JP4473390B2 - Stents and stent-grafts - Google Patents

Stents and stent-grafts Download PDF

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JP4473390B2
JP4473390B2 JP2000001255A JP2000001255A JP4473390B2 JP 4473390 B2 JP4473390 B2 JP 4473390B2 JP 2000001255 A JP2000001255 A JP 2000001255A JP 2000001255 A JP2000001255 A JP 2000001255A JP 4473390 B2 JP4473390 B2 JP 4473390B2
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stent
anti
layer
coating layer
tubular body
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JP2001190687A (en
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悦夫 土金
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川澄化学工業株式会社
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【0001】 [0001]
【発明の属する技術分野】 BACKGROUND OF THE INVENTION
本発明は血管等の生体内に生じた狭窄部の改善に使用されるステント及びステントグラフトの改良に関し、特に生物学的活性物質を含んだポリマー材料に覆われ、抗血栓性の表面を提供し、再狭窄を予防するステント及びステントグラフトに関する。 The present invention relates to improvements in stents and stent grafts that are used to improve the stenosis occurring in a living body such as blood vessels, covered with particular polymeric material including biologically active material, provide a surface of the anti-thrombotic, a stent and stent-grafts to prevent restenosis.
【0002】 [0002]
【従来の技術及び発明が解決しようとする課題】 A conventional technology and to be Solved by the Invention
ステントのほとんどはステンレスやTi−Ni系形状記憶金属等の金属製であり、血栓または血餅の形成が起こりやすく、内皮細胞でステント表面が覆われるまでの術後約2週間は補足的な治療目的でへパリン等の抗凝固剤の投与を行う必要がある。 Most stents are made of metal such as stainless steel or Ti-Ni based shape memory metal, tends to occur the formation of thrombus or blood clot, approximately 2 weeks after surgery until covered stent surface in endothelial cells supplemental treatment it is necessary to perform the administration of the anti-coagulant heparin, etc. to the purpose. このため患者の様態によっては副作用により出血を伴う等の合併症が起こる危険性があった。 Therefore, depending on aspects of the patient there is a risk of complications can occur, such as involving bleeding as a side effect. ここで、抗凝固剤の投与量、投与期間を減少することが可能であれば、合併症についても減少することが可能であるばかりでなく、入院期間の短縮につなげることが可能となる。 Here, the dosage of anticoagulant, is to reduce the period of administration, if possible, not only it is possible to reduce also complications, it is possible to lead to shorter hospital stay.
【0003】 [0003]
また抗凝固剤のような薬剤をステントへの供給も試みられ、抗凝固剤、抗血小板剤の単独または併用の開示例が特開平8−224297、特開平8−33718に示されている。 Also agents such as anticoagulants attempted also supplied to the stent, anticoagulants, disclose examples alone or in combination of antiplatelet agents is shown in JP-A-8-224297, JP-A-8-33718. しかしながら、それぞれの薬剤が有する特性の相乗効果を具体的に利用した発明は、いまだ開示されていない。 However, the invention has not yet been disclosed as specifically utilizing the synergistic effect of the characteristics of each agent has.
そこで本発明者は以上の課題を解決するために鋭意検討を重ねた結果次の発明に到達した。 The present inventor has reached the intensive result of extensive study following invention to solve the above problems.
【0004】 [0004]
【課題を解決するための手段】 In order to solve the problems]
[1]本発明は、管状のステント基材(31)の外周面に第一被覆層(32)を被覆し、 [1] The present invention, the first coating layer (32) coated on the outer peripheral surface of the tubular stent base material (31),
当該第一被覆層(32)の外周面に、第二被覆層(33)を被覆し、 The outer peripheral surface of the first coating layer (32), covering the second coating layer (33),
前記第一被覆層(32)は、抗血小板剤または抗トロンビン剤のいずれか一つを含み、 Said first coating layer (32) includes any one of the anti-platelet or anti-thrombin agents,
前記第二被覆層(33)は、前記第一被覆層(32)に含まれていない抗トロンビン剤または抗血小板剤のいずれか一つを含む、ステント(30)を提供する。 It said second coating layer (33) comprises any one of antithrombin or anti-platelet agents not included in the first coating layer (32), to provide a stent (30).
]本発明は、抗血小板剤または抗トロンビン剤のいずれか一つを含むポリマーよりなる内層管状体と、 [2] The present invention includes an inner layer tubular body made of polymer comprising any one of the anti-platelet or anti-thrombin agents,
当該内層管状体に含まれない抗トロンビン剤または抗血小板剤のいずれか一つを含む外層管状体とからなる多層管状体を、管状のステント基材の外周面に被嵌した、ステントグラフトを提供する。 The multilayer tubular body consisting of an outer layer tubular body containing any one of antithrombin or anti-platelet agents not included in the inner layer tubular body, and fitted with the outer peripheral surface of the tubular stent substrate, providing a stent-graft .
[3]本発明は、 前記抗血小板剤がシロスタゾールであり、前記抗トロンビン剤がアルガトロバンである、[1]に記載のステント(30)または[2]に記載のステントグラフトを提供する。 [3] The present invention, the antiplatelet agent is cilostazol, the antithrombin is argatroban, providing stent graft according to the stent (30) or [2] described in [1].
]本発明は、前記ポリマーが熱可塑性ポリウレタン、ポリアミド、ポリエステル、ポリエチレン、ポリプロピレン、これらのポリマーの二種以上の混合物、ブレンド、コポリマーを含む、[1]から[3]のいずれか1項に記載のステント(30)またはステントグラフトを提供する。 [4] The present invention, wherein the polymer is a thermoplastic polyurethane, polyamide, polyester, polyethylene, polypropylene, mixtures of two or more of these polymers, blends, including copolymers, any one of [1] to [3] to provide a stent (30) or stent-graft according to.
【0005】 [0005]
【発明の実施の形態】 DETAILED DESCRIPTION OF THE INVENTION
本発明のステント及びステントグラフトは基材及び基材に被覆される被覆層または基材の外周に被嵌される管状体とからなる。 The stent and stent graft of the present invention consists of a tubular body which is fitted on the outer periphery of the covering layer or substrate is coated substrate and the substrate. 基材は例えばSUS316等のステンレススチール、Ni-Ti合金等の材質からなるパイプ、平板をレーザー加工することにより表面に所定のパターンを形成した略管状体やワイヤーにより形成した網目状の略管状体等が使用されるが、略管状体の形状については目的の物性が得られるものであれば特に限定されるものではない。 The substrate, for example, stainless steel such as SUS316, Ni-Ti alloy pipe made of a material of a flat plate mesh generally tubular body formed by a substantially tubular body or a wire having a predetermined pattern formed on the surface by laser machining of a Although like it is used, but the invention is not particularly limited as long as the property of the object is obtained on the shape of the generally tubular body.
【0006】 [0006]
図1は本発明のステントの一例を示す概略図で、ステント10はステンレススチール製の基材11から構成され、その外周面に抗血小板剤及び抗トロンビン剤を含んだポリマー層12が被覆されている。 Figure 1 is a schematic diagram showing an example of a stent of the present invention, stent 10 is composed of a stainless steel substrate 11, a polymer layer 12 containing an anti-platelet and anti-thrombin agents on the outer peripheral surface thereof is coated there. 図2は図1の断面図でポリマー層12には抗血小板剤13と抗トロンビン剤14が分散して含まれている。 Figure 2 is the polymer layer 12 in a cross-sectional view of FIG. 1 antiplatelet 13 and antithrombin agent 14 is contained in the dispersion. 被覆の方法は抗血小板剤及び抗トロンビン剤とポリマーとを異なる溶媒で溶解して混合し、スプレーによる被覆やディッピングによる被覆が可能である。 The method of coating were mixed by dissolving and the polymer antiplatelet agents and anti-thrombin agents in different solvents, it is possible to coating with the coating or dipping with a spray. スプレー、ディッピングの回数は一回でも良いがポリマーの濃度等により被覆層の厚さを調整するため複数回に分けて行う方法が通常用いられる。 Spray, the number of dipping method for performing a plurality of times to adjust the thickness of the coating layer by good even once the concentration of the polymer or the like is usually used.
【0007】 [0007]
本発明に使用されるポリマーとしては、熱可塑性ポリウレタン、ポリアミド、ポリエステル、ポリエチレン、ポリプロピレン、これらのポリマーの二種以上の混合物、ブレンド、コポリマー等が挙げられるが、これらに限定されるものではなく、生体適合性に優れているポリマーであれば何でも使用することができる。 The polymer used in the present invention, a thermoplastic polyurethane, polyamide, polyester, polyethylene, polypropylene, mixtures of two or more of these polymers, blends, and copolymers, and the like, is not limited to, anything can be used as long as it is a polymer excellent in biocompatibility.
【0008】 [0008]
図3は基材21の内周面と外周面に抗血小板剤と抗トロンビン剤を含むポリマーの被覆層(内層22と外層23)を設けたステント20の一例である。 Figure 3 is an example of a stent 20 which is provided coating layer of a polymer including antiplatelet agents and anti-thrombin agent to the inner and outer peripheral surfaces of the substrate 21 (inner 22 and outer layer 23). 内層22と外層23を基材21の内外の両面に被覆するにはディッピングによる被覆が有効である。 To coat the lining 22 and the outer layer 23 on both sides of the inside and outside of the substrate 21 is effective coating with dipping.
【0009】 [0009]
図4のステント30は基材31の外周面に抗トロンビン剤または抗血小板剤を含むポリマー層(第一被覆層)32を被覆し、さらにその外周面に抗血小板剤または抗トロンビン剤を含むポリマー層(第二被覆層)33を被覆した例である。 Figure stent 30 of 4 polymer layer containing antithrombin or anti-platelet agent to the outer circumferential surface of the substrate 31 (first coating layer) 32 was coated, further polymers containing the anti-platelet agent or an anti-thrombin agent to the outer circumferential surface layer is an example of coating (second coating layer) 33. 本実施例では基材31の外周面に抗トロンビン剤または抗血小板剤とポリマーの混合溶液をスプレーしてポリマー層32を被覆し、これを乾燥させた後に抗血小板剤または抗トロンビン剤とポリマーの混合溶液をスプレーしてポリマー層32の外周面にポリマー層33の被覆を行ったものである。 The polymer layer 32 was coated by spraying a mixed solution of an outer peripheral surface antithrombin or anti-platelet agent and the polymer substrate 31 in the present embodiment, which after drying antiplatelet or anti-thrombin agent and polymer mixed solution in which it was coated polymer layer 33 on the outer circumferential surface of the sprayed polymer layer 32 a. 使用したポリマーはポリマー層32とポリマー層33で双方とも熱可塑性ポリウレタンを使用し、同一のものを使用したが、接着力が得られる組み合わせであればポリマー層32とポリマー層33に使用するポリマーは異なる種類の組み合わせも可能である。 Polymer used was both using the thermoplastic polyurethane with a polymer layer 32 and polymer layer 33, the polymer was used the same thing, to be used in the polymeric layer 32 as long as the combination of the adhesive force can be obtained a polymer layer 33 combinations are possible different types.
【0010】 [0010]
図5は本発明のステントグラフト40の一例である。 Figure 5 is an example of a stent graft 40 of the present invention. 基材41の外周面に抗血小板剤と抗トロンビン剤を含むポリマーからなる管状体42を被嵌したもので、管状体42はステントグラフト40の縮小時から拡張時のサイズまで伸縮が可能である。 The tubular body 42 comprising a polymer comprising an anti-platelet agent and the anti-thrombin agent to the outer circumferential surface of the base material 41 which was fitted over the tubular body 42 can be stretch to size during expansion from time of reduction of the stent graft 40. また管状体42は単層または二層以上の多層体を使用することができる。 The tubular body 42 may use a single layer or two or more layers of the multilayer body.
単層の場合、管状体42は抗血小板剤と抗トロンビン剤を含むポリマーから形成されるが、多層管状体の場合、管状体42は内層管状体を抗血小板剤または抗トロンビン剤のみを含むポリマーで形成し、外層管状体を抗トロンビン剤または抗血小板剤のみを含むポリマーで形成しても良い。 Case of a single layer, but the tubular body 42 is formed from a polymer containing an anti-platelet agent and antithrombin agent, the case of a multilayer tubular body, the tubular body 42 is a polymer containing only antiplatelet or anti-thrombin agents inner tubular member in formation and may form the outer layer tubular body with a polymer containing only antithrombin or anti-platelet agent.
【0011】 [0011]
【実施例】 【Example】
(実施例1) (Example 1)
テコフレックス100A(熱可塑性ポリウレタン)の10重量%溶液(溶媒THF)と、シロスタゾール、アルガトロバンをそれぞれ5重量%溶解したメタノールとを混合し、SUS316製のステント基材11の外周面にスプレーにより吹き付け、乾燥を5回繰り返して厚さ70μmのポリマー層12を形成した。 10 wt% solution of Tecoflex 100A (thermoplastic polyurethane) (solvent THF), cilostazol, mixing the methanol dissolved respectively 5 wt% of argatroban, sprayed by a spray on the outer peripheral surface of the SUS316-made stent substrate 11, dried 5 times repeatedly to form a polymeric layer 12 having a thickness of 70 [mu] m.
(実施例2) (Example 2)
バイオネート80A(ポリカーボネートタイプ熱可塑性ポリウレタン)の7重量%THF溶液とアルガトロバンの10重量%メタノール溶液の混合溶液をSUS316製のステント基材31の外周面にスプレーにて吹き付け、乾燥を5回繰り返してポリマー層32を形成した後、さらにポリマー層32の外周面にバイオネート80Aの7重量%THF溶液とシロスタゾールの10重量%メタノール溶液の混合溶液をスプレーにて吹き付け、乾燥を5回繰り返して厚さ70μmのポリマー層33を形成した。 Spraying with the mixed solution of 10 wt% methanol solution of 7 wt% THF solution and argatroban bio sulfonate 80A (polycarbonate type thermoplastic polyurethane) on the outer peripheral surface of the SUS316-made stent substrate 31, dried 5 times repeatedly after forming the polymer layer 32, further mixed solution spraying with, repeatedly thickness drying 5 times 10 wt% methanol solution of 7 wt% THF solution and cilostazol bio sulfonate 80A on the outer circumferential surface of the polymer layer 32 thereby forming a polymer layer 33 of 70 [mu] m.
(実施例3) (Example 3)
テコフレックス100Aにシロスタゾールとアルガトロバンをそれぞれ5重量%、合わせて10重量%の量で小型混連機で190℃にてコンパウンド化し、これを15mm押出機にて1.45mm×1.50mmのサイズの管状体42を成形し、ステント基材41の長さにあわせて切断し、ステント基材41に被嵌しステントグラフト40を作製した。 Each 5% by weight of cilostazol and argatroban Tecoflex 100A, combined with compounding at 190 ° C. in an amount of 10 wt% with a small kneading machine, the size of 1.45 mm × 1.50 mm this at 15mm extruder the tubular body 42 is molded, and cut to match the length of the stent base material 41 to produce a fitted and graft 40 to the stent base material 41.
(実施例4) (Example 4)
テコフレックス100Aにシロスタゾールを15重量%の量で混連したコンパウンドとテコフレックス100Aにアルガトロバン15重量%で混連したコンパウンドとを12mm/15mmの2台の押出機使用して、それぞれの層の厚さ25μmとし、1.45mm×1.50mmの二層チューブを成形し、管状体42 層)テコフレックス100A/シロスタゾール10重量%、( 層)テコフレックス100A/アルガトロバン10重量% を作製し、これをステント基材41に被嵌しステントグラフト40を作製した。 Cilostazol kneading the compounded with Tecoflex 100A in an amount of 15 wt% to Tecoflex 100A and compound was kneading in argatroban 15 wt% by using two extruders of 12 mm / 15 mm, the thickness of each layer It is a 25 [mu] m, and forming a two-layer tube of 1.45 mm × 1.50 mm, the tubular body 42 '(outer layer) Tecoflex 100A / cilostazol 10 wt%, (inner layer) Tecoflex 100A / argatroban 10 wt% of It was prepared, which was produced fitted to the stent graft 40 to the stent base material 41.
【0012】 [0012]
作製したステント(実施例1)及びステントグラフト(実施例4)を37℃、ph7.4のリン酸緩衝液中に浸漬し、経時的に50回振盪した後、シロスタゾールとアルガトロバンの溶出量及び溶出速度を測定した。 Preparation stent (Example 1) and stent graft (Example 4) 37 ° C., and immersed in a phosphate buffer of ph 7.4, after time shaken 50 times, the eluted amount and elution rate of cilostazol and argatroban It was measured. その結果をそれぞれ表1(実施例1)、表2(実施例4)に示した。 The results are in Table 1 (Example 1), shown in Table 2 (Example 4). 実施例1ではシロスタゾールとアルガトロバンの溶出性に差はほとんど見られなかったが、実施例4ではシロスタゾールとアルガトロバンの溶出性が短期間(直後より3日間)と長期間(直後より2週間)と時間差があり、被覆層の種類、構成、製法、及び薬剤の配合量の違いによって薬剤の徐放性の調整が可能なことが確認された。 Although differences in dissolution of Example 1, cilostazol and argatroban was hardly observed, Example 4 in dissolution of cilostazol and argatroban short term (3 days immediately after) and long term (2 weeks from immediately after) the time difference There are the type of coating layer, configuration, manufacturing method, and it can be adjusted in the slow release of the drug was confirmed by a difference amount of the drug.
【0013】 [0013]
【表1】 [Table 1]
【0014】 [0014]
【表2】 [Table 2]
【0015】 [0015]
【発明の作用効果】 [Effect of the invention]
本発明のステント及びステントグラフトによれば抗血小板剤と抗トロンビン剤の効果を相乗的に利用できる。 Synergistically utilize the effects of antiplatelet agents and anti-thrombin agents according to the stents and stent-grafts of the present invention. すなわち抗血小板剤により血小板粘着を阻害し、抗トロンビン剤により血液凝固反応の開始と進展の抑制が可能となる。 That the anti-platelet agent to inhibit platelet adhesion, it is possible to suppress the initiation and progression of the blood coagulation reaction by antithrombin. また、基材に被覆ないし被嵌するポリマー層の厚さと抗血小板剤及び抗トロンビン剤の配合量を調整すればステント留置直後の即効的な薬剤放出から内皮細胞再生までの2週間までの長期間に渡って薬剤が血液中に徐放するようにコントロールすることが可能になる。 Also, long-term from the coating or by adjusting the amount of thickness and antiplatelet agents and anti-thrombin agents of the fitting to the polymer layer immediately after stenting immediate drug release in the substrate up to 2 weeks up to endothelial cell regeneration agent it is possible to control so as to slow release into the blood over. また抗凝固剤の静注による副作用発生も低減でき、患者に負担の少ない治療が実現できる。 The side effects caused by intravenous injection of anticoagulants can be reduced, less treatment burden on the patient can be achieved. さらに抗血小板剤として使用するシロスタゾ−ルには平滑筋細胞増殖抑制効果及び内皮再生促進効果も有しているのでステント留置による再狭窄の危険性をより低減できるものである。 Further Shirosutazo used as an antiplatelet agent - in Le those that can further reduce the risk of restenosis stenting so also has smooth muscle cell proliferation inhibitory effect and endothelial regeneration promoting effect.
【図面の簡単な説明】 BRIEF DESCRIPTION OF THE DRAWINGS
【図1】本発明のステントの概略図【図2】図1のステントの断面図【図3】本発明のステントの概略図【図4】本発明のステントの概略図【図5】本発明のステントグラフトの概略図【符号の説明】 Schematic view of the stent of the present invention; FIG 2 is a schematic view of a stent cross-sectional view of the stent of Figure 1 a schematic view of the stent of the present invention; FIG 4 shows the invention [5] The present invention schematic view of the stent graft [description of symbols]
10 、20、30 ステント11、21、31 基材12 ポリマー層13 抗血小板剤14 抗トロンビン剤22 内層23 外層32 抗トロンビン剤を含むポリマー層(第一被覆層) 10, 20, 30 the stent 11, 21, 31 substrate 12 polymer layer 13 antiplatelet agent 14 antithrombin 22 inner 23 outer layer 32 antithrombin agents polymeric layer comprising (first coating layer)
33 抗血小板剤を含むポリマー層(第二被覆層) Polymer layer containing 33 anti-platelet agent (second coating layer)
40 ステントグラフト41 基材42 管状体 40 the stent graft 41 substrate 42 the tubular body

Claims (4)

  1. 管状のステント基材(31)の外周面に第一被覆層(32)を被覆し、 The first coating layer (32) coated on the outer peripheral surface of the tubular stent base material (31),
    当該第一被覆層(32)の外周面に、第二被覆層(33)を被覆し、 The outer peripheral surface of the first coating layer (32), covering the second coating layer (33),
    前記第一被覆層(32)は、抗血小板剤または抗トロンビン剤のいずれか一つを含み、 Said first coating layer (32) includes any one of the anti-platelet or anti-thrombin agents,
    前記第二被覆層(33)は、前記第一被覆層(32)に含まれていない抗トロンビン剤または抗血小板剤のいずれか一つを含む、ことを特徴とするステント(30)。 It said second coating layer (33) comprises any one of antithrombin or anti-platelet agents not included in the first coating layer (32), the stent (30), characterized in that.
  2. 抗血小板剤または抗トロンビン剤のいずれか一つを含むポリマーよりなる内層管状体と、 An inner layer tubular body made of polymer comprising any one of the anti-platelet or anti-thrombin agents,
    当該内層管状体に含まれない抗トロンビン剤または抗血小板剤のいずれか一つを含む外層管状体とからなる多層管状体を、管状のステント基材の外周面に被嵌した、ことを特徴とするステントグラフト。 The multilayer tubular body consisting of an outer layer tubular body containing any one of antithrombin or anti-platelet agents not included in the inner layer tubular body, and fitted with the outer peripheral surface of the tubular stent substrate, and wherein the stent graft to be.
  3. 前記抗血小板剤がシロスタゾールであり、前記抗トロンビン剤がアルガトロバンであることを特徴とする請求項1に記載のステント(30)または請求項2に記載のステントグラフト。 Wherein an antiplatelet agent is cilostazol, stent graft according to the stent (30) or claim 2 of claim 1, wherein the antithrombin agent characterized in that it is a argatroban.
  4. 前記ポリマーが熱可塑性ポリウレタン、ポリアミド、ポリエステル、ポリエチレン、ポリプロピレン、これらのポリマーの二種以上の混合物、ブレンド、コポリマーを含む、ことを特徴とする請求項1から請求項3のいずれか1項に記載のステント(30)またはステントグラフト。 Wherein the polymer is a thermoplastic polyurethane, polyamide, polyester, polyethylene, polypropylene, mixtures of two or more of these polymers, blends, wherein comprising the copolymer, from claim 1, characterized in that in any one of claims 3 of the stent (30) or stent-graft.
JP2000001255A 2000-01-07 2000-01-07 Stents and stent-grafts Expired - Fee Related JP4473390B2 (en)

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