WO2022068453A1 - 一种硅酮支架、置入系统及制造方法 - Google Patents

一种硅酮支架、置入系统及制造方法 Download PDF

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Publication number
WO2022068453A1
WO2022068453A1 PCT/CN2021/113300 CN2021113300W WO2022068453A1 WO 2022068453 A1 WO2022068453 A1 WO 2022068453A1 CN 2021113300 W CN2021113300 W CN 2021113300W WO 2022068453 A1 WO2022068453 A1 WO 2022068453A1
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Prior art keywords
silicone
frame
mesh frame
stent
protrusions
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PCT/CN2021/113300
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English (en)
French (fr)
Inventor
蒋军红
王昌国
曾大雄
冷德嵘
韦建宇
沈正华
冯明浩
Original Assignee
南微医学科技股份有限公司
苏州大学附属第一医院
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Application filed by 南微医学科技股份有限公司, 苏州大学附属第一医院 filed Critical 南微医学科技股份有限公司
Priority to US18/015,390 priority Critical patent/US20230233314A1/en
Priority to DE212021000378.8U priority patent/DE212021000378U1/de
Publication of WO2022068453A1 publication Critical patent/WO2022068453A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • 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
    • A61F2/02—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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00179—Ceramics or ceramic-like 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00179—Ceramics or ceramic-like structures
    • A61F2310/00185—Ceramics or ceramic-like structures based on metal oxides
    • A61F2310/00215—Ceramics or ceramic-like structures based on metal oxides containing silica or silicon oxide

Definitions

  • the present disclosure relates to the technical field of medical devices, and in particular, to a silicone stent, an implantation system and a manufacturing method.
  • An endotracheal stent is a support that is inserted into the trachea and has a certain tension and elasticity. The endotracheal stent is inserted into the trachea to stretch the trachea to ensure the smooth flow of the trachea.
  • Existing endotracheal stents are divided into metal stents and non-metallic stents. Non-metallic stents are further divided into silicone stents and plastic stents. After long-term clinical research, it was found that the long-term complications of silicone stents, such as granulation hyperplasia and scar stenosis, were significantly less than those of metal stents, and it had the advantages of easy removal after long-term placement. Therefore, silicone stents are recommended for benign trachea that require stent treatment. stenotic patients.
  • the existing silicone stent when the existing silicone stent is released, it needs to be placed in a specific pusher, and a rigid bronchoscope is used under general anesthesia. According to the measurement method, the stent is released under blind vision. The placement is difficult and the operation is difficult, which leads to implantation. Operation has a long learning curve.
  • the objects of the present disclosure include, for example, to provide a silicone stent, which can improve the technical problems of difficult placement of silicone stents, high surgical difficulty and long learning curve in the prior art.
  • the present disclosure also aims to provide an implantation system, which can improve the technical problems of difficult placement of silicone stents, high surgical difficulty and long learning curve in the prior art.
  • the present disclosure also aims to provide a manufacturing method, which can manufacture the above-mentioned silicone stent, and thus can also improve the technical problems of difficult placement of the silicone stent, high surgical difficulty and long learning curve in the prior art.
  • An embodiment of the present disclosure provides a silicone stent, which includes a frame body, the frame body includes a mesh frame and a silicone body formed on the mesh frame, and a circumferential direction is defined inside the silicone body A sealed space, the distal end and the proximal end of the silicone body respectively have a distal opening and a proximal opening communicated with the space; the mesh frame circumferentially covers the silicone body, and is arranged along the length of the silicone body. Axially, the grid extends from the proximal end of the silicone body to the distal end of the silicone body.
  • the outer peripheral wall of the frame body is protruded with a plurality of protrusions.
  • the collision between the protrusions and the wall surface of the trachea can help to improve the problem of displacement of the silicone stent relative to the trachea during use, that is, the protrusions can stabilize the stent in the trachea. the role of location.
  • the protrusions are integrally formed with the silicone body.
  • the mesh frame has protrusions, and the protrusions are coated to form the protrusions.
  • the protrusions are adhesively fixed to the frame body.
  • a plurality of the protrusions include a plurality of rows of protrusions evenly distributed along the circumferential direction of the frame body, and each row of the protrusions includes spaced apart along the axial direction of the frame body a plurality of said protrusions.
  • a plurality of protrusions in two adjacent rows of the protrusions are alternately arranged along the axial direction of the frame body; or, a plurality of the protrusions in each row of the protrusions spirally distributed around the axis of the frame body; or, a plurality of the protrusions are distributed and distributed.
  • the protrusions By arranging protrusions on the outer wall surface of the frame body, and specifically setting the protrusions, after the silicone stent is placed in the human trachea, the protrusions collide with the wall surface of the trachea, thereby separating the wall surface of the trachea from the outer peripheral wall of the frame body, and the trachea
  • the cilia on the wall surface have a certain space to swing, and then the secretions around the silicone stent can be removed through the cilia, that is, the function of the cilia to remove mucus is retained, and the use of the silicone stent is better.
  • the thickness of the protrusion (120) is h, 0.5mm ⁇ h ⁇ 4mm.
  • the wall thickness of the frame body is d, and 0.05mm ⁇ d ⁇ 0.8mm.
  • the silicone body coating is formed on the grid.
  • the silicone body is formed on the mesh frame by means of film coating, so that the thickness of the silicone body can be made small more conveniently and simply, that is, the thickness of the frame body of the silicone stent is small, which further ensures that the silicone stent can be installed
  • the implanter is used to realize the placement of the silicone stent by using the OTW method.
  • the mesh frame is woven from a single wire.
  • the silicone body is secured to the periphery of the grid.
  • the frame body further comprises skirts connected to both ends of the silicone body; along the axial direction of the silicone support, the skirts are located on both sides of the mesh frame .
  • the skirt is integrally formed with the silicone body.
  • the frame body further includes a silicone layer wrapping the mesh frame, and the silicone body is fixedly connected to the silicone layer.
  • Embodiments of the present disclosure also provide an implant system.
  • the implantation system includes an implanter and a silicone stent.
  • the silicone support includes a frame body, the frame body includes a mesh frame and a silicone body formed on the mesh frame, a circumferentially sealed space is defined inside the silicone body, and the far side of the silicone body is The end and the proximal end respectively have a distal opening and a proximal opening communicating with the space; the mesh frame circumferentially covers the silicone body, and along the axial direction of the silicone body, the mesh frame extends from the silicone body.
  • the proximal end of the ketone body extends to the distal end of the silicone body.
  • the implanter has an accommodating cavity, and the silicone stent is accommodated in the accommodating cavity in a contracted state, so that the silicone stent can be placed through the implanter.
  • Embodiments of the present disclosure also provide a manufacturing method for manufacturing a silicone stent. Manufacturing methods include:
  • the silicone body is formed on the cylindrical mesh frame, so that the interior of the silicone body defines a circumferentially sealed space, and the distal end and the proximal end of the silicone body are respectively provided with a proximal end opening that communicates with the space and a distal opening; the mesh frame circumferentially covers the silicone body, and along the axial direction of the silicone body, the mesh frame extends from the proximal end of the silicone body to the end of the silicone body remote.
  • the step of forming the silicone body on the cylindrical mesh frame includes: coating the mesh frame with silicone to form the silicone on the mesh frame ontology;
  • the mesh frame has a convex portion, and the convex portion is coated with silicone to form the protrusion of the silicone support.
  • the step of forming the silicone body on the cylindrical mesh frame includes: coating the mesh frame with silicone to form the silicone on the mesh frame body to obtain the frame of the silicone body;
  • the step includes: adhering the protrusions to the outer wall of the frame to obtain the silicone support.
  • the step of forming the silicone body on the cylindrical mesh frame comprises: placing the mesh frame in a mold;
  • the liquid silicone is coated on the mesh frame to form the silicone body, and the outer wall of the silicone body is provided with protrusions corresponding to the grooves.
  • the step of forming the silicone body on the cylindrical mesh frame includes:
  • the proximal end and the distal end of the grid frame are respectively bonded and fixed on the inner peripheral wall of the silicone cylinder, and the part of the silicone cylinder located between the proximal end and the distal end of the grid frame forms the silicone body, and the silicone body is formed. Both axial ends of the silicone cylinder protrude from the grid to form skirts.
  • the step of forming the silicone body on the cylindrical mesh frame includes:
  • the silicone cylinder is sleeved on the mesh frame covered with the silicone layer; the silicone cylinder and the mesh frame covered with the silicone layer are vulcanized to make the silicone cylinder and the The silicone layer is bonded; the part of the silicone cylinder between the proximal end and the distal end of the mesh frame forms the silicone body, and the axial ends of the silicone cylinder protrude from the mesh
  • the frame forms the skirt.
  • the beneficial effects of the silicone stent, the implantation system and the manufacturing method of the embodiments of the present disclosure include, for example:
  • the silicone stent provided by the embodiments of the present disclosure includes a stent body.
  • the frame body includes a mesh frame and a silicone body formed on the mesh frame.
  • the interior of the silicone body defines a circumferentially sealed space, and the distal end and the proximal end of the silicone body respectively have a distal opening and a proximal opening communicating with the space, and the silicone stent is placed into the human trachea during use, and the silicone
  • the space defined inside the ketone body connects the trachea to ensure that the trachea is in a smooth state.
  • the frame body of the silicone stent is jointly formed by the mesh frame and the silicone body, and the mesh frame covers the silicone body in the circumferential direction, the axial mesh frame extends from the proximal end of the silicone body to the distal end of the silicone body, so that through the mesh
  • the frame can effectively improve the support force of the frame body.
  • the support force of the frame body is only provided by the silicone body itself.
  • the silicone support provided in this embodiment can greatly reduce the wall of the silicone body. Thickness, and the wall thickness of the formed frame is also greatly reduced, so when implanting, the silicone stent can be put into the implanter, and the traditional OTW method can be used in the implanter. Implantation under side-view helps to reduce the difficulty of insertion and the difficulty of surgery, which can effectively shorten the learning curve of the implantation operation.
  • Embodiments of the present disclosure also provide an implantation system, which includes an implanter and the above-mentioned silicone stent.
  • the implantation system can use the traditional OTW method to insert the silicone stent into the human trachea through the implanter, so it has the beneficial effects of low implantation difficulty of the silicone stent, low surgical difficulty and short implantation operation learning curve.
  • the embodiments of the present disclosure also provide a manufacturing method, which can manufacture the above-mentioned silicone stent, so the manufactured silicone stent also has the beneficial effects of low difficulty in implantation, low difficulty in surgery, and short learning curve for implantation operation.
  • FIG. 1 is a schematic structural diagram of a silicone stent provided in an embodiment of the present disclosure from a first perspective;
  • FIG. 2 is a schematic structural diagram of an implanter provided by an embodiment of the present disclosure
  • FIG. 3 is a schematic cross-sectional view of a partial structure of an implanter provided by an embodiment of the present disclosure
  • FIG. 4 is a schematic structural diagram of the silicone support provided in the embodiment of the present disclosure from a second viewing angle
  • Fig. 5 is the partial structure enlarged schematic diagram at V in Fig. 4;
  • FIG. 6 is a schematic structural diagram of a mesh frame in a silicone stent provided by an embodiment of the present disclosure
  • FIG. 7 is a schematic structural diagram of the silicone stent provided in an embodiment of the present disclosure from a third viewing angle
  • FIG. 8 is a schematic cross-sectional structural diagram of another silicone stent provided in an embodiment of the present disclosure.
  • Icon 100-silicone stent; 110-frame body; 111-silicon body; 112-grid frame; 113-peripheral wall; 114-proximal opening; 115-distal opening; 116-space; 117-wire; 118-skirt; 120-protrusion; 121-first protrusion; 122-second protrusion; 200-injector; 211-inner tube; 212-middle tube; 213-outer tube; 214-accommodating cavity; 215-Development ring; 216-Proximal handle; 217-Distal handle.
  • FIG. 1 is a schematic structural diagram of the silicone stent 100 provided in this embodiment from a first perspective
  • FIG. 2 is a schematic structural diagram of the implanter 200 provided in this embodiment
  • FIG. 3 is a schematic diagram of the implanter 200 provided in this embodiment. Schematic diagram of the partial structure section. Please refer to FIG. 1 to FIG. 3 , this embodiment provides a silicone stent 100 , and accordingly, provides an implantation system (not shown).
  • the implantation system includes the silicone stent 100, and at the same time, the implantation system further includes an implanter 200, and the implanter 200 has a accommodating space 116.
  • the silicone stent 100 is accommodated in the accommodating cavity 214 in a contracted state, Therefore, the silicone stent 100 is implanted under the side view of the flexible bronchoscope by using the traditional guide wire-guided Over through wire (OTW for short) manner through the implanter 200 .
  • the implanter 200 may be a conventional OTW-type implanter 200 .
  • the silicone stent 100 includes a frame body 110 .
  • the frame body 110 includes a mesh frame 112 and a silicone body 111 formed on the mesh frame 112 .
  • the interior of the silicone body 111 defines a circumferentially sealed space 116, and the distal end and the proximal end of the silicone body 111 respectively have a distal opening 115 and a proximal opening 114 that communicate with the space 116, and the silicone stent 100 is in use.
  • the space 116 defined in the silicone body 111 connects the two ends of the silicone stent 100 in the trachea to ensure that the trachea is in a smooth state.
  • the frame body 110 of the silicone stent 100 is jointly formed by the mesh frame 112 and the silicone body 111 , and the mesh frame 112 covers the silicone body 111 in the circumferential direction, along the axial direction of the frame body 110 , the mesh frame 112 is separated from the silicone body 111 by the mesh frame 112 .
  • the proximal end extends to the distal end of the silicone body 111 , so that the support force of the frame body 110 can be effectively improved through the mesh frame 112 .
  • the support force of the frame body 110 is only determined by the silicone body 111 .
  • the support force required by the silicone body 111 in the silicone bracket 100 provided by this embodiment is small, so that the wall thickness of the silicone body 111 can be greatly reduced, and the wall thickness of the formed frame body 110 is also corresponding. It is greatly reduced, so that during implantation, the silicone stent 100 can be loaded into the implanter 200, and the implanter 200 can be placed under the side view of the flexible bronchoscope by using the traditional OTW method, which helps In order to reduce the difficulty of implantation and the difficulty of surgery, it can effectively shorten the learning curve of the implantation operation.
  • the proximal end of a component refers to the end of the component that is close to the outside of the human body after being inserted into the human body, and correspondingly, the “distal end” refers to the end opposite to the “proximal end” , that is, “distal end” refers to the end of the component close to the inside of the human body after being placed in the human body.
  • the frame body 110 is cylindrical, and the frame body 110 extends along the human trachea after being inserted.
  • the proximal end and the distal end of the frame body 110 are the two ends of the frame body 110 along its own axis.
  • the mesh frame 112 covers the silicone body 111 in the circumferential direction
  • the mesh frame 112 may be located inside the silicone body 111, and the mesh frame 112 Covering the inner wall of the silicone body 111, the mesh frame 112 may be located outside the silicone body 111, and the mesh frame 112 covers the outer wall of the silicone body 111, or the mesh frame 112 may cover the silicone body 111 from the inside, that is, at this time
  • the mesh frame 112 is located inside the silicone body 111 , and the circumference of the mesh frame 112 extends along the circumference of the silicone body 111 .
  • Outer diameter mesh cylinder may be understood in a broad sense, which may be that the mesh frame 112 is located inside the silicone body 111, and the mesh frame 112 Covering the inner wall of the silicone body 111, the mesh frame 112 may be located outside the silicone body 111, and the mesh frame 112 covers the outer wall of the silicone body 111, or the mesh frame 112 may cover the silicone body 111 from the inside, that is, at
  • the silicone stent 100 provided in this embodiment is further described below:
  • FIG. 4 is a schematic structural diagram of the silicone stent 100 provided in this embodiment from a second viewing angle
  • FIG. 5 is an enlarged schematic diagram of a partial structure at V in FIG. 4
  • FIG. 6 is a mesh frame in the silicone stent 100 provided in this embodiment. Schematic diagram of the structure of 112. Please refer to FIG. 1 , FIG. 4 , FIG. 5 and FIG.
  • the mesh frame 112 is cylindrical
  • the silicone body 111 is formed on the mesh frame 112 , thereby forming the frame body 110 of the silicone support 100
  • the silicone body 111 is cylindrical in shape similar to the mesh frame 112, so that a circumferentially sealed space 116 is defined inside the silicone body 111, and the distal end and the proximal end of the silicone body 111 respectively have The space 116 communicates with the distal opening 115 and the proximal opening 114, so that when the silicone stent 100 is placed in the human trachea, the trachea is stretched by the contact between the silicone stent 100 and the wall of the human trachea, and the silicone body 111 The formed space 116 can realize the unblocking of the trachea.
  • the frame body 110 is also cylindrical in shape similar to the grid frame 112 .
  • the mesh frame 112 is a mesh cylindrical integral structure formed by weaving the wire 117 , that is, the mesh frame 112 extends from the proximal end of the silicone body 111 to the distal end of the silicone body 111 .
  • the mesh frame 112 is formed by weaving a metal wire 117 .
  • the wire 117 is a Nitinol wire.
  • the silicone body 111 is formed on the grid 112 by means of film coating. Specifically, the liquid silicone is attached to the grid frame 112 , and the silicone body 111 is formed after the liquid silicone is solidified. Each mesh hole is closed, thereby forming a circumferentially closed space 116 in the silicone body 111, and the two axial ends communicate with the outside world through the proximal end opening 114 and the distal opening 115 respectively, that is, the mesh frame 112 is located in the silicone body 111 at this time. inside (as shown in Figure 5).
  • the silicone body 111 is formed on the mesh frame 112 by means of film coating, which not only ensures the reliability of the connection between the silicone body 111 and the mesh frame 112, but also helps to ensure that the fabricated frame body 110 has a sufficiently small thickness. Therefore, the implantation of the silicone stent 100 can be realized more smoothly by adopting the OTW method.
  • the manufacturing method of the silicone body 111 is not limited here. It can be understood that in other embodiments, other methods can also be used, such as coating the outer periphery of the grid frame 112 with sheet-shaped silicone. to form the silicone body 111 .
  • the wall thickness of the frame body 110 is d, 0.05mm ⁇ d ⁇ 0.8mm.
  • the wall thickness of the frame body 110 is the thickness between the inner peripheral wall and the outer peripheral wall 113 of the frame body 110 . distance. Since the silicone body 111 is coated on the mesh frame 112 , the outer peripheral wall and the inner peripheral wall of the silicone body 111 after molding can be regarded as the outer peripheral wall 113 and the inner peripheral wall of the frame body 110 .
  • the wall thickness of the frame body 110 can also be specifically set, for example, set to 0.05mm, 0.7mm or 0.8mm.
  • a plurality of protrusions 120 are protruded from the outer peripheral wall 113 of the frame body 110 .
  • the protrusions 120 collide with the wall of the trachea, and the silicone stent 100 can be effectively prevented from being displaced by the collision between the protrusions 120 and the trachea.
  • the protrusion 120 is in the shape of a column.
  • the protrusion 120 collides with the wall surface of the trachea part of the wall surface of the outer peripheral wall 113 of the frame body 110 is separated from the wall surface of the trachea, so that the outer peripheral surface of the frame body 110 and the wall surface of the trachea are separated between the outer peripheral surface of the frame body 110 and the wall surface of the trachea. gaps are formed between them.
  • the cilia on the surface of the trachea swing back and forth, thereby transporting the secretions or sputum in the trachea to the outside of the body, thus retaining the function of the cilia in the trachea to remove mucus and ensuring the mucous membrane in the trachea
  • the tension of the gas-liquid surface Specifically, the protrusions 120 protrude outward along the radial direction of the frame body 110 .
  • the protrusion 120 is cylindrical.
  • the protrusions 120 are arranged in a columnar shape. It can be understood that in other embodiments , the shape of the protrusion 120 can also be set according to requirements, for example, the protrusion 120 is set to be annular.
  • the plurality of protrusions 120 includes a plurality of rows of protrusions 120 evenly distributed along the circumferential direction of the frame body 110 , and each row of protrusions 120 includes a plurality of protrusions 120 spaced along the axial direction of the frame body 110 .
  • FIG. 7 is a schematic structural diagram of the silicone support 100 provided in this embodiment from a third viewing angle.
  • the plurality of protrusions 120 in two adjacent rows of protrusions 120 are alternately arranged along the axial direction of the frame body 110 .
  • the two adjacent rows of protrusions 120 are respectively the first row and the second row
  • the plurality of protrusions 120 in the first row are the first protrusions 121
  • the plurality of protrusions 120 in the second row are the second row Raised 122 .
  • the first protrusions 121 and the second protrusions 122 are alternately arranged.
  • the first protrusions 121 and the second protrusions 122 are alternately arranged in the axial direction of the frame body 110 , so the first protrusions 121 and the second protrusions 122 are arranged in a staggered manner to support the tracheal wall in the axial direction of the trachea, so that more If the wall surface of the trachea is well supported away from the peripheral wall 113 of the frame body 110, the cilia in the trachea have a better effect of removing mucus.
  • the arrangement form of the protrusions 120 is not limited here, and it is understood that in other embodiments, the protrusions 120 may also be arranged in other ways according to requirements, for example, a plurality of protrusions 120 may be arranged around The axes of the frame body 110 are arranged in a spiral distribution on the outer peripheral wall 113 of the frame body 110 , or a plurality of protrusions 120 are dispersedly arranged on the outer peripheral wall 113 of the frame body 110 .
  • the protrusion 120 is fixed to the frame body 110 by adhesive bonding. Specifically, after the silicone body 111 is coated on the mesh frame 112 , the prefabricated protrusions 120 are bonded and fixed to the outer peripheral wall 113 of the frame body 110 .
  • the bonding operation of the protrusions 120 is performed, and the bonding operation is performed. After that, the silicone stent 100 is subjected to vulcanization treatment.
  • the molding method of the protrusions 120 can also be set according to requirements, for example, the protrusions 120 are formed by integrally molding the protrusions 120 and the silicone body 111 to form the protrusions 120 protruding from the outer peripheral wall 113 of the frame body 110 .
  • the silicone stent 100 made in this way can be installed into the implanter 200 with an outer diameter of ⁇ 8mm or less.
  • the silicone stent 100 can also be installed into the implanter 200 with other outer diameters. It is limited to the implanter 200 with an outer diameter of ⁇ 8mm.
  • the manufacturing method of the protrusions 120 is not limited here. It can be understood that in other embodiments, the protrusions 120 can also be formed in other ways according to requirements. As for the convex portion of the outer peripheral wall of the grid frame 112 , when the grid frame 112 is coated, part of the liquid silicone adheres to the convex portion, thereby forming the protrusion 120 .
  • the mesh frame 112 can be regarded as including a cylindrical body and a convex portion protruding from the outer wall of the cylindrical body.
  • the part where the liquid silicone adheres to the cylindrical body forms a silicone Ketone body 111.
  • the protruding portion and the cylinder body are made by weaving a metal wire 117 into one piece.
  • the convex part is made of metal wire 117, so that the supporting force of the protrusion 120 can be effectively enhanced by the convex part, so that the wall of the trachea can be better supported from the outer peripheral wall 113 of the frame body 110, and the silicone stent can be reduced in size.
  • the size of the silicone stent 100 when it is in a retracted state enables the silicone stent 100 to be inserted into a smaller-sized implanter 200, which is more convenient and simple to implant.
  • the silicone stent 100 made in this way can be installed into the implanter 200 with an outer diameter of ⁇ 6mm or less.
  • the implanter 200 with a diameter of ⁇ 8mm.
  • the working principle of the silicone stent 100 is as follows:
  • the silicone stent 100 When in use, the silicone stent 100 is compressed to a contracted state and installed into the accommodating cavity 214 of the implanter 200. The distal end of the implanter 200 enters the human airway along the guide wire, and then under the side view of the flexible bronchoscope Release of the silicone stent 100 is performed. When releasing, operate the implanter 200 to push the silicone stent 100 out of the accommodating cavity 214 of the implanter 200. After the silicone stent 100 leaves the accommodating cavity 214, it self-expands to the state shown in FIG. 1, and the silicone stent 100 supports the trachea. open to ensure tracheal patency.
  • the silicone stent 100 provided in this embodiment has at least the following advantages:
  • the silicone support 100 provided in this embodiment, by arranging the mesh frame 112 in the silicone body 111 , the supporting force of the silicone support 100 comes from the mesh frame 112 and the silicone body 111 , so that the frame of the silicone support 100 can be guaranteed.
  • the silicone stent 100 still has sufficient supporting force, so that the silicone stent 100 can be placed into the accommodating cavity 214 of the implanter 200, and the silicone stent 100 can be placed in the OTW manner , avoiding the use of a rigid bronchoscope, and the implantation operation is simpler, thereby reducing the difficulty of the operation and saving a lot of operation time.
  • the positional stability of the silicone stent 100 in the trachea is high, and the function of clearing mucus of some cilia is retained, which helps to clear the secretions around the stent, and the use effect is better.
  • FIG. 8 is a schematic cross-sectional structure diagram of another silicone stent 100 provided in this embodiment.
  • the present embodiment also provides another silicone support 100 , which is substantially the same as the silicone support 100 shown in FIG. 1 , except that the silicone body 111 and the mesh frame 112 are different. relative positions are different. Specifically, the silicone body 111 is fixed to the outer periphery of the grid 112 .
  • the frame body 110 further includes skirts 118 connected to both ends of the silicone body 111 .
  • the skirts 118 are located on both sides of the mesh frame.
  • the skirts 118 located at both ends of the silicone body 111 are respectively a first skirt and a second skirt, and the first skirt is fixedly connected to the proximal end of the silicone body 111 , so that the mesh frame is connected by the first skirt.
  • the proximal end of 112 is covered to prevent the mesh frame 112 from irritating human tissue after the silicone stent 100 is placed in the human body.
  • l 0 ⁇ l ⁇ 6mm
  • l 1mm, 4mm, 5mm or 6mm.
  • the silicone body 111 and the skirt 118 are integrally formed.
  • the length of the silicone cylinder is longer than that of the mesh frame 112, so that when the mesh frame 112 is glued and fixed on the inner peripheral wall of the silicone cylinder, both ends of the silicone cylinder are protruded from the mesh frame 112, that is, the two ends of the silicone cylinder are set.
  • the end faces are respectively located on both sides of the grid frame 112 in the axial direction, so that a first skirt and a second skirt are respectively formed on the two sides of the grid frame 112 in the axial direction.
  • the part of the silicone tube between the first skirt and the second skirt forms the silicone body 111.
  • the silicone tube can be regarded as the silicone body 111, the first skirt and the second skirt being integrally formed. cylindrical structure.
  • the protrusions 120 are integrally formed on the outer peripheral wall of the silicone cylinder. Specifically, during production, a silicone cylinder with the protrusions 120 disposed on the outer peripheral wall is integrally formed by solidifying liquid silicone. It can be understood that, in other embodiments, the protrusion 120 can also be adhered and fixed to the outer peripheral wall of the silicone cylinder by means of adhesive.
  • a silicone cylinder with protrusions 120 on the outer peripheral wall is prefabricated, and the manufacture of the silicone cylinder can refer to the manufacturing method of the existing silicone support; then a small amount of liquid silicone is coated on the mesh frame 112, The silicone cylinder is sleeved outside the mesh frame 112 and then vulcanized, so that the mesh frame 112 and the silicone cylinder are fixed, thereby forming the frame body 110 with skirts 118 at both ends.
  • liquid silicone is coated on both ends of the grid frame 112 in the axial direction. After vulcanization in this way, the two axial ends of the grid frame 112 are bonded and fixed to the silicone cylinder at the same time.
  • the mesh frame 112 connected to the inner peripheral wall of the silicone cylinder is a bare frame. It can be understood that in other embodiments, the mesh frame 112 may be pre-coated with a silicone layer (Fig. (not shown), then the silicone layer is fixedly connected to the silicone cylinder, and the mesh frame 112 and the silicone body 111 are fixedly connected through the fixed connection of the silicone layer and the silicone cylinder. Specifically, the silicone cylinder is sleeved on the mesh frame 112 covered with the silicone layer. Since the materials of the silicone cylinder and the silicone layer are both silicone, the silicone cylinder and the silicone coating can be The mesh frame 112 of the layer is vulcanized, and the silicone cylinder and the silicone layer can be bonded into one body.
  • the mesh frame 112 is covered with a silicone layer, compared with the method of directly fixing the bare frame to the inner wall of the silicone cylinder, the use of a silicone cylinder with a smaller thickness can make the supporting force of the silicone support 100 meet the requirements. need.
  • This embodiment also provides an implantation system, which includes an implanter 200 and the above-mentioned silicone stent 100 .
  • the implanter 200 includes an inner tube 211 , a middle tube 212 , an outer tube 213 , a proximal handle 216 and a distal handle 217 .
  • the inner tube 211 , the middle tube 212 and the outer tube 213 are sleeved in sequence, that is, the inner tube 211 is located at the innermost side, and the outer tube 213 is located at the outermost side.
  • the inner tube 211 is fixedly connected to the middle tube 212
  • the middle tube 212 is fixed relative to the proximal handle 216
  • the outer tube 213 is fixedly connected to the distal handle 217 .
  • a accommodating cavity 214 is formed between the outer tube 213 and the inner tube 211 on the side of the distal end face of the middle tube 212 close to the distal end, in other words, The receiving cavity 214 can generally be viewed as being located at the distal end of the introducer 200 .
  • the silicone stent 100 When in use, the silicone stent 100 is installed in the accommodating cavity 214 in a contracted state, and the entire silicone stent 100 is ensured to enter the accommodating cavity 214, and then the distal end of the implanter 200 is extended into the human trachea under the guidance of the guide wire.
  • the middle tube 212 moves toward the inside of the human body relative to the outer tube 213, and the silicone stent 100 in the accommodating cavity 214 is in the middle
  • the tube 212 protrudes out of the accommodating cavity 214, after the silicone stent 100 extends out of the accommodating cavity 214, the limiting effect of the outer tube 213 on the silicone stent 100 is eliminated, and the silicone stent 100 self-expands to stretch the trachea, and the silicone stent is completed.
  • the stent 100 is placed, and the placement process can be observed by a side view of a flexible bronchoscope, so as to ensure the placement effect and reduce the difficulty of placement.
  • the distal end of the middle tube 212 is further provided with a developing ring 215 , and the distal end face of the middle tube 212 described above is the distal end face of the developing ring 215 .
  • the developing ring 215 is fixedly connected to the middle tube 212 by means of adhesive bonding.
  • This embodiment also provides a manufacturing method to manufacture the silicone stent 100, specifically, the manufacturing method includes:
  • the silicone body 111 is formed on the cylindrical mesh frame 112, so that the interior of the silicone body 111 defines a circumferentially sealed space 116.
  • the end opening 114 and the distal opening 115; the mesh frame 112 circumferentially covers the silicone body 111, and along the axial direction of the silicone body 111, the mesh frame 112 extends from the proximal end of the silicone body 111 to the distal end of the silicone body 111 . That is, the manufacturing method provided in this embodiment can be used to manufacture the above-mentioned silicone stent 100 .
  • the steps of forming the silicone body 111 on the cylindrical mesh frame 112 include:
  • the mesh frame 112 is coated with silicone to form the silicone body 111 on the mesh frame 112 .
  • the mesh frame 112 and the silicone body 111 attached to the mesh frame 112 form the frame body 110 of the silicone stent 100 .
  • the prefabricated protrusions 120 are bonded to the outer wall of the frame body 110 to obtain the silicone stent 100 .
  • the prefabricated protrusions 120 can be glued Connecting to the outer peripheral wall 113 of the frame body 110 to form the silicone stent 100 , and finally vulcanizing the entire silicone stent 100 . It can be understood that, in other embodiments, the fixing manner of the protrusion 120 and the frame body 110 can also be specifically set according to requirements.
  • the step of forming the protrusions 120 is further included.
  • the protrusions 120 are formed by stamping a sheet of silicone.
  • the step of weaving the mesh frame 112 is further included.
  • a single metal wire 117 is woven to form a cylindrical mesh frame 112 by spirally winding back and forth around a preset axis.
  • the preset axis is the axis of the mesh frame 112
  • the fabricated mesh frame 112 has diamond meshes.
  • the silicone stent 100 is made of the silicone stent 100 by first forming the frame body 110 and then adhering to the frame body 110 to make the silicone stent 100 . It can be understood that in other embodiments, The silicone stent 100 can be made in other ways.
  • the step of forming the silicone body 111 on the cylindrical mesh frame 112 includes: coating the mesh frame 112 with silicone to form the silicone body 111 on the mesh frame 112, and the mesh frame 112 has a protruding mesh frame.
  • the frame body 110 and the protrusion 120 of the bracket 100 are simultaneously formed in one step.
  • the protrusion 120 and the mesh frame 112 are made by weaving a single metal wire 117 into one piece. Specifically, during the process of weaving the metal wire 117 to form the mesh frame 112, the metal wire 117 is woven toward the mesh frame at a preset position. The radially outer side of 112 is bent to form a convex portion.
  • the protrusions 120 may be integrally formed on the outer peripheral wall of the silicone body 111 .
  • the steps of molding the silicone body 111 on the cylindrical mesh frame 112 include:
  • the grid 112 is placed in the mold.
  • the mold has a cavity for forming the silicone support 100 , and the cavity has an inner peripheral surface corresponding to the outer wall surface of the grid frame 112 , and the inner peripheral surface is provided with a groove.
  • the groove is a columnar groove formed by the inner peripheral surface being recessed radially outward.
  • the silicone body 111 can also be formed on the mesh frame 112 by means of bonding.
  • the step of molding the silicone body 111 on the grid 112 includes:
  • the proximal end and the distal end of the mesh frame 112 are respectively bonded and fixed on the inner peripheral wall of the silicone cylinder, and the part of the silicone cylinder between the proximal end and the distal end of the mesh frame 112 forms the silicone body 111, and the shaft of the silicone cylinder forms the silicone body 111.
  • the parts protruding from the mesh frame 112 to the opposite ends form skirts 118 , so that the ends of the mesh frame 112 are covered by the skirt edges 118 to prevent the mesh frame 112 from irritating human tissue when human tissue grows into the silicone stent 100 .
  • skirts 118 can also be provided at both ends of the silicone body 111 so that the mesh frame 112 can stimulate human tissue.
  • the proximal end and the distal end of the grid frame 112 are vulcanized by the liquid silicone.
  • the end is fixed to the silicone cartridge. Since the silicone cylinder forming the silicone body 111 and the mesh frame 112 are manufactured separately, and the length of the silicone cylinder is greater than the length of the mesh frame 112, the silicone cylinder of the same specification can adapt to the mesh frame 112 of different length specifications, so that there are Helps reduce production costs.
  • the protrusion 120 is integrally formed on the outer peripheral wall of the silicone cylinder.
  • a weaving step of weaving the mesh frame 112 is also included.
  • a manufacturing step of manufacturing a silicone cylinder is also included.
  • the mesh frame 112 bonded in the silicone cylinder is a bare frame. It can be understood that in other embodiments, the mesh frame 112 can also be covered with a film in advance, so as to form a package on the mesh frame 112. The silicone layer of the mesh frame 112 is covered, and then the mesh frame 112 after the film is glued and fixed in the silicone cylinder. Specifically, the steps of molding the silicone body 111 on the grid 112 include:
  • the silicone cylinder is sleeved on the mesh frame 112 covered with a silicone layer (not shown in the figure); the silicone cylinder and the mesh frame 112 covered with the silicone layer are vulcanized to make the silicone cylinder and the silicone layer Adhesive fixation. At this time, the part of the silicone cylinder between the proximal end and the distal end of the mesh frame 112 forms the silicone body 111 , and both axial ends of the silicone cylinder protrude from the mesh frame 112 to form the skirt 118 .
  • the silicone stent provided by the present disclosure includes a frame body, wherein the frame body includes a mesh frame and a silicone body formed on the mesh frame, the interior of the silicone body defines a circumferentially sealed space, and the distal end of the silicone body and the The proximal end respectively has a distal opening and a proximal opening communicating with the space.
  • the silicone stent When in use, the silicone stent is placed into the human trachea, and the space defined in the silicone body connects the trachea to ensure that the trachea is in a smooth state.
  • the frame body of the silicone stent is jointly formed by the mesh frame and the silicone body, and the mesh frame covers the silicone body in the circumferential direction, the axial mesh frame extends from the proximal end of the silicone body to the distal end of the silicone body, so that through the mesh
  • the frame can effectively improve the support force of the frame body, and compared with the existing silicone support, the support force of the frame body is only provided by the silicone body itself.
  • the silicone stent provided by the present disclosure can greatly reduce the wall thickness of the silicone body, and the wall thickness of the formed frame body is also greatly reduced accordingly, so that during the implantation, the silicone stent can be inserted into the In the device, the traditional OTW method is used to insert the device under the side view of the flexible bronchoscope, which helps to reduce the difficulty of implantation and the difficulty of surgery, which can effectively shorten the learning curve of the implantation operation.
  • the implantation system provided by the present disclosure can use the traditional OTW method to insert the silicone stent into the human trachea through the implanter, so it has the beneficial effects of low implantation difficulty of the silicone stent, low surgical difficulty, and short implantation operation learning curve;
  • the manufacturing method provided by the present disclosure can manufacture the above-mentioned silicone stent, so the manufactured silicone stent also has the beneficial effects of low implantation difficulty, low surgical difficulty and short implantation operation learning curve.

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Abstract

提供了一种硅酮支架(100)、置入系统及制造方法。硅酮支架(100)包括架体(110)。架体(110)包括网架(112)和成型在网架(112)上的硅酮本体(111)。在硅酮本体(111)的内部限定出周向密封的空间(116)。硅酮本体(111)的远端和近端分别具有与空间(116)连通的远端开口(115)以及近端开口(114)。网架(112)周向覆盖硅酮本体(111)，且沿硅酮本体(111)的轴向。网架(112)从硅酮本体(111)的近端延伸至硅酮本体(111)的远端。

Description

一种硅酮支架、置入系统及制造方法
相关申请的交叉引用
本申请要求于2020年09月30日提交中国专利局的申请号为2020110605078、名称为“一种硅酮支架、置入系统及制造方法”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本公开涉及医疗器械技术领域，具体而言，涉及一种硅酮支架、置入系统及制造方法。
背景技术
气管内支架是一种置入到气管内且具有一定张力和弹性的支撑物，通过在气管内置入气管内支架将气管撑开以保证气管的畅通。现有的气管内支架分为金属支架和非金属支架。非金属支架又分为硅酮支架和塑料支架。经过长期临床研究，发现硅酮支架远期并发症如肉芽增生、疤痕狭窄明显少于金属支架，而且具有长期置入后容易取出等优点，故硅酮支架推荐用于需要使用支架治疗的良性气管狭窄患者。
然而现有的硅酮支架释放时需置入特定的推送器中，在全麻下采用硬质支气管镜，根据测量法盲视下释放，置入困难，手术难度高，因此也就导致了置入操作的学习曲线长的问题。
发明内容
本公开的目的包括，例如，提供了一种硅酮支架，其能够改善现有技术中硅酮支架置入困难、手术难度高、学习曲线长的技术问题。
本公开的目的还包括，提供了一种置入系统，其能够改善现有技术中硅酮支架置入困难、手术难度高、学习曲线长的技术问题。
本公开的目的还包括，提供了一种制造方法，其能够制造上述的硅酮支架，因此也能够改善现有技术中硅酮支架置入困难、手术难度高、学习曲线长的技术问题。
本公开的实施例可以这样实现：
本公开的实施例提供了一种硅酮支架，其包括架体，所述架体包括网架和成型在所述网架上的硅酮本体，在所述硅酮本体的内部限定出周向密封的空间，所述硅酮本体的远端和近端分别具有与空间连通的远端开口以及近端开口；所述网架周向覆盖所述硅酮本体，且沿所述硅酮本体的轴向，所述网架从所述硅酮本体的近端延伸至所述硅酮本体的远端。
在一种或多种实施方案中，所述架体的外周壁凸设有多个凸起。
通过在架体的外周壁凸设多个凸起，凸起与气管的壁面的抵触能够有助于改善使用过程中硅酮支架相对气管移位的问题，即凸起可起到稳定支架在气管中的位置的作用。
在一种或多种实施方案中，所述凸起与所述硅酮本体一体成型。
在一种或多种实施方案中，所述网架具有凸部，所述凸部覆膜形成所述凸起。
在一种或多种实施方案中，所述凸起粘接固定于所述架体。
在一种或多种实施方案中，多个所述凸起包括沿所述架体的周向均匀分布的多列凸起，每列所述凸起包括沿所述架体的轴向间隔设置的多个所述凸起。
在一种或多种实施方案中，相邻两列所述凸起中的多个凸起沿所述架体的轴向交替设置；或者，每列所述凸起中的多个所述凸起绕所述架体的轴线螺旋分布；或者，多个所述凸起分散分布。
通过在架体的外壁面设置凸起，且对凸起进行具体设置，硅酮支架置入人体气管后，凸起与气管的壁面抵触，进而将气管的壁面与架体的外周壁分离，气管的壁面上的纤毛具有一定的空间进行摆动，进而通过纤毛能够对硅酮支架周围的分泌物进行清除，即保留了纤毛的清除粘液的功能，硅酮支架的使用效果更好。
在一种或多种实施方案中，所述凸起(120)的厚度为h，0.5mm≤h≤4mm。
在一种或多种实施方案中，所述架体的壁厚为d，0.05mm≤d≤0.8mm。
在一种或多种实施方案中，所述硅酮本体覆膜成型于所述网架。
通过采用覆膜的方式将硅酮本体成型于网架，从而能够更加方便简单地使得硅酮本体的厚度小，即硅酮支架的架体的厚度小，进一步保证了硅酮支架能够装入置入器，通过置入器采用OTW的方式实现硅酮支架的置入。
在一种或多种实施方案中，所述网架由一根金属丝编织成型。
在一种或多种实施方案中，所述硅酮本体固定于所述网架的外周。
在一种或多种实施方案中，所述架体还包括连接于所述硅酮本体两端的裙边；沿所述硅酮支架的轴向，所述裙边位于所述网架的两侧。
在一种或多种实施方案中，所述裙边与所述硅酮本体一体成型。
在一种或多种实施方案中，所述架体还包括包裹所述网架的硅酮层，所述硅酮本体与所述硅酮层固定连接。
本公开的实施例还提供了一种置入系统。该置入系统包括置入器以及硅酮支架。硅酮支架包括架体，所述架体包括网架和成型在所述网架上的硅酮本体，在所述硅酮本体的内部限定出周向密封的空间，所述硅酮本体的远端和近端分别具有与空间连通的远端开口以及近端开口；所述网架周向覆盖所述硅酮本体，且沿所述硅酮本体的轴向，所述网架从所述硅酮本体的近端延伸至所述硅酮本体的远端。所述置入器具有容纳腔，所述硅酮支架呈收缩状态容纳于所述容纳腔内，以通过所述置入器进行所述硅酮支架的置入。
本公开的实施例还提供了一种制造方法，用于制造硅酮支架。制造方法包括：
将硅酮本体成型在筒状的网架上，使得所述硅酮本体的内部限定出周向密封的空间，所述硅酮本体的远端和近端分别设置有与空间连通的近端开口以及远端开口；所述网架周向覆盖所述硅酮本体，且沿所述硅酮本体的轴向，所述网架从所述硅酮本体的近端延伸至所述硅酮本体的远端。
在一种或多种实施方案中，所述将硅酮本体成型在筒状的网架上的步骤包括：对所述网架覆膜硅酮，以在所述网架上成型所述硅酮本体；
其中，所述网架具有凸部，所述凸部覆膜硅酮形成所述硅酮支架的凸起。
在一种或多种实施方案中，所述将硅酮本体成型在筒状的网架上的步骤包括：对所述网架覆膜硅酮，以在所述网架上成型所述硅酮本体，获得所述硅酮本体的架体；
所述将硅酮本体成型在筒状的网架上的步骤之后包括：将凸起粘接于所述架体外壁，以获得所述硅酮支架。
在一种或多种实施方案中，所述将硅酮本体成型在筒状的网架上的步骤包括：将所述网架放置在模具中；
对所述模具注入液态硅酮，使得所述液态硅酮充满所述模具内周面上的凹槽；
使得冷却后，所述液态硅酮包覆于所述网架形成所述硅酮本体，且所述硅酮本体的外壁具备与所述凹槽对应凸起。
在一种或多种实施方案中，所述将硅酮本体成型在筒状的网架上的步骤包括：
将网架的近端和远端分别粘接固定在硅酮筒的内周壁，所述硅酮筒位于所述网架的近端和远端之间的部分形成所述硅酮本体，所述硅酮筒的轴向的两端凸出所述网架以形成裙边。
在一种或多种实施方案中，所述将硅酮本体成型在筒状的网架上的步骤包括：
将硅酮筒套设于包覆有硅酮层的所述网架；对所述硅酮筒和所述包覆有硅酮层的所述网架硫化，以使所述硅酮筒与所述硅酮层粘接；所述硅酮筒位于所述网架的近端和远端之间的部分形成所述硅酮本体，所述硅酮筒的轴向的两端凸出所述网架形成裙边。
本公开实施例的硅酮支架、置入系统及制造方法的有益效果包括，例如：
本公开的实施例提供的硅酮支架，其包括架体。架体包括网架和成型在网架上的硅酮本体。硅酮本体的内部限定出周向密封的空间，且硅酮本体的远端和近端分别具有与空间连通的远端开口以及近端开口，使用时将硅酮支架置入人体气管内，硅酮本体内部限定的空间将气管连通，保证气管处于畅通状态。由于硅酮支架的架体通过网架和硅酮本体共同形成，且网架周向覆盖硅酮本体，轴向上网架从硅酮本体的近端延伸至硅酮本体的远端，如此通过网架能够有效提高架体的支撑力，相较于现有的硅酮支架中架体的支撑力仅由硅酮本体自身提供，本实施例提供的硅酮支 架可以大大减小硅酮本体的壁厚，且形成的架体的壁厚也相应大大减小，如此在进行置入时，可将硅酮支架装入置入器中，通过置入器采用传统的OTW方式在软质支气管镜的旁视下进行置入，有助于减小置入难度、降低手术难度，进而能够有效缩短置入操作的学习曲线。
本公开的实施例还提供了一种置入系统，其包括置入器和上述的硅酮支架。该置入系统能够采用传统OTW方式通过置入器将硅酮支架置入人体气管，因此具有硅酮支架的置入难度低、手术难度低、置入操作学习曲线短的有益效果。
本公开的实施例还提供了一种制造方法，其能够制造上述的硅酮支架，因此制成的硅酮支架也具有置入难度低、手术难度低、置入操作学习曲线短的有益效果。
附图说明
为了更清楚地说明本公开实施例的技术方案，下面将对实施例中所需要使用的附图作简单地介绍，应当理解，以下附图仅示出了本公开的某些实施例，因此不应被看作是对范围的限定，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他相关的附图。
图1为本公开实施例提供的硅酮支架在第一视角下的结构示意图；
图2为本公开实施例提供的置入器的结构示意图；
图3为本公开实施例提供的置入器的局部结构剖面示意图；
图4为本公开实施例提供的硅酮支架在第二视角下的结构示意图；
图5为图4中Ⅴ处的局部结构放大示意图；
图6为本公开实施例提供的硅酮支架中网架的结构示意图；
图7为本公开实施例提供的硅酮支架在第三视角下的结构示意图；
图8为本公开实施例提供的另一种硅酮支架的剖面结构示意图。
图标：100-硅酮支架；110-架体；111-硅酮本体；112-网架；113-外周壁；114-近端开口；115-远端开口；116-空间；117-金属丝；118-裙边；120-凸起；121-第 一凸起；122-第二凸起；200-置入器；211-内管；212-中管；213-外管；214-容纳腔；215-显影环；216-近端手柄；217-远端手柄。
具体实施方式
为使本公开实施例的目的、技术方案和优点更加清楚，下面将结合本公开实施例中的附图，对本公开实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例是本公开一部分实施例，而不是全部的实施例。通常在此处附图中描述和示出的本公开实施例的组件可以以各种不同的配置来布置和设计。
因此，以下对在附图中提供的本公开的实施例的详细描述并非旨在限制要求保护的本公开的范围，而是仅仅表示本公开的选定实施例。基于本公开中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本公开保护的范围。
应注意到：相似的标号和字母在下面的附图中表示类似项，因此，一旦某一项在一个附图中被定义，则在随后的附图中不需要对其进行进一步定义和解释。
在本公开的描述中，需要说明的是，若出现术语“上”、“下”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，或者是该公开产品使用时惯常摆放的方位或位置关系，仅是为了便于描述本公开和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本公开的限制。
此外，若出现术语“第一”、“第二”等仅用于区分描述，而不能理解为指示或暗示相对重要性。
需要说明的是，在不冲突的情况下，本公开的实施例中的特征可以相互结合。
图1为本实施例提供的硅酮支架100在第一视角下的结构示意图，图2为本实施例提供的置入器200的结构示意图，图3为本实施例提供的置入器200的局部结构剖面示意图。请结合参照图1-图3，本实施例提供了一种硅酮支架100，相应地，提供了一种置入系统(图未示出)。
置入系统包括硅酮支架100，同时，置入系统还包括置入器200，置入器200内具有容纳空间116，置入时，将硅酮支架100呈收缩状态容纳在容纳腔214中，从而通过置入器200采用传统的导丝引导软镜下释放(Over through wire，下文 简写为OTW)的方式，在软质支气管镜旁视下进行硅酮支架100的置入。换言之，置入器200即可为传统的OTW方式的置入器200。
硅酮支架100包括架体110。架体110包括网架112和成型在网架112上的硅酮本体111。硅酮本体111的内部限定出周向密封的空间116，且硅酮本体111的远端和近端分别具有与空间116连通的远端开口115以及近端开口114，使用时将硅酮支架100置入人体气管内，硅酮本体111内部限定的空间116将气管中放置该硅酮支架100的两端连通，保证气管处于畅通状态。由于硅酮支架100的架体110通过网架112和硅酮本体111共同形成，且网架112周向覆盖硅酮本体111，沿架体110的轴向，网架112从硅酮本体111的近端延伸至硅酮本体111的远端，如此通过网架112能够有效提高架体110的支撑力，相较于现有的硅酮支架100中架体110的支撑力仅由硅酮本体111自身提供，本实施例提供的硅酮支架100中硅酮本体111所需提供的支撑力较小，如此可以大大减小硅酮本体111的壁厚，且形成的架体110的壁厚也相应大大减小，如此在进行置入时，可将硅酮支架100装入置入器200中，通过置入器200采用传统的OTW方式在软质支气管镜的旁视下进行置入，有助于减小置入难度、降低手术难度，进而能够有效缩短置入操作的学习曲线。
需要说明的是，在本实施例的描述中，某部件的“近端”指置入人体后，该部件靠近人体外侧的一端，相应地，“远端”为与“近端”相对的一端，即“远端”指置入人体后，该部件靠近人体内侧的一端。在本实施例中，架体110呈圆筒状，置入后架体110沿人体气管延伸，架体110的近端和远端即为架体110沿自身轴向的两端。
还需要说明的是，在本实施例的描述中，“网架112周向覆盖硅酮本体111”应作广义地理解，其既可以是网架112位于硅酮本体111内侧，且网架112覆盖硅酮本体111的内壁，也可以是网架112位于硅酮本体111外侧，且网架112覆盖硅酮本体111的外壁，还可以是网架112从内部覆盖硅酮本体111，即此时网架112位于硅酮本体111的内部，且网架112的周向沿硅酮本体111的周向延伸，换言之，网架112大致为内径大于硅酮本体111的内径、外径小于硅酮本体111的外径的网状筒。
下面对本实施例提供的硅酮支架100进行进一步说明：
图4为本实施例提供的硅酮支架100在第二视角下的结构示意图，图5为图4中Ⅴ处的局部结构放大示意图，图6为本实施例提供的硅酮支架100中网架112的结构示意图。请结合参照图1、图4、图5和图6，在本实施例中，网架112呈圆筒 状，硅酮本体111成型于网架112，从而形成硅酮支架100的架体110，相应地，硅酮本体111为外形与网架112相似的圆筒状，从而在硅酮本体111的内部限定出周向密封的空间116，同时硅酮本体111的远端和近端分别具有与该空间116连通的远端开口115和近端开口114，如此当硅酮支架100置入人体气管内后，通过硅酮支架100与人体气管壁面的抵触将气管撑开，同时硅酮本体111内形成的空间116即可实现气管的畅通。同时，架体110亦为外形与网架112相似的圆筒状。
具体地，网架112为金属丝117编织成型的网状筒形的一体结构，即网架112从硅酮本体111的近端一直延伸至硅酮本体111的远端。可选地，网架112采用一根金属丝117编织成型。可选地，金属丝117为镍钛合金金属丝。
可选地，硅酮本体111采用覆膜的方式成型于网架112。具体地，将液态的硅酮附着于网架112，待液态的硅酮凝固后即形成硅酮本体111，硅酮本体111整体包覆于网架112，且硅酮本体111将网架112的各个网孔封闭，从而在硅酮本体111内形成周向封闭、轴向两端分别通过近端开口114和远端开口115与外界连通的空间116，即此时网架112位于硅酮本体111内部(如图5所示)。通过采用覆膜的方式将硅酮本体111成型于网架112，不仅保证了硅酮本体111与网架112的连接可靠性，而且有助于保证制成的架体110具有足够小的厚度，从而能够更加顺利地采用OTW的方式实现硅酮支架100的置入。
需要说明的是，此处并不对硅酮本体111的制造方式进行限定，可以理解的，在其他实施例中，也可以采用其他方式，例如将片状的硅酮包覆于网架112的外周以形成硅酮本体111。
请参照图4，可选地，架体110的壁厚为d,0.05mm≤d≤0.8mm，具体地，架体110的壁厚即为架体110的内周壁与外周壁113之间的距离。由于硅酮本体111覆膜成型于网架112，因此成型后的硅酮本体111的外周壁和内周壁即可看作架体110的外周壁113和内周壁。
在本实施例中，0.1mm≤d≤0.6mm，可选地，d＝0.1mm、0.2mm、0.3mm、0.4mm、0.5mm或0.6mm。可以理解的，在其他实施例中，也可以具体设置架体110的壁厚，例如设置为0.05mm、0.7mm或0.8mm。
请结合参照图1和图4，在本实施例中，架体110的外周壁113凸设有多个凸起120，通过设置凸出架体110的外周壁113的多个凸起120，硅酮支架100置入 人体气管中后，凸起120与气管的壁面抵触，通过凸起120与气管的抵触能够有效防止硅酮支架100移位。
可选地，凸起120呈柱状，当凸起120与气管的壁面抵触时，架体110的外周壁113的部分壁面与气管的壁面脱离，从而在架体110的外周面和气管的壁面之间形成间隙。在硅酮支架100支撑在气管内的过程中，气管表面的纤毛来回摆动，从而将气管内的分泌物或痰液运输至体外，如此保留了气管内纤毛清除粘液的功能，保证了气管内粘膜层气液面的张力。具体地，凸起120沿架体110的径向向外凸出。可选地，凸起120呈圆柱状。
需要说明的是，在本实施例中，为了使硅酮支架100置入人体气管后，气管内的纤毛能够保留清除粘液的功能，凸起120设置为柱状，可以理解的，在其他实施例中，也可以根据需求设置凸起120的形状，例如将凸起120设置为环状。
可选地，凸起120的厚度为h，0.5mm≤h≤4mm。需要说明的是，凸起120的厚度h即为凸起120凸出架体110的外周壁113的高度，换言之，凸起120的厚度h为凸起120远离架体110的外周壁113的一端的端面至外周壁113的距离(如图4所示)。可选地，h＝0.5mm、1mm、2mm、3mm或4mm。
可选地，多个凸起120包括沿架体110的周向均匀分布的多列凸起120，每列凸起120包括沿架体110的轴向间隔设置的多个凸起120。
图7为本实施例提供的硅酮支架100在第三视角下的结构示意图。请结合参照图1、图4和图7，可选地，相邻两列凸起120中的多个凸起120沿架体110的轴向交替设置。具体地，相邻两列凸起120分别为第一列和第二列，第一列中的多个凸起120为第一凸起121，第二列中的多个凸起120为第二凸起122。沿架体110的轴向，第一凸起121和第二凸起122交替设置。第一凸起121和第二凸起122在架体110的轴向交替设置，因此第一凸起121和第二凸起122在气管的轴向上对气管壁面的支撑交错设置，从而能够更好地将气管的壁面撑离架体110的外周壁113，气管内纤毛清除粘液的效果更好。
需要说明的是，此处并不对凸起120的布置形式进行限制，可以理解的，在其他实施例中，也可以根据需求将凸起120按其他方式进行布置，例如将多个凸起120绕架体110的轴线螺旋分布布置于架体110的外周壁113，或者将多个凸起120分散布置于架体110的外周壁113。
在本实施例中，凸起120粘接固定于架体110。具体地，在硅酮本体111覆膜成型于网架112上后，将预先制成的凸起120粘接固定在架体110的外周壁113。可选地，为了保证凸起120与架体110的连接可靠性，在对网架112覆膜以在网架112上成型硅酮本体111后，即进行凸起120的粘接操作，粘接后，对硅酮支架100进行硫化处理。可以理解的，在其他实施例中，也可以根据需求设置凸起120的成型方式，例如采用凸起120与硅酮本体111一体成型的方式形成凸出架体110的外周壁113的凸起120。而且通过该方式制成的硅酮支架100可装入外径为Φ8mm以下的置入器200中，当然，该硅酮支架100也可以装入其他外径尺寸的置入器200中，并不局限于外径为Φ8mm的置入器200。
需要说明的是，此处并不对凸起120的制造方式进行限制，可以理解的，在其他实施例中，也可以根据需求采用其他方式形成凸起120，例如，在网架112上设置凸出网架112的外周壁的凸部，如此在对网架112进行覆膜时，部分液态硅酮附着于凸部，从而形成凸起120。
具体地，在该硅酮支架100中，网架112可看作包括圆筒状的筒体以及凸出筒体的外壁设置的凸部，成型时，液态硅酮附着于筒体的部分形成硅酮本体111。可选地，凸部与筒体通过一根金属丝117编织一体制成。通过在网架112设置凸部以使覆膜时自然在凸部处形成凸起120，不仅简化了生产过程，制造过程简单。凸部采用金属丝117制成，如此通过凸部可以有效增强凸起120的支撑力，从而能够更好地将气管的壁面撑离架体110的外周壁113，而且有助于缩小硅酮支架100处于收缩状态时的尺寸，使得硅酮支架100能够装入更小规格的置入器200中，置入更加方便简单。而且通过该方式制成的硅酮支架100可装入外径为Φ6mm以下的置入器200中，当然，该硅酮支架100也可以装入其他外径尺寸的置入器200中，例如外径为Φ8mm的置入器200。
根据本实施例提供的一种硅酮支架100，硅酮支架100的工作原理是：
使用时，将硅酮支架100压缩至收缩状态并安装进入置入器200的容纳腔214中，置入器200的远端沿导丝进入人体气道，然后在软质支气管镜的旁视下进行硅酮支架100的释放。释放时操作置入器200将硅酮支架100推出置入器200的容纳腔214，硅酮支架100离开容纳腔214后，自膨胀至如图1所示的状态，硅酮支架100将气管撑开以保证气管的畅通。
本实施例提供的一种硅酮支架100至少具有以下优点：
本实施例提供的硅酮支架100，通过在硅酮本体111内设置网架112，硅酮支架100的支撑力来源于网架112以及硅酮本体111，如此可以保证在硅酮支架100的架体110的厚度较小时，硅酮支架100仍然具有足够的支撑力，进而使得硅酮支架100能够放置进入置入器200的容纳腔214中，并采用OTW的方式进行硅酮支架100的置入，避免使用硬质支气管镜，置入操作更加简单，从而降低了手术难度和节约了大量手术时间。同时通过对凸起120的设置使得硅酮支架100在气管内的位置稳定性高，部分纤毛的清除粘液的功能得以保留，有助于清除支架周围分泌物，使用效果更好。
图8为本实施例提供的另一种硅酮支架100的剖面结构示意图。请参照图8，本实施例还提供了另一种硅酮支架100，该硅酮支架100与图1所示的硅酮支架100大致相同，不同之处在于，硅酮本体111与网架112的相对位置不同。具体地，硅酮本体111固定于网架112的外周。
可选地，架体110还包括连接于硅酮本体111的两端的裙边118，沿硅酮支架100的轴向，裙边118位于网架的两侧。具体地，位于硅酮本体111的两端的裙边118分别为第一裙边和第二裙边，第一裙边固定连接于硅酮本体111的近端，如此通过第一裙边将网架112的近端覆盖，以避免硅酮支架100置入人体后、网架112刺激人体组织。
裙边118的轴向尺寸为l,0≤l≤6mm，可选地，l＝1mm、4mm、5mm或6mm。优选地，2mm≤l≤3mm，可选地，l＝2mm、2.5mm或3mm。
可选地，硅酮本体111与裙边118一体成型。具体地，硅酮筒的长度长于网架112，如此在网架112粘接固定在硅酮筒的内周壁时，硅酮筒的两端均凸出网架112设置，即硅酮筒的两端端面分别位于网架112轴向的两侧，如此在网架112轴向的两侧分别形成第一裙边和第二裙边。硅酮筒中位于第一裙边和第二裙边之间的部分即形成硅酮本体111，换言之，硅酮筒即可看作硅酮本体111、第一裙边以及第二裙边一体成型的筒状结构。可选地，凸起120一体成型于硅酮筒的外周壁，具体地，生产时，通过液态硅酮凝固一体成型出外周壁设置有凸起120的硅酮筒。可以理解的，在其他实施例中，也可以采用粘接的方式将凸起120粘接固定于硅酮筒的外周壁。
生产时，预先制成外周壁设置有凸起120的硅酮筒，该硅酮筒的制造即可参照现有的硅酮支架的制造方法；然后在网架112上涂覆少量液体硅酮，并将硅酮筒套设网架112外后进行硫化，以使网架112与硅酮筒固定，从而制成两端具有裙边118 的架体110。可选地，液态硅酮涂覆于网架112轴向的两端，如此硫化后，网架112轴向的两端同时与硅酮筒粘接固定。
需要说明的是，此处连接在硅酮筒内周壁的网架112为裸架，可以理解的，在其他实施例中，也可以根据需求，预先在网架112上包覆硅酮层(图未示出)，然后将硅酮层固定连接于硅酮筒，通过硅酮层与硅酮筒的固定连接实现网架112与硅酮本体111的固定连接。具体地，将硅酮筒套设在包覆有硅酮层的网架112上，由于硅酮筒和硅酮层的材质均为硅酮，如此可通过对硅酮筒和包覆有硅酮层的网架112硫化，即可将硅酮筒与硅酮层粘接成一体。由于网架112上覆着有硅酮层，因此相较于直接将裸架固定在硅酮筒内壁的方式，此时采用厚度更小的硅酮筒即可使硅酮支架100的支撑力满足需求。
本实施例也提供了一种置入系统，置入系统包括置入器200以及上述的硅酮支架100。
置入器200的结构如图2和图3所示，具体地，置入器200包括内管211、中管212、外管213、近端手柄216和远端手柄217。内管211、中管212以及外管213依次套设，即内管211位于最内侧，外管213位于最外侧。内管211与中管212固定连接，同时中管212相对近端手柄216固定，外管213固定连接于远端手柄217。当中管212位于外管213的远端端面靠近近端的一侧时，外管213与内管211之间形成位于中管212的远端端面靠近远端的一侧的容纳腔214，换言之，容纳腔214基本可看作位于置入器200的远端。
使用时，将硅酮支架100呈收缩状态安装于容纳腔214内，且保证硅酮支架100整体均进入容纳腔214，然后在导丝的引导下置入器200的远端伸入人体气管内，直至伸入预设位置，然后推动近端手柄216向远端手柄217靠近，相应地，中管212相对外管213向人体内部的方向运动，位于容纳腔214中的硅酮支架100在中管212的推动下伸出容纳腔214，硅酮支架100伸出容纳腔214后，外管213对硅酮支架100的限位作用消除，硅酮支架100自膨胀以撑开气管，完成硅酮支架100的置入，同时该置入过程可通过软质支气管镜旁视观察，保证置入效果、降低置入难度。
可选地，中管212的远端还设置有显影环215，前文所述的中管212的远端端面即为显影环215的远端端面。具体地，显影环215采用胶接的方式固定连接于中管212。
本实施例也提供了一种制造方法，以制造硅酮支架100，具体地，制造方法包括：
将硅酮本体111成型在筒状的网架112上，使得硅酮本体111的内部限定出周向密封的空间116，硅酮本体111的远端和近端分别设置有与空间116连通的近端开口114以及远端开口115；网架112周向覆盖硅酮本体111，且沿硅酮本体111的轴向，网架112从硅酮本体111的近端延伸至硅酮本体111的远端。即本实施例提供的制造方法可用于制造上述的硅酮支架100。
将硅酮本体111成型在筒状的网架112上的步骤包括：
对网架112覆膜硅酮，以在网架112上成型硅酮本体111，网架112以及附着于网架112的硅酮本体111形成硅酮支架100的架体110。然后将预先制成的凸起120粘接于架体110的外壁从而获得硅酮支架100。
具体地，为了保证凸起120与架体110的粘接可靠性，在硅酮覆膜于网架112成型出硅酮本体111获得架体110后，即可将预先制成的凸起120粘接于架体110的外周壁113，形成硅酮支架100，最后将硅酮支架100整体进行硫化处理。可以理解地，在其他实施例中，也可以根据需求具体设置凸起120与架体110的固定方式。
可选地，在将凸起120粘接于架体110的外周壁113的步骤之前还包括制成凸起120的步骤。具体地，凸起120通过片状的硅酮冲压成型。
可选地，在将硅酮本体111成型在筒状的网架112上的步骤之前还包括编织网架112的步骤。具体地，采用单根金属丝117绕预设轴线来回螺旋绕设的方式编织成型筒状的网架112，预设轴线即为网架112的轴线，制成的网架112具有菱形网孔。
需要说明的是，在本实施例中，硅酮支架100采用先制成架体110然后在架体110上粘接的方式制成硅酮支架100，可以理解的，在其他实施例中，也可以采用其他方式制成硅酮支架100。
例如，将硅酮本体111成型在筒状的网架112上的步骤包括：对网架112覆膜硅酮，以在网架112上成型硅酮本体111，同时网架112具有凸出网架112的外壁面设置的凸部，在网架112覆膜过程中，凸部随同网架112进行覆膜，凸起120覆膜硅酮从而形成硅酮支架100的凸起120，换言之，硅酮支架100的架体110与凸 起120通过一个步骤同时成型。可选地，凸起120与网架112采用单根金属丝117编织一体制成，具体地，在金属丝117编织制成网架112的过程中，在预设位置将金属丝117向网架112的径向外侧弯折进而形成凸部。
或者，也可以在对网架112覆膜形成具有硅酮本体111的网架112时，将凸起120一体成型于硅酮本体111的外周壁。具体地，将硅酮本体111成型在筒状的网架112上的步骤包括：
a:将网架112放置在模具中。模具具有成型硅酮支架100的型腔，同时型腔具有对应网架112的外壁面的内周面，同时内周面上述设置有凹槽。具体地，凹槽为内周面沿径向向外凹陷形成的柱状凹槽。
b:对模具注入液态硅酮，并使液态硅酮充满模具的内周面上的凹槽。液态硅酮包覆于网架112，从而使得冷却后液态硅酮在网架112上形成硅酮本体111，且液态硅酮充满凹槽的部分形成凸起120，即使得硅酮本体111的外壁具备与凹槽对应的凸起120，凸起120与硅酮本体111一体成型制成。
或者，也可以通过粘接的方式将硅酮本体111成型在网架112上。
可选地，将硅酮本体111成型在网架112上的步骤包括：
将网架112的近端和远端分别粘接固定在硅酮筒的内周壁，硅酮筒位于网架112的近端与远端之间的部分形成硅酮本体111，硅酮筒的轴向的两端凸出网架112的部分形成裙边118，从而通过裙边118覆盖网架112的端部，避免人体组织生长进入硅酮支架100内时，网架112刺激到人体组织。可以理解的，在其他实施例中，当硅酮本体111通过覆膜成型于网架112时，也可以在硅酮本体111的两端设置裙边118，以便面网架112刺激人体组织。
具体地，通过在网架112的近端和远端分别涂覆液态硅酮，然后将硅酮筒套设网架112后进行硫化处理，以通过液态硅酮将网架112的近端和远端固定于硅酮筒。由于形成硅酮本体111的硅酮筒与网架112分体制造，且硅酮筒的长度大于网架112的长度，如此同一规格的硅酮筒能够适应不同长度规格的网架112，从而有助于降低生产成本。
可选的，凸起120一体成型在硅酮筒的外周壁。可选地，在将硅酮本体111成型在网架112上的步骤之前，还包括编织网架112的编织步骤。可选地，在将硅酮本体111成型在网架112上的步骤之前，还包括制造硅酮筒的制造步骤。
需要说明的是，此处粘接在硅酮筒内的网架112为裸架，可以理解的，在其他实施例中，也可以预先对网架112覆膜，从而在网架112上形成包覆网架112的硅酮层，然后将覆膜后的网架112粘接固定在硅酮筒内。具体地，将硅酮本体111成型在网架112上的步骤包括：
将硅酮筒套设于包覆有硅酮层(图未示出)的网架112；对硅酮筒和包覆有硅酮层的网架112硫化，以使硅酮筒与硅酮层粘接固定。此时硅酮筒位于网架112的近端和远端之间的部分形成硅酮本体111，硅酮筒的轴向的两端凸出网架112以形成裙边118。
以上所述，仅为本公开的具体实施方式，但本公开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公开揭露的技术范围内，可轻易想到的变化或替换，都应涵盖在本公开的保护范围之内。因此，本公开的保护范围应以所述权利要求的保护范围为准。
工业实用性
本公开提供的硅酮支架包括架体，其中，架体包括网架和成型在网架上的硅酮本体，硅酮本体的内部限定出周向密封的空间，且硅酮本体的远端和近端分别具有与空间连通的远端开口以及近端开口，使用时将硅酮支架置入人体气管内，硅酮本体内部限定的空间将气管连通，保证气管处于畅通状态。由于硅酮支架的架体通过网架和硅酮本体共同形成，且网架周向覆盖硅酮本体，轴向上网架从硅酮本体的近端延伸至硅酮本体的远端，如此通过网架能够有效提高架体的支撑力，相较于现有的硅酮支架中架体的支撑力仅由硅酮本体自身提供。因此，本公开提供的硅酮支架可以大大减小硅酮本体的壁厚，且形成的架体的壁厚也相应大大减小，如此在进行置入时，可将硅酮支架装入置入器中，通过置入器采用传统的OTW方式在软质支气管镜的旁视下进行置入，有助于减小置入难度、降低手术难度，进而能够有效缩短置入操作的学习曲线。本公开提供的置入系统能够采用传统OTW方式通过置入器将硅酮支架置入人体气管，因此具有硅酮支架的置入难度低、手术难度低、置入操作学习曲线短的有益效果；本公开提供的制造方法，能够制造上述的硅酮支架，因此制成的硅酮支架也具有置入难度低、手术难度低、置入操作学习曲线短的有益效果。

Claims (21)

  1. 一种硅酮支架，其特征在于，包括架体(110)，所述架体(110)包括网架(112)和成型在所述网架(112)上的硅酮本体(111)，在所述硅酮本体(111)的内部限定出周向密封的空间(116)，所述硅酮本体(111)的远端和近端分别具有与空间(116)连通的远端开口(115)以及近端开口(114)；所述网架(112)周向覆盖所述硅酮本体(111)，且沿所述硅酮本体(111)的轴向，所述网架(112)从所述硅酮本体(111)的近端延伸至所述硅酮本体(111)的远端。
  2. 根据权利要求1所述的硅酮支架，其特征在于，所述架体(110)的外周壁(113)凸设有多个凸起(120)。
  3. 根据权利要求2所述的硅酮支架，其特征在于，所述凸起(120)与所述硅酮本体(111)一体成型。
  4. 根据权利要求2所述的硅酮支架，其特征在于，所述网架(112)具有凸部，所述凸部覆膜形成所述凸起(120)。
  5. 根据权利要求2所述的硅酮支架，其特征在于，所述凸起(120)粘接固定于所述架体(110)。
  6. 根据权利要求2所述的硅酮支架，其特征在于，多个所述凸起(120)包括沿所述架体(110)的周向均匀分布的多列凸起(120)，每列所述凸起(120)包括沿所述架体(110)的轴向间隔设置的多个所述凸起(120)。
  7. 根据权利要求6所述的硅酮支架，其特征在于，相邻两列所述凸起(120)中的多个凸起(120)沿所述架体(110)的轴向交替设置；或者，
    每列所述凸起(120)中的多个所述凸起(120)绕所述架体(110)的轴线螺旋分布；或者，
    多个所述凸起(120)分散分布。
  8. 根据权利要求2所述的硅酮支架，其特征在于，所述凸起(120)的厚度为h，0.5mm≤h≤4mm。
  9. 根据权利要求1所述的硅酮支架，其特征在于，所述架体(110)的壁厚为d，0.05mm≤d≤0.8mm。
  10. 根据权利要求1-9任一项所述的硅酮支架，其特征在于，所述硅酮本体(111)覆膜成型于所述网架(112)。
  11. 根据权利要求1-9任一项所述的硅酮支架，其特征在于，所述硅酮本体(111)固定于所述网架(112)的外周。
  12. 根据权利要求11所述的硅酮支架，其特征在于，所述架体(110)还包括连接于所述硅酮本体(111)两端的裙边(118)；沿所述硅酮支架(100)的轴向，所述裙边(118)位于所述网架(112)的两侧。
  13. 根据权利要求12所述的硅酮支架，其特征在于，所述裙边(118)与所述硅酮本体(111)一体成型。
  14. 根据权利要求11所述的硅酮支架，其特征在于，所述架体(110)还包括包裹所述网架(112)的硅酮层，所述硅酮本体(111)与所述硅酮层固定连接。
  15. 一种置入系统，其特征在于，包括置入器(200)以及权利要求1-14任一项所述的硅酮支架(100)；所述置入器(200)具有容纳腔(214)，所述硅酮支架(100)呈收缩状态容纳于所述容纳腔(214)内，以通过所述置入器(200)进行所述硅酮支架(100)的置入。
  16. 一种制造方法，用于制造硅酮支架(100)，其特征在于，所述制造方法包括：
    将硅酮本体(111)成型在筒状的网架(112)上，使得所述硅酮本体(111)的内部限定出周向密封的空间(116)，所述硅酮本体(111)的远端和近端分别设置有与空间(116)连通的近端开口(114)以及远端开口(115)；所述网架(112)周向覆盖所述硅酮本体(111)，且沿所述硅酮本体(111)的轴向，所述网架(112)从所述硅酮本体(111)的近端延伸至所述硅酮本体(111)的远端。
  17. 根据权利要求16所述的制造方法，其特征在于，所述将硅酮本体(111)成型在筒状的网架(112)上的步骤包括：
    对所述网架(112)覆膜硅酮，以在所述网架(112)上成型所述硅酮本体(111)；
    其中，所述网架(112)具有凸部，所述凸部覆膜硅酮形成所述硅酮支架(100)的凸起(120)。
  18. 根据权利要求16所述的制造方法，其特征在于，所述将硅酮本体(111)成型在筒状的网架(112)上的步骤包括：
    对所述网架(112)覆膜硅酮，以在所述网架(112)上成型所述硅酮本体(111)，获得所述硅酮支架(100)的架体(110)；
    所述将硅酮本体(111)成型在筒状的网架(112)上的步骤之后包括：将凸起(120)粘接于所述架体(110)的外周壁(113)，以获得所述硅酮支架(100)。
  19. 根据权利要求16所述的制造方法，其特征在于，所述将硅酮本体(111)成型在筒状的网架(112)上的步骤包括：
    将所述网架(112)放置在模具中；
    对所述模具注入液态硅酮，并使所述液态硅酮充满所述模具内周面上的凹槽；
    使得冷却后，所述液态硅酮包覆于所述网架(112)形成所述硅酮本体(111)，且所述硅酮本体(111)的外壁具备与所述凹槽对应凸起(120)。
  20. 根据权利要求16所述的制造方法，其特征在于，所述将硅酮本体(111)成型在筒状的网架(112)上的步骤包括：
    将网架(112)的近端和远端分别粘接固定在硅酮筒的内周壁，所述硅酮筒位于所述网架(112)的近端和远端之间的部分形成所述硅酮本体(111)，所述硅酮筒的轴向的两端凸出所述网架(112)形成裙边(118)。
  21. 根据权利要求16所述的制造方法，其特征在于，所述将硅酮本体(111)成型在筒状的网架(112)上的步骤包括：
    将硅酮筒套设于包覆有硅酮层的所述网架(112)；对所述硅酮筒和所述包覆有硅酮层的所述网架(112)硫化，以使所述硅酮筒与所述硅酮层粘接；所述硅酮筒位于所述网架(112)的近端和远端之间的部分形成所述硅酮本体(111)，所述硅酮筒的轴向的两端凸出所述网架(112)形成裙边(118)。
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