CN109550085A - A kind of support casing and preparation method thereof for treating Endovascular bleeding due to trauma - Google Patents
A kind of support casing and preparation method thereof for treating Endovascular bleeding due to trauma Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/18—Materials at least partially X-ray or laser opaque
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/08—Materials for coatings
- A61L31/10—Macromolecular materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/16—Biologically active materials, e.g. therapeutic substances
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61L2300/412—Tissue-regenerating or healing or proliferative agents
- A61L2300/414—Growth factors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/602—Type of release, e.g. controlled, sustained, slow
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- 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
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/04—Materials for stopping bleeding
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Abstract
The invention discloses a kind of support casings and preparation method thereof for treating Endovascular bleeding due to trauma.The support casing has obtained a kind of support casing for treating Endovascular bleeding due to trauma using polylactide as degradable base rack using the degradability of polylactide.It is equipped with strip-like developing pipe in the middle position of support casing outer surface, convenient for determining the position of support casing release, covers bleeding part after guaranteeing support casing release.Strip-like developing pipe is centrally located simultaneously keeps strip-like developing pipe not easily to fall off during transportation；Growth factor is contained on support casing surface, can slowly release growth factor, while effectively closure to damage blood vessel, farthest promotes the healing of damage location tissue.Support casing provided by the invention has good biocompatibility, will not cause thrombus or inflammatory reaction after implantable intravascular, easy to operate, and implantation can be realized on the basis of not needing special instrument, and has many advantages, such as that drugloading rate is high, haemostatic effect is good.
Description
Technical field
The present invention relates to high molecular materials and biomedical engineering technology field, treat Endovascular more particularly to a kind of
Support casing of bleeding due to trauma and preparation method thereof.
Background technique
With the development of medical technology, the intracavitary therapy of bracket is widely used in clinical each field.However stenter to implant mistake
The iatrogenic injury incidence as caused by a variety of causes also rises with it in journey, or even to betide the damage of big blood vessel also and many
See.Such as in stent implantation procedure, arterial wall is weak, and narrow positions often involves artery of cerebral hemorrhage, and patch complex shape,
Bracket easily causes target vessel and side branch arteriorrhexis bleeding in implantation process.Doctor source caused by seal wire, conduit break-through main artery
Property damage may also lead to bleed profusely in the short time, cause haemorrhagic shock even dead.Furthermore it is also often met in surgical operation
Bleeding caused by angiorrhoxis or damage, often resulting in operation can not be successfully progress or terminates operation, or even cause life danger
Danger.
Conventional open prosthesis is difficult to find vascular injury site in a short time, when there are false aneurysms or huge
It can make to dissect when hemotoncus and become complex, such as the exposed vessel of some damage locations is extremely difficult, the solution of damaged blood vessels
The tissue for cuing open severely deformed, the neighbouring operative region of structure, which is badly damaged or pollutes, easily causes graft infection etc., and patient such as deposits in addition
In severe multiple injuries or whole body complication, the complication and the death rate of operation can be dramatically increased, and influence the success of traditional operation
Rate.
Therefore, research and develop a kind of instrument of easily treatment Endovascular bleeding lesions be it is very urgent, especially treat
The instrument of iatrogenic injury caused by seal wire, conduit break-through main artery.
It is disclosed in the Chinese invention patent application of Publication No. CN102908673A a kind of with hemostatic and antibacterial function
Bracket overlay film, the bracket overlay film are molten by the mixing that high-molecular organic material, drug molecule, the microballoon containing antibacterials form
Liquid is made up of electrostatic spinning technique；The major function of the bracket overlay film is bactericidal haemostatic, and endothelial tissue is not promoted to heal
Effect, and microballoon has the shortcomings that drugloading rate is few, is not used to treatment Endovascular bleeding lesions.
A kind of degradable magnesium alloy overlay film branch is disclosed in the Chinese invention patent application of Publication No. CN103948453A
Frame and overlay film frame system, the rack body in the overlay film frame are degradable magnesium alloy, degradation speed and vascular repair
Speed can not be consistent, will cause vascular repair, but magnesium alloy is not degraded completely；Or magnesium alloy has been degraded completely, but blood vessel is still
The situation that do not repair completely causes its therapeutic effect to be had a greatly reduced quality.In addition, if the catabolite of magnesium alloy cannot be in time by people
Body absorbs, and will affect the recovery of function of organization, it is also possible to generate adverse reaction to human body.
Therefore, caused by one kind can effectively treat Endovascular bleeding due to trauma, especially seal wire, conduit break-through main artery
The medical instrument of injury of blood vessel bleeding is the direction that this field is urgently researched and developed.
Summary of the invention
The purpose of the present invention is being directed to technological deficiency existing in the prior art, in a first aspect, providing one kind can treat
The support casing of Endovascular bleeding due to trauma, including being coated on the bracket overlay film of rack body outer surface and being located in bracket overlay film
Strip-like developing pipe；At least two layers of the bracket overlay film, and one layer is located at rack body outer surface, one layer is located on the outside of strip-like developing pipe.
The strip-like developing pipe is located in bracket overlay film along the middle position of support casing length direction.
The bracket overlay film along the both ends of support casing length direction be equipped with chamfering, it is preferred that the angle of the chamfering be 5 °-
10°。
The bracket overlay film is prepared under the action of cosolvent by electrostatic spinning by drug, flexible biodegradable block copolymer
It forms；
Preferably, the cosolvent is the mixing that 3:1-1:3 is formed by volume of n,N dimethylformamide, tetrahydrofuran
Solution.
The flexibility biodegradable block copolymer is using 1,4-butanediol as initiator, and 6-caprolactone and lactide are with (40:60)-
The molar ratio of (80:20) mixes, and stannous octoate is catalyst, and by vacuum ring-opening polymerization, obtaining intrinsic viscosity is 1.0-
The polyamide that the polyester or polyester of 1.5dl/g is further polymerized under the action of coupling agent；
Preferably, the polyester can be l-poly-Lactide, racemization polylactide, polyglycolic acid, poly-epsilon-caprolactone,
One of degradable high polymer materials such as the derivative carbonic ester of polytrimethylene carbonate, polydioxanone, polyaminoacid
Or any two and two or more blend or copolymer；Polyester is also possible to random DL- lactide-epsilon-coprolactone copolymerization
One or more of ester, trimethylene carbonate -6-caprolactone copolyesters, Lanthanum Isopropoxide -6-caprolactone copolyesters；Institute
Stating polyamide is to be polymerize to obtain under the action of coupling agent by the polyester, and coupling agent is preferably diisocyanate compound,
One of more preferable 1,4- butane diisocyanate, 1,6- hexamethylene diisocyanate, isophorone diisocyanate or
It is several.
Second aspect, the present invention provide a kind of method for preparing above-mentioned support casing, and preparation, flexibility including drug solution can
The synthesis of degraded copolymer, the preparation of cosolvent solution, the processing of support casing, bracket overlay film cladding；
Preferably, the preparation of the cosolvent solution specifically: take in the synthesis of the flexible biodegradable block copolymer and obtain
Polyester or polyamide be dissolved in N, be made into copolymer quality volume hundred in the mixed solution of N-dimethylformamide and tetrahydrofuran
Divide the cosolvent solution for being 40%-60% than (g/ml), wherein n,N dimethylformamide and the volume ratio of tetrahydrofuran are (1-
3):(1-3)。
The flexibility biodegradable block copolymer is polyester or polyamide, synthesis specifically: using 1,4-butanediol as initiator,
6-caprolactone and lactide are mixed with the molar ratio of (40:60)-(80:20), and stannous octoate is catalyst, poly- by vacuum open loop
Reaction is closed, the polyester that intrinsic viscosity is 1.0-1.5dl/g is obtained, the polyester can further gather under the action of coupling agent
Conjunction obtains the polyamide；Preferably, coupling agent can be diisocyanate compound, more preferable Isosorbide-5-Nitrae-butane diisocyanate
One or more of ester, 1,6- hexamethylene diisocyanate, isophorone diisocyanate.
The cladding of the bracket overlay film specifically: take drug solution obtained in the preparation of the drug solution, and flexible
Degradable macromolecule is dissolved in cosolvent solution obtained in the preparation of the cosolvent solution, and Ultrasonic Pulverization emulsifies 2-
10min obtains the overlay film of first thickness using electrostatic spinning；Developer is dripped on overlay film again, is further continued for carrying out electrostatic spinning,
Obtain second thickness have strip-like developing pipe bracket overlay film, twice of second thickness >=first thickness (first thickness × 2)；Cosolvent
The concentration of flexible degradable macromolecule is 0.05-0.6g/ml in solution, and the voltage of electrostatic spinning is 6-14KV；
Preferably, first thickness 0.02-0.05mm；Or
Preferably, cosolvent is n,N dimethylformamide, the tetrahydrofuran mixed solution that 3:1-1:3 is formed by volume；
Or
Preferably, the drug is growth factor, be the concentration of growth factor in drug solution is 1-40mg/ml.
The third aspect, the present invention provide a kind of bracket for treating Endovascular bleeding due to trauma, including rack body and cladding
Above-mentioned support casing in rack body outer surface；
Preferably, the internal diameter of the rack body is 0.02-10mm, outer diameter 0.12mm-12mm；Or
It is furthermore preferred that the rack body is V-shaped network, network is along its length by the big V sections of branch of a circle
Frame and the small V sections of bracket of circle are alternatively formed, and are connected between big V sections of bracket and small V sections of bracket by connecting rod.
Compared with prior art, the beneficial effects of the present invention are:
Support casing of the invention utilizes the degradability of polylactide, using polylactide as degradable base rack,
A kind of support casing for treating Endovascular bleeding due to trauma is obtained.It is equipped with strip-like developing pipe in the middle position of support casing outer surface, just
In the position for determining support casing release, guarantee that support casing discharges in bleeding part and covers bleeding part.Strip-like developing pipe is located at simultaneously
Middle position can make strip-like developing pipe not easily to fall off during transportation；Growth factor is contained on support casing surface, can delay growth factor
Slow release is released, and while effectively closure to damage blood vessel, farthest promotes the healing of damage location tissue.This hair
The support casing of bright offer has good biocompatibility, will not cause thrombus or inflammatory reaction after implantable intravascular, easy to operate,
Implantation can be realized on the basis of not needing special instrument, have many advantages, such as that haemostatic effect is good.
The hybrid mode of polylactide solution and growth factor solution is screened when the present invention prepares support casing, is sieved
The hybrid mode of choosing includes high speed machine stirring, ultrasonic oscillation and ultrasonic grind.Wherein using ultrasonic oscillation growth because
The solution dispersion that sub- solution obtains is bad, it is also necessary to which additional mechanical stirring is further dispersed；High speed machine stirring and
Ultrasonic grind (using the dispersion effect of ultrasonic wave in a liquid, makes liquid generate the effect of cavitation, to make consolidating in liquid
Body particle or breakdown of cellular tissue, are sufficiently mixed solution, and dispersibility is more preferable) preferable dispersion effect is achieved, but it is high
Fast mechanical stirring solution is spilt outside being easy, and is not easy to operate, final to determine that hybrid mode is ultrasonic grind.
During preparing support casing of the present invention it has been unexpectedly discovered that, developer is added and is sandwiched among two layers of polylactide
Not only it may be implemented to develop, but also do not influence the mechanical property of support casing.In addition, the type of developer and polylactide compatibility
Well, will not occur lamination with bracket, guarantee that developer is firm on support casing.
Detailed description of the invention
Fig. 1 show the surface structure schematic diagram of the support casing of present invention treatment Endovascular bleeding due to trauma；
Fig. 2 show the deployed configuration schematic diagram of rack body in the bracket of present invention treatment Endovascular bleeding due to trauma；
1- bracket overlay film, 2- strip-like developing pipe, 3- rack body, the small V-arrangement section bracket of 4-, the big V-arrangement section bracket of 5-, the connection of 6-S shape
Hook, 7- connection straight-bar.
Specific embodiment
The bracket for the treatment of Endovascular bleeding due to trauma provided by the invention, as depicted in figs. 1 and 2, including hollow bracket
Ontology 3 and the support casing for being coated on 3 outer surface of rack body.Support casing includes bracket overlay film 1, strip-like developing pipe 2；Bracket overlay film 1 to
Two layers few, at least one layer is located at 3 outer surface of rack body, and strip-like developing pipe 2 is located at least one layer of 1 outer surface of bracket overlay film, strip-like developing pipe 2
Outside is covered at least one layer of bracket overlay film 1 again, and strip-like developing pipe 2 is located at the middle position of 1 length direction of bracket overlay film.
Wherein, the internal diameter of rack body is 0.02-10mm, wall thickness 0.05-1mm, outer diameter 0.12mm-12mm.To prevent
The exposed puncturing arteries blood vessel of rack body, bracket overlay film both ends have the gradient, and the gradient at bracket overlay film both ends is into rack body
It shrinks, bracket overlay film can also be effectively prevent to shift in this way, wherein slope portion length is (along the size of rack body length direction
For the length of the gradient) 1-2mm, the angle of the gradient and length direction is 5 ° -10 °.Rack body is hollow out, is that V-shaped is netted
Bracket, wherein network is alternatively formed by the big V-arrangement section bracket 5 of a circle and a small V-arrangement section bracket 4 of circle along its length, big V-arrangement
It is connected between section bracket and small V-arrangement section bracket by connecting rod, connecting rod can be connection straight-bar 7, be also possible to S-shaped connecting hook
6.The edge at the edge at V-shaped network both ends, big V-arrangement section bracket 5 and small V-arrangement section bracket 4 is by arc transition.Bracket sheet
Body is made of degradation material polylactide through laser cutting, as the healing of tissue can gradually degrade, degradation in vivo
Time is 1-2, is restored to former organized normal function, which can also degrade completely, not have an impact to tissue.
Bracket overlay film is mixed by being formed containing flexible degradable high polymer material, growth factor and cosolvent through ultrasonic emulsification
Solution is closed to be made using electrostatic spinning technique.Flexible degradable high polymer material is selected from polyester or polyamide；Polyester can be a left side
It revolves polylactide, racemization polylactide, polyglycolic acid, poly-epsilon-caprolactone, polytrimethylene carbonate, gather to dioxocyclohex
The blend or copolymer of one or more of the degradable high polymer materials such as the derivative carbonic ester of ketone, polyaminoacid, pass through tune
Save the blending between material or copolymerization ratios, the flexibility and adhesion of adjustable support overlay film.Polyester is also possible to random DL-
Lactide-epsilon-coprolactone copolyesters, trimethylene carbonate -6-caprolactone copolyesters, Lanthanum Isopropoxide -6-caprolactone copolymerization
One or more of ester.Polyamide is polymerize to obtain by polyester by coupling agent, and coupling agent can be diisocyanates chemical combination
One of object, preferably Isosorbide-5-Nitrae-butane diisocyanate, 1,6- hexamethylene diisocyanate, isophorone diisocyanate or
It is several.Cosolvent is N, N-dimethylformamide, the tetrahydrofuran mixed solution that (volume ratio 3:1-1:3) is formed by a certain percentage.
The present invention also provides the methods for the support casing for preparing above-mentioned treatment Endovascular bleeding due to trauma, specifically include following step
It is rapid:
1. preparing growth factor solution: taking growth factor soluble in water, obtain growth factor solution；
2. synthesizing flexible biodegradable block copolymer: using 1,4-butanediol as initiator, 6-caprolactone and lactide with (40:
60)-(80:20) molar ratio adds corrresponding quality, and stannous octoate is catalyst (additive amount be monomer mass 5/10000ths),
140 DEG C vacuum ring-opening polymerization 12 hours, obtain intrinsic viscosity be 1.0-1.5dl/g copolymer, the copolymer be polyester
Or polyamide；
3. prepare cosolvent solution: weigh 5.0g step 2 purification after copolymer, be dissolved in n,N dimethylformamide with
It is molten that the cosolvent that copolymer concentration is 40%-60% (quality percent by volume, g/ml) is made into the mixed solution of tetrahydrofuran
Liquid, wherein n,N dimethylformamide and the volume ratio of tetrahydrofuran are 3:1-1:3；
4. processing a kind of support casing for treating Endovascular bleeding due to trauma
The cosolvent solution that growth factor solution, the 10ml step 3 for taking 1ml step 1 to obtain obtain, ultrasonic emulsification 2-
10min is added in boost motor, covers the tubulose that first thickness is 0.02-0.05mm on rack body using electrostatic spinning
Bracket overlay film；Stop electrostatic spinning, developer is dripped on bracket overlay film, forms strip-like developing pipe；Then it is further continued for carrying out Static Spinning
Silk, obtains the tubular bracket set of second thickness, second thickness is at least twice of first thickness.When operation, bracket is located at sacculus
Outer wall is delivered to injury region under DSA (blood vessel Digital Subtraction), and stent open is fixed on injury region hemostasis through balloon expandable.
Below in conjunction with specific embodiment, the content of the present invention will be explained in more detail, and the present invention is further elaborated, but
These embodiments limit the invention absolutely not.
Implementation condition used in the examples can do further adjustment according to the condition of specific producer, the implementation being not specified
Condition is usually the condition in routine experiment.
Embodiment one: the support casing of l-poly-Lactide
1. preparing growth factor suspension: taking the growth factor of 100mg nanosizing to be placed in 4ml dehydrated alcohol, using super
The method of sound dispersion prepares growth factor suspension；
2. synthesizing flexible degradable macromolecule: using 1,4-butanediol as initiator, stannous octoate is catalyst, 6-caprolactone
The l-poly-Lactide for being 1.0dl/g as intrinsic viscosity using the ratio ring-opening polymerisation of 50/50 (mol/mol) with lactide；
3. preparing cosolvent solution: weighing the above-mentioned l-poly-Lactide of 1.0g, be dissolved in n,N dimethylformamide and tetrahydro
The blend solution of furans is made into the cosolvent solution of 40% concentration, wherein the volume ratio of n,N dimethylformamide and tetrahydrofuran
For 1:1；
4. preparing a kind of support casing for treating Endovascular bleeding due to trauma
1ml growth factor solution is taken, is mixed with 3ml cosolvent solution, ultrasonic emulsification 30min is added in boost motor, benefit
The support casing with a thickness of 0.02mm is obtained with electrostatic spinning technique；Developer is dripped to the interposition covered in idler wheel upper bracket set
It sets, obtains the strip-like developing pipe positioned at support casing outer surface middle position；Continue electrostatic spinning, obtains the branch with a thickness of 0.05mm
Frame set.When operation, support casing is located at sacculus outer wall, is delivered to injury region at DSA, opens overlay film frame admittedly through balloon expandable
Stop blooding due to injury region.
The measurement of support casing property
Appearance: support casing smooth surface.
Growth factor content: about 0.7%
Elongation at break: being 395 ± 23%.
Support casing developability: under X-ray, support casing has good developability, and radiography does not find that support casing shifts,
Have no blutpunkte bleeding.
Embodiment two: the support casing of polyglycolic acid
1. preparing growth factor suspension: taking the growth factor of 100mg nanosizing to be placed in 5ml dehydrated alcohol, using super
The method of sound dispersion prepares growth factor suspension；
2. synthesizing flexible degradable macromolecule: using 1,4-butanediol as initiator, stannous octoate is catalyst, 6-caprolactone
The polyglycolic acid for being 1.2dl/g as intrinsic viscosity using the ratio ring-opening polymerisation of 40/60 (mol/mol) with lactide；
3. preparing cosolvent solution: weighing the above-mentioned polyglycolic acid of 1.0g, be dissolved in n,N dimethylformamide and tetrahydro furan
The blend solution muttered is made into the cosolvent solution of 45% concentration, and wherein n,N dimethylformamide and the volume ratio of tetrahydrofuran are
3:1；
4. preparing a kind of support casing for treating Endovascular bleeding due to trauma
1ml growth factor solution is taken, is mixed with 3ml cosolvent solution, ultrasonic emulsification 30min is added in boost motor, benefit
The support casing with a thickness of 0.02mm is obtained with electrostatic spinning technique；Developer is dripped to the interposition covered in idler wheel upper bracket set
It sets, obtains the strip-like developing pipe positioned at support casing outer surface middle position；Continue electrostatic spinning, obtains the branch with a thickness of 0.05mm
Frame set.When operation, support casing is located at sacculus outer wall, is delivered to injury region at DSA, opens overlay film frame admittedly through balloon expandable
Stop blooding due to injury region.
The measurement of support casing property
Appearance: support casing smooth surface.
Growth factor content: about 0.7%
Elongation at break: being 356 ± 20%.
Support casing developability: under X-ray, support casing has good developability, and radiography does not find that support casing shifts,
Have no blutpunkte bleeding.
Embodiment three: the support casing of poly-epsilon-caprolactone
1. preparing growth factor suspension: taking the growth factor of 100mg nanosizing to be placed in 5ml dehydrated alcohol, using super
The method of sound dispersion prepares growth factor suspension；
2. synthesizing flexible degradable macromolecule: using 1,4-butanediol as initiator, stannous octoate is catalyst, 6-caprolactone
The poly-epsilon-caprolactone for being 1.2dl/g as intrinsic viscosity using the ratio ring-opening polymerisation of 80/20 (mol/mol) with lactide；
3. preparing cosolvent solution: weighing the above-mentioned poly-epsilon-caprolactone of 1.0g, be dissolved in n,N dimethylformamide and tetrahydro furan
The blend solution muttered is made into the solution of concentration 50%, and wherein n,N dimethylformamide and the volume ratio of tetrahydrofuran are 1:3；
4. preparing a kind of support casing for treating Endovascular bleeding due to trauma
1ml growth factor solution is taken, is mixed with 3ml cosolvent solution, ultrasonic emulsification 30min is added in boost motor, benefit
The support casing with a thickness of 0.05mm is obtained with electrostatic spinning technique；Developer is dripped to the interposition covered in idler wheel upper bracket set
It sets, obtains the strip-like developing pipe positioned at support casing outer surface middle position；Continue electrostatic spinning, obtains the branch with a thickness of 0.10mm
Frame set.When operation, support casing is located at sacculus outer wall, is delivered to injury region at DSA, opens overlay film frame admittedly through balloon expandable
Stop blooding due to injury region.
The measurement of support casing property
Appearance: support casing smooth surface.
Growth factor content: about 0.7%
Elongation at break: being 326 ± 23%.
Support casing developability: under X-ray, support casing has good developability, and radiography does not find that support casing shifts,
Have no blutpunkte bleeding.
Example IV: the support casing of polytrimethylene carbonate
1. preparing growth factor suspension: taking the growth factor of 100mg nanosizing to be placed in 5ml dehydrated alcohol, using super
The method of sound dispersion prepares growth factor suspension；
2. synthesizing flexible degradable macromolecule: using 1,4-butanediol as initiator, stannous octoate is catalyst, 6-caprolactone
The polytrimethylene carbonate for being 1.5dl/g as intrinsic viscosity using the ratio ring-opening polymerisation of 60/40 (mol/mol) with lactide；
3. prepare cosolvent solution: weigh the above-mentioned polytrimethylene carbonate of 1.0g, be dissolved in n,N dimethylformamide with
The blend solution of tetrahydrofuran is made into the cosolvent solution of 55% concentration, wherein the body of n,N dimethylformamide and tetrahydrofuran
Product is than being 1:2；
4. preparing a kind of support casing for treating Endovascular bleeding due to trauma
1ml growth factor solution is taken, is mixed with 3ml cosolvent solution, ultrasonic emulsification 30min is added in boost motor, benefit
The support casing with a thickness of 0.02mm is obtained with electrostatic spinning technique；Developer is dripped to the interposition covered in idler wheel upper bracket set
It sets, obtains the strip-like developing pipe positioned at support casing outer surface middle position；Continue electrostatic spinning, obtains the branch with a thickness of 0.05mm
Frame set.When operation, support casing is located at sacculus outer wall, is delivered to injury region at DSA, opens overlay film frame admittedly through balloon expandable
Stop blooding due to injury region.
The measurement of support casing property
Appearance: support casing smooth surface.
Growth factor content: about 0.7%
Elongation at break: being 300 ± 28%.
Support casing developability: under X-ray, support casing has good developability, and radiography does not find that support casing shifts,
Have no blutpunkte bleeding.
Embodiment five: the support casing of the derivative carbonic ester of polyaminoacid
1. preparing growth factor suspension: taking the growth factor of 100mg nanosizing to be placed in 5ml dehydrated alcohol, using super
The method of sound dispersion prepares growth factor suspension；
2. synthesizing flexible degradable macromolecule: using 1,4-butanediol as initiator, stannous octoate is catalyst, 6-caprolactone
The derivative carbonic acid of polyaminoacid for being 1.5dl/g as intrinsic viscosity using the ratio ring-opening polymerisation of 70/30 (mol/mol) with lactide
Ester；
3. preparing cosolvent solution: weighing the derivative carbonic ester of the above-mentioned polyaminoacid of 1.0g, be dissolved in n,N dimethylformamide
The cosolvent solution of 60% concentration is made into the blend solution of tetrahydrofuran, wherein n,N dimethylformamide and tetrahydrofuran
Volume ratio is 2:1；
4. preparing a kind of support casing for treating Endovascular bleeding due to trauma
1ml growth factor solution is taken, is mixed with 3ml cosolvent solution, ultrasonic emulsification 30min is added in boost motor, benefit
The support casing with a thickness of 0.05mm is obtained with electrostatic spinning technique；Developer is dripped to the interposition covered in idler wheel upper bracket set
It sets, obtains the strip-like developing pipe positioned at support casing outer surface middle position；Continue electrostatic spinning, obtains the branch with a thickness of 0.10mm
Frame set.When operation, support casing is located at sacculus outer wall, is delivered to injury region at DSA, opens overlay film frame admittedly through balloon expandable
Stop blooding due to injury region.
The measurement of support casing property
Appearance: support casing smooth surface.
Growth factor content: about 0.7%
Elongation at break: being 257 ± 25%.
Support casing developability: under X-ray, support casing has good developability, and radiography does not find that support casing shifts,
Have no blutpunkte bleeding.
Embodiment six: the support casing of random DL- lactide-epsilon-coprolactone copolyesters
1. preparing growth factor suspension: taking the growth factor of 100mg nanosizing to be placed in 5ml dehydrated alcohol, using super
The method of sound dispersion prepares growth factor suspension；
2. synthesizing flexible degradable macromolecule: using 1,4-butanediol as initiator, stannous octoate is catalyst, 6-caprolactone
The random DL- lactide-ε-for being 1.5dl/g by intrinsic viscosity of the ratio ring-opening polymerisation of 50/50 (mol/mol) with lactide oneself
Lactone copolyesters；
3. preparing cosolvent solution: weighing the above-mentioned random DL- lactide-epsilon-coprolactone copolyesters of 1.0g, be dissolved in N, N bis-
The blend solution of methylformamide and tetrahydrofuran is made into the cosolvent solution of 50% concentration, wherein n,N dimethylformamide with
The volume ratio of tetrahydrofuran is 1:1；
4. preparing a kind of support casing for treating Endovascular bleeding due to trauma
1ml growth factor solution is taken, is mixed with 3ml cosolvent solution, high speed machine stirring and emulsifying 30min is added to and helps
In thruster, the support casing with a thickness of 0.05mm is obtained using electrostatic spinning technique；Developer is dripped to and is covered in idler wheel upper bracket set
Middle position, obtain the strip-like developing pipe positioned at support casing outer surface middle position；Continue electrostatic spinning, obtain with a thickness of
The support casing of 0.10mm.After when performing the operation, support casing is located at sacculus outer wall, is delivered to injury region at DSA, will cover through balloon expandable
Membrane support opening is fixed on injury region hemostasis.
The measurement of support casing property
Appearance: support casing smooth surface.
Growth factor content: about 0.7%
Elongation at break: being 262 ± 28%.
Support casing developability: under X-ray, support casing has good developability, and radiography does not find that support casing shifts,
Have no blutpunkte bleeding.
Embodiment seven: Lanthanum Isopropoxide -6-caprolactone copolyesters support casing
1. preparing growth factor suspension: taking the growth factor of 100mg nanosizing to be placed in 5ml dehydrated alcohol, using super
The method of sound dispersion prepares growth factor suspension；
2. synthesizing flexible degradable macromolecule: using 1,4-butanediol as initiator, stannous octoate is catalyst, 6-caprolactone
With lactide using the ratio ring-opening polymerisation of 70/30 (mol/mol) be 1.2dl/g as intrinsic viscosity Lanthanum Isopropoxide-ε-oneself
Lactone copolyesters；
3. preparing cosolvent solution: weighing the above-mentioned Lanthanum Isopropoxide of 1.0g -6-caprolactone copolyesters, be dissolved in N, N bis-
The blend solution of methylformamide and tetrahydrofuran is made into the cosolvent solution of 50% concentration, wherein n,N dimethylformamide with
The volume ratio of tetrahydrofuran is 1:1；
4. preparing a kind of support casing for treating Endovascular bleeding due to trauma
1ml growth factor solution is taken, is mixed with 3ml cosolvent solution, ultrasonic emulsification 30min is added in boost motor, benefit
The support casing with a thickness of 0.05mm is obtained with electrostatic spinning technique；Developer is dripped to the interposition covered in idler wheel upper bracket set
It sets, obtains the strip-like developing pipe positioned at support casing outer surface middle position.Continue electrostatic spinning, obtains the branch with a thickness of 0.10mm
Frame set, afterwards when operation, support casing is located at sacculus outer wall, is delivered to injury region at DSA, opens overlay film frame through balloon expandable
It is fixed on injury region hemostasis.
The measurement of support casing property
Appearance: support casing smooth surface.
Growth factor content: about 0.7%
Elongation at break: being 413 ± 30%.
Support casing developability: under X-ray, support casing has good developability, and radiography does not find that support casing shifts,
Have no blutpunkte bleeding.
Embodiment eight: the bracket of random DL- lactide-epsilon-coprolactone and the polyamide of isophorone diisocyanate formation
Set
1. preparing growth factor suspension: taking the growth factor of 100mg nanosizing to be placed in 5ml dehydrated alcohol, using super
The method of sound dispersion prepares growth factor suspension；
2. synthesizing flexible degradable macromolecule: using 1,4-butanediol as initiator, stannous octoate is catalyst, 6-caprolactone
The polyamide for being 1.2dl/g as intrinsic viscosity using the ratio ring-opening polymerisation of 80/20 (mol/mol) with lactide；
3. preparing cosolvent solution: weighing the above-mentioned polyamide of 1.0g, be dissolved in n,N dimethylformamide and tetrahydrofuran
Blend solution is made into the cosolvent solution of 50% concentration, and wherein n,N dimethylformamide and the volume ratio of tetrahydrofuran are 1:2；
4. preparing a kind of support casing for treating Endovascular bleeding due to trauma
1ml growth factor solution is taken, is mixed with 3ml cosolvent solution, ultrasonic emulsification 30min is added in boost motor, benefit
The support casing with a thickness of 0.05mm is obtained with electrostatic spinning technique；Developer is dripped to the interposition covered in idler wheel upper bracket set
It sets, obtains the strip-like developing pipe positioned at support casing outer surface middle position；Continue electrostatic spinning, obtains the branch with a thickness of 0.10mm
Frame set.When operation, support casing is located at sacculus outer wall, is delivered to injury region at DSA, opens overlay film frame admittedly through balloon expandable
Stop blooding due to injury region.
The measurement of support casing property
Appearance: support casing smooth surface.
Growth factor content: about 0.7%
Elongation at break: being 503 ± 15%.
Support casing developability: under X-ray, support casing has good developability, and radiography does not find that support casing shifts,
Have no blutpunkte bleeding.
Embodiment nine: the polyamides that trimethylene carbonate -6-caprolactone copolyesters and 1,4- butane diisocyanate are formed
The support casing of amine
1. preparing growth factor suspension: taking the growth factor of 100mg nanosizing to be placed in 5ml dehydrated alcohol, using super
The method of sound dispersion prepares growth factor suspension；
2. synthesizing flexible degradable macromolecule: using 1,4-butanediol as initiator, stannous octoate is catalyst, 6-caprolactone
The polyamide for being 1.2dl/g as intrinsic viscosity using the ratio ring-opening polymerisation of 40/60 (mol/mol) with lactide；
3. preparing cosolvent solution: weighing the above-mentioned polyamide of 1.0g, be dissolved in n,N dimethylformamide and tetrahydrofuran
Blend solution is made into the cosolvent solution of 50% concentration, and wherein n,N dimethylformamide and the volume ratio of tetrahydrofuran are 2:1；
4. preparing a kind of support casing for treating Endovascular bleeding due to trauma
1ml growth factor solution is taken, is mixed with 3ml cosolvent solution, ultrasonic emulsification 30min is added in boost motor, benefit
The support casing with a thickness of 0.05mm is obtained with electrostatic spinning technique；Developer is dripped to the interposition covered in idler wheel upper bracket set
It sets, obtains the strip-like developing pipe positioned at support casing outer surface middle position；Continue electrostatic spinning, obtains the branch with a thickness of 0.10mm
Frame set.When operation, support casing is located at sacculus outer wall, is delivered to injury region at DSA, opens overlay film frame admittedly through balloon expandable
Stop blooding due to injury region.
The measurement of support casing property
Appearance: support casing smooth surface.
Growth factor content: about 0.7%
Elongation at break: being 274 ± 17%.
Support casing developability: under X-ray, support casing has good developability, and radiography does not find that support casing shifts,
Have no blutpunkte bleeding.
Comparative example one: the support casing of polylactide polycaprolactone
1. preparing growth factor solution: taking 100mg growth factor to be dissolved in 5ml water, prepare growth factor solution；
2. flexible degradable macromolecule: using 1,4-butanediol as initiator, stannous octoate is catalyst, 6-caprolactone and third
The copolymer that lactide is 1.2dl/g as intrinsic viscosity using the ratio ring-opening polymerisation of 50/50 (mol/mol)；
3. preparing cosolvent solution: weighing the above-mentioned copolymer of 1.0g, be dissolved in n,N dimethylformamide and tetrahydrofuran
Blend solution is made into the cosolvent solution of 40% concentration, and wherein n,N dimethylformamide and the volume ratio of tetrahydrofuran are 4:1；
4. preparing a kind of support casing for treating Endovascular bleeding due to trauma
1ml growth factor solution is taken, is mixed with 3ml cosolvent solution, ultrasonic emulsification 30min is added in boost motor, benefit
The tubulose overlay film with a thickness of 0.02mm is obtained with electrostatic spinning technique；After stopping electrostatic spinning, developer is dripped into tubulose overlay film
On, form strip-like developing pipe；Then it is further continued for carrying out electrostatic spinning, obtains the tubulose overlay film that final thickness is 0.07mm.When operation, branch
Frame set is located at sacculus outer wall, is delivered to injury region at DSA, and stent open is fixed on injury region hemostasis through balloon expandable.
The measurement of support casing property
Appearance: support casing surface irregularity has the dot of protrusion.
Growth factor content: about 0.3%
Elongation at break: being 160 ± 10%.
Support casing developability: under X-ray, support casing can develop, and radiography does not find that support casing shifts, and has no blutpunkte
Bleeding.
Comparative example two: the support casing of polylactide polycaprolactone
1. preparing growth factor solution: taking 100mg growth factor to be dissolved in 5ml water, prepare growth factor solution；
2. flexible degradable macromolecule: using 1,4-butanediol as initiator, stannous octoate is catalyst, 6-caprolactone and third
The copolymer that lactide is 1.7dl/g as intrinsic viscosity using the ratio ring-opening polymerisation of 50/50 (mol/mol)；
3. preparing cosolvent solution: weighing the above-mentioned copolymer of 1.0g, be dissolved in n,N dimethylformamide and tetrahydrofuran
Blend solution is made into the cosolvent solution of 40% concentration, and wherein n,N dimethylformamide and the volume ratio of tetrahydrofuran are 1:1；
4. preparing a kind of support casing for treating Endovascular bleeding due to trauma
1ml growth factor solution is taken, is mixed with 3ml cosolvent solution, ultrasonic emulsification 30min is added in boost motor, benefit
The tubulose overlay film with a thickness of 0.02mm is obtained with electrostatic spinning technique；After stopping electrostatic spinning, developer is dripped into tubulose overlay film
On, form strip-like developing pipe；Then it is further continued for carrying out electrostatic spinning, obtains the tubulose overlay film that final thickness is 0.07mm.When operation, branch
Frame set is located at sacculus outer wall, is delivered to injury region at DSA, and stent open is fixed on injury region hemostasis through balloon expandable.
The measurement of support casing property
Appearance: support casing surface irregularity, have protrusion dot (this is because copolymer intrinsic viscosity is big, molecular weight is high,
Dot is easy when electrostatic spinning).
Growth factor content: about 0.3%
Elongation at break: being 170 ± 23%.
Support casing developability: under X-ray, support casing can develop, and radiography does not find that support casing shifts, and has no blutpunkte
Bleeding.
The above is only a preferred embodiment of the present invention, it is noted that for the common skill of the art
For art personnel, various improvements and modifications may be made without departing from the principle of the present invention, these improvements and modifications
Also the contents of the present invention be should be regarded as.
Claims (10)
1. a kind of support casing for treating Endovascular bleeding due to trauma, which is characterized in that including being coated on rack body outer surface
Bracket overlay film and the strip-like developing pipe in bracket overlay film；At least two layers of the bracket overlay film, and one layer is located at rack body appearance
Face, one layer is located on the outside of strip-like developing pipe.
2. support casing according to claim 1, which is characterized in that the strip-like developing pipe is located in bracket overlay film along support casing length
The middle position in direction.
3. support casing according to claim 1 or claim 2, which is characterized in that the bracket overlay film is along the two of support casing length direction
End is equipped with chamfering, it is preferred that the angle of the chamfering is 5 ° -10 °.
4. -3 any support casing according to claim 1, which is characterized in that the bracket overlay film can be dropped by drug, flexibility
Solution copolymer is prepared under the action of cosolvent by electrostatic spinning；
Preferably, the cosolvent is n,N dimethylformamide, the tetrahydrofuran mixed solution that 3:1-1:3 is formed by volume.
5. support casing according to claim 4, which is characterized in that the flexibility biodegradable block copolymer is to be with 1,4-butanediol
Initiator, 6-caprolactone and lactide are mixed with the molar ratio of (40:60)-(80:20), and stannous octoate is catalyst, by true
Empty ring-opening polymerization obtains intrinsic viscosity and further gathers under the action of coupling agent for the polyester or polyester of 1.0-1.5dl/g
Polyamide made of conjunction；
Preferably, the polyester can be l-poly-Lactide, racemization polylactide, polyglycolic acid, poly-epsilon-caprolactone, poly- three
One of degradable high polymer materials such as the derivative carbonic ester of carbonate, polydioxanone, polyaminoacid are appointed
What two kinds and two or more blend or copolymer；Polyester is also possible to random DL- lactide-epsilon-coprolactone copolyesters, three
One or more of carbonate -6-caprolactone copolyesters, Lanthanum Isopropoxide -6-caprolactone copolyesters；It is described poly-
Amide is to be polymerize to obtain under the action of coupling agent by the polyester, and coupling agent is preferably diisocyanate compound, more excellent
Select one or more of 1,4- butane diisocyanate, 1,6- hexamethylene diisocyanate, isophorone diisocyanate.
6. a kind of method for preparing any support casing of claim 1-5, preparation, flexibility including drug solution are degradable total
The synthesis of polymers, the preparation of cosolvent solution, the processing of support casing, bracket overlay film cladding；
Preferably, the preparation of the cosolvent solution specifically: gather obtained in the synthesis for taking the flexible biodegradable block copolymer
Ester or polyamide are dissolved in N, are made into copolymer quality percent by volume in the mixed solution of N-dimethylformamide and tetrahydrofuran
(g/ml) the cosolvent solution for being 40%-60%, wherein n,N dimethylformamide and the volume ratio of tetrahydrofuran are (1-3):
(1-3)。
7. method according to claim 6, which is characterized in that it is described flexibility biodegradable block copolymer be polyester or polyamide,
Synthesis specifically: using 1,4-butanediol as initiator, 6-caprolactone and lactide are mixed with the molar ratio of (40:60)-(80:20)
It closing, stannous octoate is catalyst, by vacuum ring-opening polymerization, the polyester that intrinsic viscosity is 1.0-1.5dl/g is obtained,
The polyester can further polymerize to obtain the polyamide under the action of coupling agent；Preferably, coupling agent can be two isocyanides
Acid esters compound, more preferable Isosorbide-5-Nitrae-butane diisocyanate, 1,6- hexamethylene diisocyanate, isophorone diisocyanate
One or more of ester.
8. according to claim 6 or 7 the method, which is characterized in that the cladding of the bracket overlay film specifically: take the drug
Drug solution obtained in the preparation of solution, and flexible degradable macromolecule, are dissolved in the preparation of the cosolvent solution and obtaining
Cosolvent solution in, Ultrasonic Pulverization emulsify 2-10min, obtain the overlay film of first thickness using electrostatic spinning；Again by developer
It drips on overlay film, is further continued for carrying out electrostatic spinning, obtain the bracket overlay film that second thickness has strip-like developing pipe, second thickness >=the first
Twice (first thickness × 2) of thickness；
Preferably, first thickness 0.02-0.05mm；Or
Preferably, cosolvent is n,N dimethylformamide, the tetrahydrofuran mixed solution that 3:1-1:3 is formed by volume；Or
Preferably, the drug is growth factor, be the concentration of growth factor in drug solution is 1-40mg/ml.
9. method according to claim 8, which is characterized in that the concentration of flexible degradable macromolecule in the cosolvent solution
For 0.05-0.6g/ml, the voltage of electrostatic spinning is 6-14KV.
10. a kind of bracket for treating Endovascular bleeding due to trauma, including rack body and the power for being coated on rack body outer surface
Benefit requires any support casing of 1-6；
Preferably, the internal diameter of the rack body is 0.02-10mm, outer diameter 0.12mm-12mm；Or
It is furthermore preferred that the rack body is V-shaped network, network along its length by the big V section bracket of circle with
The one small V sections of bracket of circle is alternatively formed, and is connected between big V sections of bracket and small V sections of bracket by connecting rod.
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