JP5657249B2 - 生物分解性繊維と非生物分解性繊維を組み合わせる植え込み可能なメッシュ - Google Patents
生物分解性繊維と非生物分解性繊維を組み合わせる植え込み可能なメッシュ Download PDFInfo
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- JP5657249B2 JP5657249B2 JP2009514345A JP2009514345A JP5657249B2 JP 5657249 B2 JP5657249 B2 JP 5657249B2 JP 2009514345 A JP2009514345 A JP 2009514345A JP 2009514345 A JP2009514345 A JP 2009514345A JP 5657249 B2 JP5657249 B2 JP 5657249B2
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Classifications
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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
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- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially resorbable by the body
-
- 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
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0069—Devices for implanting pellets, e.g. markers or solid medicaments
-
- 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
- A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
- A61F2002/0068—Implantable repair or support meshes, e.g. hernia meshes having a special mesh pattern
-
- 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
- A61F2250/0031—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 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
-
- 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
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/22—Materials or treatment for tissue regeneration for reconstruction of hollow organs, e.g. bladder, esophagus, urether, uterus
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- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Vascular Medicine (AREA)
- Biomedical Technology (AREA)
- Urology & Nephrology (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Cardiology (AREA)
- Surgery (AREA)
- Epidemiology (AREA)
- Dermatology (AREA)
- Hematology (AREA)
- Anesthesiology (AREA)
- Medical Informatics (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
Description
本発明は、全般的に、外科的に植え込み可能な支持スリングに関する。特に、さまざまな実施態様において、本発明は、非生物分解性繊維に織り込まれた生物分解性繊維を含むメッシュ状スリングに関する。一部の実施態様において、繊維は、生物分解性部分と非生物分解性部分の両方を含む。本発明は、このようなスリングおよび繊維の使用および製造方法にさらに関する。
米国においては1千3百万人超の男女が尿失禁を抱えている。緊張性尿失禁(SUI:Stress Urinary Incontinence)は、主に女性が罹る。SUIは、通常、固有括約筋の欠陥(ISD:Intrinsic Sphincter Deficiency)と過可動性の2つの条件によって引き起こされる。これらの条件は、個別にまたは組み合わさって発生しうる。ISDの場合、尿道内に存在する尿道括約筋弁が適正に閉鎖(接合)しないために、緊張の多い活動中に尿が尿道から漏れ出る。過可動性は、骨盤底が膨張、脆弱化、または損傷した状態であり、腹内圧の(例えば、くしゃみ、咳、いきみ、その他による)上昇に反応して膀胱頚部および近位尿道の回転および下降が起きる。この結果、尿道閉鎖を促すための反応時間が不十分であるため、尿の漏出および/または流出が引き起こされる。さらに、緊張性尿失禁の状態は、未治療の膣円蓋脱出症または他のより深刻な骨盤底障害の存在によって悪化することが多い。多くの場合、緊張性尿失禁の治療は、骨盤底障害を治療せずに行われるので、骨盤底障害の早期再発に至る可能性がある。
本発明は、患者の体内の解剖学的部位を支持するための改良された植え込み可能なスリングを提供することによって、従来技術の欠陥に対応する。より具体的には、さまざまな側面において、本発明は、スリングの植え込み後に瘢痕組織の隆起および永久的な形成を助長し、術後のスリングの張力を最適化する、非生物分解性材料と生物分解性材料との組み合わせを用いた材料で形成された支持スリングを提供する。1つの特徴によると、スリングの複数部分の分解に伴い、これらの部分が瘢痕組織に置き換わるため、例えば、体の動きおよび身体の発育に応じてスリングの張力が自動的に減弱される。別の特徴によると、生物分解性材料の分解に伴い、スリングの孔/格子隙間が大きくなって組織の内部成長および瘢痕組織の形成をさらに助けるように、生物分解性材料がスリングに組み込まれる。さらに別の特徴によると、生物分解性材料の分解産物は、組織の炎症を加速し、ひいては植え込まれたスリングの上および/または中への瘢痕組織の形成を加速する。
(項目1)
植え込み可能なスリングに使用されるメッシュであって、
格子状に配置された複数の横ストランドと複数の縦ストランドとを備え、
少なくとも1つの縦ストランドは生物分解性であり、ほぼ同じ縦方向の経路に延在するが、共通の横ストランドに接触しないように離隔されるようになっている複数の繊維セグメントを含むメッシュ。
(項目2)
項目1に記載のメッシュであって、上記複数の横ストランドが非分解性であるメッシュ。
(項目3)
項目1に記載のメッシュであって、少なくとも1つの生物分解性ストランドが、外側の分解性外皮の中に設けられた内側の非分解性芯線を有するメッシュ。
(項目4)
項目1に記載のメッシュであって、生物分解性の縦ストランドを複数備えるメッシュ。
(項目5)
項目1に記載のメッシュであって、上記複数の縦ストランドは生物分解性ストランドと非分解性ストランドの両方を含み、上記複数の横ストランドは生物分解性ストランドと非分解性ストランドの両方を含むメッシュ。
(項目6)
項目1に記載のメッシュであって、少なくとも1つの生物分解性ストランドが、外側の分解性外皮の中に設けられた内側の非分解性芯線を有するメッシュ。
(項目7)
項目1に記載のメッシュであって、上記メッシュ内への瘢痕組織の所定速度での内部成長を助長する速度で生体内で分解される材料で形成される生物分解性繊維を含むメッシュ。
(項目8)
項目1に記載のメッシュであって、上記複数の縦ストランドは生物分解性ストランドと非分解性ストランドの両方を含み、非分解性の縦ストランドに対する生物分解性の縦ストランドの比が約1/4より大きいメッシュ。
(項目9)
項目1に記載のメッシュであって、上記複数の縦ストランドは生物分解性ストランドと非分解性ストランドの両方を含み、非分解性の縦ストランドに対する生物分解性の縦ストランドの比が約1/4から約1の範囲内にあるメッシュ。
(項目10)
項目1に記載のメッシュであって、複数の生物分解性ストランドと複数の非分解性ストランドとを備え、非分解性ストランドに対する生物分解性ストランドの比が約1/4より大きいメッシュ。
(項目11)
項目1に記載のメッシュであって、複数の生物分解性ストランドと複数の非分解性ストランドとを備え、非分解性ストランドに対する生物分解性ストランドの比が約1/4から約4の範囲内にあるメッシュ。
(項目12)
項目1に記載のメッシュであって、作用物質を含むメッシュ。
(項目13)
項目12に記載のメッシュであって、上記作用物質が治療薬であるメッシュ。
(項目14)
項目1に記載のメッシュであって、少なくとも1つのストランドの分解後に、上記メッシュの隣接メッシュストランド間に約50μmより大きい隙間が形成されるメッシュ。
(項目15)
項目1に記載のメッシュであって、少なくとも1つの横ストランドが複数の縦ストランドに接着剤によって取り付けられるメッシュ。
(項目16)
項目1に記載のメッシュであって、上記少なくとも1つの縦ストランドは、患者の尿道に沿って延在するようになっているメッシュ。
(項目17)
植え込み可能なスリングに使用されるメッシュであって、
格子状に配置された複数の横ストランドと複数の縦ストランドとを備え、上記複数の縦ストランドが患者の尿道に沿って延在するようになっており、
上記横ストランドの少なくとも1つと上記縦ストランドの少なくとも1つとが生物分解性であるメッシュ。
(項目18)
項目17に記載のメッシュであって、複数の横ストランドと複数の縦ストランドとが生物分解性であるメッシュ。
(項目19)
項目17に記載のメッシュであって、少なくとも1つの生物分解性ストランドが外側の分解性外皮の中に設けられた内側の非分解性芯線を有するメッシュ。
(項目20)
項目17に記載のメッシュであって、上記複数の縦ストランドが生物分解性ストランドと非分解性ストランドとによって設けられ、非分解性ストランドに対する生物分解性ストランドの比が約1/4から約1の範囲内にあるメッシュ。
(項目21)
項目17に記載のメッシュであって、少なくとも1つの生物分解性ストランドが、外側の分解性外皮の中に設けられた内側の非分解性芯線を有するメッシュ。
(項目22)
項目17に記載のメッシュであって、上記生物分解性ストランドは、上記メッシュ内への瘢痕組織の所定速度での内部成長を助長する速度で生体内で分解される材料で形成されるメッシュ。
(項目23)
項目17に記載のメッシュであって、上記複数の縦ストランドは生物分解性ストランドと非分解性ストランドの両方を含み、非分解性の縦ストランドに対する生物分解性の縦ストランドの比が約1/4から約1の範囲内にあるメッシュ。
(項目24)
項目17に記載のメッシュであって、作用物質を含むメッシュ。
(項目25)
項目24に記載のメッシュであって、上記作用物質が治療薬であるメッシュ。
(項目26)
項目17に記載のメッシュであって、少なくとも1つのストランドの分解後に、上記メッシュの隣接メッシュストランド間に約50μmより大きい隙間が形成されるメッシュ。
(項目27)
尿道支持メッシュを形成する方法であって、
非分解性メッシュを用意するステップと、
生物分解性高分子を含有する溶液を用意するステップと、
上記溶液を上記メッシュにパターン状に塗布するステップと、
を含む方法。
(項目28)
項目27に記載の方法であって、上記パターンは、上記メッシュの中心から上記メッシュの少なくとも一端まで延在する複数のV字形、三角形、ひし形、多角形、円形、または楕円形のうちの1つである方法。
(項目29)
項目27に記載の方法であって、上記塗布された溶液から溶剤を気化させるために、上記メッシュへの塗布後に上記溶液を空気乾燥させるステップをさらに含む方法。
付属の図面を参照して本発明のさまざまな例示的実施形態を以下に説明する。これらの図面は、一定の縮尺で描かれていない場合もある。これらの図面において、同様の部分は同様の参照名によって示されている。
Claims (10)
- 植え込み可能なスリングに使用されるメッシュであって、
格子状に配置された、複数の非生物分解性横ストランドと複数の非生物分解性縦ストランドとを備え、該複数の非生物分解性横ストランドと該複数の非生物分解性縦ストランドとは、該複数の非生物分解性横ストランドおよび該複数の非生物分解性縦ストランド間に間隙空間を規定し、
該間隙空間に該複数の非生物分解性縦ストランドと同じ方向に繊維が織り込まれ、該繊維は、生物分解性であり、そして、該繊維と同じ方向に延びる該複数の非生物分解性縦ストランドよりも短い長さを有する、メッシュ。 - 請求項1に記載のメッシュであって、作用物質を含むメッシュ。
- 請求項2に記載のメッシュであって、前記作用物質が治療薬であるメッシュ。
- 請求項1に記載のメッシュであって、少なくとも1つの繊維の分解後に、前記メッシュの隣接メッシュストランド間に50μmより大きい隙間が形成されるメッシュ。
- 請求項1に記載のメッシュであって、少なくとも1つの横ストランドが複数の縦ストランドに接着剤によって取り付けられるメッシュ。
- 請求項1に記載のメッシュであって、前記少なくとも1つの横ストランドは、患者の尿道に沿って延在するようになっているメッシュ。
- 植え込み可能なスリングに使用されるメッシュであって、
格子状に配置された、複数の非生物分解性横ストランドと複数の非生物分解性縦ストランドとを備え、該複数の非生物分解性横ストランドと該複数の非生物分解性縦ストランドとは、該複数の非生物分解性横ストランドおよび該複数の非生物分解性縦ストランド間に間隙空間を規定し、該複数の非生物分解性横ストランドが患者の尿道に沿って延在するようになっており、
該間隙空間に該複数の非生物分解性縦ストランドと同じ方向に繊維が織り込まれ、該繊維は、生物分解性であり、そして、該繊維と同じ方向に延びる該複数の非生物分解性縦ストランドよりも短い長さを有する、メッシュ。 - 請求項7に記載のメッシュであって、作用物質を含むメッシュ。
- 請求項8に記載のメッシュであって、前記作用物質が治療薬であるメッシュ。
- 請求項7に記載のメッシュであって、少なくとも1つの繊維の分解後に、前記メッシュの隣接メッシュストランド間に50μmより大きい隙間が形成されるメッシュ。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US11/448,252 US8721519B2 (en) | 2006-06-06 | 2006-06-06 | Implantable mesh combining biodegradable and non-biodegradable fibers |
US11/448,252 | 2006-06-06 | ||
PCT/US2007/013282 WO2007145974A2 (en) | 2006-06-06 | 2007-06-05 | Implantable mesh combining biodegradable and non-biodegradable fibers |
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JP2009539476A JP2009539476A (ja) | 2009-11-19 |
JP5657249B2 true JP5657249B2 (ja) | 2015-01-21 |
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JP2009514345A Expired - Fee Related JP5657249B2 (ja) | 2006-06-06 | 2007-06-05 | 生物分解性繊維と非生物分解性繊維を組み合わせる植え込み可能なメッシュ |
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US (2) | US8721519B2 (ja) |
EP (1) | EP2046404B1 (ja) |
JP (1) | JP5657249B2 (ja) |
CA (1) | CA2654194A1 (ja) |
ES (1) | ES2476893T3 (ja) |
WO (1) | WO2007145974A2 (ja) |
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EP3940129A1 (en) | 2016-01-14 | 2022-01-19 | Educational Foundation Of Osaka Medical And Pharmaceutical University | Sealed fabric for use as a medical material |
US11510768B2 (en) | 2016-01-14 | 2022-11-29 | Educational Foundation Of Osaka Medical And Pharmaceutical University | Warp-knitted fabric and medical material |
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EP2046404B1 (en) | 2014-05-07 |
WO2007145974A2 (en) | 2007-12-21 |
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ES2476893T3 (es) | 2014-07-15 |
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US20140249362A1 (en) | 2014-09-04 |
EP2046404A2 (en) | 2009-04-15 |
CA2654194A1 (en) | 2007-12-21 |
JP2009539476A (ja) | 2009-11-19 |
US8968182B2 (en) | 2015-03-03 |
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