JP2016530899A - 人工血管グラフト - Google Patents
人工血管グラフト Download PDFInfo
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- JP2016530899A JP2016530899A JP2016515363A JP2016515363A JP2016530899A JP 2016530899 A JP2016530899 A JP 2016530899A JP 2016515363 A JP2016515363 A JP 2016515363A JP 2016515363 A JP2016515363 A JP 2016515363A JP 2016530899 A JP2016530899 A JP 2016530899A
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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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
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- A—HUMAN NECESSITIES
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- 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
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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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/062—Apparatus for the production of blood vessels made from natural tissue or with layers of living cells
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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
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
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- A—HUMAN NECESSITIES
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- 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
- A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
- A61F2002/0086—Special surfaces of prostheses, e.g. for improving ingrowth for preferentially controlling or promoting the growth of specific types of cells or tissues
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- A—HUMAN NECESSITIES
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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
- A61F2/04—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
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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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
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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
- A61F2210/0014—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
- A61F2210/0076—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
-
- 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
- A61F2250/0026—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 surface structures
-
- 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
- A61F2250/003—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 adsorbability or resorbability, i.e. in adsorption or resorption time
-
- 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
- A61F2250/0051—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 tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts
-
- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
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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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/00976—Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
- A61F2310/00982—Coating made of collagen
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N1/00—Microorganisms, e.g. protozoa; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
- C12N1/20—Bacteria; Culture media therefor
Abstract
Description
a.セルロース合成細菌を含むバイオリアクターを準備する工程と、
b.管状一次骨格構造をバイオリアクター内に導入し、その結果前記管状一次骨格構造が内部空間を覆い、かつ、前記一次骨格構造が前記空間に面する内部表面を有する工程と、
c.管状構造成分を前記内部空間内に導入し、それにより前記内部表面と前記管状構造成分の境界との間の距離が0.5mm〜6mmの範囲内であり、それにより前記管状構造成分が、前記管状構造成分の境界上にあり、かつ、前記管状構造成分の長さ伸長方向に沿って伸長する突出構造成分を備え、それにより前記突出構造成分の高さがおよそ2μm〜15μmの範囲内であり、かつ、幅がおよそ1μm〜50μmの範囲内である工程と、
d.一次骨格構造を、被覆を形成するセルロースで覆う工程と、
e.一次骨格構造から構造成分を除去する工程
によって特徴付けられる、前記方法に関する。
グルコース培地:セルロース合成用のグルコース2.381%を含むアセトバクター・キシリナム培地
上記の表の液体細菌培地(500mlの液体アセトバクター培地)中にセルロース合成バクテリアを含むバイオリアクターの提供。ニチノールのメッシュの形の管状一次骨格構造が突出構造成分と共に管状構造成分(心棒)に備えられる。心棒及びメッシュの約50%が液体細菌培地に覆われるような手段で、いずれも液体培地上に、前記液体培地に対して水平に配置され、かついずれも回転するバイオリアクターに回転可能に配置される。
第二被覆はスプレーの形で適用される可能性があり、具体的にはグラフトの移植及び吻合の完了の後に、吻合部への細胞移動を促進するためであり、かつ追加的な安定性が必要である場合に適用される可能性がある。スプレーは:
フィブリン60%、IV型コラーゲン30%及び残りの10%はVEGF(血管内皮細胞増殖因子)25ng/ml及び200U/mlのPen/Strep(ペニシリンストレプトマイシン「Pen−Strep」混合物は、ペニシリンG(ナトリウム塩)及び0.85%食塩水中の硫酸ストレプトマイシンを用いる、5000ユニットのペニシリン(基剤)及び5000μgのストレプトマイシン(基剤)/mlを含む)
を含む可能性がある。
図1は本発明の一態様による人工血管グラフト1の概略断面図を示す。
2 一次骨格構造
20 一次骨格構造の外部表面
21 一次骨格構造の内部表面
3 被覆
30 被覆の外部被覆表面
31 被覆の内部被覆表面
4 溝
7 第二被覆
71 第二被覆の内部第二被覆表面
8 人工血管グラフトの内部空間
A 一次骨格構造の厚さ
B 被覆の内部の厚さ
C 被覆の外部の厚さ
D 溝の深さ
N 隣接する溝の間の距離
L 溝の下部幅
U 溝の上部幅
W 溝の最大幅
X 一次骨格構造の外径
Y 被覆の内径
Claims (13)
- 一次骨格構造(2)を備える人工血管グラフト(graft)(1)であって、前記一次骨格構造(2)は前記人工血管グラフト(1)の内部空間(8)を覆い、前記一次骨格構造(2)は
a.前記内部空間(8)に面する内部表面(21)及び、
b.前記内部空間(8)から離れて面する外部表面(20)及び、
c.前記内部表面(21)及び前記外部表面(20)の被覆(3)
を有する、前記人工血管グラフト(1)であって、
複数の溝(4)が前記内部表面(21)の前記被覆(3)に備えられ、かつ、前記一次骨格構造(2)並びに前記内部表面(21)及び前記外部表面(20)の前記被覆(3)は、細胞、具体的には前駆細胞が前記被覆(3)の前記外部表面(20)、前記一次骨格構造(2)及び前記被覆(3)の前記内部表面(21)を通って前記内部空間(8)に移動しうるような手段で設計されることを特徴とする、前記人工血管グラフト(1)。 - 前記一次骨格構造(2)及び/又は前記被覆(3)が管状の形によって特徴付けられる、請求項1に記載の前記人工血管グラフト。
- 前記一次骨格構造(2)はおよそ1.5mm〜40mmの範囲内の外径(X)を有し、具体的にはおよそ1.5mm〜15mmの範囲内の外径(X)を有し、かつ、前記被覆(3)はおよそ1mm〜35mmの範囲内の内径(Y)を有し、具体的にはおよそ3.5mm〜5mmの範囲内の内径(Y)を有することを特徴とする、請求項2に記載の前記人工血管グラフト。
- 前記一次骨格構造(2)及び/又は前記被覆(3)が、400〜1000%/2.93kPaの範囲内の伸展性(compliance)で特徴付けられる材料を備え、具体的には600〜800%/2.93kPaの範囲内の伸展性で特徴付けられる材料を備えることを特徴とする、請求項1〜3のいずれか1項に記載の前記人工血管グラフト。
- 前記一次骨格構造(2)及び/又は前記被覆(3)が、前記人工血管グラフト(1)の長軸に対して垂直で対称な径方向の伸長後に、最初の状態へ萎縮しうる材料を備え、前記径方向の伸長が、前記一次骨格構造(2)の最初の前記外径(X)又は前記被覆(3)の最初の前記内径(Y)に対して、5%〜40%の範囲内であり、具体的には15%〜20%の範囲内であることを特徴とする、請求項1〜4のいずれか1項に記載の前記人工血管グラフト。
- 前記一次骨格構造(2)が穴又はメッシュ構造を備えることを特徴とする、請求項1〜5のいずれか1項に記載の前記人工血管グラフト。
- 前記一次骨格構造(2)が金属又は金属合金を備え、具体的には形状記憶合金を備えることを特徴とする、請求項1〜6のいずれか1項に記載の前記人工血管グラフト。
- 前記一次骨格構造(2)及び/又は前記被覆(3)がポリマー材料を備え、具体的にはセルロース材料を備えることを特徴とする、請求項1〜7のいずれか1項に記載の前記人工血管グラフト。
- 前記被覆(3)が50nm〜500nmの直径を有する細孔の形の構造パターンを備えることを特徴とする、請求項1〜8のいずれか1項に記載の前記人工血管グラフト。
- 前記被覆(3)は、前記人工血管グラフト(1)の前記内部空間(8)に面している内部被覆表面(31)を備え、かつ、前記被覆(3)は前記内部被覆表面(31)に第二被覆(7)を備え、具体的にはIV型コラーゲンを含む第二被覆(7)を備えることを特徴とする、請求項1〜9のいずれか1項に記載の前記人工血管グラフト。
- 前記複数の溝(4)の各々の溝は0.5μm〜200μmの幅(W)を基本的に有し、具体的には1μm〜50μmの幅(W)を有し、より具体的には2μm〜5μmの幅(W)を有することを特徴とする、請求項1に記載の前記人工血管グラフト。
- 人工血管グラフトの製造方法、具体的には請求項1〜11のいずれか1項に記載の人工血管グラフトの製造方法であって、
a.セルロース合成細菌を含むバイオリアクターを準備する工程と、
b.管状一次骨格構造(2)を前記バイオリアクター内に導入し、その結果前記管状一次骨格構造(2)が内部空間を覆い、かつ、前記一次骨格構造(2)が前記内部空間に面する内部表面(21)を有する工程と、
c.管状構造成分を前記内部空間内に導入し、それにより前記内部表面(21)と前記管状構造成分の境界との間の距離が0.5mm〜6mmの範囲内であり、それにより前記管状構造成分が、前記管状構造成分の境界上にあり、かつ、前記管状構造成分の長さ伸長方向に沿って伸長する突出構造成分を備え、それにより前記突出構造成分がおよそ2μm〜15μmの範囲内の高さ及びおよそ1μm〜50μmの範囲内の幅を備える工程と、
d.前記一次骨格構造(2)を、被覆(3)を形成するセルロースで覆う工程と、
e.前記一次骨格構造(2)から前記構造成分を除去する工程と
を含む、前記方法。 - 前記一次骨格構造(2)が請求項2〜8のいずれか1項で定義されるような特徴を備え、かつ、前記被覆(3)が請求項2〜5又は8〜11のいずれか1項で定義されるような特徴を備える、請求項12に記載の方法。
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