JP2022189966A - 自己注射器 - Google Patents
自己注射器 Download PDFInfo
- Publication number
- JP2022189966A JP2022189966A JP2022174827A JP2022174827A JP2022189966A JP 2022189966 A JP2022189966 A JP 2022189966A JP 2022174827 A JP2022174827 A JP 2022174827A JP 2022174827 A JP2022174827 A JP 2022174827A JP 2022189966 A JP2022189966 A JP 2022189966A
- Authority
- JP
- Japan
- Prior art keywords
- driver
- needle
- shuttle
- configuration
- move
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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Abstract
Description
本願は、米国特許法第119条(e)に従って、2017年5月5日に出願された米国仮特許出願第62/502,278号の利益を主張し、その全体が本明細書に参照により援用される。
本開示の態様は、添付図面に示された実施形態との関連で実施されてよい。これらの図面は、本開示の異なる態様を示し、適切な場合、異なる図で類似する構造、構成要素、材料、及び/または要素を示す参照番号は、同様に名前を付けられる。明確に示されている構造、構成要素、及び/または要素以外の構造、構成要素、及び/または要素の多様な組み合わせは、本開示の範囲内で意図され、本開示の範囲内にあることが理解される。
全体的なシステム
係る自己注射器2の例は、図1~図4に示される。自己注射器2は、組織係合(底)面4を有する筐体3を含んでよく、針は、該組織係合面を通して展開され、開口部6(図2)を介して格納されてよい。起動スイッチ1409(図2)は、組織係合面4上に配置されてよく、自己注射器2を起動する、またはそれ以外の場合自己注射器2を「準備完了」モードに入れるように構成されてよい。また、タッチセンサ1410(図2)は、組織係合面4に配置されてよく、自己注射器2のコントローラが、自己注射器2が(自己注射器が針を発射またはそれ以外の場合展開すべきであることを示す)ユーザーの皮膚上に配置されるかどうか、または(自己注射器2の動作が停止されるべきであることを示す)起動スイッチ1409が適切にトリガされたのかどうかを判断するのに役立つように構成されてよい。起動スイッチ1409及びタッチセンサ1410は、図4Aに関して以下にさらに詳細に説明される。また、接続ポート13は、自己注射器2のプログラミングを容易にするために組織係合面4に配置されてもよい。筐体3は、見る人が、筐体3の中に配置された1つ以上のディスプレイまたはLED52(図4Bを参照)を視覚化できるようにするために透明なウィンドウ50を含んでよく、(例えば、スピーカによって)筐体3の中で生成される音の移動を容易にするように構成された複数の開口部51を含んでもよい。LED52は、環状の構成でまたは他の適切な構成で配置されてよい。自己注射器2は、携帯性及びユーザーによるセルフアタッチメント(self-attachment)を可能にするために適した任意の適切な寸法を有してよい。一例では、自己注射器2は、約2.98インチの長さ、約2.07インチの幅、及び約1.07インチの高さを有する場合がある。しかしながら、例えば約0.5インチから約5.0インチの長さ、約0.5インチから約3.0インチの幅、及び0.5インチから約2.0インチの高さを含んだ他の適切な値も利用されてよい。
図5~図11を参照すると、針機構20は、第1の位置(図6)と第2の位置(図7)との間で筐体3の中で移動可能(例えば、摺動可能)であるキャリヤ202を含む。また、針機構20は、キャリヤ202に取り付けられ、ユーザーの中に展開されてよく、ドライバ320によって格納される流体管300を含んでもよい。シャトル340(例えば、シャトルアクチュエータ)は、展開ギヤ360及び格納ギヤ362を介してドライバ320を移動させるように構成されてよい。シャトル340は、弾性部材(例えば、バネ370)に結合されてよい。カバー380(図5)は、針機構20の多様な構成要素を封入するためにキャリヤ202に結合されてよい。
穿孔システム及び滅菌コネクタ
図13及び図14は、自己注射器2の穿孔システム1300の特徴を示す。例示的な穿孔システムの追加の詳細は、2016年9月15日に公開されたArnottらに対する米国特許出願公開第2016/0262984 A1号に記載される場合があり、参照によりその全体が本明細書に援用される。穿孔システム1300は、一次容器、チャンバ、注射器、カートリッジ、または第1の端部1304及び第2の端部1306を有するバイアル1302を含む。また、バイアル1302は、第1の端部1304で開かれ、第2の端部1306に向かって伸長する空洞1308を含んでもよい。第2の端部1306は、ネック1310に係合して、第2の端部1306を閉じるキャップ1312を有するネック1310を含んでよい。隔壁1314は、第2の端部1306を閉じることを支援し、針308(例えば、刺された(staked)針)をバイアル1302の中に挿入できるようにするためにバイアル1302とキャップ1312との間に配置されてよい。空洞1308は、ピストン1316によって第1の端部1304で閉じられてよい。
滅菌針シールド
図24及び図25を参照して、自己注射器2は、針306の無菌性を維持するのを助けるように構成される針カバーまたは針シールド2400を含んでよい。針シールド2400は、第1の端部2402から第2の端部2404に延在してよい。フランジ2406は、第1の端部2402に配置されてよく、管状伸長部2408は、フランジ2406を第2の端部2404に向かって伸長してよい。針シールド2400は、伸長部2408を通して伸長するルーメン2412と連絡し得るフランジ2406を通る開口部2410を含んでよい。シール2414は、ルーメン2412の中の第2の端部2404に配置されてよい。シール2414は、ルーメン2412の残りと通信する開口部2416を画定してよい。シール2414は、狭窄部分2414a、中間部2414b、及び内側シーリング部分2414cを含んでよい。中間部2414bは、狭窄部分2414aと内側シーリング部分2414cとの間に配置されてよく、3つの構成要素のうち、狭窄部分2414aは第2の端部2404に最も近く配置されてよい。中間部2414bは、狭窄部分2414aよりも大きい内径を有してよく、狭窄部分2414aは、内側シーリングゾーン2414cよりも大きい内径を有する場合がある。また、針シールド2400は、フランジ2406内の開口部2410を覆う膜2418を含んでもよい。膜2418は、例えば高密度ポリエチレン繊維膜等の液体を通さないガス透過性材料から形成されてよい。一例では、膜2418は、Tyvek(登録商標)ブランド材料であってよい。膜2418は、シール2414を無菌に保つのに役立つ場合があり、これによりシール2414は、針シールド2400が筐体3から切り離されるとき針306を汚染しない。
電子機器
図4Aは、自己注射器2の制御システム1400を示す。制御システム1400は、第1の電子ボード1402及び第2の電子ボード1404に配置された構成要素を含んでよく、電源1406を含んでもよい。第1の電子ボード1402は、コントローラ1408、起動スイッチ1409、タッチセンサ1410、針挿入スイッチ1412、及びエミッタ1414を含んでよい。第2の電子ボード1404は、検出器1416、音声モジュール1418、視覚モジュール1420、及び触覚モジュール1422を含んでよい。第1の電子ボード1402及び第2の電子ボード1404の構成要素の1つ以上は、コントローラ1408に動作可能なように結合されてよく、電源1406によって電力を供給されてよい。また、コントローラ1408は、並進機構1366に動作可能なように結合されてよく、上述したように、針の挿入及び格納を開始し、制御するために並進機構1366の動作を制御するように構成されてよい。並進機構1366は、バイアル1302が筐体3の中に挿入される最終アセンブリステップの間に1つ以上のバネ接点を介して第1の電子ボード1404に結合されてよい。
代替実施形態
針機構の別の実施形態は、図17~図19に示される。針機構2400は、基部2402及びシャトル2420を含んでよい。基部2402は、基部2402の上面から離れて伸長する伸長部材2404を有してよい。また、基部2402は、(軸40に平行な)基部2402の長手方向軸に沿って伸長し、基部2402の上面の中の奥まったところに置かれたチャネル2406を含んでもよい。チャネル2406は、基部2402の第1の壁2407及び第2の壁2408を通って伸長し、伸長部材2404を通して伸長してもよい。伸長部材2404は、例えば、伸長部材2404の上部から基部2402の一部分を通って基部2402の底面に向かって延在する長穴2410を含んでよい。長穴2410は、概してチャネル2406に垂直に配置され、軸44に平行に伸長してよい。基部2402は、ピン2412及び第2のピン2414をさらに含んでよい。
Claims (15)
- 注入装置であって、
キャリヤと、
針と、
前記針に結合されたドライバであって、格納構成と展開構成との間で前記キャリヤに対して摺動可能である前記ドライバと、
前記格納構成と前記展開構成との間で前記ドライバを移動させるように、第1の方向において移動するよう構成されたシャトルと、
前記シャトルに結合された弾性部材と、
止め具であって、前記展開構成で前記ドライバを維持するように、前記第1の方向における前記シャトルの移動を妨害する第1の構成から、前記弾性部材の変形により前記シャトルを前記第1の方向においてさらに移動させることを許容し、前記ドライバを移動させて前記針を格納することを可能にする第2の構成へ移動するように構成された、前記止め具と、
前記キャリヤ及び前記ドライバに結合された1つまたは複数の駆動ギヤとを備え、
前記シャトルは、前記1つまたは複数の駆動ギヤに係合するように構成された1つまたは複数のラックギヤを含み、
前記1つまたは複数のラックギヤの前記1つまたは複数の駆動ギヤとの直接的な係合により、前記ドライバを前記格納構成から前記展開構成に移動させ、前記1つまたは複数のラックギヤの前記1つまたは複数の駆動ギヤとの直接的な係合により、前記ドライバを移動させて前記針を格納する、注入装置。 - 前記シャトルが第1の位置から第2の位置へ、及び前記第2の位置から第3の位置へ移動可能であり、
前記シャトルが前記第1の位置にあるとき、前記ドライバが前記格納構成にあり、
前記シャトルが前記第2の位置にあるとき、前記ドライバが前記展開構成にあり、
前記シャトルが前記第3の位置にあるとき、前記針が格納されている、
請求項1に記載の注入装置。 - 前記第1の位置と前記第3の位置が異なる、請求項2に記載の注入装置。
- 前記シャトルが、前記第1の位置から前記第2の位置に、及び前記第2の位置から前記第3の位置に移動するために、軸に沿った一方向で移動する、請求項3に記載の注入装置。
- 前記シャトルが、前記一方向にのみ移動するように構成される、請求項4に記載の注入装置。
- 前記シャトルが、第1の軸に沿って移動するように構成され、前記ドライバが第2の軸に沿って移動するように構成され、前記第1の軸及び前記第2の軸が互いに垂直である、請求項1に記載の注入装置。
- 障害物をさらに含み、起動前、前記ドライバが前記障害物と接触し、前記障害物によって前記ドライバが前記格納構成から動き出すことが妨げられる、請求項1に記載の注入装置。
- 前記キャリヤを封入する筐体をさらに含み、前記障害物が前記筐体と一体である、請求項7に記載の注入装置。
- 前記障害物に対する前記キャリヤの移動により、前記ドライバが前記障害物と接触しないように移動し、前記ドライバが、前記格納構成から前記展開構成に移動できるようにする、請求項8に記載の注入装置。
- 前記ドライバが前記障害物と接触しないように移動した後、前記弾性部材は、第1の圧縮状態から第2の圧縮状態に伸長して、前記シャトルを第1の位置から第2の位置に移動させるように構成される、請求項9に記載の注入装置。
- 前記止め具が前記第1の構成から前記第2の構成に移動された後、前記弾性部材が、前記第2の圧縮状態から休止状態に伸長して、前記シャトルを前記第2の位置から第3の位置に移動させるように構成される、請求項10に記載の注入装置。
- 前記1つまたは複数の駆動ギヤは、第1の駆動ギヤ及び第2の駆動ギヤを含み、
前記第1の駆動ギヤは、前記ドライバを前記格納構成から前記展開構成に移動させるように構成され、
前記第2の駆動ギヤは、前記ドライバを移動させて前記針を格納するように構成されている、請求項1に記載の注入装置。 - 前記1つまたは複数のラックギヤは、第1のラックギヤを含み、前記第1のラックギヤは、前記第1の駆動ギヤ及び前記第2の駆動ギヤの各々に係合するように構成されている、請求項12に記載の注入装置。
- 前記ドライバは、第1のドライバラックギヤ及び第2のドライバラックギヤを含み、
前記第1の駆動ギヤは前記第1のドライバラックギヤに係合するように構成されるとともに、前記第2の駆動ギヤは前記第2のドライバラックギヤに係合するように構成されている、請求項12に記載の注入装置。 - 前記第1の駆動ギヤ及び前記第2の駆動ギヤは、互いに反対方向に回転するように構成されている、請求項14に記載の注入装置。
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