JP2005528188A - 医療用針のための安全シールド - Google Patents
医療用針のための安全シールド Download PDFInfo
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Abstract
Description
(関連出願の相互参照)
本出願は、Ferguson他による2001年6月27日に米国特許商標局に出願された米国特許出願番号第09/892,593号の部分継続出願であり、この特許の内容全体が、引用によりここに組み入れられる。
患者から針を取り除くための手順は、通常、臨床医が、他方の手で針装置を取り除きながら、片手を用いて針が引き抜かれる創傷部位に圧力をかけることを必要とする。臨床医が、針の廃棄よりも、創傷の手当てに高い優先順位を与えることは、一般的なことでもある。安全シールドのない一般的な針装置の場合には、このような優先順位は、手の届く所に利用可能な鋭利物用容器があること、或いは患者のそばを離れずに安全に廃棄するための別の手段を必要とする。このように、安全手順に従いながら適切な医療を提供する困難さは、やけど治療室及び精神科病棟におけるような、患者の物理的状態及び精神的状態によって度合いを増すことが多い。こうした状況において、患者に注意を払いながら、使用済み針を適切に廃棄することは、最先端をいく技術的挑戦である。
他の周知の装置は、ばね作動式、入れ子式、ピボット運動式などの鞘を用いる。しかしながら、不都合なことに、これらの装置は、うまく作動しなかったり、作動が面倒であったりすることがある。さらに、現在の装置の欠点は、複雑さ及び部品数のために、高い製造コストを伴う。したがって、これらの種類の従来技術の装置は、危険な露出を防止するために、針注入及び流体採取装置を適切かつ確実にシールドすることができない。
1つの特定の実施形態においては、本開示の原理に従って、予め充填された医療用針シールド装置が提供される。予め充填された医療用針シールド装置は、カラーと、該カラーから伸長可能なヒンジ式に連結されたセグメントとを含む。シールドは、引込位置から伸長位置まで伸長可能である。カラーは、予め充填された注射器の遠位端に取り付けるように構成される。
別の実施形態において、シールドは、対応するラッチと係合し、該シールドを引込位置に解放可能に配置するキャッチを含む。別の代替的な実施形態において、シールドは、該シールドを伸長位置の方向に付勢するように構成された操作アクチュエータを有する。一体型ヒンジによって、シールドのセグメントを連結することができる。シールドは、伸長位置にある針に係合する針フラップロックを含むことができる。
別の実施形態において、少なくとも1つのセグメントが、針を超えてシールドを伸長させる際に該セグメントの伸長を助けるための少なくとも1つの針ガイドを含む。シールドは、該シールドを伸長位置に付勢するのを助けるための隆起面をさらに含むことができる。
さらに別の代替的な実施形態において、医療用針シールド装置は、針を支持する針ハブを有する注射器を有する。伸長可能なシールドは、第1のセグメントと該第1のセグメントに対して関節接続された第2のセグメントとを含む。第1のセグメントは、針ハブの周りに配置されたカラーに対して関節接続されている。カラーは、一対のラッチを含む。開口部は、針の周りに移動し、引込位置から伸長位置までのシールドの伸長を助けるように構成される。第2のセグメントは、針に係合し、シールドの伸長を助ける近位方向の支柱をさらに含む。第2のセグメントは、一対のキャッチも有する。このキャッチは、シールドを引込位置に維持するラッチと係合可能である。第2のセグメントは、針に係合し、シールドを伸長位置に固定するのを助けるように構成された平坦な面を定めるノーズ部分を有する。
医療用針シールドを準備する段階は、開口部を定める第2のセグメントの周方向の壁を含むことができる。代替的に、医療用針装置を準備する段階は、該医療用針装置に取り付けられ、医療用針を実質的に囲む針カバーをさらに含み、操作段階は、針カバーが開口部を通って移動するような操作をさらに含むことができる。
開示される医療用針シールド装置及び操作方法の例示的な実施形態が、静脈内輸液の注入、薬物の注入、又は流体採取のための医療用針に関して、より具体的には、例えば不注意による針刺しなどの針カニューレの危険な露出を防止する、針カニューレと共に用いられる針シールド装置に関して説明される。保管、輸送、その後の流体の注入及び/又は採取などを含む使用中に、針カニューレをシールドできることが考えられる。しかしながら、本開示は、対象への予防薬、薬物の注入、治療などのために、幅広いカニューレ針及び装置への適用を見出すことが考えられる。静脈切開、消化、腸、尿、獣医などに関する処置中に用いられるものを含む体液の採取のために、本開示を用い得るも考えられる。静脈切開用装置、カテーテル、カテーテル導入器、ガイドワイヤ導入器、脊髄及び硬膜外、生検、アフェレーシス、透析、献血者、ベレス針、ヒューバー針などを含む、医療用針の他の用途と共に、医療用針シールド装置を用い得ることが考えられる。
以下の説明は、医療用針シールド装置の説明に引き続き、本開示に従った医療用針シールド装置の操作方法を含む。ここで、添付の図面に示される、本開示の例示的な実施形態の詳細について説明する。
安全シールド10は、例えば、予め充填された注射器11のような医療用針装置に取り付けられ、滅菌カートリッジなどから対象(図示せず)に流体を安全に注入するのを助ける。代替的に、安全シールド10は、予め充填された注射器11の遠位端に、モニリシック構造に、一体的に連結することもできる。安全シールド10は、予め充填された注射器11の針ハブ50によって支持される針カニューレ15と共に用いられる。用いられる注射器は、製薬薬剤のような流体で予め充填してもよく、或いは予め充填可能な注射器とし、後で薬剤で充填してもよいことが考えられる。安全シールド10を、上述のものに類似した、他の流体注入装置、流体採取装置、カテーテル、導入器などと共に用い得ることも考えられる。
遠位セグメント16は、例えば、該遠位セグメントの遠位部分52に隣接した、以下に詳細に説明される基部32のような平坦な面を定める。基部32は、針カニューレ15に係合し、安全シールド10を伸長位置に配置するように構成される。
安全シールド10は、望ましくは、医療用流体の注入及び/又は採取の分野に用いるものとして考えられる。より特定的には、安全シールド10は、とりわけ、臨床医及び/又は対象に不注意によりくっついたり、穿刺したりするのを防止するシールド能力を有する安全特徴、処置中の均一で信頼できる移動、及び確実な使用のためのロッキング機構を用いる使い捨て針装置にすべきであると考えられる。以下に説明されるように、とりわけ、本開示から理解される上記の利点は、保護構成まで伸長可能な開示された安全シールド10を通して得られる。本開示のこれらの特徴は、流体の安全な注入及び/又は採取を助け、臨床医及び対象の不注意による針刺しを防止する。
安全シールド10を引込位置から解放するために、手動アクチュエータ18が係合面を提供し、この係合面は、安全シールド10を伸長位置に付勢し、よってキャッチ22をラッチ20から分離させる。例えば、摩擦係合、締まり嵌めなどの他の解放可能な係合を用い得ること、雄/雌部品を逆にすること、或いはこうした解放可能な係合を用いないことも考えられる。
遠位セグメント16のノーズ部分28が、シリンダ24の開口部58から突出し、チャネル36を介して該開口部と連通状態にある。ノーズ部分28は、側壁30と、キャビティ34を定める基部32とを含む。キャビティ34は、安全シールド10が伸長位置にある場合の針カニューレ15の廃棄のために構成される。基部32は、シリンダ24からノーズ部分28の遠位端まで延びる。チャネル36は、開口部58及びキャビティ34を連結し、安全シールド10の伸長を助ける。
近位セグメント14は、予め充填された注射器11と共に取り付けるように配置される。説明されたように、近位セグメント14はカラー12を含む。近位セグメント14は、カラー12を介して、上述の幾つかの取り付け及び連結方法によって、予め充填された注射器11の外面に取り付けられる。医療用シールド装置のためのこの組み立て方法は、その構成部品を妨害することを防止し、製造中にその構成部品、特に針カニューレ15を汚染することを有利に回避する。
安全シールド10は、引込位置にある。予め充填された注射器11を用いる医療処置が完了した後、ラッチ20及びキャッチ22が分離するように、アクチュエータ18を操作する。アクチュエータ18に片手で力を加えることにより、安全シールド10が引込位置から伸長位置まで付勢されると、シリンダ24の開口部58が、針カニューレ15の周りに移動する。説明されたように、支柱60の壁64が針カニューレ15に係合し、セグメント14、16を伸長させ、その移動を案内する。
Claims (24)
- 医療用針シールド装置であって、
第1のセグメントと前記第1のセグメントから延びる第2のセグメントとを含む伸長可能なシールドを備え、
前記第2のセグメントは、前記シールドを前記医療用針装置に取り付ける際に医療用針装置の医療用針を通すように構成された開口部を含み、
前記第2のセグメントは、該第2のセグメントの遠位部分に隣接した平坦な面を定め、 前記平坦な面が、前記針に係合して、前記シールドを伸長位置に配置するように構成されたことを特徴とする医療用針シールド装置。 - 前記装置がモノリシック構造に形成されたことを特徴とする請求項1に記載の医療用針シールド装置。
- 前記第1のセグメントが、前記針を支持する装置に取り付けられたカラーに関節接続されたことを特徴とする請求項1に記載の医療用針シールド装置。
- 前記第1のセグメントが、前記針を支持する装置に取り付けられたカラーに関節接続された一対のアームを有することを特徴とする請求項1に記載の医療用針シールド装置。
- 前記カラーが、注射器に取り付けるように構成されたことを特徴とする請求項3に記載の医療用針シールド装置。
- 前記カラーが、前記伸長可能なシールドに係合し、該伸長可能なシールドを引込位置に解放可能にロックするラッチを含むことを特徴とする請求項3に記載の医療用針シールド装置。
- 前記ラッチが、前記第2のセグメント上のキャッチに係合し、前記伸長可能なシールドを引込位置に解放可能にロックするようになったことを特徴とする請求項6に記載の医療用針シールド装置。
- 前記カラーが、前記伸長可能なシールドを引込位置に解放可能にロックするために、前記第2のセグメントの一対のキャッチと係合するように配置された一対のラッチを含むことを特徴とする請求項3に記載の医療用針シールド装置。
- 前記開口部が、前記シールドの伸長時に、前記針の周りに移動するように構成されたことを特徴とする請求項1に記載の医療用針シールド装置。
- 前記第2のセグメントが、該第2のセグメントの近位部分に隣接して配置された支柱を含み、前記支柱が、前記針に係合し、引込位置から伸長位置までの前記シールドの伸長を助けるように構成されたことを特徴とする請求項1に記載の医療用針シールド装置。
- 前記支柱は、前記引込位置から前記伸長位置までの前記シールドの伸長時に、前記針を内部に案内するように構成されたスロットを含むことを特徴とする請求項10に記載の医療用針シールド装置。
- 前記第2のセグメントは、前記平坦な面の少なくとも一部を含む、ノーズ部分を含むことを特徴とする請求項1に記載の医療用針シールド装置。
- 前記ノーズ部分が、内部の前記針の廃棄のためのキャビティを定めることを特徴とする請求項12に記載の医療用針シールド装置。
- 前記キャビティが、側壁及び前記ノーズ部分の前記平坦な面によって定められることを特徴とする請求項13に記載の医療用針シールド装置。
- 前記第2のセグメントが、前記針に係合し、前記シールドを前記伸長位置に固定するロックを含むことを特徴とする請求項1に記載の医療用針シールド装置。
- 前記第1のセグメントがロックを含み、前記第2のセグメントは、協働して前記シールドを前記伸長位置に固定するロックを含むことを特徴とする請求項1に記載の医療用針シールド装置。
- 前記第1のセグメントが、前記シールドを前記伸長位置まで操作するための係合面を提要するように構成された手動アクチュエータを含むことを特徴とする請求項1に記載の医療用針シールド装置。
- 医療用針シールド装置であって、
第1のセグメントと前記第1のセグメントから延びる第2のセグメントとを含む伸長可能なシールドを備え、
前記第2のセグメントは、針の周りの引込位置から伸長位置までの前記シールドの伸長を助けるための伸長手段を有していることを特徴とする医療用針シールド装置。 - 前記第2のセグメントが、前記針に係合し、前記シールドを前記伸長位置に固定するかぎ状フラップロックを有することを特徴とする請求項18に記載の医療用針シールド装置。
- 医療用針シールド装置であって、
針を支持する針ハブを有する注射器と、
第1のセグメントと、前記第1のセグメントに対して関節接続された第2のセグメントとを含む伸長可能なシールドと、
を備え、
前記第1のセグメントは前記ハブの周りに配置されたカラーに対して関節接続され、前記カラーは一対のラッチを含んでおり、
前記第2のセグメントは、引込位置から伸長位置まで前記シールドの伸長を助けるように前記針の周りに移動するように構成された開口部を定め、該針を係合可能に受けて、該シールド及び一対のキャッチの伸長を助けるスロットを有する近位の支柱をさらに含んでおり、
前記キャッチは、前記シールドを前記引込位置に維持するように前記ラッチと係合可能であり、前記第2のセグメントは、前記針に係合し、該シールドを前記伸長位置に配置するのを助けるように構成された平坦な面を定めるノーズ部分を有しており、
前記第2のセグメントは、前記針に係合し、前記シールドを前記引込位置に固定するかぎ状フラップロックをさらに含むことを特徴とする医療用針シールド装置。 - 医療用針シールドを医療用針装置と組み立てる方法であって、
医療用針装置から延びる医療用針を有する医療用針装置を準備し、
第2のセグメントが、前記医療用針シールドを前記医療用針装置に取り付ける際に前記医療用針を通すように構成された開口部を含み、前記開口部が前記遠位セグメントに対して横断方向に配向されている場合において、第1のセグメントと前記第1のセグメントから延びる第2のセグメントとを含む伸長可能なシールドを含む医療用針シールドを準備し、
前記針が前記開口部を通って移動し、前記医療用針装置への取り付けのために前記第1のセグメントが配置されるように、該医療用針装置と組み立てるために前記医療用針シールドを位置決めし、
前記第1のセグメントを前記医療用針装置に取り付ける、
段階を含むことを特徴とする組み立て方法。 - カラーに関節接続された前記近位セグメントをさらに含む前記医療用針シールドを準備する段階及び前記取り付け段階が、前記カラーを前記医療用針装置の外面に取り付けることによって、前記第1のセグメントを該医療用針装置に取り付ける段階をさらに含むことを特徴とする請求項21に記載の組み立て方法。
- 前記医療用針シールドを準備する段階が、前記開口部を定める前記第2のセグメントの周方向の壁を含むことを特徴とする請求項21に記載の組み立て方法。
- 前記医療用針装置を準備する段階が、該医療用針装置に取り付けられ、前記医療用針を実質的に囲む針カバーをさらに含み、前記位置決め段階が、前記開口部を通って移動する前記針カバーをさらに含むことを特徴とする請求項21に記載の組み立て方法。
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PCT/US2003/017152 WO2003103755A2 (en) | 2002-06-06 | 2003-05-30 | Safety shield for medical needles |
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- 2003-05-30 AU AU2003247453A patent/AU2003247453A1/en not_active Abandoned
- 2003-05-30 KR KR10-2004-7019859A patent/KR20050016521A/ko not_active Application Discontinuation
- 2003-05-30 BR BRPI0311614-0A patent/BR0311614A/pt not_active Application Discontinuation
- 2003-05-30 EP EP03757303A patent/EP1509265A2/en not_active Withdrawn
- 2003-05-30 CA CA002488361A patent/CA2488361A1/en not_active Abandoned
- 2003-05-30 MX MXPA04012212A patent/MXPA04012212A/es active IP Right Grant
- 2003-05-30 JP JP2004510873A patent/JP2005528188A/ja active Pending
- 2003-05-30 CN CNA038187191A patent/CN1674951A/zh active Pending
- 2003-05-30 CN CN200710136842XA patent/CN101104089B/zh not_active Expired - Lifetime
- 2003-05-30 WO PCT/US2003/017152 patent/WO2003103755A2/en active Application Filing
-
2004
- 2004-12-06 IL IL165571A patent/IL165571A/en unknown
- 2004-12-09 ZA ZA2004/09988A patent/ZA200409988B/en unknown
- 2004-12-28 HR HR20041221A patent/HRP20041221A2/xx not_active Application Discontinuation
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2005
- 2005-01-04 NO NO20050032A patent/NO20050032L/no not_active Application Discontinuation
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2009535105A (ja) * | 2006-04-26 | 2009-10-01 | タイコ ヘルスケア グループ リミテッド パートナーシップ | 医療用針装置と併用するための安全シールド装置および取り付け構造 |
WO2016098861A1 (ja) * | 2014-12-19 | 2016-06-23 | 武田薬品工業株式会社 | 注射針カバー |
US10357618B2 (en) | 2014-12-19 | 2019-07-23 | Takeda Pharmaceutical Company Limited | Injection-needle cover |
CN113952554A (zh) * | 2016-12-13 | 2022-01-21 | 贝克顿·迪金森公司 | 安全针装置 |
Also Published As
Publication number | Publication date |
---|---|
MXPA04012212A (es) | 2005-04-08 |
US20060129106A1 (en) | 2006-06-15 |
NO20050032L (no) | 2005-03-07 |
WO2003103755A3 (en) | 2004-04-22 |
CA2488361A1 (en) | 2003-12-18 |
EA008261B1 (ru) | 2007-04-27 |
CN101104089B (zh) | 2010-06-02 |
US7862547B2 (en) | 2011-01-04 |
EA200500003A1 (ru) | 2006-04-28 |
KR20050016521A (ko) | 2005-02-21 |
BR0311614A (pt) | 2007-05-08 |
CN101104089A (zh) | 2008-01-16 |
CN1674951A (zh) | 2005-09-28 |
US20030004465A1 (en) | 2003-01-02 |
AU2003247453A1 (en) | 2003-12-22 |
IL165571A (en) | 2009-07-20 |
US7029461B2 (en) | 2006-04-18 |
IL165571A0 (en) | 2006-01-15 |
EP1509265A2 (en) | 2005-03-02 |
US20060015073A9 (en) | 2006-01-19 |
ZA200409988B (en) | 2006-09-27 |
WO2003103755A2 (en) | 2003-12-18 |
HRP20041221A2 (en) | 2006-12-31 |
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