JP5371107B2 - 脊椎治療用デバイス - Google Patents
脊椎治療用デバイス Download PDFInfo
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- JP5371107B2 JP5371107B2 JP2009551011A JP2009551011A JP5371107B2 JP 5371107 B2 JP5371107 B2 JP 5371107B2 JP 2009551011 A JP2009551011 A JP 2009551011A JP 2009551011 A JP2009551011 A JP 2009551011A JP 5371107 B2 JP5371107 B2 JP 5371107B2
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- elongate
- elongate member
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- augmentation
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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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0082—Three-dimensional shapes parallelepipedal
- A61F2230/0084—Three-dimensional shapes parallelepipedal cubical
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
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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
- A61F2310/00293—Ceramics or ceramic-like structures containing a phosphorus-containing compound, e.g. apatite
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- B33—ADDITIVE MANUFACTURING TECHNOLOGY
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Description
本発明は、概して、低侵襲性外科的手技で採用される装置および方法に関し、より具体的には、特に脊椎中の組織層を分離および/または支持するための装置および方法の種々の側面に関する。
例えば、本発明は以下の項目を提供する。
(項目1)
組織層の間に挿入可能であり、該組織層の間を延びる方向に寸法を有する構造物を原位置で画定するように適合される、第1の細長い部材と、
該構造物の該寸法を原位置で増加させるように、該第1の部材と動作可能に協働する、細長い増高部材と
を備える、組織離隔デバイス。
(項目2)
第1の細長い部材、および該第1の細長い部材に隣接する第2の細長い部材であって、組織層の間を延びる方向に寸法を有する構造物を原位置で画定するように、該組織層の間に挿入可能である、第1および第2の細長い部材と、
該構造物の該寸法を原位置で増加させるように、該第1の部材および該第2の部材と動作可能に協働する、細長い増高部材と
を備える、組織離隔デバイス。
(項目3)
第1の細長い部材と、その間の第2の細長い部材とを含むアセンブリを備え、
増高部材は、該アセンブリが第1の寸法を有する、該第1の細長い部材と該第2の細長い部材との間の第1の位置と、該アセンブリが該第1の寸法よりも大きい第2の寸法を有する、該第1の細長い部材と該第2の細長い部材との間の第2の位置との間で、移動可能であり、
アセンブリは、組織層の間に挿入可能である、該第1の位置における増高部材を有する、
離隔デバイス。
(項目4)
上記細長い部材のうちの少なくとも1つは、組織層の間の挿入用の第1の構成と該組織層の間に挿入されたときの第2構成との間で、その構成を変更するように適合される、項目1〜3のいずれか1項に記載の離隔デバイス。
(項目5)
上記第1の構成は、略直線状であり、上記第2の構成は、複数の巻きを有する略らせん形状である、項目4に記載の離隔デバイス。
(項目6)
上記細長い部材のうちの少なくとも1つは、略環状構造物を原位置で画定するように適合される、項目4に記載の離隔デバイス。
(項目7)
上記細長い部材のうちの少なくとも1つは、接触していない近位端および遠位端を有する、略湾曲構造物を原位置で画定するように適合される、項目4に記載の離隔デバイス。
(項目8)
上記細長い部材のうちの少なくとも1つは、上記構造物の形状を原位置で維持するのを補助する、協働表面を有する、項目1〜7のいずれか1項に記載の離隔デバイス。
(項目9)
上記細長い部材のうちの少なくとも1つは、内部長手方向通路を含み、上記増高部材は、該細長い部材の該長手方向通路への挿入用にサイズ決定される、項目1または2に記載の離隔デバイス。
(項目10)
脊椎の組織層の間に挿入されるように適合される、離隔デバイスであって、該脊椎は、全体長手方向軸を有し、該デバイスは、該脊椎の該長手方向軸に略平行な方向に、原位置で実質的に硬い、項目1〜9のいずれか1項に記載の離隔デバイス。
(項目11)
上記デバイスは、第1の方向で実質的に硬く、該第1の方向の平面とは異なる平面内で実質的に可撓性である、項目1〜10のいずれか1項に記載の離隔デバイス。
(項目12)
上記細長い部材のうちの少なくとも1つは、応力を緩和して曲げ応力を低減する、少なくとも1つの陥凹を有する、項目1〜11のいずれか1項に記載の離隔デバイス。
(項目13)
上記細長い部材または上記細長い増高部材のうちの少なくとも1つは、該部材の中の材料の量を減少させ、該部材の可撓性を増加させるように、少なくとも1つのチャンバを含む、項目1〜12のいずれか1項に記載の離隔デバイス。
(項目14)
上記細長い部材のうちの少なくとも1つは、上記寸法が増大されたときに組織層に接触するように位置付けられる、少なくとも1つの組織係合突出部を含む、項目1〜13のいずれか1項に記載の離隔デバイス。
(項目15)
上記細長い部材のうちの少なくとも1つは、少なくとも1つの通路を含み、該通路を通して、流動性を有する材料をその中へ導入することができる、項目1〜14のいずれか1項に記載の離隔デバイス。
(項目16)
上記細長い部材の各々は、近位領域、中央領域、および遠位領域を有し、該部材のうちの少なくとも1つの該遠位領域、該近位領域、および該中央領域のうちの少なくとも1つの高さは、同部材の少なくとも1つの他の領域の高さよりも大きい、項目1〜15のいずれか1項に記載の離隔デバイス。
(項目17)
上記構造物は、近位領域、中央領域、および遠位領域を有し、該構造物の該近位領域、該中央領域、および該遠位領域のうちの少なくとも1つは、該構造物の少なくとも1つの他の領域よりも大きい高さを有する、項目1〜16のいずれか1項に記載の離隔デバイス。
(項目18)
上記細長い部材のうちの少なくとも2つは、少なくとも1つの放射線不透過マーカーを含み、該放射線不透過マーカーは、部材の整列または組織中の上記構造物の整列を示すように適合される、項目1〜17のいずれか1項に記載の離隔デバイス。
(項目19)
上記第1の細長い部材は、上記細長い増高部材の第1の表面に隣接する下面を有し、上記第2の細長い部材は、該増高部材の第2の表面に隣接する上面を有し、該増高部材の該第1の表面および該増高部材の該第2の表面のうちの少なくとも1つは、該第1の細長い部材の該下面および該第2の細長い部材の該上面のうちの少なくとも1つの上の少なくとも1つの適合性係止特徴と相互作用するように構成される、少なくとも1つの係止特徴を含む、項目2〜18のいずれか1項に記載の離隔デバイス。
(項目20)
上記部材のうちの少なくとも1つを組織層の間の場所に誘導するための少なくとも1つのガイド部材を有し、該ガイド部材は、近位端部分および遠位端部分を有し、該遠位端部分は、組織層の間の挿入のために適合され、所望の支持構造物の形状を画定し、
該細長い部材のうちの少なくとも1つは、組織層の間の挿入のために、該ガイド部材に沿って遠位に該細長い部材を前進させるために該ガイド部材に沿って前進可能であり、該細長い部材のうちの少なくとも1つは、該ガイド部材の該遠位端部分によって画定される該形状に実質的に従う、項目1〜19のいずれか1項に記載の離隔デバイス。
(項目21)
上記細長い部材は、遠位端部分および近位端部分を有し、力送達システムによる機械的エネルギーを与える際に、該力送達システムは、該部材のうちの少なくとも1つを上記第2の構成で形成するように、該部材のうちの少なくとも1つの該遠位端と協働的に関連する、項目4〜19のいずれか1項に記載の離隔デバイス。
図1は、第1の細長い部材102によって画定された、概して100と指定される離隔デバイス支持構造物の一実施形態を図示する。細長い部材102は、好ましくは、治療が必要とされるヒト組織内への長期埋め込みに適した生体適合性材料でできている、糸またはリボン等の細長い要素から成る。生体適合性材料は、リン酸カルシウム、リン酸三カルシウム、ヒドロキシアパタイト、ポリエーテルエーテルケトン(PEEK)、ナイロン、ニチノール(NiTi)、または任意の他の好適な生体適合性材料であってもよい。
離隔デバイス239によって画定された離隔デバイス支持構造物の一実施形態を図22に示す。図22に示された離隔デバイスは、第1の細長い部材252、第2の細長い部材253、ならびに、第1および第2の細長い部材と協働的に相互作用して離隔デバイス支持構造物の寸法を増加させる、細長い増高部材255によって構成される。離隔デバイスが2つ以上の別個の部材またはスリーブを備えてもよいことに留意して、離隔デバイスは、好ましくは、治療が必要とされるヒト組織内への長期埋め込みに適した生体適合性材料(金属およびポリマーを含む)でできている、糸またはリボン等の細長い要素から成る。生体適合性材料は、例えば、リン酸カルシウム、リン酸三カルシウム、ヒドロキシアパタイト、ポリエーテルエーテルケトン(PEEK)、ナイロン、ニチノール(NiTi)、または任意の他の好適な生体適合性材料であってもよい。
本発明の種々の実施形態は、離隔構造物またはその使用の方法を増進させるために、他の特徴を採用してもよい。例えば、細長い部材の遠位端部分は、1回転に対して、または1つの巻きを形成するために必要とされる長さにほぼ等しい長さを有する、角度を成す、または傾斜した第1のセクションを含むことができる。
カニューレを動かさないように注意して、医師は、第1および第2の細長い部材の後端または近位端と接触するまで細長い増高部材を押す。医師は、全ての細長い部材の整列をチェックし、第1および第2の細長い部材に対して 細長い増高部材を押し始める。細長い増高部材は、第1および第2の部材の間に自らを割り込ませ始める。細長い増高部材の厚さ(高さ)によっては、さらなる割り込みを可能にするように、この時点で、ある程度の緩みが引張ワイヤに与えられる必要があり得る。
Claims (17)
- 脊柱の隣接する椎骨の間に挿入可能であり、該椎骨の間を延びる方向に寸法を有する構造物を原位置で画定するように適合される、第1の細長い部材および第2の細長い部材と、
該構造物の該寸法を原位置で増加させるように、該第1の細長い部材と該第2の細長い部材との間に挿入可能な離して設けられた細長い増高部材と
を備え、該第1の細長い部材および該第2の細長い部材のうちの少なくとも1つは、概して直線状の構成と、概してあまり直線状でない構成との間で変更するために側方のくぼみを備えて十分な可撓性を提供する、組織離隔デバイス。 - 前記第1の細長い部材および前記第2の細長い部材は、隣接する椎骨の間に対として挿入可能である、請求項1に記載の組織離隔デバイス。
- 前記第1の細長い部材および前記第2の細長い部材のうちの前記少なくとも1つは、近位端と遠位端とが離間された、全体的に湾曲した構成を原位置で画定するために十分に可撓性である、請求項1または2に記載の離隔デバイス。
- 前記脊椎は、ほぼ長手方向の軸を有し、前記デバイスは、原位置において、該脊椎の該長手方向の軸にほぼ平行な方向に実質的に硬い、請求項1〜3のいずれか1項に記載の離隔デバイス。
- 前記デバイスは、前記脊椎の前記長手方向の軸にほぼ平行な方向において実質的に硬く、該脊椎の該長手方向の軸にほぼ平行な方向とは異なる平面内で可撓性である、請求項4に記載の離隔デバイス。
- 前記第1の細長い部材および前記第2の細長い部材のうちの少なくとも1つは、少なくとも1つの応力緩和構成を有し、該応力緩和構成は、前記概してあまり直線状でない構成において曲げ応力を低減する、請求項1〜5のいずれか1項に記載の離隔デバイス。
- 前記細長い部材の少なくとも2つは、それぞれ、1つの放射線不透過マーカーを含み、該放射線不透過マーカーは、前記隣接する椎骨間での該細長い部材の少なくとも2つの部材の整列を示すように配置される、請求項1〜6のいずれか1項に記載の離隔デバイス。
- 前記第1の細長い部材は、前記細長い増高部材の第1の表面に隣接する下面を有し、前記第2の細長い部材は、該細長い増高部材の第2の表面に隣接する上面を有し、該細長い増高部材の該第1の表面および該細長い増高部材の該第2の表面のうちの少なくとも1つは、該第1の細長い部材の該下面および該第2の細長い部材の該上面のうちの少なくとも1つと相互作用することによって、それらの間の相対運動に抵抗するように構成される少なくとも1つの表面部分を含む、請求項1〜7のいずれか1項に記載の離隔デバイス。
- 前記第1の細長い部材および前記第2の細長い部材のうちの少なくとも1つに接続された引張ワイヤをさらに備え、該引張ワイヤは、前記概して直線状の構成と前記概してあまり直線状でない構成との間で変更するように、前記第1の細長い部材および前記第2の細長い部材のうちの少なくとも1つに力を及ぼすように適合されている、請求項1〜8のいずれか1項に記載の離隔デバイス。
- 前記第1の細長い部材および前記第2の細長い部材は、それぞれ、ワイヤ管腔を含み、前記引張ワイヤは、該ワイヤ管腔の両方を通過する、請求項9に記載の離隔デバイス。
- 第1の細長い部材と第2の細長い部材と細長い増高部材とを備えている構造物を組み立てるためのシステムであって、ここで、
該第1の細長い部材および該第2の細長い部材は、概して直線状の構成内の位置に向けて送達されるように構成されており、
該第1の細長い部材および該第2の細長い部材のうちの少なくとも1つの構成は、概してあまり直線状でない構成に変更されるように構成されており、
該第1の細長い部材と該第2の細長い部材との間に該細長い増高部材が挿入されるように構成されている間、該第1の細長い部材および該第2の細長い部材のうちの該少なくとも1つは、該概してあまり直線状でない構成に維持されるように構成されている、
システム。 - 概して直線状の構成内の位置に向けて送達されるように構成されている前記第1の細長い部材および前記第2の細長い部材が、対として送達されるように構成されている該第1の細長い部材および該第2の細長い部材を含む、請求項11に記載のシステム。
- 前記第1の細長い部材と前記第2の細長い部材との間に前記細長い増高部材が挿入されるように構成されている間、前記概してあまり直線状でない構成に維持されるように構成されている該第1の細長い部材および該第2の細長い部材のうちの前記少なくとも1つが、該第1の細長い部材と該第2の細長い部材との間に該細長い増高部材が挿入されるように構成されている間に加えられる外力によって、該概してあまり直線状でない構成に維持されるように構成されている該第1の細長い部材および該第2の細長い部材のうちの該少なくとも1つを含む、
請求項11または12に記載のシステム。 - 概してあまり直線状でない構成に変更されるように構成されている前記第1の細長い部材および前記第2の細長い部材のうちの少なくとも1つの構成は、概してあまり直線状でない構成に変更されるように構成されている該第1の細長い部材および該第2の細長い部材の両方の構成を含み、そして
該第1の細長い部材と該第2の細長い部材との間に前記細長い増高部材が挿入されるように構成されている間、該概してあまり直線状でない構成に維持されるように構成されている該第1の細長い部材および該第2の細長い部材のうちの該少なくとも1つは、該第1の細長い部材と該第2の細長い部材との間に該細長い増高部材が挿入されるように構成されている間、該概してあまり直線状でない構成に維持されるように構成されている該第1の細長い部材および該第2の細長い部材の両方を含む、
請求項11〜13のいずれか1項に記載のシステム。 - 概して直線状の構成内の位置に向けて送達されるように構成されている前記第1の細長い部材および前記第2の細長い部材は、
概してあまり直線状でない構成に予め成形されるように構成されている該第1の細長い部材および該第2の細長い部材のうちの少なくとも1つ、および
概して直線状の構成に一時的に維持されるように構成されている該第1の細長い部材および該第2の細長い部材のうちの少なくとも1つ
を含む、
請求項11〜14のいずれか1項に記載のシステム。 - 請求項1に記載の離隔デバイスであって、さらにカニューレを備え、該カニューレを通って前記第1の細長い部材および該第2の細長い部材ならびに前記細長い増高部材が脊柱の隣接する椎骨の間に挿入のために移動可能であり、ここで、該第1の細長い部材および該第2の細長い部材は、該細長い増高部材によって加えられる力により該カニューレを通って移動可能である、離隔デバイス。
- 請求項11に記載のシステムであって、さらにカニューレを備え、該カニューレを通って前記第1の細長い部材および該第2の細長い部材ならびに前記細長い増高部材が脊柱の隣接する椎骨の間に挿入のために移動可能であり、ここで、該第1の細長い部材および該第2の細長い部材は、該細長い増高部材によって加えられる力により該カニューレを通って移動可能である、システム。
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US8968408B2 (en) | 2015-03-03 |
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EP2124778B1 (en) | 2019-09-25 |
US20140107789A1 (en) | 2014-04-17 |
US20170035576A1 (en) | 2017-02-09 |
US9326866B2 (en) | 2016-05-03 |
EP2124778A4 (en) | 2013-03-20 |
WO2008103832A9 (en) | 2008-12-24 |
JP2010518987A (ja) | 2010-06-03 |
US20150150690A1 (en) | 2015-06-04 |
WO2008103832A2 (en) | 2008-08-28 |
US20180271675A1 (en) | 2018-09-27 |
US20190029844A1 (en) | 2019-01-31 |
ES2757819T3 (es) | 2020-04-30 |
CA2678006C (en) | 2014-10-14 |
EP2124778A2 (en) | 2009-12-02 |
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