CN101214397A - Medicament elution bracket for promoting esoderma repair and preventing vascular restenosis - Google Patents
Medicament elution bracket for promoting esoderma repair and preventing vascular restenosis Download PDFInfo
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- CN101214397A CN101214397A CN 200710144986 CN200710144986A CN101214397A CN 101214397 A CN101214397 A CN 101214397A CN 200710144986 CN200710144986 CN 200710144986 CN 200710144986 A CN200710144986 A CN 200710144986A CN 101214397 A CN101214397 A CN 101214397A
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Abstract
A drug eluting stent for promoting endothelium repairing and preventing restenosis relates to a reticular drug eluting stent. The invention solves the problem that the current drug eluting stents cannot effectively prevent the restenosis and thrombus in the stent at the same time. The drug eluting stent of the invention consists of a stent matrix, a middle layer and an antibody coating from inside to outside; the middle layer at least consists of a drug layer consisting of one or several of arsenous oxide, tetra-arsenic hexoxide and organic arsenic; the antibody coating is an antibody capable of capturing endothelia1 progenitor cells. The middle layer also includes at least a control release layer made of polymer material; release of the drug layer is controlled by the polymer material. The product of the invention can prohibit the proliferation of smooth muscle cells, and reduce the possibility of restenosis in the stent; capture the endothelia1 progenitor cells in the blood, and re-gather the endothelia1 progenitor cells where damage is produced after the equipment is implanted, so as to promote the healing of the endothelium and the recovery of the functions, and reduce thrombus in the stent.
Description
Technical field
The present invention relates to a kind of netted bracket for eluting medicament, blood vessel that it is used to implant or tubular structure.
Background technology
Atherosclerosis is a main cause dead in the world and that disable.Atherosclerosis causes the narrow and even inaccessible of tube chamber, makes the tissue ischemia and the necrosis of its blood supply, disables or threat to life.Coronary atherosclerosis disease (CAD) is that modern society is modal, the serious disease that life is constituted a threat to.Have every year 1150000 people to die from myocardial infarction in the U.S., wherein have 600,000 people (40%) to die from acute myocardial infarction, the quantity sickness rate of Chinese myocardial infarction improves year by year, and the serious harm people ' s health increases the weight of society's medical treatment burden.
The coronary disease condition of disease is treated by percutaneous transluminal coronary angioplasty (PTCA).There is every year patient's row PTCA to treat in the U.S. above 1,000,000.In the PTCA treatment, a foley's tube is inserted peripheral arterial, deliver to the coronary artery that is blocked through Arterial system.By balloon expandable, tremulous pulse extends subsequently.But there is 50% the patient who accepts the PTCA treatment nearly in 6 months, to need to accept once more the treatment of narrow arteria coronaria.This PTCA treatment artery narrows into restenosis once more.
The reason that causes restenosis is an elasticity of blood vessels retraction, and the blood vessel injury after the PTCA treatment causes partial inflammation and thrombosis to bring out the propagation of dividing a word with a hyphen at the end of a line of middle level smooth muscle, secretes a large amount of substrate, vascular remodeling.In the various treatments that prevent restenosis, it is the most effective that support is proved to be.Support is the pathological changes section of wire netting implantable intravascular, prevents the elastical retraction and the obturation of tremulous pulse.Can keep than the bigger tube chamber of independent PTCA treatment by support, can reduce restenosis like this and reach 30%.
Angiostenosis can occur in the blood vessel beyond the coronary artery, as aorta, and entocranial artery, artery of lower extremity, femoral artery far-end, rouge arterial distal, tibial artery, subclavian artery and Mesenteric artery.
After support has been arranged, have and a variety ofly support is coated anti-platelet agent or prevent the restenosis preparation, to reduce the generation of thrombosis and restenosis.The bracket for eluting medicament of rack surface coating rapamycin or paclitaxel can effectively reduce the generation of restenosis, but thrombosis has increased in the support.
Endothelium (EC) cellular layer is the important composition of normal blood vessels wall, and it can provide contact surface for blood flow and blood vessel wall surrounding tissue, after support is implanted the back blood vessel endothelium and destroyed, thrombosis in the support takes place easily.Recent research shows that endotheliocyte and endothelial progenitor cells are present in the peripheral blood and circulates.Endothelial progenitor cells is believed to move to the position of endodermis impaired in the blood circulation.In normal adult, the concentration of endothelial progenitor cells is 3-10/mm
3Rebuild the endothelial layer that function is arranged at damaged blood vessels support implant site and can provide barrier, reduce smooth muscle cell proliferation and local thrombosis that the signal of various cytokines causes for the cytokine in the circulation.
European Patent Application No. EP0 950 386 discloses a kind of support of local releasing rapamycin, and it is by the direct releasing rapamycin of micropore of stake body, in the time of perhaps rapamycin is mixed with polymer and is coated on the support.EP0 950 386 further discloses this polymer coating and contains for example polydimethylsiloxane of the simple polymer that can not absorb, poly-(ethlene-vingylacetate), acrylate or copolymer.This support can reduce the generation of in-stent restenosis, but having increased of thrombosis in the support.
Extensive use at present be rapamycin or purple mountain alcohol bracket for eluting medicament, on JIUYUE 14th, 2006, FDA has issued the statement about coronary artery medicinal FirebirdTM (DES) adverse events.This statement points out that latest data shows the current patient who has obtained the bracket for eluting medicament (CYPHER support and TAXUS support) of FDA approval of employing, and the risk of its stent thrombosis increases.
The annual over two hundred ten thousand routine patients with coronary heart disease in the whole world are accepted the drug stent implanted treatment, and the incidence rate subacute and advanced thrombus in the support is ten hundreds of, and death takes place many patients.The patient that China accepts drug stent treatment every year is up to example surplus 100,000, and annual with 30% speed increment, thrombosis serious threat patient's life security in the support.
Exploitation both promoted vascular endothelial injury healing to prevent thrombosis, and reducing the functional bracket for eluting medicament that neointimal hyperplasia prevents restenosis again is the key of dealing with problems.
A kind of support of US2005/0271701 A1 patent that the U.S. declares can be caught the endothelial progenitor cells in the blood circulation, effectively promotes the endothelium healing, reduce the generation of thrombosis in the support, but the generation of in-stent restenosis does not improve obviously.
Any method mentioned above does not all solve secular thrombosis and restenosis problem simultaneously.Need new method to solve the problem of thrombosis in in-stent restenosis and the support simultaneously, the endothelial progenitor cells that both can catch in the circulation promotes the endothelium healing to reduce thrombosis in the support, discharges the medicine that prevents in-stent restenosis simultaneously.
Summary of the invention
The objective of the invention is to solve the problem that has thrombosis to take place in in-stent restenosis and the support effectively simultaneously in order to solve existing bracket for eluting medicament; Promote the endothelium reparation to reduce thrombosis and the bracket for eluting medicament that prevents restenosis in the support and provide a kind of.Support sustained release arsenic trioxide of the present invention, six oxidations, four arsenic and organo-arsenic suppress smooth muscle cell proliferation in the blood vessel to vascular wall tissue, prevent the generation of restenosis; But rack surface scribbles the antibody of capturing endothelial ancestral cell simultaneously, catches corresponding endothelial progenitor cells, makes it to accumulate in rack surface, is divided into endotheliocyte, promotes the endothelium healing, reduces the generation of thrombosis in the support.
Promote the endothelium reparation among the present invention and prevent that the bracket for eluting medicament of restenosis from being made up of support matrix, intermediate layer and antibody coating from inside to outside.The support matrix is a net; The material of support matrix is rustless steel, polymer, Nitinol, magnesium alloy, tantalum or gold.The intermediate layer comprises one deck at least by a kind of or wherein several medicine layer of forming in arsenic trioxide, six oxidations, four arsenic and the organo-arsenic, and wherein organo-arsenic is atoxylic acid, arsamin or 3 nitros-4-kharophen.When medicine layer is mixture, press between arsenic trioxide, six oxidations, four arsenic and the organo-arsenic arbitrarily than mixing.The intermediate layer also comprises one deck controlled release layer at least, and the material of controlled release layer is a macromolecular material, and macromolecular material is a polymer.Wherein said polymer is poly-glue ester, chitosan, cellulose, extracellular matrix, the polylactic acid poly co-glycolic acid, styrene-isobutylene-styrene copolymer, hydroxy styrenes-isobutene .-hydroxy styrenes copolymer and derivant thereof, polyvinyl alcohol graft copolymerized polylactic acid poly co-glycolic acid, phosphocholine and Poly-L-lactic acid, the polyglycolic acid copolymer of poly lactic acid, ethylene-vinyl acetate copolymer (EVAC), Vinalac 5920 (PBMA), methyl methacrylate (MMA), polycaprolactone or polyurethane.The intermediate layer can also by a kind of or wherein several in arsenic trioxide, six oxidations, four arsenic and the organo-arsenic form contain the arsenic medicine and polymer is formed.Antibody in the antibody coating is monoclonal antibody, polyclonal antibody, animal's antibody or the human antibodies with identification and absorption endothelial progenitor cells function, or has the antibody fragment of identification and absorption endothelial progenitor cells function.Endothelial progenitor cells is the positive antigen of CD133, the positive antigen of CD34, the positive antigen of CD117 or VEGF
2Positive antigenic endothelial progenitor cells.
Among the present invention the poly material or with can be applied to surfaces of medical devices as a kind of ingredient by a kind of or wherein several mixture that contains the arsenic medicine of forming in arsenic trioxide, six oxidations, four arsenic and the organo-arsenic, and become independent one deck.For example, rack surface can be used in order, and ground floor contacts with the naked layer in equipment surface, and the second layer comprises ingredient, and wherein one side contacts with ground floor, and another side contacts with the 3rd layer of polymer that just contacts with surrounding tissue.
Antibody among the present invention is connected outer macromolecular material polymer surface by covalent bond, catches endothelial progenitor cells to the luminal surface of implantation equipment and can quicken the formation of the functional endothelium of damage location, reduces the formation of thrombosis in the support.
Product of the present invention can suppress smooth muscle cell proliferation, reduces the generation of in-stent restenosis; Catch the endothelial progenitor cells in the blood flow, and after this equipment is implanted, cause that the injury region endothelial progenitor cells reassembles, promote the endothelium healing, reduce thrombosis in the support, also have the function that promotes that endothelium is repaired.
Description of drawings
Fig. 1 is bracket for eluting medicament figure of the present invention.Fig. 2 is the cross sectional representation of the bracket for eluting medicament silk of the specific embodiment five.Fig. 3 is the cross sectional representation of the bracket for eluting medicament silk of the specific embodiment six.Fig. 4 is the cross sectional representation of the bracket for eluting medicament silk of the specific embodiment seven.1 expression support matrix among Fig. 2-Fig. 4,2 expression medicine layers, 3 expression antibody coatings; 4 expression controlled release layer among Fig. 3-Fig. 4.
The specific embodiment
The specific embodiment one: promote the endothelium reparation in (referring to Fig. 1-3) present embodiment and prevent that the bracket for eluting medicament of restenosis from being made up of support matrix, intermediate layer and antibody coating from inside to outside.The support matrix is a net; The material of support matrix is rustless steel, polymer, Nitinol, magnesium alloy, tantalum or gold.The intermediate layer comprises one deck at least by a kind of or wherein several medicine layer of forming in arsenic trioxide, six oxidations, four arsenic and the organo-arsenic, and wherein organo-arsenic is atoxylic acid, arsamin or 3 nitros-4-kharophen.When medicine layer is mixture, press between arsenic trioxide, six oxidations, four arsenic and the organo-arsenic arbitrarily than mixing.Antibody in the antibody coating is monoclonal antibody, polyclonal antibody, animal's antibody or the human antibodies with identification and absorption endothelial progenitor cells function, or has the antibody fragment of identification and absorption endothelial progenitor cells function.Endothelial progenitor cells is the positive antigen of CD133, the positive antigen of CD34, the positive antigen of CD117 or VEGF
2Positive antigenic endothelial progenitor cells.Total consumption of antibody is 5～100 micrograms.
The present embodiment medicine layer is by arsenic trioxide, six oxidations, four arsenic and organo-arsenic is a kind of or wherein several the composition, it mainly adopts arsenic trioxide, it also can be a kind of combination in arsenic trioxide and six oxidations, four arsenic and the organo-arsenic, medicine layer occupies one to three layer in the structure in intermediate layer, the gross weight of described medicine layer is 5～200 micrograms.
Arsenic trioxide in the present embodiment, six oxidations, four arsenic and organo-arsenic enter the vascular tissue of closing on, and suppress smooth muscle cell proliferation, promote apoptosis; The migration and the hypertrophy that can suppress the vascular smooth muscle of implant site can also prevent the restenosis after medical device is implanted.
Identification of antibody or antibody fragment structure and absorption endothelial progenitor cells (endotheliocyte, CFU-GM or stem cell) and make it ripe in the present embodiment become the surface endothelial cell antigens that function is arranged, and regulate it and be adhered to the equipment surface; Catch endothelial progenitor cells to the luminal surface of implantation equipment and can quicken the formation of the functional endothelium of damage location, reduce the formation of thrombosis in the support.
The specific embodiment two: what (referring to Fig. 2, Fig. 3) present embodiment and the specific embodiment one were different is: the intermediate layer also comprises one deck controlled release layer at least, and the material of controlled release layer is a macromolecular material, and macromolecular material is a polymer.Wherein said polymer is poly-glue ester, chitosan, cellulose, extracellular matrix, the polylactic acid poly co-glycolic acid, styrene-isobutylene-styrene copolymer, hydroxy styrenes-isobutene .-hydroxy styrenes copolymer and derivant thereof, polyvinyl alcohol graft copolymerized polylactic acid poly co-glycolic acid, phosphocholine and Poly-L-lactic acid, the polyglycolic acid copolymer of poly lactic acid, ethylene-vinyl acetate copolymer (EVAC), Vinalac 5920 (PBMA), methyl methacrylate (MMA), polycaprolactone or polyurethane.
In the present embodiment is that controlled release layer is between support matrix and medicine layer, perhaps between medicine layer and medicine layer.Controlled release layer is occupied one to three layer in the structure in intermediate layer, the gross thickness of described controlled release layer is 0.1 μ m～100 μ m.The gross weight of described controlled release layer is 30～300 micrograms.
The material of controlled release layer discharges and can change to keep the required drug level of implant site in the present embodiment; Can also make ingredient catch and be transported in the tissue.Provide effective drug level can prevent from restenosis and institute is discharged side effects of pharmaceutical drugs to be reduced to minimum for a long time at desired area.
The specific embodiment three: the difference of the present embodiment and the specific embodiment one is: promote the endothelium reparation and prevent restenosis bracket for eluting medicament the intermediate layer by a kind of or wherein several in arsenic trioxide, six oxidations, four arsenic and the organo-arsenic form contain the arsenic medicine and polymer is formed.When containing the arsenic medicine and be mixture, when arsenic trioxide, six oxidations, four arsenic and organo-arsenic mix between by arbitrarily than mixing; The gross weight that wherein contains the arsenic medicine is 5～200 micrograms.Wherein organo-arsenic is atoxylic acid, arsamin or 3 nitros-4-kharophen.
The proportioning of polymer material and ingredient can be added as required in the present embodiment.
The specific embodiment four: the difference of the present embodiment and the specific embodiment one is: antibody coating is evenly distributed on the outer surface in intermediate layer; Or scribble antibody coating at the blood flow face of the tube chamber of support.Wherein antibody in the antibody coating and macromolecular material be with covalent bonds, and antibody is distributed in the surface of support; Another kind is antibody to be dissolved in to adopt spraying process that antibody is coated in the bracket for eluting medicament outer surface in the collagen earlier.
The specific embodiment five: promote the endothelium reparation in (referring to Fig. 1) present embodiment and prevent that the bracket for eluting medicament of restenosis from being made up of support matrix, medicine layer and antibody coating from inside to outside.The support matrix is the netted thing of rustless steel; The material of medicine layer is an arsenic trioxide, and the weight of medicine layer is 5～200 micrograms.Other is identical with the specific embodiment one.
The specific embodiment six: promote the endothelium reparation in (referring to Fig. 2) present embodiment and prevent that the bracket for eluting medicament of restenosis from being made up of support matrix, medicine layer, controlled release layer and antibody coating from inside to outside; The controlled release layer material is polyvinyl alcohol graft copolymerized polylactic acid poly co-glycolic acid; The gross thickness of controlled release layer is 0.1～100 μ m; The weight of controlled release layer is 5～200 micrograms; Antibody coating is coated in the blood flow face of the tube chamber of support.Other is identical with the specific embodiment two.
The specific embodiment seven: the controlled release layer that the bracket for eluting medicament that promotes the endothelium reparation in (referring to Fig. 3) present embodiment and prevent restenosis is formed by the support matrix, by chitosan from inside to outside, the medicine layer of being made up of arsenic trioxide, the controlled release layer of being made up of extracellular matrix, medicine layer and the antibody coating be made up of by 1: 1 weight ratio arsenic trioxide and six oxidations, four arsenic are formed; Wherein antibody coating is coated in the blood flow face of the tube chamber of support; The gross weight of medicine layer is 150 micrograms.Other is identical with the specific embodiment two.
Claims (10)
1. bracket for eluting medicament that promotes the endothelium reparation and prevent restenosis, it is characterized in that the bracket for eluting medicament that promotes the endothelium reparation to prevent restenosis is made up of support matrix, intermediate layer, antibody coating from inside to outside, the intermediate layer comprises that at least one deck is by a kind of or wherein several medicine layer of forming in arsenic trioxide, six oxidations, four arsenic and the organo-arsenic; Antibody in the antibody coating is monoclonal antibody, polyclonal antibody, animal's antibody or the human antibodies with identification and absorption endothelial progenitor cells function, or has the antibody fragment of identification and absorption endothelial progenitor cells function.
2. promotion endothelium according to claim 1 reparation and prevent the bracket for eluting medicament of restenosis is characterized in that the intermediate layer comprises one deck controlled release layer at least; The material of controlled release layer is a macromolecular material, and macromolecular material is a polymer.
3. promotion endothelium according to claim 2 reparation and prevent the bracket for eluting medicament of restenosis is characterized in that described polymer is poly-glue ester, chitosan, cellulose, extracellular matrix, the polylactic acid poly co-glycolic acid, styrene-isobutylene-styrene copolymer, hydroxy styrenes-isobutene .-hydroxy styrenes copolymer and derivant thereof, polyvinyl alcohol graft copolymerized polylactic acid poly co-glycolic acid, phosphocholine and Poly-L-lactic acid, the polyglycolic acid copolymer of poly lactic acid, ethylene-vinyl acetate copolymer, Vinalac 5920, methyl methacrylate, polycaprolactone or polyurethane.
4. promotion endothelium according to claim 2 reparation and prevent the bracket for eluting medicament of restenosis, the gross thickness that it is characterized in that described controlled release layer is 0.1 μ m～100 μ m.
5. promotion endothelium according to claim 1 reparation and prevent the bracket for eluting medicament of restenosis is characterized in that the intermediate layer is made up of a kind of or the wherein several and polymer in arsenic trioxide, six oxidations, four arsenic and the organo-arsenic.
6. promote the endothelium reparation according to claim 1 or 5 and prevent the bracket for eluting medicament of restenosis, it is characterized in that organo-arsenic is atoxylic acid, arsamin or 3 nitros-4-kharophen.
7. according to claim 1,2 or 5 described promotion endothelium reparations with prevent the bracket for eluting medicament of restenosis, in the bracket for eluting medicament that it is characterized in that promoting the endothelium reparation and preventing restenosis by arsenic trioxide, six oxidations, four arsenic with organo-arsenic is a kind of or wherein several gross weight of forming medicine layer is 5～200 micrograms.
8. according to claim 1,2 or 5 described promotion endothelium reparations with prevent the bracket for eluting medicament of restenosis, the material that it is characterized in that the support matrix is rustless steel, polymer, Nitinol, magnesium alloy, tantalum or gold.
9. according to claim 1,2 or 5 described promotion endothelium reparations with prevent the bracket for eluting medicament of restenosis, it is characterized in that antibody coating is evenly distributed on the outer surface in intermediate layer; Or scribble antibody coating at the blood flow face of the tube chamber of support.
10. require the reparation of described promotion endothelium according to claim 1,2 or 5 and prevent the bracket for eluting medicament of restenosis, it is characterized in that antibody in the antibody coating and macromolecular material with covalent bonds, and antibody is distributed in the surface of support; Another kind is antibody to be dissolved in to adopt spraying process that antibody is coated in the bracket for eluting medicament outer surface in the collagen earlier.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200710144986 CN101214397A (en) | 2007-12-29 | 2007-12-29 | Medicament elution bracket for promoting esoderma repair and preventing vascular restenosis |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200710144986 CN101214397A (en) | 2007-12-29 | 2007-12-29 | Medicament elution bracket for promoting esoderma repair and preventing vascular restenosis |
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| CN101214397A true CN101214397A (en) | 2008-07-09 |
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| CN 200710144986 Pending CN101214397A (en) | 2007-12-29 | 2007-12-29 | Medicament elution bracket for promoting esoderma repair and preventing vascular restenosis |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101862477A (en) * | 2010-06-12 | 2010-10-20 | 上海交通大学医学院附属新华医院 | Bracket with drug temperature-sensitive controlled-release function and application thereof |
| CN102068718A (en) * | 2010-11-05 | 2011-05-25 | 东南大学 | Preparation technology of nano arsenic trioxide/poly (lactic-co-glycolic acid) coated bracket |
| CN102784417A (en) * | 2012-07-26 | 2012-11-21 | 江苏大学 | Slow release CD40 monoclonal antibody coated stent for coronary artery |
| CN105727379A (en) * | 2016-02-25 | 2016-07-06 | 顾宇春 | Haem oxygenase drug eluting stent |
| CN108273041A (en) * | 2018-04-11 | 2018-07-13 | 广东颜值科技有限公司 | A kind of preparation and its preparation method and application promoting skin wound healing |
| CN111246896A (en) * | 2018-01-09 | 2020-06-05 | 上海微特生物技术有限公司 | Degradable blood vessel stent capable of avoiding late restenosis |
| CN116869715A (en) * | 2023-07-10 | 2023-10-13 | 上海心玮医疗科技股份有限公司 | Anticoagulation medicine elution support |
-
2007
- 2007-12-29 CN CN 200710144986 patent/CN101214397A/en active Pending
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101862477A (en) * | 2010-06-12 | 2010-10-20 | 上海交通大学医学院附属新华医院 | Bracket with drug temperature-sensitive controlled-release function and application thereof |
| CN101862477B (en) * | 2010-06-12 | 2013-05-01 | 上海交通大学医学院附属新华医院 | Bracket with drug temperature-sensitive controlled-release function and application thereof |
| CN102068718A (en) * | 2010-11-05 | 2011-05-25 | 东南大学 | Preparation technology of nano arsenic trioxide/poly (lactic-co-glycolic acid) coated bracket |
| CN102068718B (en) * | 2010-11-05 | 2013-12-25 | 东南大学 | Preparation technology of nano arsenic trioxide/poly (lactic-co-glycolic acid) coated bracket |
| CN102784417A (en) * | 2012-07-26 | 2012-11-21 | 江苏大学 | Slow release CD40 monoclonal antibody coated stent for coronary artery |
| CN102784417B (en) * | 2012-07-26 | 2014-06-25 | 江苏大学 | Slow release CD40 monoclonal antibody coated stent for coronary artery |
| CN105727379A (en) * | 2016-02-25 | 2016-07-06 | 顾宇春 | Haem oxygenase drug eluting stent |
| CN111246896A (en) * | 2018-01-09 | 2020-06-05 | 上海微特生物技术有限公司 | Degradable blood vessel stent capable of avoiding late restenosis |
| CN108273041A (en) * | 2018-04-11 | 2018-07-13 | 广东颜值科技有限公司 | A kind of preparation and its preparation method and application promoting skin wound healing |
| CN116869715A (en) * | 2023-07-10 | 2023-10-13 | 上海心玮医疗科技股份有限公司 | Anticoagulation medicine elution support |
| CN116869715B (en) * | 2023-07-10 | 2024-02-09 | 上海心玮医疗科技股份有限公司 | Anticoagulation medicine elution support |
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Open date: 20080709 |