JP2016515406A - 薬物カセット、自動注入器、および自動注入器システム - Google Patents
薬物カセット、自動注入器、および自動注入器システム Download PDFInfo
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Abstract
Description
状態1:タブがない
状態2:低いタブがある
状態3:高いタブがある
カセット識別構成410が、例えば、各々のこのようなタブ410tが低いかまたは高い、3つまでのタブ410tを備える場合、自動注入器は、可能なコードの数を増加するために、27通りまでの異なるタブ状態を検出できることになる。
ブロック500(オフ、扉閉、カセットなし)では、使用の前、自動注入器システム100は、作動中の唯一のボタンがカセット扉開放を開始するボタン(イジェクトボタン)であり、すべての他のボタンは作動停止とされている状態であり得る。これは、自動注入器システム100を、矢印502でイジェクトボタンを押す単一の使用者の動作に応答するだけとさせることができ、すべての他の動作は無視され得るか、または、可能とされ得ない。自動注入器300のカセット扉308がブロック504で開くと、使用者はカセット600を扉内へと挿入できる。様々な実施形態において、自動注入器300およびカセット600は、正確な向きのみで挿入を可能にし、挿入軸(z軸)周りでの向きにおける挿入を防止するために、図22に示すように、自動注入器300のカセット扉308における対応するスロットまたはピン216と相互作用するカセット600上における1つ以上のピン615など、正確な向きのみでカセット600の挿入を可能にする特定の構造を備え得る。カセット600は、x軸周りの回転を防止するために、自動注入器300のカセット扉308と一致する先細りの形状または他の構造を有してもよい。
自動注入器300のカセット扉308が有効なカセット600のある状態で閉じられると、自動注入器システム100は、ブロック514(デバイス起動)において作動状態へと移り得る。この形態における使用者による次のステップは、矢印518でカセットキャップ640を取り外すことである。前述したように、自動注入器システム100は、様々な実施形態において、カセットキャップ640の有無を検出でき得るし、自動注入器300に設けられ得るカセットキャップ取り外しスイッチの状態において有から無への移行をモニターすることもでき得る。この移行は、使用者によるカセットキャップ640の取り外しと、自動注入器システム100をブロック520の状態(キャップなし)へと移すことと、を検出するために、自動注入器システム100によって用いられ得る。これは、注入プロセスに進むために、矢印518でカセットキャップ640を取り外させるか、または、矢印522でイジェクトボタンを押し、カセット600を取り外すことができるようにブロック524(扉を開けるA)で扉を開け、自動注入器システム100をブロック506(扉が閉じるのを待機A)で最後の既知の状態に戻すことによってプロセスを中断するかのいずれかを、使用者に強制することができる。使用者が必要とされる動作を実施しないことを選択する場合、自動注入器システム100は、ブロック515(スリープのカセット)で同じ状態に留まり続ける。
有効なカセット600が自動注入器300に挿入されており、カセットキャップ640が取り外されており、自動注入器システム100がブロック520(キャップなし)の状態にある場合、使用者は、矢印526において、注入場所(皮膚)に自動注入器300を配置できる。前述のように、自動注入器300の様々な実施形態は、自動注入器システム100が注入場所への近接を検出することができる皮膚センサを備え得る。そのため、自動注入器システム100は、使用者が、注入場所が検出されたときだけ注入プロセスへと進むことを可能にする。前述のように、マイクロプロセッサは、皮膚センサからの連続した肯定的な信号を検出するときのみ、注入場所の存在を指示させることができる命令をプログラムされ得る。これは、使用者がプロセスに委ねられており、ブロック528(注入準備完了)の状態へと移るために、注入場所と安定して接触していることを確実にする。前述のように、カセットキャップ640の様々な実施形態は、ひとたび取り外されるとカセット600に再び挿入させることができない構造を有することができ、それによって、使用者がカセットキャップ640を再び挿入し、ブロック514(デバイス起動)の前の状態へと戻すように移すのを防止している。
注入プロセスが完了し、自動注入器システム100がブロック548(扉が閉じるのを待機B)の状態になると、使用者は、使用済みカセット600を取り外しおよび廃棄し、矢印550で自動注入器300のカセット扉308を閉じると考えられる。使用者にこれを行わせるために、自動注入器システム100の論理は、ブロック548の状態で、使用者がカセット600のある自動注入器300のカセット扉308を閉じることができないように構成され得る。扉を閉じることが矢印552で試みられる場合、自動注入器システム100は、カセット600を検出でき、ブロック554で扉をすぐに再び開けることができる。これは、自動注入器システム100がブロック550(オフ)の状態に移り、将来の使用のために自動注入器300を保管するために、使用者にカセット600のない状態でカセット扉308を閉じさせることができる。使用者が必要とされる動作を実施しないことを選択する場合、自動注入器システム100は、ブロック556(扉開放スリープB)で同じ状態に留まり続け得る。
240de 遠位端
240pe 近位端
241 本体
241c 円筒状本体部分
241cf 可撓性部材
241i 内面
241k キー部分、キー
241kb 底壁
241kde 遠位端
241ke 端壁
241kpe 近位端
241ks 停止部
241ksw 外側壁面
242 先細り部分
243 目印
244 フランジ、把持部材
245 カラー構造
245t 舌部
246 金属管状インサート
247 片持ち梁バネ部材
248 突起、ロックタブ
260 注射器
270 アーム、タブ、キータブ
272 アーム、タブ、キータブ
300 自動注入器、注入器
301 シャーシ
301s 支持面
302 ケーシング
304 把手区域
305 把手部
305S 把持領域
306 カセット受容区域
307 スタートボタン
307I 窪み
308 カセット扉
308A 開口
310A 窓
310B 窓
312 ユーザーインターフェース
315 設定/ミュートスイッチ
316 速度選択スイッチ
317 イジェクトボタン
317I 窪み
318 近位端壁
320 目標ライト
330 電動式針挿入駆動部
331 挿入駆動モータ
332 挿入ラック
332d 遠位タブ
332p 近位タブ
333 挿入駆動歯車列
340 電動式薬物押出駆動部
341 押出駆動モータ
342 押子ロッド
343 送りネジ
344 押出駆動歯車列
350 マイクロプロセッサ
360 電池
370 検出器
372 押しボタンスイッチ
374n スイッチ
374p ピン
376 ポゴピンコネクタ
380 皮膚センサ
410 カセット識別構成
410i 窪み
410m 磁石
410o 光学機械読取可能(OMR)識別子、OMR識別子ラベル
410rf 無線周波数(RF)電磁場(EMF)放射デバイス
410s 導電性トレース、導電性ストリップ
410t 突起、タブ
600 カセット
610 カセット外側ハウジング
610a ロック開口
610b 底壁、カセット外側ハウジング壁
610is 内側壁面
610s 側壁
610de 遠位端
610pe 近位端壁
610t 頂壁
612 窓、開口
614 開口
614s スロット
614sx スロット延長部
615 ピン
620 内蔵カセット注射器、ICS
620b 底部
622 近位端
624 遠位端
640 遮蔽体除去部、カセットキャップ
650 カバー
661 本体
662 流体チャンバ
664 押子、押子ストッパ
665 注入針
667 針遮蔽体、薬物
668 駆動柱
674 リブ
680 ラッチ機構
680a ラッチアーム
680b スロット
690 ICSロック構成
692 片持ち梁ロックアーム
692a アーム部材
692ac 組立カム
692f ロック脚
692fp 近位面
692fd 遠位面
692h ハンド部材
692oc 開カム
692pe 先端縁、近位縁
694 ロック脚受容スロット 696n ノーズ面
696r 遠位斜面
698n ノーズ面
698r 近位斜面
L 長さ
P ピンスイッチ
Claims (77)
- 注入器のためのカセットであって、
ハウジングと、
薬物を収容するための流体チャンバ、および、前記流体チャンバと流体連通している注入針を有し、前記ハウジング内において、近位位置と遠位位置との間で移動可能である本体部材と、
を備えるカセット。 - 前記注入針が前記本体部材の近位端に配置される、請求項1に記載のカセット。
- 薬物を前記流体チャンバから前記注入針を通じて投与するために、前記流体チャンバのための押子ストッパをさらに備える、請求項1または2に記載のカセット。
- 前記本体部材が、前記注入器を前記押子ストッパと相互作用させることを可能にするための開放遠位端を有する、請求項3に記載のカセット。
- 前記本体部材が、前記注入器を前記本体部材と相互作用させることを可能にするための駆動柱を有する、請求項1または2に記載のカセット。
- 前記本体部材を前記ハウジングと連動させるためのロック構成をさらに備え、前記ロック構成が、前記ハウジングと前記本体部材との一方と関連付けられるバネ付勢部材と、前記ハウジングと前記本体部材との他方と関連付けられる、前記バネ付勢部材と連動するための固定部材と、を備える、請求項1または2に記載のカセット。
- 前記ロック構成は、前記バネ付勢部材および前記固定部材をロック解除するためのカムをさらに備える、請求項6に記載のカセット。
- 前記カムが前記バネ付勢部材と関連付けられる、請求項7に記載のカセット。
- 前記バネ付勢部材が少なくとも1つのロック脚を備え、前記固定部材が少なくとも1つのスロットを備え、前記少なくとも1つのロック脚が、前記本体部材を前記ハウジングと連動させるために、ロック位置において前記少なくとも1つのスロットと係合する、請求項6に記載のカセット。
- 前記少なくとも1つのロック脚がハンド部材に配置される、請求項9に記載のカセット。
- 前記ハンド部材が、前記ハンド部材を付勢する少なくとも1つの可撓性アーム部材によって、前記ハウジングと前記本体部材との前記一方と連結される、請求項10に記載のカセット。
- 前記少なくとも1つのアーム部材が、前記少なくとも1つのロック脚が前記少なくとも1つのスロットから係合解除されるロック解除位置において、前記ハンド部材を付勢する、請求項11に記載のカセット。
- 前記少なくとも1つのアーム部材が、前記少なくとも1つのロック脚が前記少なくとも1つのスロットと係合される前記ロック位置において、前記ハンド部材を付勢する、請求項11に記載のカセット。
- 前記カムが前記ハンド部材上に配置される、請求項11に記載のカセット。
- 前記カムが、前記注入器の針挿入サイクルの間に、前記注入器によって作動される、請求項7に記載のカセット。
- 前記少なくとも1つのロック脚と前記少なくとも1つのスロットとが、前記少なくとも1つのロック脚が前記少なくとも1つのスロットと係合される場合に互いに係合する角度の付けられた表面を有して、前記表面の角度に応じて、その自己ロックまたは自己ロック解除を容易にする、請求項7に記載のカセット。
- 前記ロック構成が、前記バネ付勢部材が前記ハウジングへの前記本体部材の組付と干渉するのを防止するための第2のカムをさらに備える、請求項6に記載のカセット。
- 前記第2のカムが前記ハンド部材上に配置される、請求項17に記載のカセット。
- 前記第2のカムが前記ハンド部材の先端の前方へと延びる、請求項18に記載のカセット。
- 前記ハウジングと関連付けられる第1の部材と、前記本体部材と関連付けられる第2の部材と、を備えるラッチ機構をさらに備える、請求項6に記載のカセット。
- 前記注入針を覆って配置される針遮蔽体と、
第1の本体部分および第2の本体部分を備える、前記針遮蔽体を除去するためのカセットキャップであって、前記第1の本体部分が前記針遮蔽体と係合し、前記第1の本体部分が、前記ハウジングにある前記開口を通じて延び、前記カセットキャップを前記ハウジングから引き抜いて前記針遮蔽体を除去するために掴まれ得る端を規定し、前記第2の本体部分がキーを規定する、カセットキャップと、
前記カセットキャップの曲げまたは屈曲を防止するための曲げ防止構造であって、前記カセットキャップが、前記キーと関連付けられる第1の部材を少なくとも有し、前記ハウジングが、前記第1の部材と相互作用するための第2の部材を少なくとも有する、曲げ防止構造と
をさらに備える、請求項1または2に記載のカセット。 - 前記第1の部材が第1の対のタブを備える、請求項21に記載のカセット。
- 前記第1の対のタブが前記キーの側壁上に配置される、請求項22に記載のカセット。
- 前記第1の部材が、前記第1の対のタブから離間される第2の対のタブをさらに備える、請求項22に記載のカセット。
- 前記第2の対のタブが前記キーの側壁上に配置される、請求項24に記載のカセット。
- 前記第1及び第2のタブが前記側壁の外面から延びる、請求項25に記載のカセット。
- 前記第1の対のタブが前記キーの第1の端に隣接して配置され、前記第2の対のタブが前記キーの第2の端に隣接して配置される、請求項24に記載のカセット。
- 前記第2の部材が一対のリブを備える、請求項21に記載のカセット。
- 前記リブが前記ハウジングの側壁上に配置される、請求項28に記載のカセット。
- 前記第1及び第2のタブの上面が前記リブの下面と係合する、請求項29に記載のカセット。
- 前記リブが前記側壁の内面から延びる、請求項29に記載のカセット。
- 前記第1の本体部分の端が把持フランジを備える、請求項21に記載のカセット。
- 前記カセットについての情報を含むコードを規定するカセット識別構成(カセットID)をさらに備え、前記コードが、前記注入器によって検出可能および解読可能であり、前記カセットIDが、前記ハウジング上に配置されるか、前記ハウジング内に埋め込まれるか、前記ハウジング内に収容される別体の構造体上もしくは構造体内に設けられるか、または、それらの任意の組み合わせである、請求項1または2に記載のカセット。
- 前記カセットIDが、前記カセットIDと前記注入器との間の接触を必要とする接触システム、前記カセットIDと前記注入器との間の接触を必要としない非接触システム、または、それらの任意の組み合わせを備える、請求項33に記載のカセット。
- 前記接触システムは、前記カセットが前記注入器内または前記注入器上に置かれるときに前記注入器の検出器の1つ以上の感知要素に接触するための、1つ以上のタブ、1つ以上の窪み、1つ以上の導電性ストリップ、または、それらの任意の組み合わせを備える、請求項34に記載のカセット。
- 前記コードが、前記1つ以上のタブ、窪み、導電性ストリップ、または、それらの任意の組み合わせのうちの1つまたは複数がないことによって、少なくとも部分的に決定される、請求項35に記載のカセット。
- 前記1つ以上のタブ、窪み、導電性ストリップ、または、それらの任意の組み合わせが、様々なハウジング位置に設けられ、前記コードが、前記1つ以上のタブ、窪み、導電性ストリップ、または、それらの任意の組み合わせの前記様々なハウジング位置によって、少なくとも部分的に決定される、請求項35に記載のカセット。
- 前記1つ以上のタブ、窪み、導電性ストリップ、または、それらの任意の組み合わせの数が、前記コードを少なくとも部分的に決定する、請求項35に記載のカセット。
- 前記1つ以上の導電性ストリップの各々が、真っ直ぐな経路または曲がった経路を規定し、前記コードが、前記1つ以上の導電性ストリップの各々の前記経路によって少なくとも部分的に決定される、請求項35に記載のカセット。
- 前記1つ以上のタブの各々が、2つ以上の異なる長さから選択される長さを有し、前記コードが、前記1つ以上のタブの前記長さによって少なくとも部分的に決定される、請求項35に記載のカセット。
- 前記1つ以上の窪みの各々が、2つ以上の異なる深さから選択される深さを有し、前記コードが、前記1つ以上の窪みの前記深さによって少なくとも部分的に決定される、請求項35に記載のカセット。
- 前記非接触システムが、無線周波数(RF)電磁場(EMF)を放つためのデバイス、磁場(MF)を放つためのデバイス、機械読み取りが可能なデータの光学表現(ORD)を放つためのデバイス、または、それらの任意の組み合わせを備え、前記RF EMF、MF、ORD、または、それらの任意の組み合わせは、前記カセットが前記注入器内または前記注入器上に置かれるとき、前記注入器の検出器によって感知され、前記コードが、前記RF EMF、MF、ORD、または、それらの任意の組み合わせによって少なくとも部分的に決定される、請求項34に記載のカセット。
- 前記カセットが練習用カセットを含む、請求項33に記載のカセット。
- 前記カセットが薬物用カセットを含む、請求項33に記載のカセット。
- 前記本体部材の前記流体チャンバが薬物で充填される、請求項44に記載のカセット。
- 前記カセットが1回限りの使用のカセットを含む、請求項44に記載のカセット。
- 前記情報が、カセットの種類を識別する情報、前記カセットの内容物を識別する情報、前記カセットがOEMカセットであるかどうかを識別する情報、前記カセットについての製造データを識別する情報、または、それらの任意の組み合わせを含む、請求項33に記載のカセット。
- 前記カセットの内容物を識別する前記情報が、前記本体部材における薬物の量と、薬物特性と、を含む、請求項47に記載のカセット。
- 前記薬物特性が薬物の粘度を含む、請求項48に記載のカセット。
- 前記情報が、前記注入器に、その運転パラメータを調節もしくは選択させるか、または、1つ以上の運転プログラムを選択させることができる、請求項47に記載のカセット。
- 前記運転パラメータが、注入速度、針挿入速度、注入前および注入後の待機時間、針挿入深さ、温度制限、または、それらの任意の組み合わせを含む、請求項50に記載のカセット。
- 前記薬物が治療薬を含む、請求項45に記載のカセット。
- 前記治療薬が、Epogen(登録商標)、Aranesp(登録商標)、Enbrel(登録商標)、Neulasta(登録商標)、Neupogen(登録商標)、Nplate(登録商標)、Vectibix(登録商標)、Sensipar(登録商標)、Xgeva(登録商標)、およびProlia(登録商標)から成る群から選択される、請求項52に記載のカセット。
- 前記治療薬がIL−17受容体Aに対する抗体である、請求項52に記載のカセット。
- 前記治療薬がアンジオポエチン2の拮抗薬である、請求項52に記載のカセット。
- 前記治療薬がTNF遮断薬またはTNF阻害剤である、請求項52に記載のカセット。
- 前記TNF遮断薬または前記TNF阻害剤がエタネルセプトである、請求項56に記載のカセット。
- 前記TNF遮断薬または前記TNF阻害剤がアダリムマブ、セルトリズマブ、ゴリムマブ、またはインフリキシマブである、請求項56に記載のカセット。
- 前記治療薬が、室温において、約19センチポアズの粘度を有する、請求項52に記載のカセット。
- 前記治療薬が、室温において、約1センチポアズから約320センチポアズの間の範囲である粘度を有する、請求項52に記載のカセット。
- 前記治療薬が、室温において、約5センチポアズから約40センチポアズの間の範囲である粘度を有する、請求項52に記載のカセット。
- 前記治療薬が、室温において、約10センチポアズから約35センチポアズの間の範囲である粘度を有する、請求項52に記載のカセット。
- 前記治療薬が、室温において、約15センチポアズから約30センチポアズの間の範囲である粘度を有する、請求項52に記載のカセット。
- 前記治療薬が、室温において、約20センチポアズから約25センチポアズの間の範囲である粘度を有する、請求項52に記載のカセット。
- 前記治療薬が、室温において、約16センチポアズから約42センチポアズの間の範囲である粘度を有する、請求項52に記載のカセット。
- 前記治療薬が、室温において、約1センチポアズから約29センチポアズの間の範囲である粘度を有する、請求項52に記載のカセット。
- 自動注入器装置が自動注入器とカセットとを有し、薬物が、注入針と前記注入針を覆う針遮蔽体とを有する本体部材の流体チャンバ内に収容され、前記本体部材が前記カセットに配置され、前記カセットには、前記針を取り外すためのカセットキャップが設けられる、前記自動注入器装置で前記薬物を患者へと注入する方法であって、
前記注入器の第1の扉開放状態を手動で作動するステップと、
コンピュータ処理で、前記第1の扉開放状態を作動することに応答して、前記注入器のすべての他の運転状態を作動停止するステップと、
コンピュータ処理で、前記注入器内への前記カセットの有効なものの適切な挿入の後のみ、前記注入器をデバイスオン状態にするステップと、
コンピュータ処理で、前記カセットからの前記カセットキャップの取り外しの後のみ、前記注入器をキャップなし状態にするステップと、
コンピュータ処理で、前記注入器が注入場所において皮膚との安定した接触に置かれた後のみ、前記注入器を注入準備完了状態にするステップと、
コンピュータ処理で、前記注入器の手動作動の後、前記注入器を注入処理状態にするステップと、
コンピュータ処理で、前記注入器の扉を開け、前記カセットが前記注入器から取り外されるまで、前記扉を前記開放状態に、且つ、前記注入器を前記デバイスオン状態に、維持するステップと、
を含む方法。 - 前記カセットの前記有効なものが未使用のカセットを含む、請求項67に記載の方法。
- 前記デバイスオン状態が、前記カセットからの前記カセットキャップの取り外しを許容し、前記注入器からの前記カセットの取り外しを許容する第2の手動作動扉開放状態を除いて、前記注入器のすべての他の運転状態を作動停止する、請求項67に記載の方法。
- 前記キャップなし状態が、前記注入器からの前記カセットの取り外しを許容する第2の手動作動扉開放状態を除いて、前記注入器のすべての他の運転状態を作動停止する、請求項67に記載の方法。
- 前記注入器への前記カセットの前記有効なものの前記適切な挿入が、前記カセットを、正しい向きのみで前記注入器へと挿入することができるように、前記注入器における第2の部材と相互作用する第1の部材を前記カセットに設けることで実施される、請求項67に記載の方法。
- 前記注入器における前記第2の部材は前記注入器の前記扉上に配置される、請求項71に記載の方法。
- 前記第1の部材が、前記カセットのハウジング上においてピンを備え、前記第2の部材が、前記注入器の前記扉においてスロットを備える、請求項72に記載の方法。
- 前記第1の部材が、前記カセットのハウジングの形状を少なくとも備え、前記第2の部材が、前記カセットの前記ハウジングの形状と一致する前記扉の形状を少なくとも備える、請求項72に記載の方法。
- 治療を必要としている患者を治療する方法であって、
薬物を収容するカセットを提供するステップと、
注入器を用いて前記薬物を前記患者へと投与するステップと、
を含み、
前記カセットが、請求項1から66のカセットのいずれかを備える方法。 - 前記カセットを、前記薬物を投与する前に、前記注入器内へと挿入するステップをさらに含む、請求項75に記載の方法。
- 前記カセットが使い捨ての1回限りの使用のカセットである、請求項1または2に記載のカセット。
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