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WO2022176792A1 - Endoprothèse et son procédé de fabrication - Google Patents

Endoprothèse et son procédé de fabrication Download PDF

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Publication number
WO2022176792A1
WO2022176792A1 PCT/JP2022/005551 JP2022005551W WO2022176792A1 WO 2022176792 A1 WO2022176792 A1 WO 2022176792A1 JP 2022005551 W JP2022005551 W JP 2022005551W WO 2022176792 A1 WO2022176792 A1 WO 2022176792A1
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WO
WIPO (PCT)
Prior art keywords
stent
drug
coated
region
coated region
Prior art date
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Ceased
Application number
PCT/JP2022/005551
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English (en)
Japanese (ja)
Inventor
亮輔 上田
隆 熊澤
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Terumo Corp
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Terumo Corp
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Filing date
Publication date
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Publication of WO2022176792A1 publication Critical patent/WO2022176792A1/fr
Anticipated expiration legal-status Critical
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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 sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—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 sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other

Definitions

  • the present invention relates to a stent and a method for manufacturing a stent.
  • Stents are applied, for example, to prevent restenosis in percutaneous transluminal coronary angioplasty (PTCA: Percutaneous Coronary Angioplasty, PCI: Percutaneous Coronary Intervention) used for myocardial infarction or angina pectoris.
  • PTCA percutaneous transluminal coronary angioplasty
  • PCI Percutaneous Coronary Intervention
  • Such a stent is a drug-eluting stent that prevents restenosis by coating the outer surface of the stent in contact with the vascular wall with a drug that inhibits the migration and proliferation of vascular smooth muscle cells, and eluting the drug after stent placement.
  • DES Drug Eluting Stent
  • the stent in order to place a drug-eluting stent in a lumen, the stent is first made to reach the target site in the lumen in a contracted state, and then expanded and placed. As the stent expands and contracts, the drug-coated layer, which is coated at a location where stress concentration occurs, falls off from the surface of the annular body as the stent expands and contracts.
  • Patent Document 1 discloses a stent in which a drug coat layer is formed avoiding curved portions and link portions in order to prevent peeling of the drug coat layer. According to such a stent, peeling of the drug coat layer can be prevented.
  • the present invention has been made to solve the above problems, and aims to provide a stent and a method for manufacturing a stent that can suppress the deterioration of the drug efficacy while suppressing the peeling of the drug coating layer.
  • a stent that achieves the above purpose is a cylindrical stent that can be radially expanded and contracted.
  • the stent comprises a stress concentration portion where stress concentration occurs with expansion and contraction, a non-coated area where the surface of at least a part of the stress concentration portion is not coated with a drug, and a drug-coated layer on the surface other than the non-coated area. and a convex portion provided in the coat region, made of the drug, and protruding outward in the radial direction.
  • a method for manufacturing a stent for achieving the above object is a method for manufacturing a stent having a cylindrical stent main body that can be expanded and contracted in the radial direction and a coating region containing a drug, wherein the stent is subjected to stress during expansion and contraction.
  • the agent is applied to the surface of the stent main body except for at least a part of the surface of the stress concentration portion where the stress concentration occurs, thereby forming the coating region and the protrusion projecting outward in the radial direction in the coating region.
  • the surface of at least a portion of the stress concentration portion is provided with a non-coated region that is not coated with a drug, it is possible to suppress peeling of the drug-coated layer.
  • the protruding portions made of the drug are provided in the coated region, when the stent expands and abuts against the biological tissue, the drug in the protruding portions is released from the living tissue at the position where the protruding portion is placed. It penetrates into the tissue where the uncoated regions of the stent are located. Therefore, the efficacy is improved compared to stents having no projections. As described above, it is possible to provide a stent capable of suppressing deterioration of drug efficacy while suppressing peeling of the drug coating layer.
  • FIG. 1 is a schematic diagram for explaining a stent delivery system to which a stent according to an embodiment of the invention is applied;
  • FIG. 1 is a plan view showing a stent according to this embodiment;
  • FIG. It is a partially enlarged view showing a stent according to this embodiment.
  • FIG. 4 is a plan view showing the vicinity of link portions of the stent according to the present embodiment;
  • FIG. 5 is a cross-sectional view taken along line 5-5 of FIG. 4;
  • FIG. 5 is a cross-sectional view taken along line 6-6 of FIG. 4;
  • FIG. 4 is a plan view showing the vicinity of the curved portion of the stent according to the present embodiment;
  • FIG. 8 is a cross-sectional view taken along line 8-8 of FIG.
  • FIG. 7 It is a schematic diagram for explaining the effect of the stent according to the present embodiment. It is the schematic which shows a coating device.
  • FIG. 4 is a plan view showing an application pattern in the method for manufacturing a stent according to this embodiment; It is a sectional view showing a modification of a convex part.
  • FIG. 1 is a schematic diagram for explaining a stent delivery system 100 to which a stent 10 according to an embodiment of the invention is applied.
  • a stent 10 according to an embodiment of the present invention is a drug-eluting stent (DES) having a drug-containing coating layer formed on its outer surface.
  • DES drug-eluting stent
  • the stent 10 functions as an in-vivo indwelling article that retains a lumen by being indwelled in close contact with the inner surface of the stenosis.
  • the stent 10 is applied to a stent delivery system 100, for example, as shown in FIG. 1, and used for treatment aimed at preventing restenosis.
  • the stent delivery system 100 has a hub 110, a shaft 140, a balloon 130 and a stent 10.
  • the hub 110 has a luer tapered opening 112 for connecting a device for expanding the balloon 130, as shown in FIG.
  • the shaft 140 has an outer tube shaft, an inner tube shaft, and a guidewire port 152 .
  • the stent delivery system 100 shown in FIG. 1 has a guidewire port 152 intermediate the shaft 140, and the stent delivery system 100 shown in FIG. ) type.
  • the balloon 130 has the stent 10 arranged on its outer circumference and is arranged in a folded (or contracted) state. Balloon 130 is expanded by balloon expansion fluid introduced through opening 112 of hub 110 .
  • the stent delivery system is not limited to the rapid exchange type, and can also be applied to the over-the-wire (OTW) type, in which the guidewire passes through the entire length of the stent delivery system.
  • OGW over-the-wire
  • the stent delivery system is not limited to the form applied to the stenosis caused in the coronary arteries of the heart, and can also be applied to the stenosis caused in other blood vessels, bile ducts, trachea, esophagus, urethra, and the like.
  • Placement of the stent 10 by the stent delivery system 100 according to this embodiment is performed, for example, as follows.
  • the distal end of the stent delivery system 100 is inserted into the patient's lumen, and is positioned at the stenosis, which is the target site, while leading the guide wire 150 projecting from the opening 142 of the shaft 140 .
  • a balloon expansion fluid is then introduced through the opening 112 of the hub 110 to expand the balloon 130, causing expansion and plastic deformation of the stent 10 to seal it against the stenosis.
  • the stent 10 and the balloon 130 are disengaged and the stent 10 is separated from the balloon 130 by decompressing the balloon 130 and contracting it. Thereby, the stent 10 is indwelled in the stenosis. Stent delivery system 100 with separated stent 10 is then retracted and removed from the lumen.
  • FIG. 1 the configuration of the stent 10 will be described in detail with reference to FIGS. 2 to 9.
  • FIG. 1 the configuration of the stent 10 will be described in detail with reference to FIGS. 2 to 9.
  • FIG. 2 is a plan view showing the stent 10 according to this embodiment.
  • FIG. 3 is a partially enlarged view showing the stent 10 according to this embodiment.
  • FIG. 4 is a diagram showing the vicinity of the link portion 30 of the stent 10.
  • FIG. 5 is a cross-sectional view taken along line 5-5 of FIG. 4.
  • FIG. 6 is a cross-sectional view taken along line 6--6 of FIG. 4.
  • FIG. 7 is a plan view showing the vicinity of the curved portion 24 of the stent 10 according to this embodiment.
  • 8 is a cross-sectional view taken along line 8-8 of FIG. 7.
  • FIG. 9 is a schematic diagram for explaining the effects of the stent 10 according to this embodiment.
  • the stent 10 has a plurality of annular bodies 20 provided along the axial direction D1 and link portions 30 connecting the annular bodies 20 adjacent to each other along the axial direction D1. .
  • a drug coat layer CL is formed at a predetermined position of the stent 10 .
  • the stent 10 before the drug coat layer CL is formed may be referred to as the stent main body 10A.
  • the stent main body 10A is made of a biocompatible material.
  • Biocompatible materials include, for example, iron, titanium, aluminum, tin, tantalum or tantalum alloys, platinum or platinum alloys, gold or gold alloys, titanium alloys, nickel-titanium alloys, cobalt-based alloys, cobalt-chromium alloys, Stainless steel, zinc-tungsten alloy, niobium alloy and the like.
  • the annular body 20 extends in the circumferential direction D2 while being folded in a wave shape to form an endless annular shape.
  • the annular body 20 includes linear portions 21, 22, and 23, a curved portion 24 connecting the linear portions 21 and 22, and a curved portion 25 connecting the linear portions 21 and 23. and have In this embodiment, the curved portions 24 and 25 and the link portion 30 correspond to stress concentration portions where stress concentration occurs with expansion and contraction.
  • the stent 10 has, in the vicinity of the link portion 30, a first coat region (corresponding to the coat region) 51 in which the drug coat layer CL is formed on the surface of the stent body 10A, and a stent body 10A.
  • a portion (corresponding to a convex portion) 53 is provided.
  • the first uncoated region 52 is formed on some or all of the links 30 on the stent body 10A.
  • a primer coating layer is provided between the portion of the stent body 10A where the drug coat layer CL is formed and the drug coat layer CL to reduce variations in the peelability of the drug coat layer CL. 40 are placed.
  • the primer coating layer 40 in FIG. 5 is also arranged on the surface of the stent main body 10A in the first uncoated region 52, the primer coating layer may not be arranged here.
  • the stent 10 has, in the vicinity of the link portion 30, a second coat region (corresponding to the coat region) 61 in which the drug coat layer CL is formed on the surface of the annular body 20, and an annular body A second non-coated region (corresponding to a non-coated region) 62 where the surface of 20 is not coated with a drug, and a second protrusion formed at the end of the second coated region 61 on the second non-coated region 62 side.
  • a portion (corresponding to a convex portion) 63 is provided.
  • a second uncoated region 62 is formed on some or all of the links 30 on the stent body 10A.
  • the primer coating layer 40 is arranged between the portion of the stent body 10A where the drug coat layer CL is formed and the drug coat layer CL.
  • the primer coating layer 40 in FIG. 6 is also arranged on the surface of the stent main body 10A in the second uncoated region 62, the primer coating layer may not be arranged here.
  • the stent 10 has a third coat region (corresponding to the coat region) 71 in which the drug coat layer CL is formed on the surface of the annular body 20;
  • a third uncoated region 72 is formed on part or all of the bend 24 in the stent body 10A.
  • the primer coating layer 40 is arranged between the portion of the stent body 10A where the drug coat layer CL is formed and the drug coat layer CL.
  • the primer coating layer 40 in FIG. 8 is also arranged on the surface of the stent main body 10A in the third uncoated region 72, the primer coating layer may not be arranged here.
  • the drug coated on the outer surface of the stent main body 10A is supported by a polymer to form a drug coat layer CL.
  • the drug-coated layer CL is supported by a polymer, the drug is gradually released after the stent 10 is placed in the living body, so the drug effect is sustained for a long period of time, and the risk of restenosis at the site where the stent is placed is reduced.
  • the polymer is preferably a biodegradable polymer because inflammatory reactions may occur if the polymer remains.
  • the drug coat layer CL is formed by repeatedly coating a coating liquid prepared by dissolving a drug and a polymer in a solvent.
  • Drugs (physiologically active substances) coated on the outer surface of the stent body 10A include, for example, anticancer agents, immunosuppressive agents, antibiotics, antirheumatic agents, antithrombotic agents, HMG-CoA reductase inhibitors, ACE inhibitors, and calcium.
  • Biodegradable polymers are, for example, selected from the group consisting of polyesters, aliphatic polyesters, polyanhydrides, polyorthoesters, polycarbonates, polyphosphazenes, polyphosphates, polyvinyl alcohols, polypeptides, polysaccharides, proteins, and cellulose. at least one polymer, a copolymer obtained by optionally copolymerizing monomers constituting the polymer, and a mixture of the polymer and/or the copolymer.
  • Aliphatic polyesters are, for example, polylactic acid (PLA), polyglycolic acid (PGA), lactic acid-glycolic acid copolymer (PLGA), polycaprolactone (PCL), copolymers of lactic acid and caprolactone. Copolymers of lactic acid and caprolactone are preferred here.
  • the material of the primer coating layer is, for example, a biodegradable polymer when the drug coating layer CL is carried by the polymer.
  • the drug coat layer CL is arranged only on the outer surface side of the stent 10 . That is, the drug coat layer CL is not provided on the inner surface side of the stent 10 .
  • the stent 10 when the stent 10 is indwelled in a blood vessel, the stent 10 is quickly wrapped in the vascular tissue compared to a stent having a drug coating layer on the inner surface side as well.
  • a configuration in which the drug coat layer CL is provided on the side surface side and/or the inner surface side of the stent in addition to the outer surface side of the stent is also included in the present invention.
  • the second coated region 61 and the third coated region 71 have the same configuration as the first coated region 51, and the second non-coated region 62 and the third non-coated region 72 have the same structure as the first non-coated region 52.
  • the second convex portion 63 and the third convex portion 73 have the same configuration as the first convex portion 53, so here, the first coated region 51, the first non-coated region 52, and the first A configuration of the convex portion 53 will be described.
  • the first coat region 51 is formed by repeatedly coating a coating liquid prepared by dissolving a drug and a polymer in a solvent.
  • the drug coated layer CL has an inclined portion 51T configured so that the thickness gradually decreases toward the first uncoated region 52, as shown in FIG.
  • the inclined portion 51T is formed by overcoating so that the length of the coating on the upper layer side is shorter than the length of the coating on the lower layer side.
  • the thickness of the drug coat layer CL in the first coat region 51 is, for example, 1 to 100 ⁇ m.
  • the first convex portion 53 is composed of a drug. As shown in FIG. 5, the first convex portion 53 is configured in a droplet shape.
  • the first convex portion 53 is preferably provided at the end of the first coated region 51 on the first non-coated region 52 side. More specifically, the distance L1 from the boundary portion 54 between the first coated region 51 and the first uncoated region 52 to the center position 53P of the first convex portion 53 is preferably 1000 ⁇ m or less, more preferably 500 ⁇ m or less.
  • the first projections 53 are The drug permeates from the living tissue where the first projections 53 are placed toward the living tissue where the first uncoated region 52 of the stent 10 is placed (see the arrow in FIG. 9). Therefore, efficacy can be further improved.
  • the height H of the first projection 53 is not particularly limited, it is preferably 1 to 90 ⁇ m, more preferably 70 ⁇ m or less.
  • the height of the first convex portion is less than 1 ⁇ m, the penetration effect described above is reduced.
  • the height of the first convex portion is greater than 90 ⁇ m, the time required for endothelialization after stent placement will be prolonged and thrombus will easily adhere, increasing the risk of vascular obstruction due to the adhered thrombus.
  • the width W of the first projection 53 is preferably 0.5 to 10 times the height H of the projection 53. According to this configuration, since the slope of the first convex portion 53 is gentle, it is possible to preferably prevent the stent delivery system 100 from being caught on living tissue when delivering the stent delivery system 100 into the living body.
  • the drug on the first projections 53 is From the living tissue C where the first projections 53 are placed, it permeates toward the living tissue where the first uncoated region 52 of the stent 10 is placed. Therefore, the efficacy is improved as compared with a stent in which the first projections 53 are not provided.
  • the protrusions 53, 63, 73 have an anchoring effect, and displacement (migration) of the stent 10 can be suppressed.
  • the curved portions 24 may damage the living tissue C at both ends of the stent 10 in the axial direction D1. Even if the drug coating layer CL is not formed here, since the stent of the present invention is provided with convex portions made of a drug in the coating region, the drug can be efficiently delivered to the injured site.
  • FIG. 10 is a schematic diagram showing the coating device 90.
  • FIG. 11 is a plan view showing an application pattern in the method for manufacturing the stent 10 according to this embodiment.
  • the manufacturing method of the stent 10 according to this embodiment can be substantially the same manufacturing method as in International Publication No. 2015/046168. In the present specification, a method for manufacturing the stent 10 will be described with appropriate omission.
  • the manufacturing method of the stent 10 according to the present embodiment includes a formation step of forming the stent body 10A and an application step of applying a drug to the stent body 10A to form the drug coat layer CL.
  • a predetermined pattern is formed by removing portions other than the stent main body 10A from the tubular body (specifically, the metal pipe).
  • a predetermined pattern is formed from a metal pipe by an etching method using masking and chemicals called photofabrication, an electric discharge machining method using a mold, a cutting method (e.g., mechanical polishing, laser cutting), etc. can be formed.
  • edges of the annular body 20 are removed by chemical polishing or electropolishing, and the surface is finished to have a smooth surface.
  • annealing may be performed after molding into a predetermined pattern. Annealing improves the softness and flexibility of the stent main body 10A as a whole, improves the indwelling property in a curved blood vessel, reduces the physical irritation given to the inner wall of the blood vessel, and reduces the factors of restenosis. can be done.
  • the application device 90 shown in FIG. 10 applies the drug to a predetermined portion of the stent main body 10A to form the drug coat layer CL.
  • a dipping method such as a spray method, an inkjet method, and a nozzle injection method can be used to form the drug coat layer CL.
  • the spray method, the inkjet method, and the nozzle injection method are preferred.
  • the applicator 90 includes a holding portion 91 that holds the stent main body 10A, a moving means 92 that moves the holding portion 91, and an applicator 93 that applies a drug to a predetermined position of the stent main body 10A.
  • the holding section 91, the moving means 92, and the application section 93 are controlled by a control section (not shown). Since the holding part 91, the moving means 92, and the coating part 93 have the same configuration as that of the coating device disclosed in International Publication No. 2015/046168, detailed description thereof will be omitted.
  • the application step is the first step of applying the drug to the surface of the stent body 10A to form the coated regions 51, 61, 71 so that the non-coated regions 52, 62, 72 are not coated with the drug. and a second application step of applying a chemical to the coating regions 51 , 61 , 71 to form the protrusions 53 , 63 , 73 .
  • the drug is applied to the coated regions 51, 61, 71 so that the thickness gradually decreases toward the non-coated regions 52, 62, 72, as described above.
  • the moving means 92 or the nozzle 93A of the application unit 93 is moved along a predetermined pattern to eject the drug onto the surface of the main stent body 10A to form a thin film coating.
  • a lamination method of forming a plurality of layers is used. In the lamination method, the inclined portion 51T is formed by adjusting the coating region of each thin film coat layer and gradually reducing the number of thin film coat layers as the non-coated regions 52, 62, and 72 are approached. can be done.
  • the drug is applied to the above-described positions of the coated regions 51, 61, and 71 after the predetermined application pattern is formed on the stent main body 10A in the first application step.
  • the protrusions 53 , 63 , 73 are formed by dropping the medicine from the nozzle 93 ⁇ /b>A of the application section 93 .
  • the convex portions 53, 63, and 73 may be formed by increasing the discharge amount of the medicine for the corresponding portions in the first application step.
  • the stent 10 is a cylindrical stent that can be expanded and contracted in the radial direction. part, non-coated regions 52, 62, 72 where the surface of at least some of the stress concentration parts is not coated with the drug, and a drug coating layer CL formed on the surface other than the non-coated regions 52, 62, 72 Regions 51, 61, 71, and projections 53, 63, 73 provided in the coated regions 51, 61, 71, made of a drug, and protruding radially outward.
  • the non-coated regions 52, 62, and 72 which are not coated with the drug, are provided on the surface of the stress concentration portion, so peeling of the drug-coated layer CL can be suppressed.
  • the protruding portions 53, 63, and 73 made of a drug are provided in the coated regions 51, 61, and 71, when the stent 10 expands and comes into contact with living tissue, the protruding portions 53, The drugs 63 and 73 permeate from the body tissue where the protrusions 53, 63 and 73 are placed toward the body tissue where the non-coated regions 52, 62 and 72 of the stent 10 are placed.
  • the efficacy is improved.
  • the convex portions 53, 63, 73 are provided at the ends of the coated regions 51, 61, 71 on the non-coated regions 52, 62, 72 side.
  • the medicine on the first convex portion 53 preferably permeates into the living tissue at the position where the first uncoated region 52 is placed in a shorter period of time. Therefore, efficacy can be further improved.
  • the distance L1 from the boundary portion 54 between the first coated region 51 and the first non-coated region 52 to the center position 53P of the first convex portion 53 is 1000 ⁇ m or less. According to the stent 10 configured in this way, since the location where the first convex portion 53 is arranged can be brought close to the boundary portion 54, when the stent 10 expands and the drug comes into contact with the living tissue, The medicine on the first convex portion 53 preferably permeates into the living tissue at the position where the first uncoated region 52 is placed in a shorter period of time. Therefore, efficacy can be further improved.
  • the height H of the first projection 53 is 1 to 90 ⁇ m. According to the stent 10 configured in this manner, the risk of thrombus adhesion can be reduced by shortening the time required for endothelialization after stent placement while improving the efficacy of the non-coated region.
  • the width W of the first convex portion 53 is 0.5 to 10 times the height of the first convex portion 53 . According to the stent 10 configured in this way, since the slope of the first convex portion 53 is gentle, it is possible to preferably prevent the stent delivery system 100 from being caught on the living tissue when the stent delivery system 100 is delivered into the living body. be able to.
  • the drug coat layer CL has an inclined portion 51T configured so that the thickness gradually decreases toward the first non-coated region 52 . According to the stent 10 configured in this manner, the thickness of the drug coat layer CL located near the stress concentration portion is thinner than when there is no inclined portion, so that peeling or falling off of the drug coat layer CL is prevented. Increases the effectiveness of prevention.
  • the drug coat layer CL is formed only on the outer surface side of the coat regions 51 , 61 , 71 .
  • the method for manufacturing the stent 10 includes the cylindrical stent main body 10A that can be expanded and contracted in the radial direction, and the coated regions 51, 61, and 71 containing the drug.
  • the surface of the stent main body 10A is coated with a drug except for at least a part of the surface of a stress concentration part where stress concentration occurs with expansion and contraction such as a link part and a curved part
  • the stent 10 manufactured by this manufacturing method since the surface of the stress concentration portion is not coated with the drug, peeling of the drug coat layer CL can be suppressed. Moreover, since the protruding portions 53, 63, and 73 made of a drug are provided in the coated regions 51, 61, and 71, when the stent 10 expands and comes into contact with living tissue, the protruding portions 53, The drugs 63 and 73 permeate from the body tissue where the protrusions 53, 63 and 73 are placed toward the body tissue where the non-coated regions 52, 62 and 72 of the stent 10 are placed. Therefore, compared with the stent 10 in which the projections 53, 63, 73 are not provided, the efficacy is improved.
  • the present invention is not limited to the configurations described in the embodiments, and can be appropriately modified based on the description of the claims. be.
  • the first convex portion 53 is provided at the end of the first coated region 51 on the first non-coated region 52 side.
  • the first convex portion can be provided at any location on the first coat region 51 .
  • the drug coat layer CL has the inclined portion 51T configured so that the thickness gradually decreases toward the first non-coated region 52 .
  • the drug coat layer does not have to have an inclined portion.
  • the stent 10 has a cylindrical shape in which the ring-shaped bodies 20 that are endless ring-shaped folded back in a wavy shape are continuously connected in the axial direction by the link portions 30 .
  • the stent may be formed into a cylindrical shape by spirally winding a wavy continuous component. Further, even in this shape, the constituent elements may be connected in the axial direction by the link portion.
  • the primer coating layer 40 is arranged on the surface of the stent main body 10A, but the primer coating layer may not be arranged.
  • the shape of the first convex portion 53 is droplet-like.
  • the first convex portion 53 may have a shape in which a droplet spreads out.
  • the first protrusion may have a shape with a sharp radial outer side.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Optics & Photonics (AREA)
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  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
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Abstract

Le problème décrit par la présente invention est de fournir une endoprothèse vasculaire susceptible de supprimer une réduction de l'efficacité d'un médicament tout en empêchant le décollage de la couche d'enrobage du médicament. La solution selon l'invention porte sur une endoprothèse vasculaire 10, qui est une endoprothèse vasculaire cylindrique extensible et contractable dans la direction radiale, comprenant : une partie de concentration de contraintes, les contraintes se concentrant avec l'expansion et la contraction ; une zone non enrobée 52, dans laquelle au moins une partie de la surface de la partie de concentration de contraintes n'est pas enrobée d'un médicament ; une zone enrobée 51, dans laquelle une couche d'enrobage de médicament CL est formée sur la surface autre que la zone non enrobée ; et une partie convexe 53, qui est formée dans la zone enrobée, comprend le médicament et fait saillie vers l'extérieur dans la direction radiale.
PCT/JP2022/005551 2021-02-19 2022-02-14 Endoprothèse et son procédé de fabrication Ceased WO2022176792A1 (fr)

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JP2021-025066 2021-02-19
JP2021025066A JP2024047594A (ja) 2021-02-19 2021-02-19 ステントおよびステントの製造方法

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005508671A (ja) * 2001-07-26 2005-04-07 アバンテク バスキュラー コーポレーション 治療に有効な薬剤の送達
JP2008538933A (ja) * 2005-03-03 2008-11-13 アイコン メディカル コーポレーション 医療用部材用の改良された金属合金
WO2011040218A1 (fr) * 2009-09-30 2011-04-07 テルモ株式会社 Stent

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005508671A (ja) * 2001-07-26 2005-04-07 アバンテク バスキュラー コーポレーション 治療に有効な薬剤の送達
JP2008538933A (ja) * 2005-03-03 2008-11-13 アイコン メディカル コーポレーション 医療用部材用の改良された金属合金
WO2011040218A1 (fr) * 2009-09-30 2011-04-07 テルモ株式会社 Stent

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