JP6929787B2 - 波状繊維を有する繊維補強人工心臓弁 - Google Patents
波状繊維を有する繊維補強人工心臓弁 Download PDFInfo
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- 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
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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
- A61F2/02—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
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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
- A61F2/02—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
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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
- A61F2/02—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
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/507—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials for artificial blood vessels
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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
- 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
- A61F2210/0071—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof thermoplastic
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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
- 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
- A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
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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
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0018—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in elasticity, stiffness or compressibility
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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
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0028—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in fibre orientations
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- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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- B29K2995/00—Properties of moulding materials, reinforcements, fillers, preformed parts or moulds
- B29K2995/0037—Other properties
- B29K2995/0046—Elastic
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- B—PERFORMING OPERATIONS; TRANSPORTING
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Description
例4では、各繊維の複数の波状部が、複合材料が繊維の第1の延伸方向に引き伸ばされるときに直線になるように適合されている、例1〜例3のうちの1つの人工心臓弁である。
例8では、複数の繊維が熱可塑性ポリマーを含む、例1〜例7のうちの1つの人工心臓弁である。
例10では、ポリマーマトリックスがエラストマーポリマーを含む、例1〜例9のうちの1つの人工心臓弁である。
例16では、人工心臓弁は、ポリマーマトリックスに組み込まれた第1の複数の繊維を含む複合材料を含む。各繊維は、第1の延伸方向および複数の波状部を有し、第1の複数の繊維の複数の波状部は、複合材料に多段弾性特性を与えるように適合されている。
例18では、第1の延伸方向が人工心臓弁の弁尖における周方向および半径方向のうちの一方である、例16の人工心臓弁である。
例20では、複合材料は、複数の繊維が複数の波状部を有するときに弾性が高く、かつ複数の繊維の少なくとも一部が実質的に直線の繊維に引き伸ばされたときに弾性が低い。
例23では、複数の繊維が熱可塑性ポリマーを含む、例16の人工心臓弁である。
例25では、ポリマーマトリックスがエラストマーポリマーを含む、例16の人工心臓弁である。
例27では、第1の複数の繊維の方向は第1の長手方向軸を画定し、および第2の複数の繊維の方向は第2の長手方向軸を画定し、第1の長手方向軸は第2の長手方向軸に対して直交する。
例32では、複数の湾曲繊維の各湾曲繊維が第1の延伸方向および複数の波状部を有する、例29の人工心臓弁である。
例35では、第1のポリマー層が浸漬または噴霧プロセスを使用して配置される、例33の方法である。
図1は、人体105の心臓102内における、本明細書で提供される人工心臓弁100の図を示す。人体105は、4つの心臓弁、すなわち肺動脈弁、三尖弁、大動脈弁および僧帽弁を有する。心臓弁の目的は、血液が心臓を通りかつ心臓から、大動脈および肺動脈等、心臓に連結された主要血管内に流れるようにすることである。図1の人工心臓弁100は、大動脈人工心臓弁であり、それは、大腿部切開部、鎖骨下動脈切開部または直接大動脈切開部から血管を通して配置される展開デバイス110(送達カテーテルまたは送達システムとも呼ぶことができる)の使用を含む、経カテーテル大動脈弁置換術(TAVR)処置(経皮的大動脈弁置換術(PAVR:percutaneous aortic valve replacement)または経カテーテル大動脈弁留置術(TAVI:transcatheter aortic valve implantation)とも言われる)を用いて送達することができる。展開デバイス110は、人工心臓弁100を解剖学的構造内の所望の位置まで送達し、植込み部位において植込み可能な心臓弁100を放出することができる。図1は、大動脈人工心臓弁を示すが、人工心臓弁100は、場合により別のタイプの心臓弁(たとえば、僧帽弁または三尖弁)であり得ることが理解されるべきである。場合により、本明細書で提供される人工心臓弁は、体内の弁に広く適用可能であり得る。
Xは、モノマーの繰返し単位への共有結合点であり、
各Rは、C1〜C4アルキル、特にメチルから独立して選択され、
nおよびmは、それぞれ1〜8の整数であり、
Yは、COO−、SO3−、O−SO3−、O−PO3−およびPO3−から選択されるアニオン基であり、および
Zは、脂肪族アミンもしくは芳香族アミン、アミジン、グアニジンまたは第4級アミンから導出されるカチオン基、特にNR’3+であり、各R’は、C1〜C4アルキル、特にメチルから独立して選択される。
Claims (15)
- 複数の弁尖を備え、前記弁尖は、
ポリマーマトリックスに組み込まれた第1の複数の繊維を含む複合材料を備え、前記第1の複数の繊維における各繊維は、規則的に間隔を置いて繰り返される複数の波状部を有し、各弁尖は、第1のスリーブ部分と、第2のスリーブ部分と、これら第1及び第2のスリーブ部分の間に配置された本体部分とを備え、ポリマー製の前記第1の複数の繊維は、前記第1のスリーブ部分及び前記第2のスリーブ部分の間の周方向に一致する第1の延伸方向に沿った直線経路に沿って延在し、前記第1の複数の繊維の規則的に間隔を置いて繰り返される前記複数の波状部は、前記第1の延伸方向に直交する方向に延びる頂部を有する人工心臓弁。 - 複合材料が弁尖に含まれ、および前記第1の複数の繊維の少なくとも一部が前記人工心臓弁の弁尖の縁輪郭の少なくとも一部に沿って延在している、請求項1に記載の人工心臓弁。
- 各繊維の前記複数の波状部が、前記複合材料が前記繊維の前記第1の延伸方向に引き伸ばされるときに直線になるように適合されている、請求項1または2に記載の人工心臓弁。
- 前記複合材料が、前記第1の延伸方向に対して平行な方向において弾性が高く、かつ前記第1の延伸方向に対して斜めの方向において弾性が低い、請求項1〜3のいずれか一項に記載の人工心臓弁。
- 前記複合材料が、前記複数の繊維の平均セグメント距離が前記複数の繊維の平均総繊維長未満であるときに第1の弾性を有し、かつ前記複数の繊維の前記平均セグメント距離が前記複数の繊維の前記平均総繊維長以上であるときに第2の弾性を有し、前記第1の弾性が前記第2の弾性より大きい、請求項1〜4のいずれか一項に記載の人工心臓弁。
- 前記波状部が0.5mm〜2mmの範囲の所定平均振幅と0.5mm〜2mmの範囲の所定平均波長とを有する、請求項1〜5のいずれか一項に記載の人工心臓弁。
- 前記複数の繊維が熱可塑性ポリマーを含む、請求項1〜6のいずれか一項に記載の人工心臓弁。
- 前記複数の繊維が液晶ポリマーを含む、請求項1〜7のいずれか一項に記載の人工心臓弁。
- 前記ポリマーマトリックスがエラストマーポリマーを含む、請求項1〜8のいずれか一項に記載の人工心臓弁。
- 前記ポリマーマトリックスに組み込まれた第2の複数の繊維をさらに備え、各繊維が第2の延伸方向および複数の波状部を有する、請求項1〜9のいずれか一項に記載の人工心臓弁。
- 前記第1の複数の繊維の方向が第1の長手方向軸を画定し、および前記第2の複数の繊維の方向が第2の長手方向軸を画定し、前記第1の長手方向軸が前記第2の長手方向軸に対して直交する、請求項10に記載の人工心臓弁。
- 前記第1の複数の繊維の方向が第1の長手方向軸を画定し、および前記第2の複数の繊維の方向が第2の長手方向軸を画定し、前記第1の長手方向軸が前記第2の長手方向軸に対して斜めである、請求項10に記載の人工心臓弁。
- 請求項1〜12のいずれか一項に記載の人工心臓弁を形成する方法であって、
複数の弁尖のための複合材料を形成するステップであって、
マンドレル上に第1のポリマー層を配置すること、
複数の波状部を含む第1の複数の繊維であって、前記第1の複数の繊維における各繊維は、規則的に間隔を置いて繰り返される複数の波状部を有する前記第1の複数の繊維を前記第1のポリマー層上に配置すること、および
前記第1の複数の繊維上に第2のポリマー層を配置すること
を含む前記ステップ
を含み、
各弁尖は、第1のスリーブ部分と、第2のスリーブ部分と、これら第1及び第2のスリーブ部分の間に配置された本体部分とを備え、
ポリマー製の前記第1の複数の繊維は、前記第1のスリーブ部分及び前記第2のスリーブ部分の間の周方向に一致する第1の延伸方向に沿った直線経路に沿って延在し、
前記第1の複数の繊維の規則的に間隔を置いて繰り返される前記複数の波状部は、前記第1の延伸方向に直交する方向に延びる頂部を有する方法。 - 前記複数の繊維がエレクトロスピニングプロセスを使用して配置される、請求項13に記載の方法。
- ポリマー製の前記第1の複数の繊維における規則的に間隔を置いて繰り返される前記複数の波状部は、前記複合材料に多段弾性特性を与えるように適合されている、請求項1〜12のいずれか一項に記載の人工心臓弁。
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