JP4473390B2 - Stent and stent graft - Google Patents
Stent and stent graft Download PDFInfo
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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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Description
【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。
【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。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。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。
【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。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。
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。
【0004】
【課題を解決するための手段】
[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、
当該第一被覆層(32)の外周面に、第二被覆層(33)を被覆し、
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、
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。
[2]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、
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。
[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。
[4]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。
【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。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。
【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。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。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。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。
【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。
【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。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。
【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。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。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。
【0010】
図5は本発明のステントグラフト40の一例である。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。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。
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。
【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)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。
(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。
(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×1.50mm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。
(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×1.50mmの二層チューブを成形し、管状体42[(外層)テコフレックス100A/シロスタゾール10重量%、(内層)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。
【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。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。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。
【0013】
【表1】
【0014】
【表2】
【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。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。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。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。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。
【図面の簡単な説明】
【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】
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[0001]
BACKGROUND OF THE INVENTION
The present invention relates to an improvement of a stent and a stent graft used to improve a stenosis occurring in a living body such as a blood vessel, and in particular, is provided with an antithrombotic surface covered with a polymer material containing a biologically active substance, The present invention relates to a stent and a stent graft for preventing restenosis.
[0002]
[Prior art and problems to be solved by the invention]
Most of the stents are made of metal such as stainless steel or Ti-Ni shape memory metal. Thrombus or blood clots are likely to form, and supplementary treatment is required for about 2 weeks after the operation until the stent surface is covered with endothelial cells. It is necessary to administer an anticoagulant such as heparin for the purpose. For this reason, there was a risk of complications such as bleeding due to side effects depending on the patient's condition. Here, if it is possible to reduce the dose and administration period of the anticoagulant, it is possible not only to reduce complications but also to shorten the hospital stay.
[0003]
Further, attempts have been made to supply a drug such as an anticoagulant to the stent, and disclosed examples of anticoagulant and antiplatelet agent alone or in combination are disclosed in JP-A-8-224297 and JP-A-8-33718. However, an invention that specifically utilizes the synergistic effect of the characteristics of each drug has not yet been disclosed.
Therefore, as a result of intensive studies to solve the above problems, the present inventor has reached the following invention.
[0004]
[Means for Solving the Problems]
[1] The present invention covers the outer peripheral surface of the tubular stent base material (31) with the first coating layer (32),
The outer peripheral surface of the first coating layer (32) is coated with the second coating layer (33),
The first coating layer (32) includes any one of an antiplatelet agent and an antithrombin agent,
The second covering layer (33) provides a stent (30) including any one of an antithrombin agent or an antiplatelet agent not included in the first covering layer (32).
[ 2 ] The present invention provides an inner layer tubular body made of a polymer containing any one of an antiplatelet agent and an antithrombin agent;
Provided is a stent graft in which a multilayer tubular body comprising an outer layer tubular body containing any one of an antithrombin agent and an antiplatelet agent not included in the inner layer tubular body is fitted on the outer peripheral surface of a tubular stent base material. .
[3] The present invention provides the stent graft according to [1] , wherein the antiplatelet agent is cilostazol, and the antithrombin agent is argatroban .
[ 4 ] The present invention provides the method according to any one of [1] to [3], wherein the polymer includes thermoplastic polyurethane, polyamide, polyester, polyethylene, polypropylene, a mixture, blend, or copolymer of two or more of these polymers. A stent (30) or stent graft as described in 1) is provided.
[0005]
DETAILED DESCRIPTION OF THE INVENTION
The stent and stent graft of the present invention are composed of a base material and a covering layer coated on the base material or a tubular body fitted on the outer periphery of the base material. The base material is, for example, a pipe made of a material such as stainless steel such as SUS316, a Ni—Ti alloy or the like, a substantially tubular body in which a predetermined pattern is formed on the surface by laser processing of a flat plate, or a net-like substantially tubular body formed by a wire. The shape of the substantially tubular body is not particularly limited as long as the desired physical properties can be obtained.
[0006]
FIG. 1 is a schematic view showing an example of a stent of the present invention. A
[0007]
Examples of the polymer used in the present invention include, but are not limited to, thermoplastic polyurethane, polyamide, polyester, polyethylene, polypropylene, a mixture of two or more of these polymers, blends, copolymers, and the like. Any polymer that is excellent in biocompatibility can be used.
[0008]
FIG. 3 shows an example of a stent 20 in which a coating layer (an
[0009]
In the
[0010]
FIG. 5 is an example of the
Case of a single layer, but the
[0011]
【Example】
Example 1
A 10% by weight solution of Tecoflex 100A (thermoplastic polyurethane) (solvent THF) and methanol in which 5% by weight of cilostazol and argatroban were dissolved were mixed, and sprayed onto the outer peripheral surface of the
(Example 2)
A mixed solution of 7 wt% THF solution of bionate 80A (polycarbonate type thermoplastic polyurethane) and 10 wt% methanol solution of argatroban was sprayed on the outer peripheral surface of the
(Example 3)
Tecoflex 100A was compounded with cilostazol and argatroban in amounts of 5 wt% and 10 wt%, respectively, in a small mixed machine at 190 ° C, and this was 1.45 mm x 1.50 mm in size with a 15 mm extruder. The
Example 4
The thickness of each layer was determined by using two 12 mm / 15 mm extruders composed of a compound in which cilostazol was mixed in an amount of 15% by weight with Tecoflex 100A and a compound in which Tecoflex 100A was mixed with 15% by weight of argatroban. 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 /
[0012]
The prepared stent (Example 1) and stent graft (Example 4) were immersed in a phosphate buffer solution at 37 ° C. and pH 7.4 and shaken 50 times over time, and then elution amount and elution rate of cilostazol and argatroban. Was measured. The results are shown in Table 1 (Example 1) and Table 2 (Example 4), respectively. In Example 1, there was almost no difference in the elution properties of cilostazol and argatroban, but in Example 4, the elution properties of cilostazol and argatroban were short time (3 days from immediately after) and long time (2 weeks from immediately after). It was confirmed that the sustained release of the drug can be adjusted depending on the type of coating layer, the structure, the production method, and the amount of the drug.
[0013]
[Table 1]
[0014]
[Table 2]
[0015]
[Effects of the invention]
According to the stent and stent graft of the present invention, the effects of the antiplatelet agent and the antithrombin agent can be used synergistically. That is, platelet adhesion is inhibited by an antiplatelet agent, and the initiation and progression of blood coagulation reaction can be suppressed by an antithrombin agent. In addition, if the thickness of the polymer layer to be coated or fitted on the base material and the blending amount of antiplatelet and antithrombin agents are adjusted, a long period of 2 weeks from immediate drug release immediately after stent placement to endothelial cell regeneration It is possible to control so that the drug is gradually released into the blood over a period of time. In addition, side effects caused by intravenous injection of anticoagulants can be reduced, and treatment with less burden on patients can be realized. Furthermore, since cilostazol used as an antiplatelet agent also has a smooth muscle cell proliferation inhibitory effect and an endothelium regeneration promoting effect, the risk of restenosis due to stent placement can be further reduced.
[Brief description of the drawings]
1 is a schematic view of the stent of the present invention. FIG. 2 is a cross-sectional view of the stent of FIG. 1. FIG. 3 is a schematic view of the stent of the present invention. Schematic diagram of the stent graft [Explanation of symbols]
10, 20, 30
33 Polymer layer containing antiplatelet agent (second coating layer)
40
Claims (4)
当該第一被覆層(32)の外周面に、第二被覆層(33)を被覆し、
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、
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)。Coating the outer peripheral surface of the tubular stent substrate (31) with the first coating layer (32);
The outer peripheral surface of the first coating layer (32) is coated with the second coating layer (33),
The first coating layer (32) includes any one of an antiplatelet agent and an antithrombin agent,
The stent (30), wherein the second covering layer (33) includes any one of an antithrombin agent and an antiplatelet agent not included in the first covering layer (32).
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。An inner layer tubular body made of a polymer containing any one of an antiplatelet agent or an antithrombin agent;
A multilayer tubular body comprising an outer layer tubular body containing any one of an antithrombin agent or an antiplatelet agent not included in the inner layer tubular body is fitted on the outer peripheral surface of a tubular stent base material. Stent graft.
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JP2000001255A JP4473390B2 (en) | 2000-01-07 | 2000-01-07 | Stent and stent graft |
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JP2000001255A JP4473390B2 (en) | 2000-01-07 | 2000-01-07 | Stent and stent graft |
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US7682648B1 (en) | 2000-05-31 | 2010-03-23 | Advanced Cardiovascular Systems, Inc. | Methods for forming polymeric coatings on stents |
US6953560B1 (en) | 2000-09-28 | 2005-10-11 | Advanced Cardiovascular Systems, Inc. | Barriers for polymer-coated implantable medical devices and methods for making the same |
US7771468B2 (en) | 2001-03-16 | 2010-08-10 | Angiotech Biocoatings Corp. | Medicated stent having multi-layer polymer coating |
US8741378B1 (en) | 2001-06-27 | 2014-06-03 | Advanced Cardiovascular Systems, Inc. | Methods of coating an implantable device |
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