JP2019503832A - 皮膚増強外科用縫合糸 - Google Patents
皮膚増強外科用縫合糸 Download PDFInfo
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- JP2019503832A JP2019503832A JP2018553509A JP2018553509A JP2019503832A JP 2019503832 A JP2019503832 A JP 2019503832A JP 2018553509 A JP2018553509 A JP 2018553509A JP 2018553509 A JP2018553509 A JP 2018553509A JP 2019503832 A JP2019503832 A JP 2019503832A
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Abstract
Description
(sub−cutis)または皮下組織(subcutaneous tissue)とも呼ばれる。最も外側の表皮は、下層の基底膜とともに重層扁平上皮から構成されている。それは、血管を含んでおらず、真皮からの拡散によって栄養を与えられる。表皮は、主にケラチノサイトから成り、メラニン形成細胞およびランゲルハンス細胞も存在する。皮膚のこの層は、身体と外部環境との間のバリアとして機能して、水分を身体内に保ち、有害な化学物質および病原体の侵入を防ぐ。
本発明に従って充填剤でコーティングされた縫合糸(図1A〜図1C)は、90%グリコリドおよび10%L−ラクチドで作られたポリグラクチン910(ETHICON)などの、縫合糸1.1、およびヒドロキシアパタイトなどの、皮膚充填剤を接触させることによって製造される。充填剤は、接触前および接触中、液体、半固体または固体であり、完成された製品中で液体、半固体または固体であり得る。最終製品中の充填剤は、連続したシート、層もしくは相2.1(図1Aおよび図1C)として、または実質的に別々の粒子2.2(図1Bおよび図1C)として配合され得る。図1Cでは、充填剤は、縫合糸1.1の表面上に画定された溝内に含まれる。
本発明に従った充填剤含有縫合糸(図2A〜図2C)は、内部空洞1.2を有する縫合糸と、ヒドロキシアパタイトなどの、皮膚充填剤とを接触させることによって製造される。充填剤は、接触前および接触中、液体、半固体または固体であり、完成された製品中で液体、半固体または固体であり得る。最終製品中の充填剤は、連続したシート、層もしくは相2.1(図2Aおよび図2B)として、または実質的に別々の粒子2.2(図2Aおよび図2C)として配合され得る。図2Aでは、内部空洞1.2を有する縫合糸は多孔質である。
皮膚の線、皺またはたるみ(図4A)の内容積を減少させるために、本発明によって提供される縫合糸3は、皮膚の陥凹の底および/または壁(図4Aおよび図4B)のステッチで採用され得る。この技術は、わずかな線および皺の充填において特に重要である。かかるステッチは、調整可能な量の充填剤を陥凹内に置き、従って、陥凹の容積を充填する。使用される充填剤の量2(図4B、灰色の球)および各量に対する正確な位置は、有益な美容効果(図4C)を得るために調整される。
充填剤の定義された繊維状構造を患者の身体内(図5A)に形成するために、互いに垂直な横距5および直径6を有する、本発明によって提供される縫合糸3は、身体内に挿入され得る(図5A)。図5Bは、本発明によって提供される縫合糸および方法の使用によって取得可能な、充填剤2の例示的な繊維状構造、コイルの図である。かかるコイルは、血管もしくは尿管が、膨張するのを防ぎ、かつ/または血管もしくは尿管を望ましくて有益な形状もしくは容積に限定するのに役立ち得る。図5Cは、本発明によって提供される縫合糸および方法の使用によって取得可能な、充填剤2の例示的な繊維状構造、メッシュの図である。この構造は、頬または頬骨増強のために非常に有用であり得る。
患者(図6A)の皮膚における線(皺)を処置するために、美容外科医は、本発明によって提供される外科用縫合糸および/または本発明によって提供される方法を使用できる。図6Bに示すように、線は、針4に結び付けられた吸収性縫合糸3により、その長さに沿ってステッチされ得る。吸収性縫合糸3は、複数の皮膚充填剤粒子2.2によってコーティングされた細長い糸1.1で作られており、従って、皮膚充填剤粒子2.2の線へのピンポイントターゲティングを可能にする。針4が除去された後、かつ吸収性縫合糸3が吸収された後、複数の皮膚充填剤粒子2.2は線の部位において皮膚内にとどまっており(図6C)、線は実質的に消えている(図6D)。
Claims (50)
- (i)糸の形で配合された少なくとも1つの柔軟な固体マトリックスであって、前記糸は、ヒトの皮膚または皮下組織を通して前記糸を引っ張って、前記糸を前記皮膚または皮下組織内で一度操作するのに十分な最大抗張力を有し、そのため前記糸の完全性が実質的に損なわれず、(ii)と会合している、少なくとも1つの柔軟な固体マトリックスと、
(ii)少なくとも1つの皮膚充填剤であって、前記皮膚充填剤は、前記柔軟な固体マトリックスとは化学的に異なっており、かつ前記皮膚充填剤は、前記皮膚または前記皮下組織中にある間に、前記柔軟な固体マトリックスから徐々に分離する、少なくとも1つの皮膚充填剤と
を含む、外科用縫合糸。 - 前記糸の少なくとも1つの部分が:
(i)完全な糸、前記皮膚充填剤によって少なくとも部分的に外面コーティングされている;
(ii)溝付き糸、前記溝が少なくとも部分的に前記皮膚充填剤で充填されている;
(iii)多孔質糸、少なくとも部分的に前記皮膚充填剤で充填されている;または
(iv)中空糸、少なくとも部分的に前記皮膚充填剤で充填されている;
の形で配合される、請求項1に記載の外科用縫合糸。 - 前記皮膚充填剤が、前記糸の少なくとも1つの部分に沿って、実質的に均等かつ均質に分布される、請求項1または請求項2に記載の外科用縫合糸。
- 前記糸の前記平均直径が180〜4600ミクロンである、請求項1に記載の外科用縫合糸。
- 前記糸の前記平均直径が180〜1500ミクロンである、請求項4に記載の外科用縫合糸。
- 前記糸が、生分解性または生体吸収性である、請求項1〜請求項5のいずれか1項に記載の外科用縫合糸。
- 前記糸が、グリコリド、ポリグリコリド、グリコール酸、ポリグリコール酸、ラクチド、L−ラクチド、乳酸、乳酸‐グリコール酸共重合体(PLGA)、グリコリド/ラクチド共重合体、カプロラクトン、グリコリド/イプシロン‐カプロラクトン共重合体、ジオキサノン、ポリジオキサノン、トリメチル炭酸塩、エチルグリコール、それらの塩、それらのエステル、それらの水和物、およびそれらの任意の組合せから成る群から選択される、請求項6に記載の外科用縫合糸。
- 前記糸が、非生分解性または非生体吸収性である、請求項1〜請求項5のいずれか1項に記載の外科用縫合糸。
- 前記糸が、ナイロン、絹、ポリプロピレン、ポリエステル、ステンレス鋼、およびそれらの任意の組合せから成る群から選択された材料を含む、請求項8に記載の外科用縫合糸。
- 前記皮膚充填剤が、少なくとも1つの液体皮膚充填剤または少なくとも1つの半固体皮膚充填剤を含む、請求項1〜請求項9のいずれか1項に記載の外科用縫合糸。
- 前記皮膚充填剤が、液体として配合されるか、または半固体として配合される、請求項10に記載の外科用縫合糸。
- 前記皮膚充填剤が、少なくとも1つの硬質皮膚充填剤を含む、請求項1〜請求項9のいずれか1項に記載の外科用縫合糸。
- 前記硬質皮膚充填剤が、
(i)最大で300Mpaの最大抗張力;
(ii)最大で1000Mpaの圧縮強度;
(iii)少なくとも80GPaの弾性率;
(iv)最大で1MPa.m−1/2の破壊靱性;または
(v)(i)〜(iv)の任意の組合せ
を有する、請求項12に記載の外科用縫合糸。 - 前記硬質皮膚充填剤が、
(i)40〜300Mpaの最大抗張力;
(ii)500〜1000Mpaの圧縮強度;
(iii)80〜120GPaの弾性率;
(iv)0.6〜1MPa.m−1/2の破壊靱性;または
(v)(i)〜(iv)の任意の組合せ
を有する、請求項13に記載の外科用縫合糸。 - 前記硬質皮膚充填剤が、セラミック、鉱物または準鉱物である、請求項12〜請求項14のいずれか1項に記載の外科用縫合糸。
- 前記硬質皮膚充填剤が、脆性、展性、延性または切削性である、請求項15に記載の外科用縫合糸。
- 前記硬質皮膚充填剤が、脆性である、請求項16に記載の外科用縫合糸。
- 前記硬質皮膚充填剤が、2〜10のモース硬度スコアを有する、請求項15に記載の外科用縫合糸。
- 前記硬質皮膚充填剤が、5〜10のモース硬度スコアを有する、請求項18に記載の外科用縫合糸。
- 前記硬質皮膚充填剤が、複数の粒子の形で配合される、請求項1〜請求項19のいずれか1項に記載の外科用縫合糸。
- 前記複数の粒子内の前記粒子の前記平均直径が、5〜500ミクロンである、請求項20に記載の外科用縫合糸
- 前記複数の粒子内の前記粒子の前記平均直径が、10〜100ミクロンである、請求項21に記載の外科用縫合糸。
- 前記皮膚充填剤が、アパタイト、ヒアルロン酸、ポリカプロラクトン、ポリメタクリル酸メチル、シリコーン、ポリ乳酸、コラーゲン、ゼラチン、真皮移植片、処理した真皮移植片、乾燥無細胞化粒子真皮マトリックス、脂肪細胞、幹細胞、軟骨細胞、それらの塩、それらのエステル、それらの水和物、それらの誘導体、それらの溶媒和化合物、およびそれらの任意の組合せから成る群から選択される、請求項1〜請求項22のいずれか1項に記載の外科用縫合糸。
- 前記皮膚充填剤が、ヒドロキシアパタイト、その塩、そのエステル、その水和物、その誘導体、その溶媒和化合物、およびそれらの任意の組合せを含む、請求項23に記載の外科用縫合糸。
- 前記糸が、生分解性または生体吸収性であり、かつ前記皮膚充填剤が、前記糸の少なくとも1つの部分に沿って均等に分布された、10〜100ミクロンの平均直径を有する複数の粒子の形で配合される、請求項24に記載の外科用縫合糸。
- 前記皮膚または前記皮下組織中にある間に、前記糸からの前記皮膚充填剤の分離を促進する薬剤をさらに含む、請求項1に記載の外科用縫合糸。
- 前記薬剤が、吸湿性、拡散性または浸透圧性薬剤である、請求項26に記載の外科用縫合糸。
- さらに針を含む、請求項1に記載の外科用縫合糸。
- 前記針の前記直径が、前記外科用縫合糸の前記直径と比べて、小さいか、同じか、または大きい、請求項28に記載の外科用縫合糸。
- 化粧剤または生理活性薬剤をさらに含む、請求項1に記載の外科用縫合糸。
- 前記化粧剤が、色素である、請求項30に記載の外科用縫合糸。
- 前記生理活性薬剤が、酵素、薬物、およびそれらの組合せから成る群から選択される、請求項30に記載の外科用縫合糸。
- 前記酵素が、コラゲナーゼまたはエラスターゼである、請求項32に記載の外科用縫合糸。
- 前記薬物が、抗生物質製剤、レチノイン酸、グリコサミノグリカン(GAG)、ボツリヌス毒素、鎮痛剤、瘢痕化抑制剤、またはそれらの任意の組合せである、請求項32に記載の外科用縫合糸。
- 前記瘢痕化抑制剤が、ステロイドである、請求項34に記載の外科用縫合糸。
- 請求項1〜請求項35のいずれか1項に記載の少なくとも1つの外科用縫合糸を含む、キット。
- 皮膚の望ましくない線、部位、皺、陥凹性瘢痕またはたるみを充填する美容法または治療法での使用のための、請求項1〜請求項35のいずれか1項に記載の外科用縫合糸。
- 前記方法は、前記患者の前記皮膚の望ましくない線、部位、皺、陥凹性瘢痕またはたるみの前記深さ、容積または視感度を減らすためである、請求項37に記載の外科用縫合糸。
- 前記外科用縫合糸が、前記患者の前記表皮、前記真皮、前記皮下組織(hypodermis)または前記皮下組織(sub−cutis)に挿入される、請求項37に記載の外科用縫合糸。
- それを必要としている患者の前記皮膚における望ましくない線、部位、皺、陥凹性瘢痕またはたるみの前記深さ、容積もしくは視感度を減らす美容法または治療法であって、
(i)請求項1〜請求項35のいずれか1項に記載の外科用縫合糸を取得することと、
(ii)任意選択として、針を(i)の前記外科用縫合糸に結び付けることと、
(iii)任意選択として、前記患者の前記皮膚における前記望ましくない線、部位、皺、陥凹性瘢痕またはたるみに局所麻酔を実行することと、
(iv)前記患者の前記皮膚における前記望ましくない線、部位、皺、陥凹性瘢痕またはたるみを(i)または(ii)の前記外科用縫合糸でステッチすることと、
を行うステップを含む、方法。 - 前記ステッチステップは、前記望ましくない線、部位、皺、陥凹性瘢痕またはたるみに沿って実行される、請求項40に記載の方法。
- 前記ステッチステップは、前記望ましくない線、部位、皺、陥凹性瘢痕またはたるみが実質的に改善されるか、または目立たなくなるまで、繰り返される、請求項40に記載の方法。
- 前記外科用縫合糸は、非生分解性または非生体吸収性の糸から成る少なくとも1つのセグメントを含み、前記方法は、前記患者の前記身体から前記セグメントを除去するステップをさらに含む、請求項40に記載の方法。
- 前記患者の前記身体から前記セグメントを除去する前記ステップは、前記ステッチ後、数時間〜数週間、影響を受ける、請求項43に記載の方法。
- 前記縫合糸の前記直径は、充填すべき前記線、部位、皺、陥凹性瘢痕またはたるみの前記サイズ、深さ、または容積に従って事前に決定される、請求項40に記載の方法。
- 前記縫合糸内の前記皮膚充填剤の含有量は、充填すべき前記線、部位、皺、陥凹性瘢痕またはたるみの前記サイズ、深さ、または容積に従って事前に決定される、請求項40に記載の方法。
- 少なくとも1つの皮膚充填剤の繊維状構造を、それを必要としている患者の身体内に形成する美容法または治療法であって、
(i)請求項1〜請求項35のいずれか1項に記載の外科用縫合糸を取得することと、
(ii)任意選択として、針を(i)の前記外科用縫合糸に結び付けることと、
(iii)前記患者の前記身体内に前記繊維状構造を形成するように(i)または(ii)の前記外科用縫合糸を前記患者の前記身体内に配置することと
を行うステップを含む、方法。 - 前記繊維状構造のその全長にわたる前記平均直径が、0.1〜10mmである、請求項47に記載の方法。
- 前記繊維状構造のその全長にわたる前記平均直径が、1〜5mmである、請求項48に記載の方法。
- 移植片を、それを必要としている患者の身体内に導入する美容法または治療法であって、
(i)請求項1〜請求項35のいずれか1項に記載の外科用縫合糸を取得することと、
(ii)(i)の前記外科用縫合糸を前記移植片の形状に形成することと、
(iii)任意選択として、針を前記移植片に結び付けて、前記移植片を前記患者の前記皮膚下または粘膜の下に固定できるようにすることと、
(iv)前記移植片を必要に応じて前記患者の身体内に配置することと
を行うステップを含む、方法。
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