JPH08266565A - 癒着装置、駆動工具及び移植方法 - Google Patents
癒着装置、駆動工具及び移植方法Info
- Publication number
- JPH08266565A JPH08266565A JP8072450A JP7245096A JPH08266565A JP H08266565 A JPH08266565 A JP H08266565A JP 8072450 A JP8072450 A JP 8072450A JP 7245096 A JP7245096 A JP 7245096A JP H08266565 A JPH08266565 A JP H08266565A
- Authority
- JP
- Japan
- Prior art keywords
- fusion device
- diameter
- adhesion
- shaft
- opposing
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Classifications
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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- A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
- A61B17/1662—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
- A61B17/1671—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the spine
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- A61F2/446—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
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Abstract
を提供する。 【解決手段】 体内癒着装置(10)は骨移植材料又は
代用骨材料を受け入れる中空内部(15)を備えたテー
パ状本体(11)を有する。本体は不連続的な外ネジ部
(18)を有する。癒着装置は切頭側壁(22)を有す
る。側壁は導管化開口(24、25)を備え、本体は骨
成長溝穴(27)を備える。移植ドライバー(50)を
側壁に係合させて外ネジ部の根元を完全円筒形にする。
ドライバーは椎骨間への癒着装置の挿入を容易にする。
癒着装置を椎骨間の空間へ所定量だけ挿入したとき、椎
骨における正常な前湾が回復される。前湾角度は装置の
テーパ度のみならず装置の挿入深さにより回復される。
癒着装置は椎骨の前方又は後方から容易に挿入できる。
装置は、前方挿入の場合は、適所にねじ込まれ、後方挿
入の場合は、前湾を回復すべく椎骨間を拡張するカムと
して作用する。
Description
去した後の椎骨間の空間内に配置すべき人工移植装置に
関する。特に、本発明は、特定の椎骨レベルでの正常な
脊椎構造を維持又は回復させつつ、隣接する椎骨間の間
接固定即ち癒着を容易にする移植装置に関する。
椎外科手術の数はここ数年の間に着実に増加している。
最も多い背中の下部の痛みの原因は、隣接する椎骨間の
脊椎板の損傷即ち欠損である。脊椎板はヘルニアになっ
たり、種々の変性状態になったりし、いずれの場合も、
脊椎板の構造上の機能が損なわれる。この種の変性状態
に対して最も一般に行われる外科処置は損傷した脊椎板
の両側の2つの椎骨を癒着することである。大半の場
合、切開処置により、体環を除いて全体の脊椎板を除去
する。損傷した脊椎板を除去してしまうため、除去によ
り生じた内部の円盤状の空間を何らかの物質で埋めなけ
ればならない。もし埋めなければ、空間が収縮し、脊柱
に沿って延びる神経を損傷させることとなる。
2つの隣接する椎骨を一緒に癒着させるように円盤状の
空間を骨又は代用骨で満たす。初期の技術においては、
典型的には、椎骨の後方部分において、隣接する椎骨間
に骨物質を単に挿入し、これらの椎骨を跨ぐプレート又
はロッドにより脊柱を安定させていた。この技術によれ
ば、癒着が生じた後、セグメント(椎骨)の安定を維持
するために使用したハードウエアは不必要となってい
た。更に、癒着中に椎骨レベルを安定させるためにロッ
ド又はプレートを移植するのに必要な外科処置は時間が
かかることが多く、複雑であった。
最適な解決策は、脊椎の前方又は後方でプレート移植を
行うことなく、それぞれの端プレート間で椎骨を癒着す
ることであることが判明した。損傷した脊椎板に代わっ
て使用でき、少なくとも完全な間接固定が達成されるま
で隣接する椎骨間の円盤状の空間の安定化を維持できる
許容可能な空間移植装置を開発するための多数の試みが
なされてきた。このような「体内癒着装置」は種々の形
状を呈していた。例えば、最も一般的な形状の装置の1
つは、円筒状(円柱状)移植装置である。この種の移植
装置は米国特許第4,501,269号、同第4,87
8,915号、同第4,961,740号、同第5,0
55,104号及び同第5,015,247号各明細書
に開示されている。これらの円筒状移植装置において
は、円筒体の外側部分にネジ部を設けて、体内癒着装置
の挿入を容易にしている。代わりの方法としては、一部
の癒着装置は円盤状の空間及び端プレート内に拘束され
るように設計する。この種の装置は米国特許第4,74
3,256号、同第4,834,757号及び同第5,
192,327号各明細書に開示されている。
置の横断面はその全長にわたって一定で、典型的には完
全な円筒形を呈している。一定の横断面を持たない他の
移植装置も体内癒着のために開発されてきた。例えば、
米国特許第4,714,469号明細書は椎骨の端プレ
ート内へ突出する細長い突起を備えた半球状の移植装置
を開示している。米国特許第4,349,921号明細
書は補綴と隣接する椎骨本体との間の摩擦嵌合を最適化
するように形状づけられた小球状の補綴を開示してい
る。また、米国特許第4,936,848号明細書に開
示された移植装置は、好ましくは隣接する椎骨の椎体間
に位置する球体の形をしている。
とができる。すなわち、中実移植装置と、骨の内部成長
を許容するように設計された移植装置とに分類すること
ができる。中実移植装置は米国特許第4,878,91
5号、同第4,743,256号、同第4,349,9
12号及び同第4,714,469号各明細書に開示さ
れている。残りの上述の米国特許明細書には、移植装置
を横切っての骨の成長を許容する形態が記載されてい
る。骨の自然内部成長を促進する装置は一層迅速で安定
した間接固定を達成させることが判明した。米国特許第
5,015,247号明細書に開示された装置はこの種
の型式の中空移植装置の代表例で、装置を円盤状の空間
内へ挿入する前に、装置に同原の骨を充填する。この移
植装置は、移植装置の中空内部に連通する複数個の円形
開口を備え、移植装置において椎骨端プレートと骨又は
代用骨との間に組織成長用の経路を提供する。円盤状の
空間の準備に当たり、好ましくは、組織の成長を容易に
するため骨を抽出するように端プレートを減少させる。
癒着期間中、上記米国特許第5,015,247号明細
書に開示された移植装置により提供される金属構造体は
癒着すべきセグメントの運動の開放及び安定化の補助を
なす。更に、間接固定が生じた後は、移植装置自体は中
実骨質量のためのアンカーとしての機能を果たす。
半の体内癒着装置は依然として多数の欠点を有する。骨
又は代用骨内への骨の成長を許容する中空移植装置は癒
着を達成するための最適の技術であることは分かってい
るが、従来の大半の装置においては、少なくともロッド
やプレートの如き付加的な安定装置を使用せずに、癒着
を達成することが困難である。更に、従来装置のなかに
は、最も頻繁に癒着される椎骨レベル(即ち、下部の腰
椎における椎骨)に加わる大きな負荷及び曲げモーメン
トを支えるのに十分な構造上の強度を有しないものもあ
る。
生じるまで脊椎セグメントを支持するのに十分な強度を
維持させる中空体内癒着装置を提供する必要性が指摘さ
れている。本発明者等によれば、骨の内部成長のための
開口は移植装置内に詰め込まれる同原の骨を応力から守
るという重要な役割を果たすことが判明した。換言すれ
ば、内部成長用の開口の寸法又は形状が不正確であった
場合、同原の骨は迅速で完全な癒着を保証するに必要だ
と分かっている負荷に耐えることができない。この例に
おいては、移植装置内に詰め込まれる骨は、不安定な構
造体を生じさせるような骨癒着質量内ではなく、単純な
繊維組織内に吸収されるか繊維組織内で発展する。一
方、骨内部成長用の開口は、ケージが隣接する椎骨への
陥没を避けるに十分な支えを提供できないようになるほ
ど大きくてはならない。
題は、癒着された脊椎セグメントの正常な構造の維持及
び回復である。普通、脊椎板を除去した後、脊椎の正常
な前湾曲又は後湾曲が消去される。従来の装置では、こ
の湾曲を回復させる必要性がおろそかにされている。例
えば、上記米国特許第4,501,269号明細書に開
示された如きある型式の市販の装置(米国スパインテッ
チ社(SpineTech) のBAK装置)においては、隣接する
椎骨本体は特定の移植装置に適合する円筒状リーマーに
より穴明けされる。ある場合には、穴明け前に正常な湾
曲が確立され、次いで、移植装置を挿入する。この型式
の構造は取り扱われる円盤状の空間に隣接する実質上健
康な椎骨内への円筒状移植装置の侵入深さを表す図1に
示されている。しかし、後方部分における過剰穴明けは
実質的に許容できない。その理由は、椎骨の荷重支持骨
が除去されてしまうからであり、また、前湾が最大とな
る下方の腰椎セグメントの後方部分に対して穴明けを行
うことが一般に困難だからである。この型式の移植装置
を使用する大半の場合、前湾曲を回復させるための努力
は行わず、従って、移植装置のまわりで椎骨を安定させ
るときに、円筒状の移植装置により後湾変形が生じ易く
なってしまう。この現象が生じると、脊椎が不平衡にな
るため、修正手術が必要となる場合が多い。
度と安定性とを維持したまま骨の内部成長を最適化でき
る体内癒着装置を提供する必要性が残っている。更に、
取り扱われるセグメントにおける正常な脊椎構造を維持
又は回復させることのできる移植装置を提供する必要性
もある。このような移植装置は、長期にわたり安定性を
維持しながら、取り扱われる椎骨レベルで脊椎に作用す
る大きな荷重を支持しこれに耐えるのに十分な強度を有
する必要がある。
ずに残っている必要性に鑑み、本発明は、隣接する椎骨
間の正常な角度関係を回復するように形状づけられた中
空のネジ付き体内癒着装置を提供する。特に、この癒着
装置は、実質上全長にわたってテーパし、中空内部を画
定し、隣接する椎骨間の空間の寸法より大きな外径を有
する細長い本体を含む。この本体は反対側にテーパした
円筒部分と、これらの円筒部分間に位置した一対の対向
する平坦なテーパ状の側表面とを備えた外表面を有す
る。従って、端面図において、癒着装置は円筒状本体の
形を呈し、本体の側部は本体の外径の弦に沿って切断さ
れている。円筒部分はネジ部を備え、隣接する椎骨の端
プレートに対する制御された挿入及び係合を可能にす
る。
(本発明の一実施例において)下方の腰椎骨の正常な前
湾角度に対応する角度で、全長に沿ってテーパしてい
る。また、外表面は平坦な側表面により画定された多数
の導管化開口と、円筒部分により画定された一対の対向
する細長い骨成長用溝穴(スロット)とを具備する。骨
成長用溝穴は横幅を有し、好ましくは、この横幅は溝穴
を画定する円筒部分の有効幅の約半分である。
るために駆動工具を使用する。1つの特徴においては、
駆動工具は一対の対向したテーパ状の舌片を一端に備え
たシャフトを有する。舌片はヒンジ溝穴によりシャフト
に連結され、このヒンジ溝穴は舌片間に癒着装置を収容
するために舌片を互いに離間させるように偏倚する。駆
動工具は更に、シャフトのまわりでこれと同心的に位置
したスリーブを具備し、このスリーブは、シャフトに沿
って摺動し、ヒンジを圧縮することによって舌片を一緒
に押圧して癒着装置を把持させるような形状を有する。
代わりに、内側に延びるコレットを使用し、挿入期間中
癒着装置を内側で固定保持するようにしてもよい。
舌片は癒着装置のテーパ状円筒部分の形に対応する外表
面を有する。舌片はまた、癒着装置の平坦な側表面に対
応する平坦な内向きの表面を有する。従って、舌片が癒
着装置に対して圧縮されたとき、舌片の内向きの表面が
癒着装置の平坦な側表面に接触し、舌片の外表面が癒着
装置の円錐形状を完成させ、ねじ込み挿入を容易にす
る。舌片の内向きの表面は癒着装置の開口に係合する突
起を具備することができ、この場合、内部の円盤状の空
間内での癒着装置の駆動及び回転が可能となる。
隣接する椎骨間に移植する方法が提供される。一方法に
おいては、前方から椎骨に接近し、円盤状の空間を拡張
する工程と、隣接する椎骨の端プレートに癒着装置のネ
ジの直径より小さな穴をドリルで明ける工程とを有す
る。スリーブを挿入して、ドリル穴明け工程及び次の癒
着装置の移植工程のための作業チャンネルを提供する。
移植装置は駆動工具に係合し、スリーブを通して挿入さ
れ、準備されたボア内にねじ込まれる。テーパ状の癒着
装置の挿入深さが隣接する椎骨に対して行われる角度的
な分離の量を決定する。
後部に準備する。すなわち、円盤状の空間を拡張し、小
径の穴を椎骨の端プレートにドリルで明ける。また、ス
リーブを配置して、ドリル穴明け工程及び挿入工程のた
めの作業チャンネルを提供する。平坦な側表面が隣接す
る椎骨に対面するように、癒着装置をドリル穴に挿入す
る。次いで、装置を回転させ、円筒部分の外ネジ部を隣
接する椎骨にネジ係合させる。更に、癒着装置がテーパ
状を呈するので、装置のテーパ状外表面が隣接する椎骨
を角度的に引き離し、正常な構造上の前湾を回復させ
る。
示す実施例を参照するが、実施例を説明するために特定
の用語を使用する。しかし、実施例は本発明を限定する
ものではなく、当業者なら、図示の装置の種々の変形及
び修正が可能であり、図示のような本発明の原理を別の
応用に供することができることは言うまでもない。
図2−5に示す。この装置は、好ましくは生物学的に矛
盾を生じない材料又は不活性材料で作った中実の円錐本
体11により構成されている。例えば、本体11は医学
的な等級のステンレス鋼或いはチタン、又は十分な強度
特性を有する他の適当な材料で作ることができる。ま
た、この装置は米国インプレックス社(Implex Corp.)に
より提供される多孔性タンタルの如き生物学的に矛盾を
生じない多孔性材料で作ることもできる。装置10は前
端12と後端13とを有し、これらの端部は内部の円盤
状の空間内に移植したときに装置10の構造上の位置に
対応する。円錐本体11は中空内部15を備え、この中
空内部は本体壁16により境界を定められ、後端13は
端壁17(図3)により閉じてある。装置10の中空内
部15は隣接する椎骨間で内部の円盤状の空間を横切っ
ての固体癒着を促進するに適した移植骨又は代用骨材料
を受け入れるような形状を有する。
する椎骨の端プレート内にねじ込まれるような形状を有
するネジ付き装置である。本発明の一実施例において
は、円錐本体11は一連の中断した(即ち、不連続的
な)外ネジ部18と、装置の先端に位置した完全な(即
ち、連続的な)ネジ部19とを有する。連続的なネジ部
19は内部の円盤状の空間内で椎骨の端プレート内に移
植装置をねじ込むための「スタータ」ネジ部としての機
能を果たす。ネジ部18、19は椎骨に係合するように
従来知られている種々の形をとることができる。例え
ば、これらのネジ部は三角形横断面又は切頭三角形横断
面を有することができる。好ましくは、これらのネジ部
は、脊椎に作用する大きな荷重によって装置10が内部
の円盤状の空間から飛び出さないように、椎骨内で十分
なてこ作用を提供するために1.0mm(0.038イ
ンチ)の高さを有する。ある特定の実施例におけるネジ
のピッチは、装置10を移植する椎骨レベル及び移植装
置を適所に保持するに必要なネジ係合の量に応じて、
2.3mm(0.091インチ)又は3.0mm(0.
118インチ)とすることができる。
(特に、本体壁16)は、図4に明示するように、平行
な切頭側壁22を有する。好ましくは、これらの側壁は
平坦となっていて、隣接する椎骨の端プレート間への癒
着装置の挿入を容易にし、これらの間に骨癒着用の領域
を提供する。切頭側壁は装置の前端12から後端13に
おける連続的なネジ部19まで延びる。従って、切頭側
壁22があるため、端面図において、装置10は不完全
円(円の弦に沿って切除した側部を有するもの)を呈す
る。1つの特定の例においては、体内癒着装置10の前
端の直径は16.0mm(0.630インチ)である。
この特定の実施例においては、切頭側壁22はほぼ1
2.0mm(0.472インチ)だけ離れた平行な弦
(線)に沿って形成され、従って、円の除去された円弧
部分は装置の各側部においておよそ90°の角度の内角
を有する。癒着装置10の切頭側壁22により提供され
る他の利点は後に詳述する。
2に設けた一対の導管化開口24、25を有する。これ
らの開口24、25は、癒着装置を内部の円盤状の空間
内に移植したときに、横方向に指向する(即ち、サジタ
ル面に対向する)ようになっている。これらの開口は中
空内部15内の骨移植材料とそのまわりの組織との間に
生じる導管化のための通路を提供するものである。更
に、これらの開口を通して骨の内部成長が生じる場合も
ある。開口24、25は、隣接する椎骨間の内部の円盤
状の空間を横切って作用する大きな軸方向の荷重を支え
るのに十分な量の構造体を円錐本体11内に維持させた
状態で、導管化を生じさせるための最適な通路を提供す
るような寸法を有する。
溝穴(スロット)27を備え、各溝穴は切頭側壁22に
対して90°の角度で指向している。好ましくは、これ
らの溝穴27は、装置10を移植したとき、椎骨の端プ
レートにじかに隣接する。詳細には、装置のネジ部1
8、19が椎骨の端プレート内にねじ込まれたとき、椎
骨は溝穴27内へ部分的に延び、装置10の中空内部1
5内に収容された骨移植材料に接触する。図5に明示す
るように、骨成長用の溝穴27は、完全な間接固定及び
固体癒着を保証するために、骨の成長にとって最適の開
口を提供するような形状を有する。好ましくは、これら
の溝穴は本体のネジ部の有効幅にほぼ匹敵する横方向の
幅を有する。複数個の小さな開口を備えた従来の装置は
骨材料の迅速な固体間接固定を促進できないことが判明
した。逆に、小さな開口は繊維組織の疑似関節症及び発
生を頻繁に生じさせてしまう。本発明の骨成長用溝穴2
7は椎骨にじかに対面しているため、これらの溝穴は大
きな荷重に耐えねばならない装置の部分に位置していな
い。逆に、切頭側壁22は、不連続的なネジ部18を介
して椎骨の端プレート間を通り内部の円盤状の空間を横
切る荷重の大半を支える。
は一対の直径方向で対向したノッチ(切欠き)29を備
えることができ、これらのノッチは後述の移植駆動工具
に係合できるような形状を有する。更に、移植装置の後
端13における端壁17は工具係合特性(図示せず)を
備えることができる。例えば、六角形のくぼみを設け
て、六角形の駆動工具を係合させることもできる。これ
については後に説明する。
においては、本体11はテーパ状即ち円錐状を呈してい
る。換言すれば、前端12における装置の外径は後端1
3における外径より大きい。図3に示すように、本体壁
16は装置10の中心線CLに対して角度Aでテーパ
(傾斜)している。本体壁16のこの傾斜は隣接する椎
骨間の正常な相対角度を回復させるのに適する。例え
ば、腰椎領域において、この角度Aはこの領域における
脊椎の正常な前湾角度即ち湾曲度を回復させるに適す
る。1つの特定の例においては、角度Aは8.794°
である。移植装置はテーパしていない部分を備えてもよ
い。ただし、この部分がテーパ状の本体の機能に抵触し
ない場合に限る。
み合わされる移植装置のテーパ角度Aは、移植装置を適
所にねじ込むときに隣接する椎骨間に生じる角度的な分
離の量を決定する。この特徴は、一対の癒着装置10を
使用する好ましい構造を示す図6、7に明示されてい
る。図示の構造において、装置10は下方の腰椎骨L
4、L5間に位置し、ネジ部18、19は2つの椎骨の
端プレートE内にねじ込まれている。図7に示すよう
に、装置10を端プレートE内にねじ込むとき、装置は
椎骨レベルの枢軸Pに向かって矢印Iの方向へ前進す
る。枢軸Pは運動セグメントとしての隣接する椎骨間の
相対回転の公称中心である。テーパ状の癒着装置10が
枢軸Pに向かって矢印Iの方向へ更に駆動されると、隣
接する椎骨L4、L5は矢印Sの方向に角度的に拡張さ
れる。癒着装置10の挿入の深さが2つの椎骨間で達成
される最終前湾角度Lを決定する。
前端12での外径即ちネジ山の直径は16mm、18m
m又は20mmとすることができ、装置の全長は26m
mとすることができる。装置の寸法は、装置を移植する
椎骨レベル及び達成すべき角度の量により決まる。
寸法は、図6に示すように、2つの円筒状本体11を単
一の円盤状空間内へ移植できるようなものとする。これ
により、装置10間及び装置のまわりに付加的な骨移植
材料を配置することができる。この形態は内部の円盤状
空間を横切る癒着を更に促進し、特定の椎骨レベルでの
大きな軸方向の荷重による駆逐を阻止するために隣接す
る椎骨間で装置を一層強固に係留する役目を果たす。
おいては、導管化開口24は実質上矩形形状を呈し、そ
の寸法は6.0mm(0.236インチ)×7.0mm
(0.276インチ)である。同様に、導管化開口25
も矩形形状を呈し、その寸法は4.0mm(0.157
インチ)×5.0mm(0.197インチ)である。当
然のことながら、この開口25は、装置10の小径の後
端13に位置しているので、開口24より小さい。骨成
長用溝穴27も矩形形状を呈し、その長さは20.0m
m(0.787インチ)であり、幅は6.0mm(0.
236インチ)である。導管化開口24、25及び溝穴
27のこのような寸法は最適な骨の内部成長及び導管化
を提供することが判明した。更に、これらの開口は、装
置の構造上の完全性を損ない、または、移植中中空内部
15内に収容された骨移植材料が容易に追い出されるほ
ど大きくはない。
間の適所に配置したとき、導管化開口24、25は側部
を向き、椎骨のまわりの密に導管化された組織に接触す
る。更に、図6に示すように、骨成長用溝穴27は軸方
向に向き、椎骨の端プレートEに接触する。
は、体内癒着装置30は円錐本体31を有する。先の実
施例の癒着装置10と同様、本体壁34は中空内部33
を画定する。しかし、この実施例においては、切頭側壁
38は導管化開口を備えていない。更に、装置30の両
側の骨成長用溝穴39は一層小さい。このことは、装置
30の外表面上の不連続的なネジ部36が移植装置のま
わりで一層長い距離にわたって延びることを意味する。
この構成は、組織の内部成長及び隣接する骨への係留の
ための付加的な表面積を提供するために多孔性材料(例
えば、多孔性タンタル)を使用した場合に、採用され
る。また、図8に示す実施例のこの体内癒着装置30
は、装置の追い出し(駆逐)の可能性が最大となる椎骨
レベルにおける応用に供することができる。この場合、
ネジ接触の量が増大し、装置の追い出しを防止できる。
装置の挿入前に、挿入を容易にするために癒着装置30
の中空内部33を骨又は代用骨で完全に満たす。
移植ドライバー50(図9)を用いて移植することがで
きる。移植ドライバー50はシャフト51と、このシャ
フトのまわりでこれと同心的に位置したスリーブ52と
を有する。移植のために体内癒着装置10を把持するた
めの舌片54をシャフトの一端に設ける。これらの舌片
はテーパ状の外表面55と、体内癒着装置の切頭側壁2
2に係合するようになった対向する平坦な内表面56と
を有する。テーパ状の外表面55は不連続的なネジ部1
8の根元の直径に適合し、このため、舌片4は本体壁1
6の完全円筒形状を実質上完成させる。舌片のテーパ状
の外表面55の採用により、体内癒着装置10のネジ挿
入が容易になる。その理由は、外表面55が椎骨の端プ
レートに設けたネジ穴内で移動できるからである。
56から延びる駆動突起59とを具備する。これらの素
子の機能は図11に明示する。まず図9を参照すると、
シャフト51は対をなす各舌片54を支持するヒンジ溝
穴62を有する。ヒンジ溝穴62は、舌片がテーパ状の
体内癒着装置10を舌片間に挿入できるのに十分な程度
に拡張した自然偏倚位置を有するように形状づけられて
いる。シャフト51はヒンジ溝穴62と各舌片54との
間に位置した円錐状のテーパ部63を有する。この円錐
状のテーパ部はスリーブ52の内壁に設けた円錐状の面
取り部67に適合する。従って、スリーブ52を舌片5
4の方へ前進させたとき、円錐状の面取り部67が円錐
状のテーパ部63に当接し、ヒンジ溝穴62を閉じ、こ
れを圧縮する。このため、舌片54は互いに近づくよう
に押圧され、舌片間に位置した体内癒着装置に把持係合
する。
(インターフェイス)65を具備し、シャフトの長手方
向に沿うスリーブ52の前後ネジ運動を可能にする。特
に、ネジ対面65はシャフト51上の外ネジ部と、これ
と同じピッチでスリーブ52に設けた内ネジ部とを有
し、このため、スリーブは移植ドライバー50に沿って
容易に移動できる。シャフト51はまた、体内癒着装置
10を受け入れるのに十分な距離だけ舌片54を離間さ
せるに必要な程度にスリーブ52の後方(逆戻り)運動
を制限する一対のストッパ69を具備する。
1に示す。図10に示すように、舌片54の外表面55
は不連続的なネジ部18の根元の直径部分と実質上同じ
面内に位置する。図11に示すように、相互係止フィン
ガ58は各切頭側壁22の導管化開口24内に嵌合する
ように配置することができる。同様の方法で、駆動突起
59は円錐本体11の前端12における駆動工具溝穴2
9に係合する。相互係止フィンガ58と駆動突起59と
の組み合わせにより、体内癒着装置10を強固に把持
し、装置を椎骨のネジ穴又はネジの無い穴にねじ込むこ
とができる。移植ドライバーの別の実施例を図12に示
す。このドライバー90は患者の外側から内部の円盤状
の空間へ到達するのに十分な長さのシャフト91を有す
る。シャフト91の一端に連結したヘッド92は一対の
対向する舌片93を備え、各舌片は癒着装置10の平坦
な切頭側壁22に密着するような形状を有する。前述の
移植ドライバー50の舌片54と同様、舌片の外表面は
装置のネジ付き円筒部分に対応する円筒形状を呈する。
実施例のドライバー90は人体内へ挿入される癒着装置
10を強固に把持するために拡張するコレット組立体を
使用する。特に、ヘッド92は中央の貫通コレットボア
95を備えたコレット94を有する。コレット94は環
状フランジ96で終端し、このフランジは、少なくとも
初期の状態では、前端12における癒着装置10の内径
よりも僅かに小さな直径を有する。エキスパンダーシャ
フト97はコレットボアを通って摺動自在に延び、環状
フランジ96に隣接して位置しこのフランジを僅かに越
えて延びる開拡チップ98を有する。エキスパンダーシ
ャフト97の開拡チップ98はコレットボア95内で摺
動できるような寸法の直径から出発し、ボアより大きな
直径まで漸進的に開拡する。
100内に摺動自在に配置された引っ張りシャフト99
を有する。この引っ張りシャフト99はその一端に係止
室101を備え、この係止室はエキスパンダーシャフト
97の端部に設けた係止ハブ102に係合する。引っ張
りシャフト99は外科医が触手できるようにシャフト9
1の端部を越えて突出している。引っ張りシャフト99
を引っ張ったとき、このシャフトがエキスパンダーシャ
フト97を引っ張ってコレット94の環状フランジ96
から引き離し、その結果、開拡チップ98はコレットボ
ア95内に徐々に進入する。開拡チップ98がコレット
ボア95内で更に前進したとき、環状フランジ96は、
初期の直径から、癒着装置10の内部に強固に把持係合
する一層大きな第2直径まで、拡張する。癒着装置がこ
のように係合すると、移植ドライバーを使用して、装置
10を手術箇所内へ挿入することができ、その後、コレ
ットボアを越えてエキスパンダーシャフトを前進させ、
開拡チップ従って癒着装置を解放することができる。
するための2つの方法が提供される。まず、前方から接
近する方法を図13(a)、(b)及び図14(a)、
(b)に示す。予備工程として、癒着装置を移植するた
めの適当な開始地点を(好ましくは、両側で)位置決め
する必要がある。この前方接近方法の第1工程において
は、拡張器75を椎骨の端プレートE間に配置し、椎骨
L4、L5間の円盤状の空間を拡張させる。(もちろ
ん、この工程は他の椎骨レベルにも適用できる。)図1
3(b)に示す第2工程においては、外側スリーブ76
を円盤状の空間のまわりに配置する。外側スリーブ76
は、外側スリーブ76を適所に一時的に強固に係留する
ために椎骨本体の前方部分に確実に係合するような既知
の形状とすることができる。事実、この外側スリーブ7
6はこのラパロスコピー型式の接近のための作業チャン
ネルとして作動する。図13(b)に示す工程において
は、既知の構成のドリル77を外側スリーブ76内に進
入させ、隣接する椎骨本体に円形のドリル開口を形成す
る。癒着装置のネジ挿入を容易にするためにこれらの開
口をネジ切りしてもよいが、このネジ切り(ネジ形成)
は必須ではない。
移植ドライバー50を癒着装置10に係合させ、スター
タネジ部19が骨の開口に接触するまで、外側スリーブ
76内で移植装置を前進させる。次いで、移植ドライバ
ー50を回転させて、癒着装置を椎骨の端プレートEの
ネジ穴又はネジの無い穴へ螺入することができる。この
工程においては、装置10の前端12における駆動工具
溝穴29に係合するネジ回し型式の装置の如き他の適当
な駆動工具を使用できることは言うまでもない。上述の
ように、癒着装置10の挿入の度合いが椎骨レベルにお
いて生じさせるべき(又は回復させるべき)前湾の量を
決定する。最終工程においては、移植ドライバーを取り
外し、癒着装置10を適所に残す。移植が終了した後、
閉じた端壁17が椎骨の後方に向いていることが分か
る。中空内部15は前端で開いているが、必要なら、プ
ラスチック材料又は金属材料で閉じることもできる。
(b)に示す本発明の第2の方法は、後方から接近する
方法である。この後方接近方法の最初の2つの工程は前
方接近方法の最初の2つの工程と類似しているが、異な
る点は、拡張器75、外側スリーブ76及びドリル77
を後方から取り扱い領域へ導入する点である。この接近
方法では、外側スリーブ76の導入を可能にするために
椎骨の剥皮及び部分除去が必要となることがある。この
方法の第3工程においては、外側スリーブ76を通して
拡張した円盤状の空間内へ癒着装置10を挿入する。円
盤状の空間は、切頭側壁22を椎骨の端プレートEにじ
かに対面させた状態で移植装置を収容するに必要な程度
だけ拡張されることに留意されたい。従って、図16
(a)に示すように、骨成長用溝穴27は最終移植位置
として望ましい頂部方向ではなく横方向に向いている。
適当な駆動工具80を用い、外側スリーブ76を通して
内部の円盤状空間内へ癒着装置10を突出させることが
できる。一実施例においては、駆動工具80は癒着装置
10の後端13の端壁17に設けた溝穴開口に係合でき
るような形状を有する突起81を具備する。内ネジ部
(図示せず)を設けて装置10を駆動工具80に固定で
きる。
装置10を内部の円盤状空間内へ前進させた後、駆動工
具80を使用して移植装置を図16(a)の回転矢印R
の方向へ回転させる。駆動工具80が回転すると、装置
自体が回転し、不連続的なネジ部18が端プレートEに
おいて椎骨内へねじ込まれ始める。このように、移植装
置はカムとして作用し、隣接する椎骨を図16(a)の
矢印Sの方向へ離間させる。このカム作用は、回転運動
だけで移植装置を椎骨内に係止できる幾分簡単な挿入動
作を提供する。これに反し、前述したねじ込み挿入技術
は適所への装置の連続的なねじ込みを必要とする。
関する癒着装置の位置はレントゲン写真又は椎骨間の角
度関係を確立するための他の適当な技術により確認でき
る。代わりに、移植装置の好ましい挿入深さは予め決定
でき、また、移植装置を椎骨間に位置きめするときに患
者の外側から測定できる。
び本発明の技術は従来の装置及び技術より優れた顕著な
利点を提供する。特に、癒着装置10は、移植装置自体
の完全性を維持した状態で、隣接する椎骨間での骨癒着
の可能性を最大化する中空のネジ付き移植装置を提供す
る。脊椎はその軸方向の長さに沿った大きな荷重に耐え
るが、その荷重は、少なくとも固体癒着が達成されるま
では、癒着装置10により支えねばならない。装置10
はまた、癒着速度を増大させ癒着した骨質量の強度を高
める導管化及び組織の内部成長を生じさせる手段をも提
供する。別の重要な利点は、移植装置のテーパ形状によ
り、外科医が椎骨間の湾曲度即ち相対角度を回復させ、
維持できることである。これにより、累積変形が発生し
脊椎が不平衡になるという従来装置に関連する重大な問
題を回避できる。本発明の癒着装置及び移植ドライバー
により達成される別の利点はラパロスコピー技術を利用
して前方又は後方のいずれかからの挿入が可能になるこ
とである。椎骨レベルに応じて、前方又は後方のいずれ
かからの接近が好ましく、従って、移植装置がいずれか
の方向から挿入できることは重要である。装置の制御さ
れた挿入は、前方からの挿入及びスライド挿入のために
使用されるねじ込み技術(打撃挿入技術とは異なる)並
びに後方からの挿入のために使用されるカム方法により
行われる。
詳細に説明したが、実施例は単なる例示にすぎず、本発
明の特徴を限定するものではなく、本発明の要旨内で種
々の変形及び修正が可能であることは言うまでもない。
例えば、装置10を脊椎に使用するものとして説明した
が、本発明の装置及び方法はくるぶしの関節や手首の関
節等の如き他の関節空間にも使用できる。更に、好まし
い実施例の装置10はその全長に沿ってテーパしていた
が、本発明の要旨内で、装置はテーパ形状でなくてもよ
いし、逆方向にテーパしていてもよい。
ある。
視図である。
面図である。
である。
2の2つの体内癒着装置を示す脊椎の前方から見た図で
ある。
癒着装置のサジタル面における図である。
斜視図である。
図である。
合する移植ドライバーの端部の拡大斜視図である。
移植ドライバーを示す拡大部分断面側面図である。
に係る移植ドライバーを示す拡大部分断面側面図であ
る。
着装置を移植するための本発明の一形態に係る方法の第
1工程を示す図、図13(b)は同方法の第2工程を示
す図である。
す図、図14(b)は同方法の第4工程を示す図であ
る。
着装置を移植するための本発明の別の形態に係る方法の
第1工程を示す図、図15(b)は同方法の第2工程を
示す図である。
す図、図16(b)は同方法の第4工程を示す図であ
る。
Claims (27)
- 【請求項1】 隣接する椎骨間の円盤状空間内での関節
固定を容易にするための癒着装置において、 所定の長さと、隣接する椎骨間の空間より大きな第1端
部での第1直径とを有し、骨移植材料を収容するような
寸法の中空内部を備えた細長い本体であって、一対の対
向する円筒部分と、該対向円筒部分間で一対の実質上平
坦な対向する側壁とを備えた外表面を有し、当該側壁が
上記所定長さに沿って延びている細長い本体;及び上記
外表面の上記一対の対向する円筒部分上に設けられ、上
記本体の実質上全長に沿って延びる外ネジ部;から成る
ことを特徴とする癒着装置。 - 【請求項2】 上記本体が上記所定長さの実質的な部分
に沿ってテーパしており、上記第1直径より大きな第2
直径の第2端部を有することを特徴とする請求項1の癒
着装置。 - 【請求項3】 上記対向する側壁が上記中空内部に連通
する多数の開口を備えていることを特徴とする請求項1
の癒着装置。 - 【請求項4】 上記ネジ部にわたって上記円筒部分に設
けられ、上記中空内部に連通した一対の直径方向で対向
する溝穴を更に備え、これらの対向する溝穴が上記本体
の上記所定長さに沿って細長くなっており、上記多数の
開口より大きくなっていることを特徴とする請求項3の
癒着装置。 - 【請求項5】 上記ネジ部にわたって上記円筒部分に設
けられ、上記中空内部に連通した一対の直径方向で対向
する溝穴を更に備え、これらの対向する溝穴が上記本体
の上記所定長さに沿って細長くなっていることを特徴と
する請求項1の癒着装置。 - 【請求項6】 上記対向する溝穴が矩形形状を呈し、上
記本体の上記所定長さを横断する幅寸法を有し;上記円
筒部分が上記対向する側壁と当該対向する溝穴との間に
有効幅を有し;該対向する溝穴の上記幅寸法が当該円筒
部分の上記有効幅より大きいことを特徴とする請求項5
の癒着装置。 - 【請求項7】 上記平坦な側壁が上記第1端部の近傍で
終端しており;上記円筒部分及び上記ネジ部が、当該側
壁により中断されるが、当該第1端部においては円周方
向で連続していることを特徴とする請求項1の癒着装
置。 - 【請求項8】 上記本体の上記第1端部が閉じられてお
り、当該第1端部に対向する第2端部が上記中空内部に
通じていることを特徴とする請求項1の癒着装置。 - 【請求項9】 上記本体が上記第1端部に対向する第2
端部を有し、この第2端部が上記中空内部に通じている
ことを特徴とする請求項1の癒着装置。 - 【請求項10】 上記本体が上記第1端部に対向する第
2端部を有し;上記平坦な側壁が上記第2端部で終端し
ていることを特徴とする請求項1の癒着装置。 - 【請求項11】 上記対向する各側壁が、癒着装置を移
植するための駆動工具を収容できる形状を有するノッチ
を上記第2端部に備えたことを特徴とする請求項10の
癒着装置。 - 【請求項12】 隣接する椎骨間の円盤状空間内での関
節固定を容易にするための癒着装置において、 所定の長さと、第1端部での第1直径と、上記第1端部
に対向する第2端部でのより大きい第2直径とを有する
細長い本体を備え、上記第1及び第2直径が隣接する椎
骨間の空間より大きくなっており、上記本体が骨移植材
料を収容するような寸法の中空内部を更に備え;上記本
体が、上記第1直径から上記第2直径までテーパした外
表面を有し、この外表面が、当該本体の上記所定長さに
沿って実質上その全長にわたって延びる外ネジ部を具備
する;ことを特徴とする癒着装置。 - 【請求項13】 上記ネジ部にわたって上記外表面に設
けられ、上記中空内部に連通した一対の直径方向で対向
する溝穴を更に備え、これらの対向する溝穴が上記本体
の上記所定長さに沿って細長くなっていることを特徴と
する請求項12の癒着装置。 - 【請求項14】 上記本体の上記第1端部が閉じられて
おり、上記第2端部が上記中空内部に通じていることを
特徴とする請求項12の癒着装置。 - 【請求項15】 対向する平坦な側壁により中断され外
ネジ部を備えた円筒状外表面を有する本体を具備した体
内癒着装置を隣接する椎骨間の空間内に移植するための
駆動工具において、 細長いシャフトと;ヒンジにより上記シャフトの一端に
連結された一対の対向する舌片と;から成り、 上記舌片が互いに離れるように偏倚されており、 上記各舌片が上記癒着装置の上記対向する平坦な側壁に
接触するような形状の内向き表面と、当該癒着装置の上
記円筒状外表面に適合するような形状の外向き表面とを
有する、ことを特徴とする駆動工具。 - 【請求項16】 上記癒着装置が上記平坦な側壁に設け
られた開口を備え、上記各舌片の上記内向き表面が、同
内向き表面から延びて、当該内向き表面が当該平坦な側
壁に接触したときに当該癒着装置の該平坦な側壁に設け
た対応する開口内へ突出するように配置されたフィンガ
を有することを特徴とする請求項15の駆動工具。 - 【請求項17】 上記シャフトのまわりでこれと同心的
に位置し、上記舌片を互いに近づくように押圧すべく上
記ヒンジを圧縮し、当該舌片間に位置した上記癒着装置
を同舌片により把持させるために当該シャフト上で軸方
向に移動できるスリーブを更に備えたことを特徴とする
請求項15の駆動工具。 - 【請求項18】 上記スリーブが上記シャフトにネジ係
合しており、当該スリーブが当該ネジ係合を介して回転
するときに、同スリーブが当該シャフトの長さに沿って
軸方向に移動することを特徴とする請求項17の駆動工
具。 - 【請求項19】 上記舌片が上記ヒンジに隣接したテー
パ状表面を有し;上記スリーブがその内表面にテーパ状
の面取り部を備え、この面取り部が上記テーパ状表面と
相補関係にあり、当該スリーブが当該ヒンジを圧縮すべ
く当該舌片の方へ軸方向に移動したときに、当該面取り
部が当該テーパ状表面に沿って運行することを特徴とす
る請求項17の駆動工具。 - 【請求項20】 上記癒着装置がその端部に設けられた
一対の対向する溝穴を備え;上記舌片が上記内向き表面
から延びた駆動突起を備え、これらの駆動突起が当該癒
着装置の上記対向する溝穴に係合するような形状を有す
ることを特徴とする請求項15の駆動工具。 - 【請求項21】 円筒状内表面と、対向する平坦な側壁
により中断され外ネジ部を備えた円筒状外表面とを有す
る本体を具備した中空の体内癒着装置を隣接する椎骨間
の空間内に移植するための駆動工具において、 細長いシャフトと;上記シャフトの一端に連結され、上
記癒着装置の上記対向する平坦な側壁を受け入れるよう
に互いに離れて位置した一対の対向する舌片と;上記細
長いシャフトに連結され、当該中空癒着装置の内部に位
置できるのに十分小さな第1直径から該中空癒着装置の
内部を把持するのに十分大きな第2直径まで拡張できる
部分を有する拡張コレット組立体と;から成ることを特
徴とする駆動工具。 - 【請求項22】 上記拡張コレット組立体が、 上記一対の舌片と一体で、貫通中央ボアと、当該舌片に
隣接して同舌片の内部に通じた上記ボアの一端に設けた
環状フランジとを備えたヘッド;及び上記中央ボア内で
摺動自在に位置したエキスパンダーシャフトであって、
当該中央ボア内で摺動するのに十分小さな第1直径か
ら、エキスパンダーシャフトを該中央ボア内に配置した
ときに上記環状フランジに隣接する一層大きな第2直径
まで開拡したチップを有するエキスパンダーシャフト;
を備え、上記エキスパンダーシャフトが上記中央ボア内
に引き込まれたときに、上記開拡したチップが上記環状
フランジを漸進的に拡張させて上記癒着装置の内部に係
合させる、ことを特徴とする請求項21の駆動工具。 - 【請求項23】 隣接する椎骨間の内部円盤状空間内に
癒着装置を移植する方法において、 (イ)対向する平坦な側壁により中断され外ネジ部を備
えた円筒状外表面を有する中空癒着装置を準備する準備
工程と; (ロ)上記癒着装置の内部を骨移植材料で満たす工程
と; (ハ)上記癒着装置の上記外ネジ部より小さな直径のド
リル穴を隣接する骨内に形成するドリル工程と; (ニ)上記平坦な側壁が隣接する椎骨に対面するような
状態で、上記癒着装置を上記ドリル穴に挿入する挿入工
程と; (ホ)上記ドリル穴内で上記癒着装置を回転させて、上
記外ネジ部を隣接する椎骨に係合させる工程と;からな
ることを特徴とする移植方法。 - 【請求項24】 上記準備工程が大径の第1端部から小
径の第2端部に向かってテーパした中空癒着装置を提供
する工程から成り、上記挿入工程が、上記癒着装置の上
記テーパが隣接する椎骨間の正常な構造上の角度関係に
対応するように、同癒着装置を挿入する工程から成るこ
とを特徴とする請求項23の移植方法。 - 【請求項25】 上記ドリル工程及び上記挿入工程が椎
骨の後方から行われることを特徴とする請求項24の移
植方法。 - 【請求項26】 上記ドリル工程及び上記挿入工程のた
めの作業チャンネルを提供するように、隣接する椎骨に
接触し上記内部円盤状空間に整合するスリーブを提供す
る工程を更に有することを特徴とする請求項23の移植
方法。 - 【請求項27】 隣接する椎骨間の内部円盤状空間内に
癒着装置を移植する方法において、 (イ)骨係合外ネジ部を備えたテーパ状の円筒状外表面
を有する中空癒着装置を準備する工程と; (ロ)内部円盤状空間の両側で、上記上記癒着装置の上
記外ネジ部より小さな直径のドリル穴を椎骨の端プレー
トに形成する工程と; (ハ)隣接する椎骨間の所定の角度関係を回復させるた
めに上記癒着装置の上記テーパ状の円筒状外表面により
隣接する椎骨を角度的に離間させるように、当該癒着装
置を上記ドリル穴に所定の深さだけねじ込む工程と;か
らなることを特徴とする移植方法。
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/411,017 US5782919A (en) | 1995-03-27 | 1995-03-27 | Interbody fusion device and method for restoration of normal spinal anatomy |
US411017 | 1995-03-27 | ||
US08/413,353 US5669909A (en) | 1995-03-27 | 1995-03-30 | Interbody fusion device and method for restoration of normal spinal anatomy |
US08/603,674 US5984967A (en) | 1995-03-27 | 1996-02-19 | Osteogenic fusion devices |
US79911497A | 1997-02-11 | 1997-02-11 | |
US09/489,317 US6375655B1 (en) | 1995-03-27 | 2000-01-21 | Interbody fusion device and method for restoration of normal spinal anatomy |
Publications (2)
Publication Number | Publication Date |
---|---|
JPH08266565A true JPH08266565A (ja) | 1996-10-15 |
JP3821875B2 JP3821875B2 (ja) | 2006-09-13 |
Family
ID=38626160
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP07245396A Expired - Fee Related JP3821876B2 (ja) | 1995-03-27 | 1996-03-27 | 癒着装置 |
JP07245096A Expired - Fee Related JP3821875B2 (ja) | 1995-03-27 | 1996-03-27 | 癒着装置及び駆動装置 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP07245396A Expired - Fee Related JP3821876B2 (ja) | 1995-03-27 | 1996-03-27 | 癒着装置 |
Country Status (12)
Country | Link |
---|---|
US (6) | US5782919A (ja) |
EP (3) | EP0734703B1 (ja) |
JP (2) | JP3821876B2 (ja) |
CN (2) | CN1142751C (ja) |
AT (2) | ATE240703T1 (ja) |
AU (2) | AU705991B2 (ja) |
CA (2) | CA2171921C (ja) |
DE (2) | DE69628352T2 (ja) |
ES (2) | ES2197135T3 (ja) |
MX (1) | MX9601078A (ja) |
NO (2) | NO961213L (ja) |
TR (1) | TR199600242A2 (ja) |
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- 1996-03-25 AU AU48292/96A patent/AU705991B2/en not_active Ceased
- 1996-03-26 NO NO961213A patent/NO961213L/no unknown
- 1996-03-26 TR TR96/00242A patent/TR199600242A2/xx unknown
- 1996-03-26 CN CNB961059664A patent/CN1142751C/zh not_active Expired - Lifetime
- 1996-03-26 NO NO961214A patent/NO961214L/no unknown
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