JP5932019B2 - 速やかな治療上の吸収性を有する組織修復用具 - Google Patents
速やかな治療上の吸収性を有する組織修復用具 Download PDFInfo
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- JP5932019B2 JP5932019B2 JP2014502826A JP2014502826A JP5932019B2 JP 5932019 B2 JP5932019 B2 JP 5932019B2 JP 2014502826 A JP2014502826 A JP 2014502826A JP 2014502826 A JP2014502826 A JP 2014502826A JP 5932019 B2 JP5932019 B2 JP 5932019B2
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- tissue repair
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- 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
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- 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
- 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
- A61L31/146—Porous materials, e.g. foams or sponges
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- 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
- 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
- A61L31/16—Biologically active materials, e.g. therapeutic substances
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P41/00—Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
Description
2枚の有孔Monocryl(登録商標)フィルム間にラミネートされた軽量メッシュ
エチコン社(Ethicon, Inc.)(米国ニュージャージー州、サマービル)より販売されるUltrapro(登録商標)銘柄のメッシュと同じ編組構造を有するが、吸収性Monocryl(登録商標)フィラメントは含まない軽量のポリプロピレンメッシュ(ポリグレカプロン25)を調製した。このメッシュを2枚のフィルム層間に熱ラミネートした。第1のフィルムは、押出し成形され、厚さ8μmのポリ−p−ジオキサノン(PDS)フィルムでラミネートされた厚さ20μmのポリグレカプロン25 Monocryl(登録商標)フィルムからなるものであった。この予備積層体に、穴と穴との距離が5mmとなるように1mmの穴又は小孔をレーザーで切り抜いた。厚さ__のポリグレカプロン25 Monocryl(登録商標)フィルムからなる第2のラミネート層を、上記の第1のラミネート層と同様にしてレーザーで切り抜き、予め切断した。両方のフィルムを、穴又は小孔の位置が合わない(すなわちオフセットしている)ようにして置き、ポリプロピレンメッシュの外側表面に互いに反対側の外側フィルムとして置いた。このフィルムメッシュ構造体を、数層のベーキングペーパーの間で、熱プレス機中でラミネートし、2枚の金属プレート間で冷却した(120℃で30秒間、次いで金属プレート間で約30分間冷却)。
水平浸漬
この例は、本発明の組織修復用具の濡れ性能を無孔用具と比較して実証するものである。
OR中での水平浸漬及び取り扱い性
実施例1にしたがって各積層体を調製したがサイズは18cm×14cmとした。有孔及び無孔積層体を、ブタの腹腔に挿入した従来の12mmトロカールから入れた。各インプラントは腸において容易に動かす(滑らせる)ことが可能であり、これを腹壁に接触させて配置した。有孔及び無孔積層体は、腹壁に対して脱離可能に自己付着した。積層体を定位置に保持しておくために器具を必要としなかった。
2枚の穿孔フィルム間の有孔CPTFEシート
10×10cmのOmyraメッシュ(ビー・ブラウン社(B. Braun))を、実施例1にしたがって、穿孔したMonocryl(登録商標)フィルムの間に120℃で5分間ラミネートした後、2枚の冷たい金属プレートの間で更に30分間冷却した。各フィルム同士はメッシュの小孔内において安定的にラミネートされ、この複合インプラントは通常の取り扱い及び折り曲げによっては層間剥離は示さなかった。光学的コントロールは、フィルム孔の重なり合いは示さず、小孔はオフセットしていた。
オクテニジン+コーティングポリマーによる浸漬コーティングを行った穿孔フィルム積層体
実施例1にしたがって16cm×16cmのメッシュ積層体を調製した。
本明細書の織物修復インプラント用具を用いた外科手術
腹壁ヘルニアを有する患者に従来の方法で手術の準備処置を行い、従来の方法で麻酔を施す。腹壁ヘルニア修復術は、本発明の組織修復インプラント用具を使用して以下のようにして行う。
トロカールを配置し、気腹を確立し、ヘルニア嚢内の内容物を除き、癒着を溶解した後、外科医はヘルニア欠損部のサイズを特定する。
(1) 組織インプラント医療用具であって、
互いに反対側の第1及び第2の面を有し、複数の部材孔を有する組織修復部材と、
前記部材の前記第1の面に取り付けられた、第1のフィルム孔を有する第1のポリマーフィルムと、
織物部材の前記第2の面に取り付けられた、第2のフィルム孔を有する第2のポリマーフィルムと、を含み、
前記第1のフィルム孔と前記第2のフィルム孔とが整列されていない、組織インプラント医療用具。
(2) 活性物質を更に含む、実施態様1に記載の医療用具。
(3) 前記活性物質が、抗生物質、化学療法剤、細胞増殖抑制剤、転移阻害剤、抗糖尿病薬剤、抗真菌剤、抗微生物剤、抗細菌剤、ビタミン、婦人科用薬剤、泌尿器科用薬剤、抗アレルギー剤、性ホルモン、性ホルモン阻害剤、局所麻酔剤、止血剤(haemostyptics)、ホルモン、ペプチドホルモン、ビタミン、抗鬱剤、抗ヒスタミン剤、裸のDNA、プラスミドDNA、カチオン性DNA複合体、RNA、細胞構成成分、ワクチン、体内に天然に存在する細胞、遺伝子組み換え細胞、及びこれらの組み合わせからなる群から選択される、実施態様2に記載の医療用具。
(4) 前記活性物質が、オクテニジン(octenidine)、PHMB、トリクロサン、銅、銀、ナノシルバー、金、セレン、ガリウム、タウロリジン、シクロタウロリジン、N−クロロタウリン、アルコール、LAE、MAPD、OAPD、及びこれらの混合物からなる群から選択される抗微生物剤である、実施態様2に記載の医療用具。
(5) 前記抗微生物剤がトリクロサンである、実施態様4に記載の医療用具。
(7) 前記抗微生物剤がPHMBである、実施態様4に記載の医療用具。
(8) 前記組織修復部材が織物である、実施態様1に記載の医療用具。
(9) 前記組織修復織物が、メッシュ、織布、不織布及びテープからなる群から選択される、実施態様8に記載の医療用具。
(10) 前記組織修復部材がメッシュを含む、実施態様9に記載の医療用具。
(12) 前記組織修復部材が、ポリヒドロキシ酸、ポリラクチド、ポリグリコリド、ポリヒドロキシ酪酸、ポリヒドロキシ吉草酸(polyhy droxyvaleriates)、ポリカプロラクトン、ポリジオキサノン(polydiaxanones)、合成並びに天然オリゴアミノ酸及びポリアミノ酸、ポリホスファゼン、ポリ無水物、ポリオルトエステル、ポリオキサエステル、ポリリン酸エステル、ポリホスホン酸エステル、ポリアルコール、多糖類、ポリエーテル、再吸収性ガラス、これらの重合性物質のコポリマーからなる群から選択される生体吸収性ポリマーを含む、実施態様1に記載の医療用具。
(13) 前記第1及び第2のフィルムが、ポリオレフィン、ポリエステル、ナイロン、テフロン、ポリフッ化ビニリデン、及びセルロースからなる群から選択される生体適合性非吸収性ポリマーを含む、実施態様1に記載の医療用具。
(14) 前記第1及び第2のフィルムが、ポリヒドロキシ酸、ポリラクチド、ポリグリコリド、ポリヒドロキシ酪酸、ポリヒドロキシ吉草酸、ポリカプロラクトン、ポリジオキサノン、合成並びに天然オリゴアミノ酸及びポリアミノ酸、ポリホスファゼン、ポリ無水物、ポリオルトエステル、ポリリン酸エステル、ポリホスホン酸エステル、ポリアルコール、多糖類、ポリエーテル、ポリアミド、脂肪族ポリエステル、芳香族ポリエステル、これらの重合性物質のコポリマー、及び再吸収性ガラスからなる群から選択される生体適合性生体吸収性ポリマーを含む、実施態様1に記載の医療用具。
(15) 前記フィルム孔が、約0.1mm〜約5mmの範囲の孔径を有する、実施態様1に記載の医療用具。
(17) 前記組織修復部材が、モノフィラメント繊維を含む、実施態様1に記載の医療用具。
(18) 前記組織修復部材が、マルチフィラメント繊維を含む、実施態様1に記載の医療用具。
(19) ポリマーコーティングを更に含む、実施態様1に記載の医療用具。
(20) 前記孔がほぼ円形の断面を有する、実施態様1に記載の医療用具。
(22) 組織欠損部を修復する方法であって、
組織修復インプラント用具を組織欠損部に隣接して挿入する工程であって、前記用具が、
互いに反対側の第1及び第2の面を有し、複数の部材孔を有する組織修復部材と、
前記部材の前記第1の面に取り付けられた、第1のフィルム孔を有する第1のポリマーフィルムと、
前記織物部材の前記第2の面に取り付けられた、第2のフィルム孔を有する第2のポリマーフィルムと、を含み、
前記第1のフィルム孔と前記第2のフィルム孔とが整列されていない、組織修復インプラント用具である、工程と、
前記修復用具を前記組織欠損部に固定する工程と、を含む、方法。
(23) 前記組織修復用具の挿入に先立って、活性物質を含む溶液中に前記用具を浸漬する工程を更に含む、実施態様22に記載の方法。
(24) 組み合わせであって、
a)組織インプラント医療用具であって、
互いに反対側の第1及び第2の面を有し、複数の部材孔を有する組織修復部材と、
前記部材の前記第1の面に取り付けられた、第1のフィルム孔を有する第1のポリマーフィルムと、
前記織物部材の前記第2の面に取り付けられた、第2のフィルム孔を有する第2のポリマーフィルムと、を含み、
前記第1のフィルム孔と前記第2のフィルム孔とが整列されていない、組織インプラント医療用具と、
b)活性物質と、を含む、組み合わせ。
(25) 前記活性物質が溶液中に存在する、実施態様24に記載の組み合わせ。
Claims (20)
- 組織インプラント医療用具であって、
複数のメッシュ開口またはメッシュ孔を有するメッシュを含む、組織修復部材であって、前記メッシュは、互いに反対側の第1及び第2の面を有している、組織修復部材と、
前記メッシュの前記第1の面に取り付けられた、第1のフィルム孔を有する第1のポリマーフィルムと、
前記メッシュの前記第2の面に取り付けられた、第2のフィルム孔を有する第2のポリマーフィルムと、を含み、
前記第1のフィルム孔は前記第2のフィルム孔と整列されておらず、
前記第1および第2のポリマーフィルムは、前記メッシュ開口またはメッシュ孔を通って共に接合されている、
組織インプラント医療用具。 - 活性物質を更に含む、請求項1に記載の医療用具。
- 前記活性物質が、抗生物質、化学療法剤、細胞増殖抑制剤、転移阻害剤、抗糖尿病薬剤、抗真菌剤、抗微生物剤、抗細菌剤、ビタミン、婦人科用薬剤、泌尿器科用薬剤、抗アレルギー剤、性ホルモン、性ホルモン阻害剤、局所麻酔剤、止血剤、ホルモン、ペプチドホルモン、ビタミン、抗鬱剤、抗ヒスタミン剤、裸のDNA、プラスミドDNA、カチオン性DNA複合体、RNA、細胞構成成分、ワクチン、体内に天然に存在する細胞、遺伝子組み換え細胞、及びこれらの組み合わせからなる群から選択される、請求項2に記載の医療用具。
- 前記活性物質が、オクテニジン、PHMB、トリクロサン、銅、銀、ナノシルバー、金、セレン、ガリウム、タウロリジン、シクロタウロリジン、N−クロロタウリン、アルコール、LAE、MAPD、OAPD、及びこれらの混合物からなる群から選択される抗微生物剤である、請求項2に記載の医療用具。
- 前記抗微生物剤がトリクロサンである、請求項4に記載の医療用具。
- 前記抗微生物剤がオクテニジンである、請求項4に記載の医療用具。
- 前記抗微生物剤がPHMBである、請求項4に記載の医療用具。
- 前記組織修復部材が、ポリアルケン、ポリプロピレン、ポリエチレン、フッ素化ポリオレフィン、ポリテトラフルオロエチレン、ポリフッ化ビニリデン、ポリアミド、ポリウレタン、ポリイソプレン、ポリスチレン、ポリシリコーン、ポリカーボネート、ポリアリールエーテルケトン、ポリメタクリル酸エステル、ポリアクリル酸エステル、芳香族ポリエステル、ポリイミド、セルロース、これらの重合性物質のコポリマーからなる群から選択される生体適合性非吸収性ポリマーを含む、請求項1に記載の医療用具。
- 前記組織修復部材が、ポリヒドロキシ酸、ポリラクチド、ポリグリコリド、ポリヒドロキシ酪酸、ポリヒドロキシ吉草酸、ポリカプロラクトン、ポリジオキサノン、合成並びに天然オリゴアミノ酸及びポリアミノ酸、ポリホスファゼン、ポリ無水物、ポリオルトエステル、ポリオキサエステル、ポリリン酸エステル、ポリホスホン酸エステル、ポリアルコール、多糖類、ポリエーテル、再吸収性ガラス、これらの重合性物質のコポリマーからなる群から選択される生体吸収性ポリマーを含む、請求項1に記載の医療用具。
- 前記第1及び第2のフィルムが、ポリオレフィン、ポリエステル、ナイロン、テフロン(登録商標)、ポリフッ化ビニリデン、及びセルロースからなる群から選択される生体適合性非吸収性ポリマーを含む、請求項1に記載の医療用具。
- 前記第1及び第2のフィルムが、ポリヒドロキシ酸、ポリラクチド、ポリグリコリド、ポリヒドロキシ酪酸、ポリヒドロキシ吉草酸、ポリカプロラクトン、ポリジオキサノン、合成並びに天然オリゴアミノ酸及びポリアミノ酸、ポリホスファゼン、ポリ無水物、ポリオルトエステル、ポリリン酸エステル、ポリホスホン酸エステル、ポリアルコール、多糖類、ポリエーテル、ポリアミド、脂肪族ポリエステル、芳香族ポリエステル、これらの重合性物質のコポリマー、及び再吸収性ガラスからなる群から選択される生体適合性生体吸収性ポリマーを含む、請求項1に記載の医療用具。
- 前記フィルム孔が、約0.1mm〜約5mmの範囲の孔径を有する、請求項1に記載の医療用具。
- 前記フィルムが、約5μm〜約50μmの厚さを有する、請求項1に記載の医療用具。
- 前記組織修復部材が、モノフィラメント繊維を含む、請求項1に記載の医療用具。
- 前記組織修復部材が、マルチフィラメント繊維を含む、請求項1に記載の医療用具。
- ポリマーコーティングを更に含む、請求項1に記載の医療用具。
- 前記孔がほぼ円形の断面を有する、請求項1に記載の医療用具。
- 前記孔がスリットを含む、請求項1に記載の医療用具。
- 組み合わせであって、
a)組織インプラント医療用具であって、
複数のメッシュ開口またはメッシュ孔を有するメッシュを含む、組織修復部材であって、前記メッシュは、互いに反対側の第1及び第2の面を有している、組織修復部材と、
前記メッシュの前記第1の面に取り付けられた、第1のフィルム孔を有する第1のポリマーフィルムと、
前記メッシュの前記第2の面に取り付けられた、第2のフィルム孔を有する第2のポリマーフィルムと、を含み、
前記第1のフィルム孔は前記第2のフィルム孔と整列されておらず、
前記第1および第2のポリマーフィルムは、前記メッシュ開口またはメッシュ孔を通って共に接合されている、組織インプラント医療用具と、
b)活性物質と、を含む、組み合わせ。 - 前記活性物質が溶液中に存在する、請求項19に記載の組み合わせ。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US13/075,531 US8579990B2 (en) | 2011-03-30 | 2011-03-30 | Tissue repair devices of rapid therapeutic absorbency |
US13/075,531 | 2011-03-30 | ||
PCT/US2012/031397 WO2012135593A1 (en) | 2011-03-30 | 2012-03-30 | Tissue repair devices of rapid therapeutic absorbency |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2014514941A JP2014514941A (ja) | 2014-06-26 |
JP5932019B2 true JP5932019B2 (ja) | 2016-06-08 |
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JP2014502826A Expired - Fee Related JP5932019B2 (ja) | 2011-03-30 | 2012-03-30 | 速やかな治療上の吸収性を有する組織修復用具 |
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US (1) | US8579990B2 (ja) |
EP (1) | EP2691124B1 (ja) |
JP (1) | JP5932019B2 (ja) |
KR (1) | KR101952571B1 (ja) |
CN (1) | CN103442741B (ja) |
AU (1) | AU2012236308B2 (ja) |
BR (1) | BR112013025206A2 (ja) |
CA (1) | CA2831605C (ja) |
ES (1) | ES2594773T3 (ja) |
IL (1) | IL228556A (ja) |
MX (1) | MX338766B (ja) |
RU (1) | RU2608461C2 (ja) |
WO (1) | WO2012135593A1 (ja) |
ZA (1) | ZA201308109B (ja) |
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EP2691124B1 (en) | 2016-07-06 |
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CN103442741B (zh) | 2016-12-07 |
AU2012236308A1 (en) | 2013-10-17 |
RU2013148112A (ru) | 2015-05-10 |
CA2831605C (en) | 2019-07-02 |
US8579990B2 (en) | 2013-11-12 |
JP2014514941A (ja) | 2014-06-26 |
ZA201308109B (en) | 2015-11-25 |
KR101952571B1 (ko) | 2019-02-27 |
RU2608461C2 (ru) | 2017-01-18 |
IL228556A0 (en) | 2013-12-31 |
MX338766B (es) | 2016-04-28 |
WO2012135593A1 (en) | 2012-10-04 |
CN103442741A (zh) | 2013-12-11 |
BR112013025206A2 (pt) | 2020-10-20 |
IL228556A (en) | 2017-07-31 |
AU2012236308B2 (en) | 2015-12-10 |
CA2831605A1 (en) | 2012-10-04 |
ES2594773T3 (es) | 2016-12-22 |
EP2691124A1 (en) | 2014-02-05 |
US20120253472A1 (en) | 2012-10-04 |
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