CN109953842A - Aorta carried stent and preparation method thereof - Google Patents

Aorta carried stent and preparation method thereof Download PDF

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Publication number
CN109953842A
CN109953842A CN201910082272.3A CN201910082272A CN109953842A CN 109953842 A CN109953842 A CN 109953842A CN 201910082272 A CN201910082272 A CN 201910082272A CN 109953842 A CN109953842 A CN 109953842A
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CN
China
Prior art keywords
layer
medicine
aorta
overlay film
degraded
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Pending
Application number
CN201910082272.3A
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Chinese (zh)
Inventor
周建
景在平
李逸明
冯家烜
艾克白尔江·艾尼瓦尔
冯睿
鲍贤豪
毛华娟
张磊
李振江
吴明炜
徐子依
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Shanghai Changhai Hospital
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Shanghai Changhai Hospital
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Priority to CN201910082272.3A priority Critical patent/CN109953842A/en
Publication of CN109953842A publication Critical patent/CN109953842A/en
Pending legal-status Critical Current

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Classifications

    • 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
    • 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
    • A61L31/08—Materials for coatings
    • A61L31/10—Macromolecular materials
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • 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
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/252—Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
    • 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
    • A61L2300/418—Agents promoting blood coagulation, blood-clotting agents, embolising agents
    • 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
    • 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
    • A61L2300/606—Coatings

Abstract

The present invention provides a kind of aorta carried stents, it has the feature that, it include: rack body and cladding and the load medicine overlay film being fixed on rack body, wherein, carrying medicine overlay film includes the separate layer, medicine layer and degraded layer set gradually from the inside to the outside, separate layer is made of non-porous material, and medicine layer is made of coagulant object, and degraded layer is made of degradation material.The present invention provides a kind of preparation methods of aorta carried stent, comprising the following steps: step 1, preparation carry medicine overlay film；Step 2, under conditions of being lower than 35 DEG C, medicine overlay film will be carried and coat and be fixed on rack body, obtain aorta carried stent, wherein, in step 1, under conditions of being lower than 35 DEG C, at least separate layer, medicine layer and degraded layer are sequentially placed to obtain load medicine overlay film, separate layer is made of non-porous material, for separating medicine layer and rack body, medicine layer is made of coagulant object, and degraded layer is made of degradation material.

Description

Aorta carried stent and preparation method thereof
Technical field
The present invention relates to vascular surgery technical fields, and in particular to a kind of aorta carried stent and preparation method thereof.
Background technique
Dissection of aorta (AorticDissection, AD) refers to blood as most dangerous one of vascular system disease It tears aortic tunica intima and forms breach, at film or China and foreign countries' membrane junction, form true and false two chamber of aorta, can be made in the short time Lead to death at aortoclasia.Minimally-invasive treatment in fast-developing aorta lumen in recent years (endovascularaorticrepair, EVAR) refers to by cutting 1~3cm small notch in peripheral arterial (such as femoral artery), so Graft is delivered to diseased region from Endovascular afterwards, so that closing breach carries out intracavitary repairing.Due to avoiding out chest, opening Abdomen and aorta clamping, minimally invasive and fast and effective, intracavitary therapy is widely used to the treatment of dissection of aorta.
Dissection of aorta vacation chamber thrombosis (FalseLumenThrombosis, FLT) can reflect dissection of aorta vacation chamber In thrombosis and remaining blood circumstance, it is clinical that surface analysis, whole three-dimensional reconstruction and MRI pairs are often layered by aorta CT It is evaluated.After dissection of aorta intracavitary therapy most significant complication be it is false it is intracavitary persistently there is blood flow, this will lead to master The generation of the globally expanding of artery, local Ectasia and rupture.FLT is the maximally related evaluation index of this complication, is The outer dead independent predictor of interlayer Hospital of Patients；It is simultaneously also to participate in Assessment of EVA R therapeutic effect and aorta remodeling situation Important indicator.And for the dissection of aorta patient postoperative for EVAR, because aorta is by false chamber thrombosis progress and vacation Chamber shrinks and benign remodeling and is finally attributed to stable, and the aorta that false chamber fails to be formed effective thrombosis then has higher tumor sample Expansion and risk of rupture.Due to promoting aorta vacation chamber thrombosis particularly significant and necessary, a variety of aortic dissection strategies Constantly is researched and developed and reported, and false chamber thrombosis also gradually becomes the target of intracavitary therapy from the index Forward of evaluation prognosis.
The current EVAR technology suitable for dissection of aorta patient mainly passes through remodeling aorta, while blocking or partially hindering Disconnected vacation chamber blood flow, forms the complete thrombosis of false chamber, to play the role for the treatment of dissection of aorta.However, current aorta Leakage problem in a large amount of is had found in bracket use process, i.e., still has blood stream via graft and active vascular after intracavitary therapy Gap between wall enters breach and interlayer vacation chamber, seriously affects patient's prognosis.Meanwhile the active of part specific form feature Arteries and veins interlayer cannot accomplish that whole dissection of aorta breaches completely cut off completely, therefore false intracavitary coagulation is poor.Master in the prior art Pulsation frame has following defects that one, aortic stents and active blood vessel wall stickiness are poor, rigid support and tube wall there are gap, Vacation chamber thrombosis formation rate completely only can reach 50%；Two, aorta carried stent is started late, and is lacked and is promoted local blood coagulation Aorta carried stent；Three, existing load medicine film coating technique relies primarily on electrostatic spinning technique (CN201210444956.1) and medicine Object spraying technology, but both technologies all have that drug has a large amount of losses before reaching lesion, so that drug Effect is had a greatly reduced quality.
Summary of the invention
The present invention is to carry out to solve the above-mentioned problems, and it is an object of the present invention to provide aorta carried stent and its preparation side Method.
The present invention provides a kind of aorta carried stents, have the feature that, comprising: rack body and cladding are simultaneously The load medicine overlay film being fixed on rack body, wherein carry medicine overlay film include the separate layer set gradually from the inside to the outside, medicine layer with And degraded layer, separate layer are made of non-porous material, medicine layer is made of coagulant object, and degraded layer is by degradation material system At.
It in aorta carried stent provided by the invention, can also have the following features: wherein, coagulant object is One of Human Factor Ⅸ Complex or human coagulation factor Ⅱ, VII, Ⅸ, Ⅹ are a variety of.
It in aorta carried stent provided by the invention, can also have the following features: wherein, degradation material is Acid degradation chitosan or polylactic acid, acid degradation chitosan are the chitosan handled by acid degradation, and molecular weight is 1000~1500.
It in aorta carried stent provided by the invention, can also have the following features: wherein, carry medicine overlay film and also wrap Slow release layer is included, which is arranged between medicine layer and degraded layer, has equally distributed multiple drug release micropores, drug The diameter for discharging micropore is less than or equal to 100nm.
It in aorta carried stent provided by the invention, can also have the following features: wherein, slow release layer and separation Layer is to be made from swollen polytetrafluoroethylene (PTFE).
It in aorta carried stent provided by the invention, can also have the feature that, further includes: two protections are solid Determine ring, is circumferentially positioned at the both ends for carrying the outside of medicine overlay film and being separately positioned on rack body, is made of gel sponge.
It in aorta carried stent provided by the invention, can also have the following features: wherein, the length of medicine layer Less than degraded layer and separate layer, the region of load medicine overlay film corresponding to fixed ring is protected to be not provided with medicine layer.
The present invention provides a kind of preparation methods of aorta carried stent, have the feature that, comprising the following steps: Step 1, preparation carry medicine overlay film；Step 2 will carry medicine overlay film and coat and be fixed on rack body under conditions of being lower than 35 DEG C On, obtain aorta carried stent, wherein in step 1, be lower than 35 DEG C under conditions of, at least by separate layer, medicine layer with And degraded layer is sequentially placed to obtain and carries medicine overlay film, and separate layer is made of non-porous material, for separating medicine layer and rack body, Medicine layer is made of coagulant object, and degraded layer is made of degradation material.
In the preparation method of aorta carried stent provided by the invention, it can also have the following features: wherein, it can Degradable material is acid degradation chitosan, the preparation process of degraded layer are as follows: step S1-1, by soluble starch and chitosan with etc. matter Amount is dissolved than acid solution is added after mixing, obtains the first mixed solution；Step S1-2 is added sweet into the first mixed solution Oil is reacted, and until no longer generating bubble, obtains the second mixed solution；Step S1-3, the second mixed solution is uniform It is laid on the glass plate of clean dried, is impregnated after dry cooling with sodium hydroxide solution, after film is separated with glass plate, take off film Obtain degraded layer.
It in the preparation method of aorta carried stent provided by the invention, can also have the following features: wherein, step In rapid one, under conditions of being lower than 35 DEG C, separate layer, medicine layer, slow release layer and degraded layer are sequentially placed to obtain carry medicine and cover Film.
The action and effect of invention
Related aorta carried stent according to the present invention carries medicine and covers because having rack body and carrying medicine overlay film Film includes the separate layer, medicine layer and degraded layer set gradually from the inside to the outside, wherein and separate layer is made of non-porous material, Degraded layer is made of degradation material, and therefore, when in use, separate layer enables to drug to aorta carried stent of the invention Layer can not be in contact by the gap of rack body with blood, meanwhile, degraded layer enables to medicine layer to carry medicine branch in aorta Frame is conveyed through in journey and is not in contact with blood, to solve the problems, such as the loss of medicine layer during transportation.In addition, when this The aorta carried stent of invention is transported to after lesions position, is carried medicine overlay film and is acted at interlayer cut, it is broken to block interlayer Mouth and support active blood vessel wall, with the degradation of degraded layer, medicine layer exposes in blood, under the action of medicine layer, actively Thrombus is formed between arteries and veins carried stent and active blood vessel wall, and then interlayer cut is completely cut off completely, blocks false chamber to bleed, solves Interior leakage problem in aortic stents use process.
Further, medicine layer of the invention is made of coagulant object, and coagulant object is exposed in the blood of human body It can rapidly dissolve later, and then promote the quick formation of thrombus.
The preparation method of related aorta carried stent according to the present invention, because being prepared under conditions of being lower than 35 DEG C It carries medicine overlay film and is coated on medicine overlay film is carried on rack body, avoided aorta carried stent during the preparation process because of temperature It is excessively high and caused by medicine layer coagulant object activity reduce the problem of.In addition, this preparation method is simple, easy to operate, easily In popularization and application.
Detailed description of the invention
Fig. 1 is the structural schematic diagram of aorta carried stent in the embodiment of the present invention one；
Fig. 2 is the cross-sectional view of Fig. 1；And
Fig. 3 is the structural schematic diagram that medicine overlay film is carried in the embodiment of the present invention one.
Specific embodiment
It is real below in order to be easy to understand the technical means, the creative features, the aims and the efficiencies achieved by the present invention Example combination attached drawing is applied to be specifically addressed aorta carried stent of the present invention and preparation method thereof.
<embodiment one>
Present embodiments provide a kind of aorta carried stent and preparation method thereof.
Fig. 1 is the structural schematic diagram of aorta carried stent in the embodiment of the present invention one.
Fig. 2 is the cross-sectional view of Fig. 1.
As shown in Figure 1, 2, the aorta carried stent 100 in the present embodiment includes rack body 10, carries medicine overlay film 20, protects It protects fixed ring 30 and impermeable X-ray marks (not shown).
Rack body 10 is the branch of the support ring composition of Nitinol material, laser cutting multiple continuous sine wave types Frame skeleton.
Fig. 3 is the structural schematic diagram that medicine overlay film is carried in the embodiment of the present invention one.
It carries medicine overlay film 20 to be coated and fixed on rack body 10, including separate layer 21, the drug set gradually from the inside to the outside Layer 22, slow release layer 23 and degraded layer 24.In the present embodiment, medicine overlay film 20 will be carried by way of suture be fixed on bracket sheet On body 10, and suturing used suture is the insoluble high-intensitive suture such as CV line.
Separate layer 21 is directly coated on the outer surface of rack body 10, is made of non-porous material.In the present embodiment, Non-porous material is from swollen polytetrafluoroethylene (PTFE).The length of separate layer 21 and the equal length of rack body 10.
Medicine layer 22 is coated on separate layer 21, including coagulant object and suitable stabilizer.Stabilizer is seaweed Sugar can also contain one or more of common glycine, NaCl, trisodium citrate, heparin.Coagulant object is people's blood coagulation One of proenzyme compound or human coagulation factor Ⅱ, VII, Ⅸ, Ⅹ are a variety of.In the present embodiment, coagulant object is behaved solidifying Hemase original compound.Human Factor Ⅸ Complex is by human normal plasma through cold ethanol Protein Separation method or other approved points It isolates and purifies from method, and is made through virus removal and inactivation, freeze-drying.Human Factor Ⅸ Complex gently shakes item at 20-30 DEG C Can be completely dissolved in 15 minutes under part, thus will need to be isolated before bracket discharges, and after discharging again with contacting blood and do To sustained release.
The length of medicine layer 22 is less than the length of separate layer 21, and after medicine layer 22 is covered on 21 surface of separate layer, The upper/lower terminal of separate layer 21 not is identical by the size for the part that medicine layer 22 is covered.
Slow release layer 23 is coated on medicine layer 22, is made of non-porous material.In the present embodiment, non-porous material is certainly Swollen polytetrafluoroethylene (PTFE).Equally distributed multiple drug release micropores 231 are provided on slow release layer 23.Drug release micropore 231 is Circle, diameter are less than or equal to 100nm.The length of slow release layer 23 and the equal length of separate layer 21.
Degraded layer 24 is coated on slow release layer 23, is made of degradation material.In the present embodiment, degradation material is acid Degradation chitosan, the acid degradation chitosan are the chitosan handled by acid degradation, and molecular weight is 1000~1500.Chitosan Molecular weight is 100,000~300,000, and the molecular weight of the chitosan after acid system degradation can reduce, when molecular weight is reached 1000~1500 When chitosan can substantially completely be dissolved in water.Acid degradation method applies acetic acid, hydrochloric acid, nitrous acid, the concentrated sulfuric acid, hydrofluoric acid etc. to carry out Nonspecific degradation.Amino in degradation process in chitosan can combine with proton and keep itself positively charged.Degraded layer 24 Length and separate layer 21 equal length.
The number for protecting fixed ring 30 is two, is hollow ring structure, is circumferentially positioned at carries the outer of medicine overlay film 20 respectively Side, and the end position for carrying the not set medicine layer 22 of medicine overlay film 20 is set, this position is also the end position of rack body It sets.Protect the size of fixed ring 30 and the size of part for the not set medicine layer 22 for carrying medicine overlay film 20 to be consistent, and thickness and The thickness of medicine layer 20 is roughly equal.Protection fixed ring 30 is made of gel sponge.
In the present embodiment, protection fixed ring 30 is fixed on rack body 10 by way of suture and carries medicine overlay film 20 On, and suturing used suture is the insoluble high-intensitive suture such as CV line.
The number of impermeable X-ray label be it is multiple, setting is in protection fixed ring 30 and carries between medicine overlay film 20, for master The both ends of artery carried stent 100 are positioned, and then convenient for accurate release.
The preparation process of aorta carried stent 100 in the present embodiment is as follows:
Step 1: preparation degraded layer 24.
Detailed process are as follows: soluble starch is mixed with chitosan with mass ratio 1:1,1% glacial acetic acid solution is added, stirs It mixes to being completely dissolved, is transferred in 100mL volumetric flask, obtain the first mixed solution.Add 1mL glycerol to the first mixed solution, stirs It mixes uniformly, until all sloughing to the bubble in solution, obtains the second mixed solution.Take that a certain amount of to obtain the second mixing molten Liquid is equably laid on the glass plate of clean dried, dry at a certain temperature, cooling.It is impregnated with sodium hydroxide solution, to After film is separated with glass plate, the degraded layer that membrane structure is made in film is taken off.Degraded layer is stored in drier for use.
Step 2: preparing slow release layer 23.It will be punched from swollen polytetrafluoroethylene (PTFE), it is undissolved to guarantee that aperture is less than 100nm Drug cannot pass through.
Step 3: separate layer 21, medicine layer 22, slow release layer 23 and degraded layer 24 are pressed under conditions of being lower than 35 DEG C Sequence is successively accumulated and is sutured with CV line, obtains carrying medicine overlay film 20.Pay attention to separate layer 21, slow release layer 23 and degraded layer 24 It is equal in magnitude, it needs perfectly aligned；The length of medicine layer 22 be less than with remaining each layer, need with remaining each layer align center (i.e., Carry the upper and lower ends equidimension for being not provided with medicine layer 22 of medicine overlay film 20).The suture and suture needle diameter of suture need stringent one It causes, avoids gap occur when suture.It is spare under the conditions of the load medicine overlay film 20 made is stored in -20 DEG C.
Step 4: will carry medicine overlay film 20 under conditions of being lower than 35 DEG C and be coated on rack body 10, keep separate layer 21 It is directly contacted with rack body 10 and degraded layer 24 is located at outermost.Then impermeable X-ray label is placed on and carries medicine overlay film 20 The outside at both ends (not set medicine layer 22).Fixed ring 30 will be protected to be set on the outside of the both ends for carrying medicine overlay film 20 again, so that not Saturating X-ray label is sandwiched in protection fixed ring 30 and carries between medicine overlay film 20.Finally fixed ring 30, load medicine will be protected to cover with CV line 20 end of film and rack body 10 are sutured with CV line, and will carry medicine overlay film 20 (part in addition to end) and bracket sheet Body 10 is sutured, and aorta carried stent 100 is obtained.The suture and suture needle diameter of suture need strict conformance.It will production Good aorta carried stent 100 is spare under the conditions of being stored in -20 DEG C.
The use process of aorta carried stent 100 in the present embodiment are as follows:
Firstly, paying attention to soft compression in 100 compression process of aorta carried stent, degraded layer 21 is avoided damage to, and should It avoids contacting with water.
Then, it before aorta carried stent 100 is implanted, squeezes into a small amount of physiological saline and is lubricated, and refer in DSA Positioning release is carried out under leading.
Finally, degraded layer 21 can degrade in 10 hours inner parts, to slow release layer 23 after aorta carried stent 100 discharges It is exposed with drug release micropore 231.Drug release micropore 231 allows Human Factor Ⅸ Complex and blood to mix, and Body temperature, pulse are dissolved in the case of rocking, and full activation Coagulation test promotes bracket and aorta gap and aorta clamp The false intracavitary Coagulation test of layer, plays and promotes local thrombus, accelerates the benign remodeling process of aorta, and optimization dissection of aorta is controlled The effect of therapeutic effect.Acid degradation chitosan has positive charge simultaneously, and the blood coagulation substance in blood with negative electrical charge can be attracted to assemble, Also play the role of promoting local thrombus, while there are certain antibacterial actions.The protection fixed ring 30 at bracket both ends can With the fitting aorta wall completely that absorbs water, play the role of preventing stent migration and thrombus distal embolization from occurring.
The action and effect of embodiment one
According to aorta carried stent involved in embodiment one, because there is rack body and carry medicine overlay film, medicine is carried Overlay film includes the separate layer, medicine layer and degraded layer set gradually from the inside to the outside, wherein separate layer is by non-porous material system At degraded layer is made of degradation material, and therefore, when in use, separate layer enables to aorta carried stent of the invention Medicine layer can not be in contact by the gap of rack body with blood, meanwhile, degraded layer enables to medicine layer to carry in aorta Medicine bracket is conveyed through in journey not to be in contact with blood, to solve the problems, such as the loss of medicine layer during transportation.In addition, After aorta carried stent of the invention is transported to lesions position, carries medicine overlay film and act at interlayer cut, clip occluder Layer cut and support active blood vessel wall, with the gradually degradation of degraded layer, medicine layer exposes in blood, in the effect of medicine layer Under, thrombus is formed between aorta carried stent and active blood vessel wall, and then interlayer cut is completely cut off completely, block false chamber stream Blood solves the problems, such as the interior leakage in aortic stents use process, accelerates the benign remodeling process of aorta, optimizes aorta clamp The effect of layer therapeutic effect.
Further, the medicine layer in embodiment one is made of coagulant object, and coagulant object is exposed to the blood of human body It can rapidly be dissolved after in liquid, and then promote the quick formation of thrombus.
Further, the coagulant object in embodiment one is Human Factor Ⅸ Complex, and Human Factor Ⅸ Complex exists It 20~30 DEG C, can be completely dissolved in 15 minutes under the conditions of gently shaking, promote the quick formation of thrombus.Also, human thrombin Former compound can also make the blood of the patient of single deficiency of coagulation factors generate thrombus, therefore the aorta of the present embodiment carries medicine Bracket is equally applicable to the treatment of the dissection of aorta patient of single deficiency of coagulation factors.
Further, the degradation material in embodiment one is acid degradation chitosan, and molecular weight is 1000~1500, therefore Acid degradation chitosan substantially can be completely soluble, and since acid degradation chitosan is positively charged, it can attract one As negatively charged blood coagulation substance (such as blood platelet) aggregation, promote local blood coagulation.In addition, chitosan is nontoxic, bio-compatible Property is good, securely and reliably.
Further, the load medicine overlay film in embodiment one further includes slow release layer, and slow release layer is arranged in medicine layer and degraded layer Between, there are multiple drug release micropores, therefore, after degraded layer degradation, blood can be by release micropore and medicine layer Coagulant object mixed dissolution, achieve the effect that slow releasing pharmaceutical, and the diameter of drug release micropore is necessarily less than or is equal to 100nm can be adapted with the dissolution properties of coagulant object, guarantee that undissolved coagulant object cannot be by the drug Micropore is discharged, to persistently treat to patient.
Further, the protection fixed ring in embodiment one is looped around the outside for carrying medicine overlay film and rack body is arranged in End, therefore protect fixed ring that can preferably be fixed to the end for carrying medicine overlay film.In addition, protection fixed ring is by gel sea Silk floss is made, therefore protects fixed ring that can absorb water to be bonded aorta wall completely, and playing prevents stent migration, anti-tampon stream To the effect at other positions.
Further, the region for medicine overlay film being carried corresponding to the protection fixed ring in embodiment one is not provided with medicine layer, and one Aspect avoids the hair in end position thrombus distal embolization due to caused by medicine layer and contacting blood of rack body It is raw；On the other hand reduce the thickness of the load medicine overlay film of rack body end, so that the end thickness after protection fixed ring is fixed It is identical as rack body others segment thickness, consequently facilitating the conveying of entire aorta carried stent and preferably support master Ductus arteriosus wall.
According to the preparation method of aorta carried stent involved in embodiment one, because being lower than 35 DEG C of under conditions of systems It is standby to carry medicine overlay film and be coated on medicine overlay film is carried on rack body, aorta carried stent has been avoided during the preparation process because of temperature Spend it is high and caused by the coagulant object activity of medicine layer the problem of reducing.In addition, this preparation method is simple, easy to operate, Application easy to spread.
<embodiment two>
Present embodiments provide a kind of aorta carried stent and preparation method thereof.
Aorta carried stent in the present embodiment equally includes rack body, carries medicine overlay film, protects fixed ring and not Saturating X-ray label.Between aorta carried stent 100 in aorta carried stent in the present embodiment and embodiment one only One difference is that the degradable material for carrying the degraded layer of medicine overlay film is different, and other structures are identical with the structure in embodiment one.
The degradable material of degraded layer in the present embodiment is polylactic acid (PLA), and degraded layer is by polylactic acid through two-way Stretching technique production.
The preparation method of aorta carried stent in the present embodiment and the aorta carried stent 100 in embodiment one Preparation method only difference is that the preparation process of degraded layer is different, the preparation step in other steps and embodiment one It is identical.
The preparation process of degraded layer in the present embodiment are as follows:
Firstly, the dry 5h of condition for being 80 DEG C in drying condition by polylactic acid.
Then, polylactic acid is subjected to biaxial tension: 20~25 DEG C of slab Kun temperature according to following film forming parameters；It is longitudinal When stretching, 40~75 DEG C of remaining hot zone temperature, 60~70 DEG C of drawing zone temperature degree, 20~30 DEG C of shaping area temperature；When cross directional stretch, 50~120 DEG C of preheating zone temperature, 60~130 DEG C of drawing zone temperature, 11~160 DEG C of shaping area temperature；Longitudinal and transverse draw ratio is 3.0* 3.0。
The action and effect of embodiment two
The structure being the same as example 1 in embodiment two has same action and effect, in addition, in embodiment two Degraded layer is due to using polylactic acid as degradable material, and polylactic acid is prepared through biaxial tension technology and formed, the preparation process The thickness for the degraded layer convenient for mechanization expanding production, and capableing of the preparation parameter of strict control degraded layer, therefore obtaining is easy In progress batch control.
Above embodiment is preferred case of the invention, the protection scope being not intended to limit the invention.
For example, in example 1, degradation material is acid degradation chitosan, and degradation material is poly- in example 2 Lactic acid, but in practical applications, the film type material that degradation material can also be degradable for other any one, such as seaweed Hydrochlorate etc..
In example 1 and example 2, coagulant object be Human Factor Ⅸ Complex or human coagulation factor Ⅱ, VII, Ⅸ, one of Ⅹ or a variety of, but in practical applications, coagulant object can also for pituitrin, norepinephrine, Growth hormone release inhibiting hormone, carbazochrome/Carlow willow sodium, etamsylate, tranexamic acid aminomethylbenzoic acid, amion acetic acid, diacetyl nitrilo acetic acid second Diamines, Aprotinin, fibrin ferment, snake venom blood coagulation enzyme, vitamin K1, protamine sulfate, thromboplastinum, fibrinogen etc..
In example 1 and example 2, stabilizer is trehalose, but in practical applications, and stabilizer can also be Sucrose, gelatin etc..
In example 1 and example 2, all rack body and load medicine overlay film are carried out by the way of the suture of artificial row It is fixed, but in practical applications, for the ease of expanding production, manual suture can also be substituted using the means of mechanical stitch, Either carries out rack body using a variety of adhering methods such as α cyanoacrylate, photocuring, hot melts and carry the progress of medicine overlay film Fixed, connection.
In example 1 and example 2, the support skeleton that rack body all uses the support ring of sinusoidal waveform to form, But in practical applications, rack body can also be using latticed, mesh grid, the branch of " z " shape wave or the alternate elastic waveform stereoscopic of height Frame skeleton.

Claims (10)

1. a kind of aorta carried stent characterized by comprising
Rack body and cladding and the load medicine overlay film being fixed on the rack body,
Wherein, the load medicine overlay film includes the separate layer, medicine layer and degraded layer set gradually from the inside to the outside,
The separate layer is made of non-porous material,
The medicine layer is made of coagulant object,
The degraded layer is made of degradation material.
2. aorta carried stent according to claim 1, it is characterised in that:
Wherein, the coagulant object is one of Human Factor Ⅸ Complex or human coagulation factor Ⅱ, VII, Ⅸ, Ⅹ or more Kind.
3. aorta carried stent according to claim 1, it is characterised in that:
Wherein, the degradation material be acid degradation chitosan or polylactic acid,
The acid degradation chitosan is the chitosan handled by acid degradation, and molecular weight is 1000~1500.
4. aorta carried stent according to claim 1, it is characterised in that:
Wherein, the load medicine overlay film further includes slow release layer, which is arranged between the medicine layer and the degraded layer, tool There are equally distributed multiple drug release micropores,
The diameter of the drug release micropore is less than or equal to 100nm.
5. aorta carried stent according to claim 4, it is characterised in that:
Wherein, the slow release layer and the separate layer are to be made from swollen polytetrafluoroethylene (PTFE).
6. aorta carried stent according to claim 1, which is characterized in that further include:
Two protection fixed rings are circumferentially positioned at the outside for carrying medicine overlay film and are separately positioned on the two of the rack body End, is made of gel sponge.
7. aorta carried stent according to claim 6, it is characterised in that:
Wherein, the length of the medicine layer is less than the degraded layer and the separate layer,
The region of the load medicine overlay film corresponding to the protection fixed ring is not provided with the medicine layer.
8. according to the preparation method of aorta carried stent, which comprises the following steps:
Step 1, preparation carry medicine overlay film；
The load medicine overlay film is coated and is fixed on rack body, obtain aorta under conditions of being lower than 35 DEG C by step 2 Carried stent,
Wherein, in step 1, under conditions of being lower than 35 DEG C, at least separate layer, medicine layer and degraded layer are sequentially placed To the load medicine overlay film,
The separate layer is made of non-porous material, for separating the medicine layer and the rack body,
The medicine layer is made of coagulant object,
The degraded layer is made of degradation material.
9. the preparation method of aorta carried stent according to claim 8, it is characterised in that:
Wherein, the degradation material is acid degradation chitosan,
The preparation process of the degraded layer are as follows:
Step S1-1 is added acid solution after being mixed soluble starch with equal mass ratioes with chitosan and dissolved, obtains first Mixed solution；
Glycerol is added in the first mixed solution of step S1-2, Xiang Suoshu to be reacted, until no longer generating bubble, obtains the Two mixed solutions；
Step S1-3, second mixed solution is evenly laid out on the glass plate of clean dried, hydrogen-oxygen is used after dry cooling Change sodium solution to impregnate, after film is separated with glass plate, takes off film and obtain the degraded layer.
10. the preparation method of aorta carried stent according to claim 8, it is characterised in that:
Wherein, in step 1, under conditions of being lower than 35 DEG C, separate layer, medicine layer, slow release layer and degraded layer are sequentially placed Obtain the load medicine overlay film.
CN201910082272.3A 2019-01-28 2019-01-28 Aorta carried stent and preparation method thereof Pending CN109953842A (en)

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Application publication date: 20190702