JP5706419B2 - 組織照明用の方法及び製品 - Google Patents
組織照明用の方法及び製品 Download PDFInfo
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- JP5706419B2 JP5706419B2 JP2012525679A JP2012525679A JP5706419B2 JP 5706419 B2 JP5706419 B2 JP 5706419B2 JP 2012525679 A JP2012525679 A JP 2012525679A JP 2012525679 A JP2012525679 A JP 2012525679A JP 5706419 B2 JP5706419 B2 JP 5706419B2
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- G02B6/00—Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings
- G02B6/0001—Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings specially adapted for lighting devices or systems
- G02B6/0011—Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings specially adapted for lighting devices or systems the light guides being planar or of plate-like form
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- A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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Description
本出願は2009年8月21日出願の米国仮特許出願第61/236,027号の利益を主張するものであり、その全体を参照により本明細書に援用する。
(式中、θiは入射角であり、n1及びn2はそれぞれ第1及び第2の層の屈折率である。)
図4aは、n1<n2であるような屈折率n1及びn2をそれぞれ有する第1の層110及び第2の層120を有する1対の層100を示したものである。第1の層内を伝播する光は多くの異なる入射角で界面130に入射し、透過角θtの範囲内の角度で第2の層内に屈折する。
一般に、特定の角度成分及び分布を有する光が臨界角θcよりも大きな1つ以上の角度で界面に入射する場合に全反射が起こる。
様々な形状追従性ポリマー材料を、本明細書に記載される医療物品の形状追従性ポリマー層に使用できる。例えば、純粋な弾性材料(すなわち、エラストマー)は、粘弾性材料として好適である。このような材料は、熱可塑性又は熱硬化性であり得る。好ましくは、これらは光学的に透き通って(透明又は半透明)おり、より好ましくは、光学的に透明である。
いくつかの実施形態では、粘弾性構成要素(例えば、粘弾性導光材)は、(a)ペンダントビフェニル基を有するモノマー単位と、(b)アルキル(メタ)アクリレートモノマー単位とを含む米国特許公開第2009−0105437−A1号(Determanら)に述べられるようなコポリマーを含む。
本明細書の医療物品が形状追従性ポリマー層(粘弾性又は弾性層)以外の導光材を含む場合、導光材は光学的透過性材料を含む。すなわち、導光材は、光を透過できる光学的に透明な材料を含む。光ガイドの屈折率は、約1.3〜約2.6、1.4〜約1.7、又は約1.5〜約1.7の範囲であってもよい。導光材を作製するために使用される特定の材料は、必要とされる屈折率又は屈折率の範囲に依存し、これは医療物品の他の設計要素の影響を受ける可能性がある。例えば、光ガイドを作製するために使用される材料は、粘弾性層よりも高い屈折率を有する必要があり得る。
一般には、導光材(例えば、粘弾性又は弾性導光材)は、光源によって放射された光の少なくとも一部を受光するように構成される。いくつかの実施形態では、光学的結合が起こるように、光源を導光材(例えば、粘弾性又は弾性の柔軟性導光材)に押し込むことができるため、特別に設計された入力面を必要としなくてもよい。いくつかの実施形態では、例えば、導光材がPSAを含む粘弾性導光材の場合、光源を導光材に張り付けることができる。いくつかの実施形態では、光源は、導光材(例えば、粘弾性導光材)に埋入され得る。したがって、導光材と直接的に接触する(例えば、触れる、導光材内に組み込まれる)か、接触しないかに関わらず、光源を導光材に光学的に結合してもよい。
有用な可撓性ポリマーフィルムは、好ましくは透明又は半透明のポリマー材料である。可撓性フィルムの材料は、長時間の手術中、好ましくはフィルムを通して水分を蒸発させることができる。本発明の可撓性ポリマーフィルムは、典型的には従来の外科用切開ドレープの形状で提供される。したがって本明細書では、用語「切開ドレープ」は、従来の切開ドレープ(例えば、外科手術に用いられる可撓性ポリマーフィルムで、本明細書に記載されるような形状追従性ポリマー導光材層を含まないもの)を意味してもよく、又は外科手術で用いられる本発明の医療物品(例えば、可撓性ポリマーフィルム上に任意に配置される形状追従性ポリマー導光材層)を意味してもよい。
術前皮膚用製品は、様々な周知の種類のものであってもよい。本明細書で用いるとき、術前皮膚用製品として、消毒用皮膚用製品、ポリマーフィルム形成剤を有する消毒用皮膚用製品、及び微生物封止剤、つまりバリアとして有用なフィルム形成調製物が挙げられる。また、Kimberly Clarkから商品名INTEGUSEAL(切開ドレープの代わりに皮膚に直接塗布するシアノアクリレート)で市販されるような術前ポリマー性バリアフィルムを用いてもよい。その他の術前皮膚用製品及びバリアフィルムは、米国特許第4,584,192号、同第4,542,012号、同第7,459,167号、及び同第7,030,203号、並びに米国特許公開第2008/0046004号、及び同第2007/0147947号などの多くの特許に記載されている。医療物品が手術時皮膚用製品及び/又はバリアフィルムに接着される場合、このような術前皮膚用製品及び/又はポリマー性バリアフィルムを皮膚上で直接用いることができる。
本発明の方法は、外科手術中又はその他医療用途で組織を照明することを含む。
1.
向かい合う第1及び第2の主表面を有する可撓性ポリマーフィルムと、
かかるフィルムの主表面に配置される粘弾性導光材層と、
粘弾性導光材層と光学的に結合される光源と、を含み、
前記光源によって放射される光が前記粘弾性導光材層に入射して全内部反射によって前記粘弾性導光材層の内部を伝搬し、
滅菌されている、又は滅菌可能であり、患者の身体部分に対して柔軟性のある、医療物品。
向かい合う第1及び第2の主表面を有する可撓性ポリマーフィルムと、
かかるフィルムの主表面に配置される粘弾性層と、
光源と、
導光材と、を含み、前記光源によって放射された光が前記導光材に入射して全内部反射によって前記導光材の内部を伝搬し、
皮膚が光抽出器として機能するよう十分に患者の皮膚に接着される、医療物品。
向かい合う第1及び第2の主表面を有する可撓性ポリマーフィルムと、
かかるフィルムの主表面に配置される形状追従性ポリマー層と、
光源と、
導光材と、を含み、前記光源によって放射された光が前記導光材に入射して全内部反射によって導光材の内部を伝搬し、
患者に接着される、医療物品。
向かい合う第1及び第2の主表面を有する形状追従性ポリマー導光材層と、
前記形状追従性ポリマー導光材層と光学的に結合される光源と、を含み、
前記光源によって放射された光が前記形状追従性ポリマー導光材層に入射して全内部反射により前記形状追従性ポリマー導光材層内を伝搬する、切開ドレープを提供することと、
患者組織の形状に追従するように、患者に前記切開ドレープを接着することと、
前記切開ドレープから組織内まで切開して、その切り口で光を放射する切開ドレープの切り口を形成することと、
前記切開ドレープの切り口から放射される光が切開部内及び周囲の組織を照明するような方法で、前記切開部に沿って組織及び前記切開ドレープを収縮させることと、を含む、方法。
向かい合う第1及び第2の主表面を有する形状追従性ポリマー導光材層と、
前記形状追従性ポリマー導光材層と光学的に結合される光源と、を含み、
前記光源によって放射された光が前記形状追従性ポリマー導光材層に入射して全内部反射により前記形状追従性ポリマー導光材層内を伝搬する、医療物品を提供することと、
患者組織の形状に追従し、前記医療物品の主表面及び/又は縁部から放射される光を用いて患者組織を照明するように、医療物品を患者に接着することと、を含む、方法。
向かい合う第1及び第2の主表面を有する形状追従性ポリマー導光材層と、
光源と、
前記光源によって放射された光が前記形状追従性ポリマー導光材層に入射して全内部反射により前記形状追従性ポリマー導光材層内を伝搬する、切開ドレープを提供することと、
患者組織の形状に追従するように、患者に前記切開ドレープを接着することと、
前記切開ドレープから組織内まで切開して、その切り口で光を放射する前記切開ドレープの切り口を形成することと、
切開部に沿って組織及び前記切開ドレープを収縮させ、それにより切開部に隣接する組織にしわを寄せることと、を含み、
組織のしわによって前記導光材の全内部反射角を超えるようになり、結果として切り口から放射される光が減少し、しわ領域に沿った前記切開ドレープの主表面から放射される光が上昇し、それにより切開部内及び周囲において過剰な組織のたわみが組織中に起こっている可能性を示す、方法。
3M IOBAN 2抗菌切開ドレープ(3M Company(St.Paul,MN))の裏側に、3M VHBテープ4918透明アクリル接着剤(2mm(80ミル)厚)を積層した。この2mm厚のPSAの縁部に、12ボルトの直流電源に接続される一連の側面放射LED光を含む、くさび型の3M VIKUITI Enhanced Specular Reflector(ESR)フィルムを接着した。この厚さのPSA導光材の上面を、国際公開第2010/021796号に記載の方法で調製された、50マイクロメートル(1.95ミル厚)の層の透明な二軸延伸ポリプロピレン(BOPP)フィルムで覆った。電源を入れると、光が2mm(80ミル)厚のPSAに入射し、導光材の開放末端部を出射するのを見ることができた(LEDは一方の縁部のみに挿入した)。このBOPP/PSA/Iobanのサンドイッチ状ラミネートをかみそりで切ったとき、光が新たな切断面から出射するのが目で見えた。
3M IOBAN 2抗菌切開ドレープの裏側に、1mm(40ミル)の3M VHBテープ4910透明アクリル接着剤を積層した。この1mm厚のPSAの縁部に、12ボルトの直流電源に接続される一連の側面放射LED光を含む、くさび型の3M ESRフィルムを接着した。この厚さのPSA導光材の上面を、透明BOPPの層で覆った。電源を入れると、光が1mm厚のPSAに入射し、導光材の解放末端部を出射するのを見ることができた(LEDは一方の縁部のみに挿入した)。このBOPP/PSA/Iobanのサンドイッチ状ラミネートをかみそりで切ったとき、光が新たな切断面から出るのが目で見えた。
成形されたとがった「針先」を有する、透明/半透明で堅い固体形状のポリカーボネート又はポリ(メチルメタクリレート)(PMMA)の内部にLEDを封入できた。3M RED DOT電極製品で用いられているものなどの業界標準のクリップ留め電気コネクタを利用し、封入LEDを、任意の所望の点で厚い導光材PSA層内に簡単に「挿入」し、PSA導光材を通してドレープ部位にカスタム照明をもたらすことができた。これは図9に示される。
[1]
向かい合う第1及び第2の主表面を有する可撓性ポリマーフィルムと、
前記フィルムの主表面上に配置される粘弾性導光材層と、
前記粘弾性導光材層と光学的に結合される光源と、を含む医療物品であって、
前記光源によって放射される光が前記粘弾性導光材層に入射して全内部反射によって前記粘弾性導光材層の内部を伝搬し、
前記医療物品が、滅菌されている、又は滅菌可能であり、患者の身体部分に対して形状追従性である、医療物品。
[2]
前記可撓性ポリマーフィルム、前記粘弾性導光材層、又はその両方が、これらの少なくとも一方の主表面の少なくとも一部の上に配置される感圧性接着剤を含む、項目1に記載の医療物品。
[3]
前記粘弾性導光材層が少なくとも1つの活性物質を含む、項目1又は項目2に記載の医療物品。
[4]
前記医療物品の少なくとも1つの表面がその上面に配置される活性物質を有する、項目1〜3のいずれか一項に記載の医療物品。
[5]
前記粘弾性導光材層の少なくとも1つの表面が、前記導光材層の内部を伝搬する光を抽出するように配向される複数の形状を備える、項目1〜4のいずれか一項に記載の医療物品。
[6]
前記粘弾性導光材層が感圧性接着剤を含む、項目1〜5のいずれか一項に記載の医療物品。
[7]
前記粘弾性導光材層上に配置される剥離ライナーを更に含む、項目1〜6のいずれか一項に記載の医療物品。
[8]
患者の皮膚に接着される、項目1〜7のいずれか一項に記載の医療物品。
[9]
患者の皮膚に接着される医療物品であって、
向かい合う第1及び第2の主表面を有する可撓性ポリマーフィルムと、
前記フィルムの主表面上に配置される粘弾性層と、
光源と、
導光材と、を含み、前記光源によって放射される光が前記導光材に入射して全内部反射によって前記導光材の内部を伝搬し、
前記医療物品が、皮膚が光抽出器として機能するように十分に患者の皮膚に接着される、医療物品。
[10]
前記粘弾性層が前記導光材であり、前記光源によって放射される光が前記粘弾性導光材に入射して全内部反射により前記粘弾性導光材の内部を伝搬する、項目9に記載の医療物品。
[11]
前記粘弾性導光材の少なくとも1つの表面が前記粘弾性導光材の内部を伝搬する光を抽出するように配向される複数の形状を含む、項目10に記載の医療物品。
[12]
前記粘弾性層が前記導光材上に配置されており、前記光源によって放射される光が前記導光材に入射して全内部反射により前記導光材の内部を伝搬する、項目9に記載の医療物品。
[13]
前記導光材と前記粘弾性層との間に形成される界面が、前記導光材の内部を伝搬する光を抽出するように配向される複数の形状を含む、項目12に記載の医療物品。
[14]
患者に接着される医療物品であって、
向かい合う第1及び第2の主表面を有する可撓性ポリマーフィルムと、
前記フィルムの主表面に配置される形状追従性ポリマー層と、
光源と、
導光材と、を含み、前記光源によって放射される光が前記導光材に入射して全内部反射によって前記導光材の内部を伝搬し、
前記医療物品が前記患者に接着される、医療物品。
[15]
前記患者の前記皮膚上の術前皮膚用製品又はバリアフィルムに接着される、項目14に記載の医療物品。
[16]
前記形状追従性ポリマー層が前記導光材であり、前記光源によって放射される光が形状追従性ポリマー導光材に入射して全内部反射により前記形状追従性ポリマー導光材内を伝搬する、項目14に記載の医療物品。
[17]
前記形状追従性ポリマー層が前記導光材上に配置され、前記光源によって放射される光が前記導光材に入射して全内部反射により前記導光材内を伝搬する、項目14に記載の医療物品。
[18]
外科手術中における患者組織の照明方法であって、
向かい合う第1及び第2の主表面を有する形状追従性ポリマー導光材層と、
前記形状追従性ポリマー導光材層と光学的に結合される光源と、を含み、
前記光源によって放射される光が前記形状追従性ポリマー導光材層に入射して全内部反射により前記形状追従性ポリマー導光材層内を伝搬する、切開ドレープを提供することと、
前記患者組織の形状に追従するように、前記患者に前記切開ドレープを接着することと、
前記切開ドレープを通って前記組織内まで切開して、切り口で光を放射する前記切開ドレープの前記切り口を形成することと、
前記切開ドレープの切り口から放射される前記光が前記切開部内及び周囲の前記組織を照明するような方法で、前記切開部に沿って前記組織及び前記切開ドレープを収縮させることと、を含む、方法。
[19]
患者組織の照明方法であって、
向かい合う第1及び第2の主表面を有する形状追従性ポリマー導光材層と、
前記形状追従性ポリマー導光材層と光学的に結合される光源と、を含み、
前記光源によって放射される光が前記形状追従性ポリマー導光材層に入射して全内部反射により前記形状追従性ポリマー導光材層内を伝搬する、医療物品を提供することと、
前記患者組織の形状に追従し、前記医療物品の主表面及び/又は縁部から放射される光を用いて前記患者組織を照明するように、前記医療物品を患者に接着することと、を含む、方法。
[20]
外科手術中における過剰な組織のたわみを示す方法であって、
向かい合う第1及び第2の主表面を有する形状追従性ポリマー導光材層と、
光源と、
該光源によって放射された光が前記形状追従性ポリマー導光材層に入射して全内部反射により該形状追従性ポリマー導光材層内を伝搬する、切開ドレープを提供することと、
前記患者組織の形状に追従するように、前記患者に前記切開ドレープを接着することと、
前記切開ドレープを通って前記組織内まで切開して、切り口で光を放射する前記切開ドレープの前記切り口を形成することと、
前記切開部に沿って前記組織及び前記切開ドレープを収縮させ、それにより前記切開部に隣接する前記組織にしわを寄せることと、を含み、
前記組織のしわによって前記導光材の前記全内部反射角を超えるようになり、結果として前記切り口から放射される光が減少し、前記しわ領域に沿った前記切開ドレープの主表面から放射される光が増加し、それにより前記切開部内及び周囲において過剰な組織のたわみが前記組織中に起こっている可能性を示す、方法。
Claims (4)
- 向かい合う第1及び第2の主表面を有する可撓性ポリマーフィルムと、
前記フィルムの主表面上に配置される粘弾性導光材層と、
前記粘弾性導光材層と光学的に結合される光源と、を含む医療物品であって、
前記光源によって放射される光が前記粘弾性導光材層に入射して全内部反射によって前記粘弾性導光材層の内部を伝搬し、
前記医療物品が、滅菌されている、又は滅菌可能であり、患者の身体部分に対して形状追従性である、医療物品。 - 前記可撓性ポリマーフィルム、前記粘弾性導光材層、又はその両方が、これらの少なくとも一方の主表面の少なくとも一部の上に配置される感圧性接着剤を含む、請求項1に記載の医療物品。
- 前記粘弾性導光材層の少なくとも1つの表面が、前記導光材層の内部を伝搬する光を抽出するように配向される複数の形状を備える、請求項1又は2のいずれかに記載の医療物品。
- 患者の皮膚に接着される、請求項1〜3のいずれか一項に記載の医療物品。
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- 2010-08-19 WO PCT/US2010/045956 patent/WO2011022525A1/en active Application Filing
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EP2467087A1 (en) | 2012-06-27 |
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EP2467087A4 (en) | 2014-01-08 |
WO2011022525A1 (en) | 2011-02-24 |
US8758237B2 (en) | 2014-06-24 |
CN102573692A (zh) | 2012-07-11 |
JP2013502280A (ja) | 2013-01-24 |
CN102573692B (zh) | 2015-03-25 |
EP2467087B1 (en) | 2019-09-25 |
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