JP2019531868A - 脊椎固定インプラント - Google Patents
脊椎固定インプラント Download PDFInfo
- Publication number
- JP2019531868A JP2019531868A JP2019543189A JP2019543189A JP2019531868A JP 2019531868 A JP2019531868 A JP 2019531868A JP 2019543189 A JP2019543189 A JP 2019543189A JP 2019543189 A JP2019543189 A JP 2019543189A JP 2019531868 A JP2019531868 A JP 2019531868A
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- JP
- Japan
- Prior art keywords
- blade
- implant
- moving element
- housing
- channel
- Prior art date
- 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.)
- Granted
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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
- 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
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
- A61F2/446—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
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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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- A61F2/00—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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- A61F2/4465—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
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- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
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- A61F2002/30622—Implant for fusing a joint or bone material
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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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- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
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- A61F2002/30841—Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
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- A—HUMAN NECESSITIES
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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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- A61F2002/30841—Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
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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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- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
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- A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
- A61F2002/30884—Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
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- A—HUMAN NECESSITIES
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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
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
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- A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
- A61F2002/30891—Plurality of protrusions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
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- A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
- A61F2002/30891—Plurality of protrusions
- A61F2002/30892—Plurality of protrusions parallel
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- A—HUMAN NECESSITIES
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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
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
- A61F2002/30891—Plurality of protrusions
- A61F2002/30894—Plurality of protrusions inclined obliquely with respect to each other
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- A—HUMAN NECESSITIES
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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
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2002/3093—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth for promoting ingrowth of bone tissue
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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
- A61F2/30—Joints
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2/4603—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
- A61F2002/4629—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 connected to the endoprosthesis or implant via a threaded connection
Abstract
Description
図1は、インプラント100の一実施例を示す模式図である。インプラント100は、人体104の脊柱102の絵に隣接して示されている。図2では、インプラント100の実施形態は、挿入ツール206を使用して人体104に挿入しようとしている状態のインプラント100の一実施形態が示されている。人体104とともに描かれているインプラント100および挿入ツール206の相対的なサイズは、図示するために調整されていることは理解されるべきである。
ここで図6〜図9を参照すると、本体部200の一実施形態の4つの図が提示されている。図6は、本体部200の模式的な等角上側側面図または上から見た等角図である。図7は、本体部200の模式的な等角下側側面図または下から見た等角図である。図8は、本体部200の模式的な後面図または背面図である。図9は、本体部200の模式的な前面図または正面図である。異なる実施形態において、本体部200は、ハウジング201の後方側部および前方側部、ならびにハウジング201の少なくとも1つの外側側部を提供してもよい。
図10は、ブレード移動要素260の一実施形態の等角側面図である。ブレード移動要素260の正面図または前方側面図も図11に示しており、ブレード移動要素260の外側側面図は図12に図示している。図10〜図12を参照すると、ブレード移動要素260は、従動軸部320およびブレード係合部322を含んでもよい。従動軸部320は、従動軸部320の最前方端に沿って従動端(driven shaft portion)262をさらに含む。
図5に関して上述したように、インプラント100の実施形態は、本体部200の後方開口を閉鎖するかまたは該後方開口にまたがり、インプラント100の種々の構成要素をまとめて取り付けるのを助けるように構成されているカバー220を含むことができる。
上述したように、本明細書で説明する実施形態は、インプラントが低プロファイルを維持することを許容する第1位置(「挿入位置」)から、ブレードを展開してそれを近位の上下の椎体に挿入する第2位置(「嵌め込み位置」または「展開位置」)まで移動することのできるインプラントを提供する。インプラントが第1(挿入)位置にあるとき、デバイスのブレードは、インプラントの本体部内に後退していてもよい(すなわち、ブレード自体が「後退位置」にあってもよい)。インプラントの第2(展開)位置では、ブレードは、インプラントを越えて上側(もしくは頭側)または下側(もしくは尾側)に延びて、椎体に入り、インプラントが時間とともに位置からずれることを防止する。このため、ブレード自体が「延伸位置」または「展開位置」にあると言われることもある。ブレードが展開されるとき、インプラントは、左右の回転に抵抗するとともに、屈曲および/または伸展に抵抗する。ブレードは、おおむね垂直方向(すなわち、上下方向)に移動するかもしれないが、実際の移動方向は実施形態によって変わってもよいことは認識されよう。たとえば、いくつかの実施形態では、ブレードは、インプラント内でやや傾斜させてもよく、垂直方向(または上下方向)に対してわずかな角度をもって展開してもよい。
図29〜図30は、一実施形態による止めねじ280の2つの模式図を示す。いくつかの実施形態では、止めねじ280は、1種のねじ切り留め具とすることができる。図29では、止めねじ280は、ねじ切りセグメント部284を備えるフランジ付き頭282を含み、さらに実質的に滑らかな細長い本体部288を含む。ねじ切りセグメント部284は、本体部の溝部と係合するようなサイズおよび寸法にされている(以下の図33を参照)。フランジ付き頭282は、インプラント内に止めねじを取り付けるために、打ち込みツールと係合することのできる受け凹部2900も含むことができる。このように、ねじロックが確実にされているとき、本体部288は、ブレード移動要素のねじ切り開口内に配設されているが、本体部288は、ねじ切り開口に関連付けられているねじ山と係合する必要も、またはロックする必要もない。
異なる実施形態において、インプラントは、異なる種類の構成要素を利用して、本明細書で説明する特徴および機能を提供することができる。いくつかの実施形態では、ブレード移動要素の特徴は、多様な外科的要件をもつインプラントの利用を容易にするために調整することができる。たとえば、いくつかの実施形態では、第2ブレード移動要素(「第2作動構成要素」)3300の代替実施例を、図33に示すように、本体部のハウジング内に置くことができる。
上述したように、インプラント100の実施形態は、「インプラント用の挿入ツールおよび使用法」出願で開示される特徴または構造を利用することができる。いくつかの実施形態では、インプラント100は、埋め込みプロセスを大幅に容易にすることのできる1つのツールとともに使用されるように構成することができる。たとえば、外科医が椎間板のスペースに前方アプローチからアプローチするかどうかは、外科医が、前方アプローチを用いて、大動脈および大静脈の周囲で手術をどれほど容易にこなせるかによる。脊椎の前に大動脈および大静脈があるため、前方側部から患者にアプローチすることにより、血管を傷つけるリスクがある。しかし、安定性と固定範囲とが増す利点は、非常に多くの場合、余分な手術のリスクにまさり、本明細書で提供される展開プロセスは、このようなリスクを低減するのに役立てることができる。
異なる実施形態では、インプラントのサイズを変えることができるであろう。いくつかの実施形態では、インプラントは、任意の長さを有することができるであろう。実施形態は、40mmから60mmまでの範囲の長さを有することができるであろう。ある場合には、製造者は、40mmから60mmの間で5mm刻みで長さを変えられる複数のインプラントの選択肢を提供することができるであろう。いくつかの実施形態では、インプラントは、任意の高さを有することができるであろう。実施形態は、4mmから16mmまでの範囲の高さを有することができるであろう。ある場合には、製造者は、4mmから16mmまで2mm刻みで高さを変えられるインプラントを提供することができるであろう。実施形態は、18mm、22mm、26mmおよび他のサイズの幅(すなわち、前後軸)を有することができるであろう。
実施形態は、任意選択的に、1つまたは複数の整列機能を含んでもよい。整列機能は、透視撮影の位置付け用の窓、ブレード展開の検証用の窓、ブレード移動要素を1枚または複数枚のブレードと整列させるための窓、および種々の他の種類の整列機能を含むが、これだけに限定されない。
いくつかの実施形態は、骨移植片または骨移植片代用品材料を含め、骨成長促進材料を使用してもよい。本明細書で用いられる場合、「骨成長促進材料」(BGPM)とは、骨の成長を助ける任意の材料である。骨成長促進材料は、リンカー分子またはバインダの使用により表面に凍結乾燥されるかまたは金属に付着される手段を含んでもよい。骨成長促進材料の例は、BMP−1、BMP−2、BMP−4、BMP−6およびBMP−7等の骨形成タンパク質(BMP)を含む、任意の材料である。これらは、幹細胞を骨形成細胞に変換するホルモンである。別の例には、rhBMP−2、rhBMP−4およびrhBMP−7等のリコンビナントヒトBMP(rhBMP)が挙げられる。さらに別の例には、血小板由来増殖因子(PDGF)、線維芽細胞増殖因子(FGF)、コラーゲン、BMP模倣ペプチド、およびRGDペプチドが挙げられる。一般に、これらの化学物質の組み合わせも使用してもよい。これらの化学物質は、スポンジ、基質またはゲルを使用して塗布することができる。
インプラントの種々の構成要素は、特定の用途および/または医師による選択に応じて、金属(たとえば、チタン、チタン合金、ステンレススチール、コバルトクロム、または他の金属)、合成ポリマー(たとえば、PEEKまたはPEKK)、セラミック、および/またはそれらの組み合わせを含むがこれらに限定されない、人体に埋め込むのに好適な生体適合性材料から製造されてもよい。
本開示によるインプラントは、以下の項目のリストに開示されたさまざまな特徴を含んでいてもよい。
本願は、2016年10月25日に出願されたSackの米国特許出願第15/333,892号の一部継続出願(CIP)であり、その開示全体が参照により本明細書に援用される。
Claims (26)
- インプラントであって、
第1軸を有するハウジングと、
前記ハウジング内の退避位置と、ブレードが前記ハウジングから外方に延びている延伸位置とを有するブレードと、
従動軸部およびブレード係合部を備えるブレード移動要素と、を備え、
前記ブレード移動要素は、前記退避位置と前記延伸位置との間で前記ブレードを移動させることができ、
前記ハウジングは、ガイド開口を含む第1端部を有し、前記ガイド開口は、中空溝部およびチャンバ部を備え、前記中空溝部は、前記チャンバ部に接続されており、
前記チャンバ部は、前記ブレード移動要素の前記従動軸部の一部を受け入れる、インプラント。 - 前記チャンバ部は、前記従動軸部を受け入れるように構成されており、前記チャンバ部の断面形状は、前記従動軸部の回転を防止するように構成されている、請求項1に記載のインプラント。
- 前記チャンバ部は、垂直面に実質的に矩形の断面形状を有し、前記従動軸部は、垂直面に実質的に矩形の断面形状を有する、請求項1に記載のインプラント。
- 前記第1軸は、前記インプラントの前方側部と後方側部との間に延びている、請求項1に記載のインプラント。
- 前記第1端部は、前記インプラントの前記前方側部に関連付けられている、請求項4に記載のインプラント。
- 前記ブレード移動要素は、前記第1軸に平行な方向に前記ハウジングを通って並進することができる、請求項1に記載のインプラント。
- 前記中空溝部は、ねじ切り留め具を受け入れるように構成されている、請求項1に記載のインプラント。
- 前記ねじ切り留め具は、本体部に接合されているフランジ付き頭部を含み、前記フランジ付き頭部は、ねじ切りセグメントを含み、前記ねじ切りセグメントは、前記中空溝部のねじ山に対応する、請求項7に記載のインプラント。
- 前記ねじ切り留め具は、前記従動端が前記チャンバ部から前記中空溝部の中まで移動するのを防止するように構成されている、請求項7に記載のインプラント。
- インプラントであって、
第1軸を有する本体部と、
前記本体部内の退避位置と、ブレードが前記本体部から外方に延びている延伸位置とを有するブレードと、
前記ブレードは、遠位面および近位面を有し、
前記ブレードは、前記遠位面に隣接して配設されているブリッジ部をさらに備え、前記ブリッジ部は、前記ブレードに構造的な補強を与えるように構成されており、
前記第1軸に平行な方向に前記本体部を通って並進することのできるブレード移動要素と、を備え、
前記ブレード移動要素は、前記退避位置と前記延伸位置との間で前記ブレードを移動させることができる、インプラント。 - 前記ブレードは、前縁および後縁を有し、前記本体部は、第1保持チャンネルおよび第2保持チャンネルを含み、前記ブレードの前記前縁は、前記第1保持チャンネルに受け入れられ、前記ブレードの前記後縁は、前記第2保持チャンネルに受け入れられる、請求項10に記載のインプラント。
- 前記ブレードは、第1ブレード部と第2ブレード部とがゼロではない角度で交わる第1屈曲部を有する、請求項10に記載のインプラント。
- 前記本体部の後方側部は、第1端部と第2端部との間に延びている後方開口を含み、前記後方開口にまたがるように前記本体部にカバーが装着されている、請求項10に記載のインプラント。
- 前記第1端部は、前記カバーの一部を受け入れるように構成されている第1凹部を含む、請求項13に記載のインプラント。
- 前記ブレード移動要素の後方端は、受け部を含み、前記受け部は、前記カバーが前記本体部に装着されて、前記ブレードが退避位置にあるときに、前記カバーの上側表面の上かつ下側表面の下に配設される、請求項14に記載のインプラント。
- 前記ブレード移動要素の前記チャンネルは、前記ブレード移動要素の側面に対角線上に延びている、請求項10に記載のインプラント。
- インプラントであって、
ハウジングと、第1ブレードと、ブレード移動要素と、を備え、
前記第1ブレードは、前記ハウジング内の退避位置と、前記第1ブレードが前記ハウジングから外方に延びている延伸位置とを有し、
前記ブレード移動要素は、第1軸に平行な方向に前記ハウジングを通って並進するように構成されており、前記第1軸は、前記インプラントの前方側部から前記インプラントの後方側部に延びており、
前記ブレード移動要素は、従動軸部およびブレード係合部を備え、前記従動軸部は、前記第1ブレードが前記退避位置にあるときに、少なくとも部分的に前記ハウジングの外部に配設され、前記従動軸部は、前記第1ブレードが前記延伸位置にあるときに、全体が前記ハウジング内に配設される、インプラント。 - 前記従動軸部は、前記第1軸に実質的に整列した方向に延びているねじ切り開口を含む、請求項17に記載のインプラント。
- 前記ハウジングは、前記ハウジングの前方側部に形成されている前方開口を含み、前記従動軸部は、前記第1ブレードが前記退避位置にあるときに、前記前方開口を通って延びている、請求項17に記載のインプラント。
- 前記ハウジングの前記前方側部は、挿入ツールと係合するように構成されている少なくとも1つの第1空洞を含む、請求項19に記載のインプラント。
- 第2ブレードをさらに備え、前記第1ブレードは、前記延伸位置で前記ハウジングから遠位上方に延び、前記第2ブレードは、前記延伸位置で前記ハウジングから遠位下方に延びている、請求項17に記載のインプラント。
- 前記第2ブレードは、前記第1ブレードと実質的に同様である、請求項21に記載のインプラント。
- 挿入ツールは、前記インプラントの挿入中に、前記ハウジングを把持するように構成されており、前記挿入ツールは、前記ねじ切り開口に係合して、前記第1ブレードを前記退避位置から前記延伸位置まで移行させるねじ切りドライバをさらに備え、前記挿入ツールは、前記インプラントに取り付けられて、前記第1ブレードを前記延伸位置にロックするねじ切り留め具を含む、請求項18に記載のインプラント。
- 前記ブレード移動要素は、前記ブレード移動要素の中央に向いて配設されている斜材部を含む、請求項17に記載のインプラント。
- 前記従動軸部は、前記ブレードが前記退避位置にあるときに、前記ハウジングの外部に配設される従動端を含み、前記従動端部に力が加えられると、前記ブレードは、前記退避位置から前記延伸位置に移行する、請求項17に記載のインプラント。
- 前記ブレードの外縁は、前記退避位置では、前記ハウジングの中央領域に配設され、前記ブレードの前記外縁は、前記延伸位置では、前記ハウジングに対して中央に位置付けられる、請求項25に記載のインプラント。
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US20180296359A1 (en) | 2018-10-18 |
JP2022044807A (ja) | 2022-03-17 |
CN114099093A (zh) | 2022-03-01 |
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US11413157B2 (en) | 2022-08-16 |
BR112019008323A2 (pt) | 2019-07-16 |
JP2024032871A (ja) | 2024-03-12 |
WO2018081140A1 (en) | 2018-05-03 |
EP3531969A4 (en) | 2020-12-09 |
EP3531969A1 (en) | 2019-09-04 |
JP7429249B2 (ja) | 2024-02-07 |
CN110114036A (zh) | 2019-08-09 |
CN110114036B (zh) | 2021-12-21 |
US20200188128A1 (en) | 2020-06-18 |
JP7018065B2 (ja) | 2022-02-09 |
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