Silicone stent, implantation system, and manufacturing method
Provided are a silicone stent ( 100 ), an implantation system, and a manufacturing method. The silicone stent ( 100 ) includes a stent body ( 110 ). The stent body ( 110 ) includes a mesh frame ( 112 ) and a silicone body ( 111 ) molded on the mesh frame ( 112 ). A circumferentially sealed space ( 116 ) is defined within the silicone body ( 111 ). A distal end and a proximal end of the silicone body ( 111 ) respectively have a distal-end opening ( 115 ) and a proximal-end opening ( 114 ) that communicate with the space ( 116 ). The mesh frame ( 112 ) circumferentially covers the silicone body ( 111 ), and runs in an 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 ).
1 . A silicone stent for trachea, comprising a stent body, wherein the stent body comprises a braided mesh frame and a silicone body molded on the braided mesh frame; a circumferentially sealed space is defined within the silicone body; a distal end and a proximal end of the silicone body respectively have a distal-end opening and a proximal-end opening that communicate with the space; wherein an inner diameter of the circumferentially sealed space, an inner diameter of the distal-end opening, and an inner diameter of the proximal-end opening are substantially the same; wherein the silicone body is molded on the braided mesh frame by film coating; and the braided mesh frame extends from the proximal end of the silicone body to the distal end of the silicone body,
wherein the stent body further comprises skirt edges connected at two ends of the silicone body; and along an axial direction of the silicone stent, the skirt edges are located on two sides of the braided mesh frame, with an axial size L of the skirt edge satisfying 0≤L≤6 mm,
wherein the silicone stent is configured to be received in an accommodation cavity of a delivery device in a contracted state, and to be released and implanted, under guide of a guide wire and under a side view of the flexible bronchoscope, in the trachea by the delivery device;
wherein an outer peripheral wall of the stent body is provided with a plurality of protrusions, wherein the protrusions are so configured that when the silicone stent is implanted into the human trachea, the protrusions abut against an inner wall surface of the trachea, such that an outer peripheral surface of the stent body is separated from the inner wall surface of the trachea, so as to form a gap between the outer peripheral surface of the stent body and the inner wall surface of the trachea,
wherein the plurality of protrusions comprise a plurality of columns of protrusions that are uniformly distributed along a circumferential direction of the stent body, and each column of protrusions comprise a plurality of protrusions disposed at intervals along an axial direction of the stent body, wherein protrusions in two adjacent columns of protrusions are alternately disposed along the axial direction of the stent body,
wherein a thickness (h) of the protrusions satisfies 0.5 mm≤h≤4 mm.
2 . The silicone stent according to claim 1 , wherein the protrusion is integrally formed with the silicone body.
3 . The silicone stent according to claim 1 , wherein the braided mesh frame has a protruding portion, and the protruding portion is film coated to form the protrusion.
4 . The silicone stent according to claim 1 ,
wherein a plurality of protrusions in each column of protrusions are spirally distributed around an axis of the stent body; or
a plurality of protrusions are distributed dispersedly.
5 . The silicone stent according to claim 1 , wherein a wall thickness (d) of the stent body satisfies 0.05 mm≤d≤0.8 mm.
6 . The silicone stent according to claim 1 , wherein the skirt edge is integrally formed with the silicone body.
7 . An implantation system, comprising a delivery device and the silicone stent according to claim 1 , wherein the delivery device has an accommodation cavity, and the silicone stent is accommodated in the accommodation cavity in a contracted state, so that the silicone stent is released and implanted, under guide of a guide wire and under a side view of the flexible bronchoscope, in the trachea by the delivery device.