JP4541542B2 - 画像案内式脊髄外科ガイド、システム及び方法 - Google Patents

画像案内式脊髄外科ガイド、システム及び方法 Download PDF

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JP4541542B2
JP4541542B2 JP2000523932A JP2000523932A JP4541542B2 JP 4541542 B2 JP4541542 B2 JP 4541542B2 JP 2000523932 A JP2000523932 A JP 2000523932A JP 2000523932 A JP2000523932 A JP 2000523932A JP 4541542 B2 JP4541542 B2 JP 4541542B2
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guide
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insertion instrument
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JP2001525216A (ja
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メルケント トニー
ティー.フォーリー ケビン
ティー.エステス ブラッドリー
ショウドイン ジョーゼフ
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サージカル ナビゲーション テクノロジーズ,インコーポレイテッド
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4611Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of spinal prostheses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1757Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the spine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/107Visualisation of planned trajectories or target regions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046Tracking techniques
    • A61B2034/2055Optical tracking systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2072Reference field transducer attached to an instrument or patient
    • AHUMAN NECESSITIES
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    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/25User interfaces for surgical systems
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    • AHUMAN NECESSITIES
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
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    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442Intervertebral or spinal discs, e.g. resilient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455Joints 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/28Bones
    • A61F2002/2835Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
    • A61F2002/2839Bone plugs or bone graft dowels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2002/4625Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use
    • A61F2002/4627Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2002/4632Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor using computer-controlled surgery, e.g. robotic surgery
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S606/00Surgery
    • Y10S606/907Composed of particular material or coated
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S606/00Surgery
    • Y10S606/907Composed of particular material or coated
    • Y10S606/909Bone
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S606/00Surgery
    • Y10S606/907Composed of particular material or coated
    • Y10S606/912Radiolucent material
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S606/00Surgery
    • Y10S606/914Toolkit for installing or removing spinal positioner or stabilizer

Description

【0001】
(技術分野)
本発明は、一般に、医療及び外科手術中外科手術の遂行を助成し身体の各局部と外科器具との相対位置を示す画像を創生し使用するシステムと連携して、脊髄外科を実施するのに用いるためのガイドを提供することに関し、特に、移植スペースへの人工移植片及び、又は骨ドエルの所定の軌道(挿入経路)及び位置づけを保証することができるように移植スペースを準備するために、椎間板を横切って隣接する椎骨内へ防護された状態でアクセスするためのガイド、及びガイドを用いる外科ナビゲーションシステム、及びガイド及びシステムを用いて脊椎外科手術を実施するための方法に関する。
【0002】
(背景技術)
骨ドエル又は人工移植片を挿入するために脊椎の隣接椎骨を準備するために従来からいろいろな器具及び方法が用いられている。これらの器具及び方法は、移植スペース又は開口を形成するために各椎骨の一部分を除去するとともに隣接椎骨間から椎間板材を除去するためのものである。骨ドエル又は人工移植片を受容するための移植スペースを形成するためにドリル及びその他の椎間板及び骨除去器具を脊椎内へ案内するのに用いられる防護ガイドのための器具名の幾つかを挙げると、ドリルスリーブ、筒状部材、鞘、作業チャンネル及びガード等がある。これらのガイドの幾つかは、先鋭端を有していたり、衝撃力を加えることによって椎骨に係合するための歯を有している。
【0003】
ガイドは、移植スペースを形成する作業工程中脊椎への防護されたアクセスを可能にするために椎間板スペースを跨いで隣接椎骨内に座着するように位置づけすることができる。移植スペースは、椎間板スペースを跨いで隣接椎骨の各々内へ2つの対向した切除されたアークに沿って突入する。椎間板スペースを横切る穴を穿設するための方法及びそれに関連する器具類の一例が、米国特許第5,484,437号に記載されており、その記載内容が本明細書に編入されているものとする。
【0004】
外科医は、椎間板スペースを横切って隣接椎骨内へ円筒形の穴をドリルで穿設することによって移植スペースを準備することができるので、円筒形の移植片を使用することが望ましい。円筒形穴の椎骨内に穿設された湾曲表面は、円筒形穴の直径に合致する直径の対応円筒部分を有する移植片を円筒形穴に嵌合させたとき、両者をぴったり嵌合させることを可能にする。
【0005】
通常、米国特許第5,015,247号(その記載内容が本明細書に編入されているものとする)に開示されているようなねじ付き人工移植片が隣接椎骨間の移植スペース内に挿入され、爾後に生じる椎骨間融合に直接参与し融合現象に組み込まれる。又、同特許に開示されているようなねじ付き骨ドエルは、開口に架橋する目的で移植スペース内へ挿入することができ、椎骨間の融合に組み込まれるようにすることができる。更に、本出願人の米国特許第5,593,409号(その記載内容が本明細書に編入されているものとする)に開示されているような押し込みタイプの人工移植片も、上述した器具及び方法によって形成された移植スペース内に挿入することができる。
【0006】
移植片又はドエルを移植スペース内へ押し込むにせよ、ねじ込むにせよ、外科医は、隣接椎骨の各々からほぼ同量の骨材量を除去することができるように移植スペースの形成を案内するための鞘の向きを決めようとする。移植片又はドエルが植え込まれたならば、適正な位置に植え込まれたかどうかを見極めるために螢光透視鏡を用いることができる。
【0007】
医療又は外科手術に用いられる医療器具間及び身体の局部間の相対位置を示すことを含むいろいろな異なるタイプの外科ナビゲーションシステムが従来から提案されている。例えば、米国特許第5,383,454号、PCT出願PCT/US94/04530(WO94/24933)及びPCT出願PCT/US94/04530(WO94/24933)(それらの記載内容が本明細書に編入されているものとする)は、医療又は外科手術中予めスキャナによって得られたスキャンを用いて使用するためのシステムを開示している。外科ナビゲーションシステムは、通常、例えば身体の局部に設けられたLEDアレー(配列体)のような追跡手段と、医療器具に取り付けられたエミッターと、身体の局部及び医療器具の位置を追跡するためのディジタイザーと、医療処置に用いられる器具の、身体局部に対する相対位置を表示するためのディスプレーを備えている。
【0008】
脊椎に移植スペースを準備するための手術は、脊柱内のある特定のレベル(高さ位置)において対処しなければならない特定の課題を提起する。例えば、脊椎のL4−5(レベル4−5)椎間板スペースにそのような外科手術を行う場合、下記の問題が提起される。
(1)脊椎後方アプローチ(脊椎の後方からアプローチして外科手術を行う方法)においては、L4−5椎間板スペースに到達するのに相当な量の筋肉を剥ぎ取り裂開しなければならない。
(2)脊椎前方アプローチにおいては、経腹膜による場合であれ、腹膜の後を通して行う方法であれ、あるいはL4−5椎間板スペースへの開放アプローチ方法であれ、腹腔鏡を用いたアプローチ方法であれ、このレベル位置では脊柱のほとんど直ぐ前面側に大血管が走っている。これらの血管を切開し処理するのは、時間がかかり、困難である。
【0009】
本発明者は、L5椎間板スペースへの腹膜後方「斜めアプローチ」が好ましい外科的解決法となりうることを見出した。この斜めアプローチ法は、脊柱に沿って側方に位置する腰筋の直ぐ前で行われるので、斜めアプローチ法は、又、脊柱の後面側に位置している大血管の僅かに後方からのアプローチを可能にするので、大血管を損傷するおそれを少なくする。
【0010】
側方蛍光画像からのみ脊椎を視る場合、外科医は、この斜めアプローチ法を用いたとすると、器具を椎間板スペースを横切って逸出神経根に向けて後方側方へ移動させる際その移動方向及び移動深さの表示を視る能力が制限されてしまうことになる。
【0011】
以上のことに鑑みて、脊椎にガイドを設置するためのシステム及び方法において、移植スペースを形成するのに用いられるガイドの位置ぎめ精度を高めるために外科医に方向付け援助を与えるとともに、ガイドを通して挿入される器具の挿入深度を測定するのに用いることができ、それによって移植スペース内への移植片及びドエルの位置づけ精度を高めることができるガイド設置システム及び方法があれば有益である。
【0012】
(発明の開示)
従って、本発明は、椎間板及び隣接椎骨を横切る移植スペースを準備するために脊椎外科手術を実施するのに使用するためのガイド、及びガイドを用いるシステム及び方法に関する。より具体的には、本発明の目的は、移植スペースを形成するのを案内するためのガイドの適正な位置づけ精度を向上し、従って、移植片又はドエルの適正な位置づけ精度を向上するために画像案内式外科医術を用いてガイドを脊椎内へ設置するための装置及び方法に向けられている。
【0013】
この目的及びその他の利点を達成するために、本発明は、椎間板及び隣接椎骨を横切って移植スペースを準備するために脊椎外科手術を実施するのに用いるためのガイドを提供する。このガイドは、既知の基準点に対するガイドの三次元(3D)空間での位置を追跡するためにエネルギー検出アレー即ちセンサーアレーを用いるコンピュータ制御外科ナビゲーションシステムと連携して用いられる。
【0014】
このガイドは、椎間板を横切って隣接椎骨内に移植スペースを形成するために椎骨への防護されたアクセスを設定するための本体から成る。本体は、移植スペースを形成するための骨除去器具を受容し挿通するための貫通通路を有する。隣接椎骨に対するガイドの位置を確認するのに用いるための少くとも1つのエミッターアレーが本体に付設される。
【0015】
前記ガイドには、更に、隣接椎骨間の椎間板スペース内へ挿入して隣接椎骨の終板に当接させるための、前記本体から突出させた椎間板突刺し突起を設けることができる。本体は、脊椎に突き刺すための突起を含む端部を有するチューブを備えたものであることが好ましい。又、ガイドの各突起にエミッターアレーを設けることが好ましく、少くとも1つのLEDを設けることが更に好ましい。エミッターアレーは、能動エミッターと称される電気付勢式エネルギーエミッターアレーと、受動エミッターと称される、信号を反射する反射性表面を含むことが好ましい。
【0016】
更に本発明は、椎間板及び隣接椎骨を横切って移植スペースを形成するためために脊椎外科術を実施するのに用いるためのシステムを提供する。このシステムは、上述したガイドと、既知の基準点に対するガイドの三次元空間での位置を追跡するためにエネルギー検出アレーを用いるコンピュータ制御外科ナビゲーションシステムとから成る。
【0017】
更に、本発明は、移植スペースを形成するために椎間板を横切って隣接椎骨内への防護されたアクセスを可能にするために用いられるガイドによって脊椎外科術を実施するための方法を提供する。本発明の方法は、対象椎骨に基準アレーを取りつける工程と、当該椎骨の位置をコンピュータ制御外科ナビゲーションシステムに登録する工程と、少くとも1つのエミッターアレーが付設されている前記ガイドの一端を隣接椎骨に接触させる工程と、前記外科ナビゲーションシステムをコンピュータ制御器及びディジタイザーアレーと共に用いて前記ガイドの前記エネルギーエミッターと通信する工程と、前記ガイドを三次元空間内で既知の基準点に対して位置づけする工程と、前記移植スペースを前記ガイドを通して前記椎間板スペースを横切って隣接椎骨の各々の一部分内に形成する工程とから成る。
【0018】
本発明の他の側面においては、本発明の方法は、ガイドの位置をディスプレーに表示する工程を含む。この表示工程は、各椎骨及び、又は隣接椎骨に対するガイドの軸方向の向きの画像を示すために隣接椎骨に対するガイドの位置をディスプレーすることが好ましい。椎間板突刺し突起の向きもディスプレーに表示させることができる。又、ガイドを通して挿入することができる器具の先端の位置もディスプレーに表示させることができる。ガイドを通して挿入する器具の先端の位置を確認することは、器具の挿入深さの追跡を可能にする。ディスプレー表示工程は、又、隣接椎骨の前方画像又は後方画像のいずれか一方に対するガイドの断面図を表示するために隣接椎骨に対するガイドの向きをディスプレー表示することもできる。
【0019】
本発明の方法は、又、ガイドに取り付けられたエミッターから信号を発生させ、その信号を画像として表示する装置へ送る工程を含むこともできる。又、人工移植片、骨ドエル又はその他のタイプの骨を移植スペースへ植え込む工程を含むことが好ましい。本発明の方法は、又、人工移植片又は骨ドエル挿入器具(以下、単に「挿入器具」とも称する)をそれに付設されたエミッターを介して追跡する工程を含むことができる。挿入器具は、ガイド内を通すことができる構成とすることが好ましい。コンピュータ制御外科ナビゲーションシステムは、ガイド内を通して挿通される挿入器具をディスプレー表示するように構成することができ、より好ましくは、挿入器具の幾何学的寸法形状と該挿入器具に取り付けられた人工移植片又は骨ドエルの幾何学的寸法形状に基づいて、挿入器具とそれに取り付けられた移植片又は骨ドエルの1つとの両方をディスプレー表示するように構成する。
【0020】
本発明の目的は、外科医に上記ガイドを提供すること、並びに、移植スペースを形成する際脊椎に対するガイドの適正位置を確保するために患者の脊椎に外科手術するための外科ナビゲーションシステムと連携して用いられる該ガイドを追跡するためのシステム及び方法を提供することである。
【0021】
本発明の上記目的及び発明の内容は、添付図を参照して以下に記述する本発明の実施形態の説明から一層明らかになろう。
【0022】
(発明を実施するための最良の形態)
以下に添付図を参照して、本発明の好ましい実施形態を詳しく説明する。すべての添付図を通して同じ又は同様な部品は同じ参照番号で示されている。PCT/US95/12894(その記載内容が本明細書に編入されているものとする)に説明されているような代表的な外科ナビゲーションシステムが図1に示されている。コンピュータ支援画像案内式外科手術システム10は、脊椎外科手術のために一般に用いられている脊椎外科手術フレーム125のような安定化フレーム又はデバイスに固定的に保持された脊椎要素等の1つ又はそれ以上の身体要素の位置を表す、モニター106上にディスプレーするための画像を創出する。(ここで、「要素」とは、身体や脊椎を構成する1要素又は1局部のことをいう。)例えばLEDエミッター122のような追跡手段を担持した基準アーク120が、クランプ又はその他の連結具によって脊椎の棘状突起に取り付けられている。
【0023】
画像は、通常、例えばCATスキャナによって手術前に作成された画像データセットの中から創出される。この画像は、脊椎素子のような少くとも1つの身体要素のための複数の基準点を有している。この特定の身体要素の基準点は、該特定の身体要素に対する固定的空間位置関係を有する。システム10は、手術中、アーク120上のエミッター122の位置を追跡することによってディスプレーされる各基準点の相対位置を確認するための例えば支持台112上に支持されたセンサーアレー110のようなディジタイザー又はその他の位置検出ユニット(PSU)のような装置を備えている。システム10は、又、手術中、センサーアレー110によって確認された各基準点の相対位置に従って画像データセットを改変するための制御器108に接続されたPC又は他の適当なワークステーション等のプロセッサ114も備えている。従って、このプロセッサ114は、例えば、手術中モニター106上にディスプレーするための各身体要素の位置を表す画像データセットを置き換えることができる。いずれにしても、外科ナビゲーションシステムの作動は、斯界において周知であるからここではこれ以上説明する必要はない。
【0024】
本発明の一実施形態によれば、ダイナミック照合(例えば、蛍光透視法照合、手術中磁気共鳴映像、及び超音波レジストレーション)を用いることによってエミッターを椎体に保持するクランプ又はその他の連結具を用いる必要なしに追跡を行うことができる。これらのオプションは、すべて、脊椎のリアルタイムの置き換え及び操作を画像で表示することを可能にする。
【0025】
本発明の好ましい実施形態によれば、図2及び3に示されるように、本発明は、椎間板及び隣接椎骨を横切って移植スペースを形成するために脊椎外科手術を実施するのに用いるためのガイド130を提供する。ガイド130は、既知の基準点に対するガイドの三次元空間での位置を追跡するためにエネルギー検出アレーを用いるコンピュータ制御外科ナビゲーションシステムと連携して用いられる。ガイド130は、椎間板を横切って隣接脊柱内に移植スペースを形成するために防護されたアクセスを提供するための本体132から成る。本体132は、それを通して移植スペースを形成するために図3に示されるような骨除去器具を受容するための通路を有する本体132には、隣接椎骨に対するガイド130の位置を確認するのに用いるための少くとも1つのエミッターアレー(例えば、電気的に付勢自在のエネルギーエミッターアレー)190が付設されている。図10は、椎間板突刺し突起134とエミッターアレー190を付した変型ガイド130を示す。
【0026】
好ましい骨除去器具は、図3、6A及び6Bに示されるようにされるようにLED310を有するリーマー300から成る。ガイド130、及び、リーマー300を突通された身体の既知の座標に対してみた脊椎内へのリーマー300の挿入深さを表示する視覚ディスプレーを創出することができる。
【0027】
椎間板スペースを横切って脊椎外科手術を実施するのに用いるためのその他の器具は、図9、11A、11B及び12Bに示されている。図11Aは、好ましくは図11Bに示されるようにされるようなT字ハンドル430に取り付けるようになされたタップ(雌ねじ切り工具)400を示す。T字ハンドル430は、タップ400が挿入された隣接椎骨に対するタップ400の位置を確認するのに用いるために付設されたエミッター190を有する。
【0028】
図12は、T字ハンドル430とエミッター190を備えた挿入器具420を示す。ディストラクター410、タップ400及び挿入器具420にそれぞれ付設されたエミッター190は、各器具(ディストラクター、タップ及び挿入器具)をコンピュータ制御外科ナビゲーションシステム10に組み合わされた視覚ディスプレー上に個々に表示することができるように既知の基準点に対する各器具の三次元空間での位置を確認するのに用いられる。
【0029】
ガイド130の本体からは、更に、隣接椎骨間の椎間板スペース内に挿入し、隣接椎骨の終板に当接させるための椎間板突刺し突起を突設させることができる。本体132は、チューブの形とし、その一端から突刺し突起を突設させることが好ましい。ガイドに付設するエミッターアレー190は、発光ダイオード(LED)であることが好ましいが、対応する検出器アレーによって追跡することができる、斯界において周知の他の任意のエネルギー放射器又は追跡手段であってよい。エミッターアレーは、空間内の器具のあらゆる方向の位置及び回転を測定するのみ用いるための3つのLEDを含むことが好ましい。例として挙げれば、追跡手段は、音響、磁気、電磁気、核放射線及びマイクロパルスレーダーシステムにおけるように能動的に、あるいは、反射表面に対するように受動的に信号を発生することができる。
【0030】
更に、本発明は、椎間板を横切って隣接脊柱内に移植スペースを形成するために脊椎外科手術を実施するためのシステムを提供する。このシステムは、上述したガイド130と、同様にしてセンサーアレー110によって追跡される体内の既知の基準点に対するガイド130の三次元空間での位置を追跡するためにエネルギー検出アレーを用いるコンピュータ制御外科ナビゲーションシステム10を含む。
【0031】
ガイド130と、コンピュータ制御外科ナビゲーションシステム10は、脊椎外科医が、ガイド130を通して挿入される器具の深さを観察することを可能にするとともに、ガイド130を通して適正な向きに向けられた移植スペースを形成することによって移植片又はドエルを適正に移植することを可能にする。この結果は、移植スペースを形成する前にガイド130の向きを適正に定めることによって確実に得られる。
【0032】
図4Aは、移植片又はドエル202を隣接椎骨の所定の終板204に係合させた状態にある脊椎セグメントの断面図である。通常、隣接椎骨の所定の終板204へのこのような好ましい係合は、隣接する椎骨の隣接する終板の各々からほぼ等量の骨を除去し、移植片又はドエル202を脊椎前面側Aから脊椎後面側Pへ、又はその逆に軸方向に整列させた場合に得られる。
【0033】
移植片又はドエル202を望ましくない位置へ位置づけされた状態にある脊椎セグメントの断面図が図4Bに示されている。図4Bに示された移植片又はドエル202は、斜め矢状方向の軌道を有する移植スペース内に移植された場合の状態である。これに対して、椎骨に対する移植片又はドエル202のほぼ好ましい所定の矢状方向の整列状態は、図5Bに示されている。
【0034】
図5Aは、椎骨の軸方向断面図に重ねて投影された移植片又はドエル202の断面図であり、脊椎後面側から脊椎前面側への椎骨に対する移植片又はドエル202の所定の軸方向整列関係を示す。図5Cは、隣接椎骨間に位置づけされた移植片又はドエル202の断面図であり、椎骨に対する移植片又はドエル202の所定の冠状方向の整列関係を示す。移植スペースを形成する前にガイド130を適正に位置づけすることによって移植片202を図5A、5Bに示された所定の軸方向、矢状方向及び冠状方向の向きに位置づけすることができる。
【0035】
外科医が椎体をコンピュータ制御外科ナビゲーションシステム(以下、単に「コンピュータシステム」又は「ナビゲーションシステム」とも称する)10にさせれば、椎体に対する上述したガイドの位置がコンピュータシステム上に映し出されるので、外科医は、ガイドの位置を三次元(3D)画像ででも、又、軸方向、矢状方向及び冠状方向の画像としてもリアルタイムで視ることができる。外科医は、又、この椎体に対するガイドの移動軌道を3つのすべての位置において視ることができる。この技術は、明らかに、外科医が移植スペースを形成するためにガイドを位置づけする操作を容易にし、それによって挿入すべき移植片又はドエルの位置づけを最適化することができる。
【0036】
図6A、6B、7及び8に示されたディスプレースクリーンに従って、基準アレーを患者に取り付けてナビゲーションシステムに登録をすれば、ナビゲーションシステム内のソフトウエアが以下の情報を外科医に与えてくれる。即ち、ガイド130の位置が患者の身体部位に対比して示される。ガイド130の回転方向位置も示されるので、外科医は、脊椎の隣接椎骨に対するガード突起134の向きを観察することができる。
【0037】
特に、図6A及び6Bは、ガイド130を通して挿入されたリーマー300を表示しており、リーマー300の進入の深さを示す。図6Aは、椎骨の終板から骨材を除去する直前のリーマー300を示す。図6Bは、リーマー300が更に深くへ挿入され、椎骨の終板から骨材を除去した後の状態を示す。リーマー300の最終位置は、外科医が参照するためにディスプレースクリーン上に残る。リーマー300の直径は、コンピュータに入力しておくか、あるいは、プログラムから選択することが好ましい。
【0038】
図7は、ガイド130を通して挿通されたタップ(雌ねじ切り工具)400を示す。タップ400の最終位置は、外科医が参照するためにディスプレースクリーン上に残る。タップ400の直径は、コンピュータに入力しておくか、あるいは、プログラムから選択することが好ましい。
【0039】
図8は、ガイドを通して挿入された後の移植片500の位置及び挿入深さを示す。移植片500の最終位置は、外科医が参照するためにディスプレースクリーン上に残る。移植片500の先端も尻尾もスクリーン上で視られる。移植片500の直径及び長さは、コンピュータに入力しておくか、あるいは、プログラムから選択することが好ましい。
【0040】
移植片500の寸法をコンピュータに入力しておくか、あるいは、プログラムから選択することにより、そして、挿入器具420の寸法形状をコンピュータに入力しておくことによって、ディスプレーは、挿入器具の位置を知り、それによって、該挿入器具に固定的に取り付けられた移植片500の位置を知ることにより移植片を隣接椎骨に関連して表示することができる。
【0041】
かくして、移植片500、又は、エミッターアレーを付設された既知の寸法の器具に取り付けられた既知の寸法の任意の器具の位置を追跡することができる。既知の寸法の器具にエミッターアレーを設けてその位置を追跡することによって、該器具に固定的に付設された既知の寸法の他の器具の位置をも確実に特定することができる。従って、移植片又はその他の付設器具は、その付設器具にも別個のエミッターアレーを盛るける必要なしにナビゲーションシステムのモニター(ディスプレー)上に表示させることができる。
【0042】
以上、本システムに用いられるガイドの好ましい実施形態を説明したが、次に、本発明を実施するためにこの装置を使用する方法を説明する。外科ナビゲーションシステムの作動は、周知であり、PCT/US95/12894に記載されている。最初の工程は、コンピュータ支援画像案内式外科ナビゲーション法を用いて脊椎の位置を確認することである。
【0043】
次に、基準アレー又は基準フレーム120を対象椎骨に固定する。この取り付け手段は、クランプ、ねじ又はその他の任意の手段であってよい。基準アレー120は、脊椎後方アプローチの場合は例えば脊椎の棘状突起に取り付けることができ、脊椎前方アプローチの場合は身体の前部に取り付けることができる。この基準アレーは、最少限の外科的施術により経皮的に(皮膚を通して)取り付けることができる。基準アレー120が取り付けられたならば、患者の身体をコンピュータ制御外科ナビゲーションシステム10内の画像データに登録しなければならない。この登録は、いろいろな異なる方法で行うことができる。開放型又は内視鏡手術の場合は、骨上の幾つかの点に追跡器付きポインターで物理的にタッチすることができる。経皮方法による場合は、スキャンを開始する前に身体に取り付けられた基準点アレー上の点にタッチしてもよいし、あるいは、蛍光透視又は超音波画像上記の点を同定してもよい。本発明は、任意の外科手術法(即ち、前方アプローチ法、後方アプローチ法、経腹膜法、後方内視鏡法)に適用することができる。
【0044】
基準アレー120が患者に取り付けられ、患者の身体の解剖学的構造(手術の対象となる部位及びその周辺の部位の位置関係及び形状等)がコンピュータシステムに登録されたならば、脊椎をそれ以上外科的に切開する必要なしに、外科ナビゲーションシステム10において脊椎に対するガイド130の空間的位置を追跡すればよい。ガイド130の位置は、ユーザー(外科医)が足踏みペダルを踏み込んでエミッターアレー190を付勢することによって、確認することができる。エミッターアレー190中の各エミッター195は赤外線信号を発生し、それらの赤外線信号がカメラのセンサーアレー(ディジタイザー)110によって捕捉され、三角法で測定されてガイド130の位置が確認される。
例えば棘状突起のような身体の局部の相対位置も、脊椎セグメントと機械的に連通している基準フレーム120に取り付けられた同様なエミッター122を用いて測定される。斯界において周知のように、又、PCT/US95/12894に記載されているように、脊椎セグメントとガイド130との相対位置に基づいて(例えば、既知の基準点にタッチすることなどにより)、コンピュータは、ガイド130と脊椎セグメントの位置を表示しているモニター106上に、手術前スキャン、例えば適正なCATスキャンスライスを示す。なお、手術全体を通して能動的追跡法だけでなく、受動的追跡法を用いこともできる。
【0045】
脊椎の各要素が脊椎内に登録された後、椎間板及び骨をガイドを通して除去することができるようにガイド130を適正な向きに位置づけすることができ、人工移植片又は骨ドエルを挿入するための適正な向きの移植スペースを形成することができる。
【0046】
更に、本発明は、椎間板を横切って隣接する椎骨内へ防護された状態でアクセスするための脊椎外科手術を実施するためのガイド、及びガイドを用いるシステム及び方法を提供する。この方法は、少くとも1つの電気的に付勢自在のエネルギーエミッターアレーを付設したガイドの一端を隣接椎骨に接触させる工程と、外科ナビゲーションシステムをコンピュータ制御器及びディジタイザーアレーと共に用いて該ガイドのエネルギーエミッターアレーと通信する工程と、前記ガイドを既知の基準点に対して三次元空間内で位置づけする工程と、椎間板スペースを横切って隣接する椎骨の各々の一部分内へ該ガイドを通して移植スペースを形成する工程とから成る。
【0047】
本発明の別の側面においては、本発明の方法は、ガイドの位置のディスプレーに表示する工程を含む。このディスプレー表示工程では、各椎骨及び、又は隣接椎骨に対するガイドの軸方向の向きの画像を示すために隣接椎骨に対するガイドの位置をディスプレー表示することが好ましい。又、このディスプレー表示工程では、隣接椎骨の前方又は後方画像に対比させてガイドの断面図を示すために隣接椎骨に対するガイドの位置をディスプレー表示することもできる。又、このディスプレー表示工程では、ガイドの現行の移動軌道に対する矢状平面及び冠状平面内又は他の平面内でガイドの断面図をディスプレー表示することもできる。
【0048】
本発明の方法は、又、ガイドに付設されたエミッターから信号を発生させ、その信号を画像として表示する装置に受け取らせ、該装置によってその信号を視覚ディスプレー上に画像として表示させる工程を含むこともできる。又、好ましい実施形態では、本発明の方法は、人工移植片と骨ドエルの1つを移植スペース内へ移植する工程を含む。
【0049】
以上、本発明を実施形態に関連して説明したが、本発明は、ここに例示した実施形態の構造及び形状に限定されるものではなく、いろいろな実施形態が可能であり、いろいろな変更及び改変を加えることができることを理解されたい。
【図面の簡単な説明】
【図1】 図1は、脊椎外科手術のための外科ナビゲーションシステムと連携して使用するために脊椎内に設置されるガイドと、基準アークと、ポストと配線を含むシステムの好ましい実施形態の概略説明図である。
【図2】 図2は、本発明によるガイドの好ましい実施形態の透視図である。
【図3】 図3は、ガイドを通して挿通するLEDを有する器具を備えた図2のガイドの透視図である。
【図4】 図4Aは、移植片又はドエルを椎間板スペース内の椎骨終板間の望ましい位置に位置づけされた脊椎セグメントの断面図である。
図4Bは、移植片又はドエルを椎間板スペース内の椎骨終板間の望ましくない位置に位置づけされた脊椎セグメントの断面図である。
【図5】 図5Aは、椎骨の軸方向頂面図に重ねて投影された移植片又はドエルの断面図であり、椎骨に対する移植片又はドエルの所定の軸方向整列関係を示す。
図5Bは、隣接椎骨間に位置づけされた移植片又はドエルの断面図であり、椎骨に対する移植片又はドエルの所定の矢状方向の整列関係を示す。
図5Cは、隣接椎骨間に位置づけされた移植片又はドエルの断面図であり、椎骨に対する移植片又はドエルの所定の冠状方向の整列関係を示す。
【図6】 図6Aは、本発明の好ましい実施形態に従って、ガイドと共にディスプレースクリーン上に表示された画像、ガイドを通して挿通されたリーマー、及び外科ナビゲーションシステムを示す。
図6Bは、図6Aの実施形態においてリーマーが脊椎の椎骨間の椎間板スペース内へ深く挿入されたところを示す。
【図7】 図7は、本発明の別の好ましい実施形態に従って、ガイドと共にディスプレースクリーン上に表示された画像、ガイドを通して挿通されたタップ(雌ねじ切り工具)、及び外科ナビゲーションシステムを示す。
【図8】 図8は、本発明の更に別の好ましい実施形態に従って、ガイドと共にディスプレースクリーン上に表示された画像、ガイドを通して挿通された移植片、及び外科ナビゲーションシステムを示す。
【図9】 図9は、ディストラクター(伸延器)とT字ハンドルの組立体の側面図であり、それに付設されたエミッターを断面図で示す。
【図10】 図10は、椎間板突刺し突起と隣接椎骨に係合するためのピン又はプロングを有するガイドの側面図であり、それに付設されたエミッターを断面図で示す。
【図11】 図11Aは、タップの側面図である。
図11Bは、エミッターを備えたT字ハンドルの側面図である。
【図12】 図12は、T字ハンドル及びエミッターを備えた挿入器具の側面図である。
【符号の説明】
10 コンピュータ支援画像案内式外科手術システム、コンピュータ制御外科ナビゲーションシステム、外科ナビゲーションシステム
13 本体
106 モニター
108 制御器
110 エネルギー検出アレー、センサーアレー
112 支持台
114 プロセッサ
120 基準アーク、基準アレー、基準フレーム
122 エミッター
125 脊椎外科手術フレーム
130 ガイド
132 本体
134 ガード突起
190 エミッターアレー、電気的に付勢自在のエネルギーエミッターアレー
195 エミッター
202 骨ドエル、移植片
204 終板
300 リーマー
400 タップ
410 ディストラクター
420 挿入器具
430 ハンドル
500 移植片

Claims (12)

  1. 椎間板スペース及び隣接椎骨を横切って移植スペースを形成するために脊椎外科手術を実施するのに使用するためのシステムであって、
    椎間板スペースを横切って隣接椎骨内に移植スペースを形成するための器具を挿通する貫通通路を備えており、該移植スペースを形成するために前記隣接椎骨にアクセスするためのガイドと、
    前記隣接椎骨に対する前記ガイドの位置を確認するのに用いるための、前記ガイドに付設された少くとも1つのエミッターアレーと、
    エネルギー検出アレーを用いて既知の基準点に対する前記ガイドの三次元空間での位置を追跡するコンピュータ制御外科ナビゲーションシステムと、
    前記ガイドを通して挿通することができるように寸法づけされた挿入器具とを有し、該挿入器具には、前記隣接椎骨に対する該挿入器具の位置、及び前記移植スペース内への該挿入器具の挿入深さを確認するのに用いるための少くとも1つのエミッターアレーが付設されており、該挿入器具は、前記移植スペース内へ挿入するための人工移植片と骨ドエルのいずれか1つを保持するようになされていることを特徴とするシステム。
  2. 前記ガイド及び挿入器具のエミッターアレーは、少くとも1つのLEDを含むことを特徴とする請求項に記載のシステム。
  3. 前記ガイド及び挿入器具のエミッターアレーは、電気的に付勢自在のエネルギーエミッターアレーであることを特徴とする請求項に記載のシステム。
  4. 前記ガイド及び挿入器具のエミッターアレーは、反射信号を発生することを特徴とする請求項に記載のシステム。
  5. 前記ガイドのエミッターアレーは、該エミッターアレーから前記ナビゲーションシステムのエネルギー検出アレーへの視線を設定するように前記ガイドの側部にまで延長していることを特徴とする請求項に記載のシステム。
  6. 前記ガイドは、脊椎に突き刺すための突起を備えた端部を有することを特徴とする請求項に記載のシステム。
  7. 前記ガイドは、隣接椎骨間の椎間板スペース内へ挿入して該隣接椎骨の終板に当接させるための椎間板突刺し突起を備えていることを特徴とする請求項に記載のシステム。
  8. 前記ガイドは、前記移植スペースの形成中隣接椎骨の位置ずれを防止するために隣接椎骨に係合するためのスパイクを有することを特徴とする請求項に記載のシステム。
  9. 前記移植スペースを形成するための器具は、前記ガイドを通して侵入させた侵入の深さを確認するのに用いるためのエネルギーエミッターを有することを特徴とする請求項に記載のシステム。
  10. 前記コンピュータ制御外科ナビゲーションシステムは、既知の基準点に対する前記挿入器具の三次元空間での位置を追跡することを特徴とする請求項に記載のシステム。
  11. 前記コンピュータ制御外科ナビゲーションシステムは、前記挿入器具の位置ディスプレー画像を創出することを特徴とする請求項10に記載のシステム。
  12. 前記コンピュータ制御外科ナビゲーションシステムは、該システムに入力された、前記挿入器具の幾何学的寸法形状と該挿入器具に取り付けられた人工移植片と骨ドエルのうちの1つの幾何学的寸法形状に基づいて、該挿入器具の端部に取り付けられた人工移植片と骨ドエルのうちの前記1つをディスプレー表示することを特徴とする請求項11に記載のシステム。
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US6796988B2 (en) 2004-09-28
DE69827032D1 (de) 2004-11-18
ATE279159T1 (de) 2004-10-15
EP1037567B1 (en) 2004-10-13
AU1910499A (en) 1999-06-28
WO1999029253A1 (en) 1999-06-17
JP2001525216A (ja) 2001-12-11
DE69827032T2 (de) 2005-02-17
US20020151894A1 (en) 2002-10-17
EP1037567A1 (en) 2000-09-27
CA2309610A1 (en) 1999-06-17
ZA9811435B (en) 1999-06-14
US20100286713A1 (en) 2010-11-11
US7763035B2 (en) 2010-07-27
US6348058B1 (en) 2002-02-19
US20050059885A1 (en) 2005-03-17

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