CN209392453U - A kind of absorbable stent - Google Patents
A kind of absorbable stent Download PDFInfo
- Publication number
- CN209392453U CN209392453U CN201721486491.0U CN201721486491U CN209392453U CN 209392453 U CN209392453 U CN 209392453U CN 201721486491 U CN201721486491 U CN 201721486491U CN 209392453 U CN209392453 U CN 209392453U
- Authority
- CN
- China
- Prior art keywords
- degradable
- absorbable stent
- bracket
- absorbable
- frame body
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Landscapes
- Materials For Medical Uses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
The utility model belongs to the field of medical instrument technology more particularly to a kind of absorbable stent.The absorbable stent, it include: netted degradable metal bracket frame body and the degradable macromolecule coating for being set to the reticular structure degradable metal bracket frame body twine surface, wherein, the group of the degradable macromolecule coating is divided into poly lactide-glycolide acid.The degradation time of the absorbable stent of the utility model can accordingly be regulated and controled by adjusting bracket structure and coating layer thickness, it is most short to realize that degradation excretes in 1-2 months, longest can also extend to 12 months, it can be adjusted as the case may be, the foreign body sensation that presence after not only avoiding bracket completion task generates, thus caused injury of blood vessel, at the same also avoid because bracket it is inessential there are due to excite immune system cause coating, displacement a series of problems, such as generation.
Description
Technical field
The utility model belongs to the field of medical instrument technology more particularly to a kind of absorbable stent.
Background technique
Coronary artery stent implantation is applied to clinic, the development experience of intravascular stent for the first time from Sigwart in 1987
Bare metal stent, bracket for eluting medicament and complete biological absorbable support three phases.First generation bare bracket is with higher
Restenosis rate；Though the curative effect that the second generation carries the bracket of drug has been confirmed, non-degradable metallic support is deposited for a long time
With carry Drug inhibition endothelial growth the problem of can lead to blood vessel embolism at a specified future date.
Complete biological absorbable intravascular stent includes metallic support and polymeric stent, and latter is got more attention.It is high
The compatibility of Molecularly Imprinted Polymer bracket and vascular wall is better than metallic support, can avoid the intimal proliferation in later period, especially degradable
Polymer support.Biodegradable material passes through hydrolysis in vivo and gradually degrades, and makees completing mechanical support
It is degraded into non-toxic products after, is excreted by respiratory system and urinary system.In addition, polymeric stent can carry drug
Or it is incorporated in the E1 that E1 mark position reaches control release with drug, thus the formation of pre- preventing thrombosis and new intima and smooth
The proliferation of myocyte.It is reported that carrying drug by polymeric stent, local drug concentration is oral 10 times.
Degradable metal bracket has ferrous metals bracket, magnesium alloy bracket, and iron, magnesium belong to necessary micro member in human body
Element has good biocompatibility and biodegradability, and the probability that such bracket generates chronic inflammation in vivo is low, blood vessel
Endotheliosis rate is low.It is fast than expected but there are degradation rates, it is unable to satisfy required radial support during reconstructing blood vessel
Power.
Polyglycolide, polylactic acid, poly-epsilon-caprolactone etc. are a kind of aliphatic polyester high molecular materials, due to good life
Object degradability and biocompatibility and be widely used as biomedical material.The intravascular stent of such high molecular material preparation is in blood
The pipe wound healing phase is able to maintain certain mechanical strength, keeps unobstructed blood vessel, with the healing of blood vessel, such intravascular stent energy
It is enough voluntarily to degrade and be absorbed by the body, it more will not influence patient and carry out the inspection such as nuclear magnetic resonance or magnetic therapy；But such macromolecule
Material preparation bracket radial support power is relatively poor, the probability that occurs thrombus in bracket again is high, is also easy to produce chronic inflammation, blood
Endothelial tube hyperplasia rate is relatively high, and block is easy to produce in degradation process, blocks blood vessel again.
Currently, cardiovascular disease is treated in intervention support ruling by law has achieved good effect, the preparation process of bracket is also very
Maturation, but restenosis can occur after simple degradable macromolecule stenter to implant, this may be that object has occurred in bracket in vivo
Caused by reason or chemical change, therefore, urgent need can give enough radial support power, drop during providing a kind of reconstructing blood vessel
Solve that the time is controllable and the later period thrombus low bracket of incidence again.
Summary of the invention
In view of the foregoing drawbacks, the purpose of this utility model is to provide a kind of absorbable stents.
In the therapeutic process of intracranial vessel, especially cerebral veins, venae cerebri, some cases are due to thrombus, patch hyperplasia or blood vessel
Deformity causes hemadostewnosis, or after taking bolt, thrombolysis etc. to treat, bracket is only needed to provide branch to blood vessel in specific time
Support.The degradation time of the absorbable stent of the utility model can be carried out accordingly by adjusting bracket structure and coating layer thickness
Regulation, most short to realize that degradation excrete in 1-2 months, longest can also extend to 12 months, can as the case may be into
Row is adjusted, the foreign body sensation that the presence after not only avoiding bracket completion task generates, thus caused injury of blood vessel, while also being kept away
Exempted from because bracket it is inessential there are due to excite immune system cause coating, displacement a series of problems, such as generation.
To achieve the goals above, the utility model uses following technical scheme:
A kind of absorbable stent, comprising: netted degradable metal bracket frame body and be set to the reticular structure
The degradable macromolecule coating on degradable metal bracket frame body twine surface, wherein the component of the degradable macromolecule coating
For poly lactide-glycolide acid.
In above-mentioned absorbable stent, the degradable metal bracket frame body as a preferred implementation manner,
Material is ferroalloy, magnesium alloy or kirsite.
In above-mentioned absorbable stent, the thickness of the degradable macromolecule coating as a preferred implementation manner,
Degree is 100-500 μm.
In above-mentioned absorbable stent, the degradable macromolecule coating surface as a preferred implementation manner,
Coated with phosphocholine layer.
In above-mentioned absorbable stent, as a preferred implementation manner, the phosphocholine layer with a thickness of 5-
100μm。
In above-mentioned absorbable stent, as a preferred implementation manner, the absorbable stent be with
The straight barrel of reticular structure, the diameter of the absorbable stent are 1-15mm, length 10-100mm.
In above-mentioned absorbable stent, the absorbable stent is dumbbell as a preferred implementation manner,
Type, comprising: two cylindrical support portions are used to support vascular wall and provide hollow channel of blood flow for blood flow；With a blood flow control
Portion processed, both ends are connect with two cylindrical support portions respectively, for slowing down the speed of the blood flow from the cylindrical support portion
And hollow channel of blood flow is provided for blood flow, the cross-sectional area of the blood flow control unit is less than the cross section in the cylindrical support portion
Product.
In above-mentioned absorbable stent, as a preferred implementation manner, at the end of the absorbable stent
Several developing marks are circumferentially arranged along the bracket in portion, and the material of the developing mark is gold, platinum, tungsten or iridium radiopaque mark
Will object.
Compared with prior art, the utility model has the following technical effect that
1, the bracket of the utility model can be used for intravascular stent, Nerve Scaffold, vena cave bracket, biliary tract rack, urethra branch
Frame etc..
2, the absorbable stent of the utility model, not only corrosion resistance is good, and have good biocompatibility and
Flexibility.
3, the design of blood flow control unit can be avoided blood perfusion syndrome in the utility model absorbable stent
Occur, in addition, the absorbable stent of the utility model has the function of anticoagulation anti-proliferate.
4, the degradation time of the absorbable stent of the utility model can by adjusting bracket structure and coating layer thickness come
Accordingly regulated and controled, most short to realize that degradation excretes in 1-2 months, longest can also extend to 12 months, can be according to tool
Body situation is adjusted, and still has the foreign body sensation generated after not only avoiding bracket completion task in time, thus caused blood
Pipe damage, while also avoid because bracket it is inessential there are due to excite immune system cause coating, displacement a series of problems, such as
Generation.In addition, the supporting structure of the utility model can give enough radial support power during reconstructing blood vessel；And due to
Frame body is the optimization design of degradable metal material and degradable macromolecule coating ingredients, the scaffold degradation of the utility model
It is harmless afterwards and do not form block, so greatly reducing the incidence again of thrombus.The good biodegradable coating of uniformity
Form a hollow stable bracket, radial support power needed for which still can provide the reconstructing blood vessel later period, and
Due to being hollow structure, the catabolite generated after degradation also greatly reduces.
Detailed description of the invention
Fig. 1 is the schematic diagram of the absorbable stent of an embodiment of the present invention；
Fig. 2 is the radial section schematic diagram that the twine A of absorbable stent is formed in Fig. 1；
Fig. 3 is the main view of the absorbable stent of another embodiment of the utility model.
Wherein, 1- absorbable stent；11- degradable metal bracket frame body twine；12- degradable macromolecule coating；
13- phosphocholine layer；21- the first film unit；The second film unit of 22-；23- third film unit；3- cylindrical support portion.
Specific embodiment
A kind of absorbable stent of the utility model is illustrated with reference to the accompanying drawings and examples.It should be understood that
These embodiments are only used for explaining the utility model rather than limit the scope of the utility model.Externally it should be understood that reading
After the content of the utility model, those skilled in the art make various changes or modifications the utility model, these shapes of equal value
Formula is also fallen within the scope of the appended claims of the present application.
It is in the description of the present invention, it should be noted that term " center ", "upper", "lower", "left", "right", " perpendicular
Directly ", the orientation or positional relationship of the instructions such as "horizontal", "inner", "outside" is to be based on the orientation or positional relationship shown in the drawings, and is only
For ease of description the utility model and simplify description, rather than the device or element of indication or suggestion meaning must have it is specific
Orientation, be constructed and operated in a specific orientation, therefore should not be understood as limiting the present invention.In addition, term " the
One ", " second ", " third " are used for descriptive purposes only and cannot be understood as indicating or suggesting relative importance.
In the description of the present invention, it should be noted that unless otherwise clearly defined and limited, term " is pacified
Dress ", " connected ", " connection " shall be understood in a broad sense, for example, it may be being fixedly connected, may be a detachable connection, or integrally
Connection；It can be mechanical connection, be also possible to be electrically connected；Can be directly connected, can also indirectly connected through an intermediary,
It can be the connection inside two elements.For the ordinary skill in the art, above-mentioned art can be understood with concrete condition
The concrete meaning of language in the present invention.
In the utility model, unless stated otherwise, term " proximal end " refers to one end that proximal operator is depended in art；Term is " remote
End " refers to one end in art far from operator.Alternatively, the bearing definition based on attached drawing, specifically, when observer faces attached drawing
When, the left side of sight is defined as " distal end ", and the right end of sight is defined as " proximal end ".
The utility model provides a kind of absorbable stent, referring to Fig. 1 and 2, comprising: netted degradable metal bracket
Frame body and the degradable macromolecule coating for being set to the netted degradable metal bracket frame body twine surface, wherein described
The group of degradable macromolecule coating is divided into poly lactide-glycolide acid (PLGA).The polylactic acid-glycolic that the utility model uses
Acetic acid copolymer is preferably PLGA 75:25, PLGA85:15, PLGA 50:50.
It is mentioned during entire reconstructing blood vessel to preferably control overall degradation time and the control bracket of bracket
The radial support power of confession, while making it have certain elasticity, it is preferable that the part of the poly lactide-glycolide acid
By chitosan, and it is selected from poly- hydroxacetic acid, poly butyric ester, polylactic acid, lactic acid-ethylene glycol copolymer, the poly- second of polylactic acid-
One or more artificial degradable polymer in diol block copolymer, poly- hydroxyl alkyl ester (PHA) and polyhydroxybutyrate (PHB)
Substitution, wherein relative to the component weight of the degradable macromolecule coating, the weight percent of the chitosan is 3-
10% (such as 3%, 4%, 5%, 7%, 8%, 9%)；Relative to the component weight of the degradable macromolecule coating, it is selected from
Poly (glycolide-lactide), poly- hydroxacetic acid, poly butyric ester, polylactic acid, lactic acid-ethylene glycol copolymer, polylactic acid-polyglycol
The weight percent of one or more artificial degradable polymers is in block copolymer, poly- hydroxyl alkyl ester and polyhydroxybutyrate
10-25% (such as 11%, 14%, 15%, 17%, 18%, 19%, 22%, 24%)；
It is highly preferred that the part of the chitosan is substituted by chitin and/or fiber；It is further preferred that relative to institute
The component weight for stating degradable macromolecule coating, the weight percent for the chitin and/or fiber that substitute chitosan are
1-3%.It is further preferred that by weight percentage, the degradable macromolecule coating is formed by following component: polylactic acid-
70~80wt% of co-glycolic acid, chitosan 7-10%, poly- hydroxacetic acid 5-10%, polylactic acid 5-10%.Poly- hydroxyl vinegar
The molecular weight of sour (PGA) is 2-20 ten thousand, and the molecular weight of polylactic acid (PLA) is 5-20 ten thousand.
The material of the degradable metal bracket frame body is preferably ferroalloy, magnesium alloy or kirsite；Further, in order to
Overall degradation time and control bracket provided radial support power during entire reconstructing blood vessel of bracket are controlled, preferably
Ground, the degradable macromolecule coating with a thickness of 100-500 μm (such as 120 μm, 150 μm, 200 μm, 220 μm, 250 μm,
270μm,290μm,350μm,400μm,450μm)；It is highly preferred that the degradable macromolecule coating is by spraying or dip-coating
Mode be formed in the surface of the netted degradable metal bracket frame body twine.
In order to enhance the effect of anticoagulation anti-proliferate, it is preferable that the degradable macromolecule coating surface is coated with phosphoric acid
Choline layer；It is highly preferred that the phosphocholine layer with a thickness of 5-100 μm of (such as 10 μm, 20 μm, 30 μm, 40 μm, 50 μm, 60
μm,70μm,80μm,90μm).Phosphocholine layer coating is introduced, itself and blood compatibility can be improved.
Referring to Fig. 1 and 2, the absorbable stent 1 of the utility model, comprising: netted degradable metal bracket frame body, with
And being set to the degradable macromolecule coating on the netted degradable metal bracket frame body twine surface, i.e., degradable macromolecule applies
Layer has wrapped up whole degradable metal bracket frame bodies, it may also be said to which degradable metal bracket frame body is absorbable stent 1
Metal inside, and be wrapped in metal inside outer surface degradable macromolecule coating be absorbable stent 1 crust,
Degradable macromolecule coating also still has after metal inside is degraded, and will form hollow degradable macromolecule branch at this time
Frame, to provide necessary radial support power for late blood vessel reconstruction, Fig. 2 shows the radial section structures of twine 11 at A in Fig. 1
Schematic diagram, 11 outer peripheral surface of twine coated on degradable metal bracket frame body is degradable macromolecule coating 12, and being coated on can
12 outer peripheral surface of degraded macromolecular coating is phosphocholine layer 13.
The frame body of degradable metal bracket described in the utility model be using degradable metal material individual thread braiding and
At；Or it is cut by laser using the tubing of degradable metal；Or use mould pressing method；Or it is formed using 3D printing.It is degradable
The preparation of metallic support frame body is conventional method in that art.
Raw materials used above-mentioned coating is this field conventional products, is marketable material.
Referring to Fig. 1 and 3, the utility model absorbable stent 1 is the straight barrel with reticular structure, can absorb blood vessel
The diameter of bracket 1 is preferably 0.5-15mm, and length is preferably 1-100mm；Diameter is more preferably 1-15mm, and length is more preferably
10-100mm。
The generation of postoperative blood perfusion syndrome in order to prevent, absorbable stent 1 are dumbbell shaped, comprising: two cylinders
Shape support portion is used to support vascular wall and provides hollow channel of blood flow for blood flow；With a blood flow control unit, both ends respectively with
Two cylindrical support portion connections, for slowing down the speed of the blood flow from the cylindrical support portion and being provided for blood flow hollow
Channel of blood flow, the cross-sectional area of the blood flow control unit is less than the cross-sectional area in the cylindrical support portion；It is highly preferred that described
The reticular structure of blood flow control unit is covered by degradable films layer；Preferably, the edge part of the cylinder is smooth structure, can be with
Further decrease the stimulation to vascular wall.
Further, the cross-sectional area size of the blood flow control unit covered according to the degradable films layer, institute
It states degradable films layer and is divided into multiple film units, as shown in figure 3, cylindrical support portion 3 is 2, be located at two neighboring institute
State the degradable thin of (i.e. on reticular structure, i.e., film layer covers mesh) on the blood flow control unit peripheral wall between cylindrical support portion
Film layer is divided into: the first film unit 21, positioned at the medium position of the blood flow control unit；Two the second film units 22,
Respective inside edge is connect with two outer ledges of the first film unit 21 respectively；And two third film units 23, respectively
From inside edge connect respectively with two 22 outer ledges of the second film unit, and outer side edges of two third film units 23
Edge is connect with two cylindrical support portions 3 respectively；It is highly preferred that the degradation time of the first film unit 21 is 1~15 day；Third is thin
The degradation time of film unit 23 is 1-2 months；The degradation time of second film unit 22 is 7~30 days.Each film unit
Raw material is selected from polylactic acid, polyglycolic acid, chitosan, chitin, poly butyric ester, lactic acid-ethylene glycol copolymer, poly- cream
Acid-polyethyleneglycol block copolymer, polyglycolic acid, polylactide-polyglycolic acid copolymer, polyhydroxyalkanoates, polyhydroxybutyrate
One of or it is a variety of, can be selected according to the degradation time of each film unit.
The degradable films layer can be covered on the blood flow control unit by way of dip-coating.
The above-mentioned supporting structure of the utility model can not only increase the adherence quality of bracket Yu patient's diseased region blood vessel, reduce
Stimulation and constriction to vascular wall improve patient for the adaptability of additional intravascular stent, moreover it is possible to it is excessive to be better protected from brain
The generation of syndrome is perfused.
In use, in order to improve the accuracy of positioning, in the end of absorbable stent along the bracket week
To several developing marks are arranged, setting developing mark can increase developability under the conditions of radiological installation；Preferably, described aobvious
The material of shadow label is gold, platinum, tungsten or iridium Radiopaque marker.
The preparation method of above-mentioned absorbable stent, in turn includes the following steps:
Step 1, the preparation of degradable metal bracket frame body；
Degradable metal bracket frame body can be prepared using following methods: be compiled using the individual thread of degradable metal material
It knits, for example uses magnesium alloy；Or it is cut by laser using the tubing of degradable metal；Or use mould pressing method；Or it adopts
It is formed with 3D printing.
Step 2, the preparation of degradable macromolecule spraying slurry match according to above-mentioned degradable macromolecule coating ingredients and claim
Raw material is taken, 70~90 DEG C are heated to by the dissolution of raw material in organic solvent, while being stirred, keeps the temperature 5-10min, it is cold
But the degradable macromolecule spraying slurry is obtained afterwards；Preferably, described to be stirred as mixed processing is stirred by ultrasonic；It is described to have
Solvent is preferably tetrahydrofuran or acetone；It is highly preferred that the frequency of the ultrasonic treatment be 50~130KHz (such as 55KHz,
60KHz, 70KHz, 80KHz, 90KHz, 100KHz, 110KHz, 120KHz, 125KHz), the time be 10~60min (such as
6min,10min,15min,20min,25min,27min,40min,50min)；It is highly preferred that under the conditions of nitrogen or argon gas into
Row ultrasonic agitation mixed processing；On the one hand ultrasonic treatment can be such that each composition is distributed more uniformly across and increase between component
On the other hand binding force can also drive the gas in degradable macromolecule spraying slurry away；70~90 are heated to while stirring
DEG C heat preservation, can make preferably to merge between raw material components, uniform ingredients, each point support force can be prepared using the spraying slurry
Stablize and have the absorbable stent of certain elasticity.
Step 3, the preparation of degradable macromolecule coating, by the degradable macromolecule spraying slurry be sprayed on it is described can
It degrades on the surface of metallic support frame body twine, obtains the absorbable blood vessel branch of the degradable macromolecule coating with required thickness
Frame；Or the degradable metal bracket frame body is immersed in the degradable macromolecule spraying slurry and is further taken out, is dried, it repeats
It immerses, taking-up and dry operation obtain the degradable macromolecule coating on twine with required thickness for several times (such as 5-10 times)
Absorbable stent.
Step 4, the preparation step of phosphocholine layer is soluble in water by phosphocholine, be made phosphocholine aqueous solution (
The concentration of phosphocholine is 30-50wt% in the solution), then the phosphocholine aqueous solution is sprayed into using spraying method
On the surface of the degradable macromolecule coating, the absorbable stent with phosphocholine layer is obtained；Or use dip-coating
The absorbable stent with required thickness degradable macromolecule coating is immersed the phosphocholine aqueous solution by mode
In further take out, dry, repeat to immerse, take out and dry operation obtains covering required thickness on twine for several times (such as 5-10 times)
Phosphocholine layer absorbable stent.
The degradation time of the absorbable stent can be by adjusting degradable macromolecule coating composition and degradable
Polymeric coating layer thickness controls, and the degradation time of the absorbable stent of the utility model is 1~12 month；It is described to inhale
The most short degradation time of receipts intravascular stent is 1~2 month；By adjusting the degradation time of absorbable stent, can meet not
The demand of the vascular disease of same type can play necessary supporting role, in reconstructing blood vessel in blood vessel during reconstruction
After the completion, bracket is also substantially completely degraded, can be to avoid the foreign body sensation generated due to the long-term existence of bracket, caused blood vessel damage
Wound, while also avoiding the generation for a series of problems, such as exciting immune system to cause coating, displacement because of bracket long-term existence.
Blood vessel due to generating pathological change of thrombus position inevitably will appear rough and uneven in surface phenomenon, it can absorb blood vessel branch
Frame must have certain elasticity, be achieved in preferable adherence quality, reduce stimulation and constriction of the bracket to vascular wall, improve
Adaptability of the patient to bracket.
In order to further illustrate the utility model absorbable stent, inventor devises Examples 1 to 4.Implementing
In example 1~4, used raw material, chemical reagent and drug etc. are commercial goods, and used laboratory apparatus is conventional instrument
Device.
Embodiment 1
Absorbable stent manufactured in the present embodiment includes: the netted degradable metal bracket frame body of cylinder and setting
Degradable macromolecule coating in the netted degradable metal bracket frame body twine surface of the cylinder, that is, form that cylinder is netted to drop
The twine surface of solution metallic support frame body all covers one layer of degradable macromolecule coating, wherein degradable metal is magnesium conjunction
The group of golden WE43, the degradable macromolecule coating are divided into PLGA 75:25.The preparation method is as follows:
(1) the netted degradable metal bracket frame body of cylinder, diameter 1mm, length are woven using magnesium alloy WE43 individual thread
Preferably 10mm.
(2) 1g PLGA 75:25 is weighed, is dissolved in 10mL tetrahydrofuran, under a nitrogen atmosphere ultrasonic agitation mixing
It is heated to 80 DEG C simultaneously, keeps the temperature 8min, the ultrasonic agitation mixing is still carried out in insulating process, the frequency of processing is stirred by ultrasonic
For 100KHz, time 30min, degradable macromolecule spraying slurry is obtained after cooling；
(3) that the degradable macromolecule spraying slurry that step (2) obtains is sprayed on ready-made cylinder is netted degradable
On the surface of the twine of metallic support frame body, three with 50 μm, 100 μm and 200 μm degradable macromolecule coatings are respectively obtained
A absorbable stent.
Three brackets of the present embodiment are implanted to respectively in 9 small-sized porcine coronaries, while control group is set, wherein
The bracket that control group uses is the degradable metal bracket frame body of step (1) preparation, coronal dynamic after being implanted into different time respectively
Arteries and veins radiography observe minimum pipe, in addition, observation bracket degradation situation and bracket in embolism, thrombus, extensive inflammation reaction and
The complication such as fibrin deposition, the results showed that, control group starts to degrade for general 1 month or so in implantation, at 2.5th month
Through enough support forces cannot be provided substantially, it cannot continue to become larger so as to cause blood vessels caliber, reconstructing blood vessel reparation is without completely complete
At i.e. scaffold degradation speed is faster than required speed, and blood vessel can not be made to complete to rebuild；And the polymeric coating layer of the utility model
Enough radial support power, and art are then provided during entire reconstructing blood vessel with a thickness of 100 μm and 200 μm of two brackets
Embolism in bracket, extensive inflammation reaction and the complication such as fibrin deposition are not found afterwards, polymeric coating layer is with a thickness of 200 μm of branch
Minimal amount of small blocks can be observed after macromolecule degradation in frame, and polymeric coating layer is with a thickness of the high score in 100 μm of bracket
Can observe after son degradation and not observe block substantially, but after 1.5 years monitoring result show using polymeric coating layer with a thickness of
Embolism again does not occur for 100 μm and 200 μm of two brackets.Polymeric coating layer is with a thickness of 50 μm of bracket then in entire blood vessel
Enough radial support power cannot be provided by rebuilding the later period.
In addition, being found by vascular environment simulated experiment, after 4 months, polymeric coating layer still may be used with a thickness of 100 μm of brackets
To provide the radial support power of 0.009Pa, polymeric coating layer can still provide the radial branch of 0.011Pa with a thickness of 200 μm of brackets
Support force, and polymeric coating layer cannot then provide complete radial support power with a thickness of 50 μm of brackets.
Embodiment 2
Absorbable stent manufactured in the present embodiment includes: the netted degradable metal bracket frame body of cylinder and setting
Degradable macromolecule coating in the netted degradable metal bracket frame body twine surface of the cylinder, that is, form that cylinder is netted to drop
The twine surface of solution metallic support frame body all covers one layer of degradable macromolecule coating, in degradable macromolecule coating surface
Coated with phosphocholine layer；Wherein, degradable metal is magnesium alloy WE43, and the group of the degradable macromolecule coating is divided into
80wt%PLGA 75:25,8wt% chitosan, the poly- hydroxacetic acid of 6wt%, 6wt% polylactic acid, point of poly- hydroxacetic acid (PGA)
Son amount is 100,000, and the molecular weight of polylactic acid (PLA) is 100,000.The preparation method is as follows:
(1) the netted degradable metal bracket frame body of cylinder, diameter 1mm, length are woven using magnesium alloy WE43 individual thread
Preferably 10mm.
(2) 0.8g PLGA 75:25,0.08g chitosan, the poly- hydroxacetic acid of 0.06g, 0.06wt% polylactic acid are weighed, it will
It is dissolved in 10mL tetrahydrofuran, and ultrasonic agitation mixes while being heated to 80 DEG C under a nitrogen atmosphere, and heat preservation 10min was kept the temperature
The ultrasonic agitation mixing is still carried out in journey, the frequency that processing is stirred by ultrasonic is 120KHz, time 50min, is obtained after cooling
To degradable macromolecule spraying slurry；
(3) that the degradable macromolecule spraying slurry that step (2) obtains is sprayed on ready-made cylinder is netted degradable
On the surface of the twine of metallic support frame body, the absorbable stent with 100 μm of degradable macromolecule coatings is obtained.
(4) phosphocholine is soluble in water, phosphocholine aqueous solution (concentration 40wt%) is made, then uses spraying side
The phosphocholine aqueous solution is sprayed on the surface of the degradable macromolecule coating by formula, obtains having phosphocholine layer
Absorbable stent.
By the stenter to implant into 5 small-sized porcine coronaries, while control group is set, the bracket that wherein control group uses
For the degradable metal bracket frame body of step (1) preparation, coronarography observes minimum tube after being implanted into different time respectively
Diameter, in addition, embolism, thrombus, extensive inflammation reaction and fibrin deposition etc. are concurrent in the degradation situation of observation bracket and bracket
Disease, the results showed that, control group starts to degrade for general 1 month or so in implantation, cannot provide foot substantially at 2.5th month
Enough support forces, cannot continue to become larger, reconstructing blood vessel reparation is not fully complete, i.e. scaffold degradation speed so as to cause blood vessels caliber
It is faster than required speed, blood vessel can not be made to complete to rebuild；And the bracket of the utility model is then during entire reconstructing blood vessel
Enough radial support power is provided, degradable macromolecule coating is thin, and support force is strong, and the block generated after macromolecule degradation is almost
Do not observe.And it is postoperative do not find the complication such as embolism in bracket, inflammatory reaction and fibrin deposition, compatibility is good, 1.5 years
Monitoring result shows that embolism again does not occur afterwards.
In addition, found by vascular environment simulated experiment, after 4 months, polymeric coating layer can be with a thickness of 100 μm of brackets
Uniform radial support power is provided, radial support power is 0.014Pa.
Embodiment 3
Absorbable stent manufactured in the present embodiment includes: the netted degradable metal bracket frame body of cylinder and setting
Degradable macromolecule coating in the netted degradable metal bracket frame body twine surface of the cylinder, that is, form that cylinder is netted to drop
The twine surface of solution metallic support frame body all covers one layer of degradable macromolecule coating, in degradable macromolecule coating surface
Coated with phosphocholine layer；Wherein, degradable metal is magnesium alloy WE43, and the group of the degradable macromolecule coating is divided into
80wt% PLGA 75:25,8wt% chitosan, the poly- hydroxacetic acid of 6wt%, 6wt% polylactic acid, point of poly- hydroxacetic acid (PGA)
Son amount is 100,000, and the molecular weight of polylactic acid (PLA) is 100,000.The preparation method is as follows:
(1) the netted degradable metal bracket frame body of cylinder, diameter 1mm, length are woven using magnesium alloy WE43 individual thread
Preferably 10mm.
(2) 0.8g PLGA 75:25,0.08g chitosan, the poly- hydroxacetic acid of 0.06g, 0.06wt% polylactic acid are weighed, it will
It is dissolved in 10mL tetrahydrofuran, and standard machinery is stirred while being heated to 60 DEG C under a nitrogen atmosphere, and heat preservation 10min is protected
The mechanical stirring mixing is still carried out during temperature, obtains degradable macromolecule spraying slurry after cooling；
(3) that the degradable macromolecule spraying slurry that step (2) obtains is sprayed on ready-made cylinder is netted degradable
On the surface of the twine of metallic support frame body, the absorbable stent with 100 μm of degradable macromolecule coatings is obtained.
(4) phosphocholine is soluble in water, phosphocholine aqueous solution (concentration 40wt%) is made, then uses spraying side
The phosphocholine aqueous solution is sprayed on the surface of the degradable macromolecule coating by formula, obtains having phosphocholine layer
Absorbable stent.
By the stenter to implant into 5 small-sized porcine coronaries, while control group is set, the bracket that wherein control group uses
For the degradable metal bracket frame body of step (1) preparation, coronarography observes minimum tube after being implanted into different time respectively
Diameter, in addition, embolism, thrombus, extensive inflammation reaction and fibrin deposition etc. are concurrent in the degradation situation of observation bracket and bracket
Disease, the results showed that, control group starts to degrade for general 1 month or so in implantation, cannot provide foot substantially at 2.5th month
Enough support forces, cannot continue to become larger, reconstructing blood vessel reparation is not fully complete, i.e. scaffold degradation speed so as to cause blood vessels caliber
It is faster than required speed, blood vessel can not be made to complete to rebuild；And the bracket of the utility model is then during entire reconstructing blood vessel
Enough radial support power is provided, degradable macromolecule coating is thin, and support force is strong, and the block generated after macromolecule degradation is almost
Do not observe.And it is postoperative do not find embolism in bracket, extensive inflammation reaction and the complication such as fibrin deposition, monitored after 1.5 years
The result shows that embolism again does not occur.
In addition, being found by vascular environment simulated experiment, after 4 months, polymeric coating layer cannot with a thickness of 100 μm of brackets
Uniform radial support power is provided, generally radially support force is 0.011Pa.
Embodiment 4
Absorbable stent manufactured in the present embodiment includes: degradable metal bracket frame body and is set to the circle
The degradable macromolecule coating on cylinder netted degradable metal bracket frame body twine surface, that is, form the netted degradable metal branch of cylinder
The twine surface of frame frame body all covers one layer of degradable macromolecule coating, is coated with phosphorus in degradable macromolecule coating surface
Sour choline layer；Wherein, degradable metal is magnesium alloy WE43, and the group of the degradable macromolecule coating is divided into 70wt% PLGA
75:25,10wt% chitosan, the poly- hydroxacetic acid of 10wt%, 10wt% polylactic acid, the molecular weight of poly- hydroxacetic acid (PGA) are 10
Ten thousand, the molecular weight of polylactic acid (PLA) is 100,000.Degradable metal bracket is dumbbell shaped, as shown in Figure 3, comprising: cylindrical support portion
3 be 2, be used to support vascular wall and hollow channel of blood flow be provided for blood flow, for reticular structure be include mesh (in Fig. 3 not
It shows)；With a netted blood flow control unit, both ends are connect with two cylindrical support portions respectively, for slowing down from described
The speed of the blood flow in cylindrical support portion simultaneously provides hollow channel of blood flow for blood flow, and the cross-sectional area of blood flow control unit is less than tubular
The cross-sectional area of support portion；The blood flow control unit (including mesh) of reticular structure is covered by degradable films layer, degradable thin
Film layer is divided into: the first film unit 21, positioned at the medium position of the blood flow control unit；Two the second film units 22,
Respective inside edge is connect with two outer ledges of the first film unit 21 respectively；And two third film units 23, respectively
From inside edge connect respectively with two 22 outer ledges of the second film unit, and outer side edges of two third film units 23
Edge is connect with two cylindrical support portions 3 respectively；The degradation time of the first film unit 21 is 10 days or so；Third film unit 23
Degradation time be 40 days or so；The degradation time of second film unit 22 is 25 days or so.The preparation method is as follows:
(1) dumbbell shaped degradable metal bracket frame body is woven using magnesium alloy WE43 individual thread, diameter 1mm, length is excellent
It is selected as 10mm.
(2) 0.7g PLGA 75:25,0.1g chitosan, the poly- hydroxacetic acid of 0.1g, 0.1wt% polylactic acid are weighed, its is molten
In 10mL tetrahydrofuran, ultrasonic agitation mixing under a nitrogen atmosphere is heated to 80 DEG C simultaneously, heat preservation 10min, in insulating process
The ultrasonic agitation mixing is still carried out, the frequency that processing is stirred by ultrasonic is 80KHz, time 50min, obtains to drop after cooling
Solve macromolecule spraying slurry.
(3) that the degradable macromolecule spraying slurry that step (2) obtains is sprayed on ready-made cylinder is netted degradable
On the surface of the twine of metallic support frame body, the absorbable stent with 150 μm of degradable macromolecule coatings is obtained.
(4) phosphocholine is soluble in water, phosphocholine aqueous solution (concentration 40wt%) is made, then uses spraying side
The phosphocholine aqueous solution is sprayed on the surface of the degradable macromolecule coating by formula, obtains having phosphocholine layer
Absorbable stent.
(5) in the blood flow control unit of the absorbable stent with phosphocholine layer of the dumbbell shaped of step (4) preparation
Degradable films layer is sprayed, final absorbable stent is obtained.
By the stenter to implant into 5 small-sized porcine coronaries, while control group is set, the bracket that wherein control group uses
For the degradable metal bracket frame body of step (1) preparation, coronarography observes minimum tube after being implanted into different time respectively
Diameter, in addition, embolism, thrombus, extensive inflammation reaction and fibrin deposition etc. are concurrent in the degradation situation of observation bracket and bracket
Disease, the results showed that, control group starts to degrade for general 1 month or so in implantation, cannot provide foot substantially at 2.5th month
Enough support forces, cannot continue to become larger, reconstructing blood vessel reparation is not fully complete, i.e. scaffold degradation speed so as to cause blood vessels caliber
It is faster than required speed, blood vessel can not be made to complete to rebuild；And the bracket of the utility model is then during entire reconstructing blood vessel
Enough radial support power is provided, degradable macromolecule coating is thin, and support force is strong, and the block generated after macromolecule degradation is almost
Do not observe.And it is postoperative do not find embolism in bracket, extensive inflammation reaction and the complication such as fibrin deposition, monitored after 1.5 years
The result shows that embolism again does not occur.Since there are blood flow control units for the bracket of the utility model, so when simulated experiment, nothing
The generation of blood perfusion syndrome.
In addition, being found by vascular environment simulated experiment, after 4 months, polymeric coating layer cannot with a thickness of 150 μm of brackets
Uniform radial support power is provided, generally radially support force is 0.013Pa.
Claims (7)
1. a kind of absorbable stent characterized by comprising netted degradable metal bracket frame body and be set to institute
State the degradable macromolecule coating on the twine surface of netted degradable metal bracket frame body, wherein the degradable macromolecule applies
The group of layer is divided into poly lactide-glycolide acid, the degradable macromolecule coating with a thickness of 100-500 μm.
2. absorbable stent according to claim 1, which is characterized in that the netted degradable metal bracket frame body
Material be ferroalloy, magnesium alloy or kirsite.
3. absorbable stent according to claim 1, which is characterized in that the degradable macromolecule coating surface applies
It is covered with phosphocholine layer.
4. absorbable stent according to claim 3, which is characterized in that the phosphocholine layer with a thickness of 5-
100μm。
5. absorbable stent according to any one of claims 1 to 4, which is characterized in that the absorbable blood vessel branch
Frame is the straight barrel with reticular structure, and the diameter of the absorbable stent is 1-15mm, length 10-100mm.
6. absorbable stent according to any one of claims 1 to 4, which is characterized in that the absorbable blood vessel branch
Frame is dumbbell shape, comprising: two cylindrical support portions are used to support vascular wall and provide hollow channel of blood flow for blood flow；With one
A blood flow control unit, both ends are connect with two cylindrical support portions respectively, for slowing down the blood from the cylindrical support portion
The speed of stream simultaneously provides hollow channel of blood flow for blood flow, and the cross-sectional area of the blood flow control unit is less than the cylindrical support portion
Cross-sectional area.
7. absorbable stent according to claim 6, which is characterized in that in the end of the absorbable stent
Several developing marks are circumferentially set along the bracket, the material of the developing mark is gold, platinum, tungsten or iridium radiopaque mark
Object.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201721486491.0U CN209392453U (en) | 2017-11-09 | 2017-11-09 | A kind of absorbable stent |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201721486491.0U CN209392453U (en) | 2017-11-09 | 2017-11-09 | A kind of absorbable stent |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN209392453U true CN209392453U (en) | 2019-09-17 |
Family
ID=67876192
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201721486491.0U Active CN209392453U (en) | 2017-11-09 | 2017-11-09 | A kind of absorbable stent |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN209392453U (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110934621A (en) * | 2019-12-10 | 2020-03-31 | 贺迎坤 | Degradable blood flow guiding device |
| CN112402081A (en) * | 2020-11-13 | 2021-02-26 | 东南大学 | Full-coated degradable cerebrovascular stent and preparation method thereof |
-
2017
- 2017-11-09 CN CN201721486491.0U patent/CN209392453U/en active Active
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110934621A (en) * | 2019-12-10 | 2020-03-31 | 贺迎坤 | Degradable blood flow guiding device |
| CN112402081A (en) * | 2020-11-13 | 2021-02-26 | 东南大学 | Full-coated degradable cerebrovascular stent and preparation method thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN107670121A (en) | A kind of absorbable stent and preparation method thereof | |
| CN102885665B (en) | Temporal intraluminal stent, methods of making and using | |
| AU2009283162B2 (en) | Implantable medical device coatings with biodegradable elastomer and releasable taxane agent | |
| Zilberman et al. | Drug-eluting bioresorbable stents for various applications | |
| US20070270940A1 (en) | Bioabsorbable Magnesium-Reinforced Polymer Stents | |
| WO2019076178A1 (en) | Degradation time controllable and breaking elongation adjustable medical degradable polyurethane | |
| JP5329435B2 (en) | Coronary stent with asymmetric drug release controlled coating | |
| WO2017054433A1 (en) | Elastic modulus adjustable polyurethane composition, scaffold composite and preparation method thereof | |
| CN105412996B (en) | A kind of Biodegradable scaffold and preparation method thereof | |
| CN102151185A (en) | Biodegradable stent with laminated coatings | |
| WO2020006882A1 (en) | Degradable spiral coated stent with controllable gradient, preparation method therefor and use thereof | |
| CN109939271B (en) | Coating structure of medical biodegradable zinc alloy stent and preparation method thereof | |
| CN209392453U (en) | A kind of absorbable stent | |
| Feng et al. | Mechanical properties and in vivo performance of a novel sliding-lock bioabsorbable poly-p-dioxanone stent | |
| CN108144131A (en) | A kind of load medicine implanted medical device and preparation method thereof | |
| CN104524637A (en) | High-molecular biological ceramic composite nanometer particle biodegradable stent and manufacturing method thereof | |
| JP2007152103A (en) | Treatment of aneurysms with implantable polymeric, biodegradable device incorporating mmp inhibitor | |
| CN116688254A (en) | Degradable cavity support | |
| CN107865983B (en) | Medicine stent and preparation method thereof | |
| CN111840663A (en) | Medicine-carrying implantation medical apparatus and preparation method thereof | |
| Wang et al. | Study on degradation of ureteral stent coated with Polycaprolactone lactide | |
| CN210301826U (en) | Coating structure of medical biodegradable zinc alloy bracket | |
| Lee et al. | The development of novel biodegradable bifurcation stents for the sustainable release of anti-proliferative sirolimus | |
| Sun et al. | Advancement on Digestive Tract Biomedical Stents, A | |
| Ding et al. | 3D-printed, citrate-based bioresorbable vascular scaffolds for coronary artery angioplasty |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| GR01 | Patent grant | ||
| GR01 | Patent grant |