JP2016512077A - 塞栓保護デバイスおよび使用方法 - Google Patents
塞栓保護デバイスおよび使用方法 Download PDFInfo
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- embolic protection
- sheath
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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
- A61F2/01—Filters implantable into blood vessels
- A61F2/0105—Open ended, i.e. legs gathered only at one side
-
- 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
- A61F2/01—Filters implantable into blood vessels
- A61F2/013—Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
- A61F2/014—Retrograde blood flow filters, i.e. device inserted against the blood flow direction
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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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2436—Deployment by retracting a sheath
-
- 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
- A61F2/01—Filters implantable into blood vessels
- A61F2/011—Instruments for their placement or removal
-
- 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
- A61F2/01—Filters implantable into blood vessels
- A61F2002/018—Filters implantable into blood vessels made from tubes or sheets of material, e.g. by etching or laser-cutting
-
- 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
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0067—Three-dimensional shapes conical
Abstract
Description
本出願は、2013年3月14日に出願された米国特許出願第61/782,002号の米国特許法第119条(e)の基の優先権の利益を主張し、その内容の全体は参照によって本明細書に取り込まれる。
関連技術の上記の例およびそれに関連する限界は、例示的なものであり排他的なものではないことが意図されている。関連技術の他の限界は、本明細書を読み図面を検討することによって当業者には明らかとなろう。
この明細書で使用される単数形「a(1つの)」、「an(1つの)」および「the(その)」は、文脈が明白に他様に指示しない限り、複数の指示対象を包含する。したがって、たとえば「ポリマー」への言及は単一のポリマーとともに2つ以上の同じまたは異なるポリマーを包含し、「賦形剤」への言及は単一の賦形剤とともに2つ以上の同じまたは異なるポリマーを包含する等である。
弁の修復のために実施される最小限に侵襲的でかつ経皮的な処置は、より侵襲的な形式の外科術よりも好まれることがあるが、それでもなお欠点を抱えている。そのうちの1つは、動脈への治療介入の間の閉塞性プラークまたは血栓の崩壊であり、これは下流の塞栓および微小血管の閉塞に至ることがある。本開示発明では、治療対象者内の血管中を流れる血液を、血流を閉塞しないで、ろ過して、破片、たとえばアテローム動脈硬化性プラークまたはカルシウム沈着物の崩壊から生じるような破片を捕獲し、ある場合には除去する手段を提供する構成物および装置が提供される。
図2に示されたように、順行性塞栓保護送達デバイス50は、第1の鞘70、第2の鞘80、塞栓保護デバイスおよびバルーンカテーテル40を備える。塞栓保護デバイスを送達するために、塞栓保護送達デバイスは、圧縮の立体配置に収められ、第1の鞘70および/または第2の鞘80内に少なくとも部分的に包み込まれる。
別の実施態様では、バルーンカテーテルを備えた塞栓保護デバイスの逆行性送達のための送達装置が提供される。逆行性送達とは、治療対象者の血管を通してその血管内の生来の血流とは逆の方向に該装置を送達することを指す。たとえば、そのようなデバイスは、大動脈人工弁を送達し展開するのに使用されることができ、保護装置およびバルーンカテーテルは大動脈を通って逆行方式で送達される。塞栓保護デバイスおよび任意的にバルーンカテーテルを備える逆行性弁埋め込み装置は、他の心臓弁、たとえば肺動脈弁、僧帽弁および三尖弁の治療に使用されることができることが注記される。
1つの様相では、フィルター(塞栓保護材料)を備えた人工弁が提供され、該フィルターは、サポートフレームにおよび少なくとも1個の移動可能に付属の弁補握部に、取り付けられることができる。少なくとも1個の移動可能に付属の弁補握部を備えたサポートフレームは、米国特許第8,366,768号に十分に記載されており、この内容はその全体が参照によって本明細書に取り込まれる。
上記された塞栓保護デバイスを備えた人工弁は、本明細書に記載された送達デバイスを使用して、必要としている患者に送達されることができる。この送達または埋め込みデバイスは、当業者によって容易に理解されるような最小限に侵襲的な処置を使用して、大動脈弁、肺動脈弁、僧帽弁または三尖弁の順行性または逆行性送達として設計されることができる。
Claims (14)
- フレームおよびフィルターシートを備えた塞栓保護デバイスであって、前記フレームが圧縮状態から拡張された状態まで拡張可能であり、前記フレームが少なくとも2個のU形状部材および少なくとも2個の脚部材を備えており、前記フィルターシートが前記フレームの全長に取り付けられている、塞栓保護デバイス。
- 前記フレームが、3個のU形状部材および3個の脚部材を備えている、請求項1に記載のデバイス。
- 前記脚部材のそれぞれが、前記U形状部材のうちの1個に固定された遠位端および自由端である近位端を備えている、請求項1または2に記載のデバイス。
- 前記フレームが形状記憶金属で構成されている、請求項1〜3のいずれか1項に記載のデバイス。
- 拡張された状態にある前記フレームが円錐形状を有する、請求項1〜4のいずれか1項に記載のデバイス。
- 前記フィルターシートが、ポリエステルモノフィラメントメッシュ、ナイロン(商標)モノフィラメントメッシュ、スクリーン印刷メッシュ、ナイロンメッシュおよび金属線メッシュから成る群から選ばれた材料で構成されている、請求項1〜5のいずれか1項に記載のデバイス。
- 前記フィルターシートが、前記フィルターシートを通って血液は自由に流れることを可能にするが破片は収集する材料で構成されている、請求項1〜6のいずれか1項に記載のデバイス。
- 前記破片が100μm超の半径を有する、請求項7に記載のデバイス。
- バルーンカテーテルをさらに備えている、請求項1〜8のいずれか1項に記載のデバイス。
- 順行性塞栓保護送達デバイスであって、
第1の鞘と、第2の鞘と、塞栓保護デバイスと、バルーンカテーテルとを備え、
前記第1および第2の鞘は長軸に沿って互いに隣接しており、
前記第1の鞘は前記第2の鞘から遠位にあり、
前記第1の鞘は、前記塞栓保護デバイスの少なくとも遠位の部分および前記バルーンの少なくとも遠位の部分を包み込み、および
前記第2の鞘は、前記塞栓保護デバイスの少なくとも近位の部分および前記バルーンの少なくとも近位の部分を包み込む、
順行性塞栓保護送達デバイス。 - 塞栓保護デバイスを備えた人工弁であって、
前記塞栓保護デバイスを備えた人工弁が、圧縮の立体配置と拡張された立体配置との間で拡張可能なサポートフレームと、弁補握部とを備え、前記サポートフレームおよび前記弁補握部はフィルターシートによって移動可能に接続されている、
塞栓保護デバイスを備えた人工弁。 - 第1の鞘および第2の鞘を備えた塞栓保護送達デバイスを備えた人工弁であって、前記第1および第2の鞘が塞栓保護デバイスを備えた人工弁を包み込み、前記塞栓保護デバイスを備えた人工弁が、人工弁尖を備えたサポートフレームと、少なくとも1個の移動可能に付属の弁補握部と、フィルターシートとを備えている、
塞栓保護送達デバイスを備えた人工弁。 - 治療対象者における塞栓症または微小塞栓症の発生率を低減する方法であって、前記方法が前記治療対象者に塞栓保護デバイスおよびバルーンカテーテルを送達する工程を含み、前記送達が、
前記治療対象者の血管内に前記デバイスを導入する工程、
前記デバイスを弁輪に向けて生来の血流の方向に進める工程、
前記塞栓保護デバイスを展開させる工程、
前記バルーンカテーテルを膨張させる工程、
前記バルーンカテーテルを収縮する工程、および
前記治療対象者から前記フィルター装置を取り出す工程、
を含む、方法。 - 治療対象者に塞栓保護デバイスを備えた人工弁を送達する方法であって、
前記治療対象者の血管内に塞栓保護デバイス送達装置を備えた人工弁を導入する工程であって、前記送達装置が第1の鞘、第2の鞘を備えており、前記送達装置が前記塞栓保護デバイスを備えた人工弁を包み込んでいる工程、
前記送達装置を前記血管を通って血流の方向に、前記装置の遠位端が弁輪を通り過ぎるまで、進める工程、
少なくとも1個の弁補握部を拡張する工程、
前記少なくとも1個の弁補握部を血流と逆の方向に、前記少なくとも1個の弁補握部が生来の弁洞と接触するまで、動かす工程、
前記サポートフレームを血流と逆の方向に動かす工程、
前記サポートフレームを拡張する工程、および
前記人工弁送達デバイスを取り出す工程、
を含む方法。
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JP2018225320A JP6957441B2 (ja) | 2013-03-14 | 2018-11-30 | 塞栓保護デバイスおよび使用方法 |
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US201361782002P | 2013-03-14 | 2013-03-14 | |
US61/782,002 | 2013-03-14 | ||
PCT/US2014/023715 WO2014159447A2 (en) | 2013-03-14 | 2014-03-11 | Embolic protection devices and methods of use |
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JP2018225320A Division JP6957441B2 (ja) | 2013-03-14 | 2018-11-30 | 塞栓保護デバイスおよび使用方法 |
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US (3) | US10307241B2 (ja) |
EP (1) | EP2967810B1 (ja) |
JP (2) | JP2016512077A (ja) |
CN (1) | CN105163687B (ja) |
CA (1) | CA2905422A1 (ja) |
ES (1) | ES2797575T3 (ja) |
HK (1) | HK1220351A1 (ja) |
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US20160022406A1 (en) | 2016-01-28 |
EP2967810A4 (en) | 2016-12-28 |
CA2905422A1 (en) | 2014-10-02 |
US11510769B2 (en) | 2022-11-29 |
HK1220351A1 (zh) | 2017-05-05 |
WO2014159447A3 (en) | 2014-11-20 |
EP2967810B1 (en) | 2020-04-22 |
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