JPWO2020221940A5

JPWO2020221940A5 -

Info

Publication number: JPWO2020221940A5
Application number: JP2021564755A
Authority: JP
Publication date: 2023-05-15

Description

特に、少なくとも２つの椎骨を融合する方法内で、少なくとも２つのローカライザのうちの少なくとも１つと少なくとも第３のローカライザとの間に囲まれた曲げ角度を計算する場合、方法は、計算された角度に従って、曲げられた状態で、モニター上にアクセス針の少なくとも一部のデジタル表現を視覚化するステップを含むことができる。
本発明は、例えば、以下を提供する。
（項目１）
低侵襲性脊椎外科手術を実施するための外科手術キットであって、前記外科手術キットが、
－位置検出システムの座標系内で、受信したセンサ信号から、ローカライザの位置および配向を検出するように構成されている、位置検出システムと、
－医療器具の内腔に取り外し可能に配設されるように構成されているセンサキャリアであって、前記センサキャリアが、少なくとも２つのローカライザを有し、前記ローカライザが各々、前記それぞれのローカライザの位置および配向を表すセンサ信号を提供するように構成されている、センサキャリアと、
－内腔を有する複数の異なる医療器具であって、前記センサキャリアが、前記それぞれの医療器具を前記位置検出システムに接続するために取り外し可能に配設され得る、複数の異なる医療器具と、を備える、外科手術キット。
（項目２）
内腔を有する前記複数の医療器具のうちの１つの医療器具が、
－アクセス針の遠位端からその近位端まで延在している内腔を有する、アクセス針であって、前記アクセス針が、患者の体内の標的場所に誘導されるように構成されている、アクセス針である、項目１に記載の外科手術キット。
（項目３）
内腔を有する前記複数の医療器具が、
－前記アクセス針の内腔に挿入されるように構成されている、ガイドワイヤ、
－内腔を有しており、前記ガイドワイヤの上に前進するように構成されている、ガイドロッド、
－前記ガイドロッドの上に前進し、標的場所へのアクセス経路を拡張するように構成されている、少なくとも１つの拡張チューブ、
－前記少なくとも１つの拡張チューブの上に前進し、医療器具用の作業チャネルを提供するように構成されている、作業チューブであって、その遠位端で、前記作業チューブが、患者の骨に固定され得るように成形されている、作業チューブ、
－内視鏡が配設され得る内腔を有しており、中枢神経系への後方－外側アクセスを作り出すために、前記作業チューブの前記作業チャネル内部に配設されるように構成されている、リーマー、
－別の医療器具を挿入するための少なくとも１つの内視鏡作業チャネルを有する、内視鏡であって、前記内視鏡が、患者の体内の医療撮像のために構成されている、内視鏡、または
－前記内視鏡の作業チャネル内に配設され、椎間円板および／もしくは周囲の身体組織の少なくとも一部を除去するように構成されている、医療器具、のうちの少なくとも１つを備える、項目１または２に記載の外科手術キット。
（項目４）
内腔を有する前記複数の医療器具が、
－それぞれの椎骨の間に配設されるときに、２つの椎骨間の円板空間を復元するように構成されている、脊椎ケージ、
－ラミナねじを備えたラミナドライバであって、前記ドライバが、前記ドライバの近位端から前記ラミナねじの遠位端まで延在している内腔を有し、前記ドライバが、前記ラミナねじを椎骨ラミナ内に固定するように構成されている、ラミナドライバ、
－骨ねじを固定するための椎骨への穴をタッピングするためのタップ、または
－椎弓根ねじを備えた椎弓根ドライバであって、前記ドライバが、前記ドライバの近位端から前記椎弓根ねじの遠位端まで延在している内腔を有し、前記ドライバが、前記椎弓根ねじを椎骨の椎弓根内に固定するように構成されている、椎弓根ドライバ、のうちの少なくとも１つを備える、先行項目のいずれか一項に記載の外科手術キット。
（項目５）
－前記ローカライザの第１のローカライザが、前記センサキャリアの遠位端に配設されているか、またはその遠位端の少なくとも近くに配設されており、前記ローカライザの第２のローカライザが、前記第１のローカライザから前記センサキャリアの近位端に向かってある距離で配設されており、前記センサキャリアが、
－前記センサキャリアの前記遠位端から前記近位端まで延在しており、前記少なくとも２つのローカライザを封入する、ハイポチューブ、をさらに備える、先行項目のいずれか一項に記載の外科手術キット。
（項目６）
第３のローカライザの位置および配向を表すセンサ信号を提供するように構成されている、少なくとも第３のローカライザを備え、前記第３のローカライザが、前記第１および第２のローカライザから前記センサキャリアの近位端に向かってある距離で配設されている、先行項目のいずれか一項に記載の外科手術キット。
（項目７）
医療器具識別セットアップを含み、前記医療器具識別セットアップが、
－キャリブレーションデバイスであって、前記位置検出システムの座標系におけるその位置および配向が、前記位置検出システムによって決定され得るように構成されている、キャリブレーションデバイスと、
－前記位置検出システムによって決定された前記キャリブレーションデバイスの前記位置および配向ならびに前記２つのローカライザのうちの少なくとも１つの前記位置および配向に基づいて、前記医療器具の先端と前記２つのローカライザのうちの少なくとも１つとの間の距離を計算することによって、前記センサキャリアが内腔内に配設された医療器具を較正するように構成されている、キャリブレーションユニットと、
－少なくとも前記計算された距離から前記医療器具の内腔の長さを決定し、前記医療器具を識別するために前記内腔の前記決定された長さを使用するように構成されている、医療器具識別ユニットと、を備える、先行項目のいずれか一項に記載の外科手術キット。
（項目８）
前記キャリブレーションユニットが、前記少なくとも２つのローカライザの前記位置に基づいて、医療器具の仮想長手方向軸を決定するように構成されている、項目７に記載の外科手術キット。
（項目９）
椎間円板および／または周囲の身体組織の少なくとも一部を除去する方法であって、前記方法が、
－医療器具の内腔に取り外し可能に配設されるように構成されているセンサキャリアを提供するステップであって、前記センサキャリアが、少なくとも２つのローカライザを有し、前記ローカライザが各々、前記それぞれのローカライザの位置および配向を表すセンサ信号を提供するように構成されている、提供するステップと、
－前記センサキャリアをアクセス針の内腔内に挿入するステップと、
－配設されたセンサキャリアを有する前記アクセス針を較正するステップと、
－脊椎の椎骨に、患者の体内に配設されたセンサキャリアを有する前記アクセス針をナビゲートし、同時に、前記少なくとも２つのローカライザの位置および配向をセンサ信号から決定し、前記ローカライザの前記決定された位置および配向を使用して、モニター上に視覚化された患者モデル内の前記アクセス針の先端の少なくとも位置を示すステップと、
－前記センサキャリアを前記アクセス針の内腔から除去し、続いて、ガイドワイヤを前記アクセス針の内腔内に挿入するステップと、
－前記ガイドワイヤのみが前記患者の体内に留まるように、前記アクセス針を前記ガイドワイヤから除去するステップと、
－前記センサキャリアをガイドロッドの内腔内に挿入し、前記ガイドロッドを較正するステップと、
－前記センサキャリアを前記ガイドロッドから除去し、前記ガイドロッドを前記椎骨まで前記ガイドワイヤの上に前進させるステップと、
－前記ガイドワイヤを前記ガイドロッドから除去し、前記センサキャリアを前記ガイドロッド内に挿入するステップと、
－配設されたセンサキャリアを有する前記ガイドロッドを前記椎骨の面接合部にナビゲートし、同時に、前記少なくとも２つのローカライザの位置および配向を決定し、前記ローカライザの前記決定された位置および配向を使用して、モニター上に視覚化された患者モデル内の前記ガイドロッドの遠位端の少なくとも位置を示すステップと、
－前記センサキャリアを前記ガイドロッドから除去するステップと、
－少なくとも１つの拡張チューブを前記ガイドロッドの上に前進させるステップであって、前記拡張チューブが、前記椎骨へのアクセス経路を拡張するように構成されている、前進させるステップと、
－前記センサキャリアを作業チューブの内腔内に挿入するステップであって、その遠位端で、前記作業チューブは、その遠位端で、前記作業チューブが患者の骨に固定され得るように成形されている、挿入するステップと、
－前記作業チューブを較正し、前記センサキャリアを前記作業チューブから除去するステップと、
－前記作業チューブを前記面接合部に向かって前記拡張チューブの上に前進させるステップと、
－前記ガイドロッドおよび前記拡張チューブを除去するステップと、
－前記センサキャリアを前記作業チューブ内に挿入し、前記作業チューブをその遠位端で前記椎骨に固定し、同時に、前記少なくとも２つのローカライザの位置および配向を決定し、前記ローカライザの前記決定された位置および配向を使用して、モニター上に視覚化された患者モデル内の前記作業チューブの遠位端の少なくとも位置を示すステップと、
－前記センサキャリアを前記作業チューブから除去するステップと、
－前記センサキャリアを内視鏡と一緒にリーマーの内腔内に挿入し、その後、センサキャリアおよび内視鏡とともに前記リーマーを前記作業チューブの前記作業チャネル内に挿入し、中枢神経系への後方－外側アクセスを作り出すために前記リーマーを使用し、同時に、前記少なくとも２つのローカライザの位置および配向を決定し、前記ローカライザの前記決定された位置および配向を使用して、モニター上に視覚化された患者モデル内の前記リーマーの遠位端の少なくとも位置を示すステップと、
－前記内視鏡の内視鏡作業チャネルを通して、椎間円板および／または周囲の身体組織の少なくとも一部を除去するステップと、を含む、方法。
（項目１０）
前記内視鏡のチャネルを通して椎間円板を除去する間に、前記少なくとも２つのローカライザの位置および配向が決定され、モニター上に視覚化された患者モデルにおける前記内視鏡の遠位端の少なくとも前記位置を示すために使用される、項目９に記載の方法。
（項目１１）
前記アクセス針、前記ガイドロッド、前記作業チューブ、前記作業チューブ、前記リーマー、または前記内視鏡のうちの少なくとも１つの前記内腔内に、前記センサキャリアを挿入した後に、医療器具の遠位端と前記２つのローカライザのうちの少なくとも１つの前記位置との間の距離を決定することによって、内腔に配設された前記センサキャリアを有する前記医療器具を自動的に識別し、前記決定された距離に基づいて、前記それぞれの医療器具の前記内腔の長さを決定し、その内腔の前記決定された長さに基づいて、前記配設されたセンサキャリアを有する前記医療器具を識別するステップ、を含む、項目９または１０に記載の方法。
（項目１２）
前記モデルに示された少なくとも１つの前記アクセス針、前記ガイドロッド、前記作業チューブ、前記作業チューブ、前記リーマー、または前記内視鏡の前記位置を有する患者モデルの視覚化、ならびに／あるいは前記センサキャリアおよび／もしくは前記内視鏡が特定の方法ステップで使用されているかどうかに基づいて、かつ／またはセンサキャリアと椎骨との間の相対移動が検出されているかどうかに基づいて、前記内視鏡によって捕捉される内視鏡画像を、モニター上に表示するステップを含む、項目９～１１のいずれか一項に記載の方法。
（項目１３）
少なくとも２つの椎骨を融合する方法であって、前記方法が、
－医療器具の内腔に取り外し可能に配設されるように構成されているセンサキャリアを提供するステップであって、前記センサキャリアが、少なくとも２つのローカライザを有し、前記ローカライザが各々、前記それぞれのローカライザの位置および配向を表すセンサ信号を提供するように構成されている、提供するステップと、
－作業チャネルを有する作業チューブを提供するステップであって、前記作業チューブが、患者の体内に配設されて、２つの椎骨間の円板空間への後方－外側アクセスを提供し、椎間円板および／または周囲の身体組織の少なくとも一部が、前記円板空間から除去されている、提供するステップと、
－前記２つのそれぞれの椎骨間の前記円板空間を復元するために、脊椎ケージを患者の脊椎内に移植するために前記作業チューブの作業チャネルを使用するステップと、
－前記センサキャリアをアクセス針内に挿入し、前記椎骨ラミナのうちの１つに、配設されたセンサキャリアを有する前記アクセス針をナビゲートし、同時に、前記少なくとも２つのローカライザの位置および配向を決定し、前記ローカライザの前記決定された位置および配向を使用して、モニター上に視覚化された患者モデル内の前記アクセス針の遠位端の少なくとも位置を示すステップと、
－前記アクセス針を用いて椎骨ラミナをドリル加工し、同時に、前記少なくとも２つのローカライザの位置および配向を決定し、前記ローカライザの前記決定された位置および配向を使用して、モニター上に視覚化された患者モデル内の前記アクセス針の前記遠位端の少なくとも前記位置を示すステップと、
－前記センサキャリアを前記アクセス針から除去し、続いて、前記センサキャリアのローカライザのうちの少なくとも１つがラミナねじの遠位端の少なくとも近くに位置するように取り付けられたラミナねじを有するラミナドライバの内腔内に、前記センサキャリアを挿入するステップと、
－前記センサキャリアがラミナドライバおよびラミナねじに配設されている前記椎骨ラミナに、前記ラミナねじを移植し、同時に、前記少なくとも２つのローカライザの位置および配向を決定し、前記ローカライザの前記決定された位置および配向を使用して、モニター上に視覚化された患者モデル内の前記ラミナねじの前記遠位端の少なくとも前記位置を示すステップと、
－前記センサキャリアを前記ドライバから除去し、その後、前記センサキャリアをアクセス針の内腔内に挿入し、前記椎骨の椎弓根のうちの１つに、配設されたセンサキャリアを有する前記アクセス針をナビゲートし、同時に、前記少なくとも２つのローカライザの位置および配向を決定し、前記ローカライザの前記決定された位置および配向を使用して、モニター上に視覚化された患者モデル内の前記アクセス針の前記遠位端の少なくとも前記位置を示すステップと、
－前記センサキャリアを前記アクセス針から除去し、その後、前記センサキャリアをタップの内腔内に挿入し、タッピングされた穴を前記椎骨の椎弓根にタッピングし、少なくともタッピング中に、前記少なくとも２つのローカライザの位置および配向を決定し、前記ローカライザの前記決定された位置および配向を使用して、モニター上に視覚化された患者モデル内の前記タップの前記遠位端の少なくとも前記位置を示すステップと、
－前記センサキャリアを前記タップから除去し、続いて、前記センサキャリアを、椎弓根ねじを有する椎弓根ドライバの内腔内に挿入し、前記椎弓根ねじを前記椎骨の椎弓根内に配置し、少なくとも前記ねじを配置している間に、前記少なくとも２つのローカライザの位置および配向を決定し、前記ローカライザの前記決定された位置および配向を使用して、モニター上に視覚化された患者モデル内の前記椎弓根ねじの前記遠位端の少なくとも前記位置を示すステップと、
－他の椎弓根ねじを隣接する椎骨のうちの１つに配置するために、前記センサキャリア、アクセス針、タップ、および別の椎弓根ねじを有する椎弓根ドライバを使用し、前記２つの隣接する椎骨を融合するために前記椎骨内に配置された前記少なくとも２つの椎弓根ねじをロッドと接続するステップと、を含む、方法。
（項目１４）
前記ケージを移植するために、前記ケージの前記位置が、前記センサキャリアの前記少なくとも２つのローカライザの前記位置および配向に対して追跡され、モニター上に視覚化された患者モデルに示される、項目１３に記載の方法。
（項目１５）
前記ラミナねじおよび椎弓根ねじの少なくともラミナねじ長さおよび／または椎弓根ねじ長さをそれぞれ、
－前記少なくとも２つのローカライザが、前記ドライバの長手方向軸に沿って互いに対してある距離で配設されるように、取り付けられた骨ねじを有する前記ドライバの前記内腔に、前記センサキャリアを配設することと、
－前記少なくとも２つのローカライザの位置および配向に基づいて、前記ねじの遠位端と前記２つのローカライザのうちの少なくとも１つの前記位置との間の距離を決定することと、
－前記決定された距離に基づいて、前記ねじの前記長さを自動的に検出することと、によって、自動的に検出するステップを含む、項目１３または１４に記載の方法。
（項目１６）
前記ねじを識別するために、前記決定されたねじ長さを複数の所定のねじタイプのうちの１つに割り当てることを含む、項目１５に記載の方法。
（項目１７）
前記センサキャリアの前記少なくとも２つのローカライザが、前記センサキャリアの前記遠位端の近くに配設され、前記センサキャリアが、前記センサキャリアの近位端に向かって、前記少なくとも２つのローカライザに対してある距離で配設されている少なくとも第３のローカライザを備え、前記方法が、前記ローカライザの決定された位置および配向に基づいて、ローカライザのうちの前記少なくとも１つと前記少なくとも第３のローカライザとの間に囲まれた曲げ角度を計算することによって、内腔に配設された前記センサキャリアを有する前記アクセス針の曲げを計算するステップを含む、項目１３～１６のいずれか一項に記載の方法。
（項目１８）
前記検出された曲げ角度に従って、曲げられた状態で、モニター上に前記アクセス針の少なくとも一部のデジタル表現を視覚化することを含む、項目１７に記載の方法。 In particular, when calculating a bend angle enclosed between at least one of the at least two localizers and at least a third localizer within the method of fusing at least two vertebrae, the method comprises: , visualizing on a monitor a digital representation of at least a portion of the access needle in the flexed state.
The present invention provides, for example, the following.
(Item 1)
A surgical kit for performing minimally invasive spine surgery, said surgical kit comprising:
- a position detection system configured to detect the position and orientation of the localizer from the received sensor signals within the coordinate system of the position detection system;
- a sensor carrier configured to be removably disposed in a lumen of a medical device, said sensor carrier having at least two localizers, each said localizer at a position of said respective localizer; a sensor carrier configured to provide a sensor signal representative of the orientation and
- a plurality of different medical instruments having a lumen, wherein the sensor carrier can be removably arranged to connect the respective medical instrument to the position detection system; Prepare, surgical kit.
(Item 2)
one of the plurality of medical devices having a lumen,
- an access needle having a lumen extending from its distal end to its proximal end, said access needle configured to be guided to a target location within a patient's body; , an access needle.
(Item 3)
The plurality of medical devices having lumens,
- a guidewire configured to be inserted into the lumen of the access needle;
- a guide rod having a lumen and configured to be advanced over said guidewire;
- at least one extension tube configured to advance over said guide rod and extend the access path to the target location;
- a working tube configured to advance over said at least one dilation tube and provide a working channel for a medical device, wherein at its distal end said working tube is adapted to contact the patient's bone; a working tube shaped so that it can be secured;
- having a lumen in which an endoscope may be disposed, and adapted to be disposed within the working channel of the working tube to create posterior-lateral access to the central nervous system; ,reamer,
- an endoscope having at least one endoscopic working channel for the insertion of another medical instrument, said endoscope being configured for medical imaging inside a patient's body. mirror, or
- a medical instrument disposed within a working channel of said endoscope and configured to remove at least a portion of an intervertebral disc and/or surrounding body tissue. , item 1 or 2.
(Item 4)
The plurality of medical devices having lumens,
- a spinal cage configured to restore the disc space between two vertebrae when placed between the respective vertebrae;
- a lamina driver comprising a lamina screw, said driver having a lumen extending from a proximal end of said driver to a distal end of said lamina screw, said driver threading said lamina screw; a lamina driver configured to secure within a vertebral lamina;
- taps for tapping holes into the vertebrae for fixing bone screws, or
- a pedicle driver with a pedicle screw, said driver having a lumen extending from a proximal end of said driver to a distal end of said pedicle screw; a pedicle driver configured to secure the pedicle screw within a pedicle of a vertebra. kit.
(Item 5)
- a first localizer of said localizers is arranged at or at least near a distal end of said sensor carrier, and a second localizer of said localizers is arranged at said second disposed a distance from one localizer toward the proximal end of the sensor carrier, the sensor carrier comprising:
- a surgical kit according to any one of the preceding items, further comprising a hypotube extending from the distal end to the proximal end of the sensor carrier and enclosing the at least two localizers. .
(Item 6)
at least a third localizer configured to provide a sensor signal representative of the position and orientation of a third localizer, said third localizer being integrated from said first and second localizers to said sensor carrier; A surgical kit according to any one of the preceding items arranged at a distance towards the proximal end.
(Item 7)
comprising a medical device identification setup, said medical device identification setup comprising:
- a calibration device configured such that its position and orientation in the coordinate system of said position detection system can be determined by said position detection system;
- based on the position and orientation of the calibration device and the position and orientation of at least one of the two localizers determined by the position detection system, the tip of the medical instrument and one of the two localizers; a calibration unit configured to calibrate a medical device having said sensor carrier disposed within a lumen by calculating a distance between at least one
- a medical device configured to determine a lumen length of said medical device from at least said calculated distance and use said determined length of said lumen to identify said medical device; A surgical kit according to any one of the preceding items, comprising an instrument identification unit.
(Item 8)
8. The surgical kit of item 7, wherein the calibration unit is configured to determine a virtual longitudinal axis of a medical instrument based on the positions of the at least two localizers.
(Item 9)
A method of removing at least a portion of an intervertebral disc and/or surrounding body tissue, said method comprising:
- providing a sensor carrier configured to be removably disposed in a lumen of a medical device, said sensor carrier having at least two localizers, each of said localizers providing a sensor signal representative of the position and orientation of the localizer of the
- inserting the sensor carrier into the lumen of an access needle;
- calibrating said access needle with a sensor carrier disposed thereon;
- navigating said access needle having a sensor carrier disposed within the patient's body to a vertebra of the spine, while determining the position and orientation of said at least two localizers from sensor signals; indicating at least the position of the access needle tip within a patient model visualized on a monitor using the position and orientation obtained;
- removing the sensor carrier from the lumen of the access needle and subsequently inserting a guidewire into the lumen of the access needle;
- removing the access needle from the guidewire so that only the guidewire remains in the patient;
- inserting the sensor carrier into the lumen of a guide rod and calibrating the guide rod;
- removing the sensor carrier from the guide rod and advancing the guide rod over the guide wire to the vertebra;
- removing the guide wire from the guide rod and inserting the sensor carrier into the guide rod;
- navigating the guide rod with the sensor carrier disposed thereon to the facet junction of the vertebra, simultaneously determining the positions and orientations of the at least two localizers, and determining the determined positions and orientations of the localizers; indicating at least the position of the distal end of said guide rod within a patient model visualized on a monitor using
- removing the sensor carrier from the guide rod;
- advancing at least one dilation tube over said guide rod, said dilation tube being configured to dilate an access path to said vertebra;
- inserting the sensor carrier into the lumen of a working tube, wherein at its distal end the working tube is shaped such that at its distal end the working tube can be fixed to the patient's bone; a step of inserting
- calibrating the working tube and removing the sensor carrier from the working tube;
- advancing the working tube over the extension tube towards the face joint;
- removing the guide rod and the extension tube;
- inserting the sensor carrier into the working tube, fixing the working tube at its distal end to the vertebrae, simultaneously determining the position and orientation of the at least two localizers, and determining the determined orientation of the localizers; indicating at least the position of the distal end of the working tube within a patient model visualized on a monitor using the position and orientation;
- removing the sensor carrier from the working tube;
- inserting the sensor carrier together with the endoscope into the lumen of the reamer, then inserting the reamer together with the sensor carrier and the endoscope into the working channel of the working tube and posterior to the central nervous system; - using said reamer to create a lateral access, simultaneously determining the position and orientation of said at least two localizers, and using said determined positions and orientations of said localizers, visualized on a monitor. indicating at least the location of the distal end of the reamer within a patient model;
- removing at least part of an intervertebral disc and/or surrounding body tissue through an endoscopic working channel of said endoscope.
(Item 10)
The position and orientation of the at least two localizers are determined during removal of an intervertebral disc through the channel of the endoscope, and at least the distal end of the endoscope in a patient model visualized on a monitor. 10. Method according to item 9, used for indicating said position.
(Item 11)
a distal end of a medical device after inserting the sensor carrier into the lumen of at least one of the access needle, the guide rod, the working tube, the working tube, the reamer, or the endoscope; and the position of at least one of the two localizers automatically identifies the medical device having the sensor carrier disposed in the lumen, and the determined determining the length of the lumen of each of the medical devices based on the distance, and identifying the medical device with the disposed sensor carrier based on the determined length of the lumen. 11. A method according to item 9 or 10, comprising the steps of:
(Item 12)
visualization of a patient model with said position of at least one of said access needle, said guide rod, said working tube, said working tube, said reamer, or said endoscope shown in said model and/or said sensor carrier; and/or based on whether the endoscope is being used in a particular method step and/or based on whether relative movement between the sensor carrier and the vertebrae is detected. 12. A method according to any one of items 9-11, comprising displaying the captured endoscopic image on a monitor.
(Item 13)
A method of fusing at least two vertebrae, said method comprising:
- providing a sensor carrier configured to be removably disposed in a lumen of a medical device, said sensor carrier having at least two localizers, each of said localizers providing a sensor signal representative of the position and orientation of the localizer of the
- providing a working tube having a working channel, said working tube being disposed within the patient's body to provide posterior-lateral access to the disc space between two vertebrae and intervertebral circle providing at least a portion of the disc and/or surrounding body tissue has been removed from the disc space;
- using the working channel of the working tube to implant a spinal cage into the patient's spine to restore the disc space between the two respective vertebrae;
- inserting the sensor carrier into the access needle and navigating the access needle with the sensor carrier disposed in one of the vertebral lamina while simultaneously determining the position and orientation of the at least two localizers; determining and using the determined position and orientation of the localizer to indicate at least the position of the distal end of the access needle within a patient model visualized on a monitor;
- drilling the vertebral lamina using said access needle, simultaneously determining the position and orientation of said at least two localizers, and visualizing on a monitor using said determined positions and orientations of said localizers; indicating at least the position of the distal end of the access needle in a patient model;
- removing the sensor carrier from the access needle, followed by a lamina driver having a lamina screw attached such that at least one of the localizers of the sensor carrier is located at least near the distal end of the lamina screw; inserting the sensor carrier into the lumen;
- implanting the lamina screw in the vertebral lamina, wherein the sensor carrier is arranged on the lamina driver and the lamina screw, and at the same time determining the position and orientation of the at least two localizers; indicating at least the position of the distal end of the lamina screw in a patient model visualized on a monitor using position and orientation;
- removing the sensor carrier from the driver, then inserting the sensor carrier into the lumen of an access needle, the access having the sensor carrier disposed in one of the pedicles of the vertebra; Navigating a needle while simultaneously determining positions and orientations of said at least two localizers, and using said determined positions and orientations of said localizers to navigate said access needle within a patient model visualized on a monitor. indicating at least the position of the distal end of
- removing the sensor carrier from the access needle, then inserting the sensor carrier into the lumen of the tap, tapping the tapped hole into the pedicle of the vertebra, and at least during tapping, the at least two determining the position and orientation of one localizer and using the determined position and orientation of the localizer to indicate at least the position of the distal end of the tap within a patient model visualized on a monitor; and,
- removing the sensor carrier from the tap, then inserting the sensor carrier into the lumen of a pedicle driver having a pedicle screw, the pedicle screw into the pedicle of the vertebra; and determining the positions and orientations of the at least two localizers while positioning at least the screws, and visualizing on a monitor using the determined positions and orientations of the localizers indicating at least the location of the distal end of the pedicle screw in a patient model;
- using a pedicle driver with said sensor carrier, access needle, tap and another pedicle screw to place another pedicle screw in one of the adjacent vertebrae, said two connecting said at least two pedicle screws positioned within said vertebrae with a rod to fuse two adjacent vertebrae.
(Item 14)
Item 13, wherein for implanting the cage, the position of the cage is tracked relative to the position and orientation of the at least two localizers of the sensor carrier and displayed on a patient model visualized on a monitor. The method described in .
(Item 15)
at least a lamina screw length and/or a pedicle screw length of said lamina screw and pedicle screw, respectively;
- disposing the sensor carrier in the lumen of the driver with bone screws attached such that the at least two localizers are disposed at a distance relative to each other along the longitudinal axis of the driver; and
- determining the distance between the distal end of the screw and the position of at least one of the two localizers based on the position and orientation of the at least two localizers;
- automatically detecting the length of the screw based on the determined distance;
(Item 16)
16. The method of item 15, comprising assigning the determined thread length to one of a plurality of predetermined thread types to identify the thread.
(Item 17)
The at least two localizers of the sensor carrier are disposed near the distal end of the sensor carrier, and the sensor carrier extends toward the proximal end of the sensor carrier relative to the at least two localizers. comprising at least a third localizer disposed at a distance, wherein the method comprises determining a distance between the at least one of the localizers and the at least third localizer based on the determined position and orientation of the localizer; 17. The method of any one of items 13-16, comprising calculating the bend of the access needle with the sensor carrier disposed in the lumen by calculating the bend angle enclosed by .
(Item 18)
18. The method of item 17, comprising visualizing on a monitor a digital representation of at least a portion of the access needle in a bent state according to the detected bend angle.

Claims

A surgical kit for performing minimally invasive spine surgery, said surgical kit comprising:
- a position detection system configured to detect the position and orientation of the localizer from the received sensor signals within the coordinate system of the position detection system;
- a sensor carrier configured to be removably disposed in a lumen of a medical device, said sensor carrier having at least two localizers, each said localizer at a position of said respective localizer; a sensor carrier configured to provide a sensor signal representative of the orientation and
- a plurality of different medical instruments having a lumen, wherein the sensor carrier can be removably arranged to connect the respective medical instrument to the position detection system; Prepare, surgical kit.

one of the plurality of medical devices having a lumen,
- an access needle having a lumen extending from its distal end to its proximal end, said access needle configured to be guided to a target location within a patient's body; , an access needle.

The plurality of medical devices having lumens,
- a guidewire configured to be inserted into the lumen of the access needle;
- a guide rod having a lumen and configured to be advanced over said guidewire;
- at least one extension tube configured to advance over said guide rod and extend the access path to the target location;
- a working tube configured to advance over said at least one dilation tube and provide a working channel for a medical device, wherein at its distal end said working tube is adapted to contact the patient's bone; a working tube shaped so that it can be secured;
- having a lumen in which an endoscope may be disposed, and adapted to be disposed within the working channel of the working tube to create posterior-lateral access to the central nervous system; ,reamer,
- an endoscope having at least one endoscopic working channel for the insertion of another medical instrument, said endoscope being configured for medical imaging inside a patient's body. at least one of a speculum, or - a medical instrument disposed within a working channel of said endoscope and configured to remove at least a portion of an intervertebral disc and/or surrounding body tissue. 3. The surgical kit of claim 1 or 2, comprising:

The plurality of medical devices having lumens,
- a spinal cage configured to restore the disc space between two vertebrae when placed between the respective vertebrae;
- a lamina driver comprising a lamina screw, said driver having a lumen extending from a proximal end of said driver to a distal end of said lamina screw, said driver threading said lamina screw; a lamina driver configured to secure within a vertebral lamina;
- a tap for tapping a hole into the vertebra for fixing a bone screw; a pedicle driver having a lumen extending to a distal end of a root screw, said driver configured to secure said pedicle screw within a pedicle of a vertebra; A surgical kit according to any one of the preceding claims, comprising at least one of:

- a first localizer of said localizers is arranged at or at least near a distal end of said sensor carrier, and a second localizer of said localizers is arranged at said second disposed a distance from one localizer toward the proximal end of the sensor carrier, the sensor carrier comprising:
4. The surgical procedure of any one of the preceding claims, further comprising a hypotube extending from the distal end to the proximal end of the sensor carrier and enclosing the at least two localizers. kit.

at least a third localizer configured to provide a sensor signal representative of the position and orientation of a third localizer, said third localizer being integrated from said first and second localizers to said sensor carrier; 6. A surgical kit according to any one of the preceding claims, arranged at a distance towards the proximal end.

comprising a medical device identification setup, said medical device identification setup comprising:
- a calibration device configured such that its position and orientation in the coordinate system of said position detection system can be determined by said position detection system;
- based on the position and orientation of the calibration device and the position and orientation of at least one of the two localizers determined by the position detection system, the tip of the medical instrument and one of the two localizers; a calibration unit configured to calibrate a medical device having said sensor carrier disposed within a lumen by calculating a distance between at least one
- a medical device configured to determine a lumen length of said medical device from at least said calculated distance and use said determined length of said lumen to identify said medical device; A surgical kit according to any one of the preceding claims, comprising an instrument identification unit.

The surgical kit of Claim 7, wherein the calibration unit is configured to determine a virtual longitudinal axis of a medical instrument based on the positions of the at least two localizers.

A surgical kit for removing at least a portion of an intervertebral disc and/or surrounding body tissue, said surgical kit comprising:
- a sensor carrier configured to be removably disposed in a lumen of a medical device, said sensor carrier having at least two localizers, each said localizer at a position of said respective localizer; a sensor carrier configured to provide a sensor signal representative of the orientation and
- an access needle, wherein the sensor carrier is configured to be inserted within a lumen of the access needle;
- a calibration unit configured to calibrate the access needle having a sensor carrier disposed thereon;
- a position detection system, wherein said access needle with sensor carrier disposed therein is navigated into the body of a patient, to a vertebra of the spine, and at the same time said position detection system detects the position of said at least two localizers and determining an orientation from the sensor signal; and using the determined position and orientation of the localizer to indicate at least the position of the access needle tip within a patient model visualized on a monitor. a position detection system configured to :
- a guidewire, said guidewire adapted to be inserted into the lumen of said access needle after said sensor carrier has been removed from said lumen of said access needle, said access needle comprising a guidewire configured to be removed from the guidewire such that only the guidewire remains in the patient;
- a guide rod, wherein said sensor carrier is adapted to be inserted into a lumen of said guide rod, said calibration unit is adapted to calibrate said guide rod, said A sensor carrier is configured to be removed from the guide rod, the guide rod is configured to be advanced over the guide wire to the vertebrae, and the guide wire is configured to connect to the guide rod. wherein the sensor carrier is configured to be inserted into the guide rod , the guide rod having the sensor carrier disposed thereon is adapted to be removed from the facet junction of the vertebrae. simultaneously with the position detection system determining the positions and orientations of the at least two localizers and visualized on a monitor using the determined positions and orientations of the localizers indicating at least a position of a distal tip of the guide rod within a patient model, wherein the sensor carrier is configured to be removed from the guide rod; ,
- at least one dilation tube, said at least one dilation tube configured to be advanced over said guide rod to dilate an access path to said vertebra; ,
- a working tube, wherein said sensor carrier is adapted to be inserted into a lumen of said working tube, and at its distal end said working tube is configured to be fixed to a patient's bone , the calibration unit is configured to calibrate the working tube, and the sensor carrier is configured to be removed from the working tube. wherein the working tube is configured to be advanced over the dilation tube toward the facet joint, the guide rod and the dilation tube are configured to be removed ; The sensor carrier is configured to be inserted within the working tube, the working tube is configured to be fixed at its distal end to the vertebrae, and the position detection system is configured to , determining the positions and orientations of the at least two localizers; and using the determined positions and orientations of the localizers, the distal tip of the working tube in a patient model visualized on a monitor. indicating at least the position of the working tube, wherein the sensor carrier is configured to be removed from the working tube ;
- an endoscope;
- a reamer, wherein the sensor carrier is adapted to be inserted into the lumen of the reamer together with the endoscope, after which the reamer together with the sensor carrier and the endoscope performs the operation; configured to be inserted into a working channel of a tube, wherein the reamer is configured to create posterior-lateral access to the central nervous system; Determining the position and orientation of a localizer and using the determined position and orientation of the localizer to indicate at least the position of the distal tip of the reamer within a patient model visualized on a monitor. wherein at least a portion of the intervertebral disc and/or surrounding body tissue is removed through an endoscopic working channel of the endoscope ;
A surgical kit comprising :

The position and orientation of the at least two localizers are determined while the intervertebral disc is removed through the channel of the endoscope , distal of the endoscope in a patient model visualized on a monitor. 10. The surgical kit of claim 9 used to indicate at least said position of a tip .

further comprising a medical device identification unit, wherein the sensor carrier is inserted within the lumen of at least one of the access needle, the guide rod, the working tube, the working tube, the reamer, or the endoscope; said calibration unit is configured to determine a distance between a distal tip of a medical device and said position of at least one of said two localizers after said medical device identification unit and determining the length of the lumen of the respective medical device based on the determined distance, and having the sensor carrier disposed thereon based on the determined length of the lumen. 11. The surgical kit of claim 9 or 10, wherein identifying a medical instrument automatically identifies the medical instrument having the sensor carrier disposed in its lumen.

visualization of a patient model with said position of at least one of said access needle, said guide rod, said working tube, said working tube, said reamer, or said endoscope shown in said model and/or said sensor carrier; and/or based on whether the endoscope is being used in a particular method step and/or based on whether relative movement between the sensor carrier and the vertebrae is detected. The surgical kit of any one of claims 9-11, comprising a monitor configured to display the captured endoscopic image.

A surgical kit for fusing at least two vertebrae, said surgical kit comprising:
- a sensor carrier configured to be removably disposed in a lumen of a medical device, said sensor carrier having at least two localizers, each said localizer at a position of said respective localizer; a sensor carrier configured to provide a sensor signal representative of the orientation and
- a working tube having a working channel, said working tube being disposed within a patient's body to provide posterior-lateral access to the disc space between two vertebrae, intervertebral disc and/or At least a portion of surrounding body tissue has been removed from the disc space, and the working channel of the working tube places the spinal cage into the patient to restore the disc space between the two respective vertebrae. a working tube configured to be used for implantation within the spine of
- a position detection system, wherein the sensor carrier is adapted to be inserted into an access needle, the access needle with the sensor carrier disposed navigating one of the lamina of the vertebra; Gated simultaneously, the position detection system determining positions and orientations of the at least two localizers; and a patient model visualized on a monitor using the determined positions and orientations of the localizers. indicating at least a position of a distal tip of the access needle within the access needle, wherein the access needle is configured to drill a vertebral lamina ; determining the positions and orientations of the at least two localizers; and using the determined positions and orientations of the localizers to position the distal end of the access needle within a patient model visualized on a monitor. indicating at least the position of the tip ; and
- a lamina driver having a lamina screw attached, wherein the sensor carrier is configured to be removed from the access needle, and subsequently the sensor carrier is attached to at least one of the localizers of the sensor carrier; one configured to be inserted into the lumen of the lamina driver such that one is positioned at least near a distal tip of a lamina screw, the lamina screw connecting the sensor carrier to the lamina driver and the lamina screw; configured to be implanted in the lamina of the vertebrae being disposed, while the position detection system determines the positions and orientations of the at least two localizers; using position and orientation to indicate at least the position of the distal tip of the lamina screw within a patient model visualized on a monitor, the sensor carrier comprising : configured to be removed from the driver, after which the sensor carrier is configured to be inserted within a lumen of an access needle, the access needle having the sensor carrier disposed thereon; navigating to one of the pedicles of the vertebra while simultaneously causing the position detection system to determine the positions and orientations of the at least two localizers; a lamina driver configured to be used to indicate at least the location of the distal tip of the access needle within a patient model visualized on a monitor;
- a tap, wherein the sensor carrier is adapted to be removed from the access needle, after which the sensor carrier is adapted to be inserted into the lumen of the tap ; a tap configured to tap a tapped hole into a pedicle of the vertebra, the position detection system determining the position and orientation of the at least two localizers at least during tapping; using the determined position and orientation of the localizer to indicate at least the position of the distal tip of the tap within a patient model visualized on a monitor. tap and
- a pedicle driver having a pedicle screw, wherein the sensor carrier is adapted to be removed from the tap, and subsequently the sensor carrier is inserted into the lumen of the pedicle driver; and wherein the pedicle screw is configured to be positioned within a pedicle of the vertebra, and the position sensing is performed at least during positioning of the screw. a system determining positions and orientations of the at least two localizers; and using the determined positions and orientations of the localizers of the pedicle screws in a patient model visualized on a monitor. indicating at least the position of a distal tip , and the sensor carrier, access needle, tap for placing another pedicle screw in one of the adjacent vertebrae; , and another pedicle screw configured to be used to fuse at least two pedicles positioned within said vertebrae to fuse said two adjacent vertebrae. a pedicle driver , wherein the root screw is configured to connect with the rod;
A surgical kit comprising :

12. The position of the cage is tracked relative to the position and orientation of the at least two localizers of the sensor carrier and displayed on a patient model visualized on a monitor for implanting the cage. 14. Surgical kit according to 13.

further comprising a calibration unit and a medical device identification unit;
- the sensor carrier is arranged in the lumen of the driver with bone screws attached such that the at least two localizers are arranged at a distance relative to each other along the longitudinal axis of the driver; is configured to be
- so that the calibration unit determines the distance between the distal tip of the screw and the position of at least one of the two localizers based on the positions and orientations of the at least two localizers; is composed of
- said medical device identification unit is configured to automatically detect a length of said screw based on said determined distance, thereby at least lamina screws of said lamina screw and pedicle screw; 15. A surgical kit according to claim 13 or 14 , which automatically detects length and/or pedicle screw length, respectively .

The surgical kit according to claim 15, wherein the determined screw length is assigned to one of a plurality of predetermined screw types to identify the screw.

The at least two localizers of the sensor carrier are disposed near a distal tip of the sensor carrier, and the sensor carrier extends toward the proximal end of the sensor carrier relative to the at least two localizers. comprising at least a third localizer disposed at a distance, the surgical kit aligning the at least one of the localizers with the at least third localizer based on the determined position and orientation of the localizer; 14. A calibration unit configured to calculate the bend of the access needle with the sensor carrier disposed in its lumen by calculating the bend angle enclosed between 17. A surgical kit according to any one of paragraphs 1-16.

18. The surgical kit of claim 17, comprising a monitor configured to visualize a digital representation of at least a portion of the access needle in a bent state according to the detected bend angle.