JP4510025B2 - 埋め込み型弁状人工器官 - Google Patents
埋め込み型弁状人工器官 Download PDFInfo
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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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
-
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2475—Venous valves
-
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2002/068—Modifying the blood flow model, e.g. by diffuser or deflector
-
- 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0008—Fixation appliances for connecting prostheses to the body
- A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
-
- 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
Description
本発明は医療機器、特にフレームをベースとする一方向流人工弁と、このような弁を製造する方法に関するものである。
人間の体は、体の管腔や脈管を通る流体の流れを制御する多くの生物弁を有する。例えば、循環系は様々な心臓弁を有しており、これらは、心室、静脈、および大動脈を通る血流を制御することにより、心臓がポンプとして作用できるようにしている。さらに、静脈系も多くの静脈弁を有し、これらは、心臓に戻る血流、特に下肢から心臓に戻る血流の制御に役立っている。
本発明は、医療機器、特にステントをベースとする弁に関するものである。人工弁は、長手方向軸を規定し、放射方向に広げることができる構造フレームを備えている。この構造フレームは、第1および第2の開口端部を有するアンカー構造部と、第1および第2端部を有する接続部材と、第1および第2端部を有する片持ち梁式弁支柱とを有する。接続部材の第1端部は、アンカー構造部の第2端部に取り付けられている。片持ち梁式弁支柱の第1端部は、接続部材の第2端部に、協働するように結合されている。人工弁は、生体適合性膜アセンブリをさらに有する。この生体適合性膜アセンブリは、長手方向軸回りの実質的に筒状の形状をしていて、第1の開いた端部と、第2の閉じた端部とがある。膜アセンブリの第1端部は、構造フレームに、片持ち梁式弁支柱の第2端部に沿って取り付けられている。
本発明のステントをベースとする弁は、弁不全の治療に伴う困難を克服する方法を提供するものである。ステントをベースとする静脈弁を開示して本発明の一実施形態を説明するが、当業者には、開示した発明を体の他の場所や管腔に同様に利用できることがわかるであろう。体の他の場所や管腔とは、例えば、冠状、血管の、非血管の、及び末梢の脈管、管路などであり、本発明を利用できるものには、心臓弁、静脈弁、食道及び胃にある弁、尿管および/または嚢にある弁、胆汁道にある弁、リンパ系にある弁および腸にある弁が含まれるが、これに限定はされない。
(1)人工弁において、
長手方向軸を規定する、放射方向に広げることができる構造フレームであって、第1および第2の開口した端部を有するアンカー構造部と、第1および第2端部を有する接続部材であって、前記接続部材の前記第1端部が前記アンカー構造部の前記第2端部に取り付けられている接続部材と、第1および第2端部を有する片持ち梁式弁支柱であって、前記片持ち梁式弁支柱の前記第1端部が、前記接続部材の前記第2端部に、協働するように結合している片持ち梁式弁支柱と、を含む構造フレームと、
前記長手方向軸回りの実質的に筒状の形状を有し、第1の開いた端部と、第2の閉じた端部とがある生体適合性膜アセンブリであって、前記膜アセンブリの前記第1端部が、前記片持ち梁式弁支柱の第2端部に沿って取り付けられている生体適合性アセンブリと、
を備える人工弁。
前記アンカー構造部は、部材を相互接続した格子から形成されており、前記長手方向軸回りの実質的に円筒状の形状を有する、人工弁。
(3)実施態様1記載の人工弁において、
前記構造フレームは、ステンレススチール、タンタル、プラチナ合金、ニオブ合金、コバルト合金、およびニッケル−チタン合金からなるグループから選択された材料を含む、人工弁。
(4)実施態様1記載の人工弁において、
前記構造フレームがポリマーを含む、人工弁。
前記生体適合性膜アセンブリが、可撓性の膜状の材料から形成されている、人工弁。
(6)実施態様5記載の人工弁において、
前記膜状の材料が生体物質である、人工弁。
(7)実施態様6記載の人工弁において、
前記生体物質が静脈である、人工弁。
(8)実施態様5記載の人工弁において、
前記膜状の材料が合成材料である、人工弁。
(9)実施態様8記載の人工弁において、
前記合成材料がエラストマーポリマーである、人工弁。
前記合成材料が生体吸収性材料である、人工弁。
(11)実施態様8記載の人工弁において、
前記合成材料が、補強用繊維をさらに備えている、人工弁。
(12)実施態様1記載の人工弁において、
前記構造フレームの少なくとも一部が薬剤で被覆されている、人工弁。
(13)実施態様12記載の人工弁において、
前記薬剤被覆が治療薬を含んでいる、人工弁。
(14)実施態様12記載の人工弁において、
前記薬剤被覆が調合薬を含んでいる、人工弁。
前記薬剤被覆が薬剤溶出層を含む、人工弁。
(16)実施態様1記載の人工弁において、
前記膜アセンブリの少なくとも一部が薬剤で被覆されている、人工弁。
(17)実施態様16記載の人工弁において、
前記薬剤被覆が治療薬を含んでいる、人工弁。
(18)実施態様17記載の人工弁において、
前記薬剤被覆が調合薬を含んでいる、人工弁。
(19)実施態様17記載の人工弁において、
前記薬剤被覆が薬剤溶出層を含む、人工弁。
前記膜アセンブリの少なくとも一部が治療薬で飽和している、人工弁。
(21)実施態様1記載の人工弁において、
前記膜アセンブリの少なくとも一部が調合薬で飽和している、人工弁。
(22)実施態様1記載の人工弁において、
前記接続部材は、実質的まっすぐな部材であり、前記長手方向軸に実質的に平行な方向に向けられている、人工弁。
(23)実施態様1記載の人工弁において、
前記接続部材が前記長手方向軸回りの実質的に螺旋状の形状を有する、人工弁。
(24)実施態様1記載の人工弁において、
前記片持ち梁式弁支柱は、実質的にまっすぐな部材であり、前記長手方向軸に実質的に平行な方向に向けられている、人工弁。
前記片持ち梁式弁支柱が前記長手方向軸回りの実質的に螺旋状の形状を有する、人工弁。
(26)実施態様1記載の人工弁において、
前記片持ち梁式弁支柱は、実質的に波形形状をしており、前記長手方向軸に実質的に平行な方向に向けられている、人工弁。
(27)実施態様1記載の人工弁において、
前記筒状生体適合性膜が、前記第1の端部から前記第2の端部まで、実質的に一定の径を有する、人工弁。
(28)実施態様1記載の人工弁において、
前記筒状生体適合性膜が実質的に円錐形状を有する、人工弁。
前記構造フレームが近位カラーをさらに備え、前記近位カラーが、前記接続部材の前記第2端部および前記片持ち梁式弁支柱の前記第1端部に取り付けられている、人工弁。
(30)実施態様29記載の人工弁において、
前記構造フレームがセンタリング用足部をさらに備え、前記センタリング用足部は、前記近位カラーに、協働するように結合されている、人工弁。
(31)実施態様29記載の人工弁において、
前記構造フレームが近位アンカーをさらに備え、前記近位アンカーは、前記近位カラーに、協働するように結合されている、人工弁。
放射方向に広げることができるアンカー構造部であって、部材を相互接続した格子から形成されており、実質的に円筒形状をしていて、第1および第2開口端部があり、前記第1および第2開口端部の間に延びる長手方向を規定する長手方向軸を有するアンカー構造部と、
第1および第2端部を有する接続部材であって、前記接続部材の前記第1端部が前記アンカーの前記第2端部に取り付けられている、接続部材と、
第1および第2端部を有する片持ち梁式弁支柱であって、前記片持ち梁式弁支柱の第1端部が、前記接続部材の前記第2端部に、協働できるように結合されている、片持ち梁式弁支柱と、
実質的に筒状の形状をしていて、開口した第1端部および閉じた第2端部がある生体適合性膜アセンブリであって、前記膜アセンブリの前記第1端部が、前記片持ち梁式弁支柱に、前記片持ち梁式弁支柱の前記第2端部に沿って取り付けられている、生体適合性膜アセンブリと、
を備える人工弁。
放射方向に広げることができるアンカー構造部であって、部材を相互接続した格子から形成されており、第1および第2開口端部を備えて実質的に円筒形状をしており、前記第1および第2開口端部の間に延びる長手方向を規定する長手方向軸を有するアンカー構造部と、
前記放射方向に広げることができるアンカーの近位に配置されたカラーと、
第1および第2端部を有する接続部材であって、前記接続部材の前記第1端部が前記アンカーの前記第2端部に取り付けられており、前記接続部材の前記第2端部が前記近位カラーに取り付けられている、接続部材と、
第1および第2端部を有する片持ち梁式弁支柱であって、前記片持ち梁式弁支柱の第1端部が前記近位カラーに取り付けられており、前記片持ち梁式弁支柱が、遠位方向に、前記長手方向軸に実質的に平行に延びている片持ち梁式弁支柱と、
実質的に筒状の形状をしていて、開口した第1端部および閉じた第2端部がある生体適合性膜アセンブリであって、前記膜アセンブリの前記第1端部が、前記片持ち梁式弁支柱に、前記片持ち梁式弁支柱の前記第2端部に沿って取り付けられている、生体適合性膜アセンブリと、
を備える人工弁。
Claims (33)
- 人工弁において、
長手方向軸を規定する、放射方向に広げることができる構造フレームであって、第1および第2の開口した端部を有するアンカー構造部と、第1および第2端部を有する接続部材であって、前記接続部材の前記第1端部が前記アンカー構造部の前記第2端部に取り付けられている接続部材と、第1および第2端部を有する片持ち梁式弁支柱であって、前記片持ち梁式弁支柱の前記第1端部が、前記接続部材の前記第2端部に、協働するように結合している片持ち梁式弁支柱と、を含む構造フレームと、
前記長手方向軸回りの実質的に筒状の形状を有し、第1の開いた端部と、第2の閉じた端部とがある生体適合性膜アセンブリであって、前記膜アセンブリの前記第1端部が、前記片持ち梁式弁支柱の第2端部に沿って取り付けられている生体適合性アセンブリと、
を備える人工弁。 - 請求項1記載の人工弁において、
前記アンカー構造部は、部材を相互接続した格子から形成されており、前記長手方向軸回りの実質的に円筒状の形状を有する、人工弁。 - 請求項1記載の人工弁において、
前記構造フレームは、ステンレススチール、タンタル、プラチナ合金、ニオブ合金、コバルト合金、およびニッケル−チタン合金からなるグループから選択された材料を含む、人工弁。 - 請求項1記載の人工弁において、
前記構造フレームはポリマーを含む、人工弁。 - 請求項1記載の人工弁において、
前記生体適合性膜アセンブリが、可撓性の膜状の材料から形成されている、人工弁。 - 請求項5記載の人工弁において、
前記膜状の材料が生体物質である、人工弁。 - 請求項6記載の人工弁において、
前記生体物質が静脈である、人工弁。 - 請求項5記載の人工弁において、
前記膜状の材料が合成材料である、人工弁。 - 請求項8記載の人工弁において、
前記合成材料がエラストマーポリマーである、人工弁。 - 請求項8記載の人工弁において、
前記合成材料が生体吸収性材料である、人工弁。 - 請求項8記載の人工弁において、
前記合成材料が、補強用繊維をさらに備えている、人工弁。 - 請求項1記載の人工弁において、
前記構造フレームの少なくとも一部が薬剤で被覆されている、人工弁。 - 請求項12記載の人工弁において、
前記薬剤被覆が治療薬を含んでいる、人工弁。 - 請求項12記載の人工弁において、
前記薬剤被覆が調合薬を含んでいる、人工弁。 - 請求項12記載の人工弁において、
前記薬剤被覆が薬剤溶出層を含む、人工弁。 - 請求項1記載の人工弁において、
前記膜アセンブリの少なくとも一部が薬剤で被覆されている、人工弁。 - 請求項16記載の人工弁において、
前記薬剤被覆が治療薬を含んでいる、人工弁。 - 請求項17記載の人工弁において、
前記薬剤被覆が調合薬を含んでいる、人工弁。 - 請求項17記載の人工弁において、
前記薬剤被覆が薬剤溶出層を含む、人工弁。 - 請求項1記載の人工弁において、
前記膜アセンブリの少なくとも一部が治療薬で飽和している、人工弁。 - 請求項1記載の人工弁において、
前記膜アセンブリの少なくとも一部が調合薬で飽和している、人工弁。 - 請求項1記載の人工弁において、
前記接続部材は、実質的まっすぐな部材であり、前記長手方向軸に実質的に平行な方向に向けられている、人工弁。 - 請求項1記載の人工弁において、
前記接続部材が前記長手方向軸回りの実質的に螺旋状の形状を有する、人工弁。 - 請求項1記載の人工弁において、
前記片持ち梁式弁支柱は、実質的にまっすぐな部材であり、前記長手方向軸に実質的に平行な方向に向けられている、人工弁。 - 請求項1記載の人工弁において、
前記片持ち梁式弁支柱が前記長手方向軸回りの実質的に螺旋状の形状を有する、人工弁。 - 請求項1記載の人工弁において、
前記片持ち梁式弁支柱は、実質的に波形形状をしており、前記長手方向軸に実質的に平行な方向に向けられている、人工弁。 - 請求項1記載の人工弁において、
前記筒状生体適合性膜が、前記第1の端部から前記第2の端部まで、実質的に一定の径を有する、人工弁。 - 請求項1記載の人工弁において、
前記筒状生体適合性膜が実質的に円錐形状を有する、人工弁。 - 請求項1記載の人工弁において、
前記構造フレームが近位カラーをさらに備え、前記近位カラーが、前記接続部材の前記第2端部および前記片持ち梁式弁支柱の前記第1端部に取り付けられている、人工弁。 - 請求項29記載の人工弁において、
前記構造フレームがセンタリング用足部をさらに備え、前記センタリング用足部は、前記近位カラーに、協働するように結合されている、人工弁。 - 請求項29記載の人工弁において、
前記構造フレームが近位アンカーをさらに備え、前記近位アンカーは、前記近位カラーに、協働するように結合されている、人工弁。 - 人工弁において、
放射方向に広げることができるアンカー構造部であって、部材を相互接続した格子から形成されており、実質的に円筒形状をしていて、第1および第2開口端部があり、前記第1および第2開口端部の間に延びる長手方向を規定する長手方向軸を有するアンカー構造部と、
第1および第2端部を有する接続部材であって、前記接続部材の前記第1端部が前記アンカーの前記第2端部に取り付けられている、接続部材と、
第1および第2端部を有する片持ち梁式弁支柱であって、前記片持ち梁式弁支柱の第1端部が、前記接続部材の前記第2端部に、協働できるように結合されている、片持ち梁式弁支柱と、
実質的に筒状の形状をしていて、開口した第1端部および閉じた第2端部がある生体適合性膜アセンブリであって、前記膜アセンブリの前記第1端部が、前記片持ち梁式弁支柱に、前記片持ち梁式弁支柱の前記第2端部に沿って取り付けられている、生体適合性膜アセンブリと、
を備える人工弁。 - 人工弁において、
放射方向に広げることができるアンカー構造部であって、部材を相互接続した格子から形成されており、第1および第2開口端部を備えて実質的に円筒形状をしており、前記第1および第2開口端部の間に延びる長手方向を規定する長手方向軸を有するアンカー構造部と、
前記放射方向に広げることができるアンカーの近位に配置されたカラーと、
第1および第2端部を有する接続部材であって、前記接続部材の前記第1端部が前記アンカーの前記第2端部に取り付けられており、前記接続部材の前記第2端部が前記近位カラーに取り付けられている、接続部材と、
第1および第2端部を有する片持ち梁式弁支柱であって、前記片持ち梁式弁支柱の第1端部が前記近位カラーに取り付けられており、前記片持ち梁式弁支柱が、遠位方向に、前記長手方向軸に実質的に平行に延びている片持ち梁式弁支柱と、
実質的に筒状の形状をしていて、開口した第1端部および閉じた第2端部がある生体適合性膜アセンブリであって、前記膜アセンブリの前記第1端部が、前記片持ち梁式弁支柱に、前記片持ち梁式弁支柱の前記第2端部に沿って取り付けられている、生体適合性膜アセンブリと、
を備える人工弁。
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US10/699,295 US7347869B2 (en) | 2003-10-31 | 2003-10-31 | Implantable valvular prosthesis |
PCT/US2004/034401 WO2005044138A2 (en) | 2003-10-31 | 2004-10-18 | Implantable valvular prothesis |
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JP (1) | JP4510025B2 (ja) |
AT (1) | ATE440565T1 (ja) |
AU (1) | AU2004287395B2 (ja) |
CA (1) | CA2543927C (ja) |
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-
2003
- 2003-10-31 US US10/699,295 patent/US7347869B2/en not_active Expired - Lifetime
-
2004
- 2004-10-18 DE DE602004022849T patent/DE602004022849D1/de active Active
- 2004-10-18 EP EP04795547A patent/EP1684667B1/en not_active Not-in-force
- 2004-10-18 JP JP2006538077A patent/JP4510025B2/ja not_active Expired - Fee Related
- 2004-10-18 AT AT04795547T patent/ATE440565T1/de not_active IP Right Cessation
- 2004-10-18 WO PCT/US2004/034401 patent/WO2005044138A2/en active Application Filing
- 2004-10-18 CA CA2543927A patent/CA2543927C/en not_active Expired - Fee Related
- 2004-10-18 AU AU2004287395A patent/AU2004287395B2/en not_active Ceased
Also Published As
Publication number | Publication date |
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ATE440565T1 (de) | 2009-09-15 |
DE602004022849D1 (de) | 2009-10-08 |
WO2005044138A3 (en) | 2005-11-17 |
EP1684667A4 (en) | 2007-05-09 |
EP1684667A2 (en) | 2006-08-02 |
AU2004287395B2 (en) | 2010-11-25 |
US7347869B2 (en) | 2008-03-25 |
CA2543927A1 (en) | 2005-05-19 |
AU2004287395A1 (en) | 2005-05-19 |
EP1684667B1 (en) | 2009-08-26 |
CA2543927C (en) | 2012-08-21 |
WO2005044138A2 (en) | 2005-05-19 |
JP2007509700A (ja) | 2007-04-19 |
US20050096735A1 (en) | 2005-05-05 |
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