WO2019176790A1 - Stent - Google Patents

Stent Download PDF

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Publication number
WO2019176790A1
WO2019176790A1 PCT/JP2019/009414 JP2019009414W WO2019176790A1 WO 2019176790 A1 WO2019176790 A1 WO 2019176790A1 JP 2019009414 W JP2019009414 W JP 2019009414W WO 2019176790 A1 WO2019176790 A1 WO 2019176790A1
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Prior art keywords
coating layer
stent
path
drug coating
drug
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PCT/JP2019/009414
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French (fr)
Japanese (ja)
Inventor
晋輔 仲谷
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テルモ株式会社
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Publication of WO2019176790A1 publication Critical patent/WO2019176790A1/en

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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
    • 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 sheet material 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.
  • the stent is applied to prevent restenosis in, for example, percutaneous coronary angioplasty (PTCA: Percutaneous Coronary Angioplasty, PCI: Percutaneous Coronary Intervention) used for myocardial infarction or angina.
  • PTCA Percutaneous Coronary Angioplasty
  • PCI Percutaneous Coronary Intervention
  • a drug-eluting stent that coats a drug that suppresses the migration and proliferation of vascular smooth muscle cells on the outer surface side that contacts the blood vessel wall and elutes the drug after placement of the stent to prevent restenosis (DES: Drug Eluting Sent) is being developed.
  • DES Drug Eluting Sent
  • Such a drug-eluting stent is a stent composed of a plurality of annular bodies in which wavy linear members in which linear portions and curved portions are alternately arranged are formed in an annular shape, and a link portion in which adjacent annular bodies are connected by curved portions.
  • a drug coating layer is formed on the entire surface.
  • the inner bay side of the curved portion is a place where a large tensile strain is generated when the stent is expanded, and a large tensile strain is also generated in the drug coating layer covering the portion. There is a possibility that the layer may crack and the drug coating layer may be peeled off.
  • Patent Document 1 discloses a stent in which a drug coating layer is formed avoiding curved portions and link portions in order to prevent peeling of the drug coating layer. According to such a stent, peeling of the drug coating layer can be prevented.
  • the present invention has been made to solve the problems associated with the above-described conventional technology, and an object of the present invention is to provide a stent capable of suppressing the peeling of the drug coating layer while suppressing a decrease in treatment results.
  • the stent of the present invention includes a plurality of annular bodies in which wavy linear members in which linear portions and curved portions are alternately arranged, and an annular body adjacent to each other between the curved portions. Connected link portions.
  • one route and the other route intersect each other, and one of the one route and the other route Only the drug coating layer containing the drug is formed.
  • the drug coating layer is formed only in one of the one path and the other path in the region including the link part and the curved part connected to the link part.
  • the treatment results are improved.
  • medical agent coating layer to the inner bay side of a curved part can be avoided, and it can suppress that a chemical
  • FIG. 5 is a cross-sectional view taken along line 5-5 in FIG.
  • FIG. 6 is a sectional view taken along line 6-6 in FIG. It is a figure corresponding to FIG. 4 of the stent which concerns on a modification.
  • FIG. 1 is a schematic diagram for explaining a stent delivery system 100 to which a stent 10 according to an embodiment of the present invention is applied.
  • the stent 10 includes a drug-eluting stent (DES) in which a drug coating layer 42 containing a drug is formed on the outer surface side.
  • DES drug-eluting stent
  • the stent 10 functions as an in-vivo indwelling object that holds a lumen by being placed in close contact with the inner surface of the stenosis.
  • the stent 10 is applied to a stent delivery system 100 and used for treatment for the purpose of preventing restenosis.
  • the stent delivery system 100 is a rapid exchange (RX) type having a structure in which the guide wire 150 passes only through the distal end portion.
  • the stent delivery system 100 includes a hub 110, a shaft 140, a balloon 130, and a stent 10.
  • the hub 110 has an opening 112 formed with a luer taper for connecting a device for expanding the balloon 130.
  • the shaft 140 has an outer tube shaft, an inner tube shaft, and a guide wire port 152.
  • the balloon 130 has the stent 10 disposed on the outer periphery and is disposed in a folded state (or a contracted state).
  • the balloon 130 is expanded by a balloon expansion fluid introduced from the opening 112 of the hub 110.
  • the stent delivery system is not limited to the rapid exchange type, but can be applied to an over-the-wire (OTW) type.
  • OGW over-the-wire
  • the stent delivery system is not limited to the form applied to the stenosis portion generated in the coronary artery of the heart, and can be applied to the stenosis portion generated in other blood vessels, bile ducts, trachea, esophagus, urethra and the like.
  • the placement of the stent 10 by the stent delivery system 100 according to the present embodiment is performed as follows, for example.
  • the distal end portion of the stent delivery system 100 is inserted into the lumen of the patient, and the guide wire 150 protruding from the opening 142 of the shaft 140 is positioned in advance, and positioned at the stenosis that is the target site. Then, a balloon expansion fluid is introduced from the opening 112 of the hub 110, and the balloon 130 is expanded to cause expansion and plastic deformation of the stent 10 and to be in close contact with the stenosis.
  • the balloon 130 is decompressed and contracted to release the engagement between the stent 10 and the balloon 130, and the stent 10 is separated from the balloon 130. Thereby, the stent 10 is detained in the stenosis part.
  • the stent delivery system 100 from which the stent 10 has been separated is then retracted and removed from the lumen.
  • FIG. 2 and 3 are views showing the configuration of the stent 10 according to the present embodiment
  • FIG. 4 is a view showing the vicinity of the link portion 30 of the stent 10
  • FIG. FIG. 6 is a cross-sectional view taken along the line 6-6 in FIG.
  • the stent 10 includes a plurality of annular bodies 20 provided along the axial direction D1 and a link portion 30 that connects the annular bodies 20 adjacent to each other along the axial direction D1. .
  • the stent 10 is made of a biocompatible material.
  • Biocompatible materials include, for example, iron, titanium, aluminum, tin, tantalum or tantalum alloy, platinum or platinum alloy, gold or gold alloy, titanium alloy, nickel-titanium alloy, cobalt base alloy, cobalt-chromium alloy, Stainless steel, zinc-tungsten alloy, niobium alloy, etc.
  • the annular body 20 extends in the circumferential direction D2 while being folded back in a wave shape to form an endless annular shape. As shown in FIG. 3, the annular body 20 includes linear portions 21 and 22 and a curved portion 23 that connects the linear portions 21 and 22 to each other. The annular body 20 includes a linear portion 24. The linear portions 21 and 24 are connected at the bending portion 25.
  • the stent 10 has one path 31 and another path 32 that intersect each other in a region including the link part 30 and the curved part 25 connected to the link part 30.
  • the one path 31 connects the adjacent linear portions 24 along the axial direction D1 so as to be substantially in a straight line.
  • the other path 32 connects the linear portions 21 to each other.
  • a method of forming one path 31 and another path 32 will be described in detail.
  • an imaginary circle passes through the center of the linear portions 21 and 24 around the center point P1 of the arc formed by the linear portions 21 and 24 and the curved portion 25 of the left annular body 20.
  • Draw C1 a virtual circle C2 is drawn so as to pass through the center of the linear portions 21 and 24 with the center point P2 of the arc formed by the linear portions 21 and 24 and the curved portion 25 of the right annular body 20 as the center.
  • route 31 is formed by connecting the adjacent linear part 24 along the axial direction D1, so that it may become parallel to the circumscribed line L1 of the virtual circle C1 and the virtual circle C2.
  • route 32 is formed by connecting the linear part 21 adjacent along the axial direction D1 so that it may become parallel to the circumscribed line L2 of the virtual circle C1 and the virtual circle C2.
  • the drug coated on the outer surface of the stent 10 is supported on a polymer to form a drug coating layer 42.
  • the polymer is preferably a biodegradable polymer. In this case, after the stent 10 is placed in the living body, the polymer is biodegraded and the drug is gradually released, so that restenosis at the stent placement portion is reliably prevented.
  • drugs (bioactive substances) coated on the outer surface of the stent 10 include anticancer drugs, immunosuppressive drugs, antibiotics, anti-rheumatic drugs, antithrombotic drugs, HMG-CoA reductase inhibitors, ACE inhibitors, calcium antagonists.
  • the biodegradable polymer is, for example, selected from the group consisting of polyester, aliphatic polyester, polyanhydride, polyorthoester, polycarbonate, polyphosphazene, polyphosphate ester, polyvinyl alcohol, polypeptide, polysaccharide, protein, and cellulose. At least one polymer, a copolymer obtained by arbitrarily copolymerizing monomers constituting the polymer, and a mixture of the polymer and / or the copolymer.
  • the aliphatic polyester is, for example, polylactic acid (PLA), polyglycolic acid (PGA), lactic acid-glycolic acid copolymer (PLGA), polycaprolactone (PCL), or a copolymer of lactic acid and caprolactone.
  • PLA polylactic acid
  • PGA polyglycolic acid
  • PLGA lactic acid-glycolic acid copolymer
  • PCL polycaprolactone
  • a copolymer of lactic acid and caprolactone is preferred.
  • the drug coating layer 42 is disposed only on the outer surface side of the stent 10 as shown in FIGS. That is, the drug coating layer 42 is not provided on the inner surface side of the stent 10.
  • the drug coating layer 42 is provided on the inner surface side of the stent, when such a stent is placed in a blood vessel, the endothelial cells are prevented from growing and thrombus is formed in the stent. There is a risk of developing a so-called stent thrombosis in which the inside of the stent is blocked.
  • the drug coating layer 42 is provided only on the outer surface side of the stent 10, so that when the stent 10 is placed in the blood vessel, it is also on the inner surface side. Compared to a stent provided with a drug coating layer, the stent 10 is encased in vascular tissue earlier.
  • a configuration in which the drug coating layer 42 is provided on the inner surface side of the stent is also included in the present invention.
  • the drug coating layer 42 is formed in one path 31 in a region including the link portion 30 and the curved portion 25 connected to the link portion 30.
  • the drug coating layer 42 is not formed in the other path 32 as shown in FIG.
  • the inner bay side of the curved portion 25 connected to the link portion 30 is a location where a large tensile strain is generated during stent expansion.
  • the drug coating layer 42 is formed only in one path 31, formation of the drug coating layer 42 on the inner bay side of the bending portion 25 can be avoided, and the drug coating layer 42 can be prevented from peeling off.
  • it is preferable that the drug coating layer 42 is not formed on the curved portion 23 for the same reason.
  • the drug coating layer 42 is continuously coated in one path 31. By being continuously coated in this way, treatment results are improved as compared to a stent in which the drug coating layer is intermittently coated.
  • a primer coating layer 40 for improving adhesiveness.
  • the primer constituting the primer coating layer 40 is selected in consideration of the adhesion to the polymer contained in the drug coating layer 42 and the adhesion to the outer surface of the stent 10. By providing the primer coating layer 40 in this manner, the peel resistance of the drug coating layer 42 is improved.
  • the primer coating layer 40 is preferably not disposed between the one path 31 and the drug coating layer 42 as shown in FIGS.
  • the primer coating layer 40 is likely not to be provided unless the drug coating layer 42 is peeled off because the primer coating layer 40 easily causes inflammation on the human body.
  • the distance of one path 31 is shorter than that of the linear portions 21, 22, and 24, there is little possibility that the drug coating layer 42 is peeled off without providing the primer coating layer 40.
  • a configuration in which the primer coating layer 40 is disposed between the link portion 30 and the drug coating layer 42 is also included in the present invention.
  • the drug coating layer 42 is formed by recoating a coating solution prepared by dissolving a drug and a polymer in a solvent, and the thickness of the drug coating layer 42 is changed by sequentially varying the length of the overcoating layer. Is gradually reduced. For this reason, the thickness of the drug coating layer 42 at the end of the linear portion 21 continuing to the other path 32 and the curved portion 25 is gradually reduced stepwise toward the link portion 30 as shown in FIG. Yes. Therefore, even when the thickness of the drug coating layer 42 is increased, the drug coating layer 42 located in the vicinity of the link portion 30 is thin, so that the drug coating layer is caused by the increase in the drug coating layer 42. Since the peeling or dropping of 42 is suppressed, it is possible to easily secure the necessary amount of the medicine.
  • the stent 10 includes the plurality of annular bodies 20 in which the linear portions 21, 22, 24 and the curved portions 23, 25 are alternately formed in a ring shape, And a link portion 30 in which the adjacent annular bodies 20 are connected by the curved portions 25. Moreover, in the area
  • the drug coating layer 42 is formed only in one path 31 in the region including the link portion 30 and the curved portion 25 connected to the link portion 30, and thus the link portion Compared with the stent in which the drug coating layer is not formed on 30, the treatment result is improved. Moreover, formation of the chemical
  • the one path 31 is provided so as to linearly connect the linear portions 24 adjacent to each other along the axial direction D1, and the drug coating layer 42 is formed only in the one path 31. .
  • the drug coating layer 42 is peeled off because the risk of the drug coating layer 42 being formed on the inner bay side of the curved portion 25 is lower than the other paths 32. Can be suppressed.
  • a primer coating layer 40 (in order to improve adhesiveness) between the portion of the annular body 20 where the drug coating layer 42 is formed (corresponding to the linear portions 21, 22, 24) and the drug coating layer 42 is provided.
  • the primer coating layer 40 is not provided between the one path 31 and the drug coating layer 42 of the link portion 30. According to the stent 10 configured in this way, the amount of the primer coating layer 40 can be reduced as compared with the configuration in which the primer coating layer 40 is provided between the link portion 30 and the drug coating layer 42. Inflammation caused by the primer coating layer 40 can be reduced.
  • the drug coating layer 42 is coated only on the outer surface side of the annular body 20 and the link part 30. According to the stent 10 configured as described above, the stent 10 is encapsulated in the vascular tissue at an early stage as compared with the configuration in which the drug coating layer 42 is also coated on the inner surface side.
  • the drug coating layer 42 is continuously coated in one path 31. According to the stent 10 configured in this manner, the treatment result is improved as compared with the configuration in which the drug coating layer is intermittently coated.
  • the drug coating layer 42 is formed only in the one path 31.
  • the drug coating layer 42 may be formed only in the other path 32.
  • the drug coating layer 42 is continuously coated in the one path 31.
  • the drug coating layer may be intermittently coated in one path 31.
  • the annular body 20 extends in the circumferential direction D2 while being folded back in a wave shape to form an endless annular shape.
  • the stent may extend in the circumferential direction D2 while being folded in a wave shape to form a spiral shape.

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Abstract

[Problem] To provide a stent in which peeling of drug coating layers can be suppressed while suppressing a deterioration in treatment outcomes. [Solution] The present invention has one path 31 and another path 32 that cross each other in a region having a link part 30 and a curved part 25 connected to the link part, wherein a drug coating layer 42 containing a drug is formed in only one among the one path and the other path.

Description

ステントStent
　本発明は、ステントに関する。 The present invention relates to a stent.
　ステントは、例えば、心筋梗塞あるいは狭心症に用いられる経皮的冠状動脈血管形成術（ＰＴＣＡ：Ｐｅｒｃｕｔａｎｅｏｕｓ　Ｔｒａｎｓｌｕｍｉｎａｌ　Ｃｏｒｏｎａｒｙ　Ａｎｇｉｏｐｌａｓｔｙ、ＰＣＩ：Ｐｅｒｃｕｔａｎｅｏｕｓ　Ｃｏｒｏｎａｒｙ　Ｉｎｔｅｒｖｅｎｔｉｏｎ）において再狭窄防止のために適用される。 The stent is applied to prevent restenosis in, for example, percutaneous coronary angioplasty (PTCA: Percutaneous Coronary Angioplasty, PCI: Percutaneous Coronary Intervention) used for myocardial infarction or angina.
　このようなステントとして、血管壁に接触する外表面側に、血管平滑筋細胞の遊走および増殖を抑制する薬剤を被覆し、当該薬剤をステント留置後に溶出させて再狭窄を防止する薬剤溶出性ステント（ＤＥＳ：Ｄｒｕｇ　Ｅｌｕｔｉｎｇ　Ｓｔｅｎｔ）の開発が行われている。 As such a stent, a drug-eluting stent that coats a drug that suppresses the migration and proliferation of vascular smooth muscle cells on the outer surface side that contacts the blood vessel wall and elutes the drug after placement of the stent to prevent restenosis (DES: Drug Eluting Sent) is being developed.
　このような薬剤溶出ステントは、直線状部と湾曲部が交互に連なる波状の線状部材を環状に形成した複数の環状体と、隣接する環状体を湾曲部同士で接続したリンク部からなるステント全面に薬剤被覆層が形成されている。しかしながら、湾曲部の内湾側はステント拡張時に大きな引張ひずみを生じる箇所であり、その部分を被覆する薬剤被覆層にも大きな引張ひずみが生じるため、ステント拡張時に湾曲部の内湾側を起点として薬剤被覆層に亀裂が生じ、薬剤被覆層が剥がれてしまう虞がある。 Such a drug-eluting stent is a stent composed of a plurality of annular bodies in which wavy linear members in which linear portions and curved portions are alternately arranged are formed in an annular shape, and a link portion in which adjacent annular bodies are connected by curved portions. A drug coating layer is formed on the entire surface. However, the inner bay side of the curved portion is a place where a large tensile strain is generated when the stent is expanded, and a large tensile strain is also generated in the drug coating layer covering the portion. There is a possibility that the layer may crack and the drug coating layer may be peeled off.
　これに関連して、例えば下記の特許文献１には、薬剤被覆層の剥がれを防止するために、湾曲部およびリンク部を避けて薬剤被覆層が形成されたステントが開示されている。このようなステントによれば、薬剤被覆層の剥がれを防止することができる。 In this regard, for example, Patent Document 1 below discloses a stent in which a drug coating layer is formed avoiding curved portions and link portions in order to prevent peeling of the drug coating layer. According to such a stent, peeling of the drug coating layer can be prevented.
国際公開第２０１５／０４６０２２号International Publication No. 2015/046022
　しかしながら、特許文献１に記載のステントでは、本来、薬剤被覆層の剥がれる虞の低いリンク部にも薬剤が塗布されておらず、必要以上に薬剤搭載量が減少しているため、治療成績が低下してしまう虞がある。 However, in the stent described in Patent Document 1, since the drug is not applied to the link portion where the drug coating layer is unlikely to be peeled off and the amount of the drug loaded is reduced more than necessary, the treatment result is deteriorated. There is a risk of it.
　本発明は、上記従来技術に伴う課題を解決するためになされたものであり、治療成績の低下を抑制しつつ、薬剤被覆層の剥がれを抑制できるステントを提供することを目的とする。 The present invention has been made to solve the problems associated with the above-described conventional technology, and an object of the present invention is to provide a stent capable of suppressing the peeling of the drug coating layer while suppressing a decrease in treatment results.
　上記目的を達成するための本発明のステントは、直線状部と湾曲部が交互に連なる波状の線状部材を環状に形成した複数の環状体と、隣接する前記環状体を前記湾曲部同士で接続したリンク部と、を有する。また、前記リンク部および前記リンク部に接続される前記湾曲部を含む領域内において、互いに交差する一の経路および他の経路を有し、前記一の経路および前記他の経路のうち一方の経路にのみ、薬剤を含む薬剤被覆層が形成されている。 In order to achieve the above object, the stent of the present invention includes a plurality of annular bodies in which wavy linear members in which linear portions and curved portions are alternately arranged, and an annular body adjacent to each other between the curved portions. Connected link portions. In addition, in the region including the link portion and the curved portion connected to the link portion, one route and the other route intersect each other, and one of the one route and the other route Only the drug coating layer containing the drug is formed.
　上記構成を有するステントによれば、リンク部およびリンク部に接続される湾曲部を含む領域内の一の経路および他の経路のうち一方の経路にのみ薬剤被覆層が形成されているため、リンク部に薬剤被覆層が形成されていないステントと比較して、治療成績が向上する。また、湾曲部の内湾側への薬剤被覆層の形成が避けられ、薬剤被覆層が剥がれてしまうことを抑制することができる。以上から、治療成績の低下を抑制しつつ、薬剤被覆層の剥がれを抑制できるステントを提供することができる。 According to the stent having the above-described configuration, the drug coating layer is formed only in one of the one path and the other path in the region including the link part and the curved part connected to the link part. Compared with a stent in which the drug coating layer is not formed on the part, the treatment results are improved. Moreover, formation of the chemical | medical agent coating layer to the inner bay side of a curved part can be avoided, and it can suppress that a chemical | medical agent coating layer peels. From the above, it is possible to provide a stent capable of suppressing the peeling of the drug coating layer while suppressing a decrease in therapeutic results.
本発明の実施形態に係るステントが適用されるステントデリバリーシステムを説明するための概略図である。It is the schematic for demonstrating the stent delivery system with which the stent which concerns on embodiment of this invention is applied. 本実施形態に係るステントを示す平面図である。It is a top view which shows the stent which concerns on this embodiment. 本実施形態に係るステントを示す部分拡大図である。It is the elements on larger scale which show the stent which concerns on this embodiment. 本実施形態に係るステントのリンク部近傍を示す平面図である。It is a top view which shows the link part vicinity of the stent which concerns on this embodiment. 図４の５－５線に沿う断面図である。FIG. 5 is a cross-sectional view taken along line 5-5 in FIG. 図４の６－６線に沿う断面図である。FIG. 6 is a sectional view taken along line 6-6 in FIG. 変形例に係るステントの図４に対応する図である。It is a figure corresponding to FIG. 4 of the stent which concerns on a modification.
　以下、本発明の実施の形態を、図面を参照しつつ説明する。なお、図面の寸法比率は、説明の都合上誇張されており、実際の比率とは異なる場合がある。 Hereinafter, embodiments of the present invention will be described with reference to the drawings. In addition, the dimension ratio of drawing is exaggerated on account of description, and may differ from an actual ratio.
　図１は、本発明の実施の形態に係るステント１０が適用されるステントデリバリーシステム１００を説明するための概略図である。 FIG. 1 is a schematic diagram for explaining a stent delivery system 100 to which a stent 10 according to an embodiment of the present invention is applied.
　本発明の実施形態に係るステント１０は、外表面側に薬剤を含む薬剤被覆層４２が形成された薬剤溶出性ステント（ＤＥＳ）からなる。ステント１０は、狭窄部の内面に密着させて留置されることで管腔を保持する生体内留置物として機能する。ステント１０は、例えば、図１に示すように、ステントデリバリーシステム１００に適用され、再狭窄防止を目的とした治療に利用される。 The stent 10 according to the embodiment of the present invention includes a drug-eluting stent (DES) in which a drug coating layer 42 containing a drug is formed on the outer surface side. The stent 10 functions as an in-vivo indwelling object that holds a lumen by being placed in close contact with the inner surface of the stenosis. For example, as shown in FIG. 1, the stent 10 is applied to a stent delivery system 100 and used for treatment for the purpose of preventing restenosis.
　本実施形態において、ステントデリバリーシステム１００は、ガイドワイヤー１５０が先端部のみを通る構造を有するラピッドエクスチェンジ（ＲＸ）タイプである。ステントデリバリーシステム１００は、ハブ１１０と、シャフト１４０と、バルーン１３０と、ステント１０と、を有する。 In this embodiment, the stent delivery system 100 is a rapid exchange (RX) type having a structure in which the guide wire 150 passes only through the distal end portion. The stent delivery system 100 includes a hub 110, a shaft 140, a balloon 130, and a stent 10.
　ハブ１１０は、図１に示すように、バルーン１３０を拡張させる装置を連結するためのルアーテーパーが形成された開口部１１２を有する。 As shown in FIG. 1, the hub 110 has an opening 112 formed with a luer taper for connecting a device for expanding the balloon 130.
　シャフト１４０は、外管シャフトと、内管シャフトと、ガイドワイヤーポート１５２と、を有する。 The shaft 140 has an outer tube shaft, an inner tube shaft, and a guide wire port 152.
　バルーン１３０は、外周にステント１０が配置され、折り畳まれた状態（あるいは収縮された状態）で配置される。バルーン１３０は、ハブ１１０の開口部１１２から導入されるバルーン拡張流体によって拡張される。 The balloon 130 has the stent 10 disposed on the outer periphery and is disposed in a folded state (or a contracted state). The balloon 130 is expanded by a balloon expansion fluid introduced from the opening 112 of the hub 110.
　ステントデリバリーシステムは、ラピッドエクスチェンジタイプに限定されず、オーバーザワイヤ（ＯＴＷ）タイプに適用することも可能である。また、ステントデリバリーシステムは、心臓の冠動脈に生じた狭窄部に適用する形態に限定されず、その他の血管、胆管、気管、食道、尿道等に生じた狭窄部に適用することも可能である。 The stent delivery system is not limited to the rapid exchange type, but can be applied to an over-the-wire (OTW) type. In addition, the stent delivery system is not limited to the form applied to the stenosis portion generated in the coronary artery of the heart, and can be applied to the stenosis portion generated in other blood vessels, bile ducts, trachea, esophagus, urethra and the like.
　本実施形態に係るステントデリバリーシステム１００によるステント１０の留置は、例えば、以下のように実施される。 The placement of the stent 10 by the stent delivery system 100 according to the present embodiment is performed as follows, for example.
　まず、ステントデリバリーシステム１００の先端部を、患者の管腔に挿入し、シャフト１４０の開口部１４２から突出させたガイドワイヤー１５０を先行させながら、目的部位である狭窄部に位置決めする。そして、ハブ１１０の開口部１１２からバルーン拡張流体を導入して、バルーン１３０を拡張させて、ステント１０の拡張および塑性変形を引き起こし、狭窄部に密着させる。 First, the distal end portion of the stent delivery system 100 is inserted into the lumen of the patient, and the guide wire 150 protruding from the opening 142 of the shaft 140 is positioned in advance, and positioned at the stenosis that is the target site. Then, a balloon expansion fluid is introduced from the opening 112 of the hub 110, and the balloon 130 is expanded to cause expansion and plastic deformation of the stent 10 and to be in close contact with the stenosis.
　その後、バルーン１３０を減圧して収縮させることにより、ステント１０とバルーン１３０との係合を解除し、ステント１０をバルーン１３０から分離する。これにより、ステント１０は狭窄部に留置される。そして、ステント１０が分離されたステントデリバリーシステム１００は、後退させられ、管腔から取り除かれる。 Thereafter, the balloon 130 is decompressed and contracted to release the engagement between the stent 10 and the balloon 130, and the stent 10 is separated from the balloon 130. Thereby, the stent 10 is detained in the stenosis part. The stent delivery system 100 from which the stent 10 has been separated is then retracted and removed from the lumen.
　次に、図２～図６を参照して、ステント１０の構成について詳述する。 Next, the configuration of the stent 10 will be described in detail with reference to FIGS.
　図２および図３は、本実施形態に係るステント１０の構成を示す図であって、図４は、ステント１０のリンク部３０近傍を示す図であって、図５は、図４の５－５線に沿う断面図であって、図６は、図５の６－６線に沿う断面図である。 2 and 3 are views showing the configuration of the stent 10 according to the present embodiment, FIG. 4 is a view showing the vicinity of the link portion 30 of the stent 10, and FIG. FIG. 6 is a cross-sectional view taken along the line 6-6 in FIG.
　ステント１０は、図２、図３に示すように、軸方向Ｄ１に沿って複数設けられる環状体２０と、軸方向Ｄ１に沿って隣接する環状体２０同士を接続するリンク部３０と、を有する。 As shown in FIGS. 2 and 3, the stent 10 includes a plurality of annular bodies 20 provided along the axial direction D1 and a link portion 30 that connects the annular bodies 20 adjacent to each other along the axial direction D1. .
　ステント１０は、生体適合性を有する材料から構成される。生体適合性を有する材料は、例えば、鉄、チタン、アルミニウム、スズ、タンタルもしくはタンタル合金、プラチナもしくはプラチナ合金、金もしくは金合金、チタン合金、ニッケル－チタン合金、コバルトベース合金、コバルト－クロム合金、ステンレス鋼、亜鉛－タングステン合金、ニオブ合金等である。 The stent 10 is made of a biocompatible material. Biocompatible materials include, for example, iron, titanium, aluminum, tin, tantalum or tantalum alloy, platinum or platinum alloy, gold or gold alloy, titanium alloy, nickel-titanium alloy, cobalt base alloy, cobalt-chromium alloy, Stainless steel, zinc-tungsten alloy, niobium alloy, etc.
　環状体２０は、波状に折り返されつつ周方向Ｄ２に延在して、無端の環状形状を形作っている。環状体２０は、図３に示すように、直線状部２１、２２および直線状部２１、２２同士を接続する湾曲部２３を備える。また、環状体２０は、直線状部２４を備える。直線状部２１、２４は、湾曲部２５において接続されている。 The annular body 20 extends in the circumferential direction D2 while being folded back in a wave shape to form an endless annular shape. As shown in FIG. 3, the annular body 20 includes linear portions 21 and 22 and a curved portion 23 that connects the linear portions 21 and 22 to each other. The annular body 20 includes a linear portion 24. The linear portions 21 and 24 are connected at the bending portion 25.
　ステント１０は、図３、図４に示すように、リンク部３０およびリンク部３０に接続される湾曲部２５を含む領域において、互いに交差する一の経路３１および他の経路３２を有する。 As shown in FIGS. 3 and 4, the stent 10 has one path 31 and another path 32 that intersect each other in a region including the link part 30 and the curved part 25 connected to the link part 30.
　一の経路３１は、軸方向Ｄ１に沿って隣り合う直線状部２４同士を略一直線となるように接続している。また、他の経路３２は、直線状部２１同士を接続している。以下、一の経路３１および他の経路３２の形成方法について詳述する。 The one path 31 connects the adjacent linear portions 24 along the axial direction D1 so as to be substantially in a straight line. The other path 32 connects the linear portions 21 to each other. Hereinafter, a method of forming one path 31 and another path 32 will be described in detail.
　まず、図４において、左側の環状体２０の直線状部２１、２４および湾曲部２５によって形成される円弧の中心点Ｐ１を中心にして、直線状部２１、２４の中央を通るように仮想円Ｃ１を描く。次に、右側の環状体２０の直線状部２１、２４および湾曲部２５によって形成される円弧の中心点Ｐ２を中心にして、直線状部２１、２４の中央を通るように仮想円Ｃ２を描く。そして、仮想円Ｃ１および仮想円Ｃ２の外接線Ｌ１と平行になるように、軸方向Ｄ１に沿って隣り合う直線状部２４を接続することによって、一の経路３１が形成される。さらに、仮想円Ｃ１および仮想円Ｃ２の外接線Ｌ２と平行になるように、軸方向Ｄ１に沿って隣り合う直線状部２１を接続することによって、他の経路３２が形成される。 First, in FIG. 4, an imaginary circle passes through the center of the linear portions 21 and 24 around the center point P1 of the arc formed by the linear portions 21 and 24 and the curved portion 25 of the left annular body 20. Draw C1. Next, a virtual circle C2 is drawn so as to pass through the center of the linear portions 21 and 24 with the center point P2 of the arc formed by the linear portions 21 and 24 and the curved portion 25 of the right annular body 20 as the center. . And the one path | route 31 is formed by connecting the adjacent linear part 24 along the axial direction D1, so that it may become parallel to the circumscribed line L1 of the virtual circle C1 and the virtual circle C2. Furthermore, the other path | route 32 is formed by connecting the linear part 21 adjacent along the axial direction D1 so that it may become parallel to the circumscribed line L2 of the virtual circle C1 and the virtual circle C2.
　ステント１０の外側表面に被覆される薬剤は、ポリマーに担持されて薬剤被覆層４２を構成している。ポリマーは、生分解性ポリマーであることが好ましい。この場合、生体内にステント１０を留置した後、ポリマーが生分解され、薬剤が徐放されるため、ステント留置部での再狭窄が確実に防止される。 The drug coated on the outer surface of the stent 10 is supported on a polymer to form a drug coating layer 42. The polymer is preferably a biodegradable polymer. In this case, after the stent 10 is placed in the living body, the polymer is biodegraded and the drug is gradually released, so that restenosis at the stent placement portion is reliably prevented.
　ステント１０の外側表面に被覆される薬剤（生理活性物質）は、例えば、抗癌剤、免疫抑制剤、抗生物質、抗リウマチ剤、抗血栓薬、ＨＭＧ－ＣｏＡ還元酵素阻害剤、ＡＣＥ阻害剤、カルシウム拮抗剤、抗高脂血症薬、インテグリン阻害薬、抗アレルギー剤、抗酸化剤、ＧＰＩＩｂＩＩＩａ拮抗薬、レチノイド、フラボノイド、カロチノイド、脂質改善薬、ＤＮＡ合成阻害剤、チロシンキナーゼ阻害剤、抗血小板薬、抗炎症薬、生体由来材料、インターフェロン、ＮＯ産生促進物質からなる群から選択される少なくとも１つの化合物である。 Examples of drugs (bioactive substances) coated on the outer surface of the stent 10 include anticancer drugs, immunosuppressive drugs, antibiotics, anti-rheumatic drugs, antithrombotic drugs, HMG-CoA reductase inhibitors, ACE inhibitors, calcium antagonists. Agent, antihyperlipidemic agent, integrin inhibitor, antiallergic agent, antioxidant, GPIIbIIIa antagonist, retinoid, flavonoid, carotenoid, lipid improver, DNA synthesis inhibitor, tyrosine kinase inhibitor, antiplatelet agent, anti It is at least one compound selected from the group consisting of inflammatory drugs, biological materials, interferons, and NO production promoters.
　生分解性ポリマーは、例えば、ポリエステル、脂肪族ポリエステル、ポリ酸無水物、ポリオルソエステル、ポリカーボネート、ポリホスファゼン、ポリリン酸エステル、ポリビニルアルコール、ポリペプチド、多糖、タンパク質、およびセルロースからなる群から選択される少なくとも１つの重合体、前記重合体を構成する単量体が任意に共重合されてなる共重合体、並びに前記重合体および／または前記共重合体の混合物である。脂肪族ポリエステルは、例えば、ポリ乳酸（ＰＬＡ）、ポリグリコール酸（ＰＧＡ）、乳酸－グリコール酸共重合体（ＰＬＧＡ）、ポリカプロラクトン（ＰＣＬ）、乳酸とカプロラクトンの共重合体である。ここでは、乳酸とカプロラクトンの共重合体が好ましい。 The biodegradable polymer is, for example, selected from the group consisting of polyester, aliphatic polyester, polyanhydride, polyorthoester, polycarbonate, polyphosphazene, polyphosphate ester, polyvinyl alcohol, polypeptide, polysaccharide, protein, and cellulose. At least one polymer, a copolymer obtained by arbitrarily copolymerizing monomers constituting the polymer, and a mixture of the polymer and / or the copolymer. The aliphatic polyester is, for example, polylactic acid (PLA), polyglycolic acid (PGA), lactic acid-glycolic acid copolymer (PLGA), polycaprolactone (PCL), or a copolymer of lactic acid and caprolactone. Here, a copolymer of lactic acid and caprolactone is preferred.
　薬剤被覆層４２は、図４～図６に示すように、ステント１０の外表面側にのみ配置されている。すなわち、薬剤被覆層４２は、ステント１０の内表面側には設けられていない。 The drug coating layer 42 is disposed only on the outer surface side of the stent 10 as shown in FIGS. That is, the drug coating layer 42 is not provided on the inner surface side of the stent 10.
　例えば、薬剤被覆層４２が、ステントの内表面側に設けられている場合、このようなステントが血管内に留置された場合、内皮細胞の増殖を妨げてしまい、ステント内に血栓が形成されてステント内部が閉塞する、いわゆるステント血栓症を発症する虞がある。 For example, when the drug coating layer 42 is provided on the inner surface side of the stent, when such a stent is placed in a blood vessel, the endothelial cells are prevented from growing and thrombus is formed in the stent. There is a risk of developing a so-called stent thrombosis in which the inside of the stent is blocked.
　これに対して、本実施形態に係るステント１０では、薬剤被覆層４２は、ステント１０の外表面側にのみ設けられているため、ステント１０が血管内に留置された場合、内表面側にも薬剤被覆層が設けられているステントと比較して、ステント１０が早期に血管組織内に包み込まれる。 On the other hand, in the stent 10 according to the present embodiment, the drug coating layer 42 is provided only on the outer surface side of the stent 10, so that when the stent 10 is placed in the blood vessel, it is also on the inner surface side. Compared to a stent provided with a drug coating layer, the stent 10 is encased in vascular tissue earlier.
　なお、薬剤被覆層４２が、ステントの内表面側に設けられている構成も、本発明に含まれるものとする。 A configuration in which the drug coating layer 42 is provided on the inner surface side of the stent is also included in the present invention.
　また、薬剤被覆層４２は、図５に示すように、リンク部３０およびリンク部３０に接続される湾曲部２５を含む領域において、一の経路３１に形成されている。一方、薬剤被覆層４２は、図６に示すように、他の経路３２には形成されていない。ここで、リンク部３０に接続される湾曲部２５の内湾側は、ステント拡張時に大きな引張ひずみを生じる箇所である。このように、一の経路３１のみに薬剤被覆層４２を形成すると、湾曲部２５の内湾側への薬剤被覆層４２の形成を避けることができ、薬剤被覆層４２が剥がれることを抑制できる。さらに、同様の理由から湾曲部２３にも薬剤被覆層４２が形成されないことが好ましい。 Further, as shown in FIG. 5, the drug coating layer 42 is formed in one path 31 in a region including the link portion 30 and the curved portion 25 connected to the link portion 30. On the other hand, the drug coating layer 42 is not formed in the other path 32 as shown in FIG. Here, the inner bay side of the curved portion 25 connected to the link portion 30 is a location where a large tensile strain is generated during stent expansion. As described above, when the drug coating layer 42 is formed only in one path 31, formation of the drug coating layer 42 on the inner bay side of the bending portion 25 can be avoided, and the drug coating layer 42 can be prevented from peeling off. Furthermore, it is preferable that the drug coating layer 42 is not formed on the curved portion 23 for the same reason.
　また、薬剤被覆層４２は、一の経路３１において、連続的に被覆されている。このように連続的に被覆されていることによって、薬剤被覆層が断続的に被覆されているステントと比較して、治療成績が向上する。 Further, the drug coating layer 42 is continuously coated in one path 31. By being continuously coated in this way, treatment results are improved as compared to a stent in which the drug coating layer is intermittently coated.
　さらに、図５、図６に示すように、環状体２０のうち薬剤被覆層４２が形成される部位（本実施形態では直線状部２１、２２、２４に相当）および薬剤被覆層４２の間には、接着性を向上させるためのプライマー被覆層（接着層に相当）４０が配置されている。プライマー被覆層４０を構成するプライマーは、薬剤被覆層４２に含まれるポリマーに対する接着性およびステント１０の外側表面に対する接着性を考慮して、選択されている。このようにプライマー被覆層４０を設けることによって、薬剤被覆層４２の耐剥離性が向上している。 Furthermore, as shown in FIGS. 5 and 6, between the portion of the annular body 20 where the drug coating layer 42 is formed (corresponding to the linear portions 21, 22, and 24 in this embodiment) and the drug coating layer 42. Is provided with a primer coating layer (corresponding to an adhesive layer) 40 for improving adhesiveness. The primer constituting the primer coating layer 40 is selected in consideration of the adhesion to the polymer contained in the drug coating layer 42 and the adhesion to the outer surface of the stent 10. By providing the primer coating layer 40 in this manner, the peel resistance of the drug coating layer 42 is improved.
　一方、プライマー被覆層４０は、図４～図６に示すように、一の経路３１および薬剤被覆層４２の間には配置されないことが好ましい。一般的に、プライマー被覆層４０は、人体に対して炎症を生じさせやすいため、薬剤被覆層４２が剥離しない限りにおいて、設けないことが好ましい。ここで、一の経路３１は直線状部２１、２２、２４と比較して距離が短いため、プライマー被覆層４０を設けなくても、薬剤被覆層４２が剥離する虞は少ない。なお、プライマー被覆層４０が、リンク部３０および薬剤被覆層４２の間に配置される構成も本発明に含まれるものとする。 On the other hand, the primer coating layer 40 is preferably not disposed between the one path 31 and the drug coating layer 42 as shown in FIGS. In general, the primer coating layer 40 is likely not to be provided unless the drug coating layer 42 is peeled off because the primer coating layer 40 easily causes inflammation on the human body. Here, since the distance of one path 31 is shorter than that of the linear portions 21, 22, and 24, there is little possibility that the drug coating layer 42 is peeled off without providing the primer coating layer 40. A configuration in which the primer coating layer 40 is disposed between the link portion 30 and the drug coating layer 42 is also included in the present invention.
　薬剤被覆層４２は、薬剤およびポリマーが溶媒に溶解されて調製された塗布液を重ね塗りすることによって形成されており、重ね塗り層の長さを順次異ならせることによって、薬剤被覆層４２の厚みを漸減させている。このため、他の経路３２および湾曲部２５に連続する直線状部２１の端部における薬剤被覆層４２の厚さは、図６に示すように、リンク部３０に向って階段状に漸減している。したがって、薬剤被覆層４２の厚さを増加させた場合であっても、リンク部３０の近傍に位置する薬剤被覆層４２の厚みは薄いため、薬剤被覆層４２の増加に起因する、薬剤被覆層４２の剥離あるいは脱落が抑止されるため、薬剤の必要量を容易に確保することが可能である。 The drug coating layer 42 is formed by recoating a coating solution prepared by dissolving a drug and a polymer in a solvent, and the thickness of the drug coating layer 42 is changed by sequentially varying the length of the overcoating layer. Is gradually reduced. For this reason, the thickness of the drug coating layer 42 at the end of the linear portion 21 continuing to the other path 32 and the curved portion 25 is gradually reduced stepwise toward the link portion 30 as shown in FIG. Yes. Therefore, even when the thickness of the drug coating layer 42 is increased, the drug coating layer 42 located in the vicinity of the link portion 30 is thin, so that the drug coating layer is caused by the increase in the drug coating layer 42. Since the peeling or dropping of 42 is suppressed, it is possible to easily secure the necessary amount of the medicine.
　以上説明したように、本実施形態に係るステント１０は、直線状部２１、２２、２４と湾曲部２３、２５が交互に連なる波状の線状部材を環状に形成した複数の環状体２０と、隣接する環状体２０を湾曲部２５同士で接続したリンク部３０と、を有する。また、リンク部３０およびリンク部３０に接続される湾曲部２５を含む領域において、互いに交差する一の経路３１および他の経路３２を有し、一の経路３１にのみ、薬剤を含む薬剤被覆層４２が形成されている。このように構成されたステント１０によれば、リンク部３０およびリンク部３０に接続される湾曲部２５を含む領域内の一の経路３１にのみ薬剤被覆層４２が形成されているため、リンク部３０に薬剤被覆層が形成されていないステントと比較して、治療成績が向上する。また、湾曲部２５の内湾側への薬剤被覆層４２の形成が避けられ、薬剤被覆層４２が剥がれてしまうことを抑制することができる。以上から、治療成績の低下を抑制しつつ、薬剤被覆層４２の剥がれを抑制できるステント１０を提供することができる。 As described above, the stent 10 according to the present embodiment includes the plurality of annular bodies 20 in which the linear portions 21, 22, 24 and the curved portions 23, 25 are alternately formed in a ring shape, And a link portion 30 in which the adjacent annular bodies 20 are connected by the curved portions 25. Moreover, in the area | region containing the curved part 25 connected to the link part 30 and the link part 30, it has the one path | route 31 and the other path | route 32 which mutually cross | intersect, and the chemical | medical agent coating layer which contains a chemical | medical agent only in the one path | route 31 42 is formed. According to the stent 10 configured in this way, the drug coating layer 42 is formed only in one path 31 in the region including the link portion 30 and the curved portion 25 connected to the link portion 30, and thus the link portion Compared with the stent in which the drug coating layer is not formed on 30, the treatment result is improved. Moreover, formation of the chemical | medical agent coating layer 42 to the inner bay side of the curved part 25 can be avoided, and it can suppress that the chemical | medical agent coating layer 42 peels. From the above, it is possible to provide the stent 10 that can suppress the peeling of the drug coating layer 42 while suppressing the decrease in the treatment result.
　また、一の経路３１は、軸方向Ｄ１に沿って隣り合う直線状部２４同士を直線状に接続するように設けられており、一の経路３１にのみ、薬剤被覆層４２が形成されている。このように構成されたステント１０によれば、他の経路３２よりも湾曲部２５の内湾側に薬剤被覆層４２が形成される虞が低いため、薬剤被覆層４２が剥がれてしまうことをより好適に抑制することができる。 In addition, the one path 31 is provided so as to linearly connect the linear portions 24 adjacent to each other along the axial direction D1, and the drug coating layer 42 is formed only in the one path 31. . According to the stent 10 configured in this manner, it is more preferable that the drug coating layer 42 is peeled off because the risk of the drug coating layer 42 being formed on the inner bay side of the curved portion 25 is lower than the other paths 32. Can be suppressed.
　また、環状体２０のうち薬剤被覆層４２が形成される部位（直線状部２１、２２、２４に相当）および薬剤被覆層４２の間には、接着性を向上させるためのプライマー被覆層４０（接着層に相当）が設けられ、リンク部３０の一の経路３１および薬剤被覆層４２の間には、プライマー被覆層４０が設けられない。このように構成されたステント１０によれば、リンク部３０および薬剤被覆層４２の間にプライマー被覆層４０が設けられる構成と比較して、プライマー被覆層４０の量を低減することができるため、プライマー被覆層４０に起因する炎症を低減することができる。 In addition, a primer coating layer 40 (in order to improve adhesiveness) between the portion of the annular body 20 where the drug coating layer 42 is formed (corresponding to the linear portions 21, 22, 24) and the drug coating layer 42 is provided. The primer coating layer 40 is not provided between the one path 31 and the drug coating layer 42 of the link portion 30. According to the stent 10 configured in this way, the amount of the primer coating layer 40 can be reduced as compared with the configuration in which the primer coating layer 40 is provided between the link portion 30 and the drug coating layer 42. Inflammation caused by the primer coating layer 40 can be reduced.
　また、薬剤被覆層４２は、環状体２０およびリンク部３０の外表面側にのみ被覆されている。このように構成されたステント１０によれば、薬剤被覆層４２が内表面側にも被覆されている構成と比較して、ステント１０が早期に血管組織内に包み込まれる。 Further, the drug coating layer 42 is coated only on the outer surface side of the annular body 20 and the link part 30. According to the stent 10 configured as described above, the stent 10 is encapsulated in the vascular tissue at an early stage as compared with the configuration in which the drug coating layer 42 is also coated on the inner surface side.
　また、薬剤被覆層４２は、一の経路３１において、連続的に被覆されている。このように構成されたステント１０によれば、薬剤被覆層が断続的に被覆されている構成と比較して、治療成績が向上する。 Further, the drug coating layer 42 is continuously coated in one path 31. According to the stent 10 configured in this manner, the treatment result is improved as compared with the configuration in which the drug coating layer is intermittently coated.
　以上、実施形態を通じて本発明に係るステント１０を説明したが、本発明は実施形態において説明した構成のみに限定されることはなく、特許請求の範囲の記載に基づいて適宜変更することが可能である。 As mentioned above, although the stent 10 which concerns on this invention was demonstrated through embodiment, this invention is not limited only to the structure demonstrated in embodiment, It can change suitably based on description of a claim. is there.
　例えば、上述した実施形態では、一の経路３１にのみ薬剤被覆層４２が形成されていた。しかしながら、図７に示すように、他の経路３２にのみ薬剤被覆層４２が形成されていてもよい。 For example, in the above-described embodiment, the drug coating layer 42 is formed only in the one path 31. However, as shown in FIG. 7, the drug coating layer 42 may be formed only in the other path 32.
　また、上述した実施形態では、薬剤被覆層４２は、一の経路３１において、連続的に被覆されていた。しかしながら、薬剤被覆層は、一の経路３１において、断続的に被覆されていてもよい。 In the above-described embodiment, the drug coating layer 42 is continuously coated in the one path 31. However, the drug coating layer may be intermittently coated in one path 31.
　また、上述した実施形態では、環状体２０は、波状に折り返されつつ周方向Ｄ２に延在して、無端の環状形状を形作っていた。しかしながら、ステントは、波状に折り返されつつ周方向Ｄ２に延在して、らせん形状を形作ってもよい。 In the above-described embodiment, the annular body 20 extends in the circumferential direction D2 while being folded back in a wave shape to form an endless annular shape. However, the stent may extend in the circumferential direction D2 while being folded in a wave shape to form a spiral shape.
　本出願は、２０１８年３月１５日に出願された日本国特許出願第２０１８－０４８４６１号に基づいており、その開示内容は、参照により全体として引用されている。 This application is based on Japanese Patent Application No. 2018-048461 filed on Mar. 15, 2018, the disclosure of which is incorporated by reference in its entirety.
　　１０　　ステント、
　　２０　　環状体、
　　２１　　直線状部、
　　２２　　直線状部、
　　２３　　湾曲部、
　　２４　　直線状部、
　　２５　　湾曲部、
　　３０　　リンク部、
　　３１　　一の経路、
　　３２　　他の経路、
　　４０　　プライマー被覆層（接着層）、
　　４２　　薬剤被覆層、
　　Ｄ１　　軸方向、
　　Ｄ２　　周方向。 10 stent,
20 annulus,
21 linear part,
22 linear part,
23 curved part,
24 linear part,
25 curved part,
30 link part,
31 One route,
32 Other routes,
40 Primer coating layer (adhesive layer),
42 drug coating layer,
D1 axial direction,
D2 circumferential direction.

Claims (5)

  1. 　直線状部と湾曲部が交互に連なる波状の線状部材を環状に形成した複数の環状体と、
    　隣接する前記環状体を前記湾曲部同士で接続したリンク部と、を有し、
    　前記リンク部および前記リンク部に接続される前記湾曲部を含む領域において、互いに交差する一の経路および他の経路を有し、
    　前記一の経路および前記他の経路のうち一方の経路にのみ、薬剤を含む薬剤被覆層が形成されているステント。     A plurality of annular bodies in which wavy linear members in which linear portions and curved portions are alternately arranged are annularly formed;
    A link portion connecting the adjacent annular bodies with the curved portions, and
    In a region including the link part and the curved part connected to the link part, the cross part has one path and another path crossing each other,
    A stent in which a drug coating layer containing a drug is formed only in one of the one path and the other path.
  2. 　前記一の経路は、軸方向に沿って隣り合う前記直線状部同士を一直線となるように接続しており、
    　前記一の経路および前記他の経路のうち前記一の経路にのみ、前記薬剤被覆層が形成されている、請求項１に記載のステント。     The one path connects the linear portions adjacent in the axial direction so as to be in a straight line,
    The stent according to claim 1, wherein the drug coating layer is formed only in the one path among the one path and the other path.
  3. 　前記環状体のうち前記薬剤被覆層が形成される部位および前記薬剤被覆層の間には、接着性を向上させるための接着層が設けられ、
    　前記リンク部および前記薬剤被覆層の間には、前記接着層が設けられない、請求項１または請求項２に記載のステント。     An adhesive layer for improving adhesiveness is provided between a portion of the annular body where the drug coating layer is formed and the drug coating layer,
    The stent according to claim 1 or 2, wherein the adhesive layer is not provided between the link portion and the drug coating layer.
  4. 　前記薬剤被覆層は、前記環状体および前記リンク部の外表面側にのみ形成されている、請求項１～３のいずれか１項に記載のステント。 The stent according to any one of claims 1 to 3, wherein the drug coating layer is formed only on an outer surface side of the annular body and the link portion.
  5. 　前記薬剤被覆層は、前記一方の経路において、連続的に形成されている、請求項１～４のいずれか１項に記載のステント。 The stent according to any one of claims 1 to 4, wherein the drug coating layer is continuously formed in the one path.
PCT/JP2019/009414 2018-03-15 2019-03-08 Stent WO2019176790A1 (en)

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Citations (4)

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Publication number Priority date Publication date Assignee Title
US20070032858A1 (en) * 2002-11-12 2007-02-08 Advanced Cardiovascular Systems, Inc. Stent with drug coating
US20070032856A1 (en) * 2002-09-30 2007-02-08 Advanced Cardiovascular Systems, Inc. Drug eluting stent
WO2010032643A1 (en) * 2008-09-17 2010-03-25 テルモ株式会社 Stent
WO2015046022A1 (en) * 2013-09-27 2015-04-02 テルモ株式会社 Stent, and stent production method

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070032856A1 (en) * 2002-09-30 2007-02-08 Advanced Cardiovascular Systems, Inc. Drug eluting stent
US20070032858A1 (en) * 2002-11-12 2007-02-08 Advanced Cardiovascular Systems, Inc. Stent with drug coating
WO2010032643A1 (en) * 2008-09-17 2010-03-25 テルモ株式会社 Stent
WO2015046022A1 (en) * 2013-09-27 2015-04-02 テルモ株式会社 Stent, and stent production method

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