JP7256202B2 - 模擬強膜、及び模擬眼球 - Google Patents
模擬強膜、及び模擬眼球 Download PDFInfo
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- JP7256202B2 JP7256202B2 JP2020549121A JP2020549121A JP7256202B2 JP 7256202 B2 JP7256202 B2 JP 7256202B2 JP 2020549121 A JP2020549121 A JP 2020549121A JP 2020549121 A JP2020549121 A JP 2020549121A JP 7256202 B2 JP7256202 B2 JP 7256202B2
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- simulated
- sclera
- eyeball
- fiber
- resin
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Description
である。
上記の模擬強膜2および模擬眼球1の用途としては、例えば、眼球手術練習用途が挙げられる。つまり、上記の模擬強膜2および模擬眼球1により、手術手技スキルの効率的および効果的な向上、高いスキルを有する医師数の増大、社会への安全・安心の提供を図ることができる。
上記の模擬強膜2および模擬眼球1の用途としては、例えば、手術手技の定量的な測定および評価用途が挙げられる。このような用途において上記の模擬強膜2および模擬眼球1を用いることにより、従来の医師感性に頼っていた手術手技を、定量的に数値化し、広く共有して応用することができる。
上記の模擬強膜2および模擬眼球1の用途としては、例えば、手術方法の改良検討用途、手術手技の改良検討用途、治療方法の改良検討用途、および、それらの練習用途が挙げられる。
上記の模擬強膜2および模擬眼球1の用途としては、例えば、手術や治療に用いられる器具や機器などの改良の検討用途、および、改良品の使用練習用途が挙げられる。
上記の模擬強膜2および模擬眼球1の用途としては、例えば、新手術方法、新手術手技、新治療方法などの開発用途、および、その新方法の練習用途が挙げられる。
上記の模擬強膜2および模擬眼球1の用途としては、例えば、手術方法や治療方法に用いられる新器具や新機器などの開発用途、および、その開発品の使用練習用途が挙げられる。
上記の模擬強膜2および模擬眼球1の用途としては、例えば、医療制度に対する活用が挙げられる。このような用途において上記の模擬強膜2および模擬眼球1を用いることにより、人眼を用いないなどの倫理課題をクリアすることができ、さらに、効率的かつ効果的に、医療人材を育成することができるため、各種医療制度において活用することができる。
上記の模擬強膜2および模擬眼球1の用途としては、例えば、医療ロボット(とりわけ、手術ロボット)および医療支援ロボット(とりわけ、手術支援ロボット)の開発用途、および、その操作習得のための練習用途が挙げられる。
(9)チーム医療への活用
上記の模擬強膜2および模擬眼球1の用途としては、例えば、チーム医療への活用が挙げられる。
<模擬強膜成形前の繊維層の平均繊維径の測定方法>
材料として準備した繊維層を、キーエンス社製マイクロスコープVHX-D510を用いて観察し、繊維径を測定した。100本測定した平均値を、成形前の繊維層(すなわち、成形前材料)の繊維径とした。
<繊維層の目付量の測定方法>
繊維層の目付量を、JIS L1913(2010)に準拠して測定した。
<繊維層の厚みの測定方法>
繊維層の厚みを、JIS L1913(2010)に準拠して、荷重100gf/cm2の条件で測定した。
電位差滴定装置(京都電子工業社製、型番:AT-510)を用いて、JIS K-1603-1(2007年)に準拠したトルエン/ジブチルアミン・塩酸法によりイソシアネート基濃度(イソシアネート基含有率)を測定し、以下の式により、測定試料のイソシアネート基の転化率を算出した。
<イソシアネートモノマー濃度(単位:質量%)>
国際公開第2012/121291号パンフレットの明細書における実施例1と同様にして製造されたペンタメチレンジイソシアネートまたは市販のヘキサメチレンジイソシアネートを標準物質として用い、ジベンジルアミンによりラベル化させ、以下のHPLC測定条件下で得られたクロマトグラムの面積値から作成した検量線により、未反応のイソシアネートモノマー(ペンタメチレンジイソシアネートモノマーまたはヘキサメチレンジイソシアネートモノマー)の濃度を算出した。
ポンプLC-20AT
デガッサDGU-20A3
オートサンプラSIL-20A
カラム恒温槽COT-20A
検出器SPD-20A
カラム;SHISEIDO SILICA SG-120
カラム温度;40℃
溶離液;n-ヘキサン/メタノール/1,2-ジクロロエタン=90/5/5(体積比)
流量;0.2mL/min
検出方法;UV225nm
<粘度(単位:mPa・s)>
東機産業社製のE型粘度計TV-30(ローター角度:1°34’、ローター半径:24cm)を用いて、JIS K5600-2-3(2014年)のコーンプレート粘度計法に準拠して、25℃で測定試料の粘度を測定した。測定時のコーンプレートの回転数は、粘度が高くなるのに合わせて、100rpmから2.5rpmまでの間で順次変更した。
<1H-NMRによるアロファネート基とイソシアヌレート基とのモル比率>
下記の装置および条件にて1H-NMRを測定し、脂肪族ポリイソシアネートにおける、イソシアヌレート基1モルに対するアロファネート基の含有割合(アロファネート基/イソシアヌレート基のモル比率)を以下の式により算出した。なお、化学シフトppmの基準として、D6-DMSO溶媒中のテトラメチルシラン(0ppm)を用いた。
条件;測定周波数:400MHz、溶媒:D6-DMSO、溶質濃度:5質量%
イソシアヌレート基(イソシアヌレート基に直接結合するメチレン基(CH2基))のプロトンの帰属ピーク(6H):3.8ppm
アロファネート基(アロファネート基内のNH基)のプロトンの帰属ピーク(1H):8.3~8.7ppm
アロファネート基/イソシアヌレート基(モル比率)=アロファネート基のプロトンの帰属ピークの積分値/(イソシアヌレート基のプロトンの帰属ピークの積分値/6)<平均イソシアネート基数(平均官能基数)>
脂肪族ポリイソシアネートの平均イソシアネート基数を、イソシアネート基濃度、固形分濃度(NV)、および、以下の装置および条件にて測定されるゲルパーミエーションクロマトグラフィーの数平均分子量から、下記式により算出した。
(式中、Aは、イソシアネート基濃度を示し、Bは、固形分濃度を示し、Cは、数平均分子量を示す。)
装置:HLC-8220GPC(東ソー製)
カラム:TSKgelG1000HXL、TSKgelG2000HXL、およびTSKgelG3000HXL(東ソー製)を直列連結
検出器:示差屈折率計
測定条件
注入量:100μL
溶離液:テトラヒドロフラン
流量:0.8mL/min
温度:40℃
検量線:106~22450の範囲の標準ポリエチレンオキシド(東ソー製、商品名:TSK標準ポリエチレンオキシド)
<平均水酸基数(平均官能基数)>
水酸基価を、ポリオキシアルキレンポリオール1g中の水酸基に相当する水酸化カリウムのmg数と定義した。そして、JIS K1557(2007年)6.4項「水酸基価」に従って、ポリオールの水酸基価を測定した。
(1)繊維層(A)
以下に示す繊維層を、準備した。
繊維層(a-10)の目付量は28.8g/m2であった。
繊維層(a-11)の目付量は49.0g/m2であった。
繊維層(a-12)の目付量は67.0g/m2であった。
繊維層(a-13)は、平均繊維径(成形前材料)19.3μm、目付量29.1g/m2、厚さ0.106mmであった。
(2)樹脂層(B)
(2-1)脂肪族ポリイソシアネート(b-1)
調製例1(イソシアネート(b-1-1)(PDIのアルコール変性イソシアヌレート誘導体))
温度計、撹拌装置、還流管、および、窒素導入管を備えた4つ口フラスコに、国際公開第2012/121291号パンフレットの明細書における実施例1と同様にして製造されたペンタメチレンジイソシアネート(以下、PDIとする。)を500質量部、イソブチルアルコールを6.9質量部、2,6-ジ(tert-ブチル)-4-メチルフェノールを0.3質量部、トリス(トリデシル)ホスファイトを0.3質量部、それぞれ、装入し、80℃で2時間反応させた。
PDIをヘキサメチレンジイソシアネート(三井化学社製、商品名:タケネート700(以下、HDIとする。))に変更した以外は、調製例1と同じ方法で、HDIのアルコール変性イソシアヌレート誘導体を得た。これを、イソシアネート(b-1-2)とした。
(2-2)ポリオール(b-2)
準備例1(ポリオール(b-2-1))
ポリオキシアルキレンポリオール(プロピレングリコールにプロピレンオキサイドを付加重合したポリエーテルポリオール、数平均分子量(Mn)=3000、平均官能基数2、水酸基価37mgKOH/g、全オキシアルキレン中のエチレンオキサイド濃度=0質量%)を、ポリオール(b-2-1)とした。
ポリオキシアルキレンポリオール(プロピレングリコールにプロピレンオキサイドを付加重合したポリエーテルポリオール、数平均分子量(Mn)=2000、平均官能基数2、水酸基価56mgKOH/g、全オキシアルキレン中のエチレンオキサイド濃度=0質量%)を、ポリオール(b-2-2)とした。
ポリオキシアルキレンポリオール(プロピレングリコールにプロピレンオキサイドを付加重合したポリエーテルポリオール、数平均分子量(Mn)=1000、平均官能基数2、水酸基価112mgKOH/g、全オキシアルキレン中のエチレンオキサイド濃度=0質量%)を、ポリオール(b-2-3)とした。
ポリオキシアルキレンポリオール(プロピレングリコールにプロピレンオキサイドを付加重合したポリエーテルポリオール、数平均分子量(Mn)=700、平均官能基数2、水酸基価240gKOH/g、全オキシアルキレン中のエチレンオキサイド濃度=0質量%)を、ポリオール(b-2-4)とした。
数平均分子量3000のポリオール(b-2-1)と、数平均分子量2000のポリオール(b-2-2)とを、80:20(b-2-1:b-2-2(質量比))となるように混合し、混合物として、ポリオール(b-2-5)を得た。
数平均分子量2000のポリオール(b-2-2)と、数平均分子量1000のポリオール(b-2-3)とを、75:25(b-2-2:b-2-3(質量比))となるように混合し、混合物として、ポリオール(b-2-6)を得た。
数平均分子量1800の非晶性ポリテトラメチレンエーテルグリコール(旭化成せんい社製、商品名:PTXG、水酸基価60mgKOH/g、平均官能基数2、テトラヒドロフランとネオペンチルグリコールとの共重合体)
(3)可塑剤(b-3)
ジイソノニルシクロヘキサン-1,2-ジカルボキシレート(BASF社製、商品名:Hexamol DINCH)
(4)触媒(b-4)
東京化成工業社製、試薬ジブチルチンジラウレート(ウレタン化触媒)
(5)消泡剤(b-5)
ビックケミー・ジャパン社製、商品名:BYK-088
(6)シリコーン樹脂(b-6)
(b-6-1)主剤;東レダウコーニング社製、商品名:シリコーンMG7-9800A
(b-6-2)硬化剤;東レダウコーニング社製、商品名:シリコーンMG7-9800B
(7)コーティング剤(C)
(c-1)主剤:富士塗料工業所社製、商品名:モールドコートZ UN-750(ポリオール成分)
(c-2)硬化剤:富士塗料工業所社、商品名:UB-1300(ポリイソシアネート成分:ヘキサメチレンジイソシアネート誘導体)
(c-3)希釈剤:富士塗料工業所社、商品名:マイステルシンナーTM-5510(石油系有機溶剤)
3.硬度測定用樹脂の製造方法
参考実施例1
表1に示す質量割合で、イソシアネート(b-1-1)と、ポリオール(b-2-4)とを準備した。
表1~表3に示す処方に変更した以外は、参考実施例1と同じ方法で、硬度測定用の樹脂層を得た。
実施例1
表1に示す質量割合で、イソシアネート(b-1-1)と、ポリオール(b-2-4)とを準備した。
表1~表3に示す処方に変更した以外は、実施例1と同じ方法で、手術練習用模擬強膜を得た。
実施例23
表2に示す枚数の繊維の各層に、スプレー糊(3M社製、商品名スプレーのり55)を吹き付けて、積層し、繊維層積層体を得た。次いで、得られた繊維層積層体を、厚み1.0mmの眼球形状金型において、80℃で1時間加熱し、眼球形状に賦形した。
表3に示す処方に変更した以外は、実施例23と同じ方法で、手術練習用模擬強膜(眼球形状)を得た。
以下の手順で、ポリウレタンゲルおよび模擬強膜を評価した。その結果を、表3~表4に示す。
<模擬強膜成形後の繊維層の平均繊維径の測定方法>
模擬強膜(平板状および眼球形状)から繊維層を取り出し、その繊維層を、キーエンス社製マイクロスコープVHX-D510を用いて観察し、繊維径を測定した。100本測定した平均値を模擬強膜中の繊維層(成形後)の繊維径とした。
<模擬強膜の剥離強度>
平板状の模擬強膜を、幅5mm、長さ50mmに切り出し、テストピースとした。繊維層界面の2層目または1層目をあらかじめ剥離20mm剥離させ、引張圧縮試験機(インテスコ社製、Model205N)を用いてJIS K6854-2(1999)に準拠して剥離強度を測定した。
<ポリウレタンゲルのアスカーC硬度>
各参考実施例および各参考比較例で得られたポリウレタンゲルのアスカーC硬度を、JIS K7312(1996年)のタイプC硬さ試験により測定した。
<ポリウレタンゲルのアスカーF硬度>
各参考実施例および各参考比較例で得られたポリウレタンゲルのアスカーF硬度を、JIS K7312(1996年)のタイプC硬さ試験と同様の方法により測定した。
<模擬強膜の切込性>
模擬強膜(平板状および眼球形状)を用いて、眼科医による緑内障手術を実施した。模擬強膜にメスで切込みを入れる際の感触を評価し、以下の4段階に分類した。
<模擬強膜の薄切性>
模擬強膜(平板状および眼球形状)を用いて、眼科医による緑内障手術を実施した。模擬強膜をメスで薄切する際の感触を評価し、以下の5段階に分類した。
<模擬強膜の戻り性>
模擬強膜(平板状および眼球形状)を用いて、眼科医による緑内障手術を実施した。模擬強膜をメスで薄切して作成したフラップを90°以上にめくって後の戻りを評価し、以下の4段階に分類した。
<模擬強膜のべとつき(タック性)>
模擬強膜(平板状および眼球形状)を用いて、眼科医による緑内障手術を実施した。模擬強膜の表面を触ったときの感触を、以下の3段階に分類した。
<手術練習評価>
実施例23および実施例26で得られた手術練習用模擬強膜(眼球形状)を、線維柱体切開術(トラベクロトミー)の練習に供した。
Claims (9)
- 複数の繊維層(a)と、前記繊維層(a)に接触する樹脂(b)とを含み、
前記繊維層(a)を構成する繊維の繊維径が、0.6μm以上170.0μm以下であり、
前記繊維層(a)は、互いに接触するように積層配置されている
ことを特徴とする、模擬強膜。 - 複数の前記繊維層(a)の間の剥離強度が、0.20N/cm以上であることを特徴とする、請求項1に記載の模擬強膜。
- 前記樹脂(b)のアスカーF硬度が45以上95以下、または、前記樹脂(b)のアスカーC硬度が5以上35以下であることを特徴とする、請求項1に記載の模擬強膜。
- 前記繊維層(a)が不織布を備えることを特徴とする、請求項1に記載の模擬強膜。
- 前記樹脂(b)が、ポリウレタンを含むことを特徴とする、請求項1に記載の模擬強膜。
- さらに、表面コート層(c)を備えることを特徴とする、請求項1に記載の模擬強膜。
- 眼球手術練習用の模擬強膜であることを特徴とする、請求項1に記載の模擬強膜。
- 請求項1に記載の模擬強膜を含むことを特徴とする、模擬眼球。
- 複数の繊維層(a)と、前記繊維層(a)に接触する樹脂(b)とを含み、
前記繊維層(a)を構成する繊維の繊維径が、0.6μm以上170.0μm以下であり、
前記繊維層(a)は、互いに接触するように積層配置されている模擬強膜の製造方法であって、
複数の繊維層(a)を、互いに接触するように積層する工程と、
積層された前記繊維層(a)に樹脂(b)を含浸させる工程とを備えることを特徴とする、模擬強膜の製造方法。
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WO2020066892A1 (ja) | 2020-04-02 |
CN112771594B (zh) | 2023-09-05 |
EP3859715A4 (en) | 2022-06-29 |
JPWO2020066892A1 (ja) | 2021-09-02 |
US20220051591A1 (en) | 2022-02-17 |
EP3859715A1 (en) | 2021-08-04 |
CN112771594A (zh) | 2021-05-07 |
SG11202102411WA (en) | 2021-04-29 |
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