CN106618821B - A kind of intravascular stent for preventing reangiostenosis and preparation method thereof - Google Patents
A kind of intravascular stent for preventing reangiostenosis and preparation method thereof Download PDFInfo
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- CN106618821B CN106618821B CN201710024061.5A CN201710024061A CN106618821B CN 106618821 B CN106618821 B CN 106618821B CN 201710024061 A CN201710024061 A CN 201710024061A CN 106618821 B CN106618821 B CN 106618821B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
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- 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
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
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Abstract
It is specifically a kind of to prevent intravascular stent of reangiostenosis and preparation method thereof the present invention relates to a kind of medical supplies.A kind of intravascular stent for preventing reangiostenosis, including support unit and connection unit, adjacent support unit are connected by connection unit；Support unit is respectively defined as big support unit, middle support unit and small support unit according to the difference of area coverage size, the both sides of big support unit are middle support unit in a lateral direction, the both sides of middle support unit are respectively big support unit and small support unit, and the both sides of small support unit are middle support unit；PLA Biodegradable films are coated in rack surface, PLA Biodegradable films include two layers, set radioactive element between two layers of PLA Biodegradable films, radioactive element is evenly distributed in dexamethasone gel；PLA Biodegradable films surface infiltrates medicine.The intravascular stent is rational in infrastructure, and support effect is good, and can effectively prevent reangiostenosis.
Description
Technical field
The present invention relates to a kind of medical supplies, specifically a kind of intravascular stent that can prevent reangiostenosis and its preparation side
Method.
Background technology
Dotter and Judkings in 1964 proposes the concept of percutaneous transluminal angio plasty, and assumes to use silicon rubber
Or plastics carry out support blood vessels, to keep Endovascular blood flow unobstructed.Siwart in 1987 etc. first uses intravascular metallic support
In coronary artery, good approach is provided for treatment blood vessel blockage disease.Preferable intravascular stent should possess following
Feature：(1) preferable biocompatibility：Minimum blood coagulation enhancing effect, is not susceptible to Coagulation test and thrombus after implantation, is not easy to draw
Play inflammatory reaction and the endometrial hyperplasia of vascular wall；(2) easy polarization；(3) there is good pliability, easily shift diseased region onto；
(4) easily expansion, support force is strong and has mechanical robustness.
The important means that support has become angiocardiopathy is placed in the blood vessels, but after support placement in the treatment usually
Asking for reangiostenosis be present, in support places case, there are about the problem of ISR occurs for 15-30%, seriously limit and control
The long-term effect for the treatment of, it is still problem urgently to be resolved hurrily so far.In recent years, the appearance of bracket for eluting medicament turns into a kind of support
The focus of research, with the application of bracket for eluting medicament, greatly reduce the generation of in-stent restenosis.
But existing support, in drug loading mode, one kind is that medicine is blended in various gels, coated in branch
Frame surface, this application pattern, which exists, applies unsteady shortcoming；Therefore, many supports are made that improvement, such as in support table
Face processes some micropores, and medicine is filled in micropore, but uniformly processes micropore in rack surface, and difficulty of processing is big；It is attached to carry medicine
It is poor effect.
The content of the invention
Problem to be solved by this invention is overcome the deficiencies in the prior art, there is provided a kind of rational in infrastructure, support effect is good
It is good, and can effectively prevent the intravascular stent of reangiostenosis.
To solve the above problems, the technical solution adopted by the present invention is：A kind of intravascular stent for preventing reangiostenosis, institute
It is tubular structure to state support, including support unit and connection unit, and the support unit is the net ring of elliptical shape, adjacent branch
Connected between support unit by connection unit；The support unit it is of different sizes, according to area coverage size difference respectively
Big support unit, middle support unit and small support unit are defined as, the both sides of upper big support unit are middle branch in transverse direction
Unit is supportted, the both sides of middle support unit are respectively big support unit and small support unit, and the both sides of small support unit are middle branch
Unit is supportted, the quantity of big support unit, middle support unit and small support unit is respectively 3 rows, 6 rows and 3 rows in a lateral direction；
PLA Biodegradable films are coated in rack surface, the PLA Biodegradable films include two layers, are set between two layers of PLA Biodegradable films
Radioactive element is put, the radioactive element is evenly distributed in dexamethasone gel；The PLA Biodegradable films surface infiltration
Prevent the medicine of reangiostenosis.
Preferably, the length ratio of the short axle of the big support unit, middle support unit and small support unit is 4: 3: 2,
The quantity ratio of big support unit, middle support unit and small support unit is 3: 4: 6 on support.
Preferably, connection unit in the axial direction is linear pattern.
Preferably, connection unit in the horizontal is " S " type.
Preferably, the medicine for preventing reangiostenosis of the PLA Biodegradable films surface infiltration includes rapamycin, purple
China fir alcohol.
Preferably, the radioactive element is32P。
Preferably, the support is made of magnesium metal alloy.
A kind of preparation method for the intravascular stent for preventing reangiostenosis, comprises the following steps：
(1) prepare the support of magnesium metal alloy first, by magnesium metal alloy pipe by laser engraving into setting shape；
(2) by the infiltration of PLA degradable biologicals film in the medicine of reangiostenosis is prevented；
(3) it is uniform in first layer PLA Biodegradable films one layer of dexamethasone gel of outer application, dexamethasone gel
Radioactive element is mixed, coats one layer of PLA Biodegradable films again in the outside of dexamethasone gel；
(4) the PLA degradable biological films handled well are coated on rack surface, slowly drying, removed on rack surface
Moisture.
Preferably, the time that described PLA Biodegradable films infiltrate in medicine is 1 hour to 3 hours.
The present invention is relative to the beneficial effect of prior art：
1st, support unit is divided into large, medium and small three kinds, and supported during big support unit both sides are in cross direction profiles single
Member, the both sides of middle support unit are respectively big support unit and small support unit, and the both sides of small support unit are that middle support is single
Member, the quantity of big support unit, middle support unit and small support unit is respectively 3 rows, 6 rows and 3 rows in a lateral direction；Ramuscule
The radial support power of support unit is bigger, and the radial support power of big support unit is minimum, and the different support unit of large, medium and small model makes
Support has higher elasticity, moderate radial support power；Small support unit forms three branch of support on the section of transverse direction
Support point, three triangle summits of these three strong points, and triangle is most firm shape, it is possible to increase support it is steady
Solidity, it can preferably resist the elastical retraction effect of blood vessel.
2nd, PLA Biodegradable films are coated in rack surface, the PLA Biodegradable films include two layers, two layers of PLA biology drop
Radioactive element is set between solution film.PLA (Polylactic Acid) PLA is reproducible plant resources (such as corn) institute
The starch material of proposition is made, can be degradable by microorganism after use, ultimately generates carbon dioxide and water, is body metabolism
Product, it will not remain in vivo.PLA Biodegradable films surface infiltrates the medicine for preventing reangiostenosis, can delay in human body
Slow release, endangium hyperplasia can be suppressed, prevent from doing the situation of the angiogenesis ISR of support.
3rd, also there is radioactive element among two layers of PLA Biodegradable films, and the effect of radioactive element is mainly profit
With the effects of ionizing radiation of radioactive ray, suppress the smooth muscle cell proliferation after injury of blood vessel and migration, so as to substantially reduce blood vessel
The incidence of ISR.And traditional radiant stand is that radioactive element is directly placed on support, and support is hollow out
, it is uneven that this results in radioactive element, and then problem just be present when acting on blood vessel.And PLA Biodegradable films are complete
It is coated on support, uniformly and effectively acts on damaged blood vessels.
4th, between radioactive element is fixed on two layers of PLA Biodegradable films by dexamethasone gel, dexamethasone is one
Kind antiphlogistic, using the form of gel, while immobilization of radioactive element, moreover it is possible to play a part of anti-inflammatory.
5th, the length ratio of the short axle of big support unit, middle support unit and small support unit is 4: 3: 2, is propped up greatly on support
The quantity ratio for supportting unit, middle support unit and small support unit is 3: 4: 6.So often go big support unit, middle support unit and
The distance of small support unit composition is equal.
6th, connection unit in the axial direction is linear pattern, and connection unit in the horizontal is " S " type.Comparatively speaking, " S "
The support unit spreading performance of shape is better, needs to coordinate expanded balloon to use the dilatational elasticity, it is necessary to larger in the horizontal,
Therefore the connection unit of serpentine is set in the horizontal.And in the axial direction and need not be too big extensibility, simply need preferably to connect
Connecing property.
7th, support is made of magnesium metal alloy, and magnesium alloy is a kind of biodegradable metal material, most early in previous generation
The 30's of recording begin to be used for bone tissue reparation and plastic surgery, but because the degradation rate of pure magnesium is too fast, it is big so as to produce
The hydrogen of amount, limit its application.But as the development of alloy technology, more alloying elements are found and applied, so as to
Make degradable magnesium alloy and re-recognized by people.Research surface magnesium alloy has good biocompatibility and excellent
Mechanical performance, the addition of some other metallic elements and rare earth element so that its physical and chemical performance and biological property obtain
Improve, especially solve the shortcomings that magnesium alloy degradation in vivo is too fast.
The present invention prevents the mechanism of reangiostenosis to be：(1) infiltration of PLA Biodegradable films is in medicine, as rapamycin,
In taxol etc., the slow release actions of PLA are in blood vessel.Rapamycin is by suppressing vascular smooth muscle cell curing, suppressing thin
Born of the same parents' size, the synthesis for influenceing extracellular matrix, suppress the effect such as intravascular inflammation after damaging and effectively suppress in-stent restenosis.And
Taxol has very high lipophilicity, so as to promote quick cellular uptake, and because the change of cytoskeletal structure is smooth
Effect lasting for a long time is played in myocyte.In 1.0-10.0mmol/L dosage range, taxol can cause almost complete
Growth inhibition.By the synergy of rapamycin and taxol, can suppress caused by the iatrogenic injury of blood vessel
Many vaso-active substances, promote the problems such as thrombosis and factor,mitogenic release, and then prevent reangiostenosis
Effect.(2) as the progressively degraded of superficial layer PLA Biodegradable films, middle radiation line element and dexamethasone gel are opened
Beginning plays a role, radioactive element32P, pass through32The closely radiation of P radiographic sources can prevent hyperplasia, cause cell to wither
Die and suppress cell migration so as to reduce newborn endothelium accumulation, while reacted by reducing later stage fibrosis reparation, suppress reconstruct
It is caused narrow.Dexamethasone has the function that anti-inflammatory simultaneously, can carry out anti-inflammatory to impaired blood vessel.(3) centre is worked as
Radioactive element and dexamethasone gel effect after the completion of, the medicine on the PLA Biodegradable films of the second layer start play make
With.Thus by the effect of three layers of material stage by stage, the action time for suppressing reangiostenosis medicine is extended, it is specific to suppress
Medicine includes the cytostatic medicines such as rapamycin, taxol, in addition to dexamethasone gel anti-inflammation drugs, in addition to
Radioactive element, various ways act on step by step, and enhancing prevents the effect of hemadostewnosis.
The preparation process of intravascular stent：Magnesium metal alloy pipe is engraved as following shape first with laser-engraving technique：
The net ring support unit of elliptical shape, connected by connection unit between adjacent support unit；And big branch in a lateral direction
Support unit both sides are middle support unit, and the both sides of middle support unit are respectively big support unit and small support unit, small support
The both sides of unit are the quantity of middle support unit, in a lateral direction big support unit, middle support unit and small support unit
Respectively 3 rows, 6 rows and 3 rows.The big ting model of support unit is different on support, and elasticity is moderate, and radial support power is due to three rows
The presence of small support unit is improved significantly.
To PLA degradable biologicals film infiltration medicine specific processing mode be：The infiltration of PLA degradable biologicals film is being prevented
In the medicine of reangiostenosis, rapamycin and taxol are individually positioned in container, PLA degradable biologicals film is first placed
The infiltration 1-3 hours in rapamycin solution, slowly drying after infiltration terminates, then the surface after drying is carried into rapamycin
PLA Biodegradable films are placed on infiltration 1-3 hours in the solution of taxol, slowly drying again after infiltration terminates.
Then between some radioactive elements being added into dexamethasone gel, it is slowly stirred, until radioactive element is equal
It is even to be distributed among dexamethasone gel.
The PLA degradable biological films by one layer of drying are coated on rack surface again, in first layer PLA degradable biological films
Coating contains radioactive element on surface32P dexamethasone gel, coating one layer of PLA again in dexamethasone gel outer layer can drop
Solve biomembrane.By the double-deck PLA degradable biologicals film integral coating handled well on intravascular stent, to increase the degradable lifes of PLA
The adhesion of thing film and intravascular stent, some medical bonding agents can be applied to carry out PLA degradable biologicals film and intravascular stent
Bonding.
Finally after completing to bind, support is slowly dried, moisture removal is removed, is vacuum-packed.
Brief description of the drawings
Fig. 1 is the structural representation of support unit of the present invention and connection unit；
Fig. 2 is the mplifying structure schematic diagram of part-structure in Fig. 1；
The structural representation that Fig. 3 present invention transversely splits.
Marked in figure：
1st, support unit；2nd, connection unit；11st, big support unit；12nd, middle support unit；13rd, small support unit； 3、
PLA Biodegradable films；4th, dexamethasone gel.
Embodiment
The present invention is described further below in conjunction with the accompanying drawings：
A kind of intravascular stent for preventing reangiostenosis, the support is tubular structure, including support unit 1 and connection are singly
Member 2, the support unit 1 are the net ring of elliptical shape, are connected between adjacent support unit 1 by connection unit 2；The branch
The of different sizes of unit 1 is supportted, big support unit 11, the and of middle support unit 12 are respectively defined as according to the difference of area coverage size
Small support unit 13, the upper big both sides of support unit 11 are middle support unit 12 in transverse direction, the both sides of middle support unit 12
Respectively big support unit 11 and small support unit 13, the both sides of small support unit 13 are middle support unit 12, in horizontal side
The quantity of big support unit 11, middle support unit 12 and small support unit 13 is respectively 3 rows, 6 rows and 3 rows upwards；In support table
Bread covers PLA Biodegradable films 3, and the PLA Biodegradable films 3 include two layers, set and put between two layers of PLA Biodegradable films 3
Penetrating property element, the radioactive element are evenly distributed in dexamethasone gel 4；The surface of PLA Biodegradable films 3 infiltration
Prevent the medicine of reangiostenosis.
The length ratio of the short axle of big support unit 11, middle support unit 12 and small support unit 13 is 4: 3: 2, on support
The quantity ratio of big support unit 11, middle support unit 12 and small support unit 13 is 3: 4: 6.Connection unit 2 in the axial direction is
Linear pattern, connection unit 2 in the horizontal are " S " type, the medicine for preventing reangiostenosis of the surface of PLA Biodegradable films 3 infiltration
Thing includes rapamycin, taxol, and radioactive element is32P, support are made of magnesium metal alloy.
A kind of preparation method for the intravascular stent for preventing reangiostenosis, comprises the following steps：
(1) prepare the support of magnesium metal alloy first, by magnesium metal alloy pipe by laser engraving into setting shape；
(2) by the infiltration of PLA degradable biologicals film in the medicine of reangiostenosis is prevented；
(3) one layer of PLA Biodegradable films are coated on the outside of metallic support, applied on the outside of first layer PLA Biodegradable films
One layer of dexamethasone gel 4 is covered, radioactive element is uniformly mixed in dexamethasone gel 4, in the outer of dexamethasone gel 4
Side coats one layer of PLA Biodegradable films again；
(4) support is slowly dried, removes the moisture on rack surface.
The time that PLA Biodegradable films infiltrate in medicine is 1 hour to 3 hours.
The present invention is relative to the beneficial effect of prior art：
1st, support unit 1 is divided for large, medium and small three kinds, and the big both sides of support unit 11 support in being in cross direction profiles
Unit 12, the both sides of middle support unit 12 are respectively big support unit 11 and small support unit 13, the both sides of small support unit 13
It is middle support unit 12, the quantity of big support unit 11, middle support unit 12 and small support unit 13 is divided in a lateral direction
Wei not 3 rows, 6 rows and 3 rows.The radial support power of small support unit 13 is bigger, and the radial support power of big support unit 11 is minimum, greatly
The different support unit 1 of medium and small model makes support have higher elasticity, moderate radial support power；Big support unit 11, in
Support unit 12 and small support unit 13 are three, and three small support unit 13 forms three strong points of support, these three
Three triangle summits of the strong point, and triangle is most firm shape, it is possible to increase the steadiness of support, Ke Yigeng
The elastical retraction effect of good resistance blood vessel.
2nd, in rack surface cladding PLA Biodegradable films 3, the PLA Biodegradable films 3 include two layers, two layers of PLA biology
Radioactive element is set between degradative membrane 3.PLA (Polylactic Acid) PLA is reproducible plant resources (such as jade
Rice) starch material that is proposed is made, can be degradable by microorganism after use, carbon dioxide and water are ultimately generated, is people
Body metabolite, it will not remain in vivo.The surface of PLA Biodegradable films 3 infiltrates the medicine for preventing reangiostenosis, can be in people
Slow Slow release in vivo, can suppress endangium hyperplasia, prevent from doing the situation of the angiogenesis ISR of support.
3rd, also there is radioactive element among two layers of PLA Biodegradable films 3, and the effect of radioactive element is mainly profit
With the effects of ionizing radiation of radioactive ray, suppress the smooth muscle cell proliferation after injury of blood vessel and migration, so as to substantially reduce blood vessel
The incidence of ISR.And traditional radiant stand is that radioactive element is directly placed on support, and support is hollow out
, it is uneven that this results in radioactive element, and then problem just be present when acting on blood vessel.And PLA Biodegradable films 3 are complete
It is coated on support, uniformly and effectively acts on damaged blood vessels.
4th, between radioactive element is fixed on two layers of PLA Biodegradable films by dexamethasone gel 4, dexamethasone is one
Kind antiphlogistic, using the form of gel, while immobilization of radioactive element, moreover it is possible to play a part of anti-inflammatory.
5th, the length ratio of the short axle of big support unit 11, middle support unit 12 and small support unit 13 is 4: 3: 2, in support
The quantity ratio of upper big support unit 11, middle support unit 12 and small support unit 13 is 3: 4: 6.So often go big support unit
11st, the distance of middle support unit 12 and small support unit 13 composition is equal.
6th, connection unit 2 in the axial direction is linear pattern, and connection unit 2 in the horizontal is for " S " type.Compare and
Speech, the connection unit 2 of serpentine are needed to coordinate expanded balloon to use in the horizontal, needed better for " S " type spreading performance
Larger dilatational elasticity is wanted, therefore the connection unit 2 of serpentine is set in the horizontal.And in the axial direction and need not be too big extension
Property, simply need preferable connectivity.
7th, support is made of magnesium metal alloy, and magnesium alloy is a kind of biodegradable metal material, most early in previous generation
The 30's of recording begin to be used for bone tissue reparation and plastic surgery, but because the degradation rate of pure magnesium is too fast, it is big so as to produce
The hydrogen of amount, limit its application.But as the development of alloy technology, more alloying elements are found and applied, so as to
Make degradable magnesium alloy and re-recognized by people.Research surface magnesium alloy has good biocompatibility and excellent
Mechanical performance, the addition of some other metallic elements and rare earth element so that its physical and chemical performance and biological property obtain
Improve, especially solve the shortcomings that magnesium alloy degradation in vivo is too fast.
The present invention prevents the mechanism of reangiostenosis to be：(1) PLA Biodegradable films 3 are infiltrated in medicine, and thunderous pa is mould
In element, taxol etc., the slow release actions of PLA are in blood vessel.Rapamycin is by suppressing vascular smooth muscle cell curing, suppressing
Cell size, the synthesis for influenceing extracellular matrix, suppress the effect such as intravascular inflammation after damaging and effectively suppress in-stent restenosis.
And taxol has very high lipophilicity, so as to promote quick cellular uptake, and because the change of cytoskeletal structure is flat
Effect lasting for a long time is played in sliding myocyte.In 1.0-10.0mmol/L dosage range, taxol can cause almost complete
Full growth inhibition.By the synergy of rapamycin and taxol, can suppress because the iatrogenic injury of blood vessel causes
Many vaso-active substances, promote the problems such as thrombosis and factor,mitogenic discharge, and then anti-hemostatic tube is narrow again
Narrow effect.(2) with the progressively degraded of superficial layer PLA Biodegradable films, middle radiation line element and dexamethasone gel
4 start to play a role, radioactive element32P, pass through32The closely radiation of P radiographic sources can prevent hyperplasia, cause cell
Apoptosis simultaneously suppresses cell migration so as to reduce newborn endothelium accumulation, while is reacted by reducing later stage fibrosis reparation, suppresses weight
It is narrow caused by structure.Dexamethasone has the function that anti-inflammatory simultaneously, can carry out anti-inflammatory to impaired blood vessel.(3) among
Between radioactive element and dexamethasone gel 4 act on after the completion of, the medicine on the PLA Biodegradable films of the second layer starts to play
Effect.Thus by the effect of three layers of material stage by stage, the action time for suppressing reangiostenosis medicine, specific suppression are extended
Pharmacy thing includes the cytostatic medicines such as rapamycin, taxol, in addition to the anti-inflammation drugs of dexamethasone gel 4, also
Including radioactive element, various ways act on step by step, and enhancing prevents the effect of hemadostewnosis.
The preparation process of intravascular stent：Magnesium metal alloy pipe is engraved as following shape first with laser-engraving technique：
The net ring support unit of elliptical shape, connected by connection unit 2 between adjacent support unit 1, adjacent support unit 1 is logical
Connection unit 2 is crossed to connect；And the big both sides of support unit 11 are middle support unit 12 in a lateral direction, middle support unit 12
Both sides are respectively big support unit 11 and small support unit 13, and the both sides of small support unit 13 are middle support unit 12, in horizontal stroke
The quantity of big support unit 11, middle support unit 12 and small support unit 13 is respectively 3 rows, 6 rows and 3 rows on to direction.Propping up
Connection unit 2 is different for the big ting model of " S " type on frame, and elasticity is moderate, and radial support power is due to the small support unit 13 of three rows
In the presence of being improved significantly.
To PLA degradable biologicals film infiltration medicine specific processing mode be：The infiltration of PLA degradable biologicals film is being prevented
In the medicine of reangiostenosis, rapamycin and taxol are individually positioned in container, PLA degradable biologicals film is first placed
The infiltration 1-3 hours in rapamycin solution, slowly drying after infiltration terminates, then the surface after drying is carried into rapamycin
PLA Biodegradable films 3 are placed on infiltration 1-3 hours in the solution of taxol, slowly drying again after infiltration terminates.
Then between some radioactive elements being added into dexamethasone gel 4, it is slowly stirred, until radioactive element is equal
It is even to be distributed among dexamethasone gel 4.
The PLA degradable biological films by one layer of drying are coated on rack surface again, in first layer PLA degradable biological films
Coating contains radioactive element on surface32P dexamethasone gel 4, coating one layer of PLA again in the outer layer of dexamethasone gel 4 can
Degradation biological film.It is degradable for increase PLA by the double-deck PLA degradable biologicals film integral coating handled well on intravascular stent
The adhesion of biomembrane and intravascular stent, PLA degradable biologicals film and intravascular stent can be entered using some medical bonding agents
Row bonding.
Finally after completing to bind, support is slowly dried, moisture removal is removed, is vacuum-packed.
In the present invention, so-called axial direction refers to the length direction of support, and laterally refers to the width of support.At this
The vpg connection of intravascular stent, support is splitted to both sides vertically, the connection unit 2 that the shape spread out includes a line a line exists
For " S " type and adjacent connection unit 2 is connected in the connection unit 2 for " S " type, and it is big support unit 11, middle branch that it, which puts in order,
Support unit 12, small support unit 13, middle support unit 12, big support unit 11, middle support unit 12, small support unit 13, in
Support unit 12, big support unit 11, middle support unit 12, small support unit 13 and middle support unit 12.According to this order
The intravascular stent of composition, sees in the horizontal, and distance is equal between the small support unit 13 of three rows, and the radial direction branch of small support unit 13
It is big that support force is compared to middle support unit 12 and big support unit 11, therefore the small support unit 13 of three rows is in fact equivalent to constituting
Three summits of triangle, and triangle is most firm shape, can effectively improve the radial support power of intravascular stent.And adopt
The connection unit 2 not waited with big ting model can effectively improve blood vessel for " S " type rather than all using small support unit 13
Compliance, acted on if enough radial supports all can not be played again using big support unit 11.
When preparing intravascular stent, magnesium metal alloy compositions are selected first, the wherein content of magnesium metal can account for leading, its
Remaining material includes metal and rare earth element, and other metals can be zinc, calcium, zirconium, and rare earth metal can be neodymium and niobium.By support
After predetermined shape is laser-cut into, follow-up sanding and polishing processing is carried out.Then PLA Biodegradable films are coated on support
Surface, the specific processing mode that medicine is infiltrated to PLA degradable biologicals film are：PLA degradable biologicals film is first placed on thunder pa
Infiltrated 3 hours in mycin solution, slowly drying after infiltration terminates, then the surface after drying is carried to the PLA biologies of rapamycin
Degradative membrane 3, which is placed in the solution of taxol, to be infiltrated 3 hours, slowly drying again after infiltration terminates.Then by some radioactivity member
Element is added between dexamethasone gel 4, is slowly stirred, until radioactive element is evenly distributed among dexamethasone gel 4.
The PLA degradable biological films by one layer of drying are coated on rack surface again, are applied on the surface of first layer PLA degradable biological films
Cover containing radioactive element32P dexamethasone gel 4, one layer of PLA degradable biological is coated again in the outer layer of dexamethasone gel 4
Film.By the double-deck PLA degradable biologicals film integral coating handled well on intravascular stent, for increase PLA degradable biologicals film and
The adhesion of intravascular stent, PLA degradable biologicals film and intravascular stent can be binded using some medical bonding agents.Most
Afterwards after completing to bind, support is slowly dried, moisture removal is removed, is vacuum-packed.
The scope of intravascular stent tensile strength made from this mode is 200-300MPa, modulus of elasticity 20-50GPa；
Elongation at break is 3-10%, meets the requirement of intravascular stent；The intravascular stent surface PLA degradative membranes time that all hydrolysis is completed
At -240 days 180 days, all the hydrolysis deadline was -360 days 300 days to intravascular stent, and the metal ion for generation of degrading removes few portion
Divide outside being immediately used by the body, it is most of to be excreted by renal tubule filtering.
The above described is only a preferred embodiment of the present invention, it is not the limitation for making other forms to the present invention.Appoint
What those skilled in the art changed or be modified as possibly also with the technology contents of the disclosure above equivalent variations etc.
Imitate embodiment.But it is every without departing from technical solution of the present invention content, the construction and operation principle according to the present invention are real to more than
Any simple modification, equivalent variations and remodeling that example is made are applied, still falls within the protection domain of technical solution of the present invention.
Claims (9)
1. a kind of intravascular stent for preventing reangiostenosis, the support is tubular structure, including support unit and connection unit,
The support unit is the net ring of elliptical shape, is connected between adjacent support unit by connection unit；It is characterized in that：Institute
State the of different sizes of support unit, according to the difference of area coverage size be respectively defined as big support unit, middle support unit and
Small support unit, the both sides of big support unit are middle support unit in a lateral direction, and the both sides of middle support unit are respectively
Big support unit and small support unit, the both sides of small support unit are middle support unit, in a lateral direction big support unit,
The quantity of middle support unit and small support unit is respectively 3 rows, 6 rows and 3 rows；PLA Biodegradable films, institute are coated in rack surface
Stating PLA Biodegradable films includes two layers, sets radioactive element between two layers of PLA Biodegradable films, and the radioactive element is equal
It is even to be distributed in dexamethasone gel；The PLA Biodegradable films surface infiltration prevents the medicine of reangiostenosis.
A kind of 2. intravascular stent for preventing reangiostenosis according to claim 1, it is characterised in that：The big support is single
The length ratio of the short axle of first, middle support unit and small support unit is 4: 3: 2, big support unit, middle support unit on support
Quantity ratio with small support unit is 3: 4: 6.
A kind of 3. intravascular stent for preventing reangiostenosis according to claim 2, it is characterised in that：Company in the axial direction
Order member is linear pattern.
A kind of 4. intravascular stent for preventing reangiostenosis according to claim 2, it is characterised in that：Company in the horizontal
Order member is " S " type.
A kind of 5. intravascular stent for preventing reangiostenosis according to claim 1, it is characterised in that：The PLA biologies
The medicine for preventing reangiostenosis of degradative membrane surface infiltration includes rapamycin, taxol.
A kind of 6. intravascular stent for preventing reangiostenosis according to claim 1, it is characterised in that：The radioactivity member
Element is32P。
A kind of 7. intravascular stent for preventing reangiostenosis according to claim 1, it is characterised in that：The support uses
Magnesium metal alloy is made.
A kind of 8. preparation method of intravascular stent for preventing reangiostenosis according to claim 1, it is characterised in that bag
Include following steps：
(1) prepare the support of magnesium metal alloy first, by magnesium metal alloy pipe by laser engraving into setting shape；
(2) by the infiltration of PLA degradable biologicals film in the medicine of reangiostenosis is prevented；
(3) uniformly mixed in first layer PLA Biodegradable films one layer of dexamethasone gel of outer application, dexamethasone gel
Radioactive element, coats one layer of PLA Biodegradable films again in the outside of dexamethasone gel；
(4) the PLA degradable biological films handled well are coated on rack surface, slowly drying, remove the moisture on rack surface.
A kind of 9. preparation method of intravascular stent for preventing reangiostenosis according to claim 8, it is characterised in that：Institute
The time that the PLA Biodegradable films stated infiltrate in medicine is 1 hour to 3 hours.
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| CN111067679A (en) * | 2020-03-02 | 2020-04-28 | 南京浩衍鼎业科技技术有限公司 | Intracranial degradable polyester stent with high support strength |
| CN113274175B (en) * | 2021-05-26 | 2022-07-19 | 河南科技大学第一附属医院 | Displacement-preventing heart stent capable of being unfolded in corrugated manner |
| CN115590654B (en) * | 2022-11-29 | 2023-03-14 | 季华实验室 | Degradable implant for preventing intrauterine adhesion and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| DE19633901A1 (en) * | 1996-08-22 | 1998-02-26 | Thomas Prof Dr Med Ischinger | Vascular support in the form of a tube section-like support structure |
| CN2517403Y (en) * | 2001-07-27 | 2002-10-23 | 微创医疗器械(上海)有限公司 | Coronary artery stand with non-homogeneous waveform structure |
| US20050107870A1 (en) * | 2003-04-08 | 2005-05-19 | Xingwu Wang | Medical device with multiple coating layers |
| CN1977778B (en) * | 2005-12-08 | 2011-01-12 | 上海康德莱企业发展集团有限公司 | Vascular stent |
| CN101642397B (en) * | 2009-08-20 | 2011-06-22 | 华南理工大学 | Netty circular tube type intravascular stent |
| CN102525697A (en) * | 2011-12-22 | 2012-07-04 | 上海纳米技术及应用国家工程研究中心有限公司 | Medicine-carrying membrane-covered stent and preparation method thereof |
| CN203089467U (en) * | 2013-02-18 | 2013-07-31 | 南阳医学高等专科学校第一附属医院 | Novel vascular scaffold |
| CN205144804U (en) * | 2015-11-26 | 2016-04-13 | 王传金 | Esophagus support with radiotherapy effect |
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