JP2011526176A - 創傷被覆材 - Google Patents
創傷被覆材 Download PDFInfo
- Publication number
- JP2011526176A JP2011526176A JP2011515235A JP2011515235A JP2011526176A JP 2011526176 A JP2011526176 A JP 2011526176A JP 2011515235 A JP2011515235 A JP 2011515235A JP 2011515235 A JP2011515235 A JP 2011515235A JP 2011526176 A JP2011526176 A JP 2011526176A
- Authority
- JP
- Japan
- Prior art keywords
- wound
- wound dressing
- polyurethane foam
- water
- layer
- 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.)
- Granted
Links
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- A61F2013/00727—Plasters means for wound humidity control
- A61F2013/00731—Plasters means for wound humidity control with absorbing pads
- A61F2013/0074—Plasters means for wound humidity control with absorbing pads containing foams
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- 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
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- A61F2013/00761—Plasters means for wound humidity control with permeable adhesive layers
- A61F2013/00774—Plasters means for wound humidity control with permeable adhesive layers arranged in discrete dots
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- A61F2013/00863—Plasters pervious to air or vapours with pores
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- 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
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F2013/00361—Plasters
- A61F2013/00855—Plasters pervious to air or vapours
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
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Abstract
Description
この関連において、前記水含有ヒドロゲルマトリックスは、特に0〜50重量%の多価アルコールを含んでいてもよい。さらに特には、前記ヒドロゲルマトリックスは、5〜40重量%の多価アルコール、最も好ましくは10〜30重量%の多価アルコールを含む。
a)ポリウレタン発泡体を準備する工程と、
b)少なくとも10重量%の水を前記ポリウレタン発泡体に付与する工程と、
c)b)で形成された水含有ポリウレタン発泡体を創傷接触層に積層する工程とを含む。
前記ヒドロゲルは、下記の水溶液と成分(成分A,B、C)を用いて生成される。
親水性ポリウレタン発泡体(ポリウレタン発泡体MCF.03R;コーピュラ社製:オランダ、エテン−ルール)を使用する。当該乾燥親水性ポリウレタン発泡体には以下の特徴がある:
b)平均孔径:O208μm(顕微鏡で測定)
c)層厚:2.7mm(厚み測定器:25cm2プレート、2g/cm2荷重、EN ISO 9073−2に準拠して測定)
d)水蒸気透過率:MVTR(直立カップ法)=3593g/m2/24h(DIN EN 13726−2に準拠して測定)
e)吸収率:自由吸収率A1=20.5g/g(DIN EN 13726−1に準拠して測定)
f)膨潤容量:ΔV0=89.7%
ポリウレタン発泡体の膨潤容量ΔV0は、最大吸収量に到達後、乾燥ポリウレタン発泡体に生じる体積変化を示す。膨潤容量ΔV0を測定するには、前記乾燥ポリマー発泡体の試料片の空間寸法と完全吸収後の同試料片の空間寸法とを、DIN EN 13726−1の自由吸収率に準拠して測定する。上記厚み(高さ)は、2g/cm2荷重に設定した25cm2プレートの厚み測定器を用いて、EN ISO 9073−2に準拠して測定する。水平方向の大きさ(長さ、幅)は、上記試料片が変形しないよう副尺で測定する。上記の大きさを測定するには、特定の試料片を、張力の無い状態で平滑面上に置く。吸収後の体積変化は、前記乾燥ポリウレタン発泡体の膨潤容量ΔV0に相当し、3つ全ての空間方向が考慮に入れられる。
保持値Rは、孔に吸収され得る水に関係なく、ポリウレタン発泡体がそのポリウレタンマトリックス中で最大限に結合可能な水の量を示す。保持値は、厚みが5mm以下の親水性ポリウレタン発泡体から、5×5cmの試料片(標準条件下で保存)を打ち抜きして測定する。試料片の重量は標準条件下で測定する。その後、同試料片について、水の自由吸収率試験を実施する。この試験は、DIN EN 13726−1に類似のものである。孔から吸収された水を、ローラー(重さ5000g、直径10cm、幅5cm)によって同試料片から搾り出す。同試料片を、繰り返し新しい紙繊維の間に挟みローラーにかける。この作業を、紙繊維中に吸収された水分が視認できなくなるまで繰り返す。保持値Rを測定するため、水分の吸収および搾り出し後に前記ポリウレタン発泡体中に残存している水分Wwwを、DIN EN 14079に準拠して測定し、以下のようにして算出する。
前記乾燥親水性ポリウレタン発泡体を、20×30cmのサイズにカットし、3分間水に浸して、同ポリウレタン発泡体の最大吸収量に到達するようにさせる。同ポリウレタン発泡体を水から出し、注意して手で絞る。その後、同ポリウレタン発泡体を、繰り返し乾燥した紙繊維間に挟んで、紙繊維中に吸収された水分が視認できなくなるまでローラー(線形圧力:10N/cm)で絞り出す。したがって、発泡体の孔中に水が無いという可能性は除外することができる。
a)水含有量:前記親水性ポリウレタン発泡体は、52.8重量%の水分率Ww(DIN EN 14079に準拠して測定)の水を有し、これは、前記乾燥ポリウレタン発泡体の保持値Rに相当する。
b)吸収率:自由吸収率A2=16.2g/g(DIN EN 13726−1に準拠して測定)
c)膨潤容量:ΔV1=4%
前記水含有ポリウレタン発泡体の膨潤容量は、前記乾燥ポリマー発泡体と同様に測定される。
使用される裏打ち層は、厚み60μmの不透水性ポリウレタンフィルム(エクソパック社製:英国、レクサム)である。このフィルムは、アクリレート系感圧接着剤による厚み30μmの層でコーティングされている。当該フィルムは、1100g/m2/24hの水蒸気透過率MVTR(直立カップ法)を有する(DIN EN 13726−1)。
上記創傷被覆材(見本)を以下の順で、手作業で製造する:
1.上記ポリウレタン発泡体を、B)に従って前調整し準備する。
2.経路を含むヒドロゲルマトリックスを生成するために、凸面構造を有するPTFE鋳型を準備する。前記凸面構造の凸部は円錐形で、その平均径は1.38mm(基部:1.56mm、先端:1.2mm)である。前記凸部は1.35mmの高さを有し、5mm間隔で離れて矩形パターンを形成している。
3.上記ヒドロゲルを、A)に従って作製し準備する。ただし、当該ヒドロゲルは、混合および均一化後、遅滞無くさらに処理される必要がある。このため、当該ヒドロゲルを、準備した鋳型に泡が立たないように注入してヒドロゲルマトリックスを形成する。
4.上記ゲルを、ゲル層が凸部の高さ(1.35mm)を有するようにPTFE加工のブレードで分配する。余分なゲルは鋳型から除去される。
5.約3分後に、上記前調整されたポリウレタン発泡体を上記ゲルの表面上に重ねる。当該発泡体に200N/m2の圧力をかけてプレスし、そのまま維持する。
6.さらに約7分後、上記ゲルが上記ポリウレタン発泡体に接合して、水含有ポリウレタン発泡体と水含有ヒドロゲルマトリックスとからなる積層体を鋳型から取り外すことができる。水含有ヒドロゲルマトリックスと水含有ポリウレタン発泡体とからなる移行層が、0.3mmの厚みで形成されていた。
7.上記積層体は、創傷に面する側を保護するため、準備した剥離フィルム上にそのヒドロゲル側を下向きにして置く(当該フィルムのシリコーン処理側が上記ゲルに面する)。
8.上記組立体では、上記発泡体側を自己接着性ポリウレタンフィルム(D参照)で覆い、200N/m2の圧力で、当該ポリウレタンフィルムを定位置にしっかりとプレスする。
9.端部の長さが10×10cmの創傷被覆材を、上記多重材料組立体から切り抜く。
b)吸収率:自由吸収率A1=56g/100cm2(DIN EN 13726−1に準拠して測定)
c)水の総含有量:
Claims (12)
- 多層式創傷被覆材であって、
a)第1の面と第2の面とを有する創傷接触層としての第1の層と、
b)第1の面と第2の面とを有し、親水性ポリウレタン発泡体を含む吸収層としての少なくとも1つの第2の層と
を含み、前記ポリウレタン発泡体が、少なくとも10重量%の水分率で水を含有することを特徴とする多層式創傷被覆材。 - 前記ポリマー発泡体は、少なくとも10重量%かつ最大80重量%の水を含有し、前記水は前記ポリウレタン発泡体に均一に分布していることを特徴とする、請求項1に記載の創傷被覆材。
- 前記ポリウレタン発泡体は、100〜500μmの範囲の孔径を有することを特徴とする、前記請求項の少なくとも一つに記載の創傷被覆材。
- 前記ポリウレタン発泡体は、最大80%の膨潤容量ΔV1を有することを特徴とする、前記請求項の少なくとも一つに記載の創傷被覆材。
- 前記創傷接触層は、多数の孔、経路または開口部を有することを特徴とする、前記請求項の少なくとも一つに記載の創傷被覆材。
- 前記創傷接触層は、ヒドロゲルマトリックス、ポリマーフィルム、親水コロイドマトリックス、ポリマーネット、不織布または接着剤を含むことを特徴とする、前記請求項の少なくとも一つに記載の創傷被覆材。
- 前記ヒドロゲルマトリックスは、少なくとも20重量%の水を含有する水含有ヒドロゲルマトリックスであることを特徴とする、請求項6に記載の創傷被覆材。
- 前記ヒドロゲルマトリックスは、ポリウレタン‐ポリ尿素共重合体を含むことを特徴とする、請求項6または7に記載の創傷被覆材。
- 前記ヒドロゲルマトリックスは、液体が前記ヒドロゲルマトリックスを通過できるように、第1の面から第2の面にかけて経路を有することを特徴とする、請求項6,7または8に記載の創傷被覆材。
- 前記創傷被覆材はさらに、裏打ち層として、不透水性かつ水蒸気透過性のポリマーフィルムまたは不透水性かつ水蒸気透過性のポリマー発泡体を含むことを特徴とする、前記請求項の少なくとも一つに記載の創傷被覆材。
- 吸収層としてのポリウレタン発泡体を含む多層式創傷被覆材、特には前記請求項のいずれか一つに記載の多層式創傷被覆材の製造方法であって、
a)ポリウレタン発泡体を準備する工程と、
b)前記ポリウレタン発泡体に、少なくとも10重量%の水を付与する工程と、
c)b)で製造された水含有ポリウレタン発泡体を創傷接触層に積層する工程と、
を含む、多層式創傷被覆材の製造方法。 - 前記ポリマー発泡体に付与される水の量は、少なくとも10重量%かつ最大400重量%であって、前記水は噴霧または浸漬により付与される、請求項11に記載の多層式創傷被覆材の製造方法。
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN107714291A (zh) * | 2017-10-11 | 2018-02-23 | 赵坚 | 一种透气的药贴 |
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EP3115033A1 (de) | 2017-01-11 |
BRPI0915593B1 (pt) | 2019-09-10 |
RU2519683C2 (ru) | 2014-06-20 |
CN102076291B (zh) | 2014-10-22 |
EP2309956B1 (de) | 2016-09-07 |
US10130521B2 (en) | 2018-11-20 |
ES2683649T3 (es) | 2018-09-27 |
EP3115033B1 (de) | 2018-05-09 |
CN102076291A (zh) | 2011-05-25 |
PL2309956T3 (pl) | 2017-07-31 |
DE102008031183A1 (de) | 2010-01-07 |
BRPI0915593A2 (pt) | 2016-02-02 |
WO2010000451A1 (de) | 2010-01-07 |
AU2009265996B9 (en) | 2015-03-26 |
US20110280926A1 (en) | 2011-11-17 |
RU2011102839A (ru) | 2012-08-10 |
AU2009265996B2 (en) | 2014-10-16 |
ES2606402T3 (es) | 2017-03-23 |
AU2009265996A1 (en) | 2010-01-07 |
JP5514816B2 (ja) | 2014-06-04 |
BRPI0915593B8 (pt) | 2021-06-22 |
EP2309956A1 (de) | 2011-04-20 |
PL3115033T3 (pl) | 2018-10-31 |
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