Disclosure of Invention
The embodiment of the application provides an anti-infection nasal vestibule tectorial membrane bracket, which solves the technical problem that in the prior art, an artificial trachea or a trachea bracket is transplanted to a patient and is easy to cause infection of bronchi, bronchioles and lungs, and provides an anti-infection nasal vestibule tectorial membrane bracket for placing the patient facing the trachea bracket, wherein a monofilament woven bracket is combined with a 3D tectorial membrane with a gradient filtering function, so that the inhalation of tiny particles such as viruses and bacteria is stopped from the source, and the infection probability of the patient is reduced.
The embodiment of the application provides an anti-infection nasal vestibule tectorial membrane bracket, which comprises the following components:
the shape and the size of the bracket body are matched with those of the nasal vestibule;
coating a film;
The coating is compounded on the bracket body.
Preferably, the bracket body is a bracket body with a shape memory function.
More preferably, the stent body is a net structure woven and shaped by shape memory wires.
Further, the shape memory wire is a metal wire or a polymer wire.
Further, the metal wire or the polymer wire has good biocompatibility.
Still further, the wire has a diameter of 0.01-0.5mm.
Further, the diameter of the polymer filaments is 0.05-0.5mm.
Further, the metal wire is one or more of stainless steel wire, nickel wire, titanium wire, cobalt wire, tungsten wire and alloy wire thereof.
Further, the polymer filaments are PP, PE, PGA, PGLA, PPDO, PCL, PLA, PGCL, PVA or one or more of the composite filaments thereof.
Preferably, the stent body comprises an upper surface and a lower surface, the covering film comprises an upper covering film and a lower covering film, the upper covering film is compounded on the upper surface of the stent body, and the lower covering film is compounded on the lower surface of the stent body.
More preferably, the upper coating film and the lower coating film are respectively composed of at least one fiber layer, and the pore diameters of the fiber layers are gradually reduced from the lowest layer of the lower coating film to the uppermost layer of the upper coating film.
Further, the upper and/or lower coating films have the property of filtering fine particles. The upper and/or lower cover films comprise 1-3 fiber layers, and the pore diameter of the lower fiber layer is larger than that of the upper fiber layer.
Preferably, the film-coating preparation method includes, but is not limited to, flash evaporation, melt blowing, electrospinning, centrifugal spinning, and combinations thereof.
Preferably, the cover is directly compounded onto the stent body during the molding process.
Preferably, the stent body and/or the cover film is loaded with a drug.
The embodiment of the application also provides a preparation method of the anti-infection nasal vestibule tectorial membrane stent, which comprises the following steps:
shaping a bracket by a mould through a monofilament braiding method, wherein the shape and the size of the bracket are matched with those of a nasal vestibule;
Fixing the shape of the bracket through heat setting to obtain a bracket body with a shape memory function and a shape and size matched with the shape of the nasal vestibule;
And (3) adopting a micro-nano fiber forming method to directly form a tectorial membrane on the upper surface and the lower surface of the bracket body respectively to obtain the nasal vestibule tectorial membrane bracket.
Preferably, the stent body and/or the cover film is loaded with medicine;
The method for loading the medicine on the coating film comprises the following steps:
after the film is formed, the medicine is loaded on the film, or
The preparation method comprises the steps of pre-loading medicines into materials, and directly forming a coating film on the upper surface and the lower surface of the bracket body respectively by adopting a micro-nano fiber forming method for the materials loaded with medicines;
The method for uploading the medicine on the stent body comprises the following steps:
After the stent body is woven and shaped, the stent body is coated/grafted with medicine, or
The drug is pre-coated/grafted onto the monofilaments, and the drug-loaded monofilaments are woven into the stent body.
The embodiment of the application also provides application of the anti-infective nasal vestibular stent, and application of the anti-infective nasal vestibular stent in preparation of equipment for preventing or treating bronchus, bronchioles and/or pulmonary infection after placement of a tracheal stent or implantation of an artificial trachea.
One or more technical solutions provided in the embodiments of the present application at least have the following technical effects or advantages:
1. The embodiment of the application creatively combines the monofilament woven stent with the 3D tectorial membrane with the gradient filtering function. Firstly, a monofilament shape memory stent is woven, and a stent body which is well matched with the morphological structure of the nasal vestibule of a human body is obtained by a heat setting mode. Then, by the techniques such as flash evaporation, melt blowing, electrostatic spinning, centrifugal spinning and combinations thereof, continuous pore diameter gradient coating films are respectively compounded on the upper surface and the lower surface of the stent body. Finally, the gas inhaled into the human body through the nose is subjected to gradient filtration, so that the aim of preventing bronchus, bronchioles and lung infection of the patient transplanted by the artificial trachea or a tracheal stent is fulfilled.
2. The anti-infection nasal vestibule tectorial membrane bracket provided by the embodiment of the application is especially oriented to artificial trachea or trachea bracket transplanted patients, has strong pertinence, and can effectively prevent fine particles such as viruses, bacteria, dust and the like from being inhaled into human bodies.
3. The anti-infection nasal vestibule tectorial membrane bracket provided by the embodiment of the application has the advantages of simple structure, convenient molding, attractive application and remarkable anti-infection effect.
4. The preparation method of the anti-infection nasal vestibule tectorial membrane bracket provided by the embodiment of the application is convenient to operate, has low requirements on technology and equipment, is low in cost, and has strong feasibility and popularization value.
5. The anti-infection nasal vestibule tectorial membrane stent provided by the embodiment of the application can realize the drug loading and drug releasing functions of the tectorial membrane stent without changing the process, and is easy to realize multiple additional functions.
Detailed Description
The embodiment of the application solves the technical problem that the artificial trachea or trachea stent is transplanted to a patient and is easy to cause bronchus, bronchiole and lung infection by providing the anti-infection nasal vestibule tectorial membrane stent.
The technical scheme in the embodiment of the application aims to solve the problem of crosstalk, and the overall thought is as follows:
The anti-infection nasal vestibule tectorial membrane bracket for the tracheal stent is put on a patient, so as to try to avoid the inhalation of fine particles such as viruses and bacteria from the source, and bring good news to the patient transplanted by artificial trachea or tracheal stent.
At present, no literature report is reported on the placement of an anti-infection nasal vestibular tectorial membrane bracket for a patient facing the tracheal bracket at home and abroad.
The invention combines the monofilament braided stent with the 3D tectorial membrane with gradient filtering function. Firstly, a monofilament shape memory stent is woven, and a stent body which is well matched with the morphological structure of the nasal vestibule of a human body is obtained by a heat setting mode. Then, by the techniques such as flash evaporation, melt blowing, electrostatic spinning, centrifugal spinning and combinations thereof, continuous pore diameter gradient coating films are respectively compounded on the upper surface and the lower surface of the stent body. Finally, the gas inhaled into the human body through the nose is subjected to gradient filtration, so that the aim of preventing bronchus, bronchioles and lung infection of the patient transplanted by the artificial trachea or a tracheal stent is fulfilled.
In order to better understand the above technical solutions, the following detailed description will refer to the accompanying drawings and specific embodiments.
Example 1
Fig. 1 is a schematic structural diagram of an anti-infective nasal vestibular stent provided in a first embodiment of the present application, where the anti-infective nasal vestibular stent includes:
the shape of the bracket body is matched with the shape of the nasal vestibule so as to realize good fit between the bracket body and the nasal vestibule;
coating a film;
The coating is compounded on the bracket body.
As shown in fig. 1, the stent body 1 is woven by a single shape memory wire, and is formed into a net structure matched with the nasal vestibule by heat setting. The prepared bracket body has shape memory performance, and the morphological structure of the bracket body can be well attached to the nasal vestibule of a human body.
In the embodiment, the single shape memory wire is a PP wire with a diameter of 0.25mm, and the PP wire has good biocompatibility.
The bracket body has two faces, an upper surface and a lower surface. The lower surface is located on the underside (lateral) of the nasal vestibule, i.e. on the side adjacent the nose mouth. The upper surface is located on the upper (medial) side of the nasal vestibule, i.e. the side remote from the nose and mouth.
In a preferred embodiment, the upper surface is a mesh-shaped structure surface integrally woven with the peripheral wall of the stent body.
In another preferred embodiment, the upper surface is an open structure.
In a preferred embodiment, the lower surface is a mesh-like structure surface integrally woven with the peripheral wall of the stent body.
In another preferred embodiment, the lower surface is an open structure.
The covering film comprises an upper covering film 1 and a lower covering film 3, wherein the upper covering film 1 is compounded on the upper surface of the stent body 2, and the lower covering film 3 is compounded on the lower surface of the stent body 2.
The coating film has a gradient filtering function and can filter fine particles. And the upper coating film 1 and the lower coating film 3 are directly compounded on the bracket body while being molded.
In this embodiment, the upper coating 1 is composed of two fiber layers, and as shown in fig. 2, the upper coating 1 is composed of an upper coating 12, a lower coating 12 and an upper coating 11, which are sequentially combined from bottom to top. Wherein:
The upper coating film 11 was made of PVA material by electrospinning method and had an average pore diameter of 10nm.
The upper and lower coating films 12 are made of PVA material by an electrospinning method, and have an average pore diameter of 100nm.
In this embodiment, the lower coating 3 is composed of three fiber layers, and as shown in fig. 3, the lower coating 3 is composed of a lower upper coating 31, a lower middle coating 32 and a lower coating 33 which are sequentially combined from top to bottom.
Wherein:
The lower upper film 31 is made of PP material by melt-blowing method, and has an average pore diameter of 1 μm.
The lower middle coating 32 was made of PP material by melt-blowing method and had an average pore diameter of 2.5 μm.
The lower film 33 was made of PP material by a spunbond method with an average pore size of 10 μm.
The pore diameters of the fiber layers of the lower and middle films 33, 32, 31, 12, 11 decrease in order. The pore diameters of the fiber layers from the lowermost surface of the lower coating film to the uppermost surface of the upper coating film are sequentially reduced, so that the effective filtration of the sucked air is realized, and the ventilation rate is not obviously influenced.
The anti-infective nasal vestibular stent provided in this example was tested to have a filtration efficiency of 99%.
When in use, the nasal vestibule tectorial membrane bracket is placed into the nasal vestibule of a patient placed by the tracheal bracket, and the gas inhaled into the human body by the nose is subjected to gradient filtration through the fiber layers of the lower tectorial membrane 33, the lower middle tectorial membrane 32, the lower upper tectorial membrane 31, the upper tectorial membrane 12 and the upper tectorial membrane 11, and the filtered gas is clean and sterile.
Clinical experiments show that after the patient wears the anti-infection nasal vestibule tectorial membrane stent provided in the embodiment, the tracheal stent has obvious anti-infection function, and the probability of occurrence of infection of bronchi, bronchioles and lungs is greatly reduced.
Example two
An anti-infective nasal vestibular stent graft comprising:
the shape of the bracket body is matched with the shape of the nasal vestibule so as to realize good fit between the bracket body and the nasal vestibule;
coating a film;
The coating is compounded on the bracket body.
The bracket body is woven by single shape memory wires and forms a reticular structure matched with the nasal vestibule shape through heat setting. The prepared bracket body has shape memory performance, and the morphological structure of the bracket body can be well attached to the nasal vestibule of a human body.
In the embodiment, the single shape memory wire is nickel titanium wire with the diameter of 0.01mm, and the nickel titanium wire has good biocompatibility.
The bracket body has two faces, an upper surface and a lower surface. The lower surface is located on the underside (lateral) of the nasal vestibule, i.e. on the side adjacent the nose mouth. The upper surface is located on the upper (medial) side of the nasal vestibule, i.e. the side remote from the nose and mouth.
In a preferred embodiment, the upper surface is a mesh-shaped structure surface integrally woven with the peripheral wall of the stent body.
In another preferred embodiment, the upper surface is an open structure.
In a preferred embodiment, the lower surface is a mesh-like structure surface integrally woven with the peripheral wall of the stent body.
In another preferred embodiment, the lower surface is an open structure.
The covering film comprises an upper covering film and a lower covering film, wherein the upper covering film is compounded on the upper surface of the stent body, and the lower covering film is compounded on the lower surface of the stent body.
The coating film has a gradient filtering function and can filter fine particles. And the upper coating film and the lower coating film are directly compounded on the bracket body while being molded.
In this embodiment, the upper coating is formed of a fibrous layer. Specifically, the upper coating film is made of PCL material through an electrostatic spinning method, and the average pore diameter is 50nm.
In this embodiment, the lower coating is composed of two fiber layers. Specifically, the lower coating is formed by sequentially compounding a lower upper coating and a lower coating from top to bottom. Wherein:
The lower upper coating film is made of PP material through a melt-blowing method, and the average pore diameter is 2.5 mu m.
The lower film is made of PP material by a spunbonding method, and the average pore diameter is 10 mu m.
The pore diameters of the fiber layers of the lower coating film, the lower upper coating film and the upper coating film are sequentially reduced. The pore diameters from the lowest surface of the lower coating film to the upper coating film fiber layer are sequentially reduced, so that the effective filtration of the sucked air is realized, and the ventilation rate is not obviously influenced.
The filtration efficiency of the anti-infective nasal vestibular stent provided in this example was tested to be 98.8%.
When in use, the nasal vestibule tectorial membrane bracket is put into the nasal vestibule of a patient placed by the tracheal bracket, and the gas inhaled into the human body by the nose is subjected to gradient filtration through the fiber layers of the lower tectorial membrane, the lower upper tectorial membrane and the upper tectorial membrane, so that the filtered gas is clean and sterile.
Clinical experiments show that after the patient wears the anti-infection nasal vestibule tectorial membrane stent provided in the embodiment, the tracheal stent has obvious anti-infection function, and the probability of occurrence of infection of bronchi, bronchioles and lungs is greatly reduced.
Example III
With reference to fig. 4, this embodiment provides a method for preparing an anti-infective nasal vestibular stent, which includes the following steps:
Step S1, braiding
Forming a bracket by using a mould and adopting a monofilament braiding method, wherein the shape and the size of the bracket are matched with those of a nasal vestibule;
Step S2, shaping
Fixing the shape of the bracket by heat setting to obtain a bracket body with good shape memory performance and shape and size matched with the shape of the nasal vestibule;
Step S3, film coating
And directly forming a tectorial membrane on the upper surface and the lower surface of the stent body respectively by adopting a micro-nano fiber forming method to obtain the anti-infection nasal vestibule tectorial membrane stent.
Example IV
The embodiment provides a preparation method of an anti-infection nasal vestibule tectorial membrane stent, which comprises the following steps:
Step S1, braiding
Forming a bracket by using a mould and adopting a monofilament braiding method, wherein the shape and the size of the bracket are matched with those of a nasal vestibule;
Step S2, shaping
Fixing the shape of the bracket by heat setting to obtain a bracket body with good shape memory performance and shape and size matched with the shape of the nasal vestibule;
Step S3, film coating
And (3) directly forming a coating film on the upper surface and the lower surface of the stent body respectively by adopting a micro-nano fiber forming method, and loading a medicine on the coating film to obtain the anti-infection nasal vestibule coating film stent.
Example five
The embodiment provides a preparation method of an anti-infection nasal vestibule tectorial membrane stent, which comprises the following steps:
Step S1, braiding
Forming a bracket by using a mould and adopting a monofilament braiding method, wherein the shape and the size of the bracket are matched with those of a nasal vestibule;
Step S2, shaping
Fixing the shape of the bracket by heat setting to obtain a bracket body with good shape memory performance and shape and size matched with the shape of the nasal vestibule;
Step S3, film coating
And (3) pre-loading the medicine in the material, and directly forming the coating on the upper surface and the lower surface of the stent body respectively by adopting a micro-nano fiber forming method to obtain the anti-infection nasal vestibule coating stent.
Example six
The embodiment provides a preparation method of an anti-infection nasal vestibule tectorial membrane stent, which comprises the following steps:
Step S1, braiding
Forming a bracket by using a mould and adopting a monofilament braiding method, wherein the shape and the size of the bracket are matched with those of a nasal vestibule;
Step S2, shaping
Fixing the shape of the bracket by heat setting to obtain a bracket body with good shape memory performance and shape and size matched with the shape of the nasal vestibule;
Step S3, film coating
And directly forming a tectorial membrane on the upper surface and the lower surface of the stent body respectively by adopting a micro-nano fiber forming method to obtain the anti-infection nasal vestibule tectorial membrane stent.
Example seven
The embodiment provides a preparation method of an anti-infection nasal vestibule tectorial membrane stent, which comprises the following steps:
Step S1, braiding
Coating/grafting the medicine on the monofilaments in advance, and weaving the monofilaments loaded with the medicine into a bracket by using a die, wherein the shape and the size of the bracket are matched with those of the nasal vestibule;
Step S2, shaping
Fixing the shape of the bracket by heat setting to obtain a bracket body with good shape memory performance and shape and size matched with the shape of the nasal vestibule;
Step S3, film coating
And (3) directly forming a coating film on the upper surface and the lower surface of the stent body respectively by adopting a micro-nano fiber forming method, and loading a medicine on the coating film to obtain the anti-infection nasal vestibule coating film stent.
It should be understood that references to upper, lower, left, right, front, rear, front, back, top, bottom, etc. in this specification or as may be referred to are intended to be defined with respect to the configurations shown in the various figures, as opposed to concepts, which may be adapted for use in a variety of different positions and in a variety of different orientations. These and other directional terms should not be construed as limiting terms.
While the application has been described with respect to preferred embodiments thereof, it will be understood by those skilled in the art that various modifications and additions may be made without departing from the scope of the application. Those skilled in the art will appreciate that many modifications, adaptations and variations of the present application can be made using the techniques disclosed herein without departing from the spirit and scope of the application, and that many modifications, adaptations and variations of the present application are within the scope of the application as defined by the appended claims.