JP6317346B2 - 形状記憶生体再吸収性ポリマーの末梢スキャフォールド - Google Patents
形状記憶生体再吸収性ポリマーの末梢スキャフォールド Download PDFInfo
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- JP6317346B2 JP6317346B2 JP2015524251A JP2015524251A JP6317346B2 JP 6317346 B2 JP6317346 B2 JP 6317346B2 JP 2015524251 A JP2015524251 A JP 2015524251A JP 2015524251 A JP2015524251 A JP 2015524251A JP 6317346 B2 JP6317346 B2 JP 6317346B2
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- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
- A61F2210/0019—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/0054—V-shaped
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/0056—W-shaped, e.g. M-shaped, sigma-shaped
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/006—Y-shaped
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
- A61F2250/001—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting a diameter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/16—Materials with shape-memory or superelastic properties
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Description
本明細書に記載するすべての出版物及び特許出願は、各々の個別の出版物又は特許出願が参照により組み込まれるように個別具体的に指示された場合、また前記個別の出版物又は特許出願が本明細書内に図を含めて完全に記載された場合と同程度に参照によりその全体が本明細書に組み込まれる。
(1)押出成形を用いてポリマーチューブを形成するステップ、
(2)形成されたチューブを半径方向に変形させるステップ、
(3)変形したチューブ内にステントパターンをレーザカッティングでレーザ加工することで変形したチューブからステントスキャフォールディングを形成するステップ、
(4)オプションとして、スキャフォールディング上に治療コーティングを形成するステップ、
(5)送達バルーン上でステントをクリンプするステップ、
(6)電子ビーム(E−Beam)放射線を用いた滅菌ステップ。
2つのポリ(L−ラクチド−コ−カプロラクトン)の90:10及び90:5のPLLA/PCLのモル組成のスキャフォールド試料を用意した。比較のため、PLLAスキャフォールド試料も用意した。試料をe−ビームで滅菌後に試験した。ポリ(DL−ラクチド)/エベロリムスコーティングを施したスキャフォールドも試験した。全スキャフォールド試料は、V79パターンである。
固有粘度(IV)が3.2の90:10 PLLA−PLCを押出成形処理(水分310ppm、温度約380°F)して、内径0.059mmのチューブを形成した。チューブをTgより大きく且つTm未満の温度で外径8mmに拡張した。次に、V79スキャフォールドパターンにレーザカッティングした。押出成形された管と拡張された管内のL−ラクチドモノマー含有量は0.12%であった。
90:10拡張管試料のMnは約150kDaで、滅菌したスキャフォールドのMnは約68kDaであった。95:5拡張管試料のMnは約100kDaで、滅菌したスキャフォールドのMnは約82kDaであった。
バルーンにクリンプされたスキャフォールドにおけるスキャフォールド除去力は、スキャフォールドがバルーンから除去されるまで耐えられる長手方向の軸に沿ってスキャフォールドに印加される最大の力を指す。試料のスキャフォールド除去力をテープ試験で測定した。90:10試料のスキャフォールド除去力は1.34±0.35lb、95:5試料のスキャフォールド除去力は1.00±0.10lbであった。
半径方向強度及び剛性をMSI試験機(Machines Solutions Inc., Flagstaff, AZ)で測定し、各組成物の半径方向強度は0.4N/mmより上であった。図9は、PLLAスキャフォールド、95:5 PLLA−PLC非コーティングスキャフォールド、95:5 PLLA−PLC非コーティングスキャフォールド、90:10 PLLA−PLC非コーティングスキャフォールド、90:10 PLLA−PLC非コーティングスキャフォールドの半径方向強度及び剛性を示す。
スキャフォールド試料をクリンプ直径から膨張させ、破損時の最小外径を観察した。表2に示すように、95:5、90:10スキャフォールドは両方共PLLAスキャフォールドの破損直径理論値である9.6mmよりも有意に高い破損直径を示した。
90:10 PLLA−PLCスキャフォールドの内向き及び外向きのリコイルを考察した。スキャフォールドはバルーンで6mmまで拡張し、バルーンをしぼませて、スキャフォールドの直径を経時的に記録した。図10は、拡張後の経過時間の関数としてのスキャフォールドの直径を示す。直径は最初の約60分間、内向きにリコイルし、その後、少なくとも最大28日間、時間の関数としての外径の有意な増加を伴って外向きにリコイルした。
PLLA及び90:10 PLLA−PCLスキャフォールドのクラッシュ回復性を試験した。図11は、両方のスキャフォールドの結果を示す。
PLLA、95:5 PLLA−PCL、及び90:10 PLLA−PCLスキャフォールドの軸方向疲労試験を行った。
スキャフォールドの留置後の画像を、Visicon Finescan(商標)Stent Inspection System, Visicon Inspection Technologies, LLC(Napa, Calif.)によって生成した。このシステムは、スキャフォールドの平坦な展開画像を生成する。操作で、スキャフォールドを微細な拡散面を有するマンドレル上に搭載した。このリニアアレイカメラの下に保持し、システムの電子機器で回転させ、これを用いてカメラに正確なラインごとの一連の画像データを収集させた。
Claims (12)
- ポリマーチューブから形成されたスキャフォールドを備えるステントであって、
バルーンにクリンプされるように構成され、
前記スキャフォールドが、相互接続されたストラットのパターンを有し、
前記スキャフォールドが、前記バルーンによってクリンプ状態から拡張されると拡張時直径を有し、
前記スキャフォールドが、前記拡張時直径の少なくとも50%までクラッシュした後で前記拡張時直径の約80%より大きくなり、
前記スキャフォールドが、0.3N/mmを超える半径方向剛性を有し、
前記スキャフォールドが、ポリ(L−ラクチド)(PLLA)と、コポリマーの0.1〜10重量%又はモル%であるゴム状ポリマーと、からなる形状記憶ランダムコポリマーから製造され、
前記スキャフォールドが、生理学的条件下において37℃で自己拡張特性を示し、
前記ストラットがクラウンを有する波動リングを形成し、前記リングが長手方向に延在するリンクによって相互接続され、前記クラウンがW−クラウン、Y−クラウン、及び自由クラウンを有し、
第1のリンクが第1のリングと隣接するリングとを接続し、第1のリンクが第1のリングとともにW−クラウンを形成し、且つ前記隣接するリングとともにY−クラウンを形成し、
自由クラウンがリンクに接続されず、
リングが、16個のクラウンのみを有し、このうち2つのクラウンがW−クラウン、そして2つのクラウンがY−クラウンであり、その結果、当該リングが、3つの自由クラウン、Y−クラウン、3つの自由クラウン、及びW−クラウンの順序で前記リングの軸周りに配置された、直接隣接する一連のクラウンを備え、
前記リングが、2つのリンクのみで隣接するリングに接続されている、ステント。 - 前記コポリマーのガラス転移温度(Tg)が、37℃〜55℃である、請求項1に記載のステント。
- 前記ゴム状ポリマーが、コポリマーの0.1〜10重量%又はモル%である、請求項1に記載のステント。
- 前記ゴム状ポリマーが、25℃未満のTgを有する、請求項1に記載のステント。
- 前記コポリマーのガラス転移温度(Tg)が、乾燥状態から湿り状態へ15%未満変化する、請求項1に記載のステント。
- 前記ゴム状ポリマーが、ポリカプロラクトンである、請求項1に記載のステント。
- 前記ゴム状ポリマーが、ポリヒドロキシアルカノエート(PHA)、ポリ(4−ヒドロキシブチレート)(P4HB)、ポリ(トリメチレンカーボネート)(PTMC)、ポリ(ブチレンサクシネート)(PBS)、ポリウレタン、ポリエチレングリコール(PEG)、及びポリ(p−ジオキサノン)(PDO)からなる群から選択されるモノマー、オリゴマー、又はポリマー単位を含む、請求項1に記載のステント。
- 前記コポリマーの重量平均分子量が、60〜150kDaである、請求項1に記載のステント。
- 前記ストラットがクラウンを有するリングを形成し、前記リングが長手方向に延在するリンクによって相互接続され、前記スキャフォールドが拡張時直径を有するときに前記クラウンが約90〜115度の最大クラウン角度を有する、請求項1に記載のステント。
- 前記スキャフォールドパターンが、ストラットによって形成されたリングを含み、製作状態で、
前記スキャフォールドが0.008インチ〜0.014インチの壁厚と、5〜10mmの直径を有する、請求項1に記載のステント。 - 前記相互接続されたストラットが、閉鎖セルを形成し、閉鎖セルが、12の自由クラウン、3つのY−クラウン及び3つのW−クラウンを有し、各Y−クラウンが前記W−クラウンの一つと一直線になっている、請求項1に記載のステント。
- 前記スキャフォールドのパターンが、複数のクラウンを有し、スキャフォールドが前記拡張時直径を有するときにいずれのクラウンも約90度〜115度の最大クラウン角度を有する、請求項1に記載のステント。
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US20200060851A1 (en) | 2020-02-27 |
WO2014018123A1 (en) | 2014-01-30 |
US20140025161A1 (en) | 2014-01-23 |
US10500076B2 (en) | 2019-12-10 |
CN104507510B (zh) | 2016-09-28 |
EP2874676B1 (en) | 2018-09-26 |
US8968387B2 (en) | 2015-03-03 |
US20220249262A1 (en) | 2022-08-11 |
HK1208829A1 (en) | 2016-03-18 |
US9668894B2 (en) | 2017-06-06 |
US20150142099A1 (en) | 2015-05-21 |
US11337835B2 (en) | 2022-05-24 |
CN104507510A (zh) | 2015-04-08 |
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US20170290688A1 (en) | 2017-10-12 |
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