JP2018510723A - オストミー装置 - Google Patents
オストミー装置 Download PDFInfo
- Publication number
- JP2018510723A JP2018510723A JP2017552492A JP2017552492A JP2018510723A JP 2018510723 A JP2018510723 A JP 2018510723A JP 2017552492 A JP2017552492 A JP 2017552492A JP 2017552492 A JP2017552492 A JP 2017552492A JP 2018510723 A JP2018510723 A JP 2018510723A
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- JP
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- Prior art keywords
- adhesive
- wafer
- adhesive composition
- switchable
- micrometers
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Images
Classifications
-
- 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
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
- A61F5/443—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices having adhesive seals for securing to the body, e.g. of hydrocolloid type, e.g. gels, starches, karaya gums
-
- 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
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
- A61F5/445—Colostomy, ileostomy or urethrostomy devices
Landscapes
- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Biomedical Technology (AREA)
- Epidemiology (AREA)
- Nursing (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Dispersion Chemistry (AREA)
- Orthopedics, Nursing, And Contraception (AREA)
- Adhesives Or Adhesive Processes (AREA)
Abstract
Description
実施形態において、組成物は、メタクリレートおよびそれらのコポリマーを含むアクリレートを含む。アクリレートコポリマー、例えばアルキルアクリレートコポリマーが特に好ましい。
・肌への使用に安全である:湿分硬化性配合物は皮膚と接触するので硬化前後に非毒性でなければならない。
・皮膚への接着性:湿分硬化性配合物は、硬化前後に皮膚に付着しなければならない。さもなければ、これらの材料は皮膚とオストミーケア装置との間に脆弱な界面を提供するだろう。
・体からの水分に上手く対処する:オストミーケア製品は、皮膚、排出物、および汗に由来する水分に上手く対処しなければならない。さもなければ、皮膚に残った水が接着力を弱める。
・保管中の安定性:湿分硬化性配合物は、工場内での保管中および輸送中に安定でなければならないが、使用前の使用者の手の中でも安定でなければならない。地理的な位置に依存して環境の温度および相対湿度が変化する。湿分硬化性配合物は、保管、輸送、および使用状況に関連する温度にさらされた場合に硬化しないように十分に安定でなければならない。加えて、それらは湿分が容器内に入って拡散できないように包装しなければならない。
パラメータ複素粘度|η*|を周波数掃引により以下のように測定した。接着剤を厚さ1mmの板にプレスした。直径25mmの円形の試料を切り出し、Thermo ScientificのHaake RheoStress 6000回転レオメーターに配置した。適用された幾何形状は平行板25mmであり、せん断応力は5556Paに固定し、測定の開始時に試料にギャップサイズ0.9〜1.05mmを適用し、約5Nの法線力が得られた。測定は32℃で実施した。複素粘度|η*|について周波数0.01Hzで測定した値を用いた。
水蒸気透過率(MVTR)は、逆カップ法を用いて24時間にわたってグラム毎平方メートル(g/m2)で測定した。
1/P(測定値)=1/P(フィルム)+1/P(接着剤)。
P(接着剤)=d(接着剤)/150μm*1/(1/P(測定値)−1/P(フィルム))
ここで、d(接着剤)は接着剤の実際に測定された厚さであり、P(フィルム)は接着剤のないフィルムのMVTRであり、P(測定値)は実際に測定されたMVTRであった。
2つの剥離ライナ間の厚さ0.5mmの接着フィルムに熱成形することによって試料を調製した。打ち抜き工具を用いて、試料を打ち抜いた。試料サイズは25×25mmであった。剥離ライナを除去した。試料を対象ガラスに接着し、生理食塩水を入れたビーカーに入れ、37℃のインキュベーターに入れた。
剥離試験のための基体および液体媒体
実際の使用をシミュレートするために使用される基体は皮膚である。
剥離測定における漏れの伝搬をシミュレートするために、低いおよび一定の剥離角度が選択される。この剥離セットアップは、40度の一定の剥離および500gの一定の剥離荷重を有する。剥離伸びは時間とともに測定される。第2の接着剤の瞬間接着特性ならびに本明細書に記載されているような切り替え可能な接着剤を観察するために、異なる滞留時間(接着剤を皮膚に適用してから試験開始までの時間)を使用する。剥離実験は周囲温度、約20℃で行われる。
以下の詳細な説明において添付図面を参照する。図面は本明細書の一部を形成し、本発明を実施するための例示的な実施形態を示す。「上」、「下」、「前」、「後」、「先頭」、「後尾」等などの方向性のある用語は、説明されている図の向きを参照して使用される。実施形態の構成要素は多くの向きに配置することができるので、方向性のある用語は説明のために使用されており、決して限定的ではない。本発明の範囲から逸脱することなく、他の実施形態を利用することができ、構造的または論理的変更を行うことができることを理解されたい。詳細な説明は、本発明を実施するための実施例を記載しており、本発明の範囲を限定するために読まれるべきではない。本発明の範囲は、添付の特許請求の範囲によって定義される。
切り換え可能な接着剤で完全に被覆された接着剤ウェハ
粘着性ウェハは、1mmの厚さおよび110mmの円形形状を有する切り替え可能な接着剤(組成:1%光開始剤*および25%親水コロイド**を含む74%BASF acResin A 260 UV)でコーティングされたバッキング層(DOW Saranex 630G)、とシリコーン剥離ライナ(0.11mmPPB、1803 Hutamaki製)とから構成される。
中央部分に切り替え可能な接着剤を有する接着剤ウェハ
接着剤ウェハは、バッキング層(DOW Saranex 630G)と、1mmの厚さおよび110mmの円形形状を有する標準ヒデロコロイド接着剤***をベースとするフルカバー接着剤と、中心部で2mm厚さおよび直径70mmの円形形状の切り替え可能な接着剤(組成:1%光開始剤*および25%親水コロイド**を有する74%BASF acResin A 260 UV)と、シリコーン剥離ライナ(0.11mmPPB、1803 Hutamaki製)とから構成される。第2の接着剤***は、切り替え可能な接着剤の周辺部分および遠位部分の上に設けられる。
Trio Silken(18g、36重量%、Trio Healthcare)を、スピードミキサーを用いて3000rpmで3分間、親水コロイド(5g、10重量%)の混合物と混合した。親水コロイド混合物は、カルボキシメチルセルロース(20重量%)、グアーガム(40重量%)、ゼラチン(30重量%)およびペクチン(10重量%)から構成された。非反応性シリコーンポリマー、BioPSA(27g、54重量%、Dow Corning 7−4560)を混合物に添加し、混合物を、スピードミキサーを用いて3000rpmでさらに3分間混合した。得られた混合物を、アプリケータを用いてポリウレタンBiatainフィルム(30μm)上にコーティングした。切り替え実験のために、この組成物を32℃のオーブンまたは32℃および相対湿度50%の湿式食器棚(Binder KBF)中で切り替えた。
Trio Silken(12g、24重量%、Trio Healthcare)を、スピードミキサーを用いて3000rpmで3分間、親水コロイド(20g、40重量%)の混合物と混合した。親水コロイド混合物は、カルボキシメチルセルロース(20重量%、Akucell AF 2881、Akzo Nobel)、グアーガム(40重量%、グアーガムFG−200、Nordisk Gelatine)、ゼラチン(30重量%、ゼラチンUF220、PB Gelatins GmbH)、およびペクチン(10重量%、LM 12 CG−Z/200、CP Kelco)から構成された。親水コロイドを80℃で乾燥させた後、2.43重量%の含水量に達するまで、配合物に添加した。非反応性シリコーンポリマー、BioPSA(18g、36重量%、Dow Corning 7−4560)を混合物に加え、混合物を、スピードミキサーを用いて3000rpmでさらに3分間混合した。得られた混合物を、アプリケータを用いてフィルム上にコーティングし、試験前に32℃のオーブン内で、相対湿度50%でフィルムを硬化させた。
Claims (14)
- 使用者の皮膚表面に取り付けるための接着剤ウェハと、前記接着剤ウェハに接続された収集バッグとを含むオストミー装置であって、前記接着剤ウェハが前記使用者のストーマを収容するための貫通孔を有し、前記接着剤ウェハが、バッキング層と、第1の切り替え可能な接着剤組成物と、第2の接着剤組成物と、少なくとも1つの剥離ライナとを含み、前記第1の切り替え可能な接着剤はポリマーおよび切り替え開始剤を含み、前記組成物は、前記切り替え開始剤を活性化することによって、第1の液体の状態から第2の接着性の状態へ切り替えることができ、前記装置は前記第1の切り替え可能な接着剤組成物を収容するための凹部を含む、オストミー装置。
- 前記凹部が前記剥離ライナ内にある、請求項1に記載のオストミー装置。
- 前記凹部が部分的に前記第2の接着剤組成物内にありかつ部分的に前記剥離ライナ内にある、請求項1または2に記載のオストミー装置。
- 前記凹部が前記第2の接着剤組成物内にある、請求項1〜3のいずれか一項に記載のオストミー装置。
- 前記第1および前記第2の接着剤組成物の皮膚に面する表面が面一/一列になっている、請求項4に記載のオストミー装置。
- 前記凹部が、形態の安定したテクスチャに切り替えられた前記第1の接着剤の縁部の少なくとも一部によって提供される、請求項1〜5のいずれか一項に記載のオストミー装置。
- 前記剥離ライナが、前記第1の切り替え可能な接着剤組成物および前記第2の接着剤組成物の両方と接触する、請求項1〜6のいずれか一項に記載のオストミー装置。
- 前記接着剤ウェハが、前記ストーマを収容する前記孔に隣接する中央部分と、前記孔から離れる前記接着剤ウェハの縁部に隣接する周辺部分とを有し、前記第2の接着剤組成物が前記接着剤ウェハの前記周辺部分に少なくとも配置される、請求項1〜7のいずれか一項に記載のオストミー装置。
- 前記第1の切り替え可能な接着剤組成物が前記接着剤ウェハの前記中央部分にだけ配置される、請求項1〜8のいずれか一項に記載のオストミー装置。
- 前記第1の切り替え可能な接着剤組成物が、前記第1の液体の状態において、0.4MPa s(メガパスカル−秒、すなわち、MPa・s)未満の、複素20粘性率|η*|を有し;および前記第2の接着性の状態において、前記第1の液体の状態の前記複素粘性率|η*|よりも高い複素粘性率|η*|を有し、および前記第2の接着性の状態において1Nを超える第2の繰り返し剥離力を有する、請求項1〜9のいずれか一項に記載のオストミー装置。
- 前記第1の切り替え可能な接着剤組成物が、内側境界を画定する、前記貫通孔からのある半径方向距離内の内側リムと、前記孔からのある半径方向距離内に外側境界を画定する、前記貫通孔からのある半径方向距離内の外側リムとを有する、請求項1〜10のいずれか一項に記載のオストミー装置。
- 前記第1の切り替え可能な接着剤の少なくとも前記内側リムまたは前記外側リムが切り替えられる、請求項1〜11のいずれか一項に記載のオストミー装置。
- ・請求項1〜11のいずれか一項に記載のオストミー装置を提供するステップと、
・前記装置から前記剥離ライナの少なくとも一部を除去するステップと、
・前記ストーマの周囲の皮膚に前記接着剤ウェハを適用するステップと、
・前記ストーマの周囲に適合するように前記第1の接着剤を成形するステップ、
・前記切り替え開始剤を活性化することによって、前記第1の接着剤組成物を第1の液体の状態から第2の接着性の状態へ切り替えるステップと
を含む、オストミー装置を適用する方法。 - 前記適用の前に前記貫通孔が前記ストーマに適合するように切断される、請求項12に記載の方法。
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PCT/DK2016/050099 WO2016162038A1 (en) | 2015-04-10 | 2016-04-08 | Ostomy device |
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RU2017134522A (ru) | 2019-04-04 |
HUE044528T2 (hu) | 2019-10-28 |
US20220008240A1 (en) | 2022-01-13 |
AU2016244934A1 (en) | 2017-11-09 |
PL3280368T3 (pl) | 2019-11-29 |
RU2695603C2 (ru) | 2019-07-24 |
US11819444B2 (en) | 2023-11-21 |
CA2982012C (en) | 2024-03-05 |
WO2016162038A1 (en) | 2016-10-13 |
EP3280368B1 (en) | 2019-06-12 |
DK3280368T3 (da) | 2019-09-23 |
JP6697000B2 (ja) | 2020-05-20 |
CA2982012A1 (en) | 2016-10-13 |
CN107530182B (zh) | 2020-06-30 |
AU2016244934B2 (en) | 2020-04-23 |
EP3280368A1 (en) | 2018-02-14 |
CN107530182A (zh) | 2018-01-02 |
BR112017021501A2 (pt) | 2018-07-03 |
ES2741852T3 (es) | 2020-02-12 |
RU2017134522A3 (ja) | 2019-05-22 |
US20180116859A1 (en) | 2018-05-03 |
US11160681B2 (en) | 2021-11-02 |
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