WO2023104157A1 - 一种气道支架 - Google Patents

一种气道支架 Download PDF

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Publication number
WO2023104157A1
WO2023104157A1 PCT/CN2022/137589 CN2022137589W WO2023104157A1 WO 2023104157 A1 WO2023104157 A1 WO 2023104157A1 CN 2022137589 W CN2022137589 W CN 2022137589W WO 2023104157 A1 WO2023104157 A1 WO 2023104157A1
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WO
WIPO (PCT)
Prior art keywords
stent
segment
airway
lumbar
mesh
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2022/137589
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English (en)
French (fr)
Inventor
胡龙虎
李安宁
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shenzhen Lifetech Respiration Scientific Co Ltd
Original Assignee
Shenzhen Lifetech Respiration Scientific Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202111510933.1A external-priority patent/CN116250963A/zh
Priority claimed from CN202111510932.7A external-priority patent/CN116250962A/zh
Priority claimed from CN202111510936.5A external-priority patent/CN116250964B/zh
Application filed by Shenzhen Lifetech Respiration Scientific Co Ltd filed Critical Shenzhen Lifetech Respiration Scientific Co Ltd
Priority to US18/716,866 priority Critical patent/US20250312135A1/en
Priority to EP22903576.1A priority patent/EP4445869A4/en
Publication of WO2023104157A1 publication Critical patent/WO2023104157A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • 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
    • 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
    • A61F2002/043—Bronchi
    • 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
    • A61F2002/046—Tracheae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0006—Rounded shapes, e.g. with rounded corners circular
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/001—Figure-8-shaped, e.g. hourglass-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0023—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Definitions

  • the invention belongs to the technical field of medical devices, and in particular relates to an airway stent.
  • airway metal stent is an important means of treating tracheal and bronchial stenosis, which can quickly rebuild the airway and relieve symptoms such as dyspnea.
  • airway stents can be divided into metal stents and non-metallic stents, and metal stents are further divided into covered stents and bare stents according to whether they are covered or not.
  • the early airway stents mainly used bare metal stents, and the bare metal stents mainly used nickel-titanium memory alloy mesh stents.
  • the mesh space of the bare metal stent is large, it cannot prevent tumor or granulation tissue from growing along the mesh, and malignant tumors are likely to grow into the lumen of the stent and cause airway restenosis. Therefore, bare metal stents can only be placed for a short period of time to relieve airway obstruction, and should not be placed for too long.
  • a covered stent has appeared in the prior art.
  • a covered stent is added with a layer of film on the basis of the bare stent, and the film is used to prevent tumor growth from entering the stent. Since the film has less stimulation to the inner wall of the airway, it can effectively reduce the hyperplasia of granulation tissue.
  • the covered stent prevents the mucociliary function of the airway stent, making it difficult to clean the secretions in the airway, resulting in the retention of secretions at both ends of the airway, leading to complications such as cough and pneumonia in patients.
  • the purpose of the present invention is to at least solve the problem that the existing metal-covered stent is easy to irritate the inner wall of the airway, thus increasing the hyperplasia of granulation tissue.
  • the present invention proposes an airway stent, which includes a stent body and a covering film arranged on the stent body, wherein the stent body includes a lumbar stent segment and a dense mesh bare stent segment arranged at the end of the lumbar stent segment.
  • the covering film is arranged on the lumbar support segment, and the mesh density of the dense mesh bare stent segment is greater than that of the lumbar support segment.
  • a coating film is arranged on the lumbar support section, and the irritation caused by the lumbar stent section to the inner wall of the airway is reduced by the film coating, and then a dense net bare stent section is set at the end of the lumbar stent section, and the dense mesh
  • the aperture of the mesh-bare stent section is smaller than that of the lumbar stent section; therefore, the airway stent of the present invention increases the density of the dense-mesh bare stent while ensuring the anchoring force between the dense-mesh bare stent section and the inner wall of the airway.
  • the contact area between the stent segment and the inner wall of the airway reduces the pressure per unit area of the inner wall of the airway, making the inner wall of the airway less irritated, and because the two ends of the lumbar stent segment adopt the design of the dense mesh bare stent segment , There will be no secretion retention at both ends of the airway stent; Stimulation of the inner wall, thereby reducing the hyperplasia of granulation tissue and avoiding the occurrence of airway re-narrowing.
  • airway stent according to the present invention may also have the following additional technical features:
  • the dense-mesh bare stent segment includes a single-layer densely woven mesh structure or a multi-layer woven mesh structure.
  • the dense mesh bare stent segment includes an inner support net and an outer support net
  • one end of the inner support net is connected to the waist support segment, and the inner support net
  • the other end of the net is connected to the outer support net; or one end of the outer support net is connected to the waist support segment, and the other end of the outer support net is connected to the inner support net.
  • the inner support net is integrally formed with the lumbar support section, and the end of the inner support net is turned outward and folded back to form the outer support net.
  • the inner support net is connected with the outer support net through folded ends.
  • the folded end protrudes in a direction away from the stent body relative to the outer support net; at least one raised point support portion is provided on the outer support net , the shape of the bump support portion is the same as or different from that of the folded end portion.
  • an interlayer film is arranged between the inner support net and the outer support net.
  • the covering film includes an outer membrane disposed on the outer surface of the lumbar support segment and an inner membrane disposed on the inner surface of the lumbar support segment, the inner membrane and the outer membrane The membrane is bonded and fixed through the mesh of the lumbar support segment.
  • the stent body is also provided with an extension film covering the inner surface of the dense mesh bare stent segment.
  • the lumbar support segment is provided with sutures for increasing the connection strength between the membrane and the lumbar support segment.
  • a recovery line is provided on the dense mesh bare stent segment at one end of the stent body, and the recovery line passes along the edge of the dense mesh bare stent segment.
  • Figure 1 is a schematic diagram of the overall structure of the airway stent in Embodiment 1 of the present invention.
  • FIG. 2 is a schematic structural view of the stent body in Embodiment 1 of the present invention.
  • Fig. 3 is a cross-sectional view of the stent main body in Embodiment 1 of the present invention.
  • Fig. 4 is a schematic diagram of the airway stent implanted in the airway in Embodiment 1 of the present invention.
  • Figure 5 is a schematic diagram of the growth of granulation on the inner wall of the airway in Example 1 of the present invention.
  • Fig. 6 is a schematic structural view of the folded end of the airway body in Embodiment 1 of the present invention.
  • Fig. 7 is a cross-sectional view of the folded end of the airway body in Embodiment 1 of the present invention.
  • Fig. 8 is a schematic diagram of a second embodiment of the folded end in Embodiment 1 of the present invention.
  • Fig. 9 is a schematic diagram of the third embodiment of the folded end in Embodiment 1 of the present invention.
  • Fig. 10 is a schematic structural view of the covering film in Embodiment 1 of the present invention.
  • FIG. 11 is a schematic diagram of the outer membrane structure in Embodiment 1 of the present invention.
  • Fig. 12 is a schematic diagram of the outer membrane and inner membrane structure in Embodiment 1 of the present invention.
  • Fig. 13 is a cross-sectional view of the bump support part in the second embodiment of the present invention.
  • Fig. 14 is a schematic diagram of another embodiment of the bump support part in the second embodiment of the present invention.
  • Figure 15 is a schematic structural view of the stretched film in Example 3 of the present invention.
  • Fig. 16 is a schematic structural view of an interlayer film in Embodiment 4 of the present invention.
  • Fig. 17 is a schematic structural view of the interlayer film and the stretched film in Embodiment 4 of the present invention.
  • Figure 18 is a schematic structural view of the suture in Embodiment 5 of the present invention.
  • Fig. 19 is a schematic cross-sectional structure diagram of a suture in Embodiment 5 of the present invention.
  • Fig. 20 is a schematic diagram of the second embodiment of the suture in Example 5 of the present invention.
  • Fig. 21 is a schematic diagram of the third embodiment of the suture in the fifth embodiment of the present invention.
  • Fig. 22 is a schematic diagram of the fourth embodiment of the suture in the fifth embodiment of the present invention.
  • Figure 23 is a schematic structural view of the recovery line in Embodiment 6 of the present invention.
  • Fig. 24 is a schematic cross-sectional structure diagram of the recycling line in Embodiment 6 of the present invention.
  • Fig. 25 is a schematic diagram of another embodiment of the recycling line in Embodiment 6 of the present invention.
  • Fig. 26 is a schematic diagram of the overall structure of the airway stent in Embodiment 7 of the present invention.
  • Fig. 27 is a schematic diagram of the airway stent implanted in the airway in Embodiment 7 of the present invention.
  • Fig. 28 is a schematic structural view of the stent body in Embodiment 7 of the present invention.
  • Fig. 29 is a schematic structural view of the connection part of the stent body in Embodiment 7 of the present invention.
  • Fig. 30 is a schematic structural view of another embodiment of the connection part of the stent body in Embodiment 7 of the present invention.
  • FIG. 31 is a schematic structural view of the coating in Embodiment 7 of the present invention.
  • Fig. 32 is a schematic diagram of the overall structure of the airway stent in Embodiment 8 of the present invention.
  • Fig. 33 is a schematic diagram of the overall structure of the stent body in Embodiment 8 of the present invention.
  • Fig. 34 is a schematic structural view of the second braided yarn in Embodiment 8 of the present invention.
  • Fig. 35 is a schematic structural view of another embodiment of the second braided yarn in Embodiment 8 of the present invention.
  • Fig. 36 is a schematic diagram of the overall structure of another embodiment of the airway stent in Embodiment 8 of the present invention.
  • Fig. 37 is a schematic diagram of the connection structure of the main braiding filament and the secondary braiding filament in Embodiment 8 of the present invention.
  • Fig. 38 is a partial structural schematic diagram of the main body of the stent in Embodiment 9 of the present invention.
  • Fig. 39 is a schematic structural view of the second braided wire and the third braided wire in Embodiment 9 of the present invention.
  • Fig. 40 is a schematic structural view of another embodiment of the second braided yarn and the third braided yarn in the ninth embodiment of the present invention.
  • first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be referred to as These terms are limited. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section.
  • spatial relative terms may be used herein to describe the relationship of one element or feature as shown in the figures with respect to another element or feature, such as “inner”, “outer”, “inner”. “, “Outside”, “Below”, “Below”, “Above”, “Above”, etc.
  • Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures.
  • proximal and distal refers to the end near the operator, “distal” refers to the end away from the operator, and the phrase “axial Direction” in this patent should be understood as the direction in which the interventional device is pushed and pushed out, and the direction perpendicular to the “axial direction” is defined as the “radial direction”.
  • An airway stent as shown in FIGS. 1 and 2 , includes a stent body 10 and a membrane 20 disposed on the stent body 10 .
  • the support body 10 includes a waist support section 30 and a dense net bare support section 40 disposed at one end of the waist support section 30 .
  • the stent body 10 is braided and shaped by braided wires, and the gaps between adjacent braided wires are enclosed to form meshes 11, wherein the density of the meshes 11 of the dense mesh bare stent segment 40 is greater than the density of the meshes 11 of the waist stent segment 30,
  • the covering film 20 is disposed on the lumbar support segment 30 .
  • the present application sets the coating 20 on the lumbar stent segment 30, and the coating 20 reduces the irritation caused by the lumbar stent segment 30 to the inner wall of the airway, and can prevent tumors from growing toward the airway stent.
  • the dense mesh bare stent section 40 is a stent section provided with an outer membrane-free structure, and the density of meshes 11 is the number of holes 11 per unit area. That is, the lumbar stent segment 30 of the present application is provided with a film 20 , and at least one end of the lumbar stent segment 30 is provided with a dense mesh bare stent segment 30 , thereby reducing the irritation of the stent body 10 to the inner wall 70 of the airway.
  • the function of the cilia on the inner wall of the airway 70 is not affected, ensuring that the airway secretions will not remain on the airway body 10 .
  • the density of the mesh 11 of the dense mesh bare stent section 40 is set to Larger, so the contact area between the bare stent section 40 of the dense mesh and the inner wall 70 of the airway can be increased, and the pressure on the inner wall 70 of the airway by the bare stent section 40 of the dense mesh can be reduced, thereby effectively reducing the pressure at the end of the stent body 10.
  • Internal stimulation of the airway lining 70 reduces the growth of granulation tissue 90.
  • At least one end of the lumbar support section 30 is provided with a dense mesh bare stent section 40 , or both ends of the waist support section 30 are provided with dense mesh bare stent sections 40 .
  • a dense-mesh bare stent section 40 is provided at both ends of the lumbar support section 30 .
  • the exposed dense-network bare stent section 40 at both ends of the airway body 10 ensures the anchoring between the stent body 10 and the inner wall of the airway. Because the two ends of the lumbar support section 30 have adopted the design of the dense mesh bare support section 40, there is a gap in the dense mesh bare support section 40, and there will be no secretion retention at the two ends of the support body 10.
  • the airway stent of the present application not only the anchoring force can be ensured, but also the irritation of the stent body 10 to the inner wall of the airway can be reduced while the airway secretions are not retained on the surface of the airway stent, thereby reducing the The hyperplasia of granulation tissue can effectively avoid the occurrence of airway restenosis.
  • the dense mesh bare stent section 40 of the present application can adopt a multi-layer braided mesh structure arranged in dislocation, or can adopt a single-layer braided mesh densely woven.
  • a weaving Silk can be densely woven, or two or more different weaving silks can be used for mixed weaving.
  • the dense mesh bare stent segment 40 adopts a double-layer braided mesh structure.
  • the double-layer braided net structure of the dense mesh bare support section 40 includes an inner support net 41 and an outer support net 42.
  • One end of the inner support net 41 is connected to the waist support section 30, and the other end of the inner support net 41 is connected to the outer support net 41.
  • layer support mesh 42 is connected to the outer support net 42 .
  • one end of the outer support net 42 is connected to the lumbar support segment 30 , and the other end of the outer support net 42 is connected to the inner support net 41 .
  • one end of the inner support net 41 is connected to the waist support section 30, the other end of the inner support net 41 is connected to the outer support net 42, and the inner support net 41 and the outer support net 42 The connection is made by turning over the ends 43 .
  • the granulation tissue 90 at both ends of the stent body 10 is mainly caused by the stimulation of sharp materials at both ends of the stent body 10 .
  • the turned-over end 43 since the turned-over end 43 is formed by turning over, it has a smooth surface, and the stimulation of the smooth surface to the inner wall 70 of the airway is much smaller than the sharp end of the traditional bare stent, so the stent body 10 The ends are not prone to growth of granulation tissue 90 due to stimulation.
  • the contact area between the ends of the stent body 10 and the inner wall 70 of the airway is increased, and the inner wall 70 of the airway is reduced.
  • the pressure received per unit area makes the airway inner wall 70 less irritated, further reducing the proliferation of granulation tissue 90 .
  • the airway stent of this embodiment can also slow down the time for the granulation to grow inside the stent.
  • the granulation tissue 90 proliferates, it first contacts the outer support net 42 located on the outside. If the granulation tissue 90 grows beyond the outer support net 42, it will contact the inner inner support net 41 again, and the inner support net 41 acts as the second The blocking part again blocks the growth of the granulation tissue 90 to the inside of the bracket.
  • the outer support net 42 and the inner support net 41 act as a double-layer barrier, which can increase the time for the granulation tissue 90 to grow into the inner cavity of the airway stent, and strive for more time for doctors and patients to settle.
  • the inner support net 41 and the waist support segment 30 are integrally formed, and the end of the inner support net 41 is turned outward and folded back to form the outer support net 42 .
  • the end of the outer support net 42 when one end of the outer support net 42 is connected to the lumbar support segment 30, and the other end of the outer support net 42 is connected to the inner support net 41, the end of the outer support net 42 can be turned inside out and The inner support net 41 is formed after being folded back. That is, no matter whether the dense mesh bare stent section 40 is formed by eversion or inversion, as long as a double-layer braided mesh structure can be formed so that the density of the mesh 11 of the dense mesh bare stent section 40 is greater than that of the lumbar support section 30 density.
  • two dense net bare support segments 40 respectively arranged at both ends of the waist support segment 30 include a first dense mesh segment 401 arranged at one end of the waist support segment 30 , and a set At the second dense mesh segment 402 at the other end of the waist support segment 30, after the support body 10 is braided into a network tube structure by one or more braided wires, the two ends of the network tube structure are turned outward and folded into the first dense network segment 401 respectively. and the second dense network segment 402.
  • the structure of the first dense network segment 401 and the structure of the second dense network segment 402 can be the same or different, and the doctor can choose according to the actual situation of the patient. For example, the lengths of the first dense mesh segment 401 and the second dense mesh segment 402 are different, or the structures of the folded ends 43 of the first dense mesh segment 401 and the second dense mesh segment 402 are different.
  • the folded ends 43 protrude toward the direction away from the support body 10 relative to the outer support net 42 , that is, the outer diameters of the folded ends 43 at both ends of the support body 10 are larger than the outer diameter of the waist support segment 30 .
  • the folded end portion 43 has a circular arc structure, such as a circular or spherical structure. That is, the half-fold of the inner support net 41 and the outer support net 42 adopts a circular arc transition, so that the contact surface between the folded end 43 and the inner wall 70 of the airway is smoothly transitioned, and the support body 10 is reduced to the inner wall 70 of the airway. stimulation.
  • the arc-shaped surface of the folded end 43 is in contact with the inner wall 70 of the airway, which is used to keep the stent body 10 fixed, and at the same time ensure the cleaning effect of the airway mucosa and cilia at both ends of the stent body 10. It reduces the retention of airway secretions and prevents the hyperplasia of granulation tissue90.
  • the main function of the airway stent is that when the stent is implanted in the place where the airway is narrowed by malignant airway lesions, the airway body 10 will compress the tumor 80 to restore central ventilation of the airway.
  • the main mechanism for fixing the airway body 10 in the airway is that the radial expansion force of the lumbar stent segment 30 located in the middle of the stent body 10 interacts with the tumor 80 so that the stent body 10 does not shift.
  • the malignant tumor 80 is implanted with a stent
  • radiation chemotherapy is usually performed.
  • the tumor 80 will gradually shrink.
  • the force between the lumbar stent segment 30 and the tumor 80 will be relatively decrease.
  • the airway support in the prior art is prone to displacement.
  • the outer diameter of the folded end portion 43 is larger than that of the waist support section 30 because the folded end portion 43 protrudes toward the direction away from the bracket body 10 relative to the outer support net 42 .
  • the folded end portion 43 can also be in a square shape.
  • the advantage of the above arrangement is that it can increase the contact area between the folded end portion 43 and the inner wall 70 of the airway, and increase the anchoring force between the stent body 10 and the inner wall 70 of the airway.
  • the folded end portion 43 of the first dense mesh segment 401 is square
  • the folded end 43 of the second dense mesh segment 402 is arc-shaped.
  • the covering film 20 includes an outer film 22 arranged on the outer surface of the lumbar support segment 30 .
  • a layer of biocompatible polymer is coated on the outer surface of the lumbar stent segment 30 in this embodiment. The coating 20 is used to further prevent the malignant tumor 80 from growing into the stent body 10 .
  • the material of the coating 20 can be PET, PTFE, ePTFE, silica gel, polyurethane, etc., and the thickness of the coating 20 is adjusted according to the size of the braided wire of the stent body 10 and the inner and outer diameters of the stent body 10, which is not limited in this application.
  • the covering film 20 of the present application also includes an intima 21 arranged on the inner surface of the lumbar stent segment 30, due to the presence of the stent body 10
  • the mesh 11 so the inner membrane 21 and the outer membrane 22 can be combined and fixed through the mesh 11 of the lumbar support segment 30 .
  • the inner membrane 21 and the outer membrane 22 can be fixed by hot melting or adhesive, and the materials of the inner membrane 21 and the outer membrane 22 can be selected to be the same or different.
  • dense mesh bare stent sections 40 are provided at both ends of the lumbar support section 30 , and the density of the meshes 11 of the dense mesh bare stent section 40 is higher than that of the lumbar support section 30 .
  • the airway stent of the present invention increases the contact area between the dense mesh bare stent section 40 and the airway inner wall 70 while ensuring the anchoring force between the dense mesh bare stent section 40 and the airway inner wall 70, reducing
  • the pressure received by the unit area of the airway inner wall 70 makes the airway inner wall 70 less irritating, and, because the two ends of the waist support section 30 adopt the design of the dense mesh bare support section 40, the two ends of the support body 10 will not There is retention of secretions.
  • the airway stent of the present invention it is possible to reduce the stimulation of the airway stent to the inner wall of the airway without causing the retention of airway secretions on the surface of the airway stent, thereby reducing the hyperplasia of granulation tissue and avoiding The passage narrows again.
  • Embodiment 2 of the present application provides an airway stent. As shown in FIGS.
  • the density of the meshes 11 of the bare mesh stent segment 40 is greater than the density of the meshes 11 of the lumbar support segment 30 , and the covering film 20 is arranged on the lumbar support segment 30 .
  • the dense mesh bare stent section 40 is a double-layer braided mesh structure, and the dense mesh bare stent section 40 of the double-layer braided mesh structure includes an inner layer support mesh 41 and an outer layer support mesh 42 .
  • One end of the inner support net 41 is connected to the waist support section 30 , and the inner support net 41 and the waist support section 30 are integrally formed, and the other end of the inner support net 41 is connected to the outer support net 42 .
  • the end of the inner support net 41 is turned outwards and folded back to form the outer support net 42, the inner support net 41 and the outer support net 42 are connected by a folded end 43, and the folded end 43 Relative to the outer support net 42 , it protrudes in a direction away from the stent body 10 .
  • the present embodiment is also provided with at least one bump support portion 44 on the outer support net 42, and the shape of the bump support portion 44 is the same as or different from that of the folded end portion 43.
  • the bump support portion 44 is integrally formed with the outer support net 42 , and the bump support portion 44 is formed by protruding from the outer support net 42 toward a direction away from the bracket body 10 .
  • the shape of the bump support portion 44 is preferably arc-shaped, and may also be set in other shapes such as a square according to actual needs.
  • the anchoring force between the stent body 10 and the inner wall 70 of the airway can be strengthened by adding a bump support portion 44 on the outer support network 42, and the number of folded end portions 43 and each bump support portion 44 can also be reduced.
  • the pressure between the stent body 10 and the inner wall 70 of the airway reduces the stimulation of the inner wall 70 of the airway by the stent body 10 and prevents the hyperplasia of the granulation tissue 90 .
  • the two dense mesh bare stent segments 40 respectively disposed at both ends of the lumbar support segment 30 include a first dense mesh segment 401 disposed at one end of the lumbar support segment 30 , and a second dense mesh segment 401 disposed at the other end of the lumbar support segment 30 .
  • the bump support portions 44 of the first dense mesh segment 401 can be arc-shaped or one of the bump support portions 44
  • the convex point support parts 44 of the second dense mesh segment 402 may all be square or one of the convex point support parts 44 may be square.
  • the anchoring force between the stent body 10 and the inner wall 70 of the airway is strengthened, the overall pressure between the stent body 10 and the inner wall 70 of the airway is reduced, and the stent body 10 is lowered by adding the bump support portion 44. Stimulation to the inner wall 70 of the airway effectively prevents the hyperplasia of the granulation tissue 90 .
  • Embodiment 3 of the present application provides an airway stent.
  • the density of the meshes 11 of the bare mesh stent segment 40 is greater than the density of the meshes 11 of the lumbar support segment 30 , and the covering film 20 is arranged on the lumbar support segment 30 .
  • the dense mesh bare stent section 40 has a double-layer woven mesh structure, and the dense mesh bare stent section 40 of the double-layer woven mesh structure includes an inner layer support mesh 41 and an outer layer support mesh 42 .
  • One end of the inner support net 41 is connected to the waist support segment 30
  • the other end of the inner support net 41 is connected to the outer support net 42 .
  • the covering film 20 includes an outer membrane 22 arranged on the outer surface of the lumbar support section 30 and an inner membrane 21 arranged on the inner surface of the lumbar support section 30, and the inner membrane 21 and the outer membrane 22 pass through the lumbar support section.
  • the meshes 11 of the segment 30 are bonded and fixed, for example, by means of hot-melt bonding.
  • the stent body 10 is also provided with an extension film covering the inner surface of the bare stent segment 40 with dense mesh 24 , the extension film 24 is integrated with the inner film 21 , so as to cover the entire inner surface of the stent body 10 .
  • the material of the stretch film 24 can be selected from PET, PTFE, ePTFE, silica gel, polyurethane, etc., and the thickness of the stretch film 24 can be set according to actual needs.
  • the material of the extension film 24 is the same as that of the inner film 21 .
  • extension film 24 and the inner film 21 can also be provided separately from the inner film 21 .
  • the materials of the extension film 24 and the inner film 21 can be the same or different.
  • the covering film 20 of this embodiment can cover the entire inner surface of the stent body 10, which can not only prevent the tumor 80 from growing inward, but also prevent the stent body 10 from growing inward. Ingrowth of granulation tissue 90 at both ends.
  • the valgus part of the stent body 10, that is, the outer support net 42 maintains a bare stent state, and the outer surface of the outer support net 42 has no coating 20, so that the cleaning ability of the mucociliary membranes in the airway remains unchanged and can effectively remove the stent. Retention of secretions in the lining of the airways 70 .
  • the adventitia 22 can also partially cover the dense mesh bare stent segment 40 , thereby improving the connection force between the dense mesh bare stent segment 40 and the lumbar support segment 30 .
  • the extension film 24 covering the inner surface of the dense mesh bare stent segment 40 is arranged inside the stent body 10 , so as to prevent the tumor 80 from growing inward and prevent the proliferation of the granulation tissue 90 at both ends of the stent body 10 .
  • Embodiment 4 of the present application provides an airway stent.
  • the density of the meshes 11 of the bare mesh stent segment 40 is greater than the density of the meshes 11 of the lumbar support segment 30 , and the covering film 20 is arranged on the lumbar support segment 30 .
  • the dense mesh bare stent section 40 has a double-layer woven mesh structure, and the dense mesh bare stent section 40 of the double-layer woven mesh structure includes an inner layer support mesh 41 and an outer layer support mesh 42 .
  • One end of the inner support net 41 is connected to the waist support segment 30
  • the other end of the inner support net 41 is connected to the outer support net 42 .
  • the covering film 20 includes an outer membrane 22 arranged on the outer surface of the lumbar support section 30 and an inner membrane 21 arranged on the inner surface of the lumbar support section 30, and the inner membrane 21 and the outer membrane 22 pass through the lumbar support section.
  • the meshes 11 of the segment 30 are bonded and fixed, for example, by means of hot-melt bonding.
  • a sandwich membrane 23 is provided between the inner support net 41 and the outer support net 42 .
  • the setting of the interlayer film 23 can not only prevent the inward growth of the tumor 80 and the hyperplasia of the granulation tissue 90 , but also maintain the cleaning ability of the mucociliary in the inner wall of the airway 70 .
  • the inner surface of the stent body 10 is covered with an intima 21, the outer surface of the stent body 10 is covered with an adventitia 22, and the two ends of the stent body 10 are folded back to the interlayer between the outer layer support network 42 and the inner layer support network 41.
  • the device is covered with an interlayer film 23 which can cling to the inner support net 41 .
  • the material of the interlayer film 23 can be selected from PET, PTFE, ePTFE, silica gel, polyurethane, etc., and the thickness of the interlayer film 23 can be set according to actual needs.
  • an extension film 24 covering the inner surface of the dense mesh bare stent segment 40 is also provided in the stent body 10, and the extension film 24 is connected with the inner film 21 is integrally arranged so as to cover the entire inner surface of the bracket body 10 .
  • the interlayer film 23 and the stretched film 24 are bonded and fixed through the mesh 11 of the inner support net 41 , wherein the interlayer film 23 and the stretched film 24 can be fixed by hot melting or by bonding.
  • the interlayer film 23 is added between the inner support net 41 and the outer support net 42, so as to prevent the tumor 80 from growing inward and Hyperplasia of granulation tissue90.
  • Embodiment 5 of the present application provides an airway stent. As shown in FIGS.
  • the density of the meshes 11 of the bare mesh stent segment 40 is greater than the density of the meshes 11 of the lumbar support segment 30 , and the covering film 20 is arranged on the lumbar support segment 30 .
  • the dense mesh bare stent section 40 is a double-layer braided mesh structure, and the dense mesh bare stent section 40 of the double-layer braided mesh structure includes an inner layer support mesh 41 and an outer layer support mesh 42 .
  • One end of the inner support net 41 is connected to the waist support segment 30 , and the other end of the inner support net 41 is connected to the outer support net 42 .
  • the covering film 20 includes an outer membrane 22 arranged on the outer surface of the lumbar support section 30 and an inner membrane 21 arranged on the inner surface of the lumbar support section 30, and the inner membrane 21 and the outer membrane 22 pass through the lumbar support section.
  • the meshes 11 of the segment 30 are bonded and fixed, for example, by means of hot-melt bonding.
  • a device for increasing the coupling between the coating 20 and the bracket is provided on the waist bracket section 30.
  • the lumbar support segment 30 is connected with sutures 50 for strength.
  • the covering film 20 may also partially cover the dense-mesh stent segment 40 , and the suture 50 is sutured on the dense-mesh bare stent segment 40 .
  • the suture 50 passes through the mesh 11 of the lumbar stent segment 30 or the dense mesh bare stent segment 40, and is passed around the outer edge of the stent body 10 and the edge of the membrane 20 to form a wavy line structure, and then reciprocally wound and tightened so that the covering film 20 is tightly attached to the braided wire of the stent body 10 .
  • the suture 50 goes around the outer edge of the stent body 10 for at least one circle, so as to completely suture and fix the covering membrane 20 on the stent body 10 in one circle.
  • the suture 50 can be threaded every other mesh 11 , or every other mesh 11 . As shown in FIG. 20 , the suture 50 is threaded every four meshes 11 . When the suture thread 50 passes through the covering film 20, puncture holes will be formed. If there are too many puncture holes, the strength of the covering film 20 will be affected. Therefore, the interval at which the sutures 50 are threaded can be selected according to actual conditions such as the material of the sutures 50, which is not limited in this embodiment.
  • the suture 50 is preferably made of PET, PTFE, ePTFE, etc.
  • the outer diameter of the suture 50 is determined according to the diameter of the braided wire of the stent body 10 and the thickness of the coating 20, which is not limited in this application.
  • the cover film 20 can also be partially sutured, that is, the suture 50 is set so that the length around the outer edge of the stent body 10 is less than a full circle.
  • the partial suturing method can enhance the structural strength between the covering film 20 and the stent body 10 while ensuring the structural strength of the covering film 20 .
  • the stitching thread 50 can adopt a laminated stitching method.
  • the suture 50 is arranged on the edge of the film 20, and the suture 50 tightens the film 20 through internal and external puncture.
  • the puncture hole of the suture 50 is dislocated during the internal and external puncture.
  • the suture thread 50 is formed into several suture loops 51 connected end-to-end or offset and overlapped, and each suture loop 51 passes through the mesh 11 of the stent body 10 .
  • adjacent seaming loops 51 have overlapping portions. Since the adjacent suture circles 51 have overlapping parts, the overall suture strength of the suture thread 50 is increased, achieving the purpose of enhancing the suture strength without affecting the strength of the covering film 20 .
  • the film covering 20 is sutured on the lumbar support segment 30 through the sutures 50, thereby enhancing the bonding strength between the film covering 20 and the stent body 10, effectively preventing the covering
  • the membrane 20 is detached from the stent body 10 .
  • Embodiment 6 of the present application provides an airway stent.
  • the stent body 10 includes a lumbar stent section 30 and two dense mesh bare stent sections 40 respectively arranged at both ends of the lumbar stent section 30 .
  • the density of the meshes 11 of the bare mesh stent segment 40 is greater than the density of the meshes 11 of the lumbar support segment 30 , and the covering film 20 is arranged on the lumbar support segment 30 .
  • a recovery line 60 is provided on the stent body 10 .
  • the recovery line 60 is arranged on the dense mesh bare stent section 40 at one end of the stent body 10 , and the recovery line 60 passes along the edge of the dense mesh bare stent section 40 .
  • the dense mesh bare stent section 40 includes an inner layer support net 41 and an outer layer support net 42
  • the recycling line 60 is at least partially set through the inner layer support net 41 and the outer layer support net 42 between.
  • the recovery line 60 includes a connection line 61 and an operation line 62.
  • the connection line 61 is at least partially arranged between the inner support net 41 and the outer support net 42.
  • One end of the operation line 62 is connected to the connection line 61, and the other end of the operation line 62 One end is located outside the stent body 10 for doctors to operate.
  • the doctor pulls the operating wire 62, and the connecting wire 61 is driven by the operating wire 62 to reduce the diameter of the opening of the dense mesh bare stent segment 40. Since the diameter of the opening of the bare stent section 40 is reduced, the opening of the bare stent section 40 will be separated from the inner wall 70 of the airway, so that the force between the stent body 10 and the inner wall 70 of the airway is reduced, which is convenient for doctors. Remove the airway stent.
  • the connecting wire 61 is passed along the edge of the dense mesh bare stent segment 40 .
  • the connecting wire 61 may be partially located between the two layers of braided meshes, or may be completely positioned between the two layers of braided meshes.
  • the dense mesh bare stent segment 40 is a double-layer braided mesh structure.
  • the connection line 61 may be partly located between the inner support net 41 and the outer support net 42 , and partly located outside the outer support net 42 .
  • the connecting wire 61 can also be all positioned between the inner layer supporting net 41 and the outer layer supporting net 42, and when the connecting wire 61 is completely positioned between the inner layer supporting net 41 and the outer layer supporting net 42, the connecting wire 61 is subjected to the force when moving.
  • the frictional force is smaller, and the force required to shrink the opening of the dense mesh bare stent segment 40 is smaller, which is convenient for doctors to recover.
  • the airway stent provided by this application is provided with a coating on the lumbar stent section, through which the stimulation to the inner wall of the airway by the lumbar stent section is reduced, and then a dense mesh bare stent section is set at both ends of the lumbar stent section , and the pore diameter of the dense mesh bare stent segment is smaller than that of the lumbar stent segment. Therefore, while the airway stent of the present application ensures the anchoring force between the bare stent section of the dense mesh and the inner wall of the airway, the contact area between the bare stent section of the dense mesh and the inner wall of the airway is increased, and the inner wall of the airway is reduced.
  • the pressure per unit area reduces the irritation of the inner wall of the airway, and since the two ends of the lumbar stent adopt the design of the dense mesh bare stent, there will be no secretion retention at both ends of the airway stent. Therefore, by using the airway stent of the present application, it is possible to reduce the stimulation of the airway stent to the inner wall of the airway without causing the airway secretions to remain on the surface of the airway stent, thereby reducing the hyperplasia of granulation tissue and avoiding airway secretions. Stenosis occurs again.
  • Embodiment 7 of the present application provides an airway stent, as shown in Fig. 26 to Fig. 28, including a stent body 10 and a covering film 20 arranged on the stent body 10, the stent body 10 includes a lumbar stent segment 30 and The dense mesh bare stent segment 40 at the end of the stent segment 30 and the film covering 20 are arranged on the lumbar support segment 30 .
  • the wire diameter of the dense mesh bare stent section 40 is smaller than that of the waist stent section 30 , and the dense mesh bare stent section 40 has a single-layer densely woven mesh structure.
  • the dense mesh bare stent section 40 is a stent section provided with an outer membrane-free structure, and at least one end of the waist stent section 30 is provided with a dense mesh bare stent section 40. Since the outer membrane-free structure of the dense mesh bare stent section 40 is set, it does not affect the gas flow. The function of the 70 cilia on the inner wall of the airway ensures that the airway secretions will not remain on the airway body. Moreover, the lumbar stent segment 30 of the present application is provided with a film 20 , thereby reducing the stimulation of the stent body 10 to the inner wall 70 of the airway.
  • the stent body 10 includes a plurality of first braided wires 403 and a plurality of second braided wires 301
  • the mesh wires of the dense mesh bare stent segment 40 are the first braided wires 403, and the dense mesh bare stent segment 40 passes through the first braided wires.
  • the mesh wire of the waist support segment 30 is the second braiding wire 301
  • the waist support segment 30 is formed by braiding the second braiding wire 301
  • the wire diameter of the first braiding wire 403 is smaller than the wire diameter of the second braiding wire 301
  • Both the first braided wire 403 and the second braided wire 301 are shape memory alloy wires, preferably NiTi wires.
  • the second braided wire 301 of the lumbar support segment 30 is in contact with the inner wall 70 of the airway through the coating 20, while the first braided wire 403 of the dense mesh bare stent segment 40 is directly in contact with the airway. contact with the inner wall 70 of the airway, which is likely to cause irritation to the inner wall 70 of the airway. Therefore, by reducing the diameter of the first braided wire 403 of the dense-mesh bare stent segment 40, the pressure of the single first braided wire 403 on the airway inner wall 70 is reduced, and the dense-mesh bare stent segment 40 is made softer. Furthermore, the stimulation of the airway inner wall 70 by the dense mesh bare stent segment 40 directly in contact with the airway inner wall 70 is reduced, and the growth of the granulation tissue 90 is prevented.
  • the number of the first braided wires 403 of the dense mesh bare stent segment 40 is set to be equal to the number of the second braided wires 301 of the waist support segment 30, by setting the wire diameter of the first braided wires 403 to be smaller than the second braided wire
  • the wire diameter of the wire 301 can reduce the pressure of the single first braided wire 403 on the inner wall 70 of the airway, thereby reducing the pressure on the inner wall 70 of the airway by the whole bare stent section 40 of the dense mesh, and can also effectively reduce the pressure of the inner wall 70 of the airway.
  • the stimulation of the airway stent to the inner wall 70 of the airway prevents the proliferation of granulation tissue 90 .
  • the number of the first braided wires 403 of the dense mesh bare stent segment 40 is set to be greater than the number of the second braided wires 301 of the lumbar support segment 30 .
  • the radial supporting force of a single first braiding wire 403 is smaller than the radial supporting force of the second braiding wire 301 .
  • the number of the first braided wires 403 is set to be greater than the number of the second braided wires 301 . That is, by reducing the wire diameter of a single mesh wire and increasing the number of mesh wires, the pressure of the dense mesh bare stent section 40 on the airway inner wall 70 is more uniform.
  • the dense mesh bare support section 40 and the waist support section 30 are formed separately, and the dense mesh bare support section 40 and the waist support section 30 are fixed through the connecting portion 25 .
  • connection part 25 is a connecting film
  • the dense mesh bare stent segment 40 and the lumbar support segment 30 are respectively connected and fixed to the connecting film, so that the dense mesh bare stent segment 40 and the lumbar support segment 30 are indirectly fixedly connected through the connecting film.
  • the connecting portion 25 can also be a welding point, and the first braided wire 403 of the dense mesh bare bracket segment 40 can also be welded to the second braided wire 301 of the waist bracket segment 30. Fixed connection.
  • the connecting part 25 can also be a steel sleeve (not shown in the figure), and the connection ends of the first braided wire 403 of the dense mesh bare bracket segment 40 and the second braided wire 301 of the waist bracket segment 30 are sleeved by the steel sleeve fixed.
  • connection method of the segmented dense mesh bare stent segment 40 and the lumbar support segment 30 in this application is only an example, and any connection method that can connect the dense mesh bare stent segment 40 and the lumbar support segment 30 can be used applied in this application.
  • the dense mesh bare support section 40 and the waist support section 30 formed separately are connected through the connecting part 25 after being made and formed respectively.
  • the forming method is simple and the structural design is flexible.
  • the wire diameter, the number of wires and the weaving method are highly diversified and can adapt to the needs of patients with various diseases.
  • the covering film 20 includes an outer film 22 arranged on the outer surface of the lumbar support segment 30, and the covering film 20 may also include an inner film 21 arranged on the inner surface of the lumbar support segment 30, and the inner film 21 Combined with the adventitia 22 through the mesh 11 of the lumbar support section 30 to be fixed.
  • the outer surface of the lumbar stent segment 30 is covered with a layer of biocompatible
  • the permanent polymer coating 20 is used to further prevent the malignant tumor 80 from growing into the stent body 10 .
  • the material of the coating 20 can be PET, PTFE, ePTFE, silica gel, polyurethane, etc., and the thickness of the coating 20 is adjusted according to the size of the braided wire of the stent body 10 and the inner and outer diameters of the stent body 10, which is not limited in this application.
  • the covering film 20 of the present application also includes an intima 21 arranged on the inner surface of the lumbar stent segment 30, because the stent body 10 There are mesh holes 11 , so the inner membrane 21 and outer membrane 22 can be bonded and fixed through the mesh holes 11 of the lumbar support segment 30 .
  • the inner membrane 21 and the outer membrane 22 can be fixed by hot melting or adhesive, and the materials of the inner membrane 21 and the outer membrane 22 can be selected to be the same or different.
  • the coating 20 is provided on the lumbar stent segment 30, and the coating 20 can reduce the irritation caused by the lumbar stent segment 30 to the inner wall 70 of the airway, and at the same time, the coating 20 also The tumor 80 can be prevented from growing into the airway stent.
  • the dense mesh bare stent section 40 is set at the end of the waist support section 30, and the wire diameter of the mesh wire of the dense mesh bare stent section 40 is smaller than the wire diameter of the mesh wire of the waist support section 30, which reduces the single The pressure of the root mesh on the inner wall 70 of the airway.
  • the present invention further sets the number of mesh wires of the dense mesh bare stent section 40 to be greater than that of the waist stent section 30, thereby ensuring the anchoring force between the dense mesh bare stent section 40 and the inner wall 70 of the airway, reducing air The pressure per unit area of the inner wall 70 of the airway makes the inner wall 70 of the airway less irritated.
  • the two ends of the lumbar support section 30 adopt the design of the dense mesh bare support section 40, there will be no secretion retention at both ends of the airway support. Therefore, by using the airway stent of the present invention, it is possible to prevent airway secretions from accumulating on the surface of the airway stent, prevent the tumor 80 from growing inside the airway stent, and reduce the stimulation of the airway stent to the inner wall 70 of the airway, thereby reducing granulation
  • the hyperplasia of tissue 90 avoids the occurrence of airway restenosis.
  • Embodiment 8 of the present application provides an airway stent, as shown in Figure 32 to Figure 34, and the similarities between Embodiment 8 and Embodiment 7 will not be repeated.
  • the difference between Embodiment 8 and Embodiment 7 is that
  • the dense mesh bare support segment 40 and the waist support segment 30 are integrally braided and formed.
  • the dense mesh bare stent segment 40 is formed by weaving the first weaving wire 403
  • the waist support segment 30 is formed by weaving the second weaving wire 301 .
  • a plurality of first braided filaments 403 are intertwined to form the second braided filaments 301 .
  • the process of weaving and molding the stent body 10 includes the following steps:
  • first braided wires 403 are intertwined to prepare the second braided wire 301 .
  • the lumbar support segment 30 located at the waist of the support body 10 is woven through a plurality of prepared second braiding wires 301 .
  • the unwoven mesh wires at both ends of the lumbar support segment 30 are dismantled to form the first braided wire 403 again.
  • the dense mesh bare stent segment 40 located at both ends of the stent body 10 is braided by a plurality of dismantled first braiding wires 403 .
  • the second braiding filament 301 can be formed by intertwining two first braiding filaments 403, as shown in FIG.
  • the number of the first braided wires 403 is selected according to actual needs.
  • the stent body 10 may include a dense mesh bare stent section 40 arranged at one end of the lumbar stent section 30, and the stent body 10 may also include two dense mesh bare stent sections 40 respectively arranged at both ends of the lumbar stent section 30. The actual condition of the choice.
  • the stent body 10 obtained through integral weaving and heat setting treatment has better flexibility and smoother edges, and the structure of the stent body 10 is stronger and safer.
  • the first braiding wire 403 includes a main braiding wire 404 and at least one secondary braiding wire 405, and the secondary braiding wire 405 is wound on the main braiding wire 404 to form a second braiding wire 404.
  • the braided yarn 301 and the second braided yarn 301 are braided to form the waist support segment 30 .
  • the diameter of the main braiding wire 404 is larger than that of the auxiliary braiding wire 405, and when the main braiding wire 404 and the auxiliary braiding wire 405 are entangled, the auxiliary braiding wire 405 is spirally wound on the main braiding wire 404 to form a The second braided wire 301 .
  • the overall stability of the braided structure of the waist support segment 30 is ensured by setting the main braided wire 404, and the overall radial support of the second braided wire 301 is increased by adding the secondary braided wire 405 force.
  • the end of the dense mesh bare stent segment 40 includes a mesh concentration point 45 formed by the convergence of a plurality of first braided wires 403.
  • the head end of the secondary braided wire 405 can also be directly connected to the end of the dense mesh bare stent section 40, thereby reducing the number of mesh concentration points 45 of the dense mesh bare stent section 40, and enhancing the strength of a single mesh.
  • the strength of the concentrated point 45 makes the anchoring force of the end of the bare stent section 40 stronger, effectively preventing the stent body 10 from shifting.
  • Embodiment 9 of the present application provides an airway stent, as shown in FIG. 38 to FIG. 40 , and the similarities between Embodiment 9 and Embodiment 8 will not be repeated.
  • the difference between Embodiment 9 and Embodiment 8 is that
  • the stent body 10 also includes at least one third braided wire 302, the waist support segment 30 is formed by mixing the second braided wire 301 and the third braided wire 302, and the dense mesh bare stent 40 is braided by the first braided wire 403 and the third braided wire.
  • the filaments 302 are mixed and braided.
  • the second braiding wire 301 can be formed by weaving several first braiding wires 403 with the same wire diameter, or can be formed by weaving a main braiding wire 404 and a secondary braiding wire 405 with different wire diameters.
  • the overall radial support force of the stent body 10 can be adjusted by setting the wire diameter and quantity of the third braided wire 302, and the tightness of the bare stent segment 40 against the inner wall 70 of the airway can also be adjusted. pressure.
  • the overall radial support force of the stent body 10 can be increased; 403 wire diameter, and less than or equal to the wire diameter of the second braided wire 301, while ensuring the radial support force of the lumbar support segment 30, the radial support force of the dense mesh bare support segment 40 can be reduced;
  • the wire diameter of the third braided wire 302 is smaller than or equal to the wire diameter of the first braided wire 403 , the overall radial support force of the stent body 10 can be reduced.
  • the more the quantity of the third braiding filament 302 is, the less the quantity of the second braiding filament 301 is, and the quantity of the first braiding filament 403 The smaller the number, the less the number of mesh wires in the bare stent section 40 of the dense mesh. Therefore, the greater the pressure on the inner wall 70 of the airway by the bare stent section 40 of the dense mesh; and vice versa.
  • the airway stent of the embodiment can not only prevent secretion retention at both ends of the airway stent, prevent tumor 80 from growing into the airway stent, and prevent granulation tissue 90 from growing. It is also possible to flexibly adjust the diameter and quantity of the first braided wire 403, the second braided wire 301, and the third braided wire 302 to flexibly adjust the radial support force of the stent body 10 as a whole, as well as the tight mesh bare stent segment 40 to the airway.
  • the pressure of the inner wall 70 can adapt to the needs of different patients.

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Abstract

本发明属于医疗器械技术领域，一种气道支架，包括支架本体以及设置在支架本体上的覆膜，其中，所述支架本体包括腰部支架段以及设置在所述腰部支架段端部的密网裸支架段，所述覆膜设置在所述腰部支架段上，所述密网裸支架段的网孔密度大于所述腰部支架段的网孔密度。根据本发明中的气道支架，能够减少气道支架对气管内壁的刺激，从而有效避免肉芽组织生长，进而防止气道内腔再次狭窄。

Description

一种气道支架 技术领域
本发明属于医疗器械技术领域，具体涉及一种气道支架。
背景技术
气道金属支架的治疗气管，支气管狭窄的重要手段，可迅速重建气道，缓减呼吸困难等症状。根据材质，气道支架可分为金属支架和非金属支架，根据有无覆膜，金属支架又分为覆膜支架和裸支架。
早期的气道支架主要采用金属裸支架，金属裸支架主要采用镍钛记忆合金网状支架，金属裸支架具有不易位移，气道分泌物不易潴留的优点。然而，由于金属裸支架的网格空间虚大，不能阻挡肿瘤或肉芽组织沿网眼生长，恶性肿瘤易生长进入支架内腔而导致气道再狭。故，金属裸支架仅能够短期放置以缓解气道梗阻，不宜放置时间太久。
基于上述问题，现有技术中出现了覆膜支架，覆膜支架在裸支架的基础上，增加了一层覆膜，通过覆膜阻止肿瘤生长进入支架内。由于覆膜对气道内壁的刺激少，因此可以有效的减少肉芽组织增生。但是，覆膜支架阻止了气道支架粘膜纤毛的作用，难以清洁气道内分泌物，造成气道两端分泌物潴留，导致病人出现咳嗽及肺炎等并发症。
因此，需要一种新的技术手段在不使气道分泌物在气道支架表面潴留的同时，减小气道支架对气道内壁的刺激，从而减少肉芽组织的增生。
发明内容
本发明的目的是至少解决现有的金属覆膜支架容易刺激气道内壁，从而增加肉芽组织增生的问题。
本发明提出一种气道支架，包括支架本体以及设置在支架本体上的覆膜，其中，所述支架本体包括腰部支架段以及设置在所述腰部支架段端部的密网裸支架段，所述覆膜设置在所述腰部支架段上，所述密网裸支架段的网孔密度大于所述腰部支架段的网孔密度。
根据本发明中的气道支架，在腰部支架段上设置覆膜，通过覆膜减少腰部支架段给气道内壁造成的刺激，然后在腰部支架段的端部设置密网裸支架段，且密网裸支架段的孔径相较于腰部支架段的孔径更小；因此，本发明的气道支架在保证密网裸支架段与气道内壁之间锚定力的同时，增大了密网裸支架段与气道内壁之间的接触面积，减少了气道内壁单位面积所受到的压强，使得气道内壁刺激变小，并且，由于腰部支架段的两端采用了密网裸支架段的设计，气道支架两端也不会有分泌物潴留；因此，通过使用本发明的气道支架，能够在不使气道分泌物在气道支架表面潴留的同时，减小气道支架对气道内壁的刺激，从而减少肉芽组织的增生，避免气道再次狭窄的发生。
另外，根据本发明的气道支架，还可具有如下附加的技术特征：
在本发明的一些实施例中，其中，所述密网裸支架段包括单层密集编织网结构或多层编织网结构。
在本发明的一些实施例中，其中，所述密网裸支架段包括内层支撑网以及外层支撑网，所述内层支撑网的一端连接于所述腰部支架段，所述内层支撑网的另一端连接于所述外层支撑网；或者所述外层支撑网的一端连接于所述腰部支架段，所述外层支撑网的另一端连接于所述内层支撑网。
在本发明的一些实施例中，其中，所述内层支撑网与所述腰部支架段一体成型，所述内层支撑网的端部外翻并折回后形成所述外层支撑网，所述内层支撑网与所述外层支撑网之间通过翻折端部连接。
在本发明的一些实施例中，其中，所述翻折端部相对于所述外层支撑网朝向背离所述支架本体的方向凸起；所述外层支撑网上设置有至少一个凸点支撑部，所述凸点支撑部与所述翻折端部的形状相同或不同。
在本发明的一些实施例中，其中，所述内层支撑网与所述外层支撑网之间设置有夹层膜。
在本发明的一些实施例中，其中，所述覆膜包括设置在所述腰部支架段外表面的外膜以及设置在所述腰部支架段内表面的内膜，所述内膜与所述外膜通过所述腰部支架段的网孔进行结合固定。
在本发明的一些实施例中，其中，所述支架本体内还设置有覆 盖所述密网裸支架段内表面的延伸膜。
在本发明的一些实施例中，其中，所述腰部支架段上设置有用于增加所述覆膜与所述腰部支架段连接强度的缝合线。
在本发明的一些实施例中，其中，所述支架本体一端的所述密网裸支架段上设置有回收线，所述回收线沿所述密网裸支架段的边缘穿设。
附图说明
图1为本发明的实施例一中气道支架的整体结构示意图；
图2为本发明的实施例一中支架本体的结构示意图；
图3为本发明的实施例一中支架主体的剖视图；
图4为本发明的实施例一中气道支架植入气道后的示意图；
图5为本发明的实施例一中气道内壁生长肉芽时的示意图；
图6为本发明的实施例一中气道本体的翻折端部的结构示意图；
图7为本发明的实施例一中气道本体的翻折端部的剖视图；
图8为本发明的实施例一中翻折端部的第二实施方案的示意图；
图9为本发明的实施例一中翻折端部的第三实施方案的示意图；
图10为本发明的实施例一中覆膜的结构示意图；
图11为本发明的实施例一中外膜结构的示意图；
图12为本发明的实施例一中外膜与内膜结构的示意图；
图13为本发明的实施例二中凸点支撑部的剖视图；
图14为本发明的实施例二中凸点支撑部的另一实施方案的示意 图；
图15为本发明的实施例三中延伸膜的结构示意图；
图16为本发明的实施例四中夹层膜的结构示意图；
图17为本发明的实施例四中夹层膜与延伸膜的结构示意图；
图18为本发明的实施例五中缝合线的结构示意图；
图19为本发明的实施例五中缝合线的剖面结构示意图；
图20为本发明的实施例五中缝合线的第二实施方式的示意图；
图21为本发明的实施例五中缝合线的第三实施方式的示意图；
图22为本发明的实施例五中缝合线的第四实施方式的示意图；
图23为本发明的实施例六中回收线的结构示意图；
图24为本发明的实施例六中回收线的剖面结构示意图；
图25为本发明的实施例六中回收线的另一实施方式的示意图；
图26为本发明的实施例七中气道支架的整体结构示意图；
图27为本发明的实施例七中气道支架植入气道后的示意图；
图28为本发明的实施例七中支架本体的结构示意图；
图29为本发明的实施例七中支架本体的连接部的结构示意图；
图30为本发明的实施例七中支架本体的连接部的另一实施方式的结构示意图；
图31为本发明的实施例七中覆膜的结构示意图；
图32为本发明的实施例八中气道支架的整体结构示意图；
图33为本发明的实施例八中支架本体的整体结构示意图；
图34为本发明的实施例八中第二编织丝的结构示意图；
图35为本发明的实施例八中第二编织丝的另一实施方式的结构示意图；
图36为本发明的实施例八中气道支架的另一实施方式的整体结构示意图；
图37为本发明的实施例八中主编织丝与副编织丝的连接结构示意图；
图38为本发明的实施例九中支架主体的部分结构示意图；
图39为本发明的实施例九中第二编织丝与第三编织丝的结构示意图；
图40为本发明的实施例九中第二编织丝与第三编织丝的另一实施方式的结构示意图。
附图中各标号表示如下：
10、支架本体；11、网孔；20、覆膜；21、内膜；22、外膜；23、夹层膜；24、延伸膜；25、连接部；30、腰部支架段；301、第二编织丝；302、第三编织丝；40、密网裸支架段；401、第一密网段；402、第二密网段；403、第一编织丝；404、主编织丝；405、副编织丝；41、内层支撑网；42、外层支撑网；43、翻折端部；44、凸点支撑部；45、网丝集中点；50、缝合线；51、缝合圈；60、回收线；61、连接线；62、操作线；70、气道内壁；80、肿瘤；90、肉芽组织。
具体实施方式
下面将参照附图更详细地描述本发明的示例性实施方式。虽然附图中显示了本发明的示例性实施方式，然而应当理解，可以以各种形式实现本发明而不应被这里阐述的实施方式所限制。相反，提供这些实施方式是为了能够更透彻地理解本发明，并且能够将本发明的范围完整的传达给本领域的技术人员。
应理解的是，文中使用的术语仅出于描述特定示例实施方式的目的，而无意于进行限制。除非上下文另外明确地指出，否则如文中使用的单数形式“一”、“一个”以及“所述”也可以表示包括复数形式。
尽管可以在文中使用术语第一、第二、第三等来描述多个元件、部件、区域、层和/或部段，但是，这些元件、部件、区域、层和/或部段不应被这些术语所限制。这些术语可以仅用来将一个元件、部件、区域、层或部段与另一区域、层或部段区分开。
为了便于描述，可以在文中使用空间相对关系术语来描述如图中示出的一个元件或者特征相对于另一元件或者特征的关系，这些相对关系术语例如为“内部”、“外部”、“内侧”、“外侧”、“下面”、“下方”、“上面”、“上方”等。这种空间相对关系术语意于包括除图中描绘的方位之外的在使用或者操作中装置的不同方位。
为了便于描述，以下描述使用术语“近端”和“远端”，其中“近端”是指的是离操作者近的一端，“远端”是指远离操作者的一端，短语“轴向方向”，本专利里应当被理解成表示介入器械被推进和推出的方向，与“轴向方向”相垂直的方向定义为“径向方向”。
实施例一
一种气道支架，如图1与图2所示，包括支架本体10以及设置在支架本体10上的覆膜20。其中，支架本体10包括腰部支架段30以及设置在腰部支架段30一端的密网裸支架段40。支架本体10通过编织丝编织成型，相邻编织丝之间的间隙围合形成网孔11，其中，密网裸支架段40的网孔11的密度大于腰部支架段30的网孔11的密度，且覆膜20设置在腰部支架段30上。首先，本申请在腰部支架段30上设置覆膜20，通过覆膜20减少腰部支架段30给气道内壁造成的刺激，而且能够阻止肿瘤向气道支架方向生长。
在本实施例中，结合图5所示，密网裸支架段40为外侧无膜结构设置的支架段，网孔11的密度为单位面积上网孔11的个数。即，本申请的腰部支架段30上设置有覆膜20，腰部支架段30的至少一端设置有密网裸支架段30，从而减少支架本体10对气道内壁70的刺激。由于密网裸支架段40的外侧无膜结构设置，从而不影响气道内壁70纤毛的功能，保证了气道分泌物不会在气道本体10上潴留。由于气道本体10上设置了一段无膜结构设置的密网裸支架段40，而裸露的支架容易对气道内壁70造成刺激，因此将密网裸支架段40的网孔11的密度设置的更大，因此能够增大密网裸支架段40与气道内壁70之间的接触面积，减小密网裸支架段40整体对气道内壁70的压强，从而有效的减小支架本体10端部对气道内壁70的刺激，减少肉芽组织90的生长。
本申请中，腰部支架段30的至少一端设置有密网裸支架段40， 或者腰部支架段30的两端均设置有密网裸支架段40。具体的，在腰部支架段30的两端设置密网裸支架段40通过上述技术方案，利用气道本体10两端裸露的密网裸支架段40保证支架本体10与气道内壁之间锚定力，由于腰部支架段30的两端采用了密网裸支架段40的设计，密网裸支架段40存在间隙，支架本体10两端不会有分泌物潴留。
因此，通过使用本申请的气道支架，不仅能够保证锚定力，还能够在不使气道分泌物在气道支架表面潴留的同时，减小支架本体10对气道内壁的刺激，从而减少肉芽组织的增生，有效的避免了气道再次狭窄的发生。
本申请的密网裸支架段40可以采用错位设置的多层的编织网结构，也可以采用单层的编织网密集编织的方式，当采用单层的编织网密集编织时，可以采用一种编织丝进行密集编织，也可以采用二种或多种不同的编织丝进行混合编织。
在本实施例中，如图3所示，密网裸支架段40采用双层编织网结构。密网裸支架段40的双层编织网结构包括内层支撑网41以及外层支撑网42，内层支撑网41的一端连接于腰部支架段30，内层支撑网41的另一端连接于外层支撑网42。在其他实施例中，外层支撑网42的一端连接于腰部支撑段30，外层支撑网42的另一端连接于内层支撑网41。
在本实施例中，内层支撑网41的一端连接于腰部支架段30，内层支撑网41的另一端连接于外层支撑网42，且内层支撑网41与外 层支撑网42之间通过翻折端部43连接。
如图4与图5所示，随着植入时间的增长，现有气道支架的两端部容易生长肉芽。据文献表明，支架本体10两端的肉芽组织90主要由于支架本体10两端的尖锐材料刺激造成。而本申请通过外翻并折回后形成的密网裸支架段40的端部不存在传统裸支架的尖锐的部分，即内层支撑网41与外层支撑网42之间通过翻折端部43连接。
一方面，由于翻折端部43是通过翻折形成的，因此具有平滑的表面，而平滑的表面对气道内壁70的刺激相比传统裸支架尖锐的端部小很多，故支架本体10的两端不容易因为刺激导致肉芽组织90生长。
另一方面，由于支架本体10两端为外翻对折的结构，从而形成密网编织的端部，使得支架本体10两端的端部与气道内壁70接触面积增大，减少了气道内壁70单位面积收到的压力，使气道内壁70刺激变小，进一步减少肉芽组织90的增生。
另外，即使支架本体10两端产生了肉芽增生的现象，本实施例的气道支架也可以减缓肉芽往支架内部生长的时间。当肉芽组织90增生时，首先接触位于外侧的外层支撑网42，如果肉芽组织90生长越过外层支撑网42，会再次接触到内侧的内层支撑网41，内层支撑网41作为第二阻挡部分，再次阻挡肉芽组织90向支架内部生长。外层支撑网42和内层支撑网41作为双层阻挡作用，可以增加肉芽组织90生长到气道支架内腔的时间，为医生和患者争取更多的解决时间。
具体成型时，内层支撑网41与腰部支架段30一体成型，内层支撑网41的端部外翻并折回后形成外层支撑网42。
在其他实施例中，当外层支撑网42的一端连接于腰部支撑段30，外层支撑网42的另一端连接于内层支撑网41时，外层支撑网42的端部可以内翻并折回后形成内层支撑网41。即，不论密网裸支架段40是通过外翻还是内翻形成，只要能够形成双层的编织网结构，以使密网裸支架段40的网孔11的密度大于腰部支撑段30的网孔的密度即可。
在本实施例中，如图6与图7所示，两个分别设置在腰部支架段30两端的密网裸支架段40包括设置在腰部支架段30一端的第一密网段401，以及设置在腰部支架段30另一端的第二密网段402，支架本体10通过一根或者多根编织丝编织成一个网管结构后，网管结构的两端外翻后分别折成第一密网段401和第二密网段402。第一密网段401的结构与第二密网段402的结构可以相同也可以不同，医生可以具体根据病人的实际情况进行选择。例如，第一密网段401与第二密网段402的长度不同，或者第一密网段401与第二密网段402的翻折端部43结构不同等。
其中，翻折端部43相对于外层支撑网42朝向背离支架本体10的方向凸起，即，支架本体10两端的翻折端部43的外径大于腰部支架段30的外径。
翻折端部43结构为圆弧形结构，例如圆形或球形结构。即内层支撑网41与外层支撑网42的对折处采用圆弧形过渡，使得翻折端 部43与气道内壁70之间的接触面平滑过渡，减小支架本体10对气道内壁70的刺激。
在支架本体10植入后，翻折端部43的弧形面与气道内壁70接触，用于保持支架本体10固定，且同时保证了支架本体10两端部分气道黏膜纤毛的清洁作用，减少气道分泌物的潴留，还能够组织肉芽组织90增生。
气道支架的主要作用是，当支架植入恶性气道病变造成气道狭窄的部位后，气道本体10会压缩肿瘤80，以恢复气道中央通气。此时，气道本体10固定在气道内的主要机理是，位于支架本体10中部的腰部支架段30径向扩张力与肿瘤80相互作用，而使支架本体10无移位。
一般情况下，对于恶性肿瘤80在植入支架后，通常会进行放射化疗，放射化疗后肿瘤80会逐渐缩小，随着肿瘤80的缩小，腰部支架段30与肿瘤80之间的作用力会相对减小。当出现上述情况时，现有技术的气道支架容易产生位移。
而本申请由于翻折端部43相对于外层支撑网42朝向背离支架本体10的方向凸起，从而翻折端部43的外径大于腰部支架段30的外径。在肿瘤80缩小以后，虽然腰部支架段30与肿瘤80之间的作用力减小，但是翻折端部43与气道内壁7的作用力会相对增大，从而维持了支架本体10与气道之间的整体作用力，因此本申请的气道支架不容易产生位移。
在其他实施例中，结合图8所示，翻折端部43还可以为方形形 状。上述设置的好处在于，能够增加翻折端部43与气道内壁70之间的接触面积，增加支架本体10与气道内壁70的锚定力。
在其他实施例中，如图9所示，当第一密网段401与第二密网段402的翻折端部43结构不同时，第一密网段401的翻折端部43为方形，第二密网段402的翻折端部43为圆弧形。上述设置的好处在于，医生可以根据病人的实际情况，选择不同形状的翻折端部43，以适应不同病情的患者。
进一步的，结合图10至图12所示，覆膜20包括设置在腰部支架段30外表面的外膜22。为了进一步阻止气道内的恶性肿瘤80向支架本体10内生长，造成气道内壁70再狭窄或支架本体10不易取出，本实施例在腰部支架段30的外表面覆有一层生物相容性高分子覆膜20，用于进一步阻止恶性肿瘤80向支架本体10内生长。
其中，覆膜20的材质可选用PET、PTFE、ePTFE、硅胶、聚氨酯等，覆膜20的厚度根据支架本体10编织丝的大小和支架本体10的内外径而调整，本申请不做限制。
为了增强覆膜20与支架本体10之间的结合强度，并进一步阻止肿瘤向内生长，本申请的覆膜20还包括设置在腰部支架段30的内表面的内膜21，由于支架本体10存在网孔11，因此内膜21和外膜22可以通过腰部支架段30的网孔11进行结合固定。其中，内膜21和外膜22可以通过热熔固定，也可以通过粘接固定，内膜21与外膜22的材质可以选择相同或者不同。
因此，本实施例在腰部支架段30的两端设置密网裸支架段40， 且密网裸支架段40的网孔11的密度相较于腰部支架段30的网孔11的密度更大。同时，本发明的气道支架在保证密网裸支架段40与气道内壁70之间锚定力的同时，增大了密网裸支架段40与气道内壁70之间的接触面积，减少了气道内壁70单位面积所受到的压强，使得气道内壁70刺激变小，并且，由于腰部支架段30的两端采用了密网裸支架段40的设计，支架本体10两端也不会有分泌物潴留。
综上，通过使用本发明的气道支架，能够在不使气道分泌物在气道支架表面潴留的同时，减小气道支架对气道内壁的刺激，从而减少肉芽组织的增生，避免气道再次狭窄的发生。
实施例二
本申请的实施例二提供一种气道支架，如图1至图3所示，支架本体10包括腰部支架段30以及两个分别设置在腰部支架段30两端的密网裸支架段40，密网裸支架段40的网孔11的密度大于腰部支架段30的网孔11的密度，覆膜20设置在腰部支架段30上。密网裸支架段40为双层编织网结构，双层编织网结构的密网裸支架段40包括内层支撑网41以及外层支撑网42。内层支撑网41的一端连接于腰部支架段30，且内层支撑网41与腰部支架段30一体成型，内层支撑网41的另一端连接于外层支撑网42。结合图6，内层支撑网41的端部外翻并折回后形成外层支撑网42，内层支撑网41与外层支撑网42之间通过翻折端部43连接，翻折端部43相对于外层支撑网42朝向背离支架本体10的方向凸起。
如图13与图14所示，本实施例在外层支撑网42上还设置有至 少一个凸点支撑部44，所述凸点支撑部44与所述翻折端部43的形状相同或不同。其中，凸点支撑部44与外层支撑网42一体成型，凸点支撑部44由外层支撑网42朝向背离支架本体10的方向凸起形成。
凸点支撑部44可以为一个或多个，当凸点支撑部44为多个时，多个凸点支撑部44的形状可以相同或不同。凸点支撑部44的形状优选为圆弧形，也可以根据实际需要设置为方形等其他形状。
本实施例通过在外层支撑网42上增设凸点支撑部44，能够加强支架本体10与气道内壁70之间的锚定力，还能够减少翻折端部43和每个凸点支撑部44与气道内壁70之间的压强，降低支架本体10对气道内壁70的刺激，避免肉芽组织90的增生。
在其他实施例中，两个分别设置在腰部支架段30两端的密网裸支架段40包括设置在腰部支架段30一端的第一密网段401，以及设置在腰部支架段30另一端的第二密网段402。
当第一密网段401与第二密网段402的凸点支撑部44结构不同时，第一密网段401的凸点支撑部44可以均为圆弧形或其中一个凸点支撑部44为圆弧形，第二密网段402的凸点支撑部44可以均为方形或其中一个凸点支撑部44为方形。上述设置的好处在于，医生可以根据病人的实际情况，选择不同形状的凸点支撑部44，以适应不同病情的患者。
综上，本实施例通过增设凸点支撑部44，从而加强支架本体10与气道内壁70之间的锚定力，减少支架本体10与气道内壁70之间 整体的压强，降低支架本体10对气道内壁70的刺激，有效避免肉芽组织90增生。
实施例三
本申请的实施例三提供一种气道支架，如图1至图3所示，支架本体10包括腰部支架段30以及两个分别设置在腰部支架段30两端的密网裸支架段40，密网裸支架段40的网孔11的密度大于腰部支架段30的网孔11的密度，覆膜20设置在腰部支架段30上。如图5所示，密网裸支架段40为双层编织网结构，双层编织网结构的密网裸支架段40包括内层支撑网41以及外层支撑网42。内层支撑网41的一端连接于腰部支架段30，内层支撑网41的另一端连接于外层支撑网42。
其中，如图12所示，覆膜20包括设置在腰部支架段30外表面的外膜22以及设置在所述腰部支架段30内表面的内膜21，内膜21与外膜22通过腰部支架段30的网孔11进行结合固定，例如热熔结合的方式。
如图15所示，本实施例为了进一步阻止肿瘤80向内生长，也阻止支架本体10两端肉芽组织90的增生，支架本体10内还设置有覆盖密网裸支架段40内表面的延伸膜24，延伸膜24与内膜21一体设置，从而覆盖支架本体10的全内表面。
延伸膜24的材质可选用PET、PTFE、ePTFE、硅胶、聚氨酯等，延伸膜24的厚度根据实际需要设置。当延伸膜24与内膜21一体设置时，延伸膜24的材质与内膜21相同。
在其他实施方案中，延伸膜24与内膜21还可以与内膜21分别设置，此时，延伸膜24与内膜21的材质可以相同也可以不同。
由于在密网裸支架段40内表面也增设了延伸膜24，因此本实施例的覆膜20可以覆盖支架本体10的全内表面，不仅可以阻止肿瘤80向内生长，还可以阻止支架本体10两端的肉芽组织90向内生长。同时，支架本体10外翻部分，即外层支撑网42保持裸支架状态，外层支撑网42的外表面无覆膜20，从而使气道中黏膜纤毛的清洁能力保持不变，能够有效的清除气道内壁70分泌物的潴留。
在其他实施例中，外膜22还可以部分的覆盖密网裸支架段40，从而提高密网裸支架段40与腰部支架段30之间的连接力。
综上，本实施例通过在支架本体10内侧设置覆盖密网裸支架段40内表面的延伸膜24，从而在阻止肿瘤80向内生长的同时，阻止支架本体10两端肉芽组织90的增生。
实施例四
本申请的实施例四提供一种气道支架，如图1至图3所示，支架本体10包括腰部支架段30以及两个分别设置在腰部支架段30两端的密网裸支架段40，密网裸支架段40的网孔11的密度大于腰部支架段30的网孔11的密度，覆膜20设置在腰部支架段30上。如图5所示，密网裸支架段40为双层编织网结构，双层编织网结构的密网裸支架段40包括内层支撑网41以及外层支撑网42。内层支撑网41的一端连接于腰部支架段30，内层支撑网41的另一端连接于外层支撑网42。
其中，如图12所示，覆膜20包括设置在腰部支架段30外表面的外膜22以及设置在所述腰部支架段30内表面的内膜21，内膜21与外膜22通过腰部支架段30的网孔11进行结合固定，例如热熔结合的方式。
如图16所示，本实施例为了进一步阻止肿瘤80向内生长和肉芽组织90的增生，在内层支撑网41与外层支撑网42之间设置有夹层膜23。通过夹层膜23的设置，不仅能够阻止肿瘤80向内生长和肉芽组织90的增生，还能够保持气道内壁70中黏膜纤毛的清洁能力。
具体的，支架本体10内侧表面覆有内膜21，支架本体10外侧表面覆有外膜22，支架本体10两端外翻折回的外层支撑网42与内层支撑网41之间的夹层部分设置覆有夹层膜23，夹层膜23能够紧贴内层支撑网41。
夹层膜23的材质可选用PET、PTFE、ePTFE、硅胶、聚氨酯等，夹层膜23的厚度根据实际需要设置。
在其他实施方案中，如图17所示，为了使夹层膜23的熔接性更好，支架本体10内还设置有覆盖密网裸支架段40内表面的延伸膜24，延伸膜24与内膜21一体设置，从而覆盖支架本体10的全内表面。夹层膜23与延伸膜24之间通过内层支撑网41的网孔11进行结合固定，其中，夹层膜23与延伸膜24之间可以通过热熔固定，也可以通过粘接固定。
综上，本实施例通过在内层支撑网41与外层支撑网42之间增 设夹层膜23，从而在不影响气道内壁70的黏膜纤毛的清洁能力的同时，阻止肿瘤80向内生长和肉芽组织90的增生。
实施例五
本申请的实施例五提供一种气道支架，如图1至图3所示，支架本体10包括腰部支架段30以及两个分别设置在腰部支架段30两端的密网裸支架段40，密网裸支架段40的网孔11的密度大于腰部支架段30的网孔11的密度，覆膜20设置在腰部支架段30上。密网裸支架段40为双层编织网结构，双层编织网结构的密网裸支架段40包括内层支撑网41以及外层支撑网42。内层支撑网41的一端连接于腰部支架段30，内层支撑网41的另一端连接于外层支撑网42。
其中，如图12所示，覆膜20包括设置在腰部支架段30外表面的外膜22以及设置在所述腰部支架段30内表面的内膜21，内膜21与外膜22通过腰部支架段30的网孔11进行结合固定，例如热熔结合的方式。
如图18与图19所示，本实施例为了进一步提高覆膜20与支架本体10的结合强度，防止覆膜20与支架分离，在腰部支架段30上设置了用于增加覆膜20与所述腰部支架段30连接强度的缝合线50。
在其他实施例中，覆膜20还可以部分地覆盖在密网支架段40上，且缝合线50缝合在密网裸支架段40上。
在本实施例中，缝合线50穿过腰部支架段30或密网裸支架段40的网孔11，并绕支架本体10外缘和覆膜20的边缘内外穿设，形成波浪形的线型结构，然后往复缠绕拉紧，使得覆膜20紧紧贴在支 架本体10的编织丝上。在本实施方案中，缝合线50绕支架本体10外缘至少一周，从而将覆膜20的一整圈完全缝合固定在支架本体10上。
缝合线50可以每隔一个网孔11穿设一次，也可以每隔多个网孔11穿设一次，如图20所示，为缝合线50每隔四个网孔11穿设一次。缝合线50穿过覆膜20时会产生穿刺孔，如果穿刺孔过多，会导致覆膜20的强度受到影响。因此，缝合线50穿设的间隔可以根据缝合线50的材质等实际情况进行选择，本实施例不作限定。
由于穿刺孔过多会导致覆膜20的强度受到影响，因此缝合线50在从内向外、从外向内穿过同一个网孔11时，共用一个穿刺孔，从而减少穿刺孔的数量。
其中，缝合线50优选PET、PTFE、ePTFE等材质，缝合线50的外径根据支架本体10编织丝的丝径和覆膜20的厚度确定，本申请不作限制。
在其他实施例中，如图21与图22，覆膜20还可以采用部分缝合的方式，即缝合线50设置为绕支架本体10外缘的长度小于一整周。采用部分缝合的方式，可以在保证覆膜20结构强度的同时，增强覆膜20与支架本体10之间的结构强度。
当覆膜20采用部分缝合的方式时，缝合线50可以采用叠层缝合的方式。具体的，缝合线50设置在覆膜20的边缘，并通过内外穿刺的方式缝合线50拉紧覆膜20，为了增强局部的缝合强度，缝合线50在进行内外穿刺时穿刺孔错位设置。
通过上述实施方式，使的缝合线50形成若干首尾连接或者错位重叠的缝合圈51，每个缝合圈51均穿过支架本体10的网孔11。优选的，相邻的缝合圈51具有重叠的部分。由于相邻的缝合圈51具有重叠的部分，因此缝合线50整体的缝合强度增加，实现了在不影响覆膜20强度的同时，增强缝合强度的目的。
综上，本实施例通过在支架本体10上增加缝合线50，通过缝合线50将覆膜20缝合在腰部支架段30上，从而增强了覆膜20与支架本体10的结合强度，有效防止覆膜20与支架本体10脱离。
实施例六
本申请的实施例六提供一种气道支架，如图1与图2所示，支架本体10包括腰部支架段30以及两个分别设置在腰部支架段30两端的密网裸支架段40，密网裸支架段40的网孔11的密度大于腰部支架段30的网孔11的密度，覆膜20设置在腰部支架段30上。
如图23所示，本实施例为了进一步在支架本体10植入气道后，方便支架的撤出或回收，在支架本体10上设置了回收线60。回收线60设置在支架本体10一端的密网裸支架段40上，且回收线60沿密网裸支架段40的边缘穿设。
其中，如图24与图25所示，密网裸支架段40包括内层支撑网41以及外层支撑网42，回收线60至少部分地穿设在内层支撑网41与外层支撑网42之间。回收线60包括连接线61以及操作线62，连接线61至少部分地设在内层支撑网41与外层支撑网42之间，操作线62的一端与连接线61连接，操作线62的另一端位于支架本体10 外用于医生操作。
具体操作时，医生通过拉动操作线62，连接线61在操作线62的带动下，使密网裸支架段40的开口处直径缩小。由于密网裸支架段40的开口处直径缩小，因此密网裸支架段40的开口处会与气道内壁70分离，使得支架本体10与气道内壁70之间的作用力减小，便于医生将气道支架取出。
当密网裸支架段40为单层密集编织网结构时，连接线61沿密网裸支架段40的边缘穿设。当密网裸支架段40为双层或多层编织网结构时，连接线61可以部分位于两层编织网之间，也可以全部位于两层编织网之间。
在本实施例中，密网裸支架段40为双层编织网结构。连接线61可以部分位于内层支撑网41和外层支撑网42之间，且部分位于外层支撑网42之外。连接线61还可以全部位于内层支撑网41和外层支撑网42之间，当连接线61全部位于内层支撑网41和外层支撑网42之间时，连接线61在移动时受到的摩擦力更小，收缩密网裸支架段40的开口处所需要的的力更小，便于医生的回收操作。
综上所述，本申请提供的气道支架在腰部支架段上设置覆膜，通过覆膜减少腰部支架段给气道内壁造成的刺激，然后在腰部支架段的两端设置密网裸支架段，且密网裸支架段的孔径相较于腰部支架段的孔径更小。因此，本申请的气道支架在保证密网裸支架段与气道内壁之间锚定力的同时，增大了密网裸支架段与气道内壁之间的接触面积，减少了气道内壁单位面积所受到的压强，使得气道内 壁刺激变小，并且，由于腰部支架段的两端采用了密网裸支架段的设计，气道支架两端也不会有分泌物潴留。因此，通过使用本申请的气道支架，能够在不使气道分泌物在气道支架表面潴留的同时，减小气道支架对气道内壁的刺激，从而减少肉芽组织的增生，避免气道再次狭窄的发生。
实施例七
本申请的实施例七提供一种气道支架，如图26至图28所示，包括支架本体10以及设置在支架本体10上的覆膜20，支架本体10包括腰部支架段30以及设置在腰部支架段30端部的密网裸支架段40，覆膜20设置在腰部支架段30上。本实施例中，密网裸支架段40的网丝的丝径小于腰部支架段30的网丝的丝径，密网裸支架段40为单层密集编织网结构。
支架本体10的网丝之间形成有网孔11。密网裸支架段40为外侧无膜结构设置的支架段，腰部支架段30的至少一端设置有密网裸支架段40，由于密网裸支架段40的外侧无膜结构设置，从而不影响气道内壁70纤毛的功能，保证了气道分泌物不会在气道本体上潴留。且本申请的腰部支架段30上设置有覆膜20，从而减少支架本体10对气道内壁70的刺激。
具体的，支架本体10包括多根第一编织丝403以及多根第二编织丝301，密网裸支架段40的网丝为第一编织丝403，密网裸支架段40通过第一编织丝403编织形成，腰部支架段30的网丝为第二编织丝301，腰部支架段30通过第二编织丝301编织形成，第一编 织丝403的丝径小于第二编织丝301的丝径，第一编织丝403与第二编织丝301均为形状记忆合金丝，优选镍钛丝。
由于腰部支架段30上设置有覆膜20，因此腰部支架段30的第二编织丝301通过覆膜20与气道内壁70接触，而密网裸支架段40的第一编织丝403直接与气道内壁70接触，容易对气道内壁70造成刺激。因此通过将密网裸支架段40的第一编织丝403的丝径减小，从而减小单根第一编织丝403对气道内壁70的压力，并使得密网裸支架段40更加柔软，进而减小直接与气道内壁70接触的密网裸支架段40对气道内壁70的刺激，防止肉芽组织90生长。
如图28所示，密网裸支架段40的第一编织丝403数量设置为等于腰部支架段30的第二编织丝301数量，通过将第一编织丝403的丝径设置为小于第二编织丝301的网丝的丝径，从而降低单根第一编织丝403对气道内壁70的压强，进而减小密网裸支架段40整体对于气道内壁70的压力，也能够有效减小气道支架对气道内壁70的刺激，防止肉芽组织90增生。
进一步地，结合图29与图30所示，密网裸支架段40的第一编织丝403的数量设置为大于腰部支架段30的第二编织丝301的数量。
由于第一编织丝403的丝径相较于第二编织丝301的丝径更小，因此单根第一编织丝403的径向支撑力小于第二编织丝301的径向支撑力。为了进一步提升密网裸支架段40与气道内壁70之间的锚定力，将第一编织丝403的数量设置为大于第二编织丝301的数量。即，通过减小单根网丝的丝径，并增加网丝数量的方式，使得密网 裸支架段40对气道内壁70的压力更加均匀。在保证密网裸支架段40整体锚定力的同时，降低了单根网丝对气道内壁70的压力，减少了气道内壁70单位面积所受到的压强，使得气道内壁70刺激变小。
在本实施例中，密网裸支架段40与腰部支架段30分体成型，且密网裸支架段40与腰部支架段30通过连接部25固定。
如图29所示，当密网裸支架段40与腰部支架段30分体成型，且密网裸支架段40与腰部支架段30通过连接部25固定时。连接部25为连接膜，密网裸支架段40与腰部支架段30分别与连接膜连接固定，从而密网裸支架段40与腰部支架段30通过连接膜间接地固定连接。
在其他实施方式中，如图30所示，连接部25还可以为焊接点，密网裸支架段40的第一编织丝403还可以通过焊接的方式与腰部支架段30的第二编织丝301固定连接。
在其他实施方式中，连接部25还可以为钢套(图未示)，密网裸支架段40的第一编织丝403和腰部支架段30的第二编织丝301的连接端通过钢套套接固定。
需要说明的是，本申请上述对于分段成型的密网裸支架段40和腰部支架段30的连接方式仅仅为示例，任何能够连接密网裸支架段40和腰部支架段30的连接方式均可以应用在本申请中。
对于分体成型的密网裸支架段40和腰部支架段30，在分别制作成型以后通过连接部25连接，成型方式简单且结构设计灵活，在设计及生产过程中，可以根据实际需要选择不同的网丝丝径、网丝数 量和编织方式，多样化程度高，能够适应各种不同病情的患者的需求。
其中，如图26与图31所示，覆膜20包括设置在腰部支架段30外表面的外膜22，覆膜20还可以包括设置在腰部支架段30内表面的内膜21，内膜21与外膜22通过腰部支架段30的网孔11进行结合固定。
具体的，为了进一步阻止气道内的恶性肿瘤80向支架本体10内生长，造成气道内壁70再狭窄或支架本体10不易取出，本实施例在腰部支架段30的外表面覆有一层生物相容性高分子覆膜20，用于进一步阻止恶性肿瘤80向支架本体10内生长。
其中，覆膜20的材质可选用PET、PTFE、ePTFE、硅胶、聚氨酯等，覆膜20的厚度根据支架本体10编织丝的大小和支架本体10的内外径而调整，本申请不做限制。
为了增强覆膜20与支架本体10之间的结合强度，并进一步阻止肿瘤80向内生长，本申请的覆膜20还包括设置在腰部支架段30的内表面的内膜21，由于支架本体10存在网孔11，因此内膜21和外膜22可以通过腰部支架段30的网孔11进行结合固定。其中，内膜21和外膜22可以通过热熔固定，也可以通过粘接固定，内膜21与外膜22的材质可以选择相同或者不同。
综上所述，根据本申请的气道支架，首先，在腰部支架段30上设置覆膜20，覆膜20既可以减少腰部支架段30给气道内壁70造成的刺激，同时覆膜20还可以阻止肿瘤80向气道支架内部生长。
其次，在腰部支架段30的端部设置密网裸支架段40，并且所述密网裸支架段40的网丝的丝径小于所述腰部支架段30的网丝的丝径，降低了单根网丝对气道内壁70的压力。本发明进一步将密网裸支架段40的网丝的数量设置为大于腰部支架段30的网丝的数量，从而保证密网裸支架段40与气道内壁70之间锚定力，减少了气道内壁70单位面积所受到的压强，使得气道内壁70受到刺激变小。
另外，由于腰部支架段30的两端采用了密网裸支架段40的设计，气道支架两端也不会有分泌物潴留。因此，通过使用本发明的气道支架，能够不使气道分泌物在气道支架表面潴留，阻止肿瘤80向气道支架内部生长，减小气道支架对气道内壁70的刺激从而减少肉芽组织90的增生，避免气道再次狭窄的发生。
实施例八
本申请的实施例八提供一种气道支架，如图32至图34所示，实施例八与实施例七的相同之处不再赘述，实施例八与实施例七的不同之处在于，密网裸支架段40与腰部支架段30一体编织成型。具体的，密网裸支架段40通过第一编织丝403编织形成，腰部支架段30通过第二编织丝301编织形成。多根第一编织丝403相互缠绕形成第二编织丝301。
在支架本体10编织成型的过程包括如下步骤：
首先，将至少两根第一编织丝403以相互缠绕的形式，制备成第二编织丝301。通过多根制备完成的第二编织丝301编织位于支架本体10腰部位置的腰部支架段30。
然后，当腰部支架段30编织成型以后，将腰部支架段30两端未进行编织的网丝拆散，重新形成第一编织丝403。通过多根拆散的第一编织丝403编织位于支架本体10两端的密网裸支架段40。
最后，对编织完成的支架本体10进行热定型处理。
需要说明的是，第二编织丝301可以通过两根第一编织丝403相互缠绕形成，如图35所示，也可以通过三根第一编织丝403相互缠绕编织形成，用于制备第而编织丝的第一编织丝403的数量根据实际需要进行选择。
另外，支架本体10可以包括一个设置在腰部支架段30一端的密网裸支架段40，支架本体10也可以包括两个分别设置在腰部支架段30两端的密网裸支架段40，具体根据病人的实际病情进行选择。
由上，通过一体编织并热定型处理得到的支架本体10柔顺性更好，边缘更加光滑，支架本体10的结构更加牢固，安全性更高。
在其他实施方案中，如图36与图37所示，第一编织丝403包括一根主编织丝404以及至少一根副编织丝405，副编织丝405缠绕在主编织丝404上形成第二编织丝301，第二编织丝301编织形成腰部支架段30。具体的，主编织丝404的丝径大于副编织丝405的丝径，在主编织丝404与副编织丝405之间进行缠绕时，副编织丝405呈螺旋状缠绕在主编织丝404上形成第二编织丝301。
根据本实施方案，一方面，通过设置主编织丝404的方式保证了腰部支架段30的编织结构整体的稳固性，通过增加副编织丝405的方式增加了第二编织丝301的整体径向支撑力。另一方面，通过 主编织丝404与副编织丝405混合编织形成的密网裸支架段40，由于副编织丝405的丝径相比主编织丝404的丝径小，因此单根副编织丝405对气道内壁70的压力更小，减少了气道内壁70单位面积所受到的压强，能够进一步减小密网裸支架段40对气道内壁70造成的刺激。
如图36所示，密网裸支架段40的端部包括由多根第一编织丝403汇聚形成的网丝集中点45，当采用副编织丝405缠绕在主编织丝404上形成第二编织丝301的方式时，副编织丝405的头端还可以直接连接在密网裸支架段40的端部，从而减少密网裸支架段40的网丝集中点45的数量，增强了单个网丝集中点45的强度，使得密网裸支架段40的端部的锚定力更强，有效防止支架本体10位移。
实施例九
本申请的实施例九提供一种气道支架，如图38至图40所示，实施例九与实施例八的相同之处不再赘述，实施例九与实施例八的不同之处在于，支架本体10还包括至少一根第三编织丝302，腰部支架段30通过第二编织丝301和第三编织丝302混合编织形成，密网裸支架40段通过第一编织丝403和第三编织丝302混合编织形成。第二编织丝301可以通过若干丝径相同的第一编织丝403编织形成，也可以通过丝径不同的主编织丝404和副编织丝405编织形成。
具体的，在支架本体10制备时，可以通过设置第三编织丝302的丝径和数量，调整支架本体10整体的径向支撑力，还可以调整密网裸支架段40对气道内壁70的压强。
其中，在第二编织丝301与第三编织丝302的总数量不变的情况下，第三编织丝302的丝径越大支架本体10整体的径向支撑力越大。例如，当选择第三编织丝302的丝径大于第二编织丝301的丝径时，可以增加支架本体10整体的径向支撑力；当选择第三编织丝302的丝径大于第一编织丝403的丝径，且小于或等于第二编织丝301的丝径时，可以在保证腰部支架段30的径向支撑力的同时，减小密网裸支架段40的径向支撑力；当选择第三编织丝302的丝径小于或等于第一编织丝403的丝径时，可以减小支架本体10整体的径向支撑力。
其中，在第二编织丝301与第三编织丝302的总数量不变的情况下，第三编织丝302的数量越多第二编织丝301的数量越少，则第一编织丝403的数量也越少，密网裸支架段40的网丝数量也越少，因此，密网裸支架段40对气道内壁70的压强越大；反之同理。
根据实施例的气道支架，不仅可以防止气道支架两端分泌物潴留，防止肿瘤80向气道支架内部生长，防止肉芽组织90生长。还可以通过灵活调整第一编织丝403、第二编织丝301和第三编织丝302的丝径和数量，灵活调整支架本体10整体的径向支撑力，以及密网裸支架段40对气道内壁70的压强，从而适应不同患者的需求。
以上，仅为本发明较佳的具体实施方式，但本发明的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本发明揭露的技术范围内，可轻易想到的变化或替换，都应涵盖在本发明的保护范围之内。因此，本发明的保护范围应以权利要求的保护范围为准。

Claims (30)

  1. 一种气道支架，包括支架本体以及设置在支架本体上的覆膜，其特征在于，所述支架本体包括腰部支架段以及设置在所述腰部支架段端部的密网裸支架段，所述覆膜设置在所述腰部支架段上，所述密网裸支架段的网孔密度大于所述腰部支架段的网孔密度。
  2. 根据权利要求1所述的气道支架，其特征在于，所述密网裸支架段包括单层密集编织网结构或多层编织网结构。
  3. 根据权利要求2所述的气道支架，其特征在于，所述密网裸支架段包括内层支撑网以及外层支撑网，所述内层支撑网的一端连接于所述腰部支架段，所述内层支撑网的另一端连接于所述外层支撑网；或者所述外层支撑网的一端连接于所述腰部支架段，所述外层支撑网的另一端连接于所述内层支撑网。
  4. 根据权利要求3所述的气道支架，其特征在于，所述内层支撑网与所述腰部支架段一体成型，所述内层支撑网的端部外翻并折回后形成所述外层支撑网，所述内层支撑网与所述外层支撑网之间通过翻折端部连接。
  5. 根据权利要求4所述的气道支架，其特征在于，所述翻折端部相对于所述外层支撑网朝向背离所述支架本体的方向凸起；所述外层支撑网上设置有至少一个凸点支撑部，所述凸点支撑部与所述翻折端部的形状相同或不同。
  6. 根据权利要求3所述的气道支架，其特征在于，所述内层支撑网与所述外层支撑网之间设置有夹层膜。
  7. 根据权利要求1所述的气道支架，其特征在于，所述覆膜包 括设置在所述腰部支架段外表面的外膜以及设置在所述腰部支架段内表面的内膜，所述内膜与所述外膜通过所述腰部支架段的网孔进行结合固定。
  8. 根据权利要求1-7任一项所述的气道支架，其特征在于，所述支架本体内还设置有覆盖所述密网裸支架段内表面的延伸膜。
  9. 根据权利要求1所述的气道支架，其特征在于，所述腰部支架段上设置有用于增加所述覆膜与所述腰部支架段连接强度的缝合线。
  10. 根据权利要求1所述的气道支架，其特征在于，所述支架本体一端的所述密网裸支架段上设置有回收线，所述回收线沿所述密网裸支架段的边缘穿设。
  11. 一种气道支架，包括支架本体以及设置在支架本体上的覆膜，其特征在于，所述支架本体包括腰部支架段以及设置在所述腰部支架段端部的密网裸支架段，所述覆膜设置在所述腰部支架段上，所述覆膜包括设置在所述腰部支架段外表面的外膜以及设置在所述腰部支架段内表面的内膜。
  12. 根据权利要求11所述的气道支架，其特征在于，所述内膜与所述外膜通过所述腰部支架段的网孔进行结合固定。
  13. 根据权利要求11所述的气道支架，其特征在于，所述支架本体内还设置有覆盖所述密网裸支架段内表面的延伸膜。
  14. 根据权利要求11所述的气道支架，其特征在于，所述密网裸支架段的网孔密度大于所述腰部支架段的网孔密度，所述密网裸 支架段为单层密集编织网结构或多层编织网结构。
  15. 根据权利要求14所述的气道支架，其特征在于，所述密网裸支架段包括内层支撑网以及外层支撑网，所述内层支撑网的一端连接于所述腰部支架段，所述内层支撑网的另一端连接于所述外层支撑网；或者所述外层支撑网的一端连接于所述腰部支架段，所述外层支撑网的另一端连接于所述内层支撑网。
  16. 根据权利要求15所述的气道支架，其特征在于，所述内层支撑网与所述外层支撑网之间设置有夹层膜。
  17. 根据权利要求15所述的气道支架，其特征在于，所述内层支撑网与所述腰部支架段一体成型，所述内层支撑网的端部外翻并折回后形成所述外层支撑网，所述内层支撑网与所述外层支撑网之间通过翻折端部连接。
  18. 根据权利要求15所述的气道支架，其特征在于，所述翻折端部相对于所述外层支撑网朝向背离所述支架本体的方向凸起，所述外层支撑网上设置有至少一个凸点支撑部，所述凸点支撑部与所述翻折端部的形状相同或不同。
  19. 根据权利要求11所述的气道支架，其特征在于，所述腰部支架段上设置有用于增加所述覆膜与所述腰部支架段连接强度的缝合线。
  20. 根据权利要求11所述的气道支架，其特征在于，所述支架本体一端的所述密网裸支架段上设置有回收线，所述回收线沿所述密网裸支架段的边缘穿设。
  21. 一种气道支架，包括支架本体以及设置在支架本体上的覆膜，其特征在于，所述支架本体包括腰部支架段以及设置在所述腰部支架段端部的密网裸支架段，所述覆膜设置在所述腰部支架段上，所述密网裸支架段的网丝的丝径小于或等于所述腰部支架段的网丝的丝径。
  22. 根据权利要求21所述的气道支架，其特征在于，所述密网裸支架段的网丝的数量大于所述腰部支架段的网丝的数量。
  23. 根据权利要求22所述的气道支架，其特征在于，所述密网裸支架段包括单层密集编织网结构或多层编织网结构。
  24. 根据权利要求23所述的气道支架，其特征在于，所述密网裸支架段与所述腰部支架段分体成型，且所述密网裸支架段与所述腰部支架段之间通过连接部固定；所述密网裸支架段与所述腰部支架段一体编织成型。
  25. 根据权利要求24所述的气道支架，其特征在于，所述支架本体包括多根第一编织丝以及多根第二编织丝，所述密网裸支架段通过第一编织丝编织形成，所述腰部支架段通过第二编织丝编织形成；多根所述第一编织丝相互缠绕形成所述第二编织丝。
  26. 根据权利要求25所述的气道支架，其特征在于，所述第一编织丝包括一根主编织丝以及至少一根副编织丝，所述副编织丝缠绕在所述主编织丝上形成所述第二编织丝。
  27. 根据权利要求25或26所述的气道支架，其特征在于，所述支架本体还包括至少一根第三编织丝，所述腰部支架段通过第二 编织丝和第三编织丝混合编织形成，所述密网支架段通过第一编织丝和第三编织丝混合编织形成。
  28. 根据权利要求21所述的气道支架，其特征在于，所述覆膜包括设置在所述腰部支架段外表面的外膜。
  29. 根据权利要求28所述的气道支架，其特征在于，所述覆膜还包括设置在所述腰部支架段内表面的内膜，所述内膜与所述外膜通过所述腰部支架段的网孔进行结合固定。
  30. 根据权利要求21所述的气道支架，其特征在于，所述腰部支架段上设置有用于增加所述覆膜与所述腰部支架段连接强度的缝合线。
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