JP4130535B2 - 脊椎の隣接する椎骨の間に移植するための整形外科インプラント - Google Patents

脊椎の隣接する椎骨の間に移植するための整形外科インプラント Download PDF

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JP4130535B2
JP4130535B2 JP2001056570A JP2001056570A JP4130535B2 JP 4130535 B2 JP4130535 B2 JP 4130535B2 JP 2001056570 A JP2001056570 A JP 2001056570A JP 2001056570 A JP2001056570 A JP 2001056570A JP 4130535 B2 JP4130535 B2 JP 4130535B2
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bag
polymer
adjacent vertebrae
implantation
spine
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JP2001276099A5 (ja
JP2001276099A (ja
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シー.スタルカップ グレゴリー
ジェイ.ロジアー アントニー
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Bristol Myers Squibb Co
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Bristol Myers Squibb Co
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0085Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof hardenable in situ, e.g. epoxy resins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004Rounded shapes, e.g. with rounded corners
    • A61F2230/0015Kidney-shaped, e.g. bean-shaped
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0065Three-dimensional shapes toroidal, e.g. ring-shaped, doughnut-shaped
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00353Bone cement, e.g. polymethylmethacrylate or PMMA
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/38Materials or treatment for tissue regeneration for reconstruction of the spine, vertebrae or intervertebral discs

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Description

【0001】
【発明の属する技術分野】
本発明は、整形外科インプラントすなわち整形外科移植装置に関し、より詳細には、脊椎固定(術)装置に関する。
【0002】
【従来の技術】
脊椎固定術は、通常、2つの隣接する椎骨の間の椎間板を除去してそれら椎骨の間にケージを設置することによって、2つの隣接する椎骨の間を固定することを必要とする。患者は前側及び後側(胃及び背中)の両方を切開され、椎間板が2つの隣接する椎骨の間から除去されることがある。椎間板には核部(髄核)の周囲を取り囲む輪部(線維輪)が含まれている。輪部を引き裂いたり、切開したり、若しくは椎骨の間から除去したりして、さらに、より柔軟な核部を除去する。椎骨の間の椎間板が除去された場所にケージを配置し、骨粒を含んだ骨グラフト(骨移植体)をケージ内に詰め込んで隣接する椎骨の間の終板の間に延在させる。さらに、ネジがそれぞれのロッドに取り付られそれぞれの椎骨内に延びた状態で、ロッドを脊椎の後側に配置してもよい。
【0003】
【発明が解決しようとする課題】
本発明の目的は、最小侵襲の外科手術手順で脊椎の隣接する椎骨の間に移植され得る整形外科インプラントを提供することである。
【0004】
【課題を解決するための手段】
本発明は、椎間板の輪部によって周囲を取り囲まれている空洞内に配置され且つ中央空洞部を含んでいるバッグ(すなわち、袋)を備えた整形外科インプラントを提供する。バッグはポリマを充填され、バッグによって形成される中央空洞部は骨粒及びポリマ基質を充填される。
【0005】
本発明は、1つの形態で、概略環状のバッグとこのバッグ内の硬化したポリマとを備えている脊椎の隣接する椎骨の間に移植するための整形外科インプラントからなる。
本発明は、他の形態で、隣接する椎骨の間の椎間板の輪部にアクセス孔を形成するステップと、輪部により周囲を取り囲まれている空洞を形成するために椎間板内の核部を除去するステップと、空洞内に概略環状のバッグを配置するステップと、バッグにポリマを充填するステップと、環状のバッグにより周囲を取り囲まれている空洞に骨粒を注入するステップと、ポリマを硬化させるステップと、を含む脊椎の隣接する椎骨を固定する方法からなる。
【0006】
本発明の利点は、脊椎を取り囲む靱帯及び腱が適正な張力をかけられ得ることである。
他の利点は、患者が手術後すぐにインプラントに荷重を加え始めることができることである。
さらに別の利点は、インプラントを単一の後部切開部位から移植することもできれば、後部及び/又は前部切開部位から移植することもできることである。
【0007】
【発明の実施の形態】
添付の図面に関連する本発明の実施態様の以下の説明を参照することにより、本発明の上述した特徴及び利点並びに他の特徴及び利点、それらを実施する態様がさらに明らかとなり、本発明がより深く理解されよう。
複数の図面を通して対応する参照符号は対応する部分を指している。本願に提示されている具体例は本発明の好ましい一実施態様を一形態で示しているのであり、係る具体例が如何なる形でも本発明の範囲を制限するものとして解釈されるべきではない。
【0008】
以下で、図面を参照して、本発明の脊椎の隣接する椎骨を固定するための方法の実施態様を説明する。脊椎には複数の隣接する椎骨10が含まれており、隣接する椎骨10の各対は椎間板12により分離されている。椎間板12は幾つかの理由により損傷を受けた状態になり、したがって、隣接する椎骨の固定を必要とすることがある。
【0009】
図1は患者の脊椎と平行な方向に見たときの脊髄の部分断面図を示している。椎間板12は、隣接する椎骨10の間での固定を必要とする程度まで損傷を受けているものとする。図2を参照すると、各椎骨10は長手方向の各端部に逆側を向いている終板24を含んでいる。各椎間板12は一対の隣接する椎骨の間に介在し、さらに核部(髄核)28の周囲を取り囲んでいる輪部(線維輪)26を含んでいる。
【0010】
メス18や他の適宜の切開器具を用いて患者の背中16に切開部14を形成する。切開部14は適宜の機器20を用いて開いた状態に保持されてもよい。椎間板12に対して概略示されているような角度で切開部14を形成し、それによって、脊髄が位置している領域22を回避する。切開部14が形成された後に、ドリルの刃先やメスのような公知の方法によって、選択された椎間板12の輪部26にアクセス孔30を形成する。切開部14を患者の背中16に形成することから、通常、アクセス孔30を椎間板12の後方側に形成する。
【0011】
アクセス孔30の形成後、核部28を椎間板12内から排出させる(図3)。核部28を除去するために、真空管34又は同種のものを使用することができる。核部28の除去は、輪部26によって周囲を取り囲まれている空洞42を椎間板12内に形成させる。核部28の排出後に、空洞42及び切開部14から真空管34を除去する。
【0012】
次に、弛緩状態のときに概略環状形状を有している柔軟なバッグ44を空洞42内に挿入する(図4)。より詳細には、バッグ44を折り畳んで、事前装填管46内に挿入する。事前装填管46は輪部26に形成されているアクセス孔30の内径よりも僅かに小さい外径を有する。事前装填管46の端部48がアクセス孔30を貫通して空洞42内に延びるように、内部にバッグ44が装填されている事前装填管46を切開部14及びアクセス孔30に挿入する。次に、矢印50によって示されているように、バッグ44を事前装填管46から空洞42内へ滑動させる。事前装填管46の内径よりも僅かに小さい外径を有し事前装填管46内に配置されているプランジャ(不図示)を利用することによる方法のような適宜の方法で、バッグ44を事前装填管46から駆出することが可能である。
【0013】
空洞42内に設置されたときに空洞42の周囲を概略充塞するような大きさ及び形状を有しているバッグ44が選択される(図5)。第1の充填ホース52及び第2の充填ホース54の各々がバッグ44に取り付けられる(図5〜図11)。第1のホース52は、バッグ44を貫通して延びており、バッグ44によって周囲を取り囲まれている空洞42の部分で終端している(図6)。他方、第2の充填ホース54は、バッグ44内に延びており、バッグ44内で終端している。矢印56によって示されているように、第2の充填ホース54を通してバッグ44内に高強度ポリマを注入する。バッグ44のこの第1充填段階の際には、ポリマ58を注入して、バッグ44を膨張又は変形させることなく、予め定められた第1の量までバッグ44に概略充填する。示されている実施態様では、バッグ44は多孔性のものであり、ポリマ58は生体吸収性且つ硬化性のポリマーの形態のものであり、その一部がバッグ44を透過する。ポリマ58は例えばポリメチルメタクリレートなどである。硬化は、熱エネルギや光エネルギやX線エネルギのようなエネルギの付加又は化学的触媒の添加によって行われ得る。図6に示されているバッグ44の第1充填段階の際には、好ましくは、ポリマ58は未硬化状態を維持している。
【0014】
次に、矢印62によって示されているように、第1の充填ホース52を通してバッグ44によって周囲を取り囲まれている空洞42の部分内に骨粒60の形態の骨グラフト(骨移植体)を注入する。骨代用材料を使用することもできることは了解されよう。示されている実施態様では、骨粒60は合成骨代用物のような液体内を浮遊した状態になっている。
【0015】
バッグ44によって周囲を取り囲まれている空洞42の部分が図7に示されているように概略充満されるまで、第1の充填ホース52を通して空洞42内に骨粒及び懸濁液が注入される。その後、骨粒60を空洞42内に保持して、追加でポリマ58をバッグ44内に注入する。予め定められた第2の量までバッグ44内にポリマ58を注入して、バッグ44を膨張させる。バッグ44は(椎間板12に対して)軸線方向に膨張して、終板24に接触する。さらに、バッグ44は半径方向内向き方向に膨張して、空洞42内において骨粒60を半径方向に圧縮すると共に軸線方向に膨張させる。したがって、椎骨10を取り囲む靱帯及び腱に対して、その間で骨粒60を軸線方向に膨張させることにより、張力を再度かけることが可能となる。さらに、骨粒60及びバッグ44が接触する領域の概略全てが荷重支持部材を形成することから、固定領域は大きな接触面積を備えることとなる。
【0016】
比較的早い方法で、バッグ44内のポリマ化合物又はポリマ混合物58並びに骨粒60を取り囲みそれを支持しているポリマを荷重支持状態へ硬化させることもできる。例えば、ポリマ化合物又はポリマ混合物をX線エネルギ又は化学的触媒で硬化させることができる。したがって、最小限の侵襲(minimal evasive)であることに加えて、患者は、整形外科インプラント8内でポリマを硬化させた後に、着座、起立などを通して迅速に脊椎に荷重を付加することができる。第1の充填ホース52及び第2の充填ホース54は図9に示されているように整形外科インプラント8から切断され、切開部14が適宜の閉鎖技術を用いて閉鎖される。
【0017】
上記の説明から、本発明が最小侵襲の外科手術手順で椎間板12内に容易に移植され得る整形外科インプラント8を提供することが分かるであろう。隣接する椎骨10の間でバッグ内のポリマの硬化が急速に起こり、椎骨の間に荷重の伝達のための大きな表面積と骨の再成長のための安定した構造を提供する。
【0018】
本発明が好ましい構造を有するものとして説明されたが、本発明を本開示内容の精神及び範囲内でさらに改変することができる。したがって、本願は本発明の総合的な原理を用いて本発明の任意の変化形態、用途、適用形態を網羅することを意図するものである。さらに、本願は、本発明が属する当該技術において公知のもの又は慣習的な実施の範囲となるような特許請求の範囲の限定内に入る本開示内容からの逸脱事項を網羅することを意図している。
【図面の簡単な説明】
【図1】椎骨及び椎間板の部分断面図であり、椎骨及び椎間板に対して形成された切開部の向き及び大きさを示している。
【図2】椎間板内の核部の排出を示している斜視図である。
【図3】椎間板内の環状バッグの設置を示している斜視図である。
【図4】椎間板内に設置された後の弛緩状態のバッグの斜視図である。
【図5】予め定められた第1の量までポリマを充填した際のバッグの側断面図である。
【図6】バッグによって周囲を取り囲まれた空洞内に注入された骨粒及びポリマ基質を示している側断面図である。
【図7】骨粒を注入した後に予め定められた第2の量まで充填されたバッグを示している側断面図である。
【図8】整形外科インプラントが椎間板内に移植され切開部が閉鎖された状態になっている部分断面図である。
【図9】図4〜図9に示されているバッグの斜視図である。
【図10】図4〜図10に示されているバッグの側断面図である。
【符号の説明】
10…椎骨
12…椎間板
26…輪部
28…核部
30…アクセス孔
44…バッグ
58…ポリマ
60…骨粒

Claims (5)

  1. 概略環状のバッグと、
    前記バッグ内に充填されたポリマと、
    前記バックを貫通して延びており、前記バックによって周囲を取り囲まれている空洞の部分で終端している第1の充填管と、
    前記ポリマを前記バッグに注入するために前記バッグと接続されている第2の充填管とを備える、脊椎の隣接する椎骨の間に移植するための整形外科インプラント。
  2. 前記ポリマが硬化可能なポリマからなる、請求項1に記載の脊椎の隣接する椎骨の間に移植するための整形外科インプラント。
  3. 前記ポリマが、熱エネルギ、光エネルギ、X線エネルギ及び化学的触媒のうちの1つにより硬化可能である、請求項に記載の脊椎の隣接する椎骨の間に移植するための整形外科インプラント。
  4. 前記ポリマがポリメチルメタクリレートからなる、請求項に記載の脊椎の隣接する椎骨の間に移植するための整形外科インプラント。
  5. 前記バッグが多孔性バッグからなり、前記ポリマの一部が前記バッグを透過することを許容する、請求項1に記載の脊椎の隣接する椎骨の間に移植するための整形外科インプラント。
JP2001056570A 2000-03-07 2001-03-01 脊椎の隣接する椎骨の間に移植するための整形外科インプラント Expired - Fee Related JP4130535B2 (ja)

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AU772702B2 (en) 2004-05-06
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