JP2004041357A - Phimosis treatment sheet - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a treatment sheet of which the expansion/contraction is performed with a feeling closer to the skin. <P>SOLUTION: One surface of a sheet-like part sticks to the penis part, and the other surface of the sheet-like part sticks to the preputium part, and the preputium part is positively positioned to the penis part. Thus, the preputium part is stably adhered and positioned to the penis part side by this phimosis treatment sheet. In the phimosis treatment sheet, the sheet-like part comprises a silicone gel sheet the hardness of which is set to be expectedly the same as or softer than the preputium. <P>COPYRIGHT: (C)2004,JPO

Description

【００１２】
評価理由：肌への粘着度は、粘度が低すぎると形状が安定せず却って包皮の重なりがずれる欠点があった。粘度を高くし過ぎると粘着性が落ちるため剥がれ易くなった。
取り扱い易さは、粘度が低いと柔ら過ぎて剥離紙から剥がれ難く、剥がす時ちぎれるか、変形するという傾向があった。粘度が高いと剥離紙から剥がし易くまた変形し難くなったので扱い易くなったが、同時に腰が強くなりすぎると弾性が強く却って使いにくくなることが分かった。
このことから続けての試験では下記構造の重合度の範囲の中で上記の内最適なもので試験を実施した。
【００１３】
本発明の目的に用いる最適なシリコーンジェルシールの化学構造と構造を以下に示す。
シリコーン素材の重合度を種々検討し、扱い易さと粘着効果を検討した結果以下の組成が皮膚の伸縮に同調性が高く粘着性も充分であることが知見された。
｛１｝　平均分子式Ｒ^１ａＲ^２ _ｂＳｉＯ_{（４−（ａ ＋ｂ ））／ ２}
ここにＲ^１は不飽和炭化水素基を含有する有機基、Ｒ^２は不飽和炭化水素基を含まない１価の炭化水素基、ａは０．００１〜０．３、ｂは１．８〜２．５でａ＋ｂは１．８〜２．５で示される、分子鎖両末端がそれぞれ２個を含有するシリル基で封鎖されている、２５℃における粘度が５０〜１００，０００ｃｓであるオルガノポリシロキサン１００重量部
｛２｝　平均分子式Ｒ^１ｃＲ^２ _ｄＳｉＯ_{４−（ｃ ＋ ｄ）}
ここにＲ^１は不飽和炭化水素基を含有する有機基、Ｒ^２は不飽和炭化水素基を含まない１価の炭化水素基、ｃは０．００１〜０．３、ｄは０．１〜０．９５で示される、分子鎖両末端がＲ^１またはＲ^２からなるシリル基で封鎖されているオルガノポリシロキサン１〜５０重量部
｛３｝　上記｛１｝、｛２｝成分中のＲ１で示される基１個に対しけい素原子に結合した水素原子（≡ＳｉＨ基）が０．４〜４．０の倍量となる量の平均分子式Ｒ^１ｅＲ^２ _ｆＳｉＯ_{４ − （ ｅ＋ｆ ）}
ここにＲ１は水素基、Ｒ２は不飽和炭化水素基を含まない１価の炭化水素基、ｅは０．００１〜０．３、ｄは０．１〜０．９でｅ＋ｆは０．１〜０．９で示される分子鎖末端がＲ１またはＲ２〜なるシリル基で封鎖されているオルガノハイドロジェンポリシロキサン
｛４｝　上記▲１▼成分１００重量部に対して白金換算で１〜１００ｐｐｍの白金系触媒を用いることでえられるシリコーンジェルシートあるいはシール
｛５｝　Ｒ１としてはＣＨ＝ＣＨ_２−、ＣＨ＝ＣＨ−ＣＨ_２−、ＣＨ＝ＣＨ−ＣＨ_２Ｏ−などがある。
Ｒ２としてはＣＨ_３−、ＣＨ_２ＣＨ_３−、Ｃ_６Ｈ_５−などがある。
【００１４】
対象としたゴムシートに両面にゴム糊を貼付したものを組み合わせた。アメゴムにクロロプレンゴム系ゴム糊を両面に塗布して直ちに使用した。
検体は試験Ａではそれぞれサイズを２０ｍｍ×１００ｍｍとし、厚みはこの場合１ｍｍとして作成した。試験Ｂでは、１０ｍｍ×１０ｍｍ、厚みは１ｍｍとした。
使用試験（以下は、上述の｛１｝、｛４｝および｛５｝で画定したシリコーンジェルシールを採用したものである。また、包皮と同一かもしくはそれ以下の硬度とする条件も踏襲している）。
【００１５】
試験方法、
被験者３名にそれぞれの試験シートを各３枚渡し使用感と安全性を検討した。それぞれについて５段階評価し、１〜２と４〜５段階評価の場合の理由を記載させた。
５段階評価とは、５：極めて優れている、４：優れている、３：普通、２：劣っている、１：かなり劣っている。以上のような基準とした。
【００１６】
試験結果Ａ
サイズ１０ｍｍ×１００ｍｍ×１ｍｍを帯状または筒状にして貼付した。
表２

試験結果Ｂ
表３

【００１７】
本発明の素材として挙げるシリコーンジェルシートについて、以下の試験を行った。
試験Ａ
使用感４〜５評価の理由：付けていて少し違和感があるが問題ない程度、膨張時にもこのシリコーンシールが男性器の伸縮に対し同調性が高いため特に問題はない、ただし長さが長いため膨張時には若干ひきつる感じが生ずる感じ、貼る時陰毛が絡むことがある。従ってこの目的のためには１００ｍｍほどの長さは不都合であると考える。
また、シリコーンシールの場合そのまま入浴など水中での粘着性や耐久性が高く、汗にも耐久性を示した。
安全性４〜５評価の理由：特に皮膚に刺激もなく安全と思えた。
試験Ｂ
使用感４〜５評価の理由：付けていて少し違和感がない、膨張時にもこのシリコーンシールが小さく皮膚と同じ伸縮性と極めて弱い復元力のため全くひきつれたりせず装着感がない。陰毛に絡むこともない。また透明なので付けていても外見上も違和感がない。
安全性４〜５評価の理由：特に皮膚に刺激もなく安全と思えた。
【００１８】
従来技術である、ゴムシートについて、以下の試験を行った。
試験Ａ
使用感１〜２の評価理由：ごわつく感じで付けていて違和感がある、膨張時皮膚との同調性がないためひきつる感じ、貼る時陰毛が絡む。ゴムなどの保形性を持った弾性材であると復元性が高いため男性器の柔軟性に同調できず違和感が生ずる事は避けられない。
安全性４〜５の評価理由：特に皮膚に刺激もなく安全と感じた。若干付け初めと剥がす時などひりつく感じ
安全性１〜２の評価理由：皮膚が赤くなり痒くなった、試料２，３では継続して貼付することができなかった。
試験Ｂ
使用感１〜２の評価理由：やはりごわつく感じで付けていて違和感がある、膨張時のひきつりは若干感じる程度だが、色が付いているので少しめくれて外から見える欠点がある。
ただ入浴時や汗に対し耐久性がなく直ぐ剥がれたり変形して脱落してしまった。安全性４〜５の評価理由：特に皮膚に刺激もなく安全と感じた。若干つけ初めと剥がす時などひりつく感じはする。
安全性１〜２の評価理由：皮膚が赤くなり痒くなった、試料１，２，３とも継続して貼付することができなかった。
【００１９】
次に、皮膚に対する表面的な影響について検証をした。
まず、シリコーンジェルシートは、単一のシリコーンからなるので、皮膚との接触も同一素材のシリコーンジェルシートである。一方、ゴムシートにおいては、ゴムシート自体が粘着性を持たないので、一般的に用いるクロロプレンゴム糊を塗布した状態で試験を行った。さらに、メタアクリル酸・アクリル酸Ｎ−ブチルコポリマー　（ＭＡ・ＡＡＮＢコポリマー）が塗布されて形成される医療用のハップ剤の粘着材を、一般的な例としてテストの中に入れている。これら皮膚刺激、（表面的に受ける刺激）に関して試験比較をした。
シリコーン、クロロプレンゴム系ゴム糊、さらに医療用のハップ剤の粘着材であるメタアクリル酸・アクリル酸Ｎ−ブチルコポリマー　（ＭＡ・ＡＡＮＢコポリマー）で皮膚への刺激試験を行なった
表４

【００２０】
シリコーンジェルシールは殆ど皮膚刺激性がなかった。一方クロロプレンゴム系ゴム糊、メタアクリル酸・アクリル酸Ｎ−ブチルコポリマー（ＭＡ・ＡＡＮＢコポリマー）では粘着剤にかぶれ易い体質があり、問題が起きる可能性があった。
材質的にシリコーンジェルの方が欠点が少なかった（皮膚に対する表面的な影響は、良好であった）。従って、シリコーンジェルが、表面的な影響においても好ましいことを確認した。
【００２１】
つぎに、好ましい結果のでたシリコーンジェルの形状において、好ましい条件を試験的に探った。
まず、上記２０ｍｍ（幅）×１００ｍｍ（長さ）、厚み１ｍｍを基に以下に述べるサイズなどで比較検討した。なお、被験者は上記試験と同一である。
表５その１

表５その２

表５その３

【００２２】
以上の試験結果から、次のことが知見された。
シリコーンジェルのシートの厚みが２ｍｍ以上あると折り返しても厚みがあるため外から目立つ、膨張時に引っ張られる感じがする、厚みがあると装着感があり違和感を感じる。また０．５ｍｍ以下とすると、装着時の違和感は少ないものの装着時にシリコーンシールの形が変形し易く扱い難いことが分かった。
幅が２０ｍｍ以上あると幅が広すぎて折り返してもめくれて目立つことがあることが確認できた。
長さが２０ｍｍ以上あると装着感が出てくるので違和感が強い、特に膨張時にはひきつれやこわばり感が強く出てくる。即ち帯状や筒状では陰茎の場合の特性として刺激により膨張や収縮を起こすため、包茎治療用具では実用的ではないことが確認できた。
１０ｍｍ（幅）×１０ｍｍ（長さ）のシールでも貼る枚数を多くすると余分な包皮がきちんと固定される感があるが、違和感が増した。また１枚でも固定でき、枚数が少ないほど簡便性や使用感が良好であった。ただし１枚の場合整然と貼付できない場合が生じた。
以上の試験から、サイズの適切なものは、幅１０ｍｍ×長さ１０〜２０ｍｍ×厚さ１ｍｍのシリコーンジェルによるシール素材であり、また、このような形状のものを陰茎の一方側に１枚貼り付け、その対向側である、他方側にさらにもう１枚、合計で２枚を貼付するのが簡便かつ実際上有用であることが分かった。
上記サイズ、すなわち、幅が狭く１０ｍｍで長さが１０〜２０ｍｍのシリコーンシールは、最適のサイズでしかも、厚さを１ｍｍ程度とすることで、透明性を持たせることができ、その透明性を有することで、装着時における外観上の違和感を減少でき、体感的にも好ましい結果が得られた。一方、シリコーンシールの粘着性が以上のサイズにおいて、最も扱い易くまた効果的であり、また医療用であるため皮膚への刺激が最も少なかった。また他の素材や製法に比較し形態と組成が単純で経済的であると考えられた。
【００２３】
有効な製品形態について、以下に記載する。
シリコーン製、両面の重合度を調節することで同一素材でありながら、芯は固く両面は粘着性を持たせたものが提案される。すなわち、シール形態として、厚さ１ｍｍ、サイズ１０ｍｍ（幅）×１０ｍｍ（長さ）のものの、両面に粘着性を持たせたものを複数枚（例えば２枚）を陰茎の一方側、と他方側に貼付することが好ましい結果が得られている。製品形態としては、下記のように６×１０＝６０枚（約４週間３０日分）を１箱に３枚（３か月分）又は６枚（６か月分）入りとして、毎日入浴時等に貼替えて使い捨てることが好ましい。
表６

【００２４】
上記のように、シリコーンジェルの大きさについて、１０ｍｍ×１０〜２０ｍｍ×１ｍｍのシリコーンジェルのシールが包茎治療用具として適切であるとの結果をえた。
１０ｍｍ×２０ｍｍ×１ｍｍのシリコーンジェルのシールの製品形態の例を図１に示した。図中において、１はシリコーンジェル、２は剥離紙である。
【００２５】
シリコーンジェルシールの官能試験と材質形態・重合度の検討
１）包茎治療用具の素材の検討
以上の検証において、シール型の治療用具は、その柔らかさが陰茎の包茎の原因である余剰の皮膚と同じ（あるいはそれ以上に柔らかくした）事が、取り扱い易さ（接着時の違和感や装着の意識化など）に大きく影響され、包茎の治療を簡便かつ容易に実施する上で決定的要因であることが知見された。
従って、今回は特に皮膚の柔らかさを基準化して素材の官能テストを実施した。
なお、皮膚の柔らかさの基準は皮膚に粘着性テープを貼付しこれを一定の力で横方向に引くことで皮膚が伸びる長さを計測し、柔らかさを数値化した。
【００２６】
表７

以上、人の陰茎を含む代表的な皮膚の硬度を実測した。この硬度は針入度ともいい、硬さを表す方法の１つだあり、試験方法はＪＩＳ　Ｋ２２０７に規格化されているものである。すなわち、規定重量の針を試料中に垂直に進入させ、進入した長さにより試料の硬さを表したものである。針入度の値は、１／１０ｍｍが進入度１に対応し、数字が大きいほど柔らかな材料を示す。
一方、以上に詳述したシリコーンジェルは、その素材ならびに形状によって、酸素透過度が高く、皮膚呼吸を阻害しないことが知見され、特に、ゴムと比較すると、ゴムは明らかに皮膚呼吸を阻害しますから、長期に貼ったときに、明らかな優位性をシリコーンジェル側の方が持つことが知見された。
具体的に測定すると、シリコーンジェルは、２５℃で３×１０^−９ｃｃ・ｃｍ／ｃｍ^２・ｓｅｃ・ｃｍＨｇ以上の酸素透過性を持ち、一方、ゴムは１×１０^−７ｃｃ・ｃｍ／ｃｍ^２・ｓｅｃ・ｃｍＨｇ位となっており、酸素呼吸を阻害することが実測として得られている。
【００２７】
各種素材における電気的特性を検証する。
測定雰囲気は、室温（２４．８℃）、湿度（１８％）である。試料は第１回目の検討で用いた素材であるシリコーンジェルシール、糊付き天然ゴム、バンドエイドの粘着テープ、糊付き紙テープ、ビニールテープを測定した。
通常、静電電位の測定距離は、通常１０ｃｍとされているが、各素材同士の比較を明確とするため、距離を１ｃｍとして測定した。
表８

【００２８】
シリコーンジェルシールの特性を検証する。
静電電位はマイナスイオンを表わすといわれ、静電電位により傷あとやケロイドを修復する作用があり、それは傷あとなどの細胞膜を安定化することにより炎症反応を抑制して過剰な細胞増殖や色素沈着を押さえるためであるとの報告がある。従ってこの報告に従えば、シリコーンジェルシールは、医療用の高純度シリコーンを使用し、生体に対する安全性は証明されているばかりでなく、マイナスイオンの効果により血行促進や炎症防止の作用があった方が直接包茎治療効果に影響はないものの好ましいものと考えられる。
シリコーンジェル自身の特性として、酸素透過性があるが、さらに、以下のような各種素材を配合することで、より好ましい機能を付加し得る。
【００２９】
変形実施例その１、トルマリンの粒状体を配合することによりマイナスイオンが発生し易くなる（図２参照）なお、このトルマリンは炭素粉末と変更することも可能で、その作用は、同様にマイナスイオンが発生するものである（レベルは異なる）。
【００３０】
変形実施例その２、銀粉末・イオン（ヨウ化銀など）や抗菌剤を配合することにより、局所の衛生を保つ事が期待できる。
【００３１】
変形実施例その３、空気などを、気泡の形で、混合することにより復元性を弱めて、さらに装着感が増す、さらに、接触面積が増えるので、肌に対して、よりフィットし、粘着効果を高めることができる（図３参照）。
【００３２】
変形実施例その４、図１で説明した実施例と外形サイズは同じで、素材も同じものを使用しているが、さらに、本実施例においては、長手方向に対して横方向（やや斜めでも可能）にスリットを複数設けた。そして、このスリットは好ましくは一方側の側方において、薄い部分を形成するように作り、さらに好ましくは、この薄い部分が交互の側方に形成されるように形成している。また、この薄い部分は、通常の装着課程においては破断しない程度の厚みに設定され、さらに、陰茎の膨張にともなって緊張状態になる等の予定よりも大きな緊張力を受けたときに、この薄い部分で切れて長手方向に分離する（好ましくはジグザグ状に分離する）。また、この薄い部分が切断される前の状態においては、スリットの存在により長手方向へ延びやすく形状変形する。さらに、スリットが余分な汗や湿気を通過させたり、一時的にためる効果があるので、多湿傾向の人にも、シリコーンジェルシールの本来有する粘着力をより長く保つことができる（図４参照、なお同図における下方の斜視図は、形状を明瞭にするために、部分断面として作図し、断面部分には斜線をほどこした）。
【００３３】
【発明の効果】
以上のように、請求項１で定義される本発明は、シート状部の一方の面が陰茎部に粘着し、該シート状部の他方の面が包皮部に粘着することで、陰茎部に包皮部を積極的に位置決めさせて、包皮部を安定的に陰茎部側に粘着し位置決めさせる包茎治療シートにおいて、該シート部が包皮と同一か若しくは包皮よりも柔らかくなる予定の硬度に設定した、ことを特徴としている。
従って、体内でも特別に柔らかい箇所において、その包皮と同一かそれよりも柔らかい硬度としていることで、物理的につれにくく、従って使用感が良く。さらに、追従性もよい。それは、長期間安定して包皮と陰茎の間に位置し続けることを意味する。
【００３４】
また、別の特徴からなる本発明では、請求項１の特徴に加えて、該シート状部の主成分が、水分が吸収可能な単一の素材からなるシリコーンであり、陰茎部から発生した水分が該シート状部の一方の面で吸収され、該吸収された水分の少なくとも一部が該シート状部の他方の面から外気へ放出するように、該シート部が水浸透性を有し、陰茎部から発生した水分によって該シート状部の一方の面の皮膚に対する粘着部において水分の層が形成されることを、該水分吸収性により抑止できるように該シート部の水浸透性の浸透量を設定したことを特徴としている。
従って、シリコーン表面に触れる皮膚から発生する汗や水蒸気などが、皮膚とシリコーンの粘着面との間に発生してもその少なくとも一部が他方側へ浸透するため、粘着度の低下を防ぐことができ、皮膚が汗によって、荒れることも低減できる。
【００３５】
別の特徴からなる本発明では、請求項１の特徴に加えて、該シートの構造を、硬度低下、水浸透性向上、および復元性低下をもたらすような多孔質構造としたことを特徴としている。
従って、この多孔質の構造内に、皮膚から発生する汗や水蒸気などが吸収されるので、粘着面と皮膚との間に発生した水分を、積極的に吸収し、粘着度の低下を防ぐことができ、皮膚が汗によって、荒れることも低減できる。
【００３６】
別の特徴からなる本発明では、請求項１の特徴に加えて、該硬度が、１１０｛針入度・１／１０ｍｍ、ＪＩＳ測定方法による（ＪＩＳ　Ｋ　２２０７）｝よりも大きい値となるように設定した、ことを特徴としている。つまり、包皮部の硬さを定義することにより明瞭にした。
【図面の簡単な説明】
【図１】本発明の一実施形態である、１０ｍｍ×２０ｍｍ×１ｍｍのシリコーンジェルのシールの製品形態の例を示す説明用斜視図である。
【図２】本発明の変形実施例その１を示す部分断面斜視図である。
【図３】本発明の変形実施例その３を示す部分断面斜視図である。
【図４】本発明の変形実施例その４を示す部分断面斜視図である。
【符号の説明】１，４はシリコーンジェルシール、２は剥離紙。[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention relates to a phimosis treatment sheet for treating pseudo phimosis.
[0002]
[Prior art]
As is well known, pseudo-phimosis not only inhibits the growth of male genitalia, shame is also said to be a cause of cancer in female genitalia, and its stench and dirt become a complex of men and impair healthy sexual awareness. is there. On the other hand, in the treatment of pseudo-phimosis, the foreskin around the glans is actively retracted from the glans side, and the retracted state is actively maintained. As the means therefor, there are a large conventional technique related to the present invention, a conventional technique of sticking the foreskin to the penis side with glue, and a conventional technique of sticking with an adhesive tape.
[0003]
In the former glue-type treatment, surplus foreskin on the glans is applied to the excess foreskin on the glans, and the surplus foreskin is applied on the surplus foreskin to prevent the surplus foreskin from returning to the glans.
As an advantage of this glue type treatment, since the glue is not visible from the surface, it is inconspicuous that it is being treated or that it is a phimosis. The size of the glans and penis may change in the direction in which their volume and length expand (hereinafter referred to as expansion deformation) due to the increase in blood pressure of the blood flowing inside, or the volume may be reduced mainly due to a decrease in outside air temperature. This glue basically follows even when the length shrinks (hereinafter, shrinkage deformation).
However, glue easily adheres to hands and clothes, and it is difficult to apply the glue neatly or it takes time.If it cannot be applied reliably, it stains the surroundings. If the adhesion decreases, the therapeutic effect is lost.
Adhesive treatment of the latter, which was considered to prevent the decrease in adhesive strength caused by water and sweat in the former, is based on an elastic material that does not absorb water, such as raw rubber, and provides an adhesive layer on both sides, and attaches it. By sandwiching between the foreskin and the penis, the foreskin and the penis are made to adhere. Thus, a material made in a direction that avoids water absorption can temporarily withstand water.
[Problems to be solved by the invention]
[0004]
However, sweat and moisture generated from the skin surface under the adhesive layer, unlike moisture coming from the outside, occur between the adhesive layer and the skin, and accumulate between the adhesive layer and the skin, resulting in It acts in the direction of peeling. Eventually, the adhesive strength is reduced and the foreskin loses the effect of the treatment of positioning and correcting the penis side.
In addition, those who require phimosis treatment tend to have the foreskin press on the penis more than normal people, and the foreskin shrinks during treatment of the phimosis, causing the foreskin to fall on the penis side. Tended to apply force in the direction of As a result, the foreskin tended to press the penis more strongly, especially during inflation, and tended to be painful in treating the foreskin. In addition, there is a fear that continued treatment with such distress may hinder the growth of male organs. In addition, the above-mentioned expansion and contraction deformations cause a sense of incongruity due to the fact that the base is made of an elastic member under conditions that are harder than the foreskin, and the elastic member is made of a material with less discomfort. Is preferable for the user. That is, it is desired that the expansion and contraction be performed with a feeling closer to the skin.
[0005]
[Means for Solving the Problems]
In order to solve the above-mentioned problem, the present invention defined in claim 1 is characterized in that one surface of the sheet-like portion adheres to the penis portion and the other surface of the sheet-like portion adheres to the foreskin portion. A foreskin treatment sheet that positively positions the foreskin on the penis and stably adheres and positions the foreskin on the penis side, wherein the hardness of the sheet is the same as the foreskin or will be softer than the foreskin Is set.
[0006]
According to the present invention having another feature, in addition to the features of claim 1, the main component of the sheet-shaped portion is silicone made of a single material capable of absorbing moisture, and the moisture generated from the penis portion is The sheet portion is water-permeable so that at least a portion of the absorbed moisture is released to the outside air from the other surface of the sheet portion, and the penis portion is absorbed by one surface of the sheet portion. The water permeability of the sheet portion is set so that the moisture absorption prevents the formation of a moisture layer in the adhesive portion of the one surface of the sheet portion to the skin with the water absorption. It is characterized by doing.
[0007]
According to the present invention having another feature, in addition to the features of claim 1, the structure of the sheet is characterized by having a porous structure that causes a decrease in hardness, an improvement in water permeability, and a decrease in restorability. .
[0008]
According to the present invention having another feature, in addition to the features of claim 1, the hardness is set to a value greater than 110 {penetration 1/10 mm, JIS {K {2207)} according to the JIS measurement method. Is set.
[0009]
BEST MODE FOR CARRYING OUT THE INVENTION
FIG. 1 is a perspective view showing a state in which a phimosis treatment sheet 1 according to the present invention is stuck on a plastic thin film 2. The plastic thin film 2 is a transparent sheet having a thickness of about 1 mm or less, and 16 phimosis treatment sheets 1 are uniformly arranged on the plastic thin film 2 with a gap of about 1 mm, and are adhered with silicone adhesive. is there. Also, if desired, the same plastic thin film 2 can be placed on the upper side of the phimosis treatment sheet to form a sandwich in which the phimosis treatment sheet 1 comes at the center. Also, the upper sheet can be an extremely thin vinyl sheet.
[0010]
The phimosis treatment sheet 1 has an outer shape with a thickness of 1 mm, a width of 10 mm, and a length of 20 mm, and is almost transparent. The material is composed of a single silicone gel and has a hardness equal to or less than that of the foreskin, and a hardness that does not lose its shape during the operation of being peeled from the plastic thin film 2 and transported to the foreskin or penis, that is, 30. It is configured to have a viscosity of from 2,000 cs to 70,000 cs (measured value at body temperature). The tensile modulus of the silicone gel (gel) is set to 0.001 to 0.01 kgf / mm2. That is, the elastic modulus of the ordinary silicone rubber is 0.01 to 0.1 kgf / mm2. As a result, the elastic modulus is one order of magnitude smaller than that of ordinary silicone rubber. In addition, the tensile elasticity is a property that an object deformed by an external force due to extension tends to return to the original size when the external force is removed, and the smaller the value, the smaller the external force deforms and the time it takes to return It means that power is small. In addition, the elastic modulus of natural rubber, butadiene rubber, and silicone rubber generally has a relation of natural rubber ≧ butadiene rubber ≧ silicone rubber. As described above, these rubbers and silicone gel have different elastic moduli by one digit, and Qualitative differences occur. Therefore, the silicone gel used in the present invention has physical properties as close as possible to the elastic modulus of human skin, as described later, as compared to natural rubber, butadiene rubber, and silicone rubber. As described above, when the sensory test is also evaluated, it can be understood that the user has the least feeling of discomfort when wearing. That is, the hardness could be equal to or less than that of the foreskin (penis), but if it was too soft, handling would be difficult. Therefore, a sensory test and a material form and degree of polymerization of a silicone gel seal having good adhesion to the skin and good follow-up properties and easy handling were studied.
[0011]
First, the materials were examined.
A tape with an adhesive layer on both sides of the base material and a single silicone gel seal that has been made sticky by changing the degree of polymerization (viscosity) on both sides (the silicone gel remains sticky to the skin as it is) Therefore, a comparison between the degree of adhesion to the skin and the ease of handling was carried out. The evaluation of the degree of adhesion was made on a five-point scale. Furthermore, the degree of adhesion to the skin was evaluated as 5 when the foreskin and the foreskin were adhered and did not come off. Those having poor adhesiveness were evaluated as 1, and 2 to 4 between them were equally divided and indicated stepwise. When the degree of polymerization was high, the adhesiveness was poor when the degree of polymerization was high, but the ease of peeling from the release paper was evaluated. Further, the handling was also improved depending on the stiffness of the seal.
On the other hand, those which were difficult to peel and were weak and difficult to handle were evaluated as 1, and 2 to 4 between them were equally divided and described stepwise (see Table 1).
Table 1

[0012]
Reason for evaluation: Regarding the degree of adhesion to the skin, if the viscosity was too low, the shape was not stable, and the overwrapping of the foreskin was rather displaced. When the viscosity was too high, the adhesiveness was reduced and the film was easily peeled off.
If the viscosity is low, the handleability is too soft, so that it is difficult to peel off from the release paper, and it tends to be torn or deformed when peeled. It was found that when the viscosity was high, it was easy to peel off from the release paper and became difficult to deform, so that it became easy to handle, but at the same time, when the stiffness was too strong, the elasticity was so strong that it became difficult to use.
In the subsequent tests, tests were carried out with the above-mentioned optimum ones within the range of the degree of polymerization of the following structure.
[0013]
The chemical structure and structure of the silicone gel seal most suitable for the purpose of the present invention are shown below.
As a result of studying the degree of polymerization of the silicone material in various ways and studying the ease of handling and the adhesive effect, it was found that the following compositions had high synchronicity with skin expansion and contraction and sufficient adhesiveness.
{1} average molecular formula R¹aR² _bSiO_{(4- (a + B )) / 2}
Where R¹Is an organic group containing an unsaturated hydrocarbon group, R²Is a monovalent hydrocarbon group containing no unsaturated hydrocarbon group, a is 0.001 to 0.3, b is 1.8 to 2.5, and a + b is 1.8 to 2.5. 100 parts by weight of an organopolysiloxane having a viscosity at 25 ° C. of 50 to 100,000 cs, in which both chain ends are blocked with silyl groups containing two each.
{2} average molecular formula R¹cR² _dSiO_{4- (c + d)}
Where R¹Is an organic group containing an unsaturated hydrocarbon group, R²Is a monovalent hydrocarbon group containing no unsaturated hydrocarbon group; c is 0.001 to 0.3; d is 0.1 to 0.95;¹Or R²1 to 50 parts by weight of an organopolysiloxane blocked with a silyl group comprising
{3} An amount such that the hydrogen atom ({SiH group) bonded to a silicon atom is twice as large as 0.4 to 4.0 for one group represented by R1 in the above {1} and {2} components. Average molecular formula R¹eR² _fSiO_{4 − ( e + f )}
Here, R1 is a hydrogen group, R2 is a monovalent hydrocarbon group containing no unsaturated hydrocarbon group, e is 0.001 to 0.3, d is 0.1 to 0.9, and e + f is 0.1 to 0.9. An organohydrogenpolysiloxane in which the molecular chain terminal represented by 0.9 is blocked with a silyl group consisting of R1 or R2
{4} A silicone gel sheet or seal obtained by using a platinum-based catalyst in an amount of 1 to 100 ppm in terms of platinum based on 100 parts by weight of the above component (1).
CH = CH as {5} R1₂-, CH = CH-CH₂-, CH = CH-CH₂O- and the like.
CH for R2₃-, CH₂CH₃-, C₆H₅-And so on.
[0014]
The target rubber sheet was combined with a rubber sheet stuck on both sides. A chloroprene rubber-based rubber paste was applied to both sides of candy rubber and used immediately.
In the test A, the sample was prepared with a size of 20 mm × 100 mm and a thickness of 1 mm in this case. In Test B, the size was 10 mm × 10 mm and the thickness was 1 mm.
Service test (The following is a test in which the silicone gel seal defined in the above {1}, {4} and {5} is adopted. Also, the hardness is the same as or less than that of the foreskin. There).
[0015]
Test method,
Three test sheets were passed to three test subjects, and the feeling of use and safety were examined. Each was evaluated on a 5-point scale, and the reasons for 1-2 and 4-5-point evaluations were described.
The five-point rating is 5: extremely good, 4: excellent, 3: normal, 2: poor, 1: fairly poor. Based on the above criteria.
[0016]
Test result A
A band having a size of 10 mm × 100 mm × 1 mm was attached in a band shape or a tubular shape.
Table 2

Test result B
Table 3

[0017]
The following tests were performed on the silicone gel sheets listed as the material of the present invention.
Test A
Usability 4-5 Reason for evaluation: A little uncomfortable feeling when attached, but no problem, no problem, as this silicone seal has high synchronism with the expansion and contraction of the male genitalia even when inflated. When swelling, a slight twitching feeling may occur, and pubic hair may be entangled when pasted. Therefore, a length of about 100 mm is considered inconvenient for this purpose.
In the case of a silicone seal, the stickiness and durability in water such as bathing were high, and the silicone seal showed durability.
Reason for safety 4-5 evaluation: It seemed safe without irritation to the skin.
Test B
Reason for evaluation of use feeling 4-5: There is little feeling of discomfort when attached, and even when inflated, the silicone seal is small and has the same elasticity and extremely weak restoring force as the skin. No pubic hair. In addition, it is transparent, so there is no discomfort in appearance.
Reason for safety 4-5 evaluation: It seemed safe without irritation to the skin.
[0018]
The following tests were performed on a rubber sheet, which is a conventional technique.
Test A
Reason for evaluation of feeling of use 1 and 2: The feeling of being uncomfortable due to the rugged feeling, the feeling of tightness due to lack of synchronism with the skin when inflated, and the pubic hair tangling when pasted. An elastic material having shape retention such as rubber has a high resilience, so that it cannot be synchronized with the flexibility of the male genitalia and it is inevitable that an uncomfortable feeling is caused.
Reason for evaluation of safety 4-5: I felt safe without irritation to the skin. Feeling sticky at the beginning and when peeling off slightly
Reason for evaluation of safety 1-2: Skin became red and itchy. Samples 2 and 3 could not be continuously applied.
Test B
Reason for evaluation of feeling of use 1 and 2: The feeling is uncomfortable because it is attached with a rugged feeling, but the swelling at the time of inflation is slightly felt, but there is a drawback that it is slightly turned up because it is colored and can be seen from outside.
However, it was not durable against bathing or sweat and immediately peeled off or deformed and fell off. Reason for evaluation of safety 4-5: I felt safe without irritation to the skin. I feel a little sticky at the beginning and when peeling off.
Reason for evaluation of safety 1-2: The skin became red and itchy, and samples 1, 2, and 3 could not be continuously applied.
[0019]
Next, the surface effects on the skin were verified.
First, since the silicone gel sheet is made of a single piece of silicone, the silicone gel sheet is made of the same material even when it comes into contact with the skin. On the other hand, in the case of a rubber sheet, since the rubber sheet itself does not have adhesiveness, the test was performed in a state where a generally used chloroprene rubber paste was applied. Further, an adhesive material of a medical haptic formed by applying a methacrylic acid / N-butyl acrylate copolymer (MA / AANB copolymer) is included in the test as a general example. Test comparisons were made with respect to these skin irritation, (i.e., surface irritation).
A skin irritation test was conducted using silicone, chloroprene rubber-based rubber paste, and methacrylic acid / N-butyl acrylate copolymer (MA / AANB copolymer), which is an adhesive for medical haptics.
Table 4

[0020]
The silicone gel seal had little skin irritation. On the other hand, the chloroprene rubber-based rubber paste and the methacrylic acid / N-butyl acrylate copolymer (MA / AANB copolymer) have a constitution in which the pressure-sensitive adhesive tends to be rash, which may cause a problem.
As for the material, silicone gel had fewer defects (the surface effect on the skin was better). Therefore, it was confirmed that silicone gel is preferable in terms of surface effects.
[0021]
Next, favorable conditions were tentatively searched for in the shape of the silicone gel with favorable results.
First, based on the above-mentioned 20 mm (width) × 100 mm (length) and 1 mm thickness, a comparative study was conducted with the following sizes and the like. The subject is the same as the above test.
Table 5 Part 1

Table 5 Part 2

Table 5-3

[0022]
From the above test results, the following was found.
If the thickness of the silicone gel sheet is 2 mm or more, it will be noticeable from the outside because it is thick even if it is folded back, and it will be stretched when expanded. When the thickness was 0.5 mm or less, it was found that the shape of the silicone seal was easily deformed at the time of mounting, but was difficult to handle, although the feeling of discomfort during mounting was small.
It was confirmed that when the width was 20 mm or more, the width was too wide, and even when folded up, it turned up and was conspicuous.
When the length is 20 mm or more, a feeling of wearing appears and the feeling of discomfort is strong. In particular, when inflated, tightness and stiffness are strongly felt. That is, in the case of a band or a tube, it was confirmed that it was not practical for a phimosis treatment device because the penis caused expansion and contraction as a characteristic in the case of a penis.
Increasing the number of stickers even with a 10 mm (width) × 10 mm (length) sticker has a feeling that extra foreskins are properly fixed, but the sense of discomfort has increased. Further, even one sheet could be fixed, and the smaller the number, the better the simplicity and usability. However, in the case of one sheet, there was a case where it could not be stuck neatly.
From the above test, an appropriate size is a sealing material made of silicone gel with a width of 10 mm, a length of 10 to 20 mm, and a thickness of 1 mm, and one such shape is stuck on one side of the penis. It was found that it was convenient and practically useful to attach another two sheets in total on the other side, which is the opposite side.
The above-mentioned size, that is, a silicone seal having a narrow width of 10 mm and a length of 10 to 20 mm can have transparency by being an optimum size and having a thickness of about 1 mm. By having this, the discomfort in appearance at the time of wearing can be reduced, and favorable results in terms of bodily sensation were obtained. On the other hand, when the size of the silicone seal is larger than the above, the silicone seal is the most easy to handle and effective, and because it is for medical use, the skin is least irritated. It was considered that the form and composition were simple and economical as compared with other materials and manufacturing methods.
[0023]
Effective product forms are described below.
It is proposed that the core is made rigid and both sides are made sticky while being made of silicone and having the same material by adjusting the degree of polymerization of both sides. That is, a plurality of (for example, two) seals having a thickness of 1 mm and a size of 10 mm (width) × 10 mm (length) but having stickiness on both sides are provided on one side and the other side of the penis. It has been found that it is preferable that the adhesive be applied to the surface. As a product form, 6x10 = 60 sheets (for about 4 weeks and 30 days) as shown below, 3 sheets (for 3 months) or 6 sheets (for 6 months) in one box, when bathing every day It is preferable to dispose it after displacing it.
Table 6

[0024]
As described above, regarding the size of the silicone gel, it was found that a silicone gel seal of 10 mm × 10 to 20 mm × 1 mm was suitable as a phimosis treatment tool.
FIG. 1 shows an example of a product form of a silicone gel seal of 10 mm × 20 mm × 1 mm. In the figure, 1 is a silicone gel, and 2 is a release paper.
[0025]
Sensory test of silicone gel seal and examination of material form and degree of polymerization
1) Examination of materials for phimosis treatment tools
In the above verification, it was found that the softness of the seal-type treatment device was the same as (or softer than) the excess skin that caused the phimosis of the penis. Consciousness, etc.), and was found to be a decisive factor in performing simple and easy treatment of phimosis.
Therefore, this time, the sensory test of the material was carried out with reference to the softness of the skin.
The standard of the softness of the skin was determined by applying an adhesive tape to the skin and pulling the adhesive tape in the lateral direction with a constant force to measure the length of the stretched skin, and quantified the softness.
[0026]
Table 7

As described above, the hardness of a representative skin including a human penis was measured. This hardness is also referred to as penetration and is one of the methods for expressing hardness, and the test method is standardized in JIS K2207. That is, a needle having a specified weight is vertically inserted into the sample, and the hardness of the sample is represented by the length of the needle. As for the value of the penetration, 1/10 mm corresponds to the penetration of 1, and the larger the number, the softer the material.
On the other hand, it has been found that the silicone gel described above has high oxygen permeability and does not inhibit skin respiration, depending on its material and shape, and in particular, rubber clearly inhibits skin respiration when compared to rubber From this, it was found that the silicone gel side had a clear advantage when applied for a long time.
Specifically, the silicone gel is 3 × 10 at 25 ° C.^-9cc · cm / cm²・ Second cmHg or more of oxygen permeability, while rubber is 1 × 10^-7cc · cm / cm²-It is about sec-cmHg, and it has been obtained as an actual measurement that oxygen respiration is inhibited.
[0027]
Verify the electrical characteristics of various materials.
The measurement atmosphere is room temperature (24.8 ° C.) and humidity (18%). Samples were measured for silicone gel seal, glued natural rubber, band-aid adhesive tape, glued paper tape, and vinyl tape, which were the materials used in the first study.
Usually, the measurement distance of the electrostatic potential is usually 10 cm. However, in order to clarify the comparison between the materials, the distance was measured at 1 cm.
Table 8

[0028]
Verify the characteristics of the silicone gel seal.
Electrostatic potential is said to represent negative ions, and has the effect of repairing wounds and keloids by electrostatic potential.It stabilizes cell membranes such as wounds and suppresses the inflammatory response, resulting in excessive cell proliferation and pigmentation. There is a report that it is to suppress. Therefore, according to this report, the silicone gel seal uses high-purity silicone for medical use, and not only has its safety against the living body been proven, but also has the effect of promoting blood circulation and preventing inflammation by the effect of negative ions. It is considered that the one having no direct effect on the phimosis treatment effect is preferable.
Although the silicone gel itself has oxygen permeability, a more preferable function can be added by blending the following various materials.
[0029]
Modified Example 1 The addition of tourmaline granules facilitates the generation of negative ions (see FIG. 2). This tourmaline can be replaced with carbon powder, and its action is similarly reduced by negative ions. (Levels are different).
[0030]
Modified Example 2 By blending silver powder / ion (such as silver iodide) and an antibacterial agent, local hygiene can be expected to be maintained.
[0031]
Modified Example 3 By mixing air and the like in the form of air bubbles, the resilience is weakened, the feeling of wearing is further increased, and the contact area is increased, so that it fits more on the skin and has an adhesive effect. (See FIG. 3).
[0032]
Modified Example 4 The outer size is the same as that of the embodiment described with reference to FIG. 1 and the same material is used. (Possible) with multiple slits. The slit is preferably formed so as to form a thin portion on one side, and more preferably such that the thin portion is formed on alternate sides. In addition, the thin portion is set to a thickness that does not break during a normal mounting process, and further, when subjected to a tension greater than expected, such as being in a tensioned state due to inflation of the penis, the thin portion is thinned. It cuts at a part and separates in the longitudinal direction (preferably in a zigzag shape). Further, in a state before the thin portion is cut, the shape is easily deformed in the longitudinal direction due to the presence of the slit. Furthermore, since the slit has the effect of allowing excess sweat or moisture to pass through or temporarily accumulating, even a person who tends to be humid can maintain the inherent adhesive force of the silicone gel seal for a longer time (see FIG. 4, The lower perspective view in the figure is drawn as a partial cross section for clarity, and the cross section is hatched.
[0033]
【The invention's effect】
As described above, the present invention as defined in claim 1, the one surface of the sheet portion adheres to the penis portion, the other surface of the sheet portion adheres to the foreskin portion, the penis portion The foreskin treatment sheet which positively positions the foreskin portion and stably adheres and positions the foreskin portion on the penis portion side, the sheet portion is set to the same hardness as the foreskin or to be softer than the foreskin, It is characterized by:
Therefore, in a particularly soft part of the body, by setting the hardness to be equal to or less than that of the foreskin, it is hardly physically distorted, and the feeling of use is good. Further, the tracking ability is good. It means that it stays between the foreskin and the penis stably for a long time.
[0034]
Further, in the present invention having another feature, in addition to the features of claim 1, the main component of the sheet-shaped portion is silicone made of a single material capable of absorbing moisture, and the moisture generated from the penis portion Is absorbed on one surface of the sheet portion, and the sheet portion has water permeability, so that at least a part of the absorbed moisture is released from the other surface of the sheet portion to the outside air. The amount of water permeable permeation of the sheet portion can be suppressed by the water absorbability so that the water generated from the penis portion can prevent a water layer from being formed in the adhesive portion on one surface of the sheet portion to the skin. Is set.
Therefore, even if sweat or water vapor generated from the skin that touches the silicone surface is generated between the skin and the adhesive surface of the silicone, at least a part of the permeation penetrates to the other side, so that it is possible to prevent a decrease in the adhesiveness. It can also reduce skin irritation due to sweat.
[0035]
According to the present invention having another feature, in addition to the features of claim 1, the structure of the sheet is characterized by having a porous structure that causes a decrease in hardness, an improvement in water permeability, and a decrease in restorability. .
Therefore, sweat and water vapor generated from the skin are absorbed into this porous structure, so that the water generated between the adhesive surface and the skin is positively absorbed to prevent a decrease in the adhesiveness. It can also reduce skin irritation caused by sweat.
[0036]
According to the present invention having another feature, in addition to the features of claim 1, the hardness is set to a value greater than 110 {penetration 1/10 mm, JIS {K {2207)} according to the JIS measurement method. Is set. In other words, it was made clear by defining the hardness of the foreskin.
[Brief description of the drawings]
FIG. 1 is an explanatory perspective view showing an example of a product form of a silicone gel seal of 10 mm × 20 mm × 1 mm, which is an embodiment of the present invention.
FIG. 2 is a partial sectional perspective view showing a first modified example of the present invention.
FIG. 3 is a partial sectional perspective view showing a third modification of the present invention.
FIG. 4 is a partial sectional perspective view showing a fourth modification of the present invention.
[Description of Symbols] 1 and 4 are silicone gel seals and 2 is a release paper.

Claims (4)

One surface of the sheet-shaped portion adheres to the penis portion, and the other surface of the sheet-shaped portion adheres to the foreskin portion, thereby positively positioning the foreskin portion on the penis portion, and stably positioning the foreskin portion. In a phimosis treatment sheet that adheres and positions on the penis part side,
The sheet portion was set to the same hardness as the foreskin or to a hardness that would be softer than the foreskin,
A phimosis treatment sheet, characterized in that: The main component of the sheet portion is silicone made of a single material capable of absorbing moisture, and water generated from the penis portion is absorbed on one surface of the sheet portion, and at least one of the absorbed water is absorbed. The sheet portion has water permeability so that a part is released to the outside air from the other surface of the sheet portion,
The amount of water permeable permeation of the sheet portion can be suppressed by the water absorbability so that the water generated from the penis portion can prevent a water layer from being formed in the adhesive portion on one surface of the sheet portion to the skin. The treatment device for a phimosis according to claim 1, wherein: 2. The phimosis treatment device according to claim 1, wherein the sheet has a porous structure that reduces the hardness, improves water permeability, and reduces the resilience. 2. The phimosis treatment device according to claim 1, wherein the hardness is set to a value greater than 110 (penetration, 1/10 mm) according to a JIS measurement method (JIS {K 2207)}.

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