JP2009006186A - スペーサ - Google Patents
スペーサ Download PDFInfo
- Publication number
- JP2009006186A JP2009006186A JP2008266752A JP2008266752A JP2009006186A JP 2009006186 A JP2009006186 A JP 2009006186A JP 2008266752 A JP2008266752 A JP 2008266752A JP 2008266752 A JP2008266752 A JP 2008266752A JP 2009006186 A JP2009006186 A JP 2009006186A
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- Prior art keywords
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- 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.)
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- C—CHEMISTRY; METALLURGY
- C25—ELECTROLYTIC OR ELECTROPHORETIC PROCESSES; APPARATUS THEREFOR
- C25F—PROCESSES FOR THE ELECTROLYTIC REMOVAL OF MATERIALS FROM OBJECTS; APPARATUS THEREFOR
- C25F3/00—Electrolytic etching or polishing
- C25F3/16—Polishing
- C25F3/22—Polishing of heavy metals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
- A61B17/1637—Hollow drills or saws producing a curved cut, e.g. cylindrical
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
- A61B17/22032—Gripping instruments, e.g. forceps, for removing or smashing calculi having inflatable gripping elements
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- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- 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
- A61B17/72—Intramedullary pins, nails or other devices
- A61B17/7233—Intramedullary pins, nails or other devices with special means of locking the nail to the bone
- A61B17/7258—Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone
- A61B17/7266—Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone with fingers moving radially outwardly
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- A61F2/00—Filters 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
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- A61F2/4611—Special 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
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- A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
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- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
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- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
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- A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0043—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in electric properties, e.g. in electrical conductivity, in galvanic properties
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
- A61F2250/0063—Nested prosthetic parts
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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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0097—Visible markings, e.g. indicia
-
- 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
- A61F2310/00011—Metals or alloys
- A61F2310/00017—Iron- or Fe-based alloys, e.g. stainless steel
-
- 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
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- A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
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Abstract
脊柱プロテーゼとして使用可能な、拡張可能なインプラントの提供。
【解決手段】
拡張可能な骨内スペーサであって、表面、近い端部、遠い端部、及び長さを有する、軸に沿ったチューブと、前記チューブが載置されたハンドルを備え、前記表面は、複数のスリットを規定している。前記複数のスリットは、軸方向
にずらされた少なくとも2つの拡張部を規定し、前記チューブが軸方向に圧縮された場合に、前記拡張部は前記表面から外へ拡張し、拡張されたスペーサの外形を規定するよう構成されている。
【選択図】 図1B
Description
この出願は、PCT出願PCT/IB98/00523の一部継続出願に基づく特願2000-595624の分割出願である。PCT出願PCT/IB98/00523は、米国を指定しており、その開示内容は、参照によりここに組み込まれる。この出願は、本願と同日に、椎間板・オー・テック・メディカル・テクノロジーズ社を出願人として、アトーニー・ドケット110/01357及び110/01362によりイスラエル受理官庁に提出され、米国を指定する2つのPCT出願にも関連している。上記2つのPCT出願の開示内容は、参照によりここに組み込まれる。
本発明は、特に脊柱プロテーゼとして使用するための拡張可能なインプラントに関する。
医療一般の難問の一つに脊髄における椎間板の断裂がある。椎間板を出た物質は、脊髄を圧迫し、激しい苦痛を引き起こす。破裂した椎間板は、一般に外科的処置で処理される。この処置では、損傷を受けた椎間板の一部又は全部が取り去られ、そして脊柱が融合、つまり、取り去られた椎間板に隣り合う少なくとも2つの椎骨が融合する。脊柱融合に関しては、多くのアプローチがある。あるアプ
ローチでは、プレート及び/又はねじを用いて椎骨がつなげられる。他のアプローチでは、2つの椎骨の間にスペーサ(「ケージ装置」ともいう)が挿入され、その空間内へと成長した骨が隣り合う椎骨を融合させる。一般に、スペーサの軸は、脊柱の軸及び体の面に対して垂直である。ときとして、スペーサ内への骨の成長を促進するために、スペーサは複数の孔を有する。参照によりその開示内容
がここに組み込まれるPCT公開WO98/38918は、すぼめた状態で挿入され、椎骨間の空間を満たすために拡張されるスペーサを記載している。参照によりその開示内容がここに組み込まれるピサロディの米国特許第5,123,926号(その他)により例示されている他の型のスペーサは、スペーサの一部、通常はその中心部分、が比較的小さな量だけ拡張し、近接している椎骨をつなげ、常固定用ねじとして機能する。
本発明のいくつかの好ましい実施形態の目的は、細い直径の針を用いて挿入できる椎骨間スペーサを提供することである。
であり、4つの等しい長さのスパイクが正方形の各辺の中央にあり、4つのより長いスパイクが正方形の角部にある。本発明の好ましい実施形態において、スペーサは、複数の連続したチューブのセグメントからなり、各セグメントが1以上のスパイクを含む。一例では、一方が(正方形の辺にくる)短いスパイクを有し、他方が(正方形の角にくる)より長いスパイクを有する2種類のセグメントを交互に配置することにより正方形断面を達成する。あるいは、スパイクの長さは、回転対称ではない。上記に代えて又は上記に加えて、断面は回転対称ではない。上記に代えて又は上記に加えて、スパイクの長さ及び/又は外形は、スペーサに沿ったスパイクの軸方向位置、そして恐らくは角度位置の関数として変化する。本発明の好ましい実施形態において、スパイクの配置及び/又は長さは、椎骨
間の空間の予想される形状に従う。
分を2つのスリットが形成することができる。軸方向の収縮は、折り重ねられた材料の厚み、又は、チューブの内側に当たる材料により制限される。
本発明の好ましい実施形態において、前記スリットは幅が狭い。
本発明の好ましい実施形態において、前記スリットは、その範囲の少なくとも一部において、わずかではない幅を有する。
本発明の好ましい実施形態において、前記スリットは、前記チューブの軸に非平衡である。
本発明の好ましい実施形態において、前記スリットは、長さが等しい一対として設けられている。
本発明の好ましい実施形態において、前記スリットは、長さが等しくない一対として設けられている。
本発明の好ましい実施形態において、第1の拡張部に係るスリットが、軸方向にずれている第2の拡張部に係るスリットと軸方向に重なっている。
本発明の好ましい実施形態において、前記チューブの前記遠い端部は、遠端ののエンドキャップを規定し、前記エンドキャップは、拡張された前記拡張部の外形により規定される空間から外側へ張り出す。あるいは、前記拡張部の少なくとも一つは、前記チューブの前記近い端部と面が揃っている。あるいは、前記拡張部の少なくとも一つは、前記チューブの前記遠い端部と面が揃っている。
本発明の好ましい実施形態において、スペーサは、内部ボルトを含む。好ましくは、前記内部ボルトは、滑らかな外面を有する。あるいは、前記内部ボルトは、ねじを切られた外面を有する。
本発明の好ましい実施形態において、前記ボルトは頭部を有し、前記頭部は、前記チューブの少なくとも一つの端部に対し固定され、前記チューブの軸方向の拡張を防止する。好ましくは、前記頭部は、前記チューブから前記ボルト頭部へ向けて伸びる少なくとも一つの突出部と係合する構成されている。あるいは、前記頭部は、前記チューブと係合するために、前記頭部から前記チューブへ向けて伸びる少なくとも一つの突出部を含む。あるいは、前記頭部は、前記チューブの内径よりも大きな外径を有するように外側へ張り出すフランジを含む。
本発明の好ましい実施形態において、前記スペーサは複数の切片を含み、各切片は、前記スペーサから張り出す1以上の拡張部を規定している。好ましくは、前記切片は、少なくとも2種類の切片を含み、各種類の切片は、前記チューブに対して異なる方向に張り出す拡張部を規定している。好ましくは、前記2種類の切片は、一つの線に沿って張り出す2つの拡張部を規定する水平切片と、前記2つの拡張部に対して約45°で張り出す4つの拡張部を規定する切片とを含む。
本発明の好ましい実施形態において、前記少なくとも2つの拡張部の少なくとも1つは、前記チューブの軸を含む平面内において、前記チューブの軸と鋭角を形成する。
本発明の好ましい実施形態において、前記少なくとも2つの拡張部の少なくとも1つは、前記チューブの軸を含む平面内において、先端が前記チューブから離れる方向を向いた三角形の輪郭を有する。
本発明の好ましい実施形態において、前記少なくとも2つの拡張部の少なくとも1つは、前記チューブの軸を含む平面内において、前記チューブから離れる方向に沿って、幅が狭くなり、次に幅が広くなる輪郭を有する。
本発明の好ましい実施形態において、前記少なくとも2つの拡張部の少なくとも1つは、前記チューブの軸に垂直な面内において、前記チューブから離れる方向に沿って、幅が狭くなり、次に幅がひろくなる輪郭を有する。
本発明の好ましい実施形態において、前記少なくとも2つの拡張部の少なくとも1つは、尖った先端形状を有する。あるいは、前記少なくとも2つの拡張部の少なくとも1つは、前記拡張部の基部と実質的に同じ大きさの先端形状を有する。あるいは、前記少なくとも2つの拡張部の少なくとも1つは、前記拡張部の基部より実質的に大きい先端形状を有する。
本発明の好ましい実施形態において、前記拡張部は、前記チューブの周囲に沿って不均一に分布されている。あるいは、前記拡張部は、前記チューブの周囲に沿って均一に分布されている。
本発明の好ましい実施形態において、前記スペーサが拡張されたときの外形の断面は円形である。
本発明の好ましい実施形態において、前記拡張された外形の断面は、前記拡張された外形の軸に沿って変化する。
本発明の好ましい実施形態において、前記チューブの断面の直径は、前記チューブの軸に沿って変化する。上記に代えて又は上記に加えて、前記チューブの断面は、前記チューブの軸に沿って変化する。
本発明の好ましい実施形態において、前記チューブは、楕円形断面を有する。
本発明の好ましい実施形態において、前記チューブは、矩形断面を有する。上記に代えて又は上記に加えて、前記スペーサが拡張されていないとき、前記チューブの軸は曲がっている。
本発明の好ましい実施形態において、前記スペーサが拡張されていないとき、前記チューブの軸はまっすぐである。上記に代えて又は上記に加えて、前記スペーサが拡張されているとき、前記チューブの軸は曲がっている。
本発明の好ましい実施形態において、拡張された形態において前記スペーサを保持するつめ車機構を含む。
本発明の好ましい実施形態において、前記スペーサの少なくとも一部は、前記スペーサの軸方向の収縮を防止する。好ましくは、前記少なくとも一部は、前記スペーサが軸方向に収縮されたときに当たる一対のタブを含む。あるいは、前記少なくとも一部は、折れ曲がって前記スペーサの対向する2つの側面の間に厚みを形成し、前記対向する側面が接触することを防止する細片を含む。
本発明の好ましい実施形態において、前記拡張部の少なくとも一つが、前記2つの拡張部を連結させる突出部を少なくとも含む。
本発明の好ましい実施形態において、前記拡張部が拡張された時に前記拡張部を互いに連結させる相互連結要素を少なくとも一つ含む。好ましくは、前記相互連結要素は、柔軟なワイヤを含む。あるいは、前記相互連結要素は、実質的に剛体である筋違を含む。
本発明の好ましい実施形態において、前記拡張部の少なくとも一つは、少なくとも一つのねじり動作を行う継ぎ目を含む。
本発明の好ましい実施形態において、前記拡張部の少なくとも一つは、前記拡張された外形を形成するために、かなり大きな軸方向部分を前記チューブから離れる方へ持ち上げる持ち上げ式拡張部を含む。
本発明の好ましい実施形態において、前記拡張部の少なくとも一つは、拡張部の先端部により連結された少なくとも2つの足部を含む。
本発明の好ましい実施形態において、前記拡張部の少なくとも一つは、拡張部の先端部により連結された少なくとも4つの足部を含む。上記に代えて又は上記に加えて、前記拡張部の少なくとも一つは、少なくとも2つの足部を含み、前記足部は前記チューブの軸と一直線に並んでいる。上記に代えて又は上記に加えて、前記スペーサの拡張を補助するために、複数の焼きなまされた箇所が前記スペ
ーサに設けられている。上記に代えて又は上記に加えて、前記スペーサの拡張を補助するために、複数のエッチングされた箇所が前記スペーサに設けられている。上記に代えて又は上記に加えて、前記スペーサの拡張を補助するために、複数の孔が前記スペーサに設けられている。好ましくは、前記孔は、応力を前記スペーサに分散させる。
本発明の好ましい実施形態において、前記スペーサは、全体が焼きなまされる。
本発明の好ましい実施形態において、前記スペーサは、異なる材料の別個の領域の組み合わせから形成される。
に構成されている。上記に代えて又は上記に加えて、前記スペーサは、50kg以上の軸方向圧力の下で軸方向へ変形するように構成されている。上記に代えて又は上記に加えて、前記スペーサは、70kg以上の軸方向圧力の下で軸方向へ変形するように構成されている。上記に代えて又は上記に加えて、前記スペーサは、90kg以上の軸方向圧力の下で軸方向へ変形するように構成されいてる。
の2分の1以下である。
本発明の好ましい実施形態において、前記チューブの断面の直径は、前記拡張された外形における断面の最大直径の4分の1以下である。
本発明の好ましい実施形態において、前記拡張された外形は、人間の椎骨の間に合うように大きさを定められている。
本発明の好ましい実施形態において、前記拡張部は先端部を有し、前記先端部は、対象となっている椎骨が前記スペーサの外形と接触する表面に対し、少なくとも40%の表面充填率を有する。
本発明の好ましい実施形態において、前記拡張部は先端部を有し、前記先端部は、対象となっている椎骨が前記スペーサの外形と接触する表面に対し、少なくとも60%の表面充填率を有する。
本発明の好ましい実施形態において、前記拡張した外形は、椎間板に接触していた、対象となっている椎骨の表面の少なくとも60%を覆う。
本発明の好ましい実施形態において、前記拡張した外形は、椎間板に接触していた、対象となっている椎骨の表面の少なくとも80%を覆う。
本発明の好ましい実施形態において、前記拡張部は、スパイクを含む。
本発明は、本発明の好ましい実施形態についての下記の詳細な説明、及び、添付の図面からより明確に理解できるであろう。
基本スペーサ(ケージ)の説明
図1Aは、本発明の好ましい実施形態による拡張可能なスペーサ20が拡張されていない形態を示す平面投影図である。図1Bは、スペーサ20の斜視図である。スペーサ20は、チューブのような細長い中空の物体22から構成され、その上に複数のスパイク24が(平坦な形状に)形成されており、各スパイクは、一組のスロット26によって輪郭を定められている。軸方向投影図36に示されるように、本発明の好ましい実施形態では、チューブ22の断面は円形である。図1Aに示された実施形態において、チューブ22は、スパイク部分28と非スパイク部分30とを交互に有している。好ましくは、チューブ22の一端にエンドキャップ34が形成されている。本発明の好ましい実施形態では、エンドキャップ34は中空である。あるいは、エンドキャップ34は中実であるが、骨の内部への成長を促進するために、多孔質材料から構成されるか、孔を有することが好ましい。エンドキャップの代わりに、又はエンドキャップに加えて、スペーサ20は、チューブの端部に取り付けられ、これによりチューブの一部のみ、好ましくは端部にスリットが形成されているようにする。
上記は、スペーサの限られた一部の種類についての説明であり、下記にその変形が明らかにされる。
図2A−Dは、スペーサ20を挿入し拡張させる手順を示している。図2Aにおいて、損傷を受けた椎間板54が椎骨50及び椎骨52の間である椎骨間空間55に位置している。一般に、2つの椎骨の間にスペーサを挿入する前に、椎間板54が部分的に又は完全に除去される。好ましくは、椎間板54は、最小侵襲技術を用いて、例えば図9A及び9Bを参照して後に説明するように、好ましくは細い針のみを用いて、除去される。あるいは、例えばWO98/38918に記載されている腹腔鏡によるアプローチを用いる。この場合、患者の外傷が最小となるように注意することが好ましい。
本発明の好ましい実施形態において、骨スラリーは、骨チップ、例えば球、立方体、又は平坦な矩形の形状をしたチップを含む。このようなチップは、例えば、小さな揺動のこぎり及び/又は骨刀を用いて生成できる。デリバリーチューブに骨チップを押し通すことに下垂体鉗子又は骨インパクターホルダーを利用できる。必ずしもではないが、一般的にこのデリバリーチューブは、スペーサが通されたチューブと同じである。一応用例において、チューブは内径6mmを有し、したがって、骨チップは最も大きくて5.9mmでなければならない。
埋込手順の次の段階は、好ましくは、スペーサ20を供給するために用いた切断部を閉じることである。あるいは、より一般的には、最小侵襲処理において、部材60を引き出すことである。本発明のいくつかの好ましい実施形態では、部材60がまだ挿入されている間よりも、部材60が取り去られた後に、針を用いて骨スラリーを注入することができる。
スペーサの埋め込みにおいて考慮すべき問題の一つは、スペーサ20を椎骨間の空間55に確実に合わせることである。本発明の好ましい実施形態では、(例えば工具一式として)各々が異なる(圧縮された)軸方向長さ及び/又は異なる径方向の直径を有する埋込用の複数のスペーサを利用できる。必要なスペーサのサイズは、椎骨間の空間55のCT画像又はX線画像における測定値から決めることができる。あるいは、拡張可能な要素を椎骨間の空間に挿入し、その要素が拡張した程度に基づいて、充填すべき空間の大きさ、及び必要とするスペーサの外形を見積もってもよい。
本発明の好ましい実施形態において、外科的アプローチは、患者の背中から行われる。あるいは、横から又は後横からのアプローチを用いてもよい。埋め込まれたスペーサは、埋込中は非常に細いので、他の融合装置を用いると提供できないアプローチを計画し、及び/又はアプローチ方向を使用することが容易である。上記に代えて又は上記に加えて、本発明のいくつかの好ましい発明において、少なくとも拡張していない形態において、特にそこにスリットを形成した結果として、スペーサをその主軸に沿って曲げやすく作ることができる。したがって、スペーサは、曲がったガイド、たぶん内視鏡やカテーテルのような曲げることのできるガイド、を用いて椎骨間の空間55に備えることができる。あるいは、スペーサが形状記憶材料から形成されている場合には、スペーサを容易に曲げられるように、延性を示すようになる温度以下にスペーサを冷やしてもよい。上記の代わり又は上記に加えて、特にスペーサが弾性又は超弾性を有する場合、曲がった外側チューブを用いるのに代えて又は加えて、スペーサの中を通して挿入された、曲がったスタイレットを用いて、挿入の間、スペーサを曲がった形状に維持する。後述する図2Pは、挿入の代替方法を描いている。この代替方法では、都合のよい方向からの椎骨へのアプローチを可能とするために、スペーサの小さな断面と、いくつかの拡張可能な構造における固有の柔軟性とを利用する。
図2E−2Gは、本発明の好ましい実施形態による、スペーサを拡張させ、その拡張を制御する種々の方法を示している。図2Eでは、示されているように、拡張は本質的に制御されていない。スペーサ70は、エンドキャップ74に取り付けられた拡張部材72を用いて拡張される。部材72がスペーサ70と相対的に矢印の方向に動かされると、その結果生じた応力によりスペーサ70が軸方向につぶれ、スパイクが外に張り出す。スパイクが張り出す順番は、とりわけ、スパイクの相対的な硬さに依存する。通常、スパイクはほぼ同じ硬さを有するので、拡張はスペーサ全体で徐々に生じるか、最初に曲がった位置で突然生じるであろう。あるいは、スペーサは、設計により、特定の順番にスパイクの張り出しが規定できるように、いくつかのスパイクが他のスパイクより弱くなるように構成できる。
ねじを用いてエンドキャップ74と結合される。したがって、部材72は、ねじ切ることができる。ある実施形態では、エンドキャップのねじは、スペーサのねじと同じ方向に切られる。
直接引っ張ることにより拡張される。
図13A−13Cは、本発明の好ましい実施形態による、スペーサを拡張する方法の例を示す。スペーサ1002は、内部にボルト1008を有するチューブとして用意される。ボルト1008は、好ましくは、スペーサ1002の端部がそのボルトを通り過ぎて前進することを防止する。スペーサの拡張部を形作るために、外側束縛具1004が備えられている。腹腔鏡管1006も示されている。この実施形態では、ボルト1008及び管1006の双方が体の外のベース1010に固定されている。このベースは、体の方へ進むことを防止するために、例えば患者及び/又は患者のベッドに固定してもよい。
次に、束縛具及びスペーサの双方が再び前進できるように、束縛具1004が後ろに引かれる(図13C)。
ときに、スペーサが挿入された後、事によるとスペーサの挿入処置が完了した数日後であっても、スパイクの長さを調整する必要が生じることがある。
スペーサが不正確に埋め込まれたことが、例えばX線画像により証明された場合にも、スペーサを除去する必要が生じるだろう。本発明の好ましい実施形態によれば、スペーサの調整及び/又は除去が可能である。
本発明の好ましい実施形態では、スペーサの下記3つの特性、スペーサの軸方向長さ、スパイクの長さ、及びスパイクの張力、のうち1つ以上が独立して制御できるべきである。いくつかの実施形態では、利用可能なスペーサのセットから特定のスペーサを挿入のために選択することで、これらの特性を制御できる。他の実施形態では、所望の特性を得るようにスペーサを適合させてもよい。例えば
、長さは、スペーサ全体を拡張させず、そして非拡張部分を切断することで制御できる。さらに、本発明のいくつかの実施形態では、スペーサの特性をその挿入後に変更することが望まれる。従って、体の中にありながら、スペーサを最適な動作形態に維持又は変更できることが望まれている。
上記に加えて、スペーサが挿入された後、ワイヤガイドがスペーサに取り付けられたまま残り、内視鏡その他の挿入された物体がそのワイヤをたどってスペーサまで案内されることであってもよい。ワイヤの一方の端は、体の外へ出ていてもよい。上記に代えて又は上記に加えて、例えば大径のボールを取り付けることで、ワイヤの端は容易に認識できるようになる。
本発明の好ましい実施形態において、スペーサは、その素材の塑性変形を利用して拡張したり、すぼんだりする。つまり、チューブは、拡張したスペーサを形成するために塑性変形する。あるいは、拡張又はすぼみの少なくとも1つは、素材の弾性、超弾性、又は形状記憶特性を利用して行う。一例として、スペーサは、部分的に拡張されてから、挿入の前に、弾性変形により完全にすぼまされる。したがって、拡張が開始されると、いくつかの又は全てのスパイクがスペーサから突出する。そして、スペーサにかかる軸方向の力が増大すると、スパイクはさらに外へ動くが、中へ動くことはない。スペーサのいくつかの部分は、中へ折れ曲がるように構成されてもよい。これらの部分は、スペーサの挿入の前に、それらの「内部の位置」からどくように弾性変形させられてもよい。後述する図6XI−6XLは、拡張されたスパイクの形状を制御するためにスペーサの弱化された部分を示す。
本発明のいくつかの好ましい実施形態において、エンドキャップは、(図2Hのエンドキャップ108がそうであるように)スペーサが拡張した後にスペーサから突出する。いくつかのケースにおいて、エンドキャップは、骨の組織と係合するスパイクを有していてもよい。あるいは、エンドキャップは、最も端にあるスパイクによって規定される平面内に存在するように形成されてもよい。一例として、これは、エンドキャップをスペーサの中へ予め折り曲げることにより達成できる。あるいは、エンドキャップを拡張過程の一部においてスペーサの中へ折り曲げる、例えば、部材72を引っ張ることによりエンドキャップ74を逆さまにする(図2E参照)ことであってもよい。あるいは、エンドキャップは、スペーサの中に弾性により折り曲げられるように製作されてもよい。あるいは、端にあるスパイクの変形によりエンドキャップをスペーサに折り曲げることであってもよい。上記に代えて又は上記に加えて、スペーサが拡張した後に、エンドキャップに係合しているねじを引っ張ることによりエンドキャップを引っ込めることであってもよい。先に飛んで、図2Oのスペーサは、エンドキャップがスペーサの内側に形成されており、その結果、張り出したスパイクが広い範囲でスペーサの端部に達している。
図2Iを参照する。いくつかの実施形態において、ボルト112は、スペーサ110にねじ付けられていないが、一旦スペーサの拡張が完了すると、ボルトがスペーサ110に、例えばエンドキャップ118において、固定されることが好ましい。この場合、必ずしもねじ山を用いることはない。
(a)スペーサ保持機構を引っ込めると、スペーサが固定される;
(b)スペーサ保持機構を(特にねじを用いて)前進させると、スペーサが固定される;
(c)機構は、スペーサの拡張が完了した場合にのみ固定することを主とする;及び/又は
(d)固定機構は(変形において)塑性を有するか、弾性(つまり、拘束状態が解除されて機構が固定される)を有する。
図14A及び14Bは、フィンに基づく固定機構を示している。示された固定機構では、1以上のフィンがボルトから跳ね出てスペーサと係合することで、スペーサがすぼまるのを防止する。他の実施形態、例えば後述する例では、ボルトは塑性変形し、及び/又はフィンの少なくとも一部は、ボルトと係合するために、スペーサから提供できる。
図15A及び15Bは、塑性変形を利用している点を除き、図14A−14Bと類似する固定機構を示す。エンドキャップ1036に固定するための複数のフィン1038がボルト1032から伸びている。棒要素1034をボルト1032へと前進させると、フィンが塑性変形をしてエンドキャップと係合する。好ましくは、棒要素1034は、ボルト1032内に切られているねじ山に合うねじ山が設けられており、棒要素1034が回転することで前進する。棒は、ねじ出すことにより引くことができる。あるいは、ねじは周方向の一部のみに沿って設け、半回転が完了したときに、棒要素1034がねじから外れることであってもよい。
図16A−16Fは、本発明の好ましい実施形態による、広がるフランジを利用した固定機構を示す。
図16Bでは、棒1044がボルト1042に対して相対的に前進し、これによりフランジ1048を広げ、この結果、フランジがエンドキャップ1036に形成された開口より大きくなり、スペーサがボルトから引き抜けなくなっている。
図16Dは、棒要素1044の構造の詳細を示す線図である。
図16Eは、ボルト1042の斜視図であり、幅の広い基部1043を示している。基部1043は、図13A−13Cに示されるようにスペーサが前進させられたときに、スペーサ1040がボルトを通り過ぎて前進することを防ぐ。
図16Fは、ボルト1042の構造の詳細を示す線図である。
図17A−17Cは、他の固定機構を示す。この固定機構では、スペーサ上のフィンがスペーサの内側のボルトに係合する。図17Aは、固定機構が作動する前の形態を示す。スペーサ1050は、その端に形成された複数のフィン1058を有する。スペーサの内側のボルト1052は、1以上のくぼみ1057を有する。くぼみ1057は、ボルト1052をまわる帯状に形成することができる。プッシングチューブ1059は、内側に向けて突出する先端部1056を有する。先端部1056は、フィンがくぼみ1057内にないときに、フィン1058と係合する。したがって、プッシャーチューブ1059は、スペーサ1050から滑り落ちることはない。
図17Bは、固定機構が作動した後の形態を示す。
図17Cは、スリーブがない状態における図17Aの形態の斜視図である。
図18A−18Dは、本発明の好ましい実施形態による、ボルトの棒要素が引かれたときにボルト上のフィンが広がる固定機構を示す。
図18Aは、拡張していない形態のスペーサ1060を示す。棒要素1064の伸長部1065は、内側に向けて曲がっている複数のボルト1062のフィン1068によって保持されている。伸長部1065は、フィンの面1063と接触し、軸方向に束縛を受けている。フィン1068は、スペーサ1060により、内側に向いた形態に維持されている。
図18Cは、ボルト1062の斜視図であり、基部1061をも示している。
図18Dは、棒要素1064の斜視図であり、伸長部1065及び残りの棒1064の好ましい取り付け方法を示している。
図19A−19Cは、本発明の好ましい実施形態による、リングを用いた固定機構を示す。ケージ1070とボルト1072は、リング1075を用いて互いに固定される。リング1075は、ボルト1072に形成された溝1077に嵌り、それにより、ボルトをスペーサ1070のエンドキャップ1076に固定する。
図19Bでは、リング1075が溝1077内へと収縮し、それによりスペーサを固定している。
図19Cは、リング1075の一例を示す。リング1075は、ニチノールのような超弾性材料から形成されるのが好ましい。しかし、これは必須ではない。
本発明の好ましい実施形態において、チューブ22(図1A−1D)の断面は円形である。あるいは、他の断面、例えば、三角形や正方形等の多角形断面を用いる。スパイクは、多角形の側面に形成されることが好ましい。上記に代えて又は上記に加えて、スパイクは、多角形の頂点に形成される。本発明の好ましい実施形態では、チューブの内側断面と外側断面とが同じ形を有し、及び/又は、位置合せがされている。あるいは、チューブ22の素材は、径方向の厚みが不均一である。一例では、内側断面は三角形であり、外側断面は正方形又は円形である。上記に代えて又は上記に加えて、断面はチューブ22の主軸に対して非対称であってもよい。上記に代えて又は上記に加えて、チューブの断面形状は、スペーサの軸方向寸法に沿って変化してもよい。本発明の好ましい実施形態では、断面及び/又はチューブ素材の厚みの変化は、スパイクの位置及び/又は求められるその機能による。例えば、チューブの直径は、エンドキャップにおいて増大する。
図2Mは、ワイヤ121を示す。このワイヤ121は、例えば、スペーサの拡張を制限することに使用できる。図において、ワイヤ121は、隣り合うスパイク、スパイク123及びスパイク125、の先端間のとりうる距離を制限する。このようなワイヤが、スペーサの周囲の全てのスパイクの先端間に形成された場合、スパイクが拡張できる最大限がワイヤの長さにより制限される。上記に代えて又は上記に加えて、ワイヤは、2つのスパイク間の角度距離のみを制限することであってもよい。上記に代えて又は上記に加えて、このようなワイヤは、スパイクと、スペーサの拡張されない部分とを結ぶことであってもよい。上記に代えて又は上記に加えて、このようなワイヤは、スパイクの先端以外の部分、例えばスパイクの足部の中央に取り付けられてもよい。実施形態によっては、ワイヤ配置が、スペーサの回りに一様に分布するのではない。例えば、軸方向位置、径方向位置の関数、及び/又はスパイク形状又は分布のである。上記に代えて又は上記に加えて、いくつかのワイヤは、スペーサの挿入前に、医者によって切断又は除去されてもよい。
一般に、拡張されたスペーサの断面は、所望の用途に合うように適当に選択される。椎骨では、椎間板を、それぞれが脊柱の端に配置された平行な2つのスペーサに置き換えることができる。このような配置において、椎骨間スペーサの断面は、端よりも中央が厚い矩形の箱に近いものとなる。本発明の好ましい実施形態では、前述したように、スパイクの長さ又はチューブの直径を変化させることにより断面を軸方向に変化させられる。上記に代えて又は上記に加えて、スペーサの断面形状は、円形から、例えば矩形又は正方形に変化させられる。正方形のスペーサは、たいてい、丸いスペーサより動き回ることがない。
本発明の好ましい実施形態において、チューブ22の軸は、すぼんだ形態でも、拡張された形態でも実質的にまっすぐである。あるいは、スペーサの挿入中、及び/又は挿入完了後において、スペーサの軸は曲がっていてもよく、ピースワイズに折れ曲がっていてもよい。上記に代えて又は上記に加えて、すぼんだスペーサにおいて、スペーサの軸は、曲がっていても、おれていてもよい。
実施形態によっては、椎骨間の空間をスペーサが可能な限り完璧に充填することが望まれる。特に、スペーサと椎骨とを最大限接触させることが望まれる。結果として、スペーサがなるべく椎骨に埋め込まれないことが期待される。後述するように、このような結果は、スペーサをメッシュ、織物、又はバルーンで包むことにより達成できる。あるいは、図6F及び6Cと関連して後述するようなスパイクの形状も接触領域を増大させる。図6Fの例では、椎骨に刺すための小さな伸長部がスパイクに設けられ、スペーサの滑りを防止している。
本発明の好ましい実施形態において、スペーサが拡張し、スパイクが広がると、本明細書で「筋違」と呼ぶ付加的な構造要素が、2(若しくはそれ以上)のスパイク間、又は1(若しくはそれ以上)のスパイクとスペーサのリング部分との間に張られる。明快のために、(拡張されたスペーサにおける)種々の筋違の形態を説明し、それから、そのような筋違の形態を生成する仕組みについて説明する。
ここで、継ぎ目のいくつかの型と、継ぎ目の動きの相対運動とについて考察することは有益である:
(a)拡張過程において軸方向にのみ移動する継ぎ目、例えばスパイクの基部の継ぎ目;
(b)拡張過程において径方向に移動する継ぎ目、例えばスパイクの頂点;そして、
(c)角度方向に動く継ぎ目。
さらに、一組の継ぎ目の間では数種類の相対運動がある、例えば:
(a)相対運動なし−スペーサの同じ円周上にある2つのスパイクの基部;
(b)軸方向移動−同じスパイクの2つの基部の継ぎ目;
(c)径方向移動−スパイクの基部の継ぎ目と頂点の継ぎ目;
(d)一定距離−スパイクの基部の継ぎ目と頂点の継ぎ目;
(e)距離が変化−同じスパイクの2つの基部の継ぎ目;
(f)角度方向移動−拡張の間にスペーサがねじれる場合。
場合によっては、これらのいろいろなタイプの移動及び相対運動は、1つの継ぎ目において組み合わされることもある。
図3F及び3Gは、すぼんだ状態にある筋違付きスペーサの展開図(3F)及び軸方向から見た図(3G)である。展開図では、スペーサは軸方向に割って開かれ、上から見られている(やや円筒図法に類似している)。
図3H−3Jは、スパイクは広がっているが筋違がその最終的な位置にない準拡張状態にある同じスペーサを示している(展開図、軸方向図、及び側面図)。
図3K−3Mは、最終的な拡張状態にある同じスペーサを示している(展開図、軸方向図、及び側面図)。
歪んでいたり、あるいは、1つの図に示されている小さな形が他の対応する図に
示されていなかったりする。
図3Hは、スパイクが完全に拡張された後のスペーサを展開したレイアウトである。各スパイクAEI、BFJ、CGK、及びDHLは、実質的に単一の点として示されている。なお、複数のスパイクはまだ軸方向にずれている。
図3Iは、スペーサの軸方向の図である。この図において、スパイクは拡張しており、筋違がスパイクの頂点を相互に連結している。
図3Lは、スペーサを軸方向から見た図であり、完全に展開されたスパイク及び筋違を示している。
図3Mは、スペーサの側面図であり、スペーサと筋違とが同じ軸方向位置にあることを示している。
スペーサの設計において、すぼんだスペーサ、及び/又は拡張されたスペーサの特性は、スペーサの種々の形態で制御することで変えることができる。特に、下記の形態の1以上を変えることができる:
(a)すぼんでいるスペーサの長さ;
(b)すぼんでいるスペーサの外形;
(c)スパイクの長さ、幅、数、密度、及び/又は外形;
(d)スパイク間、及び/又はスペーサの他の部分に対するスパイクの相対的位置;
(e)スペーサを構成する部分の、及び/又は、スパイクの、及び/又は、(もしあれば)スペーサの拡張しない部分の材料の弾性、剛性、塑性、及び他の機械的特性;
(f)スペーサの冶金処理及び他の処理;
(g)スペーサの厚み及び厚みの変化;及び
(h)コーティング
本発明の好ましい実施形態では、金属性のチューブをレーザ又は電子ビームで切断することによりスペーサを製造する。金属製のチューブは、例えば押し出しにより管として成形されてもよく、又は、例えば溶接によりシートから管として形成してもよい。溶接線は、これは直線でないかもしれないが、スパイクの間に配置されることが好ましい。シートは、はじめに切断され、及び/又は、さもなければ少なくとも部分的に形づくられてから管に成形される。
る。上記に代えて又は上記に加えて、そのセンサは、特定の領域が焼き鈍されるために、さらに処理を施す必要があるかどうかを決定するのに使用できる。
(a)弾性特性、好ましくは、力の作用方向の関数として;
(b)すぼみ特性、つまり、どれだけの径方向の力が(通常は望まれていないのに)スペーサをすぼまさせ、そしてスペーサはどれだけすぼむか;
(c)挿入前、挿入中、及び/又は挿入後の軸方向、回転方向、径方向、ねじり方向、及び/又は曲げの運動に対する抵抗;
(d)拡張されている最中、及び/又は適所に置かれた後に、体の構造の形に対する一致度及び形を合わせる能力、事によると、スペーサの特性を変えること
が要求される
(e)骨と接触する仕方及び/又は程度、特に骨に食い込むことに関して;
(f)表面領域、特に新たに成長した骨へ付着及び/又は体を刺激する危険性に関して;
(g)挿入、拡張、骨の固定、調整、及び/又は回収の方法及びその容易;
(h)作業域の大きさ、つまり、特定の医療状況に特定のスペーサを合わせるときの許容誤差;及び
(i)新たに成長した骨の支持及び/又は質の向上
本発明の好ましい実施形態では、スペーサは、ASTM F67による第2等級の純粋なチタンから作られる。内部ボルトは、好ましくは、ASTM 136によるTi−6AL−4Vから作られる。
その後、スペーサにいくつかの処理、汚染物質を取り去る、成形過程で生じたくずを取り去る、尖った縁を滑らかにする、バリを取り去る、及び/又は微小な割れを縮小するために、下記のうちの一以上を施すことができる。
第2の処理、機械的洗浄では、スペーサはトラマル内に置かれ、ガラス(好ましくは小さな結晶を用いる)を吹き付けられ、砂を吹き付けられ、及び/又は(好ましくは粒子サイズが小さい)ダイヤモンドペーストで研磨される。
(a)油及びくずを除去するためにレーザ切断の後に光洗浄が行われる;
(b)水洗い;
(c)室温で1から5分の酸洗浄;
(d)水洗い;
(e)超音波攪拌されている60℃の水で洗浄;及び
(f)空気乾燥。
からなる。
酸洗浄用の酸は、例えば、20−40mlのHNO3と、1−2mlのHFの混合物を水を用いて100mlにしたもの、又は、10mlのHNO3、5mlHF、及び30mlの乳酸の混合物である。
(a)5−10分間、20℃の塩浴に浸す;
(b)水で洗浄する;
(c)2−5分間、体積比10%のH2SO4溶液に浸す;
(d)水で洗浄する;そして
(e)所望の厚さの層が除去されるまで酸に浸すことを繰り返す。耐酸材料を用いてスペーサを選択的に被覆することにより、選択性エッチングを行える。
図4Aは、本発明の好ましい実施形態による、拡張されたときに四角い断面を有するスペーサが拡張されていない形態にあるときの平面図投影図である。図4Bは、拡張された状態における図4Aのスペーサの平面投影図である。図4Cは、拡張された状態における図4Aのスペーサの斜視図である。上記の図は、本発明の好ましい実施形態の寸法をも含んでいる。例えば、長さは114mm(非拡
張時)及び23.9mm(拡張時)、各々の端の直径が4mm(非拡張時)及び14mm(拡張時)、材質はチタン、厚みが0.5mmである。上記に代えて又は上記に加えて、材質は、ニチノール(NiTi)、チタン、外科用のステンレススチール、合成樹脂、複合材、及び/又は種々の合金、例えば生物不活性合金、を含んでもよい。
本発明の好ましい実施形態において、本明細書において説明するように、スペーサは滑らかな表面を有する。一般に、滑らかな表面は、破砕する傾向、及び/又は微小な割れが伝播する傾向が少ない。上記に代えて又は上記に加えて、骨の成長及び/又は付着を促進するために、スペーサの表面の少なくとも一部が荒く仕上げられている。上記に代えて又は上記に加えて、スペーサの表面の少なくとも一部は、骨又は柔らかい組織と係合するための小さな棘を有する。いくつかの実施形態では、スパイクの先端及び/又は先端近くの領域のみが円滑でない表面を有する。このような荒さ及び/又は棘は、滑らかなスペーサをコーティングすることによっても得られる。
図4Dは、本発明の好ましい実施形態による、図4A−4Cのスペーサの変形例を示す。これらの変形例では、スパイクが8つではなく6つの軸に交わる方向にのみ拡張している。
図4Eは、例えばスペーサの剛性を増大させるために、スペーサ142が他のスペーサ140の内側で拡張されているというスペーサの形態を示す。本発明の好ましい実施形態では、内側のスペーサ142のスパイク146が、外側のスペーサ140のスパイク144のくぼみに合う形態を有する。上記に代えて又は上記に加えて、スペーサ140は、内側のスペーサ142の拡張に対し、(例えば
図2Gのように)型枠として機能してもよい。実施形態によっては、このことは、内側のスペーサのスパイクがより鋭い形となることを必要とするであろうし、及び/又は、拡張する内側のスペーサのスパイクが適切に案内されるように、外側のスペーサの内部構造が案内部のようになることを必要とするであろう。
らく、第1のスペーサの拡張は、第2のスペーサの拡張に合わせるように調整されるであろう。場合によっては、スペーサは同軸ではなく、例えば図2Pに関連して説明したように、それらの軸はほぼ直角である。
図5は、スリット152が螺旋状のパターンでスペーサ上に形成されたスペーサ150を示す。この実施形態では、軸方向の力よりも、スペーサに回転方向の力を加えることでスペーサ150を拡張できる。本発明の好ましい実施形態では、骨に適した固定具を提供すべく、例えば一組の伸張部154で例示されるように、骨と噛み合うようにスペーサの一端が変形される。本発明の好ましい実施形
態において、伸張部154は、例えば点線156により示されるように、外に折れ曲がり、スペーサが拡張する前に径方向において骨と噛み合う。好ましくは、伸張部が弾性又は超弾性材料から作られ、スペーサが適切な場所に挿入されるまで軸方向の形状に維持される。このような固定方法は、ここに記載されている本発明の他の実施形態においても有用である。しかし、本発明の他の実施形態では、スペーサを固定しなくても適切な場所で拡張できるので、骨の固定部は備えられていない。
図6A−6Vは、本発明の好ましい実施形態によるスパイクの変形例、及び/又はスパイクの向き、及び/又はスパイクの配置パターンを示す。
図6A−6Kは、本発明の好ましい実施形態による、種々のスパイク側面の(つまり、スペーサの側面からみた)輪郭を示している。一般に、スパイクの両側の輪郭はつり合っている。しかし、本発明のいくつかの好ましい実施形態では、その輪郭は、幅方向において変化してもよい。例えば、スパイクに垂直な面、及び/又はスパイクの軸に平行な面へのスパイクの投影は、四角形であってもよくが、三角形であってもよく、例えば砂時計のようなより複雑な形であってもよい。
図6Bは、四角形の輪郭を示している。
図6Cは、逆算角形の輪郭を示している。
図6Dは、砂時計の輪郭を示している。6C及び6Dの輪郭は、隣り合う骨と大きな領域で接触するという利点を有し得る。おそらく、図6Dのスパイクの利点は、つぶれることに対する抵抗力、及び、つぶれるても、部分的であり、完全につぶれる代わりにスパイクが短くなることが見込まれるということにある。これら逆さまのスパイクの他の利点は、それらの逆さまになった基部が隣り合うスパイクの基部に寄り掛かり、恐らくスペーサの剛性を高め点である。
図6Hは、スペーサ表面よりも低い部分を有するスパイクを示している。
図6Iは、張り出しており、スペーサに対して角度が垂直でないスパイクを示している。角度は、89°と20°の間でもよく、例えば約40°、約60°、約70°、又は約80°である。上記に代えて又は上記に加えて、スパイクの輪郭は曲がっていてもよい。
図6Kは、複数のサブスパイクを有するスパイクを示している。
図6L−6Nは、スペーサの軸に垂直な面におけるスパイクとスペーサ間の角度の変形例を(軸方向からみた図を用いて)示している。右に傾いたスパイクが示されているが、本発明のいくつかの好ましい実施形態では、左に傾いたスパイクが用いられている。
図6Lは、スペーサ表面に垂直なスパイクを示している。
図6Mは、スペーサ表面に対して中間の角度、例えば10°と80°の間、例
えば約30°、約50°、又は約70°にあるスパイクを示している。
図6Nは、スペーサ表面に対して平行なスパイクを示している。
図6Pは、台形の輪郭を示している。
図6Qは、三角形の輪郭を示している。
図6Rは、斜めになった輪郭を示している。
図6Sは、曲がった輪郭を示している。
図6T−6Vは、本発明の種々の好ましい実施形態による、すぼんだスペーサの表面上におけるスパイクの展開されたレイアウトを示している。
図において、スペーサは拡張され、軸方向に切断され、平らにされ、上から見られている。スパイクは、上から見たときに他の形、典型的には矩形をしているかもしれないが、その位置は、円で示されている。径方向、及び/又は軸方向、及び/又は空間の密度は、いくつかの実施形態で図に示すものとは異なる可能性がある。
図6Uは、矩形グリッドのグリッド頂点に配置されたスパイクの一様な分布を示している。
図6W及び6Xは、2以上の足部を有するスパイクを示す。特に図6Wのスパイク300は、3つの足部302、304、及び306を有する。図6Xにおいて、スパイク308も3つの足部を有する:2つの足部314及び1つの足部312である。スパイク308が(図に垂直な方向に)張り出すと、バー310が、前述したいくつかのスパイクのように曲がるよりはむしろ、ねじれる。利用可能な別のタイプの変形は、ピボット型の変形である。このピボット型の変形では、継ぎ目がスペーサの中に形成される。この様な継ぎ目は、スペーサの他の部分とは異なる材料(又は異なる処理を施された材料)を継ぎ目に用いることで形成されるだろう。これらの変形のタイプ(曲げ、ねじり、及びピボット)及び/又は他の変形タイプは、筋違及びワイヤを形成することにも用いることができる。図6Xにおいて、例えば足部312が足部314の間へと軸方向に移動する場合には、スパイク308の基部の幅はゼロになるであろうことに注意する。
図6XA−6XCは、リフトアップ機構を示す。リフトアップ機構では、スパイク(この例では頂部が平坦なスパイク)が拡張されていないスペーサの面から持ち上げられる。図6XAは、側面図であり、図6XBは、斜視図であり、図6XCは、平面の見取り図である。図6XB及び図6XG(後述)を参照する。スペーサ部分の端部315及び316がくっつけられると、足部320が曲がり、部分318が矢印の方向へスペーサから外へ持ち上げられる。本発明の好ましい実施形態では、足部320がその端部において弱化されており、足部は、弱化された領域及び/又は弱化により規定される方向にのみ曲がる。
図6XI−6XLは、図6A−6Kに示したスパイクの輪郭のいくつかを達成することを補助するために、スペーサ材を弱化する例(スペーサの軸方向部分を取り去った側面図を用いて)を示す。図示した弱化は、スペーサ表面に垂直な方向に材料をエッチング及び/又は切断するというものである。弱化は、化学的処理又は冶金処理により、例えば継ぎ目に小さな孔をあけるなど、他の方法によって達成してもよい。さらに、弱化の方向は、他の方向、(図6XAに示すように)例えばスペーサの表面に沿った方向、又はそこに対して斜め方向であってもよい。上記に代えて又は上記に加えて、スペーサの弱化及び/又は強化は、優先的に歪む方向を定めるために加えてもよい。図6XIは、対称形のスパイクを得ることを補助する弱化パターンを示している。図6XJは、非対称形のスパイクを得ることを補助する弱化パターンを示している。図6XKは、平坦な頂部のスパイクを得ることを補助する弱化パターンを示している。図6XLは、円弧形状のスパイクを得ることを補助する弱化パターンを示している。
これまでの図では、個々のスペーサの形を例示したが、本発明のいくつかの好ましい実施形態では、一つのスペーサに、事によると一つのスパイクに、2以上の上記図面における形を組み合わせることができる。その選択される特定のスパイク形状は、とりわけ、スペーサの予定される用途に依存するであろう。特に、スパイクの組み合わせ及び/又は形状は、例えば隣り合わせるスパイクが互いにもたれかかる、又は互いに係合するというスパイク間で望まれる相互作用に応じて選択されるだろう。
図7は、本発明の好ましい実施形態によるスペーサ部分400における突出部を概略的に示している。上記部分は、側面図及び斜視図で示されている。部分400は、スパイク402及び(場合によってはリング部分である)基部410を有する。本発明の好ましい実施形態では、スパイク402の剛性を高めるために、及び/又は圧力によりすぼむことを防止するために、突出部404及び/又は突出部406が備えられている。突出部404の例では、突出部404が動きを妨げるので、スパイク402は右に折れ曲がることがきない。突出部406の例では、そのような動きは再び妨げられる。突出部406は、スパイク402と(軸方向及び/又は径方向にずれた)隣接するスパイク408との間の隙間を埋めることにより、スペーサの剛性を高めることに代わる又はそれに付加される機能を有することができる。
図8Aは、本発明の好ましい実施形態によるスペーサ420を示している。スペーサ420は、スペーサのチューブ部分422の構造により、軸方向の収縮が制限されている。スペーサ420が拡張する場合、チューブ422が軸方向に縮み、スパイク424が張り出す。さらに、両側のチューブ部分が互いの方向へと進む。これらの部分は、図中、タブ428及びタブ426と印を付けられている。しかし、タブは一つだけが必要であり、他方のチューブ部分はスパイクの基部と面がそろっていてもよく、あるいは、それよりも下がってすらいてもよい。2つのタブが当たると、さらに軸方向に縮むことは不可能になるか、厳しく制限される。さらなる収縮は、もし起こった場合は、一方のタブがつぶれること、又は、一方のタブが他方のタブの上を移動することを要する。図6Jに関連して言及したように、この様なタブは、スパイクの張り出し方向をガイドするのに役立つであろう。
図8Bは、本発明の他の実施形態を示す。この実施形態では、スペーサ430の一部が自身の上に折り畳まれ、スペーサの軸方向の縮みを制限する。本発明の好ましい実施形態において、この様な折り畳みは、スペーサ430の細片を例えば参照番号436で示される複数の箇所で弱化することにより達成される。好ましくは、弱化は、素材を折る側において薄くすることを含む。上記に代えて又は上記に加えて、その部分は波状の形に予め形成され、そして、(例えば塑性変形する前の)張り出していないスパイク、又は、(例えば図2に関連して前述したような)制限装置のいずれかにより折り畳まれていない状態に維持される。点線438は、スペーサが拡張したときのスパイクの張り出しを示す。
本発明の他の実施形態では、スペーサの内腔の外の代わりに中へスパイクが張り出し、それによりスペーサの軸方向の収縮を制限する。
図9Aは、本発明の好ましい実施形態による穴掘り用の工具450を示す。本発明の好ましい実施形態では、工具450は、スペーサの挿入に先立って椎間板を砕くのに用いられる。工具450は、好ましくは、シャフト452と先端部454とを有する。本発明の好ましい実施形態では、先端部454が、スペーサとの関連で前述したように、半径方向に膨張可能な要素を有する。これにより、工具は、すぼんでいる直径で挿入でき、掘るべき空間内でのみ膨張させることができる。シャフト452が回転させられると、先端部454も回転し、椎間板の物質を砕く。
前述したように、拡張可能なスペーサは、脊柱融解に特に適している。しかし、類似の外形をした装置は、他の用途を有していてもよい。一つの用法は、例えば、先に言及したPCT刊行物WO98/38918に記載された一般的な要求を満たす骨の固定装置である。図10Aは、(この例では骨の固定具として用いられている)スペーサ704が挿入された骨折部702を有する骨を例示している。オプションとしての細長い部材706が、例えば図2との関連で前述したように、ガイドとしてあってもよく、又はスペーサの延長部用としてあってもよい。本発明のスペーサは、いくつかの実施形態では、小さな孔を通して、おそらく切開手術をせずに、挿入できる。スペーサは、少なくともその先端部に雄ねじを有し、それによって骨の中へねじ込むことができることとしてもよい。好ましくは、切開手術による切り口を必要とせずに、骨にもうけた同じ孔又は新しい孔を通してスペーサを除去することもできる。図10Bに示されるように、スペーサの挿入が完了すると、スペーサの調整及び/又は除去を補助するために、恐らくスペーサの延長部を用いて、フレア状の開口部708が骨に維持される。あるいは、通常、スペーサは骨の大きな容積を塞ぐのではないので、スペーサを除去する必要がないかもしれない。図10Cは、曲がった骨710、例えば肋骨、へのスペーサの挿入を示している。このようなスペーサは、小さな骨、例えば指の骨、にも挿入することができる。
図11は、本発明の好ましい実施形態による歯科用インプラント600の分解図である。顎601において歯が失われ、その後に穴602が残っている。本発明の好ましい実施形態では、拡張可能なスペーサ604が穴に挿入され、そこで拡張され、歯の被せ物606用の支えを形成する。好ましくは、粉状の骨又は歯の物質のような充填剤が穴602を充填するために用いられる。歯の被せ物のための完全な支えを形成する代わりに又はそれに加えて、支えと、穴602の壁との間の空間を充填するために拡張可能なスペーサを用いることもできる。上記に代えて又は上記に加えて、複数の根を有する自然の歯の一つの根を拡張可能なスペーサで置き換えてもよい。骨の組織、歯の物質、神経組織、及び/又は血管は、スペーサの中空部の中へと成長できることに注意する。強化のために、内部の支え、例えば図2との関連で前述したねじ、をスペーサの中に挿入することであってもよい。
図12A−12Cは、本発明の好ましい実施形態による、軸方向に収縮する、生組織の留め具610の使用状態を示している。組織612が組織614に留められる。留め具610の先端部611は、好ましくは先鋭であり、おそらく返し又は曲げが設けられており、好ましくは、図12Aに示すように2つの組織を突き通す。留め具610は、幅が狭く及び/又は柔軟であり、このためにカテーテル、内視鏡を用いた、及び又は外部のシリンジのような装置を用いた応用に適している。
拡張するスペーサの他の可能な用途は、体内の空洞を充填すること、及び/又は体の組織の機械特性、例えば剛性、弾性、圧縮されたときの最小寸法、を変えることである。例えば、このようなスペーサは、椎間板を硬化するのに使用できる。上記に代えて又は上記に加えて、このようなスペーサは、新しい組織の成長のための枠組みとして使用できる。上記に代えて又は上記に加えて、排膿を向上させるのに使用される。体の組織の機械的特性を変えることは、美容目的、例えば弛みを減らすこと、しまりのない肉の隠蔽、にも使用できる。
このようなスペーサの他の可能な用途は、押しつぶされた、又はそうでなければ塞がれた空気の通路をあけることである。上記スペーサのいくつかの実施形態の利点は、例えばスペーサが適切に開けることに失敗しても、スペーサが本質的にさえぎることにならないことである。
本発明の好ましい実施形態において、スペーサは、例えば前述したように、挿入後に、体の外から制御することができる。一例では、図2Jにもどって、例えば小さな永久磁石がねじに連結されていれば、体の外から磁力を作用させることにより、ねじ124を回すことができる。強力な永久磁石が体の外で回されると、小さいねじにトルクが加わり、ねじがまわる。他の例において、外部から加えられた磁場及び/又は電場を、加圧された流体にバルーンの膨張又は収縮をさせるバルブの制御に使用し、それにより、軸方向に、及び/又は半径方向にスペーサを拡張又はすぼまさせることができる。いくつかの実施形態において、例えば、スペーサを周期的に軸方向に圧縮するために、スペーサの中に統合された(電
気的又は機械的)ロジック(logic)を使用してスペーサの拡張を制御する。電力及び/又は制御信号は、体の内側から、又は体の外の電源(又はコンピュータ)から供給されてもよい。
22、122 チューブ
24 スパイク
26 スリット
28 スパイク部分
30 非スパイク部分
34、108、116 エンドキャップ
50、52 椎骨
54 椎間板
104 把持部材
106 維持部材
112、124 ねじ
128 ねじ回し
Claims (10)
- 拡張可能な骨内スペーサであって、
表面、近い端部、遠い端部、及び長さを有する、軸に沿ったチューブと、
前記チューブが載置されたハンドルを備え、
前記表面は、複数のスリットを規定しており、前記複数のスリットは、軸方向にずらされた少なくとも2つの拡張部を規定し、
前記チューブが軸方向に圧縮された場合に、前記拡張部は前記表面から外へ拡張し、拡張されたスペーサの外形を規定する、
拡張可能なスペーサ。 - 前記少なくとも2つの軸方向にずらされた拡張部は、少なくとも3つの拡張部を含み、前記3つの拡張部は、前記チューブから少なくとも3つの異なる方向へ張り出す、請求項1のスペーサ。
- 前記少なくとも2つの軸方向にずらされた拡張部は、少なくとも4つの拡張部を含み、前記4つの拡張部は、前記チューブから少なくとも4つの異なる方向へ張り出す、請求項1のスペーサ。
- 前記スリットはまっすぐである、請求項1から3のいずれか1項のスペーサ。
- 前記スリットは曲がっている、請求項1から3のいずれか1項のスペーサ。
- 前記スリットは前記チューブへの切り目により形成される、請求項1から5のいずれか1項のスペーサ。
- 前記スリットは、前記チューブから除去された切片により形成される、請求項1から5のいずれか1項のスペーサ。
- 前記スリットは、前記チューブの軸にほぼ平行である、請求項1から7のいずれか1項のスペーサ。
- 前記スリットは、前記チューブの軸に非平行である、請求項1から7のいずれか1項のスペーサ。
- 前記スリットは、長さの等しい対として設けられている、請求項1から9のいずれか1項のスペーサ。
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US7621950B1 (en) | 2009-11-24 |
JP4897766B2 (ja) | 2012-03-14 |
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