JPWO2020163805A5 - - Google Patents

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JPWO2020163805A5
JPWO2020163805A5 JP2021569257A JP2021569257A JPWO2020163805A5 JP WO2020163805 A5 JPWO2020163805 A5 JP WO2020163805A5 JP 2021569257 A JP2021569257 A JP 2021569257A JP 2021569257 A JP2021569257 A JP 2021569257A JP WO2020163805 A5 JPWO2020163805 A5 JP WO2020163805A5
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Priority claimed from PCT/US2020/017343 external-priority patent/WO2020163805A2/en
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複合スキャフォールドであって、
その第1および第2の端部により定義される長さ寸法を有し、内部空間により区切られた第1および第2の外層により定義される、三次元支持構造体と、
前記内部空間を通って延在し、前記第1の外層と前記第2の外層を接続する複数のスペーサー要素と、
前記内部空間に配置され、前記支持構造体の第1の端部と第2の端部との間の空隙を集合的に定義する多数の相互接続された細孔を有する微多孔マトリクスとを含む、
前記スキャフォールド。
A composite scaffold,
a three-dimensional support structure defined by first and second outer layers having a length dimension defined by first and second ends thereof and separated by an interior space;
a plurality of spacer elements extending through the interior space and connecting the first outer layer and the second outer layer;
a microporous matrix having a plurality of interconnected pores disposed in the interior space and collectively defining a void between a first end and a second end of the support structure. ,
Said scaffold.
前記空隙の少なくとも約60%が、少なくとも10μm以上の径寸法を有する細孔を含む、請求項に記載の複合スキャフォールド。 2. The composite scaffold of claim 1 , wherein at least about 60% of the voids include pores having a diameter dimension of at least 10 [mu]m or greater. 空隙の容積が約3.0cm/グラムから9.0cm/グラムの間である、請求項に記載の複合スキャフォールド。 2. The composite scaffold of claim 1 , wherein the void volume is between about 3.0 cm <3> /gram and 9.0 cm <3> /gram. 3mmから250mm程度の断面積を有し、13%のひずみ率において、前記断面積が約17%未満の変化をする、請求項に記載の複合スキャフォールド。 2. The composite scaffold of claim 1 , having a cross-sectional area on the order of 3 mm <2> to 250 mm <2> , wherein at a strain rate of 13%, the cross-sectional area changes by less than about 17%. 前記複合スキャフォールドの表面積が約0.3m/グラムから1.5m/グラムの間である、請求項に記載の複合スキャフォールド。 2. The composite scaffold of claim 1 , wherein the surface area of the composite scaffold is between about 0.3 m <2> /gram and 1.5 m <2> /gram. 2.5MPaから30MPa程度の終局応力を有する、請求項に記載の複合スキャフォールド。 The composite scaffold according to claim 1 , having an ultimate stress of the order of 2.5 MPa to 30 MPa. 2.5MPaから30MPa程度の降伏応力を有する、請求項に記載の複合スキャフォールド。 The composite scaffold according to claim 1 , having a yield stress of the order of 2.5 MPa to 30 MPa. 請求項に記載の複合スキャフォールドであって、前記複合スキャフォールドは2.5MPaから70MPa程度の弾性率を有し、弾性率は、前記複合スキャフォールドおよび前記空隙を含む材料の断面積を使用して計算される、前記スキャフォールド。 The composite scaffold according to claim 1 , wherein the composite scaffold has an elastic modulus of about 2.5 MPa to 70 MPa, and the elastic modulus is determined using the cross-sectional area of the composite scaffold and the material containing the void. The scaffold is calculated as follows. 請求項に記載の複合スキャフォールドであって、前記複合スキャフォールドは150MPaから600MPa程度の弾性率を有し、弾性率は、前記複合スキャフォールドを含む材料のみの断面積を使用して計算される、前記スキャフォールド。 2. A composite scaffold according to claim 1 , wherein the composite scaffold has an elastic modulus of the order of 150 MPa to 600 MPa, the elastic modulus being calculated using the cross-sectional area of only the material comprising the composite scaffold. , said scaffold. 三次元支持構造体が三次元織物構造体を含む、請求項に記載の複合スキャフォールド。 2. The composite scaffold of claim 1 , wherein the three-dimensional support structure comprises a three-dimensional woven structure. 前記微多孔マトリクスが、スポンジ、フォーム、または加工繊維または加工ヤーンのいずれか、またはそれらの任意の組み合わせを含む、請求項に記載の複合スキャフォールド。 2. The composite scaffold of claim 1 , wherein the microporous matrix comprises any of sponge, foam, or processed fibers or yarns, or any combination thereof. 前記微多孔マトリクスが、凍結乾燥スポンジ、連続気泡押出フォーム、粒子浸出スポンジのいずれか、またはそれらの任意の組み合わせを含む、請求項に記載の複合スキャフォールド。 2. The composite scaffold of claim 1 , wherein the microporous matrix comprises any of a freeze-dried sponge, an open cell extruded foam, a particle-infused sponge, or any combination thereof. 前記微多孔マトリクスが、編成、製織、凍結乾燥、粒子浸出、連続気泡押出し、溶液流延、固体発泡、および架橋のいずれかによる、三次元支持構造体内に配置されたスポンジ、フォーム、または加工繊維または加工ヤーンのいずれか、またはそれらの任意の組み合わせを含む、請求項に記載の複合スキャフォールド。 The microporous matrix is a sponge, foam, or fabricated in which the microporous matrix is placed within a three-dimensional support structure by knitting, weaving, freeze drying, particle leaching, open cell extrusion, solution casting, solid foaming, and crosslinking. 2. The composite scaffold of claim 1 , comprising either fibers or textured yarns, or any combination thereof. 前記微多孔マトリクスがコラーゲンおよびヒドロゲルのうちの1つを含む、請求項に記載の複合スキャフォールド。 2. The composite scaffold of claim 1 , wherein the microporous matrix comprises one of collagen and hydrogel. 三次元支持構造体が、三次元構造体に編成されたモノフィラメント、マルチフィラメント、または加工ヤーン、またはそれらの任意の組み合わせを含む、請求項に記載の複合スキャフォールド。 2. The composite scaffold of claim 1 , wherein the three-dimensional support structure comprises monofilaments, multifilaments, or textured yarns, or any combination thereof, organized into a three-dimensional structure. 三次元支持構造体が、合成生体吸収性ポリマー、天然ポリマー、および/または添加剤の任意の組み合わせを含む、請求項に記載の複合スキャフォールド。 2. The composite scaffold of claim 1 , wherein the three-dimensional support structure comprises any combination of synthetic bioabsorbable polymers, natural polymers, and/or additives. 三次元支持構造体が、ホモポリマー、コポリマー、または以下:ポリ乳酸、ポリグリコール酸、ポリカプロラクトン、ポリジオキサノン、ポリヒドロキシアルカン酸、ポリ無水物、ポリ(オルトエステル)、ポリホスファゼン、ポリ(アミノ酸)、ポリアルキルシアノアクリレート、ポリ(プロピレンフマル酸、トリメチレンカーボネート、ポリ(グリセロールセバシン酸)、ポリ(グリコネート)、ポリ(エチレングリコール)、ポリ(ビニルアルコール)およびポリウレタンのいずれかのポリマーブレンドのいずれか、またはそれらの任意の組み合わせを含む、請求項に記載の複合スキャフォールド。 The three-dimensional support structure is a homopolymer, copolymer, or the following: polylactic acid, polyglycolic acid, polycaprolactone, polydioxanone, polyhydroxyalkanoic acid, polyanhydride, poly(orthoester), polyphosphazene, poly(amino acid), any of the following polymer blends: polyalkylcyanoacrylate, poly(propylene fumaric acid, trimethylene carbonate), poly(glycerol sebacic acid), poly(glyconate), poly(ethylene glycol), poly(vinyl alcohol) and polyurethane; or any combination thereof . 複合スキャフォールドであって、
内部空間によって区切られた第1および第2の外層、および前記内部空間を通って延在し、前記第1の外層と前記第2の外層を接続する複数のスペーサー要素を含む支持構造体;支持構造体は外部プロファイルを有する、と
前記支持構造体の外部に開口する多数の相互接続された細孔を有し、前記内部空間内に配置された微多孔マトリクスとを含み、
複数の相互接続された細孔が、前記支持構造体の寸法特性に対して配向されている、
前記スキャフォールド。
A composite scaffold,
a support structure comprising first and second outer layers separated by an interior space and a plurality of spacer elements extending through the interior space and connecting the first and second outer layers; the structure has an external profile;
a microporous matrix having a plurality of interconnected pores opening to the exterior of the support structure and disposed within the interior space;
a plurality of interconnected pores are oriented relative to the dimensional characteristics of the support structure;
Said scaffold.
前記複数の相互接続された細孔が、前記外部プロファイルの外面から前記内部空間に向け放射状に内側に配向されている、請求項18に記載の複合スキャフォールド。 19. The composite scaffold of claim 18 , wherein the plurality of interconnected pores are oriented radially inward from an outer surface of the outer profile toward the inner space. 前記複数の相互接続された細孔が、前記支持構造体の長さ寸法に向け配向されている、請求項18に記載の複合スキャフォールド。 19. The composite scaffold of claim 18 , wherein the plurality of interconnected pores are oriented toward a longitudinal dimension of the support structure. 前記支持構造体が、実質的に長方形形状の断面外部プロファイルを有する、請求項18に記載の複合スキャフォールド。 19. The composite scaffold of claim 18 , wherein the support structure has a cross-sectional external profile that is substantially rectangular in shape. 前記支持構造体が、実質的に円形形状の断面外部プロファイルを有する、請求項18に記載の複合スキャフォールド。 19. The composite scaffold of claim 18 , wherein the support structure has a cross-sectional external profile that is substantially circular in shape. スキャフォールド構造体であって、
その第1および第2の端部により定義される長さ寸法と、少なくとも部分的にその間の内部空間により区切られた第1および第2の外層によりさらに定義される、前記長さ寸法に垂直な厚み寸法とを有する支持構造体、および
前記内部空間を通って延在し、前記第1の外層と前記第2の外層を接続する複数のスペーサー要素、および
第1および第2の外層の間の内部空間内に配置された前記内部空間内に配置された微多孔マトリクスを含み、
前記支持構造体の前記厚み寸法が、前記長さ寸法の約5%伸張時に約10%未満の変化をする、
前記スキャフォールド。
A scaffold structure ,
a longitudinal dimension perpendicular to said longitudinal dimension defined by first and second ends thereof and further defined by first and second outer layers separated at least in part by an interior space therebetween; a support structure having a thickness dimension; and a plurality of spacer elements extending through the interior space and connecting the first outer layer and the second outer layer ;
a microporous matrix disposed within the interior space between the first and second outer layers;
the thickness dimension of the support structure changes by less than about 10% when stretched by about 5% of the length dimension;
Said scaffold.
前記複数のスペーサー要素がスペーサーヤーンを含む、請求項23に記載のスキャフォールド構造体。 24. The scaffold structure of claim 23 , wherein the plurality of spacer elements comprises spacer yarns. 前記複数のスペーサー要素が、前記第1および第2の外層との間に延在する約100μmから5000μmの間の長さを有する、請求項23に記載のスキャフォールド構造体。 24. The scaffold structure of claim 23 , wherein the plurality of spacer elements have a length extending between about 100 [mu]m and 5000 [mu]m between the first and second outer layers. スキャフォールド構造体が、約20%から125%の間の引張破壊点での伸張を有する、請求項23に記載のスキャフォールド構造体。 24. The scaffold structure of claim 23 , wherein the scaffold structure has an elongation at tensile failure of between about 20% and 125%. スキャフォールド構造体が、約5%から50%の間の降伏点での伸張を有する、請求項23に記載のスキャフォールド構造体。 24. The scaffold structure of claim 23 , wherein the scaffold structure has an elongation at yield between about 5% and 50%. スキャフォールド構造体が、2.5N/mmから25N/mm程度の剛性を有する、請求項23に記載のスキャフォールド構造体。 24. The scaffold structure of claim 23 , wherein the scaffold structure has a stiffness on the order of 2.5 N/mm to 25 N/mm. スキャフォールド構造体が、20%から70%程度の終局ひずみを有する、請求項23に記載のスキャフォールド構造体。 24. The scaffold structure of claim 23 , wherein the scaffold structure has an ultimate strain on the order of 20% to 70%. スキャフォールド構造体が、2.5MPaから30MPa程度の終局応力を有する、請求項23に記載のスキャフォールド構造体。 24. A scaffold structure according to claim 23 , wherein the scaffold structure has an ultimate stress of the order of 2.5 MPa to 30 MPa. スキャフォールド構造体が、2.5MPaから30MPa程度の降伏応力を有する、請求項23に記載のスキャフォールド構造体。 24. A scaffold structure according to claim 23 , wherein the scaffold structure has a yield stress of the order of 2.5 MPa to 30 MPa. キャフォールド構造体2.5MPaから70MPa程度の弾性率を有し、弾性率は、応力を前記空隙を含む前記スキャフォールドの断面積のひずみで除したものと定義する、請求項23に記載のスキャフォールド構造体。 24. The scaffold structure has an elastic modulus of about 2.5 MPa to 70 MPa, and the elastic modulus is defined as stress divided by strain in the cross - sectional area of the scaffold including the voids. Scaffold structure as described . キャフォールド構造体150MPaから600MPa程度の弾性率を有し、弾性率は、応力を前記空隙を除いた前記スキャフォールドを構成するバルク材料のひずみで除したものと定義する、請求項23に記載のスキャフォールド構造体。 23. The scaffold structure has an elastic modulus of about 150 MPa to 600 MPa, and the elastic modulus is defined as stress divided by strain of the bulk material constituting the scaffold excluding the voids. Scaffold structure as described in . スキャフォールド構造体が、2.5N/mmから250N/mm程度の剛性を有る、請求項23に記載のスキャフォールド構造体。 24. The scaffold structure of claim 23 , wherein the scaffold structure has a stiffness of the order of 2.5 N/mm to 250 N/mm. スキャフォールド構造体が、0.07グラム力(grams-force)/デニールから1.10グラム力(grams-force)/デニール程度の引張強さを有する、請求項23に記載のスキャフォールド構造体。 24. The scaffold structure of claim 23 , wherein the scaffold structure has a tensile strength on the order of 0.07 grams-force/denier to 1.10 grams-force/denier. スキャフォールド構造体が、0.3グラム力(grams-force)/デニールから2グラム力(grams-force)/デニール程度の破壊点での引張強さを有する、請求項23に記載のスキャフォールド構造体24. The scaffold structure of claim 23 , wherein the scaffold structure has a tensile strength at failure on the order of 0.3 gram-force/denier to 2 gram-force/denier. body . スキャフォールド構造体の少なくとも一部が親水性溶液でコーティングされている、請求項23に記載のスキャフォールド構造体24. The scaffold structure of claim 23 , wherein at least a portion of the scaffold structure is coated with a hydrophilic solution. 前記親水性溶液がポリエチレングリコール(PEG)を含む、請求項23に記載のスキャフォールド構造体24. The scaffold structure of claim 23 , wherein the hydrophilic solution comprises polyethylene glycol (PEG). 三次元構造体に編成されたモノフィラメント、マルチフィラメント、または加工ヤーン、またはそれらの任意の組み合わせのいずれかを含む、請求項23に記載のスキャフォールド構造体24. The scaffold structure of claim 23 , comprising any of monofilaments, multifilaments, or engineered yarns, or any combination thereof, organized into a three-dimensional structure. スキャフォールド構造体が、生体吸収性ポリマー、天然ポリマー、および/または添加剤の任意の組み合わせを含む、請求項23に記載のスキャフォールド構造体24. The scaffold structure of claim 23 , wherein the scaffold structure comprises any combination of bioabsorbable polymers, natural polymers, and/or additives. スキャフォールド構造体が、ホモポリマー、コポリマー、または以下:ポリ乳酸、ポリグリコール酸、ポリカプロラクトン、ポリジオキサノン、ポリヒドロキシアルカン酸、ポリ無水物、ポリ(オルトエステル)、ポリホスファゼン、ポリ(アミノ酸)、ポリアルキルシアノアクリレート、ポリ(プロピレンフマル酸、トリメチレンカーボネート、ポリ(グリセロールセバシン酸)、ポリ(グリコネート)、ポリ(エチレングリコール)、ポリ(ビニルアルコール)およびポリウレタンのいずれかのポリマーブレンドのいずれか、またはそれらの任意の組み合わせを含む、請求項23に記載のスキャフォールド構造体 The scaffold structure may be a homopolymer, copolymer, or the following: polylactic acid, polyglycolic acid, polycaprolactone, polydioxanone, polyhydroxyalkanoic acid, polyanhydride, poly(orthoester), polyphosphazene, poly(amino acid), poly any of the following polymer blends: alkyl cyanoacrylates, poly(propylene fumaric acid, trimethylene carbonate), poly(glycerol sebacic acid), poly(glyconate), poly(ethylene glycol), poly(vinyl alcohol) and polyurethane; or 24. A scaffold structure according to claim 23 , comprising any combination thereof. キャフォールド構造体3mmから3000mm程度の断面積を有し、前記断面積は、前記スキャフォールド構造体の長さに対して垂直な点での前記スキャフォールド構造体の2次元形状の面積を定義し、5%の伸張率において、前記断面積が約10%未満の変化をする、請求項23に記載のスキャフォールド構造体。 The scaffold structure has a cross-sectional area of about 3 mm 2 to 3000 mm 2 , and the cross-sectional area is the two-dimensional shape of the scaffold structure at a point perpendicular to the length of the scaffold structure. 24. The scaffold structure of claim 23 , wherein at a 5% stretch, the cross-sectional area changes by less than about 10%. 微多孔マトリクスが、集合的に微多孔マトリクスの外面に開口する多数の相互接続された細孔を定義する、請求項23に記載のスキャフォールド構造体。24. The scaffold structure of claim 23, wherein the microporous matrix defines a number of interconnected pores that collectively open to the outer surface of the microporous matrix.
JP2021569257A 2019-02-07 2020-02-07 Composite scaffold for soft tissue repair, reconstruction, and regeneration Pending JP2022520670A (en)

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