JP5734650B2 - 自己拡張プロテーゼ - Google Patents
自己拡張プロテーゼ Download PDFInfo
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- JP5734650B2 JP5734650B2 JP2010515085A JP2010515085A JP5734650B2 JP 5734650 B2 JP5734650 B2 JP 5734650B2 JP 2010515085 A JP2010515085 A JP 2010515085A JP 2010515085 A JP2010515085 A JP 2010515085A JP 5734650 B2 JP5734650 B2 JP 5734650B2
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- 229910001566 austenite Inorganic materials 0.000 claims description 24
- 239000012781 shape memory material Substances 0.000 claims description 22
- 206010002329 Aneurysm Diseases 0.000 claims description 16
- 229910000734 martensite Inorganic materials 0.000 claims description 16
- 230000036760 body temperature Effects 0.000 claims description 14
- 230000007704 transition Effects 0.000 claims description 9
- 230000007423 decrease Effects 0.000 claims 1
- 238000000034 method Methods 0.000 description 15
- 238000010438 heat treatment Methods 0.000 description 14
- 239000000463 material Substances 0.000 description 6
- 230000007246 mechanism Effects 0.000 description 3
- 210000004204 blood vessel Anatomy 0.000 description 2
- 238000000113 differential scanning calorimetry Methods 0.000 description 2
- 229910001000 nickel titanium Inorganic materials 0.000 description 2
- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 description 2
- 230000008467 tissue growth Effects 0.000 description 2
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- 230000003213 activating effect Effects 0.000 description 1
- 230000004913 activation Effects 0.000 description 1
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- 230000000916 dilatatory effect Effects 0.000 description 1
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- 210000002889 endothelial cell Anatomy 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 239000007952 growth promoter Substances 0.000 description 1
- 238000003698 laser cutting Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
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- 229920000642 polymer Polymers 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 229910001285 shape-memory alloy Inorganic materials 0.000 description 1
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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
- 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
-
- 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
- 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
-
- 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
- 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
- A61F2002/823—Stents, different from stent-grafts, adapted to cover an aneurysm
-
- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- 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
-
- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- 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
- A61F2210/0023—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 different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
- A61F2210/0033—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 different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply electrically, e.g. heated by resistor
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Cardiology (AREA)
- Animal Behavior & Ethology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Prostheses (AREA)
- Surgical Instruments (AREA)
- Materials For Medical Uses (AREA)
Description
本出願は、2007年6月25に出願された、名称が「Self−Expanding Prosthesis」である米国仮出願第60/946,101号の利益を主張し、該仮出願は、本明細書に参考として援用される。
より一般的にはステントと呼ばれる体内プロテーゼは、広範囲の医学状態の治療のために、当該分野において公知である。概して、体内プロテーゼは、より小さい直径構成からより大きい直径構成に拡張され得る円筒形デバイスからなる。より小さい直径構成は、患者のしばしば曲がった管腔を通って体内プロテーゼを前進させることを容易にし、一方、拡張された直径構成は、患者の管腔の壁に対して圧し、しばしば、プロテーゼを固定することおよび管腔の開通性を回復することの両方を行う。
従来技術の不利な点を克服することが本発明の目的である。
(項目1)
体内でプロテーゼを拡張する方法であって、
形状記憶材料を備えているプロテーゼを提供することと、
体内の所望の部位に該プロテーゼを送達することと、
該プロテーゼの温度を人間の体温より上昇させ、該形状記憶材料の相を変化させ、それによって、該プロテーゼを拡張された状態に拡張することと、
該拡張された状態を維持しながら、該プロテーゼの該温度を該人間の体温に減少させることと
を包含する、方法。
(項目2)
上記プロテーゼを拡張することは、該プロテーゼの直径を拡張することをさらに包含する、項目1に記載の方法。
(項目3)
上記温度を上昇させることは、上記形状記憶材料の上記相をマルテンサイト状態からオーステナイト状態に変化させることをさらに包含する、項目1に記載の方法。
(項目4)
上記プロテーゼを拡張された状態に上記拡張することは、該プロテーゼの第1のセグメントを拡張することと、該プロテーゼの第2のセグメントを拡張することとをさらに包含する、項目1に記載の方法。
(項目5)
上記プロテーゼを上記拡張することは、該プロテーゼに隣接して熱を生成することをさらに包含する、項目1に記載の方法。
(項目6)
上記プロテーゼを上記拡張することは、該プロテーゼを用いて熱を生成することをさらに包含する、項目1に記載の方法。
(項目7)
上記プロテーゼを体内の所望の部位に上記送達することは、
動脈瘤を捜し出すことと、
該動脈瘤の開口部の上に該プロテーゼの位置を決めること
をさらに包含する、項目1に記載の方法。
(項目8)
形状記憶材料を備えているプロテーゼを上記提供することは、その後、上記動脈瘤内にプロテーゼコイルを送達することが続く、項目1に記載の方法。
(項目9)
体内に配置するプロテーゼであって、
第1の相である間に第1の所定の形状を有し、第2の相である間に第2の所定の形状を有する、プロテーゼ本体を備え、
該第1の相から該第2の相への遷移は、人間の体温より高い温度で起り、
該第2の相から該第1の相への遷移は、該人間の体温より低い温度で起る、プロテーゼ。
(項目10)
上記プロテーゼ本体は、形状記憶材料を備えている、項目9に記載のプロテーゼ。
(項目11)
上記第1の相はオーステナイト状態であり、上記第2の相はマルテンサイト状態である、項目9に記載のプロテーゼ。
(項目12)
上記プロテーゼは、37℃より高い、活性オーステナイト開始温度および活性オーステナイト終了温度をさらに含む、項目9に記載のプロテーゼ。
(項目13)
上記活性オーステナイト終了温度は、約40℃〜約55℃の範囲内である、項目12に記載のプロテーゼ。
(項目14)
上記プロテーゼ本体は、第1のセグメントと第2のセグメントとをさらに備え、該第1のセグメントは、該第2のセグメントに対して独立して拡張可能である、項目9に記載のプロテーゼ。
(項目15)
上記プロテーゼは内部の直径を有する管状の形状をさらに備え、該直径は、上記第1の所定の形状中に第1の長さを有し、上記第2の所定の形状中に第2の増加した長さを有する、項目14に記載のプロテーゼ。
(項目16)
体に入る形状の送達ツールと、
該送達ツールに取り外し可能に配置されたプロテーゼと
を備え、
該プロテーゼは、第1の形状記憶構成と第2の記憶形状構成とを含み、該プロテーゼは、約37℃より高い温度で該第1の形状記憶構成から該第2の記憶形状構成に変化し、
該送達ツールは、該体内で該プロテーゼを選択的に加熱する、プロテーゼ送達システム。
(項目17)
上記送達ツールに配置された少なくとも1つの加熱要素をさらに備えている、項目16に記載のプロテーゼ送達システム。
(項目18)
上記プロテーゼは、複数の独立して拡張可能な領域をさらに備え、上記送達ツールは、複数の個々に作動可能なヒータをさらに備えている、項目16に記載のプロテーゼ送達システム。
(項目19)
上記複数の独立して拡張可能な領域の各々は、上記複数の個々に作動可能なヒータのうちの1つの対応するヒータの上に配置される、項目18に記載のプロテーゼ送達システム。
本発明は、選択的に拡張され得るプロテーゼを提供することによってこれらの目的を達成するように努める。一好ましい実施形態において、プロテーゼは、平均体温より高い温度に加熱されたとき拡張する形状記憶材料から構成される。プロテーゼの内部に位置を決められるヒータが起動されたとき、プロテーゼの形状記憶材料は所定の形状に拡張する。
図1および図2を参照すると、本発明の好ましい実施形態に従うプロテーゼ配置システム100が示される。この配置システム100は、ヒータ110を起動することによって患者の管腔内に選択的に拡張され得るプロテーゼ102(例えば、ステント)を含む。その構成のために、プロテーゼ102は、所定の温度に加熱されたとき直径が拡張し、患者の体温で拡張されたままである。この点において、配置システム100は、ユーザが患者内でプロテーゼ102の直径が拡張する時を決定することを可能にする。
Claims (11)
- 体内でプロテーゼを拡張するためのシステムであって、
形状記憶材料を備えているプロテーゼであって、該プロテーゼは、体内の所望の部位において減少した直径の送達状態から拡張することを妨げられないように、該所望の部位に送達されるように構成されており、ここで、該プロテーゼはさらに、第1のセグメント、第2のセグメントおよび該第1のおよび第2のセグメントと一体化された中間セグメントを備え、ここで、該第1のおよび第2のセグメントは、該中間セグメントの反対端に接続される、プロテーゼと、
該第1のセグメントを通過させられる電流が該第2のセグメントを通過させられる電流から独立するように該プロテーゼを通過させられる電流であって、ここで、該プロテーゼを通過させられる該電流が、該プロテーゼの温度を人間の体温より上昇させ、該形状記憶材料の相を変化させ、それによって、該プロテーゼを該減少した直径の送達状態から拡張された直径の状態に拡張し、ここで、該第1のおよび第2のセグメントを通過させられる該電流が、該中間セグメントを通過して該プロテーゼから流れ出る、電流と、
該プロテーゼの該温度を該人間の体温に減少させるための手段と
を備え、該プロテーゼは、該プロテーゼの該温度を減少させた後に、該拡張された直径の状態を維持するように構成されている、システム。 - 前記プロテーゼを通過させられる、温度を上昇させる電流は、前記形状記憶材料の前記相をマルテンサイト状態からオーステナイト状態に変化させるように構成されている、請求項1に記載のシステム。
- 前記プロテーゼは、動脈瘤の開口部の上に該プロテーゼの位置を決められるように構成されている、請求項1に記載のシステム。
- 前記動脈瘤内に送達されるように構成されたプロテーゼコイルをさらに備える、請求項3に記載のシステム。
- 人間の体内に配置するプロテーゼであって、
第1の相である間に減少した直径の送達形状を有し、第2の相である間に拡張した直径の形状を有する、管状のプロテーゼ本体であって、ここで、該プロテーゼはさらに、第1のセグメント、第2のセグメントおよび該第1のおよび第2のセグメントと一体化された中間セグメントを備え、ここで、該第1のおよび第2のセグメントは、該中間セグメントの反対端に接続される、プロテーゼ本体;および
該第1のセグメントを通過させられる電流が該第2のセグメントを通過させられる電流から独立するように該プロテーゼを通過させられる電流であって、ここで、該第1のおよび第2のセグメントを通過させられる該電流が、該中間セグメントを通過して該プロテーゼから流れ出る、電流;
を備え、
該第1の相から該第2の相への遷移は、人間の体温より高い温度で起り、
該第2の相から該第1の相への遷移は、該人間の体温より低い温度で起る、プロテーゼ。 - 前記プロテーゼ本体は、形状記憶材料を備えている、請求項5に記載のプロテーゼ。
- 前記第1の相はマルテンサイト状態であり、前記第2の相はオーステナイト状態である、請求項5に記載のプロテーゼ。
- 前記プロテーゼは、37℃より高い、活性オーステナイト開始温度および活性オーステナイト終了温度をさらに含む、請求項5に記載のプロテーゼ。
- 前記活性オーステナイト終了温度は、約40℃〜約55℃の範囲内である、請求項8に記載のプロテーゼ。
- 体に入る形状の送達ツールと、
該送達ツールに取り外し可能に配置されたプロテーゼであって、ここで、該プロテーゼは、第1のセグメント、第2のセグメントおよび該第1のおよび第2のセグメントと一体化された中間セグメントを備え、ここで、該第1のおよび第2のセグメントは、該中間セグメントの反対端に接続される、プロテーゼと、
該第1のセグメントを通過させられる電流が該第2のセグメントを通過させられる電流から独立するように該プロテーゼを通過させられる電流であって、ここで、該第1のおよび第2のセグメントを通過させられる該電流が、該中間セグメントを通過して該プロテーゼから流れ出る、電流と
を備え、
該プロテーゼは、減少した直径の送達形状記憶構成と拡張した直径の記憶形状構成とを含み、該プロテーゼは、体内の所望の部位への該プロテーゼの送達後に、約37℃より高い温度で該減少した直径の送達形状記憶構成から該拡張した直径の記憶形状構成に変化する、
プロテーゼ送達システム。 - 前記プロテーゼに接続された第1の端部および電源に接続された第2の端部を有する複数のワイヤをさらに備えている、請求項10に記載のプロテーゼ送達システム。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US94610107P | 2007-06-25 | 2007-06-25 | |
US60/946,101 | 2007-06-25 | ||
PCT/US2008/068210 WO2009003049A2 (en) | 2007-06-25 | 2008-06-25 | Self-expanding prosthesis |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2010531209A JP2010531209A (ja) | 2010-09-24 |
JP2010531209A5 JP2010531209A5 (ja) | 2012-08-02 |
JP5734650B2 true JP5734650B2 (ja) | 2015-06-17 |
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Application Number | Title | Priority Date | Filing Date |
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JP2010515085A Active JP5734650B2 (ja) | 2007-06-25 | 2008-06-25 | 自己拡張プロテーゼ |
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---|---|
US (1) | US9023094B2 (ja) |
EP (1) | EP2162101B1 (ja) |
JP (1) | JP5734650B2 (ja) |
CN (2) | CN101842061A (ja) |
CA (1) | CA2704920C (ja) |
WO (1) | WO2009003049A2 (ja) |
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US9023094B2 (en) | 2015-05-05 |
EP2162101B1 (en) | 2019-02-20 |
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