JP2017080495A - 軟口蓋組織持ち上げ手術のための用具 - Google Patents
軟口蓋組織持ち上げ手術のための用具 Download PDFInfo
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Abstract
Description
本出願は、2011年6月6日に出願された米国特許仮出願第61/493,941号及び2012年6月5日に出願された同第13/488,527号の利益を主張する。
本発明は、概して、自己保持縫合材及び、軟口蓋持ち上げ手術において自己保持縫合材を使用する方法に関する。
以下で用いられ得る特定の用語の定義は、次のものを含む。
上述のように、本発明は、自己保持縫合材及び、軟口蓋を持ち上げる外科手術における自己保持縫合材の使用方法を提供する。
本発明の方法は、上述の双方向自己保持縫合材を部分的台形の縫合材経路において軟口蓋組織に敷設して組織を持ち上げることを含む。ここで図3Aを参照すると、まず臨床医は、硬口蓋と軟口蓋との接合部の場所を見つけ、縫合材の第1の端を、口蓋正中線の片側の、硬口蓋と軟口蓋の接合部と軟口蓋の後方の端との間の「1」と表示されている挿入点にて、挿入する。次いで臨床医は、第1の端を軟口蓋の内側部分で横断させて、口蓋正中線の反対側の、硬口蓋と軟口蓋の接合部と軟口蓋の後方の端との間の「2」と表示されている第1出口点に渡す。点「1」及び「2」は、軟口蓋と硬口蓋との接合部の後方の約半分の距離にあってよい。次いで臨床医は、縫合材の第2の端に隣接し、かつ第2の端に向いている複数の保持体のいくつかが、縫合材の中間点の周囲又は、中間点若しくは移行部分にマークが付けられている場所と係合し、そのマークが挿入点に近づくのを臨床医が視認するまで、縫合材を引くことができる。次いで臨床医は、第1の端を第1出口点「2」に再び挿入し、軟口蓋を通じて後方に口蓋正中線から離れる方向に第1の端を、「3」と表示されている第2出口点まで敷設し、第2出口点「3」にて、第1の端を軟口蓋から出すように促し、第2出口点「3」を通じて縫合材を引き出す。次いで、最後に臨床医は、縫合材の第2の端を取り、挿入点「1」に挿入し、軟口蓋を通じて後方に口蓋正中線から離れる方向に、第3出口点「4」まで第2の端を敷設する。次いで、出口点「4」にて、縫合材の第2の端を組織の外へ引き出す。
本明細書において記載される縫合スレッドは、射出成形、スタンピング、切削、押出成形などを含むがこれらに限定されない好適な方法によって作製され得る。好ましい実施形態において、縫合スレッドは、強度の直径に対する高い比率を有する、延伸ポリマー単繊維である。ポリマー縫合スレッド/フィラメントは、縫合材本体のために製造又は購入されてもよく、その後、縫合材本体に保持体が切削され得る。縫合スレッド/フィラメントは、特定の用途に対する所望に応じて、生分解性又は非生分解性であり得る。保持体は、ブレード、切削ホイール、粉砕ホイールなどを使用して機械的に切削され得る。切削中、大きさ、形状及び深さを制御するため、切削用具又は縫合スレッドのいずれかが、互いに対して移動されてもよく、又は両方が移動されてもよい。
(1) 双方向の自己保持縫合材を使用して軟口蓋組織を近づける方法であって、前記双方向の自己保持縫合材は、第1及び第2の組織貫通端、第1及び第2の複数の組織保持体を有し、前記第1及び第2の複数の組織保持体が、それぞれ、前記第1及び第2の端に向かって配向されており、かつ保持体のない移行部分によって分離されており、前記方法が、
a.縫合材の前記第1の端を、口蓋正中線の片側の、硬口蓋と軟口蓋の接合部と前記軟口蓋の後方の端との間の挿入点にて、前記軟口蓋に挿入する工程と、
b.前記第1の端を、前記軟口蓋を通し、前記口蓋正中線を横切って、前記口蓋正中線の反対側の、硬口蓋と軟口蓋の接合部と軟口蓋の後方の端との間の第1出口点まで敷設する工程と、
c.前記第1の端を前記第1出口点にて前記軟口蓋の外へ突き進め、前記第2の複数の組織保持体が前記組織と係合するまで、前記縫合材を前記軟口蓋を通して引き出す工程と、
d.前記第1の端を前記第1出口点に再び挿入し、前記軟口蓋を通して前記第1の端を後方に、前記口蓋正中線から離れる方向へと、第2出口点まで敷設する工程と、
e.前記第1の端を前記第2出口点にて前記軟口蓋の外へ突き進め、前記第2出口点を通して前記縫合材を引き出す工程と、
f.前記第2の端を前記挿入点に挿入し、前記軟口蓋を通して前記第2の端を後方に、前記口蓋正中線から離れる方向へと、第3出口点まで敷設する工程と、
g.前記第2の端を前記第3出口点にて前記軟口蓋の外へ突き進め、前記第3出口点を通して前記縫合材を引き出す工程と、を含む、方法。
(2) 前記縫合材を前記第2出口点及び前記第3出口点と平らになるように調整する工程を更に含む、実施態様1に記載の方法。
(3) 前記軟口蓋の持ち上げを増すために、工程「g」において前記縫合材を前方かつ頭側に引く工程を更に含む、実施態様1に記載の方法。
(4) 前記縫合材を引くことにより、患者の気道の容積が増加する、実施態様1に記載の方法。
(5) 前記縫合材の前記第1及び第2の組織貫通端が、前記縫合材の第1の端及び第2の端にそれぞれ取り付けられた第1及び第2の双曲針(first and second bi-curved needles)を更に備える、実施態様1に記載の方法。
(7) 軟口蓋持ち上げ手術用の外科手術キットであって、前記キットは縫合パッケージを備え、前記縫合パッケージが、
周辺部と第1及び第2の組織貫通端とを有し、前記第1及び第2の組織貫通端のそれぞれに曲率を有する針が備わっている、細長い縫合材本体と、前記細長い本体の第1の部分に配置され、前記第1の端に向かって配向された複数の第1の保持体であって、前記第1の端の敷設方向に前記縫合材が組織を通して移動される間に前記縫合材本体に向かってたわみ、かつ組織内にある際には、前記第1の端の敷設方向と実質的に反対の方向への前記縫合材の移動に抵抗する、複数の第1の保持体と、前記細長い本体の第2の部分に配置され、前記第2の端に向かって配向された複数の第2の保持体であって、前記第2の端の敷設方向に前記縫合材が組織を通して移動される間に前記縫合材本体に向かってたわみ、かつ組織内にある際には、前記第2の端の敷設方向と実質的に反対の方向への移動に抵抗する、複数の第2の保持体と、前記複数の第1の保持体と前記複数の第2の保持体との間に配置された、保持体のない移行部分であって、最高10mmまでの長さを有する、移行部分と、を含む、縫合材アセンブリと、
針ドライバーと、
ピンセットと、
はさみと、
舌圧子と、を備える、外科手術キット。
(8) 前記縫合材アセンブリの前記縫合材本体が生体吸収性の材料で構成される、実施態様7に記載の外科手術キット。
(9) 前記縫合材アセンブリの前記縫合材本体が非吸収性の材料で構成される、実施態様7に記載の外科手術キット。
(10) 前記移行部分の長さが0.5〜5mmである、実施態様7に記載の外科手術キット。
(12) 前記移行部分の長さが約1mmである、実施態様11に記載の外科手術キット。
(13) 前記第1の部分及び前記第2の部分が70mm未満の長さを有する、実施態様7に記載の外科手術キット。
(14) 前記第1の部分及び前記第2の部分が50mm未満の長さを有する、実施態様13に記載の外科手術キット。
(15) 前記第1の保持体及び前記第2の保持体が螺旋パターンに配置される、実施態様7に記載の外科手術キット。
(17) 前記螺旋パターンが1センチメートル当たり少なくとも250個の保持体密度を更に備える、実施態様16に記載の外科手術キット。
(18) 前記螺旋パターンが四重螺旋(quada-helix)である、実施態様15に記載の外科手術キット。
(19) 前記螺旋パターンが1センチメートル当たり少なくとも250個の保持体密度を更に備える、実施態様18に記載の外科手術キット。
(20) 自己保持縫合材であって、
a.周辺部と第1及び第2の組織貫通端とを有し、前記第1及び第2の端のそれぞれに双曲針が備わっている、細長い縫合材本体と、
b.前記細長い本体の第1の部分に配置され、前記第1の端に向けて配向された複数の第1の保持体であって、前記複数の第1の保持体は、前記第1の端の敷設方向に組織を通して前記縫合材が移動する間、前記縫合材本体に向かってたわみ、かつ組織内にある際には、前記第1の端の前記敷設方向と実質的に反対の方向に前記縫合材が移動することに抵抗する、複数の第1の保持体と、
c.前記細長い本体の第2の部分に配置され、前記第2の端に向けて配向された複数の第2の保持体であって、前記複数の第2の保持体は、前記第2の端の敷設方向に組織を通して前記縫合材が移動する間、前記縫合材本体に向かってたわみ、かつ組織内にある際には、前記第2の端の敷設方向と実質的に反対の方向への移動に抵抗する、複数の第2の保持体と、
d.前記複数の第1の保持体と前記複数の第2の保持体との間に配置された、保持体のない移行部分と、を備える、自己保持縫合材。
(22) 前記第1の保持体及び前記第2の保持体が1センチメートル当たり少なくとも250個の保持体密度を有する、実施態様21に記載の自己保持縫合材。
(23) 前記螺旋パターンが二重螺旋である、実施態様21に記載の自己保持縫合材。
(24) 前記螺旋パターンが四重螺旋である、実施態様21に記載の自己保持縫合材。
(25) 前記移行部分の長さが約0.5〜5mmであり、前記第1の部分及び前記第2の部分の長さが約70mm以下である、実施態様21に記載の自己保持縫合材。
(27) 前記移行部分の長さが約1mmである、実施態様25に記載の自己保持縫合材。
Claims (21)
- 軟口蓋持ち上げ手術用の外科手術キットであって、前記キットは縫合パッケージを備え、前記縫合パッケージが、
縫合材アセンブリであって、
周辺部と、第1及び第2の組織貫通端と、前記第1の組織貫通端と前記第2の組織貫通端とを接続する縫合糸スレッドと、を有し、前記第1及び第2の組織貫通端のそれぞれに曲率を有する針が備わっている、細長い縫合材本体と、
前記細長い本体の第1の部分に配置され、前記第1の端に向かって配向された複数の第1の保持体であって、前記第1の端の敷設方向に前記縫合材アセンブリが組織を通して移動される間に前記縫合材本体に向かってたわみ、かつ組織内にある際には、前記第1の端の敷設方向と実質的に反対の方向への前記縫合材アセンブリの移動に抵抗する、複数の第1の保持体と、
前記細長い本体の第2の部分に配置され、前記第2の端に向かって配向された複数の第2の保持体であって、前記第2の端の敷設方向に前記縫合材アセンブリが組織を通して移動される間に前記縫合材本体に向かってたわみ、かつ組織内にある際には、前記第2の端の敷設方向と実質的に反対の方向への移動に抵抗する、複数の第2の保持体と、
前記複数の第1の保持体と前記複数の第2の保持体との間に配置された、保持体のない移行部分であって、最高10mmまでの長さを有する、移行部分と、を含む、
縫合材アセンブリと、
を備えており、
前記針のそれぞれは、前記縫合糸スレッドに接続される前記針の近位端に近接する第1部分と、前記針の遠位端に近接する第2部分と、を有し、前記第1部分は、前記第2部分より小さい曲率半径を有する、
外科手術キット。 - 前記縫合材アセンブリの前記縫合材本体が生体吸収性の材料で構成される、請求項1に記載の外科手術キット。
- 前記縫合材アセンブリの前記縫合材本体が非吸収性の材料で構成される、請求項1に記載の外科手術キット。
- 前記移行部分の長さが0.5〜5mmである、請求項1に記載の外科手術キット。
- 前記移行部分の長さが0.5〜1.5mmである、請求項4に記載の外科手術キット。
- 前記移行部分の長さが約1mmである、請求項5に記載の外科手術キット。
- 前記第1の部分及び前記第2の部分が70mm未満の長さを有する、請求項1に記載の外科手術キット。
- 前記第1の部分及び前記第2の部分が50mm未満の長さを有する、請求項7に記載の外科手術キット。
- 前記第1の保持体及び前記第2の保持体が螺旋パターンに配置される、請求項1に記載の外科手術キット。
- 前記螺旋パターンが二重螺旋である、請求項9に記載の外科手術キット。
- 前記螺旋パターンが1センチメートル当たり少なくとも250個の保持体密度を更に備える、請求項10に記載の外科手術キット。
- 前記螺旋パターンが四重螺旋である、請求項9に記載の外科手術キット。
- 前記螺旋パターンが1センチメートル当たり少なくとも250個の保持体密度を更に備える、請求項12に記載の外科手術キット。
- 軟口蓋持ち上げ手術用の自己保持縫合材であって、
a.周辺部と、第1及び第2の組織貫通端と、前記第1の組織貫通端と前記第2の組織貫通端とを接続する縫合糸スレッドと、を有し、前記第1及び第2の端のそれぞれに双曲針が備わっている、細長い縫合材本体と、
b.前記細長い本体の第1の部分に配置され、前記第1の端に向けて配向された複数の第1の保持体であって、前記複数の第1の保持体は、前記第1の端の敷設方向に組織を通して前記縫合材が移動する間、前記縫合材本体に向かってたわみ、かつ組織内にある際には、前記第1の端の前記敷設方向と実質的に反対の方向に前記縫合材が移動することに抵抗する、複数の第1の保持体と、
c.前記細長い本体の第2の部分に配置され、前記第2の端に向けて配向された複数の第2の保持体であって、前記複数の第2の保持体は、前記第2の端の敷設方向に組織を通して前記縫合材が移動する間、前記縫合材本体に向かってたわみ、かつ組織内にある際には、前記第2の端の敷設方向と実質的に反対の方向への移動に抵抗する、複数の第2の保持体と、
d.前記複数の第1の保持体と前記複数の第2の保持体との間に配置された、保持体のない移行部分と、を備えており、
前記双曲針のそれぞれは、前記縫合糸スレッドに接続される前記双曲針の近位端に近接する第1部分と、前記双曲針の遠位端に近接する第2部分と、を有し、前記第1部分は、前記第2部分より小さい曲率半径を有する、
自己保持縫合材。 - 前記複数の第1の保持体及び前記複数第2の保持体が螺旋パターンで配置される、請求項14に記載の自己保持縫合材。
- 前記第1の保持体及び前記第2の保持体が1センチメートル当たり少なくとも250個の保持体密度を有する、請求項15に記載の自己保持縫合材。
- 前記螺旋パターンが二重螺旋である、請求項15に記載の自己保持縫合材。
- 前記螺旋パターンが四重螺旋である、請求項15に記載の自己保持縫合材。
- 前記移行部分の長さが約0.5〜5mmであり、前記第1の部分及び前記第2の部分の長さが約70mm以下である、請求項15に記載の自己保持縫合材。
- 前記第1の部分及び第2の部分の長さが約50mm以下である、請求項19に記載の自己保持縫合材。
- 前記移行部分の長さが約1mmである、請求項19に記載の自己保持縫合材。
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AU2017200682A1 (en) | 2017-02-23 |
NZ617993A (en) | 2015-04-24 |
JP6356063B2 (ja) | 2018-07-11 |
US10188384B2 (en) | 2019-01-29 |
JP6615799B2 (ja) | 2019-12-04 |
WO2012170468A1 (en) | 2012-12-13 |
CA2838706C (en) | 2020-12-15 |
CA2838706A1 (en) | 2012-12-13 |
JP2014523762A (ja) | 2014-09-18 |
AU2012268334A1 (en) | 2013-12-12 |
US20130172931A1 (en) | 2013-07-04 |
EP2717810B1 (en) | 2020-08-19 |
EP2717810A4 (en) | 2015-01-21 |
US20160000435A1 (en) | 2016-01-07 |
AU2017200682B2 (en) | 2018-10-18 |
EP2717810A1 (en) | 2014-04-16 |
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