JP6574780B2 - 眼内シャントインサーター - Google Patents
眼内シャントインサーター Download PDFInfo
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- JP6574780B2 JP6574780B2 JP2016544872A JP2016544872A JP6574780B2 JP 6574780 B2 JP6574780 B2 JP 6574780B2 JP 2016544872 A JP2016544872 A JP 2016544872A JP 2016544872 A JP2016544872 A JP 2016544872A JP 6574780 B2 JP6574780 B2 JP 6574780B2
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Images
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
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- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
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- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
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Description
本出願は、2013年11月14日に出願した米国仮出願第61/904,429号の利益を主張し、その全体が参照により本明細書に組み込まれる。
本発明は、例えば、以下を提供する。
(項目1)
穴を有するニードル、
穴内で可動のプランジャー、
ニードル及びプランジャーに連結するドライブコンポーネントであって、ドライブコンポーネントの回転時に、インサーターの縦軸に沿ったニードル及びプランジャーへの移動となるドライブコンポーネント、及び
ハウジングに連結し、細長い溝に沿って摺動可能なスライダーコンポーネントであって、軸に沿ったスライダーコンポーネントの移動がハウジング内でドライブコンポーネントを回転させ、その結果、軸に沿ったニードル及びプランジャーの移動となるスライダーコンポーネントを含む、
緑内障を治療するためのインサーター。
(項目2)
前記ドライブコンポーネントが空洞の円柱部材を含む、項目1に記載のインサーター。
(項目3)
前記ドライブコンポーネントが複数の溝を含む、項目1に記載のインサーター。
(項目4)
前記ドライブコンポーネントが、スライダー溝を有する円柱部材を含み、前記スライダー溝が、前記スライダーコンポーネントと係合するように構成され、前記スライダーコンポーネントの移動時、前記係合が前記ドライブコンポーネントでの回転運動となる、項目1に記載のインサーター。
(項目5)
前記ドライブコンポーネントが、プランジャー溝を有する円柱部材を含み、前記プランジャー溝が、前記プランジャーと係合するように構成され、前記ドライブコンポーネントの回転時、前記係合が、前記ドライブコンポーネントの回転運動に応じて軸に沿った前記プランジャーへの移動となる、項目1に記載のインサーター。
(項目6)
前記ドライブコンポーネントが、ニードル溝を有する円柱部材を含み、前記ニードル溝が、前記ニードルと係合するように構成され、前記ドライブコンポーネントの回転時、前記係合が、前記ドライブコンポーネントの回転運動に応じて軸に沿った前記ニードルへの移動となる、項目1に記載のインサーター。
(項目7)
内側空洞を有するハウジングをさらに含み、前記ドライブコンポーネントが、前記空洞内で支持される、項目1に記載のインサーター。
(項目8)
前記ハウジングが、前記ハウジングの外側表面から前記空洞に伸張する細長いスロットを含み、前記スライダーコンポーネントが、前記スロットに沿って摺動可能である、項目7に記載のインサーター。
(項目9)
前記ハウジングスロット内で前記スライダーコンポーネントの移動を制限するために、前記ハウジングの外側構造に係合するように構成されるロックコンポーネントをさらに含む、項目7に記載のインサーター。
(項目10)
前記ハウジングの近位端部に連結するノブコンポーネントをさらに含み、前記ノブコンポーネントが、回転可能に前記ドライブコンポーネントに連結し、前記ノブコンポーネントの回転の結果、前記ドライブコンポーネントへの回転運動となる、項目7に記載のインサーター。
(項目11)
前記ニードルが、回転調整コンポーネントに連結し、前記調整コンポーネントが、ニードルアセンブリのニードルドライバーに連結し、前記調整コンポーネントが、前記ニードルドライバーに対して回転可能であり、前記調整コンポーネントの回転が、前記ハウジングに対する前記ニードルの回転整列を変え、前記調整コンポーネントが、前記ハウジングに対する前記ニードルの回転整列を固定するように回転可能である、項目1に記載のインサーター。
(項目12)
緑内障を治療するためのインサーターを駆動するためのドライブコンポーネントであって、ドライブコンポーネントが、第1、第2、及び第3の細長いトラックを有する円柱本体であって、細長いトラックが本体に沿って伸張する円柱本体を含み、第1の細長いトラックが、近位部から本体の遠位部に向かってらせん状に伸張し、第2の細長いトラックが、(1)本体の周囲にらせん状に伸張する第1の部分、及び(2)本体の周囲に周方向に伸張する第2の部分を有し、第3の細長いトラックが、(i)本体の周囲に周方向に伸張する第1の部分、及び(ii)本体の周囲にらせん状に伸張する第2の部分を有する、ドライブコンポーネント。
(項目13)
前記第2の細長いトラックの前記第2の部分が、前記本体の縦軸に対して実質的に垂直に向いた平面内で伸張し、前記第1の細長いトラックの前記第1の部分が、前記本体の縦軸に対して実質的に垂直に向いた平面内で伸張する、項目12に記載のコンポーネント。
(項目14)
前記第2の細長いトラックの前記第1の部分が、前記第2の細長いトラックの前記第2の部分から前記本体の近位部の方向にらせん状に伸張し、前記第3の細長いトラックの前記第2の部分が、前記第3の細長いトラックの前記第1の部分から前記本体の近位部の方向にらせん状に伸張する、項目12に記載のコンポーネント。
(項目15)
前記本体が、ともに連結可能である2つの部品を含み、前記第1、第2、または第3のトラックのうちの少なくとも1つが、両部品に沿って伸張する、項目12に記載のコンポーネント。
本明細書に開示したいくつかの実施形態に従うと、インサーターは、操作者が、眼球を保持する固定器具、例えば、フック上に別の手を維持できるように片手器具として機能することができる。これにより、外科的操作及び配置精度を改善し、手術を容易にすることもできる。眼球12を治療するための方法の実例が、図1Aに示されている。図1Aは、眼球12を保持するためのフック14及び眼球に眼内シャントを挿入するためのインサーター100の使用を示す。
ここで図17〜19Cを参照すると、ニードルアセンブリの回転操作をもたらすためにインサーターのいくつかの実施形態の態様を実施することができる。図1Bに示すとおり、インサーターは、ニードルアセンブリ104を含むことができる。いくつかの実施形態に従うと、ニードルアセンブリ104は、ハウジング102に対してニードルコンポーネント120の回転整列の操作が可能になるように構成することができる。それゆえに、患者に対しての操作者の位置(例えば、操作者が左または右の眼球のどちらに近づくか、または操作者が患者の左側または右側のどちらにいるか)に応じて、ニードルコンポーネント120の回転整列は、ニードルのベベル360が眼球組織に対しての所望の方向に回転して配置することができるように調整することができる。この形状構成により、操作者がインサーターを保持する自由度を増すことができる一方で、さらに強膜を通ってニードル貫入中にベベルが上にあることを確実にする。また、左または右の眼球手術のために同じインサーターを用いて対応することができる。異なる手術設定(側頭、上方、右の眼球、左の眼球、右手、左手)で、接近が容易であるようにいくぶん回転させてインサーターを保持することが有利となる可能性がある。ニードルベベルを予め回転させることによって、強膜貫入段階の間にニードルベベルが上にあることを確実にするように、そのような回転を予め補うことができる。
前に記載したとおり、いくつかの実施形態では、ハウジング102に対してベベル360の回転方向の調整を可能にする駆動機構(図17に示した調整ピン390及び実施形態として示す)を提供するための回転調整コンポーネント370を実装することができる。しかし、他の実施形態では、回転調整コンポーネント370を省くことができ、これによってドライブアセンブリ及びニードルアセンブリを単純化し、操作者が当該方法中にユニットとしてインサーターを回転させることによってインサーター全体の回転操作を実行することが可能になる。
ここで図24〜29を参照すると、ここでインサーターのもうひとつの実施形態及びインサーターの別の形状構成を記載する。図24〜25は、インサーター500のハウジング504に連結する回転機構502を有するインサーター500を示す。回転機構502は、ドライブアセンブリ130のドライブコンポーネント160を回転するための別の手段として使用することができる。それでも、インサーターは、また、前に記載したインサーター100のスライダーコンポーネント106と同一の方法で機能することができる、ドライブコンポーネントを回転するための手段を提供するスライダーコンポーネント506を含むことができる。インサーター500の他の形状構成及び機能は、インサーター100とほぼ同じもの、または同一のものとすることができ、簡潔のためにここに繰り返し記載しない。
図30Aは、第1の位置610のハンドルコンポーネントを示し、図30Bは、第2の位置612のハンドルコンポーネントを示す。図26A〜26Bに関して前に記載したのと同様に、インサーター600の移動及び機能は、ハンドルコンポーネント602が第1の位置610から第2の位置612へ移動する場合、インサーター100の移動及び機能とほぼ同じもの、または同一とすることができる。
図31〜32Cは、さらに動力を備えたインサーターの実施形態を示す。例えば、インサーターのドライブアセンブリを駆動するために操作者によって加えられる力以外に、またはこれに加えて機械的力を実現することができる。ドライブアセンブリに加えられる回転力は、電気モーター、またはインサーターのドライブアセンブリの回転運動を操作することができるさまざまな機械系の1つから駆動することができる。
いくつかの実施形態に従うと、インサーターまたはニードルアセンブリの輸送及び運送中に、インサーターのニードル内にシャントの保持を容易にするインプラント保持器具を提供することができる。このため、インサーターは、シャントが偶然にニードルから外れるのを阻止するためにインサーターのニードルと係合するシャント保持器具と併用することができる。
図34A〜39は、本明細書に開示したいくつかの実施形態に従うと実施することができるさまざまな方法を示す。そのような方法では、操作者が、眼球内の低い圧力の領域または範囲内に眼内シャントの出口端部を配置し、シャントの入口端部を眼球の前眼房と流体連結したままとすることを可能とさせる。いくつかの実施形態に従うと、眼球中にシャント遠位端部の最初の前進を行うために空間を生じさせるための方法は、眼球の流出領域中の眼球の深層(例えば、強膜または他の層、例えば、テノン内癒着層)から離れて眼球のより多くの表面層(例えば、結膜または他の層、例えば、テノン内癒着層)を「テンティング」することによって、シャントの最初の配置及び前進を非常に容易にすることができる。そのような方法により、眼球中への前進中に、シャントの遠位端部を保護することができ、シャントの完全性を維持することができる。これに反して、単純に眼球(例えば、結膜下空間、脈絡膜上空間、またはテノン下空間)にシャントを押し込む以前の方法では、ステントの近位端部上で作用している遠位押力のために、シャントの遠位部を閉鎖するまたは破壊することによって、またはシャントがひねられる、もしくは曲げられることによって、シャントを損傷する可能性が多く、それと同時にステントの遠位端部が、結膜によって阻止され、ニードルの外へ移動することができない。
Claims (15)
- 緑内障を治療するためのインサーターであって、前記インサーターが、片手によって操作されるように構成され、前記インサーターが、
ハウジング、
穴を有するニードル、
前記穴内で可動のプランジャー、
空洞の円柱部材を含むドライブコンポーネントであって、前記空洞の円柱部材が、スライダー溝、ニードル溝、及びプランジャー溝を含み、前記空洞の円柱部材が、前記ニードル溝を介して前記ニードルに連結され、前記プランジャー溝を介して前記プランジャーに連結されて、前記ドライブコンポーネントの回転時に前記インサーターの縦軸に沿った移動を前記ニードル及び前記プランジャーに生じさせ、前記スライダー溝と、前記ニードル溝または前記プランジャー溝のうちの少なくとも1つとが、前記空洞の円柱部材に沿って前記インサーターの前記縦軸に対して垂直に伸張する第1の平面と交差する、ドライブコンポーネント、及び
前記ハウジングに連結され、それに沿って摺動可能なスライダーコンポーネントであって、前記スライダーコンポーネントは、前記インサーターの前記縦軸に沿った前記スライダーコンポーネントの移動が、前記ハウジング内で前記ドライブコンポーネントを回転させ、前記インサーターの前記縦軸に沿った前記ニードル及び前記プランジャーの移動を生じさせるように、前記スライダー溝を介して前記ドライブコンポーネントに連結されている、スライダーコンポーネントを含む、インサーター。 - 前記スライダー溝は、前記スライダーコンポーネントの移動時に前記スライダー溝と前記スライダーコンポーネントとの係合が前記ドライブコンポーネントでの回転運動を生じさせるように、前記スライダーコンポーネントと係合するように構成される、請求項1に記載のインサーター。
- 前記プランジャー溝は、前記ドライブコンポーネントの回転時に前記プランジャー溝と前記プランジャーとの係合が、前記ドライブコンポーネントの回転運動に応じて前記インサーターの前記縦軸に沿った移動を前記プランジャーに生じさせるように、前記プランジャーと係合するように構成される、請求項1に記載のインサーター。
- 前記ニードル溝は、前記ドライブコンポーネントの回転時に前記ニードル溝と前記ニードルとの係合が、前記ドライブコンポーネントの回転運動に応じて前記インサーターの前記縦軸に沿った移動を前記ニードルに生じさせるように、前記ニードルと係合するように構成される、請求項1に記載のインサーター。
- 前記ハウジングが、内側空洞を含み、前記ドライブコンポーネントが、前記空洞内で支持される、請求項1に記載のインサーター。
- 前記ハウジングが、前記ハウジングの外側表面から前記空洞に伸張するハウジング溝を含み、前記スライダーコンポーネントが、前記ハウジング溝に沿って摺動可能である、請求項5に記載のインサーター。
- ハウジング溝内での前記スライダーコンポーネントの移動を制限するために、前記ハウジングの外側構造に係合するように構成されるロックコンポーネントをさらに含む、請求項5に記載のインサーター。
- 前記ハウジングの近位端部に連結されたノブコンポーネントをさらに含み、前記ノブコンポーネントは、前記ノブコンポーネントの回転が、前記ドライブコンポーネントの回転運動を生じさせるように、前記ドライブコンポーネントに連結される、請求項5に記載のインサーター。
- 前記ニードルのニードルコンポーネントが、回転調整コンポーネントに連結され、前記調整コンポーネントが、前記ニードルのニードルドライバーに連結され、前記調整コンポーネントは、前記調整コンポーネントの回転が、前記ハウジングに対する前記ニードルコンポーネントの回転整列を変えるように、前記ニードルドライバーに対して回転可能であり、前記調整コンポーネントが、前記ハウジングに対する前記ニードルコンポーネントの回転整列を固定するように前記インサーターの前記縦軸に沿って平行移動可能である、請求項1に記載のインサーター。
- 前記スライダー溝が、前記ドライブコンポーネントの遠位部に向かって近位部かららせん状に伸張し、前記プランジャー溝が、(1)前記ドライブコンポーネントの周囲にらせん状に伸張する第1の部分、及び(2)前記ドライブコンポーネントの周囲に周方向に伸張する第2の部分を有し、前記ニードル溝が、(i)前記ドライブコンポーネントの周囲に周方向に伸張する第1の部分、及び(ii)前記ドライブコンポーネントの周囲にらせん状に伸張する第2の部分を有する、請求項1に記載のインサーター。
- 前記プランジャー溝の前記第1の部分が、前記ドライブコンポーネントの前記近位部に向かう方向に前記プランジャー溝の前記第2の部分かららせん状に伸張し、前記ニードル溝の前記第2の部分が、前記ドライブコンポーネントの前記近位部に向かう方向に前記ニードル溝の前記第1の部分かららせん状に伸張する、請求項10に記載のインサーター。
- 前記空洞の円柱部材が、ともに連結可能である2つの部品を含み、前記スライダー溝、前記ニードル溝、または前記プランジャー溝のうちの少なくとも1つが、両部品に沿って伸張する、請求項10に記載のインサーター。
- 前記スライダー溝が、前記ドライブコンポーネントの半回転を可能にするように伸張する、請求項1に記載のインサーター。
- 前記プランジャー溝が、前記ドライブコンポーネントの半回転を可能にするように伸張する、請求項1に記載のインサーター。
- 前記ニードル溝が、前記ドライブコンポーネントの半回転を可能にするように伸張する、請求項1に記載のインサーター。
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