JP5940585B2 - 薬剤送出ワイヤ内の穴を充填するシステムおよびワイヤ内に形成された穴に作用物質が充填された前記ワイヤを製造する方法 - Google Patents
薬剤送出ワイヤ内の穴を充填するシステムおよびワイヤ内に形成された穴に作用物質が充填された前記ワイヤを製造する方法 Download PDFInfo
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- 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
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- 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
- A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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- A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00526—Methods of manufacturing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00867—Material properties shape memory effect
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00893—Material properties pharmaceutically effective
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B17/06166—Sutures
- A61B2017/06171—Sutures helically or spirally coiled
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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
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
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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
- 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
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
- A61F2250/0068—Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir
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Description
本出願は、その全体の内容が参照により本明細書に援用される2004年2月13日に出願された米国仮特許出願第60/544,663号に対して優先権を主張する。
体の局所的な領域の多くの疾患は、治療薬の全身的な送出によって処置される。残念ながら、治療薬の全身的な送出は、効果的でなく、非効率的で、且つ/又は、望ましくない副作用をもたらすことが多い。たとえば、ガンの処置は、化学療法薬の全身的な投与を必要とすることが多く、該全身的な投与によって、患者に対する重篤な副作用がもたらされる。
本発明は、サイズの小さい薬剤送出デバイスに関するものであり、該薬剤送出デバイスは、体内の特定の標的組織器官に適合するように形作ることができる1つ又は複数のフィラメント又はワイヤから、長い期間にわたって制御された方法で治療薬を送出できる。
用語「薬剤」及び「治療薬」は、生物の体内管路に送出されて、所望の、通例は治療上の効果をもたらす任意の治療活性物質(therapeutically active substance)を指すように交換可能に用いられる。
本発明と共に使用するための治療薬の一部は、
免疫抑制薬、抗生物質、抗脂質薬、抗炎症薬、化学療法薬、抗悪性腫瘍薬、抗血小板薬、血管形成薬、抗血管形成薬、ビタミン、抗有糸分裂薬、メタロプロテイナーゼ阻害剤、NOドナー、エストラジオール、硬化防止薬、及び血管作用薬、内皮成長因子、エストロゲン、ベータブロッカー、AZブロッカー、ホルモン、スタチン、インシュリン成長因子、抗酸化薬、膜安定化薬、カルシウム拮抗薬、レチノイド、抗悪性腫瘍薬、抗血管形成薬、抗再狭窄薬、ヘパリン等の抗血栓薬、パクリタキセル及びラパマイシン等の抗増殖薬、組織再生薬、血管拡張薬、及び利尿剤を、単独で、又は、本明細書で述べる任意の治療薬との組合せで含むが、それらに限定されない。治療薬はまた、例を少数だけ挙げると、ペプチド、リポ蛋白、ポリペプチド、ポリペプチドをコード化するポリヌクレオチド、脂質、蛋白質薬剤、蛋白質共役薬剤、酵素、オリゴヌクレオチドとその誘導体、リボザイム、他の遺伝物質、細胞、アンチセンス、オリゴヌクレオチド、モノクローナル抗体、血小板、プリオン、ウィルス、細菌、及び内皮細胞等の真核細胞、幹細胞、ACE阻害剤、単核細胞/大食細胞、又は血管平滑筋細胞を含む。治療薬はまた、宿主に投与されると、代謝して所望の薬剤になるプロドラッグであってもよい。さらに、治療薬は、ワイヤの穴に送出される前に、マイクロカプセル、微粒子、マイクロバブル、リポソーム、ニオソーム、エマルジョン、分散等として前もって処方されてもよい。治療薬はまた、放射性同位元素であってもよく、光又は超音波エネルギー等の他の或る形態のエネルギーによって、又は全身に投与することができる他の循環分子によって活性化される作用物質であってもよい。治療薬は、血管形成、再狭窄、細胞増殖、血栓、血小板凝集、凝固、及び血管拡張を調整することを含む複数の機能を実施してもよい。抗炎症薬は、アリル酢酸誘導体、たとえば、ジクロフェナック(Diclofenac);アリールプロピオン酸誘導体、たとえば、ナプロクサン、及びサリチル酸誘導体、たとえば、アスピリン、ジフルーニサル(Diflunisal)等の非ステロイド性抗炎症薬(NSAID)を含む。抗炎症薬はまた、デキサメタゾン、プレドニゾロン、及びトリアムシノロン等のグルココリチコイド(glucocoriticoids)(ステロイド)を含む。抗炎症薬は、薬剤及びインプラントに対する組織の反応を緩和するために他の薬剤と共に使用される。
図8は、薬剤送出デバイスの穴を充填するシステム80の一例を示す。システム80は連続して動作し、ワイヤが、スプールから充填システムを通って、巻き取りスプール上か、或いは、別の仕上げシステム又は形成システムに進む時に、ワイヤの長さに沿って複数の穴を充填することができる。
Claims (9)
- 薬剤送出ワイヤ内の穴を作用物質で充填するシステムであって、
前記システム(90)はモールド(92)を特徴とし、
前記モールド(92)は内部モールド空洞(94)を有し、
液化された作用物質が、作用物質入口(96)を通って内部モールド空洞(94)に送出されることができ、
前記モールドは、前記ワイヤ(70)が前記モールドの内部を通過することができるように構成され、
前記モールド内の圧力が逃げるように、前記モールドは、前記薬剤送出ワイヤ内に画定され複数の方向に向けられた穴が、前記作用物質で充填可能となるように構成される、システム。 - 冷却コイルを有する冷却ゾーン(98)をさらに備え、
前記ワイヤ(70)はそこを通過して、前記ワイヤ(70)がモールド(92)を出る前に、前記内部モールド空洞内の前記ワイヤの前記穴に充填された前記作用物質を少なくとも部分的に凝固させる、請求項1に記載のシステム。 - 前記液化された作用物質は、ポリマー、溶剤成分及びホットメルト作用物質のうちの1つである、請求項1または2に記載のシステム。
- 前記モールド(92)は、前記穴の底部面を閉塞させる閉じた底部を含む、請求項1〜3のいずれか一項に記載のシステム。
- 前記モールド(92)はシール要素を含む、請求項1〜4のいずれか一項に記載のシステム。
- 前記システムは、前記ワイヤが前記システムを通過する時に連続して動作する、請求項1〜5のいずれか一項に記載のシステム。
- ワイヤ内に形成された穴に作用物質が充填された前記ワイヤを製造する方法であって、
前記ワイヤ(70)が保持されている間に、前記作用物質入口(96)に作用物質の小滴又はフィラメントを個々に送出することと、
十分に凝固するまで、穴の中に分注された作用物質を保持する間に、前記穴の中で前記作用物質を凝固させることと、
を含む、方法において、
請求項1〜6のいずれか一項に記載のシステムを用い、前記ワイヤ(70)が前記システムを通過する時に前記システムが連続して動作することを特徴とする、方法。 - シール要素によってシールされた前記モールド(92)を維持することをさらに含む、請求項7に記載の方法。
- 前記ワイヤが前記システムを通過する時に、前記穴を連続的に充填することをさらに含む、請求項7または8に記載の方法。
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US54466304P | 2004-02-13 | 2004-02-13 | |
US60/544,663 | 2004-02-13 |
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JP2010266716A Division JP5586439B2 (ja) | 2004-02-13 | 2010-11-30 | 薬剤送出ワイヤ内の穴を充填するシステム、ワイヤを製造する方法、および薬剤送出ワイヤ |
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JP5940585B2 true JP5940585B2 (ja) | 2016-06-29 |
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JP2006553326A Pending JP2007521928A (ja) | 2004-02-13 | 2005-02-11 | ワイヤフィラメントを含む埋め込み可能薬剤送出デバイス |
JP2010266716A Active JP5586439B2 (ja) | 2004-02-13 | 2010-11-30 | 薬剤送出ワイヤ内の穴を充填するシステム、ワイヤを製造する方法、および薬剤送出ワイヤ |
JP2014095920A Active JP5940585B2 (ja) | 2004-02-13 | 2014-05-07 | 薬剤送出ワイヤ内の穴を充填するシステムおよびワイヤ内に形成された穴に作用物質が充填された前記ワイヤを製造する方法 |
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JP2006553326A Pending JP2007521928A (ja) | 2004-02-13 | 2005-02-11 | ワイヤフィラメントを含む埋め込み可能薬剤送出デバイス |
JP2010266716A Active JP5586439B2 (ja) | 2004-02-13 | 2010-11-30 | 薬剤送出ワイヤ内の穴を充填するシステム、ワイヤを製造する方法、および薬剤送出ワイヤ |
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US (1) | US20050182390A1 (ja) |
EP (3) | EP2407203B1 (ja) |
JP (3) | JP2007521928A (ja) |
AT (2) | ATE536154T1 (ja) |
AU (3) | AU2005214894B2 (ja) |
CA (1) | CA2556212C (ja) |
DE (1) | DE602005011105D1 (ja) |
WO (1) | WO2005079387A2 (ja) |
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WO2005079387A3 (en) | 2005-12-01 |
JP2011101804A (ja) | 2011-05-26 |
WO2005079387A2 (en) | 2005-09-01 |
CA2556212A1 (en) | 2005-09-01 |
EP2407203A3 (en) | 2013-01-02 |
AU2011202305B2 (en) | 2014-09-04 |
ATE414491T1 (de) | 2008-12-15 |
AU2005214894B2 (en) | 2011-05-26 |
CA2556212C (en) | 2013-05-28 |
DE602005011105D1 (de) | 2009-01-02 |
EP1713453A4 (en) | 2007-03-07 |
US20050182390A1 (en) | 2005-08-18 |
EP1713453B1 (en) | 2008-11-19 |
EP2407203A2 (en) | 2012-01-18 |
AU2005214894A1 (en) | 2005-09-01 |
EP2407203B1 (en) | 2019-09-18 |
EP1997456B1 (en) | 2011-12-07 |
JP2014208083A (ja) | 2014-11-06 |
AU2014213485A1 (en) | 2014-08-28 |
ATE536154T1 (de) | 2011-12-15 |
AU2011202305A1 (en) | 2011-06-09 |
JP5586439B2 (ja) | 2014-09-10 |
EP1713453A2 (en) | 2006-10-25 |
EP1997456A1 (en) | 2008-12-03 |
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