JP2023510677A - 医療注射システム及び方法 - Google Patents
医療注射システム及び方法 Download PDFInfo
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- JP2023510677A JP2023510677A JP2022523737A JP2022523737A JP2023510677A JP 2023510677 A JP2023510677 A JP 2023510677A JP 2022523737 A JP2022523737 A JP 2022523737A JP 2022523737 A JP2022523737 A JP 2022523737A JP 2023510677 A JP2023510677 A JP 2023510677A
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- needle
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Abstract
Description
装置の操作シーケンスは以下の通りである。
1.装置1が第2の装置1と対になって取り付けられている場合(図2参照)、一度に1つの装置を使用できるように使用者は装置1を取り外す。
2.使用者はカバー4を取り外す(図3および図4参照)。
3.使用者は装置本体2を生体の皮膚に当てる。
4.注射のための皮膚への安定した並置が得られるまで、または任意の検出器12が押しボタン14を解除する(図3および図4、ある所定の圧力の大きさの際に)ように十分になるまで、生体の皮膚に加える圧力を大きくする。代替的に、任意の検出器12はトリガ機構200を作動させ、その場合ステップ6に進む。
5.使用者は押しボタン14を押下し、トリガ機構200を作動させる。
6.トリガ機構200は挿入サブアセンブリ300を解除する(図9A)。
7.針注入端454が注入深さまで生体に挿入できるまで、挿入サブアセンブリ300は針サブアセンブリ400を押下し、針抽出端456はリザーバ隔壁604を貫通する(図9B~図9D)。
8.この位置に到達すると、挿入サブアセンブリ300はラッチシステム334、134によって主構造102にロックされる。その結果、挿入サブアセンブリ300に取り付けられている針サブアセンブリ400も、ロックされる。同時に、注入アセンブリ500が解除され、流体リザーバサブアセンブリ600を針サブアセンブリ400に押し出す(図11および図12)。
9.隔壁604は流体リザーバ602の底面方向に変位し、ピストンとして作用して、流体606を、針抽出端456、針452、針注入端434を介して生体に注入する(図13)。
10.任意で、注入サブアセンブリ500がリザーバを空にした後、針サブアセンブリ400は、挿入サブアセンブリ300から解除され、開始位置に押し戻されて、針注入端454が完全に主構造102内に退避するまで針452を退避させる(図14Aおよび図14B)。
ーより小さな針の利用を可能にし、生体の身体に挿入する際の痛みの発生を抑えることができる。
ー流体を、1回大容量注入する代わりに、少量を複数回、同時に生体に注射することで、局所組織損傷の発生を抑え、したがって患者の注射による痛みを低減できる。
ー流体の複数部位への注入を可能にすることで、注入された流体が生体の体内でより容易かつ迅速に拡散するので、患者により効果的な治療を提供することができる。
1.生体への筋肉内/皮下注射に適した流体注入装置1であって、ハウジング2に内蔵されるエネルギー貯蔵機構352、552を有し、該エネルギー貯蔵機構は少なくとも2つのバーストでエネルギーを提供し、第1のバーストは、前記生体の皮膚を貫通し、少なくとも1つの針454を該注射部位に挿入するのに必要なものであり、第2のバーストは、前記流体を該リザーバ602から吸い出し前記生体に注入し、任意で、前記針を前記生体から退避するのにするために必要なものである流体注入装置。
2.前記第1のバーストは第1のエネルギー源352によって提供され、前記第2のバーストは第2のエネルギー源552によって提供される、特徴セット1に記載の装置。
3.前記エネルギー貯蔵装置352、552がばねである、上記特徴セットのいずれかに記載の装置。
4.前記少なくとも1つの針452は第1の端と第2の端とを有し、使用の際に、前記少なくとも1つの針の第1の端が動く方向は患者の皮膚に平行に、前記少なくとも1つの針の第2の端が動く方向は生体の皮膚にほぼ非直交な方向になるように、ある方向にともに並進する、上記特徴セットのいずれかに記載の装置。
5.前記少なくとも1つの針は、前記少なくとも1つの針の並進方向を1つの向きから、前記患者の皮膚については通常、非直交な角度に平行にそらすマンドレルを通過する、上記特徴セットのいずれかに記載の装置。
6.前記マンドレル702は、前記針452が通過する際に前記針452を変形するのに適している、上記特徴セットに記載の装置。
7.前記マンドレル702は、前記針の弾性限界を超えて前記針を変形させるのに適しており、それにより前記装置の再利用を防ぐことのできる、上記特徴セットに記載の装置。
8.注射が作動すると前記少なくとも1つの針が貫通し拡張する前記装置内で、少なくとも1つの開口706を被覆し封止するように、前記ハウジング2に少なくとも1つの不浸透性薄膜704が貼り付けられている、上記特徴セットのいずれかに記載の装置。
9.前記装置1を操作する方法は、以下のステップを含む:
a.前記装置1を第2の装置1に1対として取り付ける場合、一度に1つの装置を使用できるように装置1を取り外すステップと、
b.前記少なくとも1つの針454が貫通できる薄膜704を用いて、カバーを必要としない場合に本装置を封止するまで、カバー4を取り外すステップと、
c.前記装置本体2を前記生体の皮膚に押圧するステップと、
d.任意で、次のステップで手動トリガを可能にする前記押しボタン14を任意の前記検出器12が解除するのに、または、代替的に、前記検出器12は前記トリガ機構200を自動で操作するのに十分になるまで前記生体の皮膚に加える圧力を大きくするステップであり、後者の場合はステップfに移るステップと、
e.前記押しボタン14を押下し、それによって、代わりに前記少なくとも1つの挿入サブアセンブリ300を解除するトリガ機構200を操作するステップと、
f.前記針注入端454が注入深さまで前記生体に挿入されるまで前記挿入サブアセンブリ300を使用する、前記少なくとも1つの針サブアセンブリ400を押下し、前記針抽出端456が前記少なくとも1つのリザーバ602の、少なくとも1つの隔壁604を貫通するステップと、
h.この位置に到達すると、前記挿入サブアセンブリ300を前記主構造102にロックするステップと、
i.前記少なくとも1つの挿入サブアセンブリ300に取り付けられている、前記少なくとも1つの針サブアセンブリ400をロックし、同時に、前記注入アセンブリ500を解除し、前記流体リザーバサブアセンブリ600を前記針サブアセンブリ400に押し出すステップと、
j.前記少なくとも1つの隔壁604を前記少なくとも1つの流体リザーバ602の底面方向に変位させ、ピストンとして作用して前記流体606を、前記針抽出端456、前記少なくとも1つの針452、前記少なくとも1つの針注入端434を介して前記生体に注入するステップと、
k.前記装置を前記生体から取り外すステップ。
10.特徴セット9に記載の方法であって、ステップkでの除去に先んじて、前記注入サブアセンブリ500が前記少なくとも1つのリザーバを空にする際に、前記少なくとも1つの針サブアセンブリ400を前記少なくとも1つの挿入サブアセンブリ300から解除し、その後開始位置に押し戻し、それによって前記針注入端454が完全に前記主構造102内に退避するまで前記少なくとも1つの針452を退避させて、露出した針が引き起こしうる害を防ぐ追加ステップを含む方法。
11.ステップhでのロックがラッチシステム(334)を利用して達成される、特徴セット1に記載の操作方法。
12.前記流体を導く前記針(452)の内部流路の少なくとも一部が、前記針の前記内部流路の別の一部(756)の直径と異なる直径を有する、上記特徴セットのいずれかに記載の装置。
13.1つのハウジング内で少なくとも2つの針が、前記生体へ前記流体を導入するのに同時に使用される、上記特徴セットのいずれかに記載の装置。
1 注入装置
2 前記注入装置の本体/ハウジング
4 カバー
12 患者の皮膚の感存在(任意)/圧安全解除機構の検出器
14 トリガボタン
16 使用可能/使用済インジケータ―装置
100 主機構
102 主構造
132 ラッチ要素
134 突起
154 ラッチ要素
200 トリガ機構
232 ラッチ要素
300 挿入サブアセンブリ
302 挿入サブアセンブリ構造
332 ラッチ要素
334 ラッチ要素
336 ラッチ解除レバー
352 挿入ばね/エネルギー源
400 針サブアセンブリ
402 針サブアセンブリ構造
452 針
454 針注入端
456 針抽出端
500 注入サブアセンブリ
502 注入サブアセンブリ構造
504 ラッチ要素
506 突起
512 中間部
514 ラッチ要素
552 注入および退避ばね/エネルギー源
600 リザーバサブアセンブリ
601 カートリッジ(標準カートリッジまたは市販品カートリッジ)
602 リザーバ本体
604 隔壁
606 流体
702 マンドレル
704 不浸透性膜
706 開口
754 内部流路の一部
756 内部流路の一部
Claims (13)
- 生体への筋肉内および/または皮下注射に適した流体注入装置(1)であって、
ハウジング(2)に内蔵されるエネルギー貯蔵機構(352、552)を有し、前記エネルギー貯蔵機構は少なくとも2つのバーストでエネルギーを提供する2つのエネルギー源を含み、第1のバーストは、前記生体の皮膚を貫通し、少なくとも1つの針(454)を注射部位に挿入するのに適した第1のエネルギー量を第1のエネルギー源から提供し、第2のバーストは、所定の粘度の流体を注入し、前記流体を、少なくとも1つのリザーバ(602)から前記生体に押し出し、前記少なくとも1つの針を前記生体から退避するのに適した第2のエネルギー量を第2のエネルギー源から提供する装置。 - 前記エネルギー貯蔵装置(352、552)は、ばねである請求項1に記載の装置。
- 前記少なくとも1つの針(452)は第1の端と第2の端とを有し、該第1の端と第2の端は、使用の際に、前記少なくとも1つの針の前記第1の端が動く方向は患者の皮膚に平行な方向に、前記少なくとも1つの針の前記第2の端が動く方向は前記患者の皮膚にほぼ非直交な方向になるように、一緒に並進しながらそれぞれの表面を指すように適合された請求項1または2に記載の装置。
- 前記少なくとも1つの針は、前記少なくとも1つの針の並進方向を、患者の皮膚に対して典型的には平行な1つの向きから、患者の皮膚に対して非直交な角度に変化させるマンドレルを通過する請求項1から3のいずれか1項に記載の装置。
- 前記マンドレル(702)は、前記針(452)が通過する際に前記針(452)を変形するように適合されている請求項4に記載の装置。
- 前記マンドレル(702)は、前記針の弾性限界を超えて前記針を変形させるように適合されており、それによって前記装置の再利用を防ぐ請求項4に記載の装置。
- 注射のための作動時に前記少なくとも1つの針が貫通し延在する前記装置内の少なくとも1つの開口(706)を被覆し封止するように、前記ハウジング(2)に少なくとも1つの不浸透性薄膜(704)が貼り付けられている請求項1~6のいずれか1項に記載の装置。
- 請求項1に記載の装置(1)を作動する方法であって、以下のステップ:
a.前記装置(1)を第2の装置(1)に対として取り付けられている場合、前記装置(1)を取り外して一度に1つの装置を使用するステップと、
b.前記少なくとも1つの針(454)が貫通できる薄膜(704)が前記装置を封止するために使用されない限り、カバー(4)を取り外し、カバーを不要とするステップと、
c.装置本体(2)を前記生体の皮膚に押圧するステップと、
d.次のステップで手動トリガを可能にする押しボタン(14)を任意の検出器(12)が解除するのに十分になるまで、または、代替的に、前記検出器(12)がトリガ機構(200)を自動的に作動させるのに十分になるまで、前記生体の皮膚に加わる圧力を任意的に大きくするステップであり、後者の場合はステップfに移るステップと、
e.前記押しボタン(14)を押下し、それによって、代わりに少なくとも1つの挿入サブアセンブリ(300)を解除する前記トリガ機構(200)を作動させるステップと、
f.針注入端(454)が注入深さで前記生体に挿入されるまで、前記挿入サブアセンブリ(300)を使用して少なくとも1つの針サブアセンブリ(400)を押下し、針抽出端(456)が少なくとも1つのリザーバ(602)の、少なくとも1つの隔壁(604)を貫通するステップと、
h.一定の位置に到達すると、前記挿入サブアセンブリ(300)を主構造(102)にロックするステップと、
i.前記少なくとも1つの挿入サブアセンブリ(300)に取り付けられている、前記少なくとも1つの針サブアセンブリ(400)をロックするのと同時に、注入アセンブリ(500)を解除し、流体リザーバサブアセンブリ(600)を前記針サブアセンブリ(400)に押し出すステップと、
j.前記少なくとも1つの隔壁(604)を前記少なくとも1つのリザーバ(602)の底面方向に変位させ、ピストンとして作用して、前記流体(606)を、前記針抽出端(456)、前記少なくとも1つの針(452)、前記少なくとも1つの針注入端(454)を介して前記生体に注入するステップと、
k.前記装置を前記生体から取り外すステップと、
を含む方法。 - 請求項8に記載の方法であって、ステップkでの除去に先んじて、前記注入サブアセンブリ(500)が前記少なくとも1つのリザーバを空にする際に、前記少なくとも1つの針サブアセンブリ(400)を前記少なくとも1つの挿入サブアセンブリ(300)から解除し、その後開始位置に押し戻し、それによって前記針注入端(454)が完全に前記主構造(102)内に退避するまで前記少なくとも1つの針(452)を退避させて、露出した針が引き起こしうる害を防ぐ追加ステップを含む方法。
- ステップhでのロックがラッチシステム(334)を利用して達成される請求項8に記載の作動の方法。
- 前記流体を導く前記針(452)の内部流路の少なくとも一部(754)が、前記針の前記内部流路の別の一部(756)の直径と異なる直径を有する請求項1~7のいずれか1項に記載の装置。
- 少なくとも2つの針が1つのハウジング内で同時に使用されて前記流体を前記生体へ導入する請求項1~7、11のいずれか1項に記載の装置。
- 本願の明細書、従属請求項、要約書(その内容は参照として組み込まれる)、および/または図面に記載のシステムおよび/または方法。
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CH323176A (de) * | 1954-06-28 | 1957-07-15 | Deare Soc | Betätigungsvorrichtung an einer medizinischen Spritze |
US4227528A (en) * | 1978-12-26 | 1980-10-14 | Wardlaw Stephen C | Automatic disposable hypodermic syringe |
WO1985005275A1 (en) * | 1984-05-12 | 1985-12-05 | Dieter Lucas | Injection syringe |
DK2609946T3 (en) * | 2003-08-12 | 2018-08-27 | Becton Dickinson Co | PLASTER-LIKE INFUSION DEVICE WITH PROTECTIVE ELEMENT |
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