JP2015530904A - 薬物溶出外科用ねじ - Google Patents
薬物溶出外科用ねじ Download PDFInfo
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- JP2015530904A JP2015530904A JP2015527529A JP2015527529A JP2015530904A JP 2015530904 A JP2015530904 A JP 2015530904A JP 2015527529 A JP2015527529 A JP 2015527529A JP 2015527529 A JP2015527529 A JP 2015527529A JP 2015530904 A JP2015530904 A JP 2015530904A
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- drug eluting
- surgical screw
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Images
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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
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
-
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- 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
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
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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
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
- A61B17/8605—Heads, i.e. proximal ends projecting from bone
- A61B17/861—Heads, i.e. proximal ends projecting from bone specially shaped for gripping driver
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- Health & Medical Sciences (AREA)
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Abstract
Description
本出願は、2012年8月15日に出願された「Drug Eluting Surgical Screw」と題する米国仮特許出願第61/683,262号の利益を主張するものであり、当該出願は参照によりその全体が本明細書に組み込まれる。
(1) 薬物溶出外科用ねじであって、
ねじ部を有する軸と、
前記軸の近位末端に配置された駆動凹部を有する頭部であって、前記駆動凹部が収容容器領域及びドライバ係合領域を有する、頭部と、
ドライバが前記ドライバ係合領域内に動作可能に配置された場合、前記ドライバと前記外科用ねじとの間の接続を実質的に損なわない様式で、前記駆動凹部の前記収容容器領域内に配置された少なくとも1つ又は2つ以上の薬物溶出構成要素と、を含み、前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちのそれぞれが、
担体マトリックス及び治療薬を含み、前記治療薬が、前記薬物溶出外科用ねじの任意の植え込み前に、前記薬物溶出構成要素の少なくとも約20重量%である、薬物溶出外科用ねじ。
(2) 前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの少なくとも1つの、前記治療薬の濃度が、前記薬物溶出外科用ねじの任意の植え込み前に、前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの前記少なくとも1つの約20重量%〜約60重量%である、実施態様1に記載の薬物溶出外科用ねじ。
(3) 前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの少なくとも1つの、前記治療薬の濃度が、前記薬物溶出外科用ねじの任意の植え込み前に、前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの前記少なくとも1つの約20重量%〜約40重量%である、実施態様2に記載の薬物溶出外科用ねじ。
(4) 前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの少なくとも1つが、その治療薬の少なくとも約80%を、前記薬物溶出外科用ねじが動物に植え込まれたときから3日間の期間にわたり、溶出するように設計される、実施態様1に記載の薬物溶出外科用ねじ。
(5) 前記収容容器領域が、収容容器容積を画定し、前記駆動凹部が、駆動凹部容積を画定し、前記収容容器容積が、前記駆動凹部容積の約10%〜約12%である、実施態様1に記載の薬物溶出外科用ねじ。
(7) 前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの少なくとも1つの、前記担体マトリックスが、生体吸収性ポリマーを含む、実施態様1に記載の薬物溶出外科用ねじ。
(8) 前記生体吸収性ポリマーが、ポリカプロラクトン、ポリ乳酸、ポリグリコール酸、ポリエチレングリコール、又はこれらの組み合わせを含む、実施態様7に記載の薬物溶出外科用ねじ。
(9) 前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの少なくとも1つの、前記担体マトリックスが、ポリエチレングリコール、ポリビニルアルコール、グリセリン、塩、又は水溶性結晶固体を含む、実施態様1に記載の薬物溶出外科用ねじ。
(10) 前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの少なくとも1つの、前記担体マトリックスが、シリカ、ヒドロキシアパタイト、リン酸カルシウム、バイオガラス、又はこれらの組み合わせを含む、実施態様1に記載の薬物溶出外科用ねじ。
(12) 前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの少なくとも1つの、前記担体マトリックスが、非吸収性ポリマーを含む、実施態様1に記載の薬物溶出外科用ねじ。
(13) 前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの少なくとも1つの、前記担体マトリックスが、非吸収性ポリマー及び生体吸収性ポリマーを含む、実施態様1に記載の薬物溶出外科用ねじ。
(14) 前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの少なくとも1つの、前記担体マトリックスが、浸食可能セラミック又は生体安定セラミックを含む、実施態様1に記載の薬物溶出外科用ねじ。
(15) 前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの少なくとも1つの、前記担体マトリックスが、非吸収性ポリマー及び可溶性添加剤を含む、実施態様1に記載の薬物溶出外科用ねじ。
(17) 前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの少なくとも1つの、前記治療薬が、ゲンタマイシンを含む、実施態様1に記載の薬物溶出外科用ねじ。
(18) 前記収容容器領域が、前記少なくとも1つ又は2つ以上の薬物溶出構成要素が硬化状態にある場合、前記少なくとも1つ又は2つ以上の薬物溶出構成要素を保持するように形作られ、そのような寸法にされる、実施態様1に記載の薬物溶出外科用ねじ。
(19) 前記少なくとも1つ又は2つ以上の薬物溶出構成要素が硬化状態にある場合、前記薬物溶出構成要素を保持するように設計され、そのような寸法にされた縁を更に含む、実施態様1に記載の薬物溶出外科用ねじ。
(20) 少なくとも2つの薬物溶出構成要素を更に含む、実施態様1に記載の薬物溶出外科用ねじ。
Claims (20)
- 薬物溶出外科用ねじであって、
ねじ部を有する軸と、
前記軸の近位末端に配置された駆動凹部を有する頭部であって、前記駆動凹部が収容容器領域及びドライバ係合領域を有する、頭部と、
ドライバが前記ドライバ係合領域内に動作可能に配置された場合、前記ドライバと前記外科用ねじとの間の接続を実質的に損なわない様式で、前記駆動凹部の前記収容容器領域内に配置された少なくとも1つ又は2つ以上の薬物溶出構成要素と、を含み、前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちのそれぞれが、
担体マトリックス及び治療薬を含み、前記治療薬が、前記薬物溶出外科用ねじの任意の植え込み前に、前記薬物溶出構成要素の少なくとも約20重量%である、薬物溶出外科用ねじ。 - 前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの少なくとも1つの、前記治療薬の濃度が、前記薬物溶出外科用ねじの任意の植え込み前に、前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの前記少なくとも1つの約20重量%〜約60重量%である、請求項1に記載の薬物溶出外科用ねじ。
- 前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの少なくとも1つの、前記治療薬の濃度が、前記薬物溶出外科用ねじの任意の植え込み前に、前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの前記少なくとも1つの約20重量%〜約40重量%である、請求項2に記載の薬物溶出外科用ねじ。
- 前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの少なくとも1つが、その治療薬の少なくとも約80%を、前記薬物溶出外科用ねじが動物に植え込まれたときから3日間の期間にわたり、溶出するように設計される、請求項1に記載の薬物溶出外科用ねじ。
- 前記収容容器領域が、収容容器容積を画定し、前記駆動凹部が、駆動凹部容積を画定し、前記収容容器容積が、前記駆動凹部容積の約10%〜約12%である、請求項1に記載の薬物溶出外科用ねじ。
- 前記駆動凹部の前記収容容器領域が、前記ドライバ係合領域と隣接しており、前記少なくとも1つ又は2つ以上の薬物溶出構成要素が、前記ドライバ係合領域内に延出しない、請求項1に記載の薬物溶出外科用ねじ。
- 前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの少なくとも1つの、前記担体マトリックスが、生体吸収性ポリマーを含む、請求項1に記載の薬物溶出外科用ねじ。
- 前記生体吸収性ポリマーが、ポリカプロラクトン、ポリ乳酸、ポリグリコール酸、ポリエチレングリコール、又はこれらの組み合わせを含む、請求項7に記載の薬物溶出外科用ねじ。
- 前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの少なくとも1つの、前記担体マトリックスが、ポリエチレングリコール、ポリビニルアルコール、グリセリン、塩、又は水溶性結晶固体を含む、請求項1に記載の薬物溶出外科用ねじ。
- 前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの少なくとも1つの、前記担体マトリックスが、シリカ、ヒドロキシアパタイト、リン酸カルシウム、バイオガラス、又はこれらの組み合わせを含む、請求項1に記載の薬物溶出外科用ねじ。
- 前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの少なくとも1つの、前記担体マトリックスが、疎水性生体吸収性ポリマーを含む、請求項1に記載の薬物溶出外科用ねじ。
- 前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの少なくとも1つの、前記担体マトリックスが、非吸収性ポリマーを含む、請求項1に記載の薬物溶出外科用ねじ。
- 前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの少なくとも1つの、前記担体マトリックスが、非吸収性ポリマー及び生体吸収性ポリマーを含む、請求項1に記載の薬物溶出外科用ねじ。
- 前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの少なくとも1つの、前記担体マトリックスが、浸食可能セラミック又は生体安定セラミックを含む、請求項1に記載の薬物溶出外科用ねじ。
- 前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの少なくとも1つの、前記担体マトリックスが、非吸収性ポリマー及び可溶性添加剤を含む、請求項1に記載の薬物溶出外科用ねじ。
- 前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの少なくとも1つが、濃度勾配を含む、請求項1に記載の薬物溶出外科用ねじ。
- 前記少なくとも1つ又は2つ以上の薬物溶出構成要素のうちの少なくとも1つの、前記治療薬が、ゲンタマイシンを含む、請求項1に記載の薬物溶出外科用ねじ。
- 前記収容容器領域が、前記少なくとも1つ又は2つ以上の薬物溶出構成要素が硬化状態にある場合、前記少なくとも1つ又は2つ以上の薬物溶出構成要素を保持するように形作られ、そのような寸法にされる、請求項1に記載の薬物溶出外科用ねじ。
- 前記少なくとも1つ又は2つ以上の薬物溶出構成要素が硬化状態にある場合、前記薬物溶出構成要素を保持するように設計され、そのような寸法にされた縁を更に含む、請求項1に記載の薬物溶出外科用ねじ。
- 少なくとも2つの薬物溶出構成要素を更に含む、請求項1に記載の薬物溶出外科用ねじ。
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN108778405A (zh) * | 2016-02-26 | 2018-11-09 | 神经毫微股份公司 | 细胞聚集物和组织片段的植入方法 |
Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9364273B2 (en) | 2012-08-15 | 2016-06-14 | DePuy Synthes Products, Inc. | Drug eluting surgical screw |
US10537373B2 (en) * | 2015-04-24 | 2020-01-21 | Biomet Sports Medicine, Llc | Porous implants with injectable capabilities |
JP6755301B2 (ja) * | 2016-02-29 | 2020-09-16 | メドトロニックソファモアダネック株式会社 | 抗菌性生体内埋込用器具用セットスクリュー |
CN117642207A (zh) * | 2021-01-15 | 2024-03-01 | 舒缓处方公司 | 具有治疗剂的恒定且连续释放的关节植入物 |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2004537495A (ja) * | 2000-11-03 | 2004-12-16 | コントロール・デリバリー・システムズ | 関節疾患を治療するための改善された装置及び方法 |
US20090163919A1 (en) * | 2007-12-19 | 2009-06-25 | Peter Tarcha | Devices, systems, and methods for delivery of a pharmaceutical to a subject's spine |
JP2012016593A (ja) * | 2010-07-08 | 2012-01-26 | Tyco Healthcare Group Lp | 自己解離可能な医療デバイス |
Family Cites Families (22)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE2843963A1 (de) * | 1978-10-09 | 1980-04-24 | Merck Patent Gmbh | Im koerper resorbierbare geformte masse auf basis von kollagen und ihre verwendung in der medizin |
EP0048246B1 (en) * | 1980-03-27 | 1986-05-28 | National Research Development Corporation | Antimicrobial surgical implants |
JPS5770816A (en) * | 1980-10-17 | 1982-05-01 | Ono Pharmaceut Co Ltd | Multilayered film preparation of prostagladin of prolonged action |
US4905680A (en) * | 1986-10-27 | 1990-03-06 | Johnson & Johnson Orthopaedics, Inc. | Absorbable bone plate |
US5387419A (en) * | 1988-03-31 | 1995-02-07 | The University Of Michigan | System for controlled release of antiarrhythmic agents |
US5985317A (en) * | 1996-09-06 | 1999-11-16 | Theratech, Inc. | Pressure sensitive adhesive matrix patches for transdermal delivery of salts of pharmaceutical agents |
TW402930U (en) * | 1999-02-12 | 2000-08-21 | Yang Je Jung | Improvement of marrow internal nail structure |
US20050203612A1 (en) * | 2000-12-22 | 2005-09-15 | Avantec Vascular Corporation | Devices delivering therapeutic agents and methods regarding the same |
US7235079B2 (en) * | 2004-11-18 | 2007-06-26 | Acumed Llc | Composite bone fasteners |
IL163771A0 (en) * | 2002-02-28 | 2005-12-18 | Novartis Ag | N-ä5-Ä4-(4-methyl-piperazino-methyl benzoylamidoÜ--2-methylphenylü-4-(3-pyridyl)-2-pyrimidine-amine coated stents |
US7220755B2 (en) * | 2003-11-12 | 2007-05-22 | Biosensors International Group, Ltd. | 42-O-alkoxyalkyl rapamycin derivatives and compositions comprising same |
US20070053963A1 (en) * | 2004-01-13 | 2007-03-08 | Hotchkiss Robert N | Drug delivery to a joint |
US20050250838A1 (en) * | 2004-05-04 | 2005-11-10 | Challapalli Prasad V | Formulation for sustained delivery |
US8535357B2 (en) * | 2004-12-09 | 2013-09-17 | Biomet Sports Medicine, Llc | Continuous phase compositions for ACL repair |
US8273086B2 (en) * | 2005-03-24 | 2012-09-25 | Depuy Spine, Inc. | Low profile spinal tethering devices |
US9247973B2 (en) * | 2007-09-28 | 2016-02-02 | DePuy Synthes Products, Inc. | Anti-microbial implant |
CA2734254C (en) * | 2008-08-13 | 2018-06-05 | Smed-Ta/Td, Llc | Orthopaedic screws |
US20100249783A1 (en) * | 2009-03-24 | 2010-09-30 | Warsaw Orthopedic, Inc. | Drug-eluting implant cover |
WO2011133655A1 (en) | 2010-04-22 | 2011-10-27 | Micell Technologies, Inc. | Stents and other devices having extracellular matrix coating |
US20120109111A1 (en) * | 2010-10-29 | 2012-05-03 | Empire Technology Development Llc | Fenestration system |
US9364273B2 (en) | 2012-08-15 | 2016-06-14 | DePuy Synthes Products, Inc. | Drug eluting surgical screw |
US10307194B2 (en) * | 2017-08-01 | 2019-06-04 | Warsaw Orthopedic, Inc. | Spinal implant and method of manufacture |
-
2013
- 2013-03-13 US US13/800,342 patent/US9364273B2/en active Active
- 2013-08-13 CN CN201380043534.6A patent/CN104582612B/zh active Active
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Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2004537495A (ja) * | 2000-11-03 | 2004-12-16 | コントロール・デリバリー・システムズ | 関節疾患を治療するための改善された装置及び方法 |
US20090163919A1 (en) * | 2007-12-19 | 2009-06-25 | Peter Tarcha | Devices, systems, and methods for delivery of a pharmaceutical to a subject's spine |
JP2012016593A (ja) * | 2010-07-08 | 2012-01-26 | Tyco Healthcare Group Lp | 自己解離可能な医療デバイス |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN108778405A (zh) * | 2016-02-26 | 2018-11-09 | 神经毫微股份公司 | 细胞聚集物和组织片段的植入方法 |
JP2019506250A (ja) * | 2016-02-26 | 2019-03-07 | ニューロナノ アーベー | 細胞凝集体及び組織片の移植の方法 |
JP7006941B2 (ja) | 2016-02-26 | 2022-01-24 | ニューロナノ アーベー | 細胞凝集体及び組織片の移植の方法 |
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