the fusion of the connecting member 345 can completely cover the surface of the coil 312. Of course, the gap can also be large under certain conditions, and the connecting member 345 can also form a discontinuous envelope on the surface of the wire.
请参阅图12,通过覆膜工艺将第一膜片341、第二膜片343及连接件345,热熔粘合后,连接件345热熔包覆在支架本体310表面形成包膜,连接件345填补了第一膜片341及第二膜片343之间的空隙,使支架本体310在覆膜340内充分固定,支架本体310与覆膜340的连接强度大大提高,保证了覆膜支架300的稳定性及安全性。Referring to FIG. 12, after the first diaphragm 341, the second diaphragm 343 and the connecting member 345 are thermally fusion-bonded by the laminating process, the connecting member 345 is hot-melted and coated on the surface of the bracket body 310 to form a coating. 345 fills the gap between the first diaphragm 341 and the second diaphragm 343, so that the bracket body 310 is fully fixed in the coating 340, and the connection strength between the bracket body 310 and the coating 340 is greatly improved, and the stent graft 300 is ensured. Stability and safety.
上述覆膜支架300,在受到外力的作用下,支架本体310通过连接件345与第一膜片341及第二膜片343粘合固定,从而不易在第一膜片341及第二膜片 343之间发生松动,降低了覆膜支架300在受力或变形时支架本体310的移位造成覆膜支架300失效的风险。The stent body 300 is bonded and fixed to the first diaphragm 341 and the second diaphragm 343 by the connecting member 345 under the action of an external force, so that the first diaphragm 341 and the second diaphragm 343 are not easily adhered. Loosening occurs between them, reducing the risk of failure of the stent graft 300 due to displacement of the stent body 310 when the stent graft 300 is stressed or deformed.
请参阅图13及图14,另一实施方式的覆膜支架400的结构与覆膜支架300的结构大致相同,其不同在于:覆膜支架400的支架本体410为切割金属支架,连接件445为涂覆在支架本体410表面的涂层形成的包膜。Referring to FIG. 13 and FIG. 14 , the structure of the stent graft 400 of another embodiment is substantially the same as that of the stent graft 300 . The difference is that the stent body 410 of the stent graft 400 is a cut metal stent, and the connecting member 445 is An envelope formed by a coating applied to the surface of the stent body 410.
在图示的实施方式中,覆膜支架400为不锈钢球扩覆膜支架,支架本体410的波圈412为由金属激光雕刻制备得到的切割金属波圈。波圈412的横截面为矩形。优选的,矩形的四个角为圆角。In the illustrated embodiment, the stent graft 400 is a stainless steel ball expanded membrane stent, and the coil 412 of the stent body 410 is a cut metal coil prepared by metal laser engraving. The cross section of the wave ring 412 is rectangular. Preferably, the four corners of the rectangle are rounded.
在其中一个实施例中,连接件445为通过喷涂的方式形成的涂层,涂层附着在波圈412的表面形成包膜。连接件445的材料优选为膨体聚四氟乙烯。In one of the embodiments, the connector 445 is a coating formed by spraying, and the coating adheres to the surface of the coil 412 to form a coating. The material of the connecting member 445 is preferably expanded polytetrafluoroethylene.
在其中一个实施例中,第一膜片441及第二膜片445的厚度之和与包膜的厚度比为4:1~20:1。In one embodiment, the thickness of the first film 441 and the second film 445 is 4:1 to 20:1.
在其中一个实施例中,波峰4121及波谷4123表面的包膜的厚度小于侧杆3125表面的包膜的厚度。优选的,第一膜片341及第二膜片443的厚度之和与波峰4121及波谷4123表面的包膜的厚度比为大于8:1,第一膜片441及第二膜片443的厚度之和侧杆4125表面的包膜的厚度比为2:1~6:1。In one of the embodiments, the thickness of the envelope of the surface of the peak 4121 and the valley 4123 is less than the thickness of the envelope of the surface of the sidebar 3125. Preferably, the ratio of the sum of the thicknesses of the first diaphragm 341 and the second diaphragm 443 to the thickness of the envelope of the peaks 4121 and the valleys 4123 is greater than 8:1, and the thicknesses of the first diaphragm 441 and the second diaphragm 443 are The thickness ratio of the envelope on the surface of the side bar 4125 is 2:1 to 6:1.
上述覆膜支架400,先在支架本体410的表面制备涂层得到连接件445,通过覆膜工艺将第一膜片441、第二膜片443及连接件445,热熔粘合后,连接件445热熔包覆在支架本体410表面形成包膜,连接件445填补了第一膜片441及第二膜片443之间的空隙,使支架本体410在覆膜440内充分固定,支架本体410与覆膜440的连接强度大大提高,保证了覆膜支架400的稳定性及安全性。In the above-mentioned stent graft 400, a coating is prepared on the surface of the stent body 410 to obtain a connecting member 445, and the first diaphragm 441, the second diaphragm 443 and the connecting member 445 are thermally fusion-bonded by a laminating process, and the connecting member is connected. The 445 hot-melt coating forms a coating on the surface of the bracket body 410, and the connecting member 445 fills the gap between the first diaphragm 441 and the second diaphragm 443, so that the bracket body 410 is sufficiently fixed in the coating 440. The bracket body 410 The connection strength with the film 440 is greatly improved, and the stability and safety of the film stent 400 are ensured.
上述覆膜支架400,在受到外力的作用下,支架本体410通过连接件445与第一膜片441及第二膜片443粘合固定,从而不易在第一膜片441及第二膜片443之间发生松动,降低了覆膜支架400在受力或变形时支架本体410的移位造成覆膜支架400失效的风险。The stent graft 400 is bonded and fixed to the first diaphragm 441 and the second diaphragm 443 by the connecting member 445 under the action of an external force, so that the first diaphragm 441 and the second diaphragm 443 are not easily attached. Loosening occurs between them, reducing the risk of failure of the stent graft 400 due to displacement of the stent body 410 when the stent graft 400 is stressed or deformed.
请参阅图15及图16,另一实施方式的覆膜支架500的结构与覆膜支架400的结构大致相同,其不同在于:覆膜支架500的波圈512的表面形成有凹槽5121。Referring to FIGS. 15 and 16 , the structure of the stent graft 500 of another embodiment is substantially the same as that of the stent graft 400 , except that the surface of the coil 512 of the stent graft 500 is formed with a groove 521.
在图示的实施方式中,凹槽5121自波圈512的第一表面向内凹陷形成,当 然在其他实施方式中,凹槽5121还可以自波圈512的第二表面向内凹陷形成,或者波圈512的第一表面及第二表面均形成有凹槽。In the illustrated embodiment, the recess 5121 is recessed inwardly from the first surface of the coil 512. Of course, in other embodiments, the recess 5121 may also be recessed inward from the second surface of the coil 512, or The first surface and the second surface of the wave ring 512 are each formed with a groove.
在图示的实施方式中,凹槽5121为盲槽,当然在其他实施方式中,凹槽5121还可以为通槽,凹槽5121贯穿第一表面及第二表面。In the illustrated embodiment, the recess 5121 is a blind slot. Of course, in other embodiments, the recess 5121 can also be a through slot, and the recess 5121 extends through the first surface and the second surface.
请同时参阅图15、图17及图18,当在波圈512的表面喷涂形成包裹波圈512的包膜作为连接件545时,涂层的材料填充凹槽5121,从而可以增加连接件545与波圈512之间的粘合力,收容在凹槽5121的部分成为连接件545与波圈512连接的锚定点,当连接件545与第一膜片541及第二膜片543通过热熔粘合时,支架本体与第一膜片541及第二膜片543的连接更稳固。Referring to FIG. 15 , FIG. 17 and FIG. 18 , when the surface of the wave ring 512 is sprayed to form the envelope enclosing the wave ring 512 as the connecting member 545 , the material of the coating fills the groove 5121 , so that the connecting member 545 can be added. The adhesive force between the wave ring 512, the portion received in the groove 5121 becomes an anchor point connecting the connecting member 545 and the wave ring 512, and the connecting member 545 and the first diaphragm 541 and the second diaphragm 543 are thermally melt-bonded. In time, the connection between the bracket body and the first diaphragm 541 and the second diaphragm 543 is more stable.
可以理解,连接件545不限于为通过喷涂形成的包覆波圈512的包膜,在其他实施方式中,连接件545还可以为螺旋缠绕于波圈512的包膜,此时,对覆膜进行热压处理后,连接件545、第一膜片541及第二膜片543热熔填充凹槽5121即可。当然,还可以理解,涂覆在波圈512的涂层也可以省略,对覆膜进行热压处理后,第一膜片541及第二膜片543热熔后填充凹槽5121形成收容于凹槽的凸起作为连接件,此时连接件收容并固定于凹槽,成为覆膜与波圈512连接的锚定点。当受到外力的作用下,支架本体510通过连接件545与第一膜片541及第二膜片543粘合固定,从而不易在第一膜片541及第二膜片543之间发生松动,降低了覆膜支架500在受力或变形时支架本体510的移位造成覆膜支架500失效的风险。It can be understood that the connecting member 545 is not limited to the envelope of the coated wave ring 512 formed by spraying. In other embodiments, the connecting member 545 may also be spirally wound around the envelope of the wave ring 512. After the hot pressing process, the connecting member 545, the first diaphragm 541 and the second diaphragm 543 are hot-melted to fill the recess 5121. Of course, it can be understood that the coating applied to the wave ring 512 can also be omitted. After the hot pressing treatment of the coating film, the first film piece 541 and the second film piece 543 are melted and filled into the groove 5121 to be received in the concave shape. The protrusion of the groove serves as a connecting member, and the connecting member is received and fixed to the groove at this time, and becomes an anchor point connecting the film and the coil 512. When the external force is applied, the bracket body 510 is adhered and fixed to the first diaphragm 541 and the second diaphragm 543 through the connecting member 545, so that loosening between the first diaphragm 541 and the second diaphragm 543 is not easy, and the reduction is reduced. The displacement of the stent body 510 when the stent graft 500 is stressed or deformed poses a risk of failure of the stent graft 500.
上述的覆膜支架的制备方法,包括以下步骤:The method for preparing the above-mentioned stent graft comprises the following steps:
步骤S710、提供支架本体。Step S710, providing a stent body.
支架本体具有第一表面及与第一表面相对的第二表面。支架本体包括波圈。The bracket body has a first surface and a second surface opposite the first surface. The bracket body includes a wave ring.
在其中一个实施例中,支架本体的第一表面及所述第二表面中的至少一个向内凹陷形成凹槽。In one of the embodiments, at least one of the first surface and the second surface of the stent body is recessed inwardly to form a groove.
步骤S720、在支架本体上形成包裹支架本体的连接件。Step S720, forming a connector for wrapping the bracket body on the bracket body.
在其中一个实施例中,将连接件缠绕于支架本体形成包裹支架本体的包膜。优选的,连接件螺旋缠绕于波圈。进一步优选的,螺旋缠绕于波圈的连接件形成的条纹之间平齐、无交叠且无间隙从而保证形成的包膜平滑无突起。当然, 在其他实施方式中,螺旋缠绕于波圈的连接件形成的条纹之间形成有间隙。In one of the embodiments, the connector is wrapped around the stent body to form a wrap that surrounds the stent body. Preferably, the connector is spirally wound around the coil. Further preferably, the strips formed by the connectors wound by the coils are flush, non-overlapping, and free of gaps to ensure smooth formation of the envelope without protrusions. Of course, in other embodiments, a gap is formed between the stripes formed by the connectors spirally wound around the coil.
进一步的,波峰及波谷表面的连接件的厚度小于侧杆表面的连接件的厚度。可以理解的是,在一实施方式中,也可以仅在波圈的侧杆处缠绕连接件,在波圈的波峰和波谷处不缠绕。Further, the thickness of the connector of the peak and trough surface is less than the thickness of the connector of the side bar surface. It will be appreciated that in one embodiment it is also possible to wrap the connector only at the side bars of the coil, not at the crests and troughs of the wave ring.
在其中一个实施例中,在支架本体表面形成涂层得到连接件。优选的,通过喷涂、旋涂或刮涂浆料形成涂层得到连接件。在其中一个实施例中,波峰及波谷表面的涂层的厚度小于侧杆表面的涂层的厚度。可以理解的是,在一实施方式中,也可以仅在波圈的侧杆处涂覆涂层,在波圈的波峰和波谷处无涂层。还可以理解的是,也可以在波圈的周向方向上设置不同的涂层厚度。例如,波圈的金属丝的两个侧面处的厚度与第一表面及第二表面处的涂层的厚度大。优选的,在波圈金属丝的两个侧面处的涂层的厚度为金属丝第一表面与第二表面之间的距离的比值为2:1~4:1。In one of the embodiments, a coating is formed on the surface of the stent body to obtain a connector. Preferably, the coating is obtained by spraying, spin coating or knife coating to form a coating. In one of the embodiments, the thickness of the coating of the crest and trough surface is less than the thickness of the coating of the side bar surface. It will be appreciated that in one embodiment, it is also possible to apply the coating only at the side bars of the coils, without coating at the crests and troughs of the coils. It will also be appreciated that different coating thicknesses may also be provided in the circumferential direction of the coil. For example, the thickness at both sides of the wire of the coil is greater than the thickness of the coating at the first and second surfaces. Preferably, the thickness of the coating at both sides of the coiled wire is a ratio of the distance between the first surface of the wire and the second surface of from 2:1 to 4:1.
在其中一个实施例中,连接件为套设于支架的波圈的软管。In one of the embodiments, the connector is a hose that is sleeved over the coil of the stent.
在其中一个实施例中,连接件的材料为膨体聚四氟乙烯。在其他实施方式中,连接件的材料还可以为胶粘剂,比如聚全氟乙丙烯(FEP)。In one of the embodiments, the material of the connector is expanded polytetrafluoroethylene. In other embodiments, the material of the connector may also be an adhesive such as polyperfluoroethylene propylene (FEP).
步骤S730、将第一膜片设于支架本体的第一表面,将第二膜片设于支架本体的第二表面,对第一膜片及第二膜片进行热处理使第一膜片与第二膜片粘合固定。Step S730, the first diaphragm is disposed on the first surface of the bracket body, the second diaphragm is disposed on the second surface of the bracket body, and the first diaphragm and the second diaphragm are heat treated to make the first diaphragm and the first diaphragm The two membranes are adhesively fixed.
第一膜片及第二膜片的材料为膨体聚四氟乙烯,第一膜片、第二膜片及连接件的材料相同。当然,在其他实施方式中,第一膜片及第二膜片中的至少一个与连接件的材料相同即可。可以理解,连接件的材料为胶粘剂时,连接件的材料可以与第一膜片及第二膜片的材料不同。The material of the first diaphragm and the second diaphragm is expanded polytetrafluoroethylene, and the materials of the first diaphragm, the second diaphragm and the connecting member are the same. Of course, in other embodiments, at least one of the first diaphragm and the second diaphragm may be the same material as the connector. It can be understood that when the material of the connecting member is an adhesive, the material of the connecting member may be different from the materials of the first diaphragm and the second diaphragm.
该步骤中,对第一膜片及第二膜片进行热处理使第一膜片与第二膜片热熔粘合,同时第一膜片、第二膜片与连接件热熔粘合。在支架本体表面形成有凹槽的情况下,缠绕于支架本体的连接件热熔填充凹槽。In this step, the first film and the second film are heat-treated to thermally bond the first film and the second film, and the first film and the second film are thermally bonded to the connecting member. In the case where a groove is formed on the surface of the stent body, the connector wound around the stent body is thermally melted to fill the groove.
上述覆膜支架的制备方法操作简单,制备得到的覆膜支架能提高覆膜与支架之间连接强度。The preparation method of the above-mentioned stent graft is simple in operation, and the prepared stent graft can improve the joint strength between the membrane and the stent.
可以理解,支架本体表面的凹槽可以省略,直接在支架本体形成包膜同样 可以提高覆膜与支架之间连接强度。步骤S720可以省略,直接在表面有凹槽的支架本体的第一表面设置第一膜片,将第二膜片设于支架本体的第二表面,对第一膜片及第二膜片进行热处理使第一膜片与第二膜片粘合固定即可,此时覆盖在凹槽表面的第一膜片及第二膜片中的至少一个热熔后填充凹槽得到收容并固定于凹槽的连接件。当然,为了更好的填充凹槽,可以在第一膜片及第二膜片中的至少一个的表面设置于凹槽对应的凸起,热熔后,凸起收容并固定于凹槽形成连接件。需要说明的是,凹槽可以为通槽,贯穿波圈的第一表面及第二表面,第一膜片及第二膜片进行热熔后填充凹槽得到同时与第一膜片及第二膜片固接的连接件。It can be understood that the groove of the surface of the bracket body can be omitted, and forming the envelope directly on the body of the bracket can also improve the connection strength between the film and the bracket. Step S720 can be omitted. The first diaphragm is directly disposed on the first surface of the bracket body having the groove on the surface, and the second diaphragm is disposed on the second surface of the bracket body to heat treat the first diaphragm and the second diaphragm. The first film and the second film are bonded and fixed, and at least one of the first film and the second film covering the surface of the groove is filled and fixed in the groove. Connector. Of course, in order to better fill the groove, the surface of at least one of the first diaphragm and the second diaphragm may be disposed on the corresponding protrusion of the groove. After the heat fusion, the protrusion is received and fixed to the groove to form a connection. Pieces. It should be noted that the groove may be a through groove, penetrate the first surface and the second surface of the wave ring, and the first film and the second film are hot-melted and filled into the groove to obtain the first film and the second film simultaneously Membrane-attached connector.
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。The technical features of the above-described embodiments may be arbitrarily combined. For the sake of brevity of description, all possible combinations of the technical features in the above embodiments are not described. However, as long as there is no contradiction between the combinations of these technical features, All should be considered as the scope of this manual.
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。The above-described embodiments are merely illustrative of several embodiments of the present invention, and the description thereof is more specific and detailed, but is not to be construed as limiting the scope of the invention. It should be noted that a number of variations and modifications may be made by those skilled in the art without departing from the spirit and scope of the invention. Therefore, the scope of the invention should be determined by the appended claims.

Claims (10)

  1. 一种覆膜支架,包括支架本体及覆膜,所述支架本体具有第一表面及与所述第一表面相对的第二表面,所述覆膜包括第一膜片及第二膜片,所述第一膜片设于所述第一表面,所述第二膜片设于所述第二表面且与所述第一膜片粘合,其特征在于,所述覆膜还包括与所述支架本体固接的连接件,所述连接件位于所述第一膜片及所述第二膜片之间,所述连接件与所述第一膜片及所述第二膜片中的至少一个粘合。A stent graft comprising a stent body and a coating, the stent body having a first surface and a second surface opposite to the first surface, the coating comprising a first membrane and a second membrane The first film is disposed on the first surface, and the second film is disposed on the second surface and bonded to the first film, wherein the film further comprises a connector body fixed to the bracket body, the connecting member is located between the first diaphragm and the second diaphragm, and the connecting member is at least at least one of the first diaphragm and the second diaphragm One bond.
  2. 根据权利要求1所述的覆膜支架,其特征在于,所述连接件为包裹所述支架本体的包膜。The stent graft of claim 1 wherein said connector is an envelope encasing said stent body.
  3. 根据权利要求2所述的覆膜支架,其特征在于,所述第一膜片及所述第二膜片的厚度之和与所述包膜的厚度比为4:1~20:1。The stent graft according to claim 2, wherein a ratio of a thickness of the first membrane and the second membrane to a thickness of the envelope is 4:1 to 20:1.
  4. 根据权利要求2所述的覆膜支架,其特征在于,所述支架本体包括波圈,所述波圈包括波峰、波谷及侧杆,所述侧杆连接所述波峰及波谷,所述波峰及所述波谷表面的包膜的厚度小于所述侧杆表面的包膜的厚度。The stent graft according to claim 2, wherein the stent body comprises a wave ring, the wave circle comprises a wave crest, a trough and a side bar, the side bar connecting the crest and the trough, the crest and The thickness of the envelope of the trough surface is less than the thickness of the envelope of the side rod surface.
  5. 根据权利要求1所述的覆膜支架,其特征在于,所述第一表面及所述第二表面中的至少一个向内凹陷形成凹槽,所述连接件收容于并固定于所述凹槽。The stent graft according to claim 1, wherein at least one of the first surface and the second surface is recessed inwardly to form a groove, and the connecting member is received in and fixed to the groove. .
  6. 根据权利要求1所述的覆膜支架,其特征在于,所述连接件的材料与所述第一膜片和/或所述第二膜片的材料相同。The stent graft of claim 1 wherein the material of the connector is the same as the material of the first membrane and/or the second membrane.
  7. 权利要求1所述的覆膜支架的制备方法,其特征在于,包括以下步骤:The method for preparing a stent graft according to claim 1, comprising the steps of:
    在所述支架本体上形成包裹所述支架本体的连接件;及Forming a connector covering the bracket body on the bracket body; and
    将所述第一膜片设于所述支架本体的第一表面,将所述第二膜片设于所述支架本体的第二表面,对所述第一膜片及所述第二膜片进行热处理使所述第一膜片、第二膜片及所述连接件粘合固定。The first diaphragm is disposed on the first surface of the bracket body, and the second diaphragm is disposed on the second surface of the bracket body, the first diaphragm and the second diaphragm The first film, the second film, and the connecting member are bonded and fixed by heat treatment.
  8. 根据权利要求8所述的覆膜支架的制备方法,其特征在于,所述在所述支架本体上形成包裹所述支架本体的连接件的步骤具体为:将所述连接件缠绕于所述支架本体形成包裹所述支架本体的包膜。The method for manufacturing a stent graft according to claim 8, wherein the step of forming a connector covering the stent body on the stent body is specifically: winding the connector around the stent The body forms an envelope encasing the stent body.
  9. 根据权利要求8所述的覆膜支架的制备方法,其特征在于,所述在所述支架本体上形成包裹所述支架本体的连接件的步骤具体为:在所述支架本体表 面形成涂层得到所述连接件。The method for preparing a stent graft according to claim 8, wherein the step of forming a connector covering the stent body on the stent body is specifically: forming a coating on the surface of the stent body The connector.
  10. 权利要求1所述的覆膜支架的制备方法,其特征在于,包括以下步骤:The method for preparing a stent graft according to claim 1, comprising the steps of:
    提供所述支架本体,所述支架本体的所述第一表面及所述第二表面中的至少一个向内凹陷形成凹槽;Providing the bracket body, at least one of the first surface and the second surface of the bracket body is recessed inward to form a groove;
    将所述第一膜片设于所述支架本体的第一表面,将所述第二膜片设于所述支架本体的第二表面,对所述第一膜片及所述第二膜片进行热处理使所述第一膜片与第二膜片粘合固定,所述第一膜片及所述第二膜片中的至少一个热处理后填充所述凹槽得到收容并固定于所述凹槽的连接件。The first diaphragm is disposed on the first surface of the bracket body, and the second diaphragm is disposed on the second surface of the bracket body, the first diaphragm and the second diaphragm Performing a heat treatment to bond the first film to the second film, and at least one of the first film and the second film is filled with the groove after heat treatment to be received and fixed to the concave The connector of the slot.
PCT/CN2018/102827 2017-08-30 2018-08-29 Covered stent and preparation method therefor WO2019042302A1 (en)

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