JP6259513B2 - 外科処置を行うための患者適合器具及び方法 - Google Patents
外科処置を行うための患者適合器具及び方法 Download PDFInfo
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- JP6259513B2 JP6259513B2 JP2016518045A JP2016518045A JP6259513B2 JP 6259513 B2 JP6259513 B2 JP 6259513B2 JP 2016518045 A JP2016518045 A JP 2016518045A JP 2016518045 A JP2016518045 A JP 2016518045A JP 6259513 B2 JP6259513 B2 JP 6259513B2
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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
- A61F2310/00011—Metals or alloys
- A61F2310/00017—Iron- or Fe-based alloys, e.g. stainless steel
-
- 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
- A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
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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
- A61F2310/00011—Metals or alloys
- A61F2310/00029—Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
-
- 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
- A61F2310/00035—Other metals or alloys
- A61F2310/00047—Aluminium or Al-based alloys
-
- 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
- A61F2310/00035—Other metals or alloys
- A61F2310/00059—Chromium or Cr-based alloys
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Description
本出願は、2013年3月15日出願の米国特許出願第13/841,069号明細書の一部継続出願である。本出願はまた、2013年6月7日出願の米国仮特許出願第61/832,583号明細書、2013年7月12日出願の同第61/845,463号明細書、及び2013年9月13日出願の同第61/877,837号明細書の優先権を主張する。これらの特許出願は全て、参照によりそれらの全開示内容が本明細書に組み入れられるものとする。
患者の解剖学的構造に関連したデータを得るステップ;
得られたデータを3次元データセットに変換するステップ;
患者に対して行われる外科処置を容易にするための少なくとも1つの軌道又は経路を決定するステップ;
患者の解剖学的構造に関連した少なくとも1つの表面を決定するステップ;
カスタマイズされた外科装置又は器械の3次元表現を作成するステップであって、この3次元表現が、患者の解剖学的構造に関連した少なくとも1つの表面に対する少なくとも1つの軌道又は経路及び適合面を含む、ステップ;及び
3次元表現を用いてカスタマイズされた外科装置又は器械を製造するステップ。
MRI又はCTスキャンによって患者の解剖学的構造に関連したデータを得るステップ;
このMRI又はCTスキャンデータを3次元データセットに変換するステップ
患者に対して行われる外科処置を容易にするために使用するために構成される装置の向きの1つ以上の軸又は平面を決定するステップ;
決定された軸を使用し、かつ変換されたデータセットから導き出される全ての他の制約を考慮して、外科処置を容易にするために使用される装置をモデル化するステップ;
例えば、高速試作機の使用によって、モデル化装置のプロトタイプを作成するステップ;及び
外科処置中に使用するためのプロトタイプを用意するステップ。
患者の固有の解剖学的構造に一致する患者からのデータを収集するステップ;
収集されたデータからテンプレートのモデルを作成するステップであって、このモデルが、患者の固有の解剖学的構造に対する複数の適合面を備える、ステップ;
このモデルに関連したデータを製造装置に供給するステップ;
複数の適合面を備え、かつ外科手術に使用される少なくとも1つの道具又は器械に一致する少なくとも1つの追加の適合面を更に備えるようにテンプレートを迅速に作製するステップ;及び
外科手術に使用されるテンプレートに基づいて永久装置を作製するステップを含む。
外科用ガイドであって;
患者からスキャンされたデータから決定される複数の表面を備え、この複数の表面が、患者の解剖学的骨構造に適合するように構成され;
外科処置を容易にするために患者の解剖学的骨構造から決定される少なくとも1つの軌道又は経路を更に備え、
少なくとも1つのスリーブを更に備え、このスリーブが、導電材料から構成され、かつ第1の端部及び第2の端部を有する、外科用ガイドと;
導電材料から構成された少なくとも第1の部分を備える器具であって、少なくとも第1の部分を少なくとも1つのスリーブの第1の端部の中に挿入することによって少なくとも1つのスリーブ内に収容され、かつ少なくとも1つのスリーブの導電材料に接触するように適合された、器械と;を備え
この器具の少なくとも第1の部分が、少なくとも1つのスリーブを通過して、少なくとも1つのスリーブの第2の端部から出るように適合され;かつ
この外科用ガイド及び患者の解剖学的構造との接触中に、器械の手術中の監視(IOM)を行うために、この外科用ガイドに電流を流すことができる。
(A)MRI又はCTスキャンによって患者の解剖学的構造に関連したデータを得るステップ;
(B)MRI又はCTスキャンのデータを3次元データセットに変換するステップ、
(C)患者に対して行われる外科処置を容易にするために使用される、作製される装置の1つ以上の軸の向きを決定するステップ;
(D)決定された軸を使用して外科処置を容易にするために使用される装置をモデル化して、変換されたデータセットから導き出されるその他の制約を考慮するステップ;
(E)例えば、高速試作機の使用によって、モデル化装置のプロトタイプを作成するステップ;及び
(F)外科処置中に使用するためのプロトタイプを用意するステップ。
・ガイドスリーブ;
・ガイドスリーブインサート;
・ホルダー取り付け領域;
・ガイドのアーム(即ち、クリップ、孔、位置合わせ点などを用いて)。
・外科手術の数及び特定のレベルZ1〜Z4(即ち、複数のガイドが使用される場合);
・椎弓根スクリューインプラントの直径及び長さの選択(任意選択の変形形態を含む);
・選択されたインプラントに対応する誘導ガイド;
・特定の適用例のために提供される直列及び/又は一体式ガイドを含む、ガイド及び/又はスリーブの組み合わせ。
Claims (10)
- 最小侵襲性外科処置に使用される外科装置において:
近位端部及び遠位端部を有する1つ以上のガイドであって、前記遠位端部が、患者の複数の対応する解剖学的特徴に実質的に一致するように形成された複数の異なる独立した患者接触面を備える、1つ以上のガイド;
前記1つ以上のガイドの前記近位端部に選択的に取り付け可能な結合部材を備え;
前記結合部材が、前記1つ以上のガイドに、前記患者の皮膚の外側において選択的に取り付けられるように構成され;
前記1つ以上のガイドの前記遠位端部が、その適切な整合及び配置を確実にするために前記患者の対応する解剖学的特徴に接触するように構成され;かつ
前記1つ以上のガイドが、前記結合部材に結合すると、所定の方向に向けられることを特徴とする、外科装置。 - 請求項1に記載の外科装置において、前記遠位端部が、前記1つ以上のガイドの前記近位端部に選択的に相互接続可能であり、前記1つ以上のガイドが、骨アンカー、インプラント、ドリル、ラスプ、ブレード、ねじ回し、キューレット、レトラクター、伸延器、エレベーター、及びデブリドマン器具の1つ以上を受容するように構成されていることを特徴とする、外科装置。
- 請求項1に記載の外科装置において、前記1つ以上のガイドが、管状レトラクターとして使用するため、又は前記管状レトラクターと共に使用するために実質的に円筒状であり、前記結合部材が、前記患者の解剖学的特徴に設置された整列要素を受容するよう構成されたチャンネルを含むことを特徴とする、外科装置。
- 請求項1に記載の外科装置において、ステンレス鋼、チタン合金、アルミニウム合金、クロム合金、PEEK材料、炭素繊維、ABSプラスチック、ポリウレタン、樹脂、繊維封入樹脂材料、ゴム、ラテックス、合成ゴム、ポリマー、及び天然材料からなる群から選択される材料から形成されることを特徴とする、外科装置。
- 特定の患者の解剖学的構造データによって形成される外科装置において:
近位端部及び遠位端部を有する第1のガイド;
前記第1のガイドの前記遠位端部に選択的に結合される患者特有の要素であって、前記患者特有の要素に対応する患者特有の解剖学的特徴に配置されるように構成された、患者特有の要素を備え;
前記第1のガイドが、少なくとも1つのインサートを受容するように構成された孔を更に備え、前記少なくとも1つのインサートが、器械又はインプラントを受容するための孔を備え;
前記少なくとも1つのインサートの前記孔が、前記器械を受容し、又は、インプラントを所定の深さまでしか進ませないようにカスタマイズされていることを特徴とする、外科装置。 - 請求項5に記載の外科装置において、前記第1のガイドの前記近位端部及び第2のガイドの近位端部に、前記患者の皮膚の外側において選択的に取り付けられた少なくとも1つの結合部材を更に備えることを特徴とする、外科装置。
- 請求項6に記載の外科装置において、前記外科装置が、光学又は電子認識手段によって認識可能であり、前記光学又は電子認識手段が、前記患者特有の解剖学的特徴に対する前記外科装置の位置及び向きの確認を容易にすることを特徴とする、外科装置。
- 請求項5に記載の外科装置において、前記外科装置を少なくとも1つの追加の外科装置に機能的に結合させるように構成された複数の表面を更に備え、この組合せが、前記外科装置及び前記少なくとも1つの追加の外科装置と前記患者特有の解剖学的特徴との整合及び向き合わせを容易にすることを特徴とする、外科装置。
- 請求項8に記載の外科装置において、前記少なくとも1つの追加の外科装置が、前記患者に留まるように設計され、かつ骨固着装置、植え込み装置、ケージ、プレート、及び生物活性装置からなる群から選択されることを特徴とする、外科装置。
- 請求項5に記載の外科装置において、前記少なくとも1つのインサートの前記孔は、特定の器械又はインプラントを収容するための1つ以上のサイズおよび形状であることを特徴とする、外科装置。
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PCT/US2014/041379 WO2014197844A1 (en) | 2013-06-07 | 2014-06-06 | Patient-matched apparatus and methods for performing surgical procedures |
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US8641721B2 (en) * | 2011-06-30 | 2014-02-04 | DePuy Synthes Products, LLC | Customized patient-specific orthopaedic pin guides |
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US9198678B2 (en) | 2015-12-01 |
KR20170026460A (ko) | 2017-03-08 |
EP3003143B1 (en) | 2021-11-10 |
WO2014197844A1 (en) | 2014-12-11 |
AU2014274748B2 (en) | 2018-03-01 |
EP3151768A1 (en) | 2017-04-12 |
US20140350614A1 (en) | 2014-11-27 |
EP3797716A1 (en) | 2021-03-31 |
AU2014274748A1 (en) | 2015-12-10 |
JP2016524506A (ja) | 2016-08-18 |
EP3003143A4 (en) | 2017-05-24 |
EP3151768A4 (en) | 2018-05-02 |
AU2018200895A1 (en) | 2018-02-22 |
AU2015271069A1 (en) | 2017-01-12 |
CA2953224A1 (en) | 2015-12-10 |
CA2914005C (en) | 2018-01-09 |
EP3151768B1 (en) | 2020-12-16 |
KR101974287B1 (ko) | 2019-04-30 |
BR112016028546A2 (pt) | 2017-08-22 |
EP3003143A1 (en) | 2016-04-13 |
AU2018200895B2 (en) | 2019-07-18 |
MX2016016124A (es) | 2017-07-20 |
CA2914005A1 (en) | 2014-12-11 |
WO2015187397A1 (en) | 2015-12-10 |
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