JP5203610B2 - 椎骨椎間関節プロテーゼおよびその固定方法 - Google Patents
椎骨椎間関節プロテーゼおよびその固定方法 Download PDFInfo
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- JP5203610B2 JP5203610B2 JP2006552309A JP2006552309A JP5203610B2 JP 5203610 B2 JP5203610 B2 JP 5203610B2 JP 2006552309 A JP2006552309 A JP 2006552309A JP 2006552309 A JP2006552309 A JP 2006552309A JP 5203610 B2 JP5203610 B2 JP 5203610B2
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- prosthesis
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- facet joint
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- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7062—Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
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- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7062—Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
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- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
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- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
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- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
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- A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
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- A61F2310/00029—Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
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- A—HUMAN NECESSITIES
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00179—Ceramics or ceramic-like structures
- A61F2310/00185—Ceramics or ceramic-like structures based on metal oxides
- A61F2310/00203—Ceramics or ceramic-like structures based on metal oxides containing alumina or aluminium oxide
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00179—Ceramics or ceramic-like structures
- A61F2310/00185—Ceramics or ceramic-like structures based on metal oxides
- A61F2310/00239—Ceramics or ceramic-like structures based on metal oxides containing zirconia or zirconium oxide ZrO2
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Description
いくつかの実施形態においては、デバイスの少なくとも1つの表面は、高度に研磨された表面を有している。いくつかの実施形態においては、長尺部材は、増大された断面積を有した少なくとも1つの端部を備えることができる。長尺部材は、球状の保持部分やフレアー状の保持部分やTバー状の保持部分や一体的リング状の保持部分を有した少なくとも1つの端部を備えることができる。いくつかの実施形態においては、デバイスの少なくとも1つの表面は、関節表面の少なくとも一部の形状に対して追従し得るよう十分にソフトなものとされている。
図1に示すように、脊柱2は、互いに交互に配置された、一連をなす複数の脊椎4と、身体の上部に対する軸線方向の支持と運動とをもたらす線維状ディスク6と、を備えている。脊柱2は、典型的には、33個の脊椎4から構成され、7個の頸椎(C1〜C7)と、12個の胸椎(T1〜T12)と、5個の腰椎(L1〜L5)と、5個の融合仙椎(S1〜S5)と、4個の融合尾椎と、を備えている。図2Aおよび図2Bは、典型的な胸椎を示している。各脊椎は、前方ボディ8と、後方アーチ10と、を備えている。後方アーチ10は、2つの茎12と、棘突起16を形成し得るよう後方において連結される2つの薄片14と、を備えている。後方アーチ10の両側から突出しているものは、側方突起18と、上方関節突起20と、下方関節突起22と、である。上方関節突起20と下方関節突起22の側面24,26は、隣接する脊椎の関節突起と一緒に、椎間関節28を形成している。図3Aおよび図3Bを参照されたい。椎間関節は、軟骨表面と関節カプセルとを有した実際の滑膜関節である。
Orthop. Clin. North Am., 6:19 1975 という一研究により、脊柱のある部分においては、椎間関節による荷重支持が30%であることが判明した。椎間関節は、また、脊椎どうしの間の剪断応力に対抗するという役割を果たすことができる。経時的に、椎間関節に作用するこれらの力は、劣化や関節炎を引き起こすことがあり得る。
本発明の1つの実施形態においては、椎間関節の2つの側面の間の間隔を復元させるためのデバイスが、設けられる。図7Aおよび図7Bに示すように、デバイスは、少なくとも2つの面を有したプロテーゼ34を備えている。第1面36は、椎間関節の一方の側面がなす関節表面に対して接触し得るよう構成されている。第2面38は、他方の側面をなす関節表面に対して接触し得るよう構成されている。1つの実施形態においては、プロテーゼ34は、全体的に円形のプロファイル(あるいは、外形形状)を有しており、椎間関節28の関節カプセル内に全体が収まるようなサイズとされている。図8は、椎間関節内に配置された図7Aおよび図7Bのプロテーゼ34を示している。本発明の他の実施形態においては、プロテーゼは、様々なプロファイルを有することができる。限定するものではないけれども、例えば、正方形や、長方形や、卵形や、星形や、多角形や、あるいは、これらの組合せ、とすることができる。八角形のプロテーゼが、図9Aおよび図9Bに示されている。本発明の1つの実施形態においては、所望の形状を有したプロテーゼが、関節突起のX線撮影視覚化の後に、および/または、関節カプセルを可視化し得るよう椎間関節内へのX線的注入によって、一群をなす複数のプロテーゼの中から選択される。1つの実施形態においては、プロテーゼは、約4mm〜約30mmという直径を有している。他の実施形態においては、プロテーゼは、約5mm〜約25mmという直径を有している。さらに他の実施形態においては、プロテーゼは、約10mm〜約20mmという直径を有している。1つの実施形態においては、プロテーゼは、約10mm2 〜約700mm2 という断面積を有している。他の実施形態においては、プロテーゼは、約25mm2 〜約500mm2 という断面積を有している。さらに他の実施形態においては、プロテーゼは、約20mm2 〜約400mm2 という断面積を有し、好ましくは、約25mm2 〜約100mm2 という断面積を有している。
本発明の1つの実施形態においては、プロテーゼは、椎間関節を囲んでいる関節カプセルおよび/または他の生体組織を利用することによって、椎間関節の2つの側面の間で維持される。これにより、椎間関節からのプロテーゼの抜け出しを制限することができる。本発明のいくつかの実施形態においては、プロテーゼ自体の形状によって、プロテーゼは、椎間関節の側面どうしの間の所定位置からの位置ズレに対して抵抗することができる。1つの実施形態においては、片面において凹状とされた構成あるいは両面において凹状とされた構成により、プロテーゼの周縁部分での厚さを増大させこれにより位置ズレを引き起こすに必要な力をより大きなものとすることによって、プロテーゼの位置ズレに対して抵抗することができる。他の実施形態においては、上述したように、表面処置を使用することにより、すなわち、肌め(テクスチャー)を使用することにより、椎間関節の側面に対してプロテーゼを維持することができる。いくつかの実施形態においては、ディスクの構成と、表面の肌めと、生体組織または生体構造の存在と、の組合せを使用することにより、プロテーゼを所定位置に維持することができる。
プロテーゼは、椎間関節の関節カプセル内におけるプロテーゼの保持を容易なものとする保持部材と係合し得るよう、保持インターフェースを備えて構成することができる。保持部材の使用は、経時的なプロテーゼの移動を防止し得るという観点において、また、プロテーゼを滑り出させてしまいかねないような過度な範囲での椎骨移動が起こった場合であってもプロテーゼの移動を防止し得るという観点において、有利なものとすることができる。
本発明の1つの実施形態においては、図20〜図21Bに示すように、保持部材は、ワイヤまたはケーブル72を備えている。ワイヤまたはケーブル72は、保持インターフェース78のところにおいてプロテーゼ76と係合する部分74と、椎間関節を囲んでいる骨または軟組織に対して係合するあるいはアンカー止めされる少なくとも1つの他の部分80と、を有している。ワイヤまたはケーブルは、中実のものとも、また、編み込まれたものとも、また、多繊維構造のもの(マルチフィラメント)とも、することができる。この実施形態における保持部材は、主に、ケーブルまたはワイヤとして説明される。しかしながら、中央開口を挿通して延在し得る任意の様々な長尺構造であっても、例えばピンやネジや単一ストランド型のあるいはマルチストランド型のポリマー製のストリングや織物やポリマー製メッシュや編物や他の構造といったような構造であっても、同様に作用し得ることは、当業者には自明であろう。
本発明の1つの実施形態においては、図36Aに示すように、保持部材は、ネジまたはボルト126を備えている。ネジまたはボルト126は、基端部128と、ボディ130と、先端部132と、を有している。ネジまたはボルトの先端部132は、プロテーゼまたはスペーサ136の相補的保持インターフェース134に対して機械的インターロックを形成することができる。先端部132は、典型的には、ネジ山を備えている。しかしながら、当業者であれば、機械的インターロックを形成するに際して他の構成を使用し得ることは、理解されるであろう。プロテーゼ136の相補的保持インターフェース134は、ネジ山付きの貫通穴とすることができ、好ましくは、有底の穴(先端が閉塞された穴)とすることができる。ネジまたはボルト126の基端部128は、ネジまたはボルト126を操作するための回転ツールを係合し得るものとして当業者に公知であるような六角タイプのインターフェースや他のタイプのインターフェースを有している。ネジまたはボルト126のボディは、プロテーゼを固定し得るよう関節突起内にわたって形成された穴または導管の延在長さと比較して、同等またはそれ以上の長さを有している。図36Bにおいては、保持部材は、さらに、回転可能なワッシャ127を備えている。回転可能なワッシャ127は、ネジ126の基端部128に対して関節結合される回転表面129を有している。1つの実施形態においては、回転可能なワッシャ127は、ネジ126に対して、一群をなす複数の位置をとることができ、ネジ126に対し、骨に対するより良好な表面接触を提供することができる。
本発明のいくつかの実施形態においては、図40A〜図41Bに示すように、保持部材は、プロテーゼに対して一体型とされているすなわちプロテーゼに対して取り付けられている。保持部材は、プロテーゼ144から延出された突起142を備えている。突起142は、隣接した関節突起または周囲組織に対して係合し得るものとして、構成されている。1つの実施形態においては、突起は、プロテーゼ144の1つの面から延出された少なくとも1つのスパイク142またはフックを有している。1つの実施形態においては、スパイク142またはフックは、リブ付きのものや、あるいは、逆棘付きのものや、あるいは、ネジ山付きのものとすることができる。これにより、骨または組織内へと挿入された後には、脱離に対する抵抗性を提供することができる。図42は、椎間関節28の側面24に対して係合した状態での図40Aのプロテーゼ144を示している。2部材型プロテーゼ146を備えてなる1つの実施形態においては、図43に示すように、各ディスク148は、それぞれ個別的に、突起タイプの保持部材142を備えることができる。本発明のいくつかの実施形態においては、図44に示すように、複数の突起150が、プロテーゼ152上に設けられる。図45は、椎間関節28内に配置されたる図44のプロテーゼを示している。突起150は、プロテーゼ152に対して角度付きのものとすることができる。これにより、関節のところにおける位置ズレに対して抵抗性を有することができる。
1.頸椎に対する外科手術的アプローチ
本発明の1つの実施形態においては、全身麻酔を実行し、患者を、テーブルに対して取り付けられた回転フレームまたは三点ヘッドレスト上においてうつ伏せで配置する。トングを使用して、骨格の牽引を実施する。患者は、通常の無菌状態で、布で覆われる。手術前のX線フィルムをチェックし、脊柱の異常または変形を確認する。1つの実施形態においては、脊椎突起を触診し、頸椎の位置を特定する。そして、図48に示すように、所望の脊柱上において、皮膚に切開口を形成する。他の実施形態においては、所望の椎間関節上において、パラスピナスな皮膚切開口を形成する。露出させた皮膚エッジと皮下組織とに対して、エピネフリン1:500,000溶液を注射し、止血を行う。電気焼灼ナイフを使用して、棘突起椎間関節への解剖を実施する。1つの実施形態においては、図49に示すように、解剖は、脈管筋組織内へのカットを避けるために、項靭帯164に沿って行う。軟組織の回収器を使用することにより、組織の張力を維持するとともに、解剖プロセスを補助する。棘突起16に対する靭帯付着を分離し、椎間関節を露出させる。他の実施形態においては、解剖を、筋組織を通して行い、これにより、椎間関節に対して直接的にアクセスする。椎間関節の関節カプセルは、切開または穿孔によって開放する。椎間関節の側面を、必要に応じて除去し、これにより、関節スペースへに対するアクセスを可能とする。1つの実施形態においては、影響を受ける椎間関節のサイズを計測し、関節プロテーゼを選択する。1つの実施形態においては、関節プロテーゼを受領し得るように、関節突起を準備する。限定するものではないけれども、関節突起の関節表面を粗面化したり、および/または、プロテーゼのアンカー止め部材または保持部材のための穴を開けたり、する。椎間関節スペース内へとプロテーゼを挿入し、必要に応じて、アンカー止め部材または保持部材を、関節突起に対して取り付ける。すべての関節プロテーゼを挿入するまで、ステップを繰り返す。吸入チューブまたは排水チューブを所定位置に有した層内において、手術サイトを閉塞する。手術部位を洗浄して包帯を巻く。
本発明の1つの実施形態においては、全身麻酔を実行し、患者を、パッド付き脊椎手術フレーム上においてうつ伏せで配置する。患者は、通常の無菌状態で、布で覆われる。手術前のX線フィルムをチェックし、脊柱の異常または変形を確認する。1つの実施形態においては、図50に示すように、所望の脊柱上において、中央ライン皮膚切開口を形成する。他の実施形態においては、所望の椎間関節上において、パラスピナスな皮膚切開口を形成する。露出させた皮膚エッジと皮下組織と脊椎起立筋とに対して、エピネフリン1:500,000溶液を注射し、止血を行う。電気焼灼ナイフまたはメスを使用して、浅在筋膜およびランボドーサル筋膜を通して棘突起の先端への解剖を実施する。脊椎起立筋を、横突起の先端にまで側方へと押し出し、これにより、後弓を露出させる。すべての所望の脊椎を露出させた後に、手術最中のX線を撮影し、これにより、所望の脊椎に対するアクセスを確認する。椎間関節の側面を、必要に応じて除去し、これにより、関節スペースへに対するアクセスを可能とする。椎間関節の関節カプセルは、切開または穿孔によって開放する。1つの実施形態においては、影響を受ける椎間関節のサイズを計測し、関節プロテーゼを選択する。1つの実施形態においては、関節プロテーゼを受領し得るように、関節突起を準備する。限定するものではないけれども、関節突起の関節表面を粗面化したり、および/または、プロテーゼのアンカー止め部材または保持部材のための穴を開けたり、する。椎間関節スペース内へとプロテーゼを挿入し、必要に応じて、アンカー止め部材または保持部材を、関節突起に対して取り付ける。すべての関節プロテーゼを挿入するまで、ステップを繰り返す。吸入チューブまたは排水チューブを所定位置に有した層内において、手術サイトを閉塞する。手術部位を洗浄して包帯を巻く。
本発明の1つの実施形態においては、全身麻酔を実行し、患者を、パッド付き脊椎手術フレーム上においてうつ伏せであるいは膝を曲げた状態で配置する。1つの実施形態においては、腹部を吊り下げることにより、静脈内圧力を低減させて、手術時の失血を低減させる。患者は、通常の無菌状態で、布で覆われる。手術前のX線フィルムをチェックし、脊柱の異常または変形を確認する。図51Aは、所望の脊柱上において中央ライン皮膚切開口を形成した様子を示している。露出させた皮膚エッジと皮下組織とに対して、エピネフリン1:500,000溶液を注射し、止血を行う。図51Bおよび図51Cにおいては、解剖は、ランボドーサル筋膜にまで継続され、皮膚および皮下組織を側方に退避させることによって、手術部位を露出させる。図51Dおよび図51Eにおいては、多裂筋と最長筋との間において、鈍いフィンガー解剖を行い、これにより、椎間関節に対してアクセスする。自己保持型のジェルピリトラクターを筋肉群の間に挿入する。電気焼灼ナイフまたはメスを使用して、多裂筋の側方繊維を、重い浅在付着部位から切り離す。横突起と筋膜平面との露出へと、継続される。焼灼を使用して、横突起のベースに沿って腰部の動脈および静脈から止血を行うことができる。椎間関節の側面を、必要に応じて除去し、これにより、関節スペースへに対するアクセスを可能とする。椎間関節の関節カプセルは、切開または穿孔によって開放する。1つの実施形態においては、影響を受ける椎間関節のサイズを計測し、関節プロテーゼを選択する。1つの実施形態においては、関節プロテーゼを受領し得るように、関節突起を準備する。限定するものではないけれども、関節突起の関節表面を粗面化したり、および/または、プロテーゼのアンカー止め部材または保持部材のための穴を開けたり、する。椎間関節スペース内へとプロテーゼを挿入し、必要に応じて、アンカー止め部材または保持部材を、関節突起に対して取り付ける。すべての関節プロテーゼを挿入するまで、ステップを繰り返す。吸入チューブの上方の層内において、手術サイトを閉塞し、皮膚弁を筋膜に対して縫合し、これにより、組織内のデッドスペースを除去する。手術部位を洗浄して包帯を巻く。
本発明の1つの実施形態においては、全身麻酔または局所麻酔を実行し、患者を、テーブルに対して取り付けられた回転フレームまたは三点ヘッドレスト上においてうつ伏せで配置する。トングを使用して、骨格の牽引を実施する。患者は、通常の無菌状態で、布で覆われる。手術前のX線フィルムをチェックし、脊柱の異常または変形を確認する。棘突起を触診し、これにより、頸椎の位置を特定する。そして、所望の挿入サイト上において、小さな1cmの皮膚切開口を形成する。切開サイトの周辺に対して、エピネフリン1:500,000溶液を適用し、止血を行う。蛍光透視法の下で、トロカールまたはニードルを、切開サイトおよび関節カプセルを通して、所望の椎間関節にまで、挿入する。ニードルまたはトロカールは、導入器と交換する。1つの実施形態においては、挿入は、脈管筋組織内へのカットを避けるために、項靭帯に沿って行う。他の実施形態においては、挿入は、椎間関節の上に位置する皮膚および筋肉を通して直接的に行う。椎間関節の側面を、必要に応じて除去し、これにより、関節スペースへのアクセスを可能とする。1つの実施形態においては、影響を受ける椎間関節のサイズを計測し、関節プロテーゼを選択する。1つの実施形態においては、関節プロテーゼを受領し得るように、関節突起を準備する。限定するものではないけれども、関節突起の関節表面を粗面化したり、および/または、当業者に公知の内視鏡器具を使用して穴を開けたり、する。導入器を通して椎間関節スペース内へとプロテーゼを挿入し、必要に応じて、アンカー止め部材または保持部材を、関節突起に対して取り付ける。すべての関節プロテーゼを挿入するまで、ステップを繰り返す。手術サイトを閉塞して、洗浄して包帯を巻く。
本発明の1つの実施形態においては、全身麻酔または局所麻酔を実行し、患者を、パッド付き脊椎手術フレーム上においてうつ伏せで配置する。患者は、通常の無菌状態で、布で覆われる。手術前のX線フィルムをチェックし、脊柱の異常または変形を確認する。所望の挿入サイト上において、小さな1cmの皮膚切開口を形成する。切開サイトの周辺に対して、エピネフリン1:500,000溶液を適用し、止血を行う。蛍光透視法の下で、トロカールまたはニードルを、浅在筋膜およびランボドーサル筋膜を通して、および、脊椎起立筋および関節カプセルを通して、挿入する。これにより、椎間関節へのアクセスを可能とする。ニードルまたはトロカールは、導入器と交換する。椎間関節の側面を、必要に応じて除去し、これにより、関節スペースへのアクセスを可能とする。手術最中のX線を撮影しまたは蛍光透視法を使用し、これにより、所望の脊椎に対するアクセスを確認する。1つの実施形態においては、影響を受ける椎間関節のサイズを計測し、関節プロテーゼを選択する。1つの実施形態においては、関節プロテーゼを受領し得るように、関節突起を準備する。限定するものではないけれども、関節突起の関節表面を粗面化したり、および/または、当業者に公知の内視鏡器具を使用して、プロテーゼのアンカー止め部材または保持部材のための穴を開けたり、する。椎間関節スペース内へとプロテーゼを挿入し、必要に応じて、アンカー止め部材または保持部材を、関節突起に対して取り付ける。すべての関節プロテーゼを挿入するまで、ステップを繰り返す。手術サイトを閉塞して、洗浄して包帯を巻く。
本発明の1つの実施形態においては、全身麻酔または局所麻酔を実行し、患者を、パッド付き脊椎手術フレーム上においてうつ伏せであるいは膝を曲げた状態で配置する。1つの実施形態においては、腹部を吊り下げることにより、静脈内圧力を低減させて、手術時の失血を低減させる。患者は、通常の無菌状態で、布で覆われる。手術前のX線フィルムをチェックし、脊柱の異常または変形を確認する。所望の挿入サイト上において、小さな1cmの皮膚切開口を形成する。切開サイトの周辺に対して、エピネフリン1:500,000溶液を適用し、止血を行う。蛍光透視法の下で、トロカールまたはニードルを、ランボドーサル筋膜を通して、挿入する。ニードルまたはトロカールは、導入器と交換する。1つの実施形態においては、導入器を通してX線造影剤を注入し、ランボドーサル筋膜と多裂筋と最長筋との間において、関節を確認する。導入器を介して鈍い解剖器を挿入し、多裂筋と最長筋との間において解剖を行い、関節カプセルを穿孔し、これにより、関節スペースに対してアクセスを可能とする。1つの実施形態においては、影響を受ける椎間関節のサイズを計測し、関節プロテーゼを選択する。1つの実施形態においては、関節プロテーゼを受領し得るように、関節突起を準備する。限定するものではないけれども、関節突起の関節表面を粗面化したり、および/または、プロテーゼのアンカー止め部材または保持部材のための穴を開けたり、する。椎間関節スペース内へとプロテーゼを挿入し、必要に応じて、アンカー止め部材または保持部材を、関節突起に対して取り付ける。すべての関節プロテーゼを挿入するまで、ステップを繰り返す。手術サイトを閉塞して、洗浄して包帯を巻く。
34 プロテーゼ
36 第1面
38 第2面
72 ワイヤまたはケーブル(保持部材)
78 保持インターフェース
126 ネジまたはボルト(保持部材)
136 スペーサ
150 突起(保持部材)
Claims (29)
- 椎間関節のところにおいて位置ズレを防止しつつ脊柱障害を治療するためのデバイスであって、
第1面と第2面とを備えたプロテーゼを具備し、
このプロテーゼが、単一のボディから形成され、
前記第1面が、椎間関節の隣接する関節表面のうちの一方の側面に対して固定され得るよう構成され、
前記第2面が、椎間関節の前記隣接する関節表面のうちの、前記一方の側面に対して対向した他方の側面に対してスライド接触し得るよう構成されていることを特徴とするデバイス。 - 請求項1記載のデバイスにおいて、
椎間関節の関節カプセル内に実質的に適合し得る寸法とされ、
椎間関節の2つの側面の間の解剖学的間隔とほぼ同じ厚さを有していることを特徴とするデバイス。 - 請求項1記載のデバイスにおいて、
側面がなす天然の形状に適合し得る湾曲を有し、
椎間関節の関節カプセル内に実質的に適合し得る寸法とされ、
椎間関節の2つの側面の間の解剖学的間隔とほぼ同じ厚さを有していることを特徴とするデバイス。 - 請求項1記載のデバイスにおいて、
ポリマーと、ポリエーテルエーテルケトン(PEEK)と、ポリエーテルケトンケトン(PEKK)と、ポリエチレンと、フッ素系ポリマーと、ヒドロゲルと、エラストマーと、セラミクスと、酸化ジルコニウムと、アルミナと、窒化ケイ素と、金属と、チタンと、チタン合金と、コバルトクロミウムと、ステンレススチールと、これら材料の組合せと、からなるグループの中から選択された少なくとも1つの材料を備えていることを特徴とするデバイス。 - 請求項1記載のデバイスにおいて、
前記第2面が、高度に研磨された表面を有していることを特徴とするデバイス。 - 請求項1記載のデバイスにおいて、
前記第1面が、粗面化された表面を有していることを特徴とするデバイス。 - 請求項1記載のデバイスにおいて、
前記第1面が、多孔質表面を有していることを特徴とするデバイス。 - 請求項1記載のデバイスにおいて、
前記デバイスの少なくとも1つの表面が、通常の解剖学的負荷の下において、隣接する表面または隣接する構造に対して追従し得るよう十分にソフトなものとされていることを特徴とするデバイス。 - 椎間関節のところにおいて位置ズレを防止しつつ脊柱障害を治療するためのデバイスであって、
第1面と第2面とを備えた単一のプロテーゼを具備し、
前記第1面が、椎間関節の第1関節突起に対してスライド接触し得るよう構成され、
前記第2面が、椎間関節の第2関節突起に対してスライド接触し得るよう構成されていることを特徴とするデバイス。 - 請求項9記載のデバイスにおいて、
椎間関節の関節カプセル内に実質的に適合し得る寸法とされ、
椎間関節の2つの側面の間の解剖学的間隔とほぼ同じ厚さを有していることを特徴とするデバイス。 - 請求項9記載のデバイスにおいて、
側面がなす天然の形状に適合し得る湾曲を有し、
椎間関節の関節カプセル内に実質的に適合し得る寸法とされ、
椎間関節の2つの側面の間の解剖学的間隔とほぼ同じ厚さを有していることを特徴とするデバイス。 - 請求項9記載のデバイスにおいて、
0.5mm〜3mmという範囲の平均厚さを有していることを特徴とするデバイス。 - 請求項9記載のデバイスにおいて、
1mm〜2mmという範囲の平均厚さを有していることを特徴とするデバイス。 - 請求項9記載のデバイスにおいて、
5mm〜25mmという範囲の直径を有していることを特徴とするデバイス。 - 請求項9記載のデバイスにおいて、
10mm〜20mmという範囲の直径を有していることを特徴とするデバイス。 - 請求項9記載のデバイスにおいて、
前記デバイスの少なくとも1つの表面が、25mm2 〜700mm2 という骨接触表面積を有していることを特徴とするデバイス。 - 請求項9記載のデバイスにおいて、
前記デバイスの少なくとも1つの表面が、20mm2 〜400mm2 という骨接触表面積を有していることを特徴とするデバイス。 - 請求項9記載のデバイスにおいて、
前記デバイスの少なくとも1つの表面が、20mm2 〜100mm2 という骨接触表面積を有していることを特徴とするデバイス。 - 請求項9記載のデバイスにおいて、
前記デバイスの少なくとも1つの表面が、高度に研磨された表面を有していることを特徴とするデバイス。 - 請求項9記載のデバイスにおいて、
前記プロテーゼが、さらに、椎間関節の前記第1関節突起と前記第2関節突起との間に前記プロテーゼの少なくとも一部を維持し得るよう構成されたアンカー止めアセンブリを備えていることを特徴とするデバイス。 - 請求項20記載のデバイスにおいて、
前記アンカー止めアセンブリが、長尺部材と、少なくとも1つの保持部材と、を有していることを特徴とするデバイス。 - 請求項21記載のデバイスにおいて、
前記長尺部材が、ワイヤまたはケーブルを有していることを特徴とするデバイス。 - 請求項22記載のデバイスにおいて、
前記長尺部材が、中実のワイヤまたはケーブルを有していることを特徴とするデバイス。 - 請求項22記載のデバイスにおいて、
前記長尺部材が、編込ケーブルを有していることを特徴とするデバイス。 - 請求項22記載のデバイスにおいて、
前記保持部材が、セットネジ保持リングを有していることを特徴とするデバイス。 - 請求項22記載のデバイスにおいて、
少なくとも1つの端部が、ネジ山付きインターフェースを有していることを特徴とするデバイス。 - 請求項22記載のデバイスにおいて、
前記保持部材が、ネジ山付き保持器を有していることを特徴とするデバイス。 - 請求項22記載のデバイスにおいて、
前記保持部材が、前記長尺部材の一端に対して一体的に形成されていることを特徴とするデバイス。 - 請求項22記載のデバイスにおいて、
前記デバイスの少なくとも1つの表面が、通常の解剖学的負荷の下において、隣接する表面または隣接する構造に対して追従し得るよう十分にソフトなものとされていることを特徴とするデバイス。
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2005
- 2005-02-04 EP EP19158915.9A patent/EP3517077A1/en not_active Withdrawn
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Publication number | Priority date | Publication date | Assignee | Title |
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JP2012509740A (ja) * | 2008-11-25 | 2012-04-26 | ジンテス ゲゼルシャフト ミット ベシュレンクテル ハフツング | 粘弾性面関節インプラント |
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