CN108771573B - Completely degradable and absorbable drug eluting stent and application thereof - Google Patents
Completely degradable and absorbable drug eluting stent and application thereof Download PDFInfo
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- CN108771573B CN108771573B CN201810669126.6A CN201810669126A CN108771573B CN 108771573 B CN108771573 B CN 108771573B CN 201810669126 A CN201810669126 A CN 201810669126A CN 108771573 B CN108771573 B CN 108771573B
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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
- 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
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- A—HUMAN NECESSITIES
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially resorbable by the body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/16—Biologically active materials, e.g. therapeutic substances
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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
- 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
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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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/41—Anti-inflammatory agents, e.g. NSAIDs
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/602—Type of release, e.g. controlled, sustained, slow
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Abstract
The invention discloses a completely degradable and absorbable drug eluting stent, which comprises an inner-layer stent, an outer-layer stent and a foldable shaft lever, wherein the inner-layer stent is arranged on the outer-layer stent; the inner layer bracket and the outer layer bracket are connected through a foldable shaft lever; the surface of the inner layer stent is coated with an antiproliferative drug coating, and the surface of the outer layer stent is coated with an anti-inflammatory drug coating; the meshes of the inner layer bracket and the meshes of the outer layer bracket are arranged in a staggered way. The support force of the stent is increased, and the restenosis of a lumen can be effectively prevented; the drug on the outer layer bracket can play a role in diminishing inflammation, and the drug is slowly released along with the degradation of the outer layer bracket, and the outer layer drug is completely released after the outer layer bracket is completely degraded; after the outer layer stent is completely degraded, the inner stent automatically expands to be in contact with the lumen, and the medicament on the inner stent starts to be slowly released to prevent the hyperplasia of the lumen tissue; the inner layer bracket and the outer layer bracket are contacted with different tissues of the lumen, so that the uniformity of drug release is ensured.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a completely degradable and absorbable drug eluting stent.
Background
The eustachian tube is connected with the middle ear cavity and the nasopharynx part, the tympanogram opening is arranged on the front wall of the tympanogram, and the pharyngeal opening is arranged on the side wall of the nasopharynx, so that the eustachian tube is the only passage for communicating the middle ear with the outside and is also an important factor for maintaining the normal ventilation of the middle ear and sound transmission of the auditory bone chain. Occlusion or blockage of the eustachian tube results in negative middle ear pressure with retraction (aspiration) of the eardrum. In adults, this is often accompanied by some ear discomfort, fullness or pressure sensation, and can lead to mild hearing impairment and head noise (tinnitus). There may be no symptoms in children. If the occlusion is prolonged, fluid may be withdrawn from the mucosa of the middle ear, creating a focus of serous otitis media. This occurs frequently in children in combination with upper respiratory tract infections and is the cause of hearing impairment associated with the disease.
The incidence of Eustachian Tube Dysfunction (ETD) in adults is between 1% and 5%, with higher rates of ETD and otitis media in children relative to adults, with about 40% of children under the age of 10 experiencing at least 1 transient ETD. ETD is caused by a variety of causes, but is closely related to the unique anatomy of the eustachian tube. The mucous membrane of the cartilaginous part of the eustachian tube is inflamed, blocked by excessive secretion, hyperemia, hypertrophy and even ossification, so that the eustachian tube can not be actively and normally opened, and tympanogram is caused to generate symptoms such as ear distress, tinnitus, hearing loss and the like. Serious complications such as secretory otitis media, suppurative otitis media, cholesteatoma and the like can occur when ETD is aggravated.
ETD treatment can be divided into drug treatment and surgical treatment, and commonly used drugs include nasal spray hormone, decongestants, antihistamines and the like, but the ETD treatment has the defects of long treatment time, complicated operation and limited function improvement. The operative treatment of ETD usually adopts eustachian tube insufflation, floating catheter dilatation, myringotomy catheterization and the like, but the operability, safety, effectiveness and the like are required to be improved, and complications such as tympanostomy, permanent perforation of the tympanic membrane, suppurative otitis media, even cholesteatoma and the like can be caused. Balloon Eustachian tube dilation (BET) is clinically applied with the advantages of minimal invasion, simple and convenient operation, good treatment effect and the like, but has a high restenosis rate.
At present, the stent is developed on the basis of balloon dilatation, and the interventional therapy technology has the advantages of reliable effect, simple and convenient method, small wound and easy acceptance for patients.
Chinese patent application No. 201210507878.5 discloses a degradable magnesium alloy esophageal stent for infants, which comprises: the annular single body is formed by folding a magnesium alloy metal wire in a W shape, is connected into a cylinder shape and has elasticity, and two ends of the annular single body are provided with bending parts; a connection point connecting the cyclic monomers axially in series with each other; the bottom of the protrusion is positioned at the connecting point, the top end of the protrusion is positioned at the outer side of the esophageal stent, and the protrusion can be embedded into the esophageal wall after the magnesium alloy esophageal stent is expanded and released to play a role of fixing the stent.
Chinese patent application No. 200710012808.1 discloses a medicine slow release magnesium alloy stent capable of being completely degraded and absorbed and application thereof, wherein the stent is made of a magnesium alloy precise pipe by laser cutting, the surface of the stent is provided with a double-layer coating structure, the inner layer is a temporary protective layer of a magnesium alloy matrix, and the outer layer is a degradable high polymer film mixed with medicines.
Although the magnesium alloy stent plays a certain role in the treatment of the stenosis of the cavity, the magnesium alloy tube of the stent is cut into a net-shaped stent by laser, and the defects of uneven stress, weaker supporting force, uneven drug release and weak pertinence of the stenosis part exist in the process of supporting the cavity.
Disclosure of Invention
The first technical problem to be solved by the invention is to provide a drug eluting stent which can be completely degraded and absorbed; the stent expands the eustachian tube lumen after interventional operation, recovers the normal function of the eustachian tube lumen, and finally is completely degraded and absorbed; in addition, the stent can ensure that the medicine is uniformly and slowly released on the inner wall of the eustachian tube lumen to the maximum extent.
The second technical problem to be solved by the invention is to provide the application of the completely degradable and absorbable drug eluting stent.
In order to solve the first technical problem, the invention adopts the following technical scheme:
the invention relates to a completely degradable and absorbable drug eluting stent, which comprises an inner layer stent, an outer layer stent and a foldable shaft lever; the inner layer bracket and the outer layer bracket are connected through a foldable shaft lever; the surface of the inner layer stent is coated with an antiproliferative drug coating, and the surface of the outer layer stent is coated with an anti-inflammatory drug coating; the meshes of the inner layer bracket and the meshes of the outer layer bracket are arranged in a staggered way.
Furthermore, the thickness of the inner layer bracket is 0.05-0.5mm, the diameter is 1.0-28mm, and the length is 5-400 mm.
Furthermore, the thickness of the outer layer bracket is 0.02-0.3mm, the diameter is 2.0-30mm, and the length is 5-400 mm.
Further, the thickness of the inner layer bracket is larger than that of the outer layer bracket; the diameter of the inner layer bracket is smaller than that of the outer layer bracket; the length of the inner layer bracket is the same as that of the outer layer bracket.
Further, the angle of the collapsible shaft is 10 ° -80 ° or 100 ° -170 °.
Further, the inner layer bracket is made of magnesium alloy, iron alloy, zinc alloy or polylactic acid; the outer layer bracket is made of magnesium alloy, zinc alloy, polylactic acid or iron alloy; the foldable shaft rod is made of magnesium alloy, iron alloy, zinc alloy, polylactic acid, collagen or chitosan.
Further, the anti-proliferative drug coating comprises one or more of paclitaxel, sirolimus, everolimus, sotalolimus, basilimus, nafolimus, marimastat, mitomycin, and batroxobin; the anti-inflammatory drug coating comprises one or more of maffuo liquid drop nose, fexofenadine, epinastine hydrochloride, dexamethasone, betamethasone, antibiotics, ephedrine, naristilla and oxymetazoline hydrochloride.
Further, the anti-proliferative drug coating and the anti-inflammatory drug coating are prepared by one or more methods of dipping, spraying and coating.
Further, the inner layer bracket, the outer layer bracket and the foldable shaft rod are fixedly connected by one or more of laser integral cutting, laser welding, hot melt welding and adhesive bonding.
The invention discloses application of a completely degradable and absorbable drug eluting stent in coronary artery, peripheral blood vessel, esophagus, trachea, ureter, bile duct, intestinal tract and eustachian tube lesions.
Any range recited herein is intended to include the endpoints and any number between the endpoints and any subrange subsumed therein or defined therein.
The starting materials of the present invention are commercially available, unless otherwise specified, and the equipment used in the present invention may be any equipment conventionally used in the art or may be any equipment known in the art.
Compared with the prior art, the invention has the following beneficial effects:
1) the supporting force of the bracket is increased, so that the restenosis of the lumen can be effectively prevented;
2) the drug on the outer layer bracket can play a role in diminishing inflammation, and the drug is slowly released along with the degradation of the outer layer bracket, and the outer layer drug is completely released after the outer layer bracket is completely degraded;
3) after the outer layer stent is completely degraded, the inner stent automatically expands to be in contact with the lumen, and the medicament on the inner stent starts to be slowly released to prevent the hyperplasia of the lumen tissue;
4) the inner layer bracket and the outer layer bracket are contacted with different tissues of the lumen, so that the uniformity of drug release is ensured.
Drawings
The following detailed description of embodiments of the invention is provided in connection with the accompanying drawings
FIG. 1 is a schematic structural view of a drug eluting stent of the present invention;
fig. 2 is a schematic side view of the drug eluting stent of fig. 1.
Detailed Description
In order to more clearly illustrate the invention, the invention is further described below in connection with preferred embodiments. It is to be understood by persons skilled in the art that the following detailed description is illustrative and not restrictive, and is not to be taken as limiting the scope of the invention.
It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or be indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or be indirectly connected to the other element.
It will be understood that the terms "length," "width," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like, as used herein, refer to an orientation or positional relationship indicated in the drawings that is solely for the purpose of facilitating the description and simplifying the description, and do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and is therefore not to be construed as limiting the invention.
Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means two or more unless specifically defined otherwise.
Referring to fig. 1 and 2, the present invention provides a completely degradable and absorbable drug-eluting stent, which comprises an inner stent 10, an outer stent 20 and a foldable shaft 30; the inner layer bracket 10 and the outer layer bracket 20 are connected through a foldable shaft rod 30; the surface of the inner stent 10 is coated with an antiproliferative drug coating (not shown in the figure), and the surface of the outer stent is coated with an anti-inflammatory drug coating (not shown in the figure); the meshes of the inner layer bracket 10 and the meshes of the outer layer bracket 20 are arranged in a staggered way.
The inner layer bracket 10 and the outer layer bracket 20 are connected through the foldable shaft rod 30, so that the supporting force of the whole bracket is increased, and the restenosis of a lumen can be effectively prevented; the drug on the outer stent 20 can play a role in diminishing inflammation, and the drug is slowly released along with the degradation of the outer stent, and the outer drug is completely released after the outer stent 20 is completely degraded; after the outer stent 20 is completely degraded, the inner stent automatically expands to contact with the lumen, the drug on the inner stent starts to be slowly released to prevent the proliferation of the lumen tissue, and the inner stent 10 is finally degraded. The bracket degraded layer by layer can furthest ensure the restenosis of the eustachian tube cavity.
The mesh of inner support 10 and the mesh of outer support 20 are in the staggered arrangement, and in the use, the eustachian tube wall cell contacts outer support 20 at first, and the position medicine that contacts can take effect, and the partial cell tissue of eustachian tube wall forms the protruding portion through outer support 20 mesh, and these protruding portions can contact inner support 10 for the effect of medicine is more accurate and even.
In certain embodiments of the present invention, the inner stent 10 has a thickness of 0.05 to 0.5mm, a diameter of 1.0 to 28mm, and a length of 5 to 400 mm.
In certain embodiments of the present invention, the outer stent 20 has a thickness of 0.02 to 0.3mm, a diameter of 2.0 to 30mm, and a length of 5 to 400 mm.
In certain embodiments of the present invention, the thickness of the inner stent 10 is greater than the thickness of the outer stent 20; the diameter of the inner stent 10 is smaller than that of the outer stent 20; the inner stent 10 and the outer stent 20 have the same length. The thickness of the inner layer bracket 10 is larger than that of the outer layer bracket 20, so that the outer layer bracket 20 can be completely degraded firstly, and the hollow phenomenon that the inner layer bracket 10 is completely degraded firstly can not occur.
In some embodiments of the invention, the angle of the collapsible shaft is 10-80 or 100-170.
In some embodiments of the present invention, the material of the inner stent 10 is magnesium alloy, iron alloy or polylactic acid; the outer layer bracket is made of magnesium alloy, polylactic acid or iron alloy; the foldable shaft rod is made of magnesium alloy, iron alloy, polylactic acid, collagen or chitosan.
In certain embodiments of the invention, the anti-proliferative drug coating comprises one or more of paclitaxel, sirolimus, everolimus, sotalolimus, basilimus, nafolimus, and malilimus; the anti-inflammatory drug coating comprises one or more of maffuo liquid drop nose, fexofenadine, epinastine hydrochloride, dexamethasone, betamethasone, antibiotics, ephedrine, naristilla and oxymetazoline hydrochloride.
In certain embodiments of the present invention, the anti-proliferative drug coating and the anti-inflammatory drug coating are prepared by one or more of dipping, spraying, and coating.
In some embodiments of the present invention, one or more of laser welding, thermal welding and adhesive bonding are used to fixedly connect the inner and outer stents 10, 20 to the collapsible shaft 30.
Example 1
A fully degradable and absorbable drug eluting stent comprising an inner stent 10, an outer stent 20 and a collapsible shaft 30; the inner layer bracket 10 and the outer layer bracket 20 are connected through a foldable shaft rod 30; the surface of the inner stent 10 is coated with an antiproliferative drug coating (not shown in the figure), and the surface of the outer stent is coated with an anti-inflammatory drug coating (not shown in the figure); the meshes of the inner layer bracket 10 and the meshes of the outer layer bracket 20 are arranged in a staggered way.
The thickness of the inner layer bracket 10 is 0.05mm, the diameter is 1.0mm, and the length is 5 mm;
the thickness of the outer layer bracket 20 is 0.02mm, the diameter is 2.0mm, and the length is 5 mm;
the angle of the collapsible shaft 30 is 10 °;
the inner layer bracket 10 is made of degradable magnesium alloy; the outer layer bracket is made of degradable magnesium alloy; the foldable shaft lever is made of degradable magnesium alloy;
the anti-proliferative drug coating comprises paclitaxel and sirolimus; the anti-inflammatory drug coating comprises a nifuroxime axetil and fexofenadine;
the anti-proliferative drug coating and the anti-inflammatory drug coating are prepared by adopting a dipping method;
the inner layer bracket 10 and the outer layer bracket 20 are fixed with the foldable shaft rod 30 by laser welding.
Example 2
A fully degradable and absorbable drug eluting stent comprising an inner stent 10, an outer stent 20 and a collapsible shaft 30; the inner layer bracket 10 and the outer layer bracket 20 are connected through a foldable shaft rod 30; the surface of the inner stent 10 is coated with an antiproliferative drug coating (not shown in the figure), and the surface of the outer stent is coated with an anti-inflammatory drug coating (not shown in the figure); the meshes of the inner layer bracket 10 and the meshes of the outer layer bracket 20 are arranged in a staggered way;
the thickness of the inner layer bracket 10 is 0.5mm, the diameter is 4.0mm, and the length is 400 mm;
the thickness of the outer layer bracket 20 is 0.3mm, the diameter is 5.0mm, and the length is 400 mm;
the angle of the collapsible shaft 30 is 80 °;
the inner layer bracket 10 is made of polylactic acid; the outer layer bracket is made of polylactic acid; the foldable shaft lever is made of polylactic acid;
the anti-proliferative drug coating comprises a balipimox; the anti-inflammatory drug coating comprises epinastine hydrochloride;
the anti-proliferative drug coating and the anti-inflammatory drug coating are prepared by a spraying method;
the inner layer bracket 10 and the outer layer bracket 20 are fixed with the foldable shaft rod 30 by adopting glue.
Example 3
The invention relates to a completely degradable and absorbable drug eluting stent, which comprises an inner layer stent 10, an outer layer stent 20 and a foldable shaft lever 30; the inner layer bracket 10 and the outer layer bracket 20 are connected through a foldable shaft rod 30; the surface of the inner stent 10 is coated with an antiproliferative drug coating (not shown in the figure), and the surface of the outer stent is coated with an anti-inflammatory drug coating (not shown in the figure); the meshes of the inner layer bracket 10 and the meshes of the outer layer bracket 20 are arranged in a staggered way.
The thickness of the inner layer bracket 10 is 0.2mm, the diameter is 2.5mm, and the length is 50 mm;
the thickness of the outer layer bracket 20 is 0.1mm, the diameter is 3.5mm, and the length is 50 mm;
the angle of the collapsible shaft is 50 °;
the inner layer bracket 10 is made of degradable iron alloy; the outer layer bracket is made of degradable iron alloy; the foldable shaft lever is made of degradable iron alloy;
the anti-proliferative drug coating comprises nateglinide and marimastat; the anti-inflammatory drug coating comprises oxymetazoline hydrochloride;
the anti-proliferative drug coating and the anti-inflammatory drug coating are prepared by a coating method;
the inner layer bracket 10 and the outer layer bracket 20 are fixed with the foldable shaft rod 30 by laser welding.
Example 4
The application of the completely degradable and absorbable drug eluting stent in the eustachian tube lesion comprises the following steps:
the completely degradable and absorbable drug eluting stent obtained in the example 2 is placed in a eustachian tube through an operation, and the outer stent is completely degraded in about 60 days through observation; the inner layer stent is completely degraded in about 90 days.
It should be understood that the above-described embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. Not all embodiments are exhaustive. All obvious changes and modifications which are obvious to the technical scheme of the invention are covered by the protection scope of the invention.
Claims (8)
1. A fully degradable and absorbable drug-eluting stent, characterized in that: the drug eluting stent comprises an inner stent, an outer stent and a foldable shaft lever; the inner layer bracket and the outer layer bracket are connected through a foldable shaft lever; the surface of the inner layer stent is coated with an antiproliferative drug coating, and the surface of the outer layer stent is coated with an anti-inflammatory drug coating; the meshes of the inner layer bracket and the meshes of the outer layer bracket are arranged in a staggered manner;
the angle of the foldable shaft lever is 10-80 degrees or 100-170 degrees;
after the outer stent is completely degraded, the inner stent automatically expands to contact with the lumen.
2. A fully degradable absorbable drug eluting stent according to claim 1, characterized in that: the thickness of the inner layer bracket is 0.05-0.5mm, the diameter is 1.0-28mm, and the length is 5-400 mm.
3. A fully degradable absorbable drug eluting stent according to claim 1, characterized in that: the thickness of the outer layer bracket is 0.02-0.3mm, the diameter is 2.0-30mm, and the length is 5-400 mm.
4. A fully degradable absorbable drug eluting stent according to claim 1, characterized in that: the thickness of the inner layer bracket is greater than that of the outer layer bracket; the diameter of the inner layer bracket is smaller than that of the outer layer bracket; the length of the inner layer bracket is the same as that of the outer layer bracket.
5. A fully degradable absorbable drug eluting stent according to claim 1, characterized in that: the inner layer bracket is made of magnesium alloy, iron alloy, zinc alloy or polylactic acid; the outer layer bracket is made of magnesium alloy, zinc alloy, polylactic acid or iron alloy; the foldable shaft rod is made of magnesium alloy, zinc alloy, iron alloy, polylactic acid, collagen or chitosan.
6. A fully degradable absorbable drug eluting stent according to claim 1, characterized in that: the anti-proliferative drug coating comprises one or more of paclitaxel, sirolimus, everolimus, sotalolimus, pelliolimus, nafolimus, marimastat, mitomycin, and batroxobin; the anti-inflammatory drug coating comprises one or more of maffuo liquid drop nose, fexofenadine, epinastine hydrochloride, dexamethasone, betamethasone, antibiotics, ephedrine, naristilla and oxymetazoline hydrochloride.
7. A fully degradable absorbable drug eluting stent according to claim 1, characterized in that: the anti-proliferative drug coating and the anti-inflammatory drug coating are prepared by one or more methods of dipping, spraying and coating.
8. A fully degradable absorbable drug eluting stent according to claim 1, characterized in that: the inner layer bracket, the outer layer bracket and the foldable shaft rod are fixedly connected by one or more of laser integral cutting, laser welding, hot melt welding and adhesive bonding.
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| WO2023018844A1 (en) * | 2021-08-11 | 2023-02-16 | Efemoral Medical, Inc. | Absorbable intravascular stents having a therapeutic drug within the scaffold |
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| CN112618120A (en) * | 2020-12-31 | 2021-04-09 | 郑州美港高科生物科技有限公司 | Completely degradable magnesium alloy cardiovascular stent |
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