JP2001190687A - Stent and stent graft - Google Patents

Stent and stent graft

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Publication number
JP2001190687A
JP2001190687A JP2000001255A JP2000001255A JP2001190687A JP 2001190687 A JP2001190687 A JP 2001190687A JP 2000001255 A JP2000001255 A JP 2000001255A JP 2000001255 A JP2000001255 A JP 2000001255A JP 2001190687 A JP2001190687 A JP 2001190687A
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stent
agent
anti
polymer
peripheral surface
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JP4473390B2 (en
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Etsuo Tsuchikane
悦夫 土金
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Kawasumi Lab Inc
川澄化学工業株式会社
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Abstract

PROBLEM TO BE SOLVED: To provide a stent and a stent graft which can synergistically utilize the effects of an antiplatelet agent and an antithrombin agent. SOLUTION: The stent is obtained by coating the outer peripheral surface and/or inner peripheral surface of a base material with a polymer containing the antiplatelet agent and antithrombin agent. The stent graft is obtained by putting a tubular body having one or two or more polymer layers containing the antiplatelet agent and/or antithrombin agent on the outer peripheral surface of a base material.

Description

【発明の詳細な説明】 DETAILED DESCRIPTION OF THE INVENTION

【0001】 [0001]

【発明の属する技術分野】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 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 especially polymeric material including biologically active material, an antithrombotic providing sexual surface, 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】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 Most stent BACKGROUND OF INVENTION Problems to be Solved] is made of metal such as stainless steel or Ti-Ni based shape memory metal, it tends to occur the formation of thrombus or blood clot, covering the stent surface with endothelial cells postoperative to divide about 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。 Week, it is necessary to perform the administration of anticoagulant heparin such as to at supplemental treatment purposes. 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】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8−33 [0003] agents such as anticoagulants attempted also supplied to the stent, anticoagulants, disclose examples alone or in combination of antiplatelet agents Hei 8-224297, Hei 8-33
718に示されている。 It has been shown in 718. 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】[1]本発明は抗血小板剤及び抗トロンビン剤を含むポリマーを基材の外周面及び/又は内周面に被覆したステントである。 SUMMARY OF THE INVENTION [1] The present invention is a stent coated with the outer peripheral surface and / or the inner circumferential surface of the base polymer containing the anti-platelet and anti-thrombin agents. [2]本発明は抗血小板剤及び/又は抗トロンビン剤を含む第一被覆層と第二被覆層を基材の外周面に形成したステントである。 [2] The present invention is a stent to form a first coating layer and second coating layer comprising an anti-platelet agent and / or anti-thrombin agents to the outer peripheral surface of the base material. [3]本発明は抗血小板剤及び/又は抗トロンビン剤を含むポリマーよりなる単層又は二層以上の管状体を基材の外周面に被嵌したステントグラフトである。 [3] The present invention is a stent graft that is fitted on the outer peripheral surface of the anti-platelet agent and / or anti-thrombin agents consisting of polymers comprising a single layer or two or more layers of the tubular body substrate. [4]本発明は前記抗血小板剤がシロスタゾールである[1]ないし[3]のステントである。 [4] The present invention is a stent of the to antiplatelet agent is cilostazol [1] to [3]. [5]本発明は前記抗トロンビン剤がアルガトロバンである[1]ないし[3]に記載のステントである。 [5] The present invention is a stent according to the to antithrombin agent is argatroban [1] to [3]. [6]本発明は前記ポリマーが熱可塑性ポリウレタン、 [6] The present invention wherein the polymer is a thermoplastic polyurethane,
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[1]ないし[3]に記載のステントである。 Polyamide, polyester, polyethylene, polypropylene, mixtures of two or more of these polymers, a stent according to the blend, to [1] that comprises a copolymer [3]. 本発明で「アルガトロバン」とは(2R,4R)−4−メチル−1−[N 2 −((RS) The "argatroban" in the present invention (2R, 4R) -4- methyl -1- [N 2 - ((RS )
−3−メチル−1,2,3,4−テトラヒドロ−8−キノリンスルホニル)−L−アルギニル]−2−ピペリジンカルボン酸の1水和物であるが、本発明では「アルガトロバン」とは前記アルガトロバンを含むポリマーから徐放される(2R,4R)−4−メチル−1−[N 2 -3-methyl-1,2,3,4-tetrahydro-8-quinoline-sulfonyl) -L- arginyl] is a monohydrate of 2-piperidine carboxylic acid, in the present invention the term "argatroban" argatroban are slow release from a polymer comprising (2R, 4R) -4- methyl -1- [N 2 -
((RS)−3−メチル−1,2,3,4−テトラヒドロ−8−キノリンスルホニル)−L−アルギニル]−2 ((RS) -3- methyl-1,2,3,4-tetrahydro-8-quinoline-sulfonyl) -L- arginyl] -2
−ピペリジンカルボン酸も意味する。 - also means piperidine carboxylic acid. アルガトロバンは抗凝固剤の中で抗トロンビン剤に分類され、血液凝固反応の開始及びその進展を抑制する作用を有している。 Argatroban is classified as antithrombin agents in the anti-coagulant, and has an action to suppress the onset and progression of the blood coagulation reaction.
「シロスタゾール」とは6−[4−(1―シクロヘキシルテトラゾール−5−イル)ブトキシ]−3,4−ジヒドロカルボスチリルである。 The "cilostazol" is 6- [4- (5-1-cyclohexyl tetrazolyl) butoxy] -3,4-dihydrocarbostyril. シロスタゾ−ルは抗血小板剤であり、血小板の粘着、凝集塊形成を阻害する作用を有している。 Shirosutazo - Le is an anti-platelet agent, and has an effect of inhibiting platelet adhesion, aggregates formation.

【0005】 [0005]

【発明の実施の形態】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 embodiment 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SU The substrate is, for example, SU
S316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。 S316 like stainless steel pipe made of a material such as Ni-Ti alloy, flat laser processing mesh generally tubular body or the like formed by a substantially tubular body or a wire having a predetermined pattern formed on the surface by is used that is, it is not limited particularly as long as the target properties are obtained for the shape of the generally tubular body.

【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 [0006] Figure 1 is a schematic diagram showing an example of a stent of the present invention, stent 10 is a stainless steel substrate 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。 Is configured, the polymer layer 12 containing an anti-platelet and anti-thrombin agents on its outer peripheral surface is coated from. 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】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、 [0007] As 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,
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。 It is not limited to, whatever may be used as long as it is a polymer excellent in biocompatibility.

【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2 [0008] Figure 3 is a coating layer of a polymer including antiplatelet agents and anti-thrombin agent to the inner and outer peripheral surfaces of the substrate 21 (inner layer 2
2と外層23)を設けたステント20の一例である。 2 and the outer layer 23), which is an example of a stent 20 which is provided. 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】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。 [0009] The stent 30 of FIG. 4 is a polymer layer containing an anti-thrombin or anti-platelet agent to the outer circumferential surface of the substrate 31 (first coating layer) 32 was coated, further the outer peripheral surface antiplatelet or anti-thrombin agents it is an example of coating the polymer layer (second coating layer) 33 containing. 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】図5は本発明のステントグラフト40の一例である。 [0010] FIG. 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、多層の場合、管状体42は内層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 42 forms an inner layer of a polymer containing only antiplatelet or anti-thrombin agents, outer layer may be formed of a polymer containing only antithrombin or anti-platelet agent.

【0011】 [0011]

【実施例】(実施例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) EXAMPLES 10 wt% solution of (Example 1) Tecoflex 100A (thermoplastic polyurethane) (solvent 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。 When cilostazol was mixed with methanol, dissolved respectively 5 wt% of argatroban, sprayed by a spray on the outer peripheral surface of the SUS316-made stent substrate 11, thereby forming a polymeric layer 12 having a thickness of 70μm by repeating drying five times. (実施例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1 (Example 2) spraying with the outer peripheral surface of the bio-sulfonate 80A stent substrate 31 mixed solution made SUS316 of 10 wt% methanol solution of 7 wt% THF solution and argatroban (polycarbonate type thermoplastic polyurethane), dried repeated five times after the formation of the polymer layer 32, further 7 wt% THF solution and cilostazol bio sulfonate 80A on the outer circumferential surface of the polymer layer 32 1
0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。 Blowing 0 wt% mixed solution of methanol solution by a spray to form a polymeric layer 33 having a thickness of 70μm by repeating drying five times. (実施例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×1.50 (Example 3) lever respectively 5 wt% cilostazol and argatroban flex 100A, and compounded with combined 190 ° C. in a small kneading machine in an amount of 10 wt%, 1.45 mm × 1 this at 15mm extruder .50
mmのサイズの管状体42を成形し、ステント基材41 Molding the tubular body 42 of mm size, the stent base material 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。 Taken together of the length to produce a fitted and graft 40 to the stent base material 41. (実施例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 (Example 4) lever cilostazol kneading the compounded with Tecoflex 100A in an amount of 15 wt% to flex 100A and kneading the compounded with argatroban 15 wt% by using two extruders of 12 mm / 15 mm, and a thickness of 25μm of the respective layers, 1.45 mm
×1.50mmの二層チューブを成形し、管状体42 × molding a two layer tube of 1.50 mm, the tubular body 42
((内層)テコフレックス100A/シロスタゾール1 ((Inner layer) Tecoflex 100A / cilostazol 1
0重量%、(外層)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 0 wt%, to prepare a (outer layer) Tecoflex 100A / argatroban 10 wt%), which stent substrate 41
に被嵌しステントグラフト40を作製した。 It was produced fitted to the stent graft 40.

【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。 [0012] 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 amount of elution of cilostazol and argatroban and it was measured dissolution rate. 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、 Although the difference was hardly observed in the dissolution of Example 1, cilostazol and argatroban,
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。 There is a time difference (2 weeks from immediately after) Example 4 In dissolution of cilostazol and argatroban short term (3 days immediately after) the long term, the kind of the coating layer, configuration, manufacturing method, and the difference amount of the drug it can be adjusted for the sustained release of the drug has been confirmed.

【0013】 [0013]

【表1】 [Table 1]

【0014】 [0014]

【表2】 [Table 2]

【0015】 [0015]

【発明の作用効果】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。 The effect of antiplatelet and antithrombotic agent according to the stents and stent-grafts of the present invention acts according to the present invention can be synergistically utilized. 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 Schematic view of the stent of the present invention; FIG

【図2】図1のステントの断面図 FIG. 2 is a cross-sectional view of the stent shown in FIG. 1

【図3】本発明のステントの概略図 Schematic view of the stent of the present invention; FIG

【図4】本発明のステントの概略図 Schematic view of the stent of the present invention; FIG

【図5】本発明のステントグラフトの概略図 Schematic view of the stent graft of the present invention; FIG

【符号の説明】 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) 33 抗血小板剤を含むポリマー層(第二被覆層) 40 ステントグラフト 41 基材 42 管状体 10, the polymer layer containing 20, 30 stent 11, 21, 31 substrate 12 polymer layer 13 polymer layer containing the anti-platelet agent 14 antithrombin 22 inner 23 outer layer 32 antithrombin (first coating layer) 33 antiplatelet (second coating layer) 40 grafts 41 substrate 42 the tubular body

Claims (6)

    【特許請求の範囲】 [The claims]
  1. 【請求項1】抗血小板剤及び抗トロンビン剤を含むポリマーを基材の外周面及び/又は内周面に被覆したことを特徴とするステント。 1. A antiplatelet agents and stent, characterized in that the polymer containing antithrombin was coated on the outer peripheral surface and / or the inner circumferential surface of the base material.
  2. 【請求項2】抗血小板剤及び/又は抗トロンビン剤を含む第一被覆層と第二被覆層を基材の外周面に形成したことを特徴とするステント。 Wherein the anti-platelet agent and / or stent, characterized in that the first coating layer comprising an anti-thrombin agent a second coating layer formed on the outer peripheral surface of the base material.
  3. 【請求項3】抗血小板剤及び/又は抗トロンビン剤を含むポリマーよりなる単層又は二層以上の管状体を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。 3. A stent graft, characterized in that the fitted on the outer peripheral surface of the anti-platelet agent and / or anti-thrombin agents consisting of polymers comprising a single layer or two or more layers of the tubular body substrate.
  4. 【請求項4】前記抗血小板剤がシロスタゾールであることを特徴とする請求項1ないし請求項3に記載のステント。 Wherein said stent of claim 1 to claim 3 antiplatelet agent characterized in that it is a cilostazol.
  5. 【請求項5】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ないし請求項3に記載のステント。 Wherein said stent of claim 1 to claim 3 antithrombin agent characterized in that it is a argatroban.
  6. 【請求項6】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、 Wherein said polymer is a thermoplastic polyurethane, polyamide, polyester, polyethylene, polypropylene, mixtures of two or more of these polymers, blends,
    コポリマーを含むことを特徴とする請求項1ないし請求項3に記載のステント。 The stent of claim 1 to claim 3, characterized in that it comprises a copolymer.
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US10064982B2 (en) 2001-06-27 2018-09-04 Abbott Cardiovascular Systems Inc. PDLLA stent coating
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