JP2016120303A - 角膜移植片の挿入システム - Google Patents
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Abstract
Description
[0006]一実施形態では、挿入システムは、角膜移植片を角膜の中または上の所望部位に送達する挿入器を備える。挿入器は、遠位端および近位端を有する細長い本体を備える。細長い本体は、その遠位端に、送達すべき角膜移植片を保持する保持空間を有する。保持空間は、細長い本体の頂部遠位部分と底部遠位部分との間に形成される。好ましい一実施形態では、移植片を水和させておき、かつ溶液の表面張力によって移植片を保持空間内で保持するため、溶液、例えば生理食塩水が、角膜移植片を含む保持空間をほぼ充填する。挿入器の細長い本体はまた、角膜の曲率に沿う湾曲部分と、挿入器と患者の顔の造作、例えば鼻との間に隙間を作るクリアランスベンド(clearance bend)とを有してもよい。
なっている。
ップ300は、生理食塩水410で充填されたバイアル400に入れられているとき、移植片200が挿入器100から外れるのを防ぐ。バイアル400は、キャップを閉められ、使用時まで挿入システムを保管するために殺菌された外装420に入れられる。
の、2004年8月23日出願の同時係属中の米国特許出願第10/924,152号にさらに詳細に記載されており、その全体を参照により本明細書に組み込む。内部が露出すると、外科医は、角膜600上の所望部位に、例えば、図5Aに示されるように、患者の瞳孔または視軸に移植片200があるようにして、挿入器100を位置付ける。挿入器100を位置付ける前に、外科医は、生理食塩水を保持空間101から取り除かないように注意して、外科用スポンジを使用して挿入器100の外表面上の余分な流体を取り除いてもよい。クリアランスベンド104により、外科医が挿入器100を操作する際に挿入器が患者の顔の造作(例えば、鼻)を邪魔しないことが可能になっている。移植片200を精密に位置付けるため、外科医は、挿入器スロット102および110と透明である移植片200とを介して角膜600を見てもよい。移植片200が所望部位にあるとき、外科医は、外科用カニューレ、シンスキーフック、または他の器具610を使用して、底部スロット100を介して移植片200が角膜600の支質床に優しく触れるように、移植片
200を角膜600上に押さえつける。この器具610は、図5Bに示されるように、頂部挿入器スロット102を介して移植片200を押さえつける。次に、外科医は、挿入器100を角膜600から引込して、移植片200を挿入器100から解放するとともに、移植片200を所望部位に置く。移植片200が精密に所望部位にない場合、外科医は、外科用スポンジ、先端が丸み付けされた器具、または他の器具を使用して、移植片200を所定位置へと優しく動かしてもよい。図5Cに示される例では、移植片200は患者の瞳孔1130上で心合わせされている。移植片200が正確に位置付けられた後、外科医はフラップ1120を移植片200の上に配置する。
月30日出願の米国特許出願第11/554,544号に見出すことができ、その明細書を参照により本明細書に組み込む。
形態では、移植片200を所望部位で押さえつけ、移植片200を挿入器100から解放するため、外科用カニューレまたは他の器具も、フラップとその下にある角膜組織との間に挿入されてもよい。
いう名称の、2006年6月1日出願の米国特許出願第11/421,597号に見出すことができ、その明細書を参照により本明細書に組み込む。角膜にポケットを作成する方法は、「Method of Creating Stromal Pockets for Corneal Implants」という名称の、
2003年1月16日公開の米国特許出願公開第2003/0014042号に記載されており、その全体をやはり参照により本明細書に組み込む。例えば、挿入器は、角膜に切り込まれたチャネルまたはポケットに挿入され、チャネルを介して前進させられて、移植片を角膜内の所望部位で位置付けてもよい。移植片を所望部位で押さえつけるのに使用される外科用カニューレまたは他の器具のためのアクセスを提供するため、第2のチャネルも角膜に切り込まれてもよい。ポケットは、角膜移植片を受け入れるために角膜組織内に形成される陥凹部であり、角膜に形成されたチャネルを介してアクセスされてもよい。図5Dは、開口部710を介して角膜600に形成されたポケット700内に移植片200を配置している挿入器100の一例を示す。
端から保持空間101まで延在するチャネルを含んでもよい。挿入器100の近位端は、チャネルを介して流体を保持空間101に送達するため、流体で、例えば生理食塩水で充填された注射器に接続されてもよい。この実施形態では、チャネルは保持空間101の後部に流体を送達してもよい。これにより、外科医が、少量の流体を保持空間101内に送達して移植片200を水和し、かつ/または、移植片200を挿入器100から解放するため、移植片200を保持空間101から優しく押し出すことが可能になる。例えば、移植片200が角膜上の所望部位にあるとき、外科医は、チャネルを介して流体を送達して、移植片200を挿入器101から解放する助けとしてもよい。これは、移植片200を押さえつけるのに使用される器具の代わりに、またはそれと併せて行われてもよい。図7は、注射器または他の流体送達デバイスの対応するルアーロックと噛合するように構成されたルアーロック810を挿入器100の近位端に備える、一実施形態による挿入器100を示す。図8は、チャネルを介して流体を送達するため、ルアーロック810を介して注射器820が挿入器100の近位端に接続された一実施形態を示す。
を所望部位に置くため、角膜の所望部位の上に位置付けられた挿入器900の一例を示す。
[形態1]
遠位端および近位端を有する細長い本体と、
前記細長い本体の前記遠位端における、角膜移植片を中に保持するように構成された保持空間であって、前記細長い本体の頂部遠位部分と底部遠位部分との間に規定される保持空間と、
前記細長い本体の前記頂部遠位部分を通るスロットであって、前記細長い本体の前縁まで延在するスロットとを備える、角膜移植片の挿入システム。
[形態2]
形態1に記載の挿入システムにおいて、前記保持空間が、前記挿入器によって送達される前記角膜移植片の直径よりも20パーセント増し以下の幅を有する挿入システム。
[形態3]
形態1に記載の挿入システムにおいて、前記細長い本体の前記頂部遠位部分が前記前縁に向かって下向きに傾斜している挿入システム。
[形態4]
形態1に記載の挿入システムにおいて、前記前縁が半円である挿入システム。
[形態5]
形態1に記載の挿入システムにおいて、前記細長い本体の前記遠位部分を通る底部スロットをさらに備える挿入システム。
[形態6]
形態5に記載の挿入システムにおいて、前記底部スロットが、前記細長い本体の前記前縁まで延在し、前記頂部遠位部分を介して前記スロットとほぼ整列された挿入システム。
[形態7]
形態1に記載の挿入システムにおいて、前記細長い本体が材料の単一片から作られる挿入システム。
[形態8]
形態7に記載の挿入システムにおいて、前記材料がチタンを含む挿入システム。
[形態9]
形態1に記載の挿入システムにおいて、前記細長い本体が前記遠位端付近に湾曲部分を有する挿入システム。
[形態10]
形態9に記載の挿入システムにおいて、前記細長い本体の前記湾曲部分が角膜の曲率にほぼ適応する挿入システム。
[形態11]
形態9に記載の挿入システムにおいて、前記細長い本体が前記湾曲部分に近接した曲げ部分を有する挿入システム。
[形態12]
形態1に記載の挿入システムにおいて、前記細長い本体を通り、前記保持空間から前記近位端まで延在するチャネルをさらに備える挿入システム。
[形態13]
形態12に記載の挿入システムにおいて、前記チャネルを流体送達デバイスに接続する、前記細長い本体の前記近位端に取り付けられたルアーロックをさらに備える挿入システム。
[形態14]
形態1に記載の挿入システムにおいて、前記細長い部材の前記保持空間内で保持される角膜移植片をさらに含む挿入システム。
[形態15]
形態14に記載の挿入システムにおいて、前記角膜移植片が1mmから7mmの直径を有する挿入システム。
[形態16]
形態15に記載の挿入システムにおいて、前記保持空間が、前記角膜移植片の直径よりも20パーセント増し以下の幅を有する挿入システム。
[形態17]
形態14に記載の挿入システムにおいて、前記細長い本体の前記遠位端上に配置されるキャップをさらに備え、前記キャップが前記細長い本体の前記保持空間をほぼ取り囲む挿入システム。
[形態18]
形態17に記載の挿入システムにおいて、少なくとも部分的に流体で充填された保管容器をさらに備え、前記キャップおよび前記細長い本体の前記保持空間が前記流体に沈められる挿入システム。
[形態19]
形態18に記載の挿入システムにおいて、前記流体が生理食塩水を含む挿入システム。
[形態20]
角膜移植片を送達する方法であって、
前記角膜移植片を受け入れる部位を角膜の上または中に形成する工程と、
角膜移植片を中に含むとともに、前記細長い本体の頂部遠位部分と底部遠位部分との間に規定される保持空間を備える挿入器の遠位端を、前記部位に位置付ける工程と、
前記挿入器の前記保持空間から前記角膜移植片を取り除く工程と、
前記角膜移植片を前記部位で前記角膜の上または中に置く工程とを含む、方法。
[形態21]
形態20に記載の方法において、前記挿入器が、前記頂部遠位部分を通り、前記挿入器の前縁まで延在するスロットをさらに備え、前記方法が、
前記保持空間内の前記角膜移植片を、前記スロットを介して外科器具を用いて押さえつける工程と、
前記角膜移植片を前記角膜の上または中に置くため、前記挿入器を前記角膜から引込する工程とをさらに含む方法。
[形態22]
形態20に記載の方法において、
前記角膜にフラップを形成する工程と、
角膜床を露出させるため、前記フラップを持ち上げる工程と、
前記角膜移植片を前記角膜床上に配置する工程と、
前記フラップを前記角膜床上の前記角膜移植片の上に置く工程とをさらに含む方法。
[形態23]
形態20に記載の方法において、
前記部位までのチャネルを前記角膜内に形成する工程と、
前記部位にアクセスするため、前記チャネルを介して前記挿入器の前記遠位端を前進させる工程とをさらに含む方法。
[形態24]
形態20に記載の方法において、
前記角膜移植片を受け入れるため、前記角膜内にポケットを形成する工程と、
前記挿入器の前記遠位端を前記ポケットに前進させる工程とをさらに含む方法。
[形態25]
形態20に記載の方法において、前記角膜移植片を含む前記保持空間が溶液でほぼ充填され、前記流体の表面張力によって前記角膜移植片が前記保持空間内で保持される方法。
[形態26]
形態25に記載の方法において、前記溶液が生理食塩水を含む方法。
Claims (26)
- 遠位端および近位端を有する細長い本体と、
前記細長い本体の前記遠位端における、角膜移植片を中に保持するように構成された保持空間であって、前記細長い本体の頂部遠位部分と底部遠位部分との間に規定される保持空間と、
前記細長い本体の前記頂部遠位部分を通るスロットであって、前記細長い本体の前縁まで延在するスロットとを備える、角膜移植片の挿入システム。 - 請求項1に記載の挿入システムにおいて、前記保持空間が、前記挿入器によって送達される前記角膜移植片の直径よりも20パーセント増し以下の幅を有する挿入システム。
- 請求項1に記載の挿入システムにおいて、前記細長い本体の前記頂部遠位部分が前記前縁に向かって下向きに傾斜している挿入システム。
- 請求項1に記載の挿入システムにおいて、前記前縁が半円である挿入システム。
- 請求項1に記載の挿入システムにおいて、前記細長い本体の前記遠位部分を通る底部スロットをさらに備える挿入システム。
- 請求項5に記載の挿入システムにおいて、前記底部スロットが、前記細長い本体の前記前縁まで延在し、前記頂部遠位部分を介して前記スロットとほぼ整列された挿入システム。
- 請求項1に記載の挿入システムにおいて、前記細長い本体が材料の単一片から作られる挿入システム。
- 請求項7に記載の挿入システムにおいて、前記材料がチタンを含む挿入システム。
- 請求項1に記載の挿入システムにおいて、前記細長い本体が前記遠位端付近に湾曲部分を有する挿入システム。
- 請求項9に記載の挿入システムにおいて、前記細長い本体の前記湾曲部分が角膜の曲率にほぼ適応する挿入システム。
- 請求項9に記載の挿入システムにおいて、前記細長い本体が前記湾曲部分に近接した曲げ部分を有する挿入システム。
- 請求項1に記載の挿入システムにおいて、前記細長い本体を通り、前記保持空間から前記近位端まで延在するチャネルをさらに備える挿入システム。
- 請求項12に記載の挿入システムにおいて、前記チャネルを流体送達デバイスに接続する、前記細長い本体の前記近位端に取り付けられたルアーロックをさらに備える挿入システム。
- 請求項1に記載の挿入システムにおいて、前記細長い部材の前記保持空間内で保持される角膜移植片をさらに含む挿入システム。
- 請求項14に記載の挿入システムにおいて、前記角膜移植片が1mmから7mmの直径を有する挿入システム。
- 請求項15に記載の挿入システムにおいて、前記保持空間が、前記角膜移植片の直径よりも20パーセント増し以下の幅を有する挿入システム。
- 請求項14に記載の挿入システムにおいて、前記細長い本体の前記遠位端上に配置されるキャップをさらに備え、前記キャップが前記細長い本体の前記保持空間をほぼ取り囲む挿入システム。
- 請求項17に記載の挿入システムにおいて、少なくとも部分的に流体で充填された保管容器をさらに備え、前記キャップおよび前記細長い本体の前記保持空間が前記流体に沈められる挿入システム。
- 請求項18に記載の挿入システムにおいて、前記流体が生理食塩水を含む挿入システム。
- 角膜移植片を送達する方法であって、
前記角膜移植片を受け入れる部位を角膜の上または中に形成する工程と、
角膜移植片を中に含むとともに、前記細長い本体の頂部遠位部分と底部遠位部分との間に規定される保持空間を備える挿入器の遠位端を、前記部位に位置付ける工程と、
前記挿入器の前記保持空間から前記角膜移植片を取り除く工程と、
前記角膜移植片を前記部位で前記角膜の上または中に置く工程とを含む、方法。 - 請求項20に記載の方法において、前記挿入器が、前記頂部遠位部分を通り、前記挿入器の前縁まで延在するスロットをさらに備え、前記方法が、
前記保持空間内の前記角膜移植片を、前記スロットを介して外科器具を用いて押さえつける工程と、
前記角膜移植片を前記角膜の上または中に置くため、前記挿入器を前記角膜から引込する工程とをさらに含む方法。 - 請求項20に記載の方法において、
前記角膜にフラップを形成する工程と、
角膜床を露出させるため、前記フラップを持ち上げる工程と、
前記角膜移植片を前記角膜床上に配置する工程と、
前記フラップを前記角膜床上の前記角膜移植片の上に置く工程とをさらに含む方法。 - 請求項20に記載の方法において、
前記部位までのチャネルを前記角膜内に形成する工程と、
前記部位にアクセスするため、前記チャネルを介して前記挿入器の前記遠位端を前進させる工程とをさらに含む方法。 - 請求項20に記載の方法において、
前記角膜移植片を受け入れるため、前記角膜内にポケットを形成する工程と、
前記挿入器の前記遠位端を前記ポケットに前進させる工程とをさらに含む方法。 - 請求項20に記載の方法において、前記角膜移植片を含む前記保持空間が溶液でほぼ充填され、前記流体の表面張力によって前記角膜移植片が前記保持空間内で保持される方法。
- 請求項25に記載の方法において、前記溶液が生理食塩水を含む方法。
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EP2136745A1 (en) | 2009-12-30 |
AU2008232842A1 (en) | 2008-10-09 |
US20120165823A1 (en) | 2012-06-28 |
CA2680070A1 (en) | 2008-10-09 |
US8162953B2 (en) | 2012-04-24 |
JP2010522622A (ja) | 2010-07-08 |
CA2680070C (en) | 2016-09-20 |
WO2008121649A1 (en) | 2008-10-09 |
JP2013230391A (ja) | 2013-11-14 |
JP5324561B2 (ja) | 2013-10-23 |
AU2008232842B2 (en) | 2013-01-24 |
US20080243138A1 (en) | 2008-10-02 |
US8540727B2 (en) | 2013-09-24 |
JP5881649B2 (ja) | 2016-03-09 |
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