CN101385669A - Anti-coagulation stainless steel coronary arterial bracket and uses thereof - Google Patents
Anti-coagulation stainless steel coronary arterial bracket and uses thereof Download PDFInfo
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- CN101385669A CN101385669A CNA2007100128043A CN200710012804A CN101385669A CN 101385669 A CN101385669 A CN 101385669A CN A2007100128043 A CNA2007100128043 A CN A2007100128043A CN 200710012804 A CN200710012804 A CN 200710012804A CN 101385669 A CN101385669 A CN 101385669A
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Abstract
The invention relates to a medical apparatus, in particular to an anticoagulant stainless steel coronary support which is made from a high-nitrogen nickel-free austenitic stainless steel material with good blood compatibility. The support is of tubular structure with a mesh surface which is formed by orderly arranging a unit figure on the side surface of a tube along the circumference and axial direction, the primary supporting function is provided by U-shaped corrugated mesh wires extending along the axial direction, the corrugated mesh wires are connected into a whole body by soft mesh wires arranged at intervals, and the diameter of the mesh wire (width or thickness) is 40-100mum; and the surface of the support is passivated and coated with a medication. The anticoagulant stainless steel support has the advantages of good mechanical properties, good flexibility and good anticoagulant property, and can be used as a support for cardiovascular and cerebrovascular systems or a support for other cavity bodies.
Description
Technical field
The present invention relates to medical apparatus and instruments, specifically a kind of anticoagulation high-nitrogen nickel-free stainless steel coronary arterial bracket and application thereof.
Background technology
Along with the development of modern medical service technology and being gradually improved of armarium, coronary arterial bracket is implanted becomes a kind of main means that get involved the cardiovascular therapy gradually.China has patients with coronary heart disease about more than 2,500 ten thousand at present, and be in the rapid growth period.Along with aged tendency of population, dietary structure change and the rhythm of life quickening, the Incidence of CHD of China will continue to increase.Therefore can foretell that China is the coronary artery bracket market of tool potentiality.But the clinical practice of coronary artery bracket still is subjected to the restriction of problems such as postoperative restenosis at present.In-stent restenosis mainly is after support is implanted, because blood vessel wall is impaired, vascular tissue's fibrocyte hyperplasia or generation inflammatory response cause thrombosis and cause.Behind the coronary artery bracket implant into body, can bring out biologically active pdgf simultaneously, the reaction between blood and the timbering material takes place by shearing force, and the meeting release metal ions, these all stimulate the formation of thrombosis easily.
Be widely used in clinically at present and contain 14% the nickel of having an appointment in the 316L rustless steel of coronary arterial bracket material, nickel element is a kind of potential sensitizing factor, and organism is had teratogenesis, carcinogenic and bring out the hazardness of thrombosis.There are some researches show that the contact allergy that the release of nickel ion causes in the stainless steel stent can exacerbate inflammation be reacted, and stimulates the hypertrophy of a frame peripheral cambium, thereby increase the probability of stent restenosis.Clinical experiment is found, metal ion particularly the probability of coronary artery bracket restenosis is taken place apparently higher than there not being anaphylactoid patient to nickel ion patient hypersensitive.Research simultaneously also finds, even very the nickel ion of low concentration also can bring out cell adhesion molecule ICAM-1, VCAM-1, ELAM-1 and GMP-140 (P lectin) at short notice to the expression of endotheliocyte.This ligand can promote the reaction between platelet and endothelium and platelet and the leukocyte, has so just increased the weight of thrombotic inducement.Therefore support may be one of remote cause of coronary artery bracket restenosis with the metal ion stripping in the rustless steel (particularly nickel).
The many countries in west formulate already and issue that at the harm of nickel associated documents and standard limit the nickel content in the bio-medical metal.The U.S. is listed high nitrogen and nickel-less austenitic stainless steel in the ASTM standard in as surgical implant at present.Therefore the medical high nitrogen and nickel-less austenitic stainless steel implant devices of function admirable will be an important trend of medical device development.
At home, Metal Inst., Chinese Academy of Sciences has taken the lead in carrying out the research of medical high nitrogen and nickel-less austenitic stainless steel, granted patent is " a kind of medical embedded austenitic stainless steel material " (patent No.: ZL03110896.2) and apply for a patent " a kind of medical free nickel high nitrogen stainless steel material " (patent No.: 200610046658.1), compare with medical 316L rustless steel, these two kinds of materials have more good comprehensive mechanical property, corrosion resisting property and blood compatibility, and do not contain the toxicity nickel element, cost is lower, the biological safety height demonstrates great advantage as body implanting material.Find that in research process the blood compatibility performance of new medical nickelles stainless steel (haemolysis, the multiple calcium of blood plasma, dynamically blood coagulation, platelet adhesion etc.) obviously is better than clinical widely used medical 316L rustless steel at present, has tangible anticoagulation function obvious.
At the blood compatibility of high nitrogen and nickel-less austenitic stainless steel excellence and inevitable anaphylaxis of nickel element in the 316L stainless steel material and the restenosis that may bring out intravascular stent, the stainless steel stent that adopts high nitrogen and nickel-less austenitic stainless steel processing is because its excellent mechanical property, competent support force can be provided, and has good blood compatibility simultaneously, significantly the generation of restenosis can be avoided and reduce to the anticoagulation characteristic.Therefore the anticoagulation advantage and the potentiality that show of high-nitrogen nickel-free stainless steel stent must cause more and more people's concern, create new society and economic benefit.
Summary of the invention
The objective of the invention is to utilize high nitrogen and nickel-less austenitic stainless steel material excellent mechanical property and blood compatibility, its anticoagulation characteristic particularly, a kind of anticoagulation nickelles stainless steel implant frame is provided, the high strength of material and high tenacity can guarantee under the prerequisite of the sufficient support force of network, make the support twine more tiny, thus submissiveer and be convenient to support and open side opening.Simultaneously because timbering material does not comprise nickel element, can avoid and reduce the patient because the irritated stenting infectious-related complication that causes that infects of nickel ion, the more important thing is that the good blood compatibility of material self can reduce the formation of implant frame surface thrombosis, thereby reduce postoperative restenosis.Anticoagulation nickelles stainless steel support of the present invention can be used for cardio-cerebrovascular support or other cavity support.
For achieving the above object, the technical solution used in the present invention is:
Timbering material adopts medical high nitrogen and nickel-less austenitic stainless steel embedded material, its chemical constituent is formed percentage by weight: chromium Cr:16～24, manganese Mn:10～20, molybdenum Mo:1～3, copper Cu:0.5～1.5, nickel≤0.02, nitrogen N:0.4～1.0, carbon C≤0.03, silicon Si≤0.75, sulfur S≤0.010, phosphorus P≤0.025, ferrum Fe: surplus.The used high-nitrogen nickel-free rustless steel of the present invention should strictly be controlled nickel≤0.02 (wt) %, and all the other impurity contents all should satisfy surgery and implant rustless steel current techique code requirement.
Nitrogen element in the stainless steel stent material of the present invention is important austenitizing alloying element, can effectively improve stainless mechanical property and corrosion resistance, but the supersaturation nitrogen element of solid solution in the rustless steel is easy and nitride such as chromium element wherein or other elements formation chromium nitride, influence stainless corrosion resistance, therefore suitable solution treatment is necessary, recommending Technology for Heating Processing is 1000～1200 ℃ of solution treatment insulations, determine temperature retention time according to sample thickness by 5min/mm, air cooling or water-cooled are to room temperature.
Anti-coagulation stainless steel coronary arterial implant frame of the present invention is formed through cut by the high nitrogen and nickel-less austenitic stainless steel precision tube, support is the tubular structure of surface mesh, surface mesh is that a kind of unit figure constitutes along circumference and axial ordered arrangement at the side surface of pipe, accompanying drawing 1 has provided support grid cell figure, and accompanying drawing 2 is support grid expanded views.The unit figure of forming support constitutes: that plays main supporting role organizes axially extended double-U-shaped ripple twine for n, the waviness width alternate, alternately connect as one by the camber line flexible mesh that is provided with at interval between corrugated twine, the crest radius of curvature of wherein double-U-shaped ripple twine is R1, the trough radius of curvature that is adjacent is R2, and the straight line segment length between the trough that crest is adjacent is L1; Described flexible mesh middle part is provided with along the circumferential direction horizontal big " S " type curved section, and the straight line segment length of serpentine curved section both sides is L2, and the radius of curvature of serpentine curved section is R3, and connecting the intermediary straight line segment length of sigmoid curve section is in the L3 unit figure.
Constituting major parameter R1, R2, R3 and straightway L1, the L2 of an interconnect function of U type twine r (support mesh wire diameter or width) and the pass of the unit number n on L3 and support pipe original size (pipe diameter) D and the support circumference is: R1 〉=(π D/n-5r)/6, R2≤(π D/n-5r)/12, R3≤R1, L1〉R1, L2〉L1+1/2 π (R1+R2), L3 〉=R3, n 〉=3.
Because the high nitrogen and nickel-less austenitic stainless steel fracture strength reaches more than the 800MPa, and plasticity and toughness are suitable with traditional 316L rustless steel, therefore in order further to increase the compliance of support, fully guaranteeing under the prerequisite of stent support power, the mesh wire diameter (thickness or width) of design New-support grid can be thinner, and graded, the U type ripple twine thickness and the width that wherein play main supporting role are 60-100 μ m, the serpentine twine thickness and the width that play interconnect function are 40-70 μ m, guarantee that support is submissiveer, make things convenient for operation technique, be easy to be implanted to assigned address, and be convenient on the support circumference, open side opening.。
High-nitrogen nickel-free stainless steel stent material itself has good blood compatibility, in order to make high-nitrogen nickel-free rustless steel coronary artery bracket have good blood compatibility and anticoagulation characteristic, support must carry out surface passivation behind electrobrightening handles, and reduces the interfacial tension that rack surface contacts with blood.Passivation process is that support soaked in concentrated nitric acid 0.5-1 hour after the acetone oil removing, is incubated 5-10 hours then in 60 ℃ of-90 ℃ of baking ovens.In order further to improve the blood compatibility and the histocompatibility of support, can further improve the rack surface characteristic by surface modification or medicament slow release.
Surface modifying method is a surface-coated, reduce restenosis rate and thrombosis in order to make support implant the back, blend has antitumor and anti-proliferative drug in the rack outer surface modified layer, and the support inner surface is climbed life for the ease of blood vessel endothelium, and surface-coated and mixed medicine are not carried out in the surface.The rack outer surface coating layer thickness is 5-20 μ m, and external surface coating is made of the blend of medicine and polymer, and the medicine amount of carrying is 0.001-150 μ g/cm2, and medicine accounts for 0.12% of polymer weight.Coating on inner surface thickness≤5 μ m scribbles endothelial cell growth factor (ECGF) (VEGF) on the inner surface, its amount of carrying is less than 2 μ g/cm
2
Rack outer surface has good biocompatibility and anti-hamartoplasia ability, and the support inner surface is convenient to blood vessel endothelium and is climbed life, can reduce post stent implantation restenosis rate and thrombosis;
Described polymer is the copolymer between silicone rubber, polyacrylic acid, politef, poly-propylhomoserin, polymethyl methacrylate, polylactide, poly-Acetic acid, hydroxy-, bimol. cyclic ester, polycaprolactone and/or these synthetic polymers of poly-anhydride.
Described use of slow releasing medication medicine is antitumor, anti-proliferative drug, as heparin, and rapamycin, taxol, aspirin etc.
Anti-coagulation stainless steel coronary arterial bracket of the present invention can be used for cardio-cerebrovascular or other tube chamber uses, and as being preced with arteries support etc., other intraluminal stent is: Esophageal Stent, trachea bracket, catheter support, biliary tract prosthesis etc.
The present invention has following advantage:
At first, traditional relatively stainless steel stent, support of the present invention not only has good biocompatibility with the high nitrogen and nickel-less austenitic stainless steel material, and does not contain the nickel element of potential sensitization, can avoid the patient because the postoperative restenosis that the irritated induce tissue reaction of nickel causes.
Next is that support not only has high strength with material, and has high plasticity and toughness, therefore the twine of support is thinner than the conventional stent twine, and the twine of its interconnect function is thinner in the support, so New-support can fully guarantee to have better compliance in the support force.
The 3rd, because the New-support twine is thinner submissiveer,, guarantee the support implantation at complicated blood vessel places such as vascular bypass so be more convenient on the support circumference, opening side opening.
The 4th, New-support surfaces externally and internally performance is according to human vas physiological characteristics design, and outer surface has good biocompatibility and anti-hamartoplasia ability, and the support inner surface is convenient to blood vessel endothelium and is climbed life, can reduce post stent implantation restenosis rate and thrombosis.
The more important thing is that at last support is relatively low with the interfacial tension of material surface and blood, the high-nitrogen nickel-free coronary arterial bracket has good blood compatibility, particularly good antiplatelet sticks ability and good dynamic blood coagulation characteristic, owing to have better anticoagulation characteristic than traditional stainless steel stent.
Description of drawings
Fig. 1 is support grid cell figure;
Fig. 2 is a support grid expanded view.
The specific embodiment
Shown in accompanying drawing 1 and accompanying drawing 2, support is the tubular structure of surface mesh, surface mesh is that a kind of unit figure constitutes along circumference and axial ordered arrangement at the side surface of pipe, that plays main supporting role organizes axially extended double-U-shaped ripple twine for n, alternately connect as one n 〉=3 by the camber line flexible mesh that is provided with at interval between the ripple twine; Described flexible mesh middle part is provided with along the circumferential direction horizontal big serpentine curved section.The cellular construction figure of pressing among Fig. 1 is processed, and radially repeats ordered arrangement at the high nitrogen and nickel-less austenitic stainless steel tubular axis to reaching, and has just constituted a kind of novel flexible and flexible anticoagulation high-nitrogen nickel-free rustless steel tube chamber support of expanding of energy.
The table 1 anticoagulation support stainless chemical constituent of high-nitrogen nickel-free
| Rustless steel | C | Cr | Mn | N | Mo | Cu | Si | S | P | Fracture strength/MP a | Percentage elongation/% |
| HNS1 | 0.026 | 16.8 | 14.3 | 0.46 | 2.0 | 0.42 | 0.26 | 0.008 | 0.01 1 | 927 | 56.0 |
| HNS2 | 0.029 | 18.2 | 15.8 | 0.64 | 2.7 | 0.6 | 0.18 | 0.004 | 0.01 4 | 961 | 53.5 |
| HNS3 | 0.025 | 19.3 | 18.8 | 0.88 | 2.1 | 0.88 | 0.34 | 0.007 | 0.01 2 | 1095 | 46 |
| HNS4 | 0.018 | 17.4 | 15.1 | 0.52 | 2.4 | -- | 0.14 | 0.005 | 0.01 0 | 945 | 56 |
Embodiment 1:
Adopt high-nitrogen nickel-free rustless steel HNS1 (seeing Table 1) to be made into the coronary artery bracket sample (after polishing, average silk footpath 70 μ m ± 5 μ m), ultrasonic cleaning 5 minutes in acetone, ethanol respectively, passivation is 30 minutes in concentrated nitric acid, insulation 6 hours in 80 ℃ of drying baker then.The oxolane of then support being put into mass concentration 1% polymethyl methacrylate contains medicine solution (including mass concentration 0.1% taxol), soaked 30 minutes, lift place's support rapidly, centrifugal treating is 1 minute under 500rpm, behind the careful cleaning support coating on inner surface, on inner surface, evenly apply the solution that contains mass concentration 20% endothelial cell growth factor (ECGF) (VEGF), put into vacuum drying oven subsequently, cool to room temperature with the furnace 90 ℃ of insulations 30 minutes.
Embodiment 2:
Adopt high-nitrogen nickel-free rustless steel HNS2 (seeing Table 1) to be made into the coronary artery bracket sample (after polishing, average silk footpath 55 μ m ± 5 μ m), ultrasonic cleaning 5 minutes in acetone, ethanol respectively, passivation is 30 minutes in concentrated nitric acid, insulation 8 hours in 70 ℃ of drying baker then.Then support is put in the spray equipment; with spray gun the oxolane of mass concentration 0.8% politef for preparing is contained medicine (including mass concentration 0.05% rapamycin) colloid and spray to rack outer surface several times; inner surface is protected with built-in core; on inner surface, evenly apply the solution that contains mass concentration 30% endothelial cell growth factor (ECGF) (VEGF) then, will prop up at last and be placed on dry 12h in 60 ℃ of vacuum drying ovens.
Embodiment 3:
Adopt high-nitrogen nickel-free rustless steel HNS3 (seeing Table 1) to be made into the coronary artery bracket sample (after polishing, average silk footpath 45 μ m ± 5 μ m), ultrasonic cleaning 5 minutes in acetone, ethanol respectively, passivation is 30 minutes in concentrated nitric acid, insulation 5 hours in 100 ℃ of drying baker then.Then support is put in the spray equipment; with spray gun the oxolane of the mass concentration for preparing 3% poly-Acetic acid, hydroxy-, bimol. cyclic ester is contained medicine (including mass concentration 0.08% heparin) colloid and spray to rack outer surface several times; inner surface is protected with built-in core; on inner surface, evenly apply the solution that contains mass concentration 40% endothelial cell growth factor (ECGF) (VEGF) then, will prop up at last and be placed on dry 20h in 50 ℃ of vacuum drying ovens.
Embodiment 4:
Adopt high-nitrogen nickel-free rustless steel HNS2 (seeing Table 1) to be made into the coronary artery bracket sample (after polishing, average silk footpath 50 μ m ± 5 μ m), ultrasonic cleaning 5 minutes in acetone, ethanol respectively, passivation is 30 minutes in concentrated nitric acid, insulation 5 hours in 100 ℃ of drying baker then.Then support is put in the spray equipment; with spray gun the oxolane of mass concentration 5% polylactide for preparing is contained medicine (including mass concentration 0.05% heparin) colloid and spray to rack outer surface several times; inner surface is protected with built-in core; on inner surface, evenly apply the solution that contains mass concentration 25% endothelial cell growth factor (ECGF) (VEGF) then, will prop up at last and be placed on dry 20h in 50 ℃ of vacuum drying ovens.
Embodiment 5:
Difference from Example 4 is: the support material is HNS4 (seeing Table 1), and rack outer surface spray solution composition is that mass concentration 2% polycaprolactone contains medicine (including mass concentration 0.05% taxol) solution.
Embodiment 6:
Difference from Example 1 is: the support material is HNS4 (seeing Table 1), and support dip-coating solution composition is that mass concentration 1% polyacrylic acid contains medicine (including mass concentration 0.1% rapamycin) solution.
Claims (9)
1. anti-coagulation stainless steel coronary arterial bracket, it is characterized in that: described support is the tubular structure of surface mesh, surface mesh is that a kind of unit figure constitutes along circumference and axial ordered arrangement at the tubing side surface, what play main supporting role is the axially U type ripple twine of continuous extension of n group, connect as one n 〉=3 by the flexible mesh that is provided with at interval between the ripple twine; The all outwards mutual circumscribed arc that is extended with π/4 sizes at interval in the both sides, top of U type ripple twine, the ripple twine interconnects by the outward extending circumscribed arc in U type top and extends vertically.
2. according to the described anti-coagulation stainless steel coronary arterial bracket of claim 1, it is characterized in that: the residing crest radius of curvature R 1 in described U type ripple twine U type lower end 〉=(π D/n-5r)/6, the trough radius of curvature R 2 that is adjacent≤(π D/n-5r)/12, straight line segment length between the trough that crest is adjacent is L1, and L1〉R1, wherein D is the support caliber, and r is mesh wire diameter or width.
3. according to the described anti-coagulation stainless steel coronary arterial bracket of claim 2, it is characterized in that: described flexible mesh middle part is provided with along the circumferential direction horizontal big serpentine curved section, the straight line segment length of serpentine curved section both sides is L2, the radius of curvature of serpentine curved section is R3, R3≤R1, L2〉L1+1/2 π (R1+R2), the middle part of sigmoid curve section is to be parallel to axial connection straightway, the straight line segment length is L3, L3 〉=R3.。
4. according to claim 1,2 or 3 described anti-coagulation stainless steel coronary arterial brackets, it is characterized in that: described support is formed through cut by the high nitrogen and nickel-less austenitic stainless steel precision tube, the U type ripple twine thickness and the width that play main supporting role are 60-100 μ m, the serpentine flexible mesh thickness and the width that play interconnect function are 40-70 μ m, guarantee that support is submissiveer.
Thin and the size of support twine changes in gradient, play serpentine twine L2, L3 and the more passive U type of the R3 mesh wire diameter thin 30%-50% of interconnect function, guarantee that support has good compliance, be easy to be implanted to assigned address, and be convenient on the support circumference, open side opening.
5. according to claim 1 or 4 described anti-coagulation stainless steel coronary arterial brackets, it is characterized in that: the chemical constituent of described high nitrogen and nickel-less austenitic stainless steel is formed percentage by weight and is: chromium Cr:15～24%, manganese Mn:10～20%, molybdenum Mo:1～3%, copper Cu:0～1.5%, nickel≤0.02%, nitrogen N:0.4～1.0%, carbon C≤0.03%, silicon Si≤0.75%, sulfur S≤0.010%, phosphorus P≤0.025%, ferrum Fe: surplus;
Its Technology for Heating Processing is 1000～1200 ℃ of solution treatment insulations, determines temperature retention time according to sample thickness by 5min/mm, and air cooling or water-cooled are to room temperature; Making the anti-coagulation stainless steel support is single austenitic structure with the material microstructure, nickel element Ni≤0.02 in the chemical constituent, and material surface has good blood compatibility.
6. according to the described anti-coagulation stainless steel coronary arterial bracket of claim 1, it is characterized in that: in order further to improve the blood compatibility and the histocompatibility of support, support after electrobrightening and surface passivation processing, can further improve the rack surface characteristic by surface modification or medicament slow release according to a conventional method; Surface modifying method is a surface-coated, and the rack outer surface coating layer thickness is 5-20 μ m, and external surface coating is made of the blend of medicine and polymer, and the medicine amount of carrying is 0.001-150 μ g/cm
2, medicine accounts for 0.12% of polymer weight; Coating on inner surface thickness≤5 μ m scribbles endothelial cell growth factor (ECGF) on the inner surface, its amount of carrying is less than 2 μ g/cm
2
7. according to the described anti-coagulation stainless steel coronary arterial bracket of claim 6, it is characterized in that: described polymer is the copolymer between silicone rubber, polyacrylic acid, politef, poly-propylhomoserin, polymethyl methacrylate, polylactide, poly-Acetic acid, hydroxy-, bimol. cyclic ester, polycaprolactone and/or these synthetic polymers of poly-anhydride; Described use of slow releasing medication medicine is antitumor and/or anti-proliferative drug.
8. the application of the described anti-coagulation stainless steel coronary arterial bracket of claim 1 is characterized in that: described anti-coagulation stainless steel coronary arterial bracket can be used for the cardio-cerebrovascular support or other intraluminal stent uses.
9. according to the application of the described anti-coagulation stainless steel coronary arterial bracket of claim 8, it is characterized in that: described anti-coagulation stainless steel coronary arterial bracket can be used for being preced with the arteries support, Esophageal Stent, trachea bracket, catheter support or biliary tract prosthesis.
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