JP7419430B2 - 構造スペーサを有する細胞カプセル化デバイス - Google Patents
構造スペーサを有する細胞カプセル化デバイス Download PDFInfo
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- JP7419430B2 JP7419430B2 JP2022072463A JP2022072463A JP7419430B2 JP 7419430 B2 JP7419430 B2 JP 7419430B2 JP 2022072463 A JP2022072463 A JP 2022072463A JP 2022072463 A JP2022072463 A JP 2022072463A JP 7419430 B2 JP7419430 B2 JP 7419430B2
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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
- 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
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
-
- 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
- A61F2210/0071—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
-
- 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
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
-
- 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
- A61F2250/0023—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 porosity
-
- 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
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
- A61F2250/0068—Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/16—Materials with shape-memory or superelastic properties
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/09—Body tissue
- A61M2202/097—Body tissue endothelial cells
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Description
[0001]外側多孔質(血管新生)層並びに内側多孔質(細胞保持)層として有用な材料の一例としては、アルギネート、セルロースアセテート、ポリアルキレングリコール、例えばポリエチレングリコール及びポリプロピレングリコール、パンビニルポリマー(panvinyl polymers)、例えばポリビニルアルコール、キトサン、ポリアクリレート、例えばポリヒドロキシエチルメタクリレート、アガロース、加水分解ポリアクリロニトリル、ポリアクリロニトリルコポリマー、ポリビニルアクリレート、例えばポリエチレン-コ-アクリル酸、多孔質ポリテトラフルオロエチレン(PTFE)、多孔質改質ポリテトラフルオロエチレンポリマー、多孔質テトラフルオロエチレン(TFE)コポリマー、多孔質ポリアルキレン、例えば多孔質ポリプロピレン、及び多孔質ポリエチレン、多孔質ポリビニリデンフルオリド、多孔質ポリエステルスルホン(PES)、多孔質ポリウレタン、多孔質ポリエステル、多孔質PPX(ePPX)、多孔質超高分子量ポリエチレン(eUHMWPE)、多孔質エチレンテトラフルオロエチレン(eETFE)、多孔質ビニリデンフルオリド(eVDF)、多孔質ポリ乳酸(ePLLA)、及びこれらのコポリマー及び組み合わせ、並びに繊維又は糸の製織又は不織収集物、又は繊維マトリックスが、単独又は組み合わせの形で挙げられる。
前記チャンバの長さ及び/又は幅に沿って前記第1内面と前記第2内面との間の平均距離を維持するように、前記チャンバ内に配置された構造スペーサと、
を含み、
前記構造スペーサは、前記チャンバ内部に細胞を配置するための少なくとも1つのリザーバ空間を更に画定する、
細胞カプセル化デバイス。
細胞カプセル化デバイス。
を含み、前記内側多孔質層の空隙率が、前記外側多孔質層よりも低く、そして前記内側多孔質層の一部が前記第1内面又は第2内面である、
請求項1に記載の細胞カプセル化デバイス。
細胞カプセル化デバイス。
細胞カプセル化デバイス。
を含み、前記構造スペーサは、前記チャンバ内部に細胞を配置するための少なくとも1つのリザーバ空間を更に画定し、そして前記構造スペーサの基底部に対する高さのアスペクト比が1/5~10/1である、
細胞カプセル化デバイス。
細胞カプセル化デバイス。
を含み、前記内側多孔質層の空隙率が、前記外側多孔質層よりも低く、そして前記内側多孔質層の一部が前記第1内面又は第2内面である、
請求項1に記載の細胞カプセル化デバイス。
細胞カプセル化デバイス。
細胞カプセル化デバイス。
以下の項目[1]~[54]に、本発明の実施形態の例を列記する。
[1]
細胞カプセル化デバイスであって、
第1層が上記第1層の周囲の一部に沿って、第2層に対して上記第2層の周囲の一部に沿ってシールされて、第1内面と反対側の第2内面とを含むチャンバを画定しており、上記第1内面が上記チャンバ内で上記第2内面から離隔している、第1層と、
上記チャンバの長さ及び/又は幅に沿って上記第1内面と上記第2内面との間の平均距離を維持するように、そして上記第1内面と上記第2内面とを相互接続するように、上記チャンバ内に配置された構造スペーサと、
を含み、
上記構造スペーサは、上記チャンバ内部に細胞を配置するための少なくとも1つのリザーバ空間を更に画定する、
細胞カプセル化デバイス。
[2]
上記リザーバ空間と流体連通する少なくとも1つのポートを更に含む、項目1に記載の細胞カプセル化デバイス。
[3]
上記少なくとも1つのリザーバ空間内に複数の細胞を更に含む、項目1に記載の細胞カプセル化デバイス。
[4]
上記第1層及び第2層が細胞内方成長を遮る、項目1に記載の細胞カプセル化デバイス。
[5]
上記第1層及び第2層の少なくとも一方が複合層であり、上記複合層が、
a) 外側多孔質層と、
b) 上記外側多孔質層に隣接する内側多孔質層と
を含み、上記内側多孔質層の空隙率が、上記外側多孔質層よりも低く、そして上記内側多孔質層の一部が上記第1内面又は第2内面である、
項目1に記載の細胞カプセル化デバイス。
[6]
上記第1層及び第2層の両方が複合層である、項目5に記載の細胞カプセル化デバイス。
[7]
上記外側多孔質層は、患者からの血管組織が上記外側多孔質層の孔内部で、上記内側多孔質層まで成長するのを許すが、しかし上記内側多孔質層を貫通するのは許さないほどに充分に多孔性である、項目6に記載の細胞カプセル化デバイス。
[8]
上記第1層及び第2層のうちの少なくとも一方が生体吸収性材料を含む、項目1に記載の細胞カプセル化デバイス。
[9]
上記構造スペーサが酸素透過性材料を含む、項目1に記載の細胞カプセル化デバイス。
[10]
上記第1外側多孔質層及び上記第2外側多孔質層の多孔性が維持される、項目1に記載の細胞カプセル化デバイス。
[11]
上記生体吸収性材料が粉末又はスクリーンの形態を成す、項目8に記載の細胞カプセル化デバイス。
[12]
上記内側多孔質層が細胞内方成長を遮る、項目6に記載の細胞カプセル化デバイス。
[13]
上記構造スペーサが、上記第1複合層及び第2複合層の内側多孔質層に接着されている、項目6に記載の細胞カプセル化デバイス。
[14]
上記構造スペーサが接着剤を介して接着されており、上記接着剤は上記第1複合層及び第2複合層の外側多孔質層の孔内へ浸透していない、項目13に記載の細胞カプセル化デバイス。
[15]
上記カプセル化デバイスがほぼ管状の形態を有している、項目1に記載の細胞カプセル化デバイス。
[16]
上記構造スペーサが、加えられた力のもとで平均距離を維持する、項目1に記載の細胞カプセル化デバイス。
[17]
上記構造スペーサが多孔質材料を含む、項目1に記載の細胞カプセル化デバイス。
[18]
上記構造スペーサが形状記憶材料を含む、項目1に記載の細胞カプセル化デバイス。
[19]
上記構造スペーサが酸素透過性材料を含む、項目1に記載の細胞カプセル化デバイス。
[20]
上記構造スペーサが無孔質材料を含む、項目1に記載の細胞カプセル化デバイス。
[21]
上記第1内面と上記第2内面との間の平均距離が少なくとも約50ミクロンである、項目1に記載の細胞カプセル化デバイス。
[22]
上記デバイスが、相互接続された複数のリザーバ空間を含む、項目1に記載の細胞カプセル化デバイス。
[23]
上記デバイスが、不連続的な少なくとも2つのリザーバ空間を含む、項目1に記載の細胞カプセル化デバイス。
[24]
上記内側多孔質層及び上記外側多孔質層のうちの少なくとも一方が、延伸ポリテトラフルオロエチレンを含む、項目6に記載の細胞カプセル化デバイス。
[25]
上記構造スペーサが複数の繊維を含む、項目1に記載の細胞カプセル化デバイス。
[26]
上記構造スペーサが、熱可塑性ポリマーから成る3D印刷されたビーズを含む、項目1に記載の細胞カプセル化デバイス。
[27]
上記構造スペーサが、構造的拘束具を含む三次元織布を含む、項目1に記載の細胞カプセル化デバイス。
[28]
細胞カプセル化デバイスであって、
第1層が上記第1層の周囲の一部に沿って、第2層に対して上記第2層の周囲の一部に沿ってシールされて、第1内面と反対側の第2内面とを含むチャンバを画定しており、上記第1内面が上記チャンバ内で上記第2内面から離隔している、第1層と、
上記第1内面と上記第2内面との間の平均距離を維持するように、上記チャンバ内に配置された構造スペーサと、
を含み、上記構造スペーサは、上記チャンバ内部に細胞を配置するための少なくとも1つのリザーバ空間を更に画定し、そして上記構造スペーサの基底部に対する高さのアスペクト比が1/5~10/1である、
細胞カプセル化デバイス。
[29]
上記リザーバ空間と流体連通する少なくとも1つのポートを更に含む、項目28に記載の細胞カプセル化デバイス。
[30]
上記少なくとも1つのリザーバ空間内に複数の細胞を更に含む、項目28に記載の細胞カプセル化デバイス。
[31]
上記第1層及び第2層が細胞内方成長を遮る、項目28に記載の細胞カプセル化デバイス。
[32]
上記第1層及び第2層の少なくとも一方が複合層であり、上記複合層が、
a) 外側多孔質層と、
b) 上記外側多孔質層に隣接する内側多孔質層と
を含み、上記内側多孔質層の空隙率が、上記外側多孔質層よりも低く、そして上記内側多孔質層の一部が上記第1内面又は第2内面である、
項目28に記載の細胞カプセル化デバイス。
[33]
上記第1層及び第2層の両方が複合層である、項目32に記載の細胞カプセル化デバイス。
[34]
上記外側多孔質層は、患者からの血管組織が上記外側多孔質層の孔内部で、上記内側多孔質層まで成長するのを許すが、しかし上記内側多孔質層を貫通するのは許さないほどに充分に多孔性である、項目33に記載の細胞カプセル化デバイス。
[35]
上記第1層及び第2層のうちの少なくとも一方が生体吸収性材料を含む、項目28に記載の細胞カプセル化デバイス。
[36]
上記構造スペーサが酸素透過性材料を含む、項目28に記載の細胞カプセル化デバイス。
[37]
上記第1外側多孔質層及び上記第2外側多孔質層の多孔性が維持される、項目28に記載の細胞カプセル化デバイス。
[38]
上記生体吸収性材料が粉末又はスクリーンの形態を成す、項目35に記載の細胞カプセル化デバイス。
[39]
上記内側多孔質層が細胞内方成長を遮る、項目33に記載の細胞カプセル化デバイス。
[40]
上記構造スペーサが、上記第1複合層及び第2複合層の内側多孔質層に接着されている、項目33に記載の細胞カプセル化デバイス。
[41]
上記構造スペーサが接着剤によって接着されており、上記接着剤は上記第1複合層及び第2複合層の外側多孔質層の孔内へ浸透していない、項目40に記載の細胞カプセル化デバイス。
[42]
上記カプセル化デバイスがほぼ管状の形態を有している、項目28に記載の細胞カプセル化デバイス。
[43]
上記構造スペーサが、加えられた力のもとで平均距離を維持する、項目28に記載の細胞カプセル化デバイス。
[44]
上記構造スペーサが多孔質材料を含む、項目28に記載の細胞カプセル化デバイス。
[45]
上記構造スペーサが形状記憶材料を含む、項目28に記載の細胞カプセル化デバイス。
[46]
上記構造スペーサが酸素透過性材料を含む、項目28に記載の細胞カプセル化デバイス。
[47]
上記構造スペーサが無孔質材料を含む、項目28に記載の細胞カプセル化デバイス。
[48]
上記第1内面と上記第2内面との間の平均距離が少なくとも約50ミクロンである、項目28に記載の細胞カプセル化デバイス。
[49]
上記デバイスが、相互接続された複数のリザーバ空間を含む、項目28に記載の細胞カプセル化デバイス。
[50]
上記デバイスが、不連続的な少なくとも2つのリザーバ空間を含む、項目28に記載の細胞カプセル化デバイス。
[51]
上記内側多孔質層及び上記外側多孔質層のうちの少なくとも一方が、延伸ポリテトラフルオロエチレンを含む、項目33に記載の細胞カプセル化デバイス。
[52]
上記構造スペーサが複数の繊維を含む、項目28に記載の細胞カプセル化デバイス。
[53]
上記構造スペーサが、熱可塑性ポリマーから成る3D印刷されたビーズを含む、項目28に記載の細胞カプセル化デバイス。
[54]
上記構造スペーサが、構造的拘束具を含む三次元織布を含む、項目28に記載の細胞カプセル化デバイス。
Claims (10)
- 第1層が前記第1層の周囲の一部に沿って、第2層に対して前記第2層の周囲の一部に沿ってシールされて、第1内面と反対側の第2内面とを含むチャンバを画定しており、前記第1内面が前記チャンバ内で前記第2内面から離隔している、第1層と、
前記チャンバの長さ及び/又は幅に沿って前記第1内面と前記第2内面との間の平均距離を維持し、前記第1内面と前記第2内面とを相互接続するように、前記チャンバ内に配置された構造スペーサと、
前記チャンバ内部に細胞を配置するよう構成された複数のリザーバ空間と
を含み、
前記複数のリザーバ空間は、前記構造スペーサによって形成されたチャネルによって相互接続されており、
前記第1層及び第2層の少なくとも一つが複合層であり、前記複合層が、
a)外側多孔質細胞透過性層と、
b)前記外側多孔質細胞透過性層に隣接する内側多孔質細胞不透過性層と
を含み、そして前記内側多孔質細胞不透過性層の一部が前記第1内面又は第2内面である、カプセル化デバイス。 - 前記構造スペーサが、外部圧縮力及び内部拡張力の両方のもとで平均距離を維持する、請求項1に記載のカプセル化デバイス。
- 前記内側多孔質細胞不透過性層の空隙率が、前記外側多孔質細胞透過性層よりも低い、請求項1に記載のカプセル化デバイス。
- 前記第1層及び第2層が複合層であり、前記構造スペーサが接着剤を介して接着されており、前記接着剤は前記第1複合層及び第2複合層の前記外側多孔質細胞透過性層の孔内へ浸透していない、請求項3に記載のカプセル化デバイス。
- 前記複数のリザーバ空間は、流体的に相互接続されている、請求項1に記載のカプセル化デバイス。
- 前記複数のリザーバ空間内へ挿入される一つ又は複数の細胞は、生体材料内部でマイクロカプセル化されている、請求項1に記載のカプセル化デバイス。
- 前記生体材料がヒドロゲル生体材料である、請求項6に記載のカプセル化デバイス。
- 前記第1層及び第2層の一方が前記複合層であり、他方の層が細胞透過性層である、請求項1に記載のカプセル化デバイス。
- 前記第1層及び第2層のうちの少なくとも一方が生体吸収性材料を含む、請求項1に記載のカプセル化デバイス。
- 前記構造スペーサが、多孔質材料、形状記憶材料、酸素透過性材料、無孔質材料、複数の繊維、熱可塑性ポリマーの3D印刷されたビーズ、及びこれらの組み合わせから選択される部材を含む、請求項1に記載のカプセル化デバイス。
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