JP3558924B2

JP3558924B2 - Intubation device for lacrimal canal reconstruction

Info

Publication number: JP3558924B2
Application number: JP17045699A
Authority: JP
Inventors: 栗橋克昭
Original assignee: 有限会社エム・エル・シー
Priority date: 1999-06-17
Filing date: 1999-06-17
Publication date: 2004-08-25
Anticipated expiration: 2019-06-17
Also published as: JP2001000469A

Description

【０００１】
【発明の属する技術分野】
この発明は、涙道再建用挿管器具に関するものである。
【０００２】
【従来の技術】
挿管法は、涙道の再建に有効な治療法である。しかし、クロフォード法に代表される従来のシリコーンチューブ留置法は、日本においてはヌンチャク型シリコーンチューブに比較して一般には普及していない。これは、涙道内に留置されたシリコーンチューブに十分な安定性がなかったためである。
【０００３】
従来のシリコーンチューブは、例えばシリコーンゴムで形成されるが、柔軟性が充分でなかった。従って、その中央部をピンセットで持ち上げても、逆Ｕ字形に楽に折れ曲ることはなかった。この弾力性が涙道内での不安定性の一因になっていた。
【０００４】
また、クロフォード法では、チューブの先端を鼻腔内で結び、鼻涙管下端の開口部の大きさより大きな結び目を作りそのまま放置する構成になっていた。しかし、鼻涙管下端の開口部の大きさを確認することは困難である。また、結び目が鼻涙管下端の開口部より小さいときは、結び目が上方に移動して涙嚢内に入ってしまう難点もあった。涙小管の径が非常に小さいため、一度涙嚢に入った結び目を抜去することは非常に困難であった。
【０００５】
そこで本発明者は、図１に示すように全長が８０〜１３０ｍｍであり、中央部の２０〜４０ｍｍが細くしなやかになったチューブを提案した。このチューブは、中央部が細くかつしなやかで、その両側が太く硬めになっていて、図２に示すように中央部を支持すると重力で楽に逆Ｕ字形に湾曲する構成になっている。従って、このチューブは、従来のシリコンチューブと比較して安定性が格段に優れていて、抜け出しが起ることは非常に稀である。
【０００６】
また、このチューブは両端が盲端になっていて、消息子を挿入する切れ目を有するので、涙道内への挿入も容易である。さらに、抜去も容易にできる等の利点を有している。
【０００７】
本発明者は、このチューブを１００例以上の涙道閉塞の症例に適用したが、涙道内での安定性及び抜け出しが稀であることが確認されている。
【０００８】
【発明が解決しようとする課題】
しかしながら、一般に、チューブの両端は涙道の働きによって鼻腔の方に引っ張られる。このため、図３に示すように、チューブ中央部の細くしなやかな部分４０が涙点や涙小管に食い込んで、涙点や涙小管に裂傷１９が生じる場合があった。裂傷は、チューブ中央部が細く硬いほど生じ易い傾向があった。また、両側からの張力が大きい場合には、チューブ中央部がさらに細くなることによってさらに裂傷１９が生じ易くなっていた。
【０００９】
このような従来技術の問題点に鑑み、本発明は、涙道内での安定性が良く、涙道内への挿入も容易であって、留置後に涙点や涙小管に裂傷が生じる恐れが無い涙道再建用挿管器具を提供することを目的としている。
【００１０】
【課題を解決するための手段】
本発明の解決手段は、請求項１〜５に記載された涙道再建用挿管器具である。
【００１１】
【実施例】
以下、図面を参照して、本発明による涙道再建用挿管器具の好適な実施例を説明する。
【００１２】
図４、５、６は、本発明の３つの実施例による涙道再建用挿管器具（以下、単に挿管器具と言う）の外形を示す斜視図である。
【００１３】
図４〜６の３つの実施例では、挿管器具は、両側に配置される２つの端部材４２と、２つの端部材４２を連結する連結部材４０、２４から構成されている。連結部材は、中央部２４とその両側に位置する側部４０からなり、両側部４０は、やわらかいシリコーンゴム製のチューブまたはロッドで形成されている。連結部材の中央部２４は硬いシリコーンゴム製のチューブまたはロッドで形成されている。
【００１４】
この図４〜６の例では、端部材４２もシリコーンゴム製のパイプ材で形成されている。
【００１５】
端部材４２の終端部５３（１〜２ｍｍ程度）は、盲端になっている。また、端部材４２の他端の部分には、消息子を挿入するための小さな切込み４９が形成されている。切込み４９は軸芯方向に平行に形成されている。消息子を切込み４９から盲端まで挿入して、消息子を利用して挿管器具を涙道内に留置する。
【００１６】
図４〜６に示される３つの実施例では、連結部材４０、２４は端部材４２より０．４〜０．６ｍｍ程度小径になっている。また、連結部材の両側部４０は連結部材の中央部２４や端部材４２よりしなやかである。
【００１７】
図４の実施例では連結部材の中央部２４と両側部４０の軸心のなす角度は１８０°である。
【００１８】
図５の実施例に示されるように連結部材の中央部２４と両側部４０のなす角度ｒを８０〜１８０°にしてもよい。
【００１９】
図６の実施例は角度ｒを９０°にしたものであるが、糸８１でつるしても連結部材の中央部２４は、硬く短かくなっているので、曲りにくく、それだけ涙点に加る力が軽減されるので、図３に示される涙点や涙小管が裂けて行くという合併症が起こりにくくなる。
【００２０】
挿管器具の材料としては、適当なしなやかさと強度が望まれる。強度的には、涙道内への留置操作で加わる引張り力、留置後に働く引張り力、抜去の際の引張り力等に耐え得る強度が必要である。一方、しなやかさの点では、留置操作が円滑に行え、留置後の涙道内での安定性が得られるだけのしなやかさが必要である。
【００２１】
このような引張強度としなやかさの条件に加えて、人体に無害であることも重要である。このような観点から、挿管器具に適する材料としてシリコーンゴムが適している。表面の層のみをシリコーンゴムで形成することも可能である。シリコーンゴムは、一般に、硬さが増すと引張り強さ等の強度も増大する傾向にある。シリコーンチューブは、短いほど、そして硬さが増すほど、曲りにくくなる。
【００２２】
連結部材４０、２４と端部材４２のしなやかさは、例えばＪＩＳで定められたショア硬さで評価できる。ショア硬さは、硬度計デュロメータ（Ｄｕｒｏｍｅｔｅｒ）で計測され、単位はｓｈｏｒｅＡ（ＪＩＳ）である。ショア硬さの数値が大きいほど、硬さも大きくなる。
【００２３】
連結部材の両側部４０と中央部２４と端部材４２の硬さ（しなやかさ）について述べる。
【００２４】
連結部材の両側部４０は、ショア硬さが２０〜６０｛ｓｈｏｒｅＡ（ＪＩＳ）｝であるが、望ましくは３０〜５０（ｓｈｏｒｅＡ）、最適には３８〜４２（ｓｈｏｒｅＡ）の範囲に設定できる。一方、連結部材の中央部２４と端部材４２は、ショア硬さが５０〜８０｛ｓｈｏｒｅＡ（ＪＩＳ）｝であるが、望ましくは６０〜８０（ｓｈｏｒｅＡ）、最適には７０〜８０（ｓｈｏｒｅＡ）の範囲に設定できる。
【００２５】
次に、挿管器具及び各部材の長さについて述べる。
【００２６】
挿管器具の全長は、一般に５０〜１３０ｍｍであるが、望ましくは９０〜１２５ｍｍ、最適には１０５〜１１５ｍｍの範囲に設定できる。連結部分４０、２４の長さは、１５〜３０ｍｍであるが、望ましくは２０〜３０ｍｍ、最適には２０〜２８ｍｍの範囲に設定できる。
【００２７】
図１０に示すように、連結部の両側部４０の長さは７〜１３ｍｍで、中央部２４の長さは４〜８ｍｍである。
【００２８】
図１１はその代表的１例を示したものであるが、端部材４２Ａ、４２Ｂの内部に段ｇ１を有している。
【００２９】
図１２もその代表的１例を示しているが端部材４２Ａ、４２Ｂの内部に隔壁Ｗ１を有している。また、端部材４２の長さは、１０〜６０ｍｍであるが、望ましくは２５〜５０ｍｍ、最適には３０〜４５ｍｍの範囲に設定できる。
【００３０】
次に、各部材の外径、内径、肉厚について述べる。連結部分の両側部４０と中央部２４の外径、内径、肉厚は、各々０．２〜０．７ｍｍ、０〜０．３ｍｍ、０．１〜０．２５ｍｍであるが、望ましくは各々０．３〜０．６ｍｍ、０〜０．２５ｍｍ、０．１〜０．２ｍｍ、最適には各々０．４〜０．５ｍｍ、０〜０．２ｍｍ、０．１５〜０．１８ｍｍの範囲に設定できる。なお、連結部分４０、２４の外径は０．２〜０．７ｍｍであるが、内腔のないロッドでもよい。内径０ｍｍはロッドであることを意味する。連結部材の中央部２４を両側部４０より硬くしたのは、連結部材の中央部２４をやわらかくした場合には涙点や涙小管の裂傷が起こり易いからである。
【００３１】
一方、端部材４２の外径、内径、肉厚は、各々０．６〜１．３ｍｍ、０．２〜０．７ｍｍ、０．１５〜０．３ｍｍであるが、望ましくは各々０．７〜１．２ｍｍ、０．３〜０．６ｍｍ、０．１８〜０．２８ｍｍ、最適には各々０．９〜１．１ｍｍ、０．３５〜０．５５ｍｍ、０．２〜０．２５ｍｍの範囲に設定できる。
【００３２】
図７、８、１１〜１３に示すように、端部材が、異なる外径のチューブ４２Ａ、４２Ｂから形成されているものも優れている。端部材の前方部分４２Ａの外径はそれにつながる後方部分４２Ｂの外径よりも０．１〜０．３ｍｍ細くなっているので挿入しやすい。端部材の前方部分４２Ａの長さは７〜２０ｍｍ、望ましくは１０〜１８ｍｍ、最適には１０〜１５ｍｍである。端部材の前方部分４２Ａと後方部分４２Ｂの間はなめらかな境界部５２となっている。境界部５２の内部には、図７に示されるような段ｇ１や図８に示されるような隔壁Ｗ１があり、消息子６１で端部材を涙道内に押し込みやすくしている。
【００３３】
図１３に示される実施例においては、連結部材は両側部４０と中央部２４の間に垂直部２２が配置されている。垂直部２２の長さは１〜２ｍｍが適当で、中央部２４の長さは４〜６ｍｍ、両側部４０の長さは７〜１５ｍｍが適当である。また図１３の実施例では、端部材４２Ａ、４２Ｂの内部に隔壁Ｗ１を有し消息子で端部材を涙道内に押し込むことを容易にしている。
【００３４】
図１４に示される実施例においては、キャロット型の端部材４５となっている。図１５は図１４に示された実施例のサイズを示しているが内部に隔壁Ｗ１を有している。
【００３５】
図１６の実施例においては、挿管器具は、ショア硬さが７０〜８０（ｓｈｏｒｅＡ）の端部材（４２Ａ、４２Ｂ）と、それに連結する、ショア硬さが３８〜４２（ｓｈｏｒｅＡ）、長さ１２〜１５ｍｍ、外径０．３〜０．５ｍｍの連結部材（４０）と、連結部材の他端に接着する、ショア硬さが７０〜８０（ｓｈｏｒｅＡ）の直径１．５ｍｍ、厚さ０．１〜０．２ｍｍの円形のツバ（２３）から構成され、消息子（６１）を挿入するため切込み（４９）を有している。
【００３６】
図１７に示すように、ツバ（２３）は扇型でもよい。
【００３７】
図１８、１９に示されるように端部材はキャロット型（４５）を図１６に示される実施例に採用することができるし、図１０に示されるような端部材（４２）を図１６に示される実施例の端部材（４２Ａ、４２Ｂ）の代りとして採用することもできる。
【００３８】
ツバ（２３）はショア硬さが７０〜８０（ｓｈｏｒｅＡ）の硬いシリコーンゴム製のものが望ましく、短径１．５ｍｍ、長径２ｍｍの楕円形やその他の形でもよい。
【００３９】
以上述べた範囲に硬さ及び寸法形状を設定することによって本発明の効果をより増大することができる。
【００４０】
図４の実施例の製造方法を説明する。
【００４１】
まず、前述した寸法及び硬さを有する連結部材の両側部４０と中央部２４と端部材４２を準備する。そして、連結部材の両側部４０の一端を、端部材４２の開放端に挿入し、シリコーン糊で接着する。連結部材の両側部４０と端部材４２の接合領域は、２ｍｍ以上とし、段差をつくらず、なめらかな境界部５１とするのが望ましい。さらに連結部材の中央部２４の両端のそれぞれを連結部材の両側部の他端にシリコーン糊で接着する。
【００４２】
次に、端部材４２の他端の部分に長手方向に沿って１〜２ｍｍの切れ目を形成する。
【００４３】
さらに、センタリングに便利なように、挿管器具の中央部にセンタ印４４を設ける。センタ印４４で、挿管器具が涙道内に正しく挿入されたかどうかを確認することができる。上下涙点の間にセンタ印４４が来るように留置を行えば良い。また、図示していないが、盲端５３から１０ｍｍの部分にも印を設ける。印は、挿管器具挿入時の目安として利用するためのもので、大体１０ｍｍの涙小管の長さに合わせて設けると都合が良い。
【００４４】
図５の実施例は、連結部材の中央部２４に連結部材の両側部４０が８０°〜１８０°の角度ｒをなすように接着されている。
【００４５】
図６〜１２の実施例では、連結部材の中央部２４と連結部材の両側部４０のなす角度ｒが９０°になるように接着されている。
【００４６】
図６の実施例では、端部材４２の内部が図示されていないが、図９、１０に示されるように、段ｇ１をつけたり、図８に示されるように隔壁Ｗ１を配置した方がよい。
【００４７】
また、図６、９、１０の実施例では、端部材４２の外径は前方部分と後方部分は同じであるが、図７、８、１１、１２、１３に示すように端部材の前方部分４２Ａを後方部分４２Ｂより０．１〜０．３ｍｍ細くしてもよい。
【００４８】
図１３の実施例では連結部材の両側部４０と垂直部２２と中央部２４を一体のものとしてつくってもよい。また端部材４２の内部の隔壁Ｗ１は、端部材４２の軸心方向に切開を入れそこから先が鈍の注射針を挿入して、シリコーン糊を注入することにより、形成することができる。隔壁Ｗ１の厚さは１〜２ｍｍである。段ｇ１の高さは１ｍｍほどである。
【００４９】
端部材４２の盲端部５３の形状は中央部に向けて凹になっているものが優れている。凸になっていると、端部材４２に挿入している消息子６１の先端が盲端部５３に接する端部材４２の壁を突き破る恐れが生じ得る。
【００５０】
図２０は、従来の涙道再建用器具（ＭｏｎｏＫａ）を示す。この従来例はシリコーンゴムでつくられ、ツバ２３とそれに接続するシャフト９３と先端部９１と先端部９１に連結するチューブ９２からなるが、従来の涙点プラグにチューブ９２を接着した形をとっている。そのため、従来の涙点プラグと同様に先端部９１の突出した部分９５が涙小管の腔壁を刺激して肉芽腫の発生の原因となる。（例えば、ＦａｙｅｔＢ他：“Ｂｉｃａｎａｌｉｃｕｌａｒｖｅｒｓｕｓｍｏｎｏｃａｎａｌｉｃｕｌａｒｓｉｌｉｃｏｎｅｉｎｔｕｂａｔｉｏｎｆｏｒｎａｓｏｌａｃｒｉｍａｌｄｕｃｔｉｍｐａｔｅｎｃｙｉｎｃｈｉｌｄｒｅｎ” ＯｒｂｉｔＶｏｌ．１２，Ｐ１４９−１５６，１９９３参照）
図２１は、図２０に示した従来の涙道再建用器具のチューブ９２を改良した本発明の実施例を示す。図２１に示すように端部材４２とチューブ９２とすると、涙道内における安定性がよくなる。
【００５１】
さらに図２１に示す先端部の突出した部分９５を除去して、図２２のように丸くし、図２１におけるシャフト９３と先端部９１を一体化し連結部材の垂直部２２とすると、涙小管の腔壁を刺激することなく長時間涙道内に留置することが可能となる。
【００５２】
また図２１に示す端部材４２を、図２２に示すように端部材の前方部分４２Ａと後方部分４２Ｂとしたものも優れている。
【００５３】
連結部材４０すなわち細い法のチューブまたはロッド４０は、細いほど、そして材質がやわらかいほど、柔軟になり、ツバ２３がかしがらず、涙点部に正しく位置するようになる。細い方のチューブまたはロッド４０に硬い材質を用いたときは、ツバ２３から少くとも５ｍｍほどは、ツバ２３がかしがらないようにするために、やわらかい材質を用いたり、図２４に示すようにツバ２３から少くとも５ｍｍほどをさらに細くしたり、図２５に示すようにツバ２３に近づくほど細くしたりする。
【００５４】
図２６に示すように端部材４２Ａ、４２Ｂ、すなわち太い方のチューブからツバ２３に近づくほど細い方のチューブまたはロッド４０を徐々に細くなるようにしてもよい。細い方のチューブまたはロッドの最大径は０．５〜０．７ｍｍ、最小径は０．３〜０．４ｍｍになるようにする。
【００５５】
図２７に示すように硬い材質の細い方のチューブまたはロッドの水平部４０に垂直部２２が連結しているときややわらかい材質の細い方のチューブ状またはロッド状の水平部４０に垂直部２２が連結しているときも、ツバ２３に接する部分４７はツバ２３に近づくほど徐々に細くなるようにした方がよい。
【００５６】
図２８に示すように細い方のチューブまたはロッド４０から湾曲したツバに接する部分４７とし、ツバに近づくほど細くなるようにしてもよい。
【００５７】
図２９は涙小管閉塞の難病例に使用されているマッチ棒状シリコーンチューブの例を示している。この例では、マッチ棒のように一端に膨大部２６が存在する（例えば栗橋克昭：ダクリオロジー、メディカル葵出版、東京、１９９８参照）。このようなチューブは安定性が悪いので、膨大部２６を内眼角部でナイロン糸などで固定したほうが良いことがある。
【００５８】
図３０に示すように、マッチ棒状シリコーンチューブのチューブ部分４２を太い方のチューブ４２と細い方のチューブまたはロッド４０とすることで、涙道内の安定性がよくなり、膨大部２６を内眼角部でナイロン糸などで固定する必要がない。
【００５９】
図３１は図３０の代表的一例を示す。
【００６０】
図３２は図１６の例に似た例を示している。端部材４２の２つの部分４２Ａと４２Ｂが互いに硬さの異なる別々の部材で、接着材により一体化されている。例えば端部材の前方部分４２Ａを後方部分４２Ｂよりやわらかい材質にすると涙道内の隆起部や湾曲部を通過させやすくなる。図３２に示す寸法は好適例である。
【００６１】
【発明の効果】
本発明の涙道再建用挿管器具により、連結部材４０、２４の外径が端部材４２の外径より小さくすると、連結部材の両側部４０がやわらかく、連結部材の中央部２４が比較的硬いので、留置後に涙点や涙小管に裂傷が生じる恐れは極めて小さい。
【００６２】
また、連結部材の両側部４０が連結部材の中央部２４や端部材４２よりもしなやかな構成にすると、涙道内で安定性が高く、留置後のトラブルが非常に少ない。連結部材が細いと、角膜に触れることがない。
【００６３】
さらに、端部材の前方部分４２Ａを後方部分４２Ｂより細くすると、涙道内に挿入しやすくなる。
【００６４】
さらに端部材４２の内部に隔壁Ｗ１や段ｇ１を配置すると、消息子６１で端部材４２を涙道内に正確に押し込むことができる。
【００６５】
なお、本発明は前述の実施例に限定されない。例えば、端部材の内部に隔壁Ｗ１や段ｇ１の代りに隆起やその他の凸形状や凹形状をつけてもよい。
【図面の簡単な説明】
【図１】従来技術を示す図。
【図２】従来の技術を示す図。
【図３】従来の技術を示す図。
【図４】本発明の１つの実施例を示す斜視図である。
【図５】本発明の他の実施例を示す斜視図である。
【図６】本発明のさらに他の実施例を示す説明図である。
【図７】本発明のさらに他の実施例を示す説明図である。
【図８】本発明のさらに他の実施例を示す説明図である。
【図９】本発明のさらに他の実施例を示す説明図である。
【図１０】図９に示した実施例のサイズを示した断面図。
【図１１】図７に示した実施例の代表的一例の断面図。
【図１２】図８に示した実施例の代表的一例の断面図。
【図１３】本発明のさらに別の実施例を示す説明図。
【図１４】本発明のさらに別の実施例を示す断面図。
【図１５】（Ａ）は、図１４に示した実施例のサイズを示した断面図。（Ｂ）は、（Ａ）の一方の端部を示す端面図。
【図１６】（Ａ）は、本発明のさらに別の実施例を示す斜視図。（Ｂ）は、本発明のさらに別の実施例を示す断面図。（Ｃ）は、（Ｂ）の一方の端部を示す端面図。
【図１７】（Ａ）は、本発明のさらに別の実施例を示す断面図。（Ｂ）は、（Ａ）の一方の端部を示す端面図。
【図１８】本発明のさらに別の実施例を示す斜視図。
【図１９】本発明のさらに別の実施例を示す断面図。
【図２０】（Ａ）は、従来の技術を示す側面図。（Ｂ）は、（Ａ）の一方の端部を示す端面図。（Ｃ）は、（Ａ）のもう一方の端部を示す端面図。
【図２１】（Ａ）は、本発明のさらに他の実施例を示す斜視図。（Ｂ）は、（Ａ）の一方の端部を示す端面図。
【図２２】（Ａ）は、本発明のさらに他の実施例を示す斜視図。（Ｂ）は、（Ａ）の一方の端部を示す端面図。
【図２３】本発明のさらに他の実施例を示す斜視図。
【図２４】本発明のさらに他の実施例を示す斜視図。
【図２５】本発明のさらに他の実施例を示す斜視図。
【図２６】（Ａ）は、本発明のさらに他の実施例を示す斜視図。（Ｂ）は、本発明のさらに他の実施例を示す断面図。（Ｃ）は、（Ｂ）の一方の端部を示す端面図。
【図２７】本発明のさらに他の実施例を示す斜視図。
【図２８】本発明のさらに他の実施例を示す斜視図。
【図２９】従来の技術を示す斜視図。
【図３０】本発明のさらに他の実施例を示す斜視図。
【図３１】図３０に示した実施例の代表的一例の断面図。
【図３２】（Ａ）は、本発明のさらに別の実施例の寸法の一例を示す断面図。（Ｂ）は、その端面図。
【符号の説明】
１上涙点
２下涙点
７上涙小管
１１涙嚢
１２鼻涙管
１９破傷
２２細い方のチューブ状またはロッド状の垂直部
２３ツバ
２４中央部
２６膨大部
４０側部
４０連結部材
４２端部材、チューブ
４２Ａ端部材の前方部分
４２Ｂ端部材の後方部分
４４センター印
４５キャロット型の端部材
４７ツバに接する部分
４９切込み
５１、５２なめらかな境界部
５３盲端
６１消息子
９１先端部
９２涙道再建用器具のチューブ
９３シャフト
９５先端部の突出した部分
Ｗ１隔壁
ｇ１段
ｒ角度[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention relates to an intubation device for lacrimal canal reconstruction.
[0002]
[Prior art]
Intubation is an effective treatment for reconstructing the lacrimal canal. However, the conventional silicone tube indwelling method represented by the Crawford method is not widely used in Japan as compared with the nunchaku type silicone tube. This is because the silicone tube placed in the lacrimal passage was not sufficiently stable.
[0003]
Conventional silicone tubes are formed of, for example, silicone rubber, but have insufficient flexibility. Therefore, even if the center portion was lifted with tweezers, it was not easily bent in an inverted U-shape. This elasticity contributed to instability in the lacrimal passage.
[0004]
In the Crawford method, the tip of the tube is tied in the nasal cavity, and a knot larger than the size of the opening at the lower end of the nasolacrimal duct is formed and left as it is. However, it is difficult to confirm the size of the opening at the lower end of the nasolacrimal duct. Further, when the knot is smaller than the opening at the lower end of the nasolacrimal duct, there is also a problem that the knot moves upward and enters the lacrimal sac. Because of the very small diameter of the lacrimal canaliculus, it was very difficult to remove the knot once in the lacrimal sac.
[0005]
Therefore, the present inventor has proposed a tube having a total length of 80 to 130 mm and a thin and flexible 20 to 40 mm in the center as shown in FIG. This tube is thin and flexible at the center and thick and stiff on both sides. When the tube is supported at the center as shown in FIG. 2, the tube is easily bent into an inverted U-shape by gravity. Therefore, this tube is much more stable than the conventional silicon tube, and it is very rare that the tube comes out.
[0006]
In addition, since this tube has blind ends at both ends and has a cut for inserting the probe, it can be easily inserted into the lacrimal canal. Further, there is an advantage that removal can be easily performed.
[0007]
The inventor has applied this tube to more than 100 cases of lacrimal passage obstruction, but it has been confirmed that stability and escape from the lacrimal passage are rare.
[0008]
[Problems to be solved by the invention]
However, generally, both ends of the tube are pulled toward the nasal cavity by the action of the lacrimal passage. For this reason, as shown in FIG. 3, the thin flexible part 40 at the center of the tube may bite into the punctum or lacrimal canaliculus, causing tear 19 in the punctum or lacrimal canaliculus. The tear tended to occur more easily as the tube center became thinner and harder. When the tension from both sides was large, the center part of the tube became thinner, so that the tear 19 was more likely to occur.
[0009]
In view of such problems of the prior art, the present invention has good stability in the lacrimal canal, is easy to insert into the lacrimal canal, and has no risk of causing tears in the lacrimal punctum or lacrimal canaliculus after placement. It is intended to provide an intubation device for road reconstruction.
[0010]
[Means for Solving the Problems]
A solution of the present invention is an intubation device for lacrimal canal reconstruction according to claims 1 to 5 .
[0011]
【Example】
Hereinafter, a preferred embodiment of an intubation device for lacrimal canal reconstruction according to the present invention will be described with reference to the drawings.
[0012]
FIGS. 4, 5, and 6 are perspective views showing the external shape of an intubation device for lacrimal canal reconstruction (hereinafter, simply referred to as an intubation device) according to three embodiments of the present invention.
[0013]
In the three embodiments of FIGS. 4 to 6, the intubation device is composed of two end members 42 arranged on both sides and connecting members 40 and 24 connecting the two end members 42. The connecting member includes a central portion 24 and side portions 40 located on both sides of the central portion 24. The both side portions 40 are formed of a soft silicone rubber tube or rod. The central portion 24 of the connecting member is formed of a hard silicone rubber tube or rod.
[0014]
4 to 6, the end member 42 is also formed of a silicone rubber pipe material.
[0015]
The end portion 53 (about 1 to 2 mm) of the end member 42 is a blind end. In addition, a small cut 49 for inserting the probe is formed in the other end portion of the end member 42. The cut 49 is formed parallel to the axial direction. The probe is inserted from the incision 49 to the blind end, and the intubation device is placed in the lacrimal canal using the probe.
[0016]
In the three embodiments shown in FIGS. 4 to 6, the connecting members 40 and 24 are smaller in diameter than the end member 42 by about 0.4 to 0.6 mm. Further, both side portions 40 of the connecting member are more flexible than the center portion 24 and the end member 42 of the connecting member.
[0017]
In the embodiment shown in FIG. 4, the angle formed by the axis of the central portion 24 and the side portions 40 of the connecting member is 180 °.
[0018]
As shown in the embodiment of FIG. 5, the angle r between the central portion 24 and the side portions 40 of the connecting member may be set to 80 to 180 °.
[0019]
In the embodiment of FIG. 6, the angle r is set to 90 °. However, even if it is hung with the thread 81, the central portion 24 of the connecting member is hard and short, so it is difficult to bend, and the force applied to the punctum Is reduced, and the complication of tearing of the punctum and lacrimal canaliculus shown in FIG. 3 is less likely to occur.
[0020]
As the material of the intubation device, appropriate flexibility and strength are desired. In terms of strength, it is necessary to have a strength that can withstand the tensile force applied during the operation of indwelling in the lacrimal canal, the tensile force acting after being indwelled, the tensile force at the time of removal, and the like. On the other hand, in terms of flexibility, it is necessary to be flexible enough to perform the placement operation smoothly and to obtain stability in the lacrimal passage after placement.
[0021]
In addition to such conditions of tensile strength and flexibility, it is also important to be harmless to the human body. From such a viewpoint, silicone rubber is suitable as a material suitable for the intubation device. It is also possible to form only the surface layer with silicone rubber. In general, as the hardness of silicone rubber increases, the strength such as tensile strength tends to increase. The shorter and more rigid the silicone tubing, the harder it bends.
[0022]
The flexibility of the connecting members 40 and 24 and the end member 42 can be evaluated, for example, by the Shore hardness defined by JIS. Shore hardness is measured with a durometer (Durometer), and the unit is Shore A (JIS). The higher the numerical value of Shore hardness, the higher the hardness.
[0023]
The hardness (flexibility) of the side portions 40, the center portion 24, and the end members 42 of the connecting member will be described.
[0024]
The side portions 40 of the connecting member have a Shore hardness of 20 to 60 (Shore A (JIS)), but are preferably set to a range of 30 to 50 (Shore A), and optimally to a range of 38 to 42 (Shore A). it can. On the other hand, the center portion 24 and the end member 42 of the connecting member have a Shore hardness of 50 to 80 (Shore A (JIS)), preferably 60 to 80 (Shore A), and most preferably 70 to 80 (Shore A). It can be set in the range of A).
[0025]
Next, the length of the intubation device and each member will be described.
[0026]
The overall length of the intubation device is generally 50-130 mm, but can be set preferably in the range of 90-125 mm, and optimally in the range of 105-115 mm. The length of the connecting portions 40 and 24 is 15 to 30 mm, but may be preferably set to 20 to 30 mm, and optimally to 20 to 28 mm.
[0027]
As shown in FIG. 10, the length of both side portions 40 of the connecting portion is 7 to 13 mm, and the length of the central portion 24 is 4 to 8 mm.
[0028]
FIG. 11 shows one typical example of the above, and has a step g1 inside the end members 42A and 42B.
[0029]
FIG. 12 also shows a typical example, but has a partition wall W1 inside the end members 42A and 42B. The length of the end member 42 is 10 to 60 mm, but can be set to a range of preferably 25 to 50 mm, and most preferably 30 to 45 mm.
[0030]
Next, the outer diameter, inner diameter, and thickness of each member will be described. The outer diameter, inner diameter, and wall thickness of both sides 40 and the central portion 24 of the connecting portion are 0.2 to 0.7 mm, 0 to 0.3 mm, and 0.1 to 0.25 mm, respectively. 0.3 to 0.6 mm, 0 to 0.25 mm, 0.1 to 0.2 mm, optimally set to 0.4 to 0.5 mm, 0 to 0.2 mm, 0.15 to 0.18 mm, respectively it can. Although the outer diameter of the connecting portions 40 and 24 is 0.2 to 0.7 mm, a rod having no lumen may be used. An inner diameter of 0 mm means a rod. The reason why the central portion 24 of the connecting member is made harder than the both side portions 40 is that if the central portion 24 of the connecting member is softened, tears of the punctum and lacrimal canaliculi are likely to occur.
[0031]
On the other hand, the outer diameter, the inner diameter, and the wall thickness of the end member 42 are 0.6 to 1.3 mm, 0.2 to 0.7 mm, and 0.15 to 0.3 mm, respectively. 1.2mm, 0.3-0.6mm, 0.18-0.28mm, optimally in the range of 0.9-1.1mm, 0.35-0.55mm, 0.2-0.25mm respectively Can be set.
[0032]
As shown in FIGS. 7, 8, 11 to 13, those in which the end members are formed from tubes 42A and 42B having different outer diameters are also excellent. The outer diameter of the front portion 42A of the end member is smaller by 0.1 to 0.3 mm than the outer diameter of the rear portion 42B connected thereto, so that the end member can be easily inserted. The length of the front portion 42A of the end member is 7 to 20 mm, preferably 10 to 18 mm, and most preferably 10 to 15 mm. A smooth boundary portion 52 is formed between the front portion 42A and the rear portion 42B of the end member. Inside the boundary portion 52, there are a step g1 as shown in FIG. 7 and a partition wall W1 as shown in FIG. 8, which facilitates pushing the end member into the lacrimal canal with the probe 61.
[0033]
In the embodiment shown in FIG. 13, the connecting member has a vertical portion 22 disposed between the side portions 40 and the central portion 24. The length of the vertical portion 22 is suitably 1-2 mm, the length of the central portion 24 is 4-6 mm, and the length of both side portions 40 is suitably 7-15 mm. Further, in the embodiment of FIG. 13, the partition members W1 are provided inside the end members 42A and 42B, and the end members are easily pushed into the lacrimal canal by the probe.
[0034]
In the embodiment shown in FIG. 14, the end member 45 is of a carrot type. FIG. 15 shows the size of the embodiment shown in FIG. 14, but has a partition wall W1 inside.
[0035]
In the embodiment of FIG. 16, the intubation device has an end member (42A, 42B) having a Shore hardness of 70 to 80 (Shore A) and a shore hardness of 38 to 42 (Shore A), long connected thereto. A connecting member (40) having a thickness of 12 to 15 mm and an outer diameter of 0.3 to 0.5 mm, and a shore hardness of 70 to 80 (shore A) having a diameter of 1.5 mm and a thickness adhered to the other end of the connecting member. It consists of a 0.1 to 0.2 mm circular collar (23) and has a cut (49) for inserting the probe (61).
[0036]
As shown in FIG. 17, the collar (23) may be fan-shaped.
[0037]
As shown in FIGS. 18 and 19, the end member can adopt the carrot type (45) in the embodiment shown in FIG. 16, and the end member (42) as shown in FIG. 10 is shown in FIG. It can be adopted as a substitute for the end members (42A, 42B) of the embodiment.
[0038]
The brim (23) is desirably made of a hard silicone rubber having a Shore hardness of 70 to 80 (Shore A), and may be an elliptical shape having a short diameter of 1.5 mm and a long diameter of 2 mm or other shapes.
[0039]
The effects of the present invention can be further increased by setting the hardness and the dimensional shape in the above-described ranges.
[0040]
The manufacturing method of the embodiment of FIG. 4 will be described.
[0041]
First, the side portions 40, the central portion 24, and the end members 42 of the connecting member having the dimensions and hardness described above are prepared. Then, one end of each of the two side portions 40 of the connecting member is inserted into the open end of the end member 42, and bonded with silicone glue. It is desirable that the joint region between the both side portions 40 of the connecting member and the end member 42 be 2 mm or more and a smooth boundary portion 51 with no step. Further, both ends of the central portion 24 of the connecting member are bonded to the other ends of both sides of the connecting member with silicone glue.
[0042]
Next, a cut of 1-2 mm is formed in the other end portion of the end member 42 along the longitudinal direction.
[0043]
Further, a center mark 44 is provided at the center of the intubation device for convenient centering. With the center mark 44, it can be confirmed whether the intubation device has been correctly inserted into the lacrimal canal. The detention may be performed so that the center mark 44 comes between the upper and lower punctum. Although not shown, a mark is also provided at a portion 10 mm from the blind end 53. The mark is used as a guide when inserting the intubation device, and it is convenient to provide the mark in accordance with the length of the canaliculus, which is approximately 10 mm.
[0044]
In the embodiment of FIG. 5, both side portions 40 of the connecting member are bonded to the center portion 24 of the connecting member so as to form an angle r of 80 ° to 180 °.
[0045]
In the embodiment of FIGS. 6 to 12, the bonding is performed such that the angle r between the central portion 24 of the connecting member and both side portions 40 of the connecting member is 90 °.
[0046]
Although the inside of the end member 42 is not shown in the embodiment of FIG. 6, it is better to form a step g1 as shown in FIGS. 9 and 10, or to arrange a partition wall W1 as shown in FIG.
[0047]
Also, in the embodiment of FIGS. 6, 9 and 10, the outer diameter of the end member 42 is the same at the front part and the rear part, but the front part of the end member as shown in FIGS. 42A may be 0.1-0.3 mm thinner than rear portion 42B.
[0048]
In the embodiment shown in FIG. 13, both side portions 40, the vertical portion 22, and the central portion 24 of the connecting member may be formed integrally. The partition wall W1 inside the end member 42 can be formed by making an incision in the axial direction of the end member 42, inserting a blunt injection needle from there, and injecting silicone glue. The thickness of the partition wall W1 is 1 to 2 mm. The height of the step g1 is about 1 mm.
[0049]
The shape of the blind end 53 of the end member 42 is preferably concave toward the center. If it is convex, there is a possibility that the tip of the probe 61 inserted into the end member 42 may break through the wall of the end member 42 in contact with the blind end 53.
[0050]
FIG. 20 shows a conventional lacrimal canal reconstruction device (MonoKa). This conventional example is made of silicone rubber, and comprises a collar 23, a shaft 93 connected thereto, a distal end portion 91, and a tube 92 connected to the distal end portion 91. The tube 92 is bonded to a conventional punctal plug. I have. Therefore, like the conventional punctal plug, the protruding portion 95 of the distal end portion 91 stimulates the cavity wall of the lacrimal canaliculus, causing the occurrence of granuloma. (See, for example, Fayet B et al .: "Bicanalicular vs. monocanalicular silicone induction for nasola criminal duct impulsity in children", Orbit Vol. 12, P149-156, 1993).
FIG. 21 shows an embodiment of the present invention in which the tube 92 of the conventional lacrimal canal reconstruction device shown in FIG. 20 is improved. When the end member 42 and the tube 92 are used as shown in FIG. 21, the stability in the lacrimal passage is improved.
[0051]
Further, the protruding portion 95 of the distal end portion shown in FIG. 21 is removed and rounded as shown in FIG. 22, and the shaft 93 and the distal end portion 91 in FIG. 21 are integrated to form the vertical portion 22 of the connecting member. It is possible to stay in the lacrimal passage for a long time without stimulating the wall.
[0052]
Also, the end member 42 shown in FIG. 21 having a front portion 42A and a rear portion 42B of the end member as shown in FIG. 22 is excellent.
[0053]
The connecting member 40, that is, the thin tube or rod 40 becomes thinner and softer as the material becomes softer, so that the collar 23 does not bend and is correctly positioned at the puncta. When a hard material is used for the thin tube or the rod 40, a soft material is used at least about 5 mm from the collar 23 in order to prevent the collar 23 from caulking, or as shown in FIG. At least about 5 mm from the brim 23 is further narrowed, and as shown in FIG.
[0054]
As shown in FIG. 26, the thinner tube or rod 40 may be gradually thinner as the end members 42A, 42B, that is, the thicker tube approaches the collar 23. The smaller tube or rod should have a maximum diameter of 0.5-0.7 mm and a minimum diameter of 0.3-0.4 mm.
[0055]
As shown in FIG. 27, when the vertical portion 22 is connected to the thin tube or rod horizontal portion 40 of a hard material, the vertical portion 22 is connected to the thin tube or rod horizontal portion 40 of a soft material. Even when connected, it is preferable that the portion 47 in contact with the collar 23 is gradually narrowed toward the collar 23.
[0056]
As shown in FIG. 28, a portion 47 that comes into contact with a curved brim from a thinner tube or rod 40 may be formed so that the portion becomes thinner as it approaches the brim.
[0057]
FIG. 29 shows an example of a matchstick-shaped silicone tube used for an intractable disease of lacrimal canaliculus obstruction. In this example, there is an enlarged portion 26 at one end like a match stick (for example, see Katsuaki Kurihashi: Dakoriology, Medical Aoi Shuppan, Tokyo, 1998). Since such a tube has poor stability, it may be better to fix the enlarged portion 26 at the inner eye corner with a nylon thread or the like.
[0058]
As shown in FIG. 30, by using the thick tube 42 and the thin tube or rod 40 as the tube portion 42 of the match stick-shaped silicone tube, the stability in the lacrimal passage is improved, and the enormous portion 26 is formed in the inner eye corner. There is no need to fix with nylon thread.
[0059]
FIG. 31 shows a representative example of FIG.
[0060]
FIG. 32 shows an example similar to the example of FIG. The two portions 42A and 42B of the end member 42 are separate members having different hardnesses and are integrated by an adhesive. For example, if the front portion 42A of the end member is made of a softer material than the rear portion 42B, it becomes easier to pass through a raised portion or a curved portion in the lacrimal canal. The dimensions shown in FIG. 32 are preferred examples.
[0061]
【The invention's effect】
When the outer diameters of the connecting members 40 and 24 are smaller than the outer diameters of the end members 42 according to the intubation device for lacrimal canal reconstruction of the present invention, both sides 40 of the connecting member are soft and the central portion 24 of the connecting member is relatively hard. The risk of tearing of the punctum or lacrimal canaliculus after placement is extremely small.
[0062]
Further, when the both side portions 40 of the connecting member are more flexible than the central portion 24 and the end member 42 of the connecting member, stability is high in the lacrimal canal, and trouble after placement is very small. If the connecting member is thin, it does not touch the cornea.
[0063]
Further, when the front portion 42A of the end member is thinner than the rear portion 42B, it becomes easier to insert the end member into the lacrimal canal.
[0064]
Further, when the partition wall W1 and the step g1 are arranged inside the end member 42, the end member 42 can be accurately pushed into the lacrimal canal by the probe 61.
[0065]
Note that the present invention is not limited to the above-described embodiment. For example, a bump or other convex or concave shape may be provided inside the end member instead of the partition wall W1 or the step g1.
[Brief description of the drawings]
FIG. 1 is a diagram showing a conventional technique.
FIG. 2 is a diagram showing a conventional technique.
FIG. 3 is a diagram showing a conventional technique.
FIG. 4 is a perspective view showing one embodiment of the present invention.
FIG. 5 is a perspective view showing another embodiment of the present invention.
FIG. 6 is an explanatory view showing still another embodiment of the present invention.
FIG. 7 is an explanatory view showing still another embodiment of the present invention.
FIG. 8 is an explanatory view showing still another embodiment of the present invention.
FIG. 9 is an explanatory view showing still another embodiment of the present invention.
FIG. 10 is a sectional view showing the size of the embodiment shown in FIG. 9;
FIG. 11 is a sectional view of a representative example of the embodiment shown in FIG. 7;
FIG. 12 is a sectional view of a representative example of the embodiment shown in FIG. 8;
FIG. 13 is an explanatory view showing still another embodiment of the present invention.
FIG. 14 is a sectional view showing still another embodiment of the present invention.
FIG. 15A is a sectional view showing the size of the embodiment shown in FIG. 14; (B) is an end view showing one end of (A).
FIG. 16 (A) is a perspective view showing still another embodiment of the present invention. (B) is sectional drawing which shows another Example of this invention. (C) is an end view showing one end of (B).
FIG. 17A is a cross-sectional view showing still another embodiment of the present invention. (B) is an end view showing one end of (A).
FIG. 18 is a perspective view showing still another embodiment of the present invention.
FIG. 19 is a sectional view showing still another embodiment of the present invention.
FIG. 20A is a side view showing a conventional technique. (B) is an end view showing one end of (A). (C) is an end view showing the other end of (A).
FIG. 21 (A) is a perspective view showing still another embodiment of the present invention. (B) is an end view showing one end of (A).
FIG. 22 (A) is a perspective view showing still another embodiment of the present invention. (B) is an end view showing one end of (A).
FIG. 23 is a perspective view showing still another embodiment of the present invention.
FIG. 24 is a perspective view showing still another embodiment of the present invention.
FIG. 25 is a perspective view showing still another embodiment of the present invention.
FIG. 26A is a perspective view showing still another embodiment of the present invention. (B) is sectional drawing which shows another Example of this invention. (C) is an end view showing one end of (B).
FIG. 27 is a perspective view showing still another embodiment of the present invention.
FIG. 28 is a perspective view showing still another embodiment of the present invention.
FIG. 29 is a perspective view showing a conventional technique.
FIG. 30 is a perspective view showing still another embodiment of the present invention.
FIG. 31 is a sectional view of a representative example of the embodiment shown in FIG. 30;
FIG. 32 (A) is a sectional view showing an example of the dimensions of still another embodiment of the present invention. (B) is an end view.
[Explanation of symbols]
REFERENCE SIGNS LIST 1 upper puncta 2 lower puncta 7 upper lacrimal canaliculus 11 lacrimal sac 12 nasolacrimal duct 19 rupture 22 slender tube-shaped or rod-shaped vertical part 23 brim 24 central part 26 expanding part 40 side part 40 connecting member 42 end Member, tube 42A Front part 42B of end member Rear part 44 of end member Center mark 45 Carrot-shaped end member 47 Part in contact with brim 49 Cut 51, 52 Smooth border 53 Blind end 61 Probe 91 Tip 92 Lacrimal passage Reconstruction instrument tube 93 Shaft 95 Protruding part of tip W1 Partition wall g1 Step r Angle

Claims

Consisting of two thick tube-shaped end members (42) arranged on both sides and a thin tube-shaped or rod-shaped connection member (40, 24) connecting the two end members (42). Each end member (42) has a cut (49) for inserting a probe, the end member (42) has a blind end (53), and the connecting members (40, 24) It comprises a central portion (24) and side portions (40) connected to both sides thereof, and both side portions (40) of the connecting member are more flexible than the central portion (24) and the end member (42) of the connecting member. The outer diameter of the members (40, 24) is smaller than the outer diameter of the end member (42), and the end member comprises a front portion (42A) and a rear portion (42B), and the outer diameter of the front portion (42A). Is smaller than the outer diameter of the rear part (42B) by 0.1 to 0.3 mm. Lacrimal duct reconstruction for intubation device according to claim Rukoto.

Consisting of two thick tube-shaped end members (42) arranged on both sides and a thin tube-shaped or rod-shaped connection member (40, 24) connecting the two end members (42). Each end member (42) has a cut (49) for inserting a probe, the end member (42) has a blind end (53), and the connecting members (40, 24) It comprises a central portion (24) and side portions (40) connected to both sides thereof, and both side portions (40) of the connecting member are more flexible than the central portion (24) and the end member (42) of the connecting member. An intubation device for lacrimal canal reconstruction characterized in that the outer diameter of the members (40, 24) is smaller than the outer diameter of the end member (42), and the end member is of a carrot type (45).

Consisting of two thick tube-shaped end members (42) arranged on both sides and a thin tube-shaped or rod-shaped connection member (40, 24) connecting the two end members (42). Each end member (42) has a cut (49) for inserting a probe, the end member (42) has a blind end (53), and the connecting members (40, 24) It comprises a central portion (24) and side portions (40) connected to both sides thereof, and both side portions (40) of the connecting member are more flexible than the central portion (24) and the end member (42) of the connecting member. An outer diameter of the member (40, 24) is smaller than an outer diameter of the end member (42), and the partition member (W1) is provided inside the end member (42, 45). Intubation device for road reconstruction.

Consisting of two thick tube-shaped end members (42) arranged on both sides and a thin tube-shaped or rod-shaped connection member (40, 24) connecting the two end members (42). Each end member (42) has a cut (49) for inserting a probe, the end member (42) has a blind end (53), and the connecting members (40, 24) It comprises a central portion (24) and side portions (40) connected to both sides thereof, and both side portions (40) of the connecting member are more flexible than the central portion (24) and the end member (42) of the connecting member. The tears are characterized in that the outer diameter of the members (40, 24) is smaller than the outer diameter of the end members (42) and that the end members (42, 45) have a step (g1) inside. Intubation device for road reconstruction.

The shore hardness of both sides (40) of the connecting member is 38 to 42 (shore A), and the shore hardness of the central portion (24) and the end member (42) of the connecting member is 70 to 80 (shore A). The intubation device for lacrimal canal reconstruction according to any one of claims 1 to 4, wherein