JP6768501B2 - 薬物カセット、自動注入機、および自動注入機システム - Google Patents
薬物カセット、自動注入機、および自動注入機システム Download PDFInfo
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- JP6768501B2 JP6768501B2 JP2016502669A JP2016502669A JP6768501B2 JP 6768501 B2 JP6768501 B2 JP 6768501B2 JP 2016502669 A JP2016502669 A JP 2016502669A JP 2016502669 A JP2016502669 A JP 2016502669A JP 6768501 B2 JP6768501 B2 JP 6768501B2
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Description
の速度を変えるが、一方で、注入の間に速度選択スイッチ316の位置を変えることは、リアルタイムで注入の速度を変えることはない。自動注入機300は、使用者が異なる速度の薬物送達を試すことができるように、1つまたは複数の実演用カセットが設けられてもよい。開始ボタン307は、把手部305の自由端に配置され得る。ボタン307は、ボタン307に親指を置くのを最適化するための窪み307I(図2F)を備え得る。ボタン307は、ボタンを合図として光らせる照明効果を可能とする半透明な材料から製作され得る。取り出しボタン317(図2D)は、筐体302のカセット受入れ区域306に配置され得る。取り出しボタン317は、ボタン317に指を置くのを最適化するための窪み317I(図2F)を備え得る。ある実施形態では、取り出しボタン317は、注入過程の間、偶発的な入力を排除するようにプログラムされ得る自動注入機300のマイクロプロセッサ350(図2H)によって、制御され得る。
選択は、使用者が所与の薬物のための適切な運転パラメータを決定し、そしてそれらの運転パラメータを自動注入機に手入力しなければならない必要性を排除する。
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、自動注入機は、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、自動注入機システム100は、動作中の唯一のボタンがカセット扉開を開始するボタン(取り出しボタン)であり、すべての他のボタンは非作動とされている状態であり得る。これは、自動注入機システム100を、矢印502で取り出しボタンを押す単一の使用者の行為に応答するだけとさせることができ、すべての他の行為は無視され得るか、または、可能とされ得ない。自動注入機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200を扉へと挿入できる。様々な実施形態において、自動注入機300およびカセット200は、正確な配向のみで挿入を可能にし、挿入軸(z軸)周りでの配向における挿入を防止するために、図22に示すように、自動注入機300のカセット扉308における対応する長穴またはピン216と相互作用するカセット200における1つまたは複数のピン215など、正確な配向のみでカセット200の挿入を可能にする特定の構造を備え得る。カセット200は、x軸の周りの回転を防止するために、自動注入機300のカセット扉308と一致する先細りの形または他の構造を有してもよい。
自動注入機300のカセット扉308が有効なカセット200のある状態で閉じられると、自動注入機システム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。この構造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240を取り外すことである。前述したように、自動注入機システム100は、様々な実施形態において、カセットキャップ240の存在または非存在を検出でき得るし、自動注入機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存在から非存在への移行を監視もでき得る。この移行は、使用者によるカセットキャップ240の取り外しと、自動注入機システム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、自動注入機システム100によって用いられ得る。これは、注入過程に進むために、矢印518でカセットキャップ240を取り外させるか、または、矢印522で取り出しボタンを押し、カセット200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、自動注入機システム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処理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行為を実施しないことを選択する場合、自動注入機システム100は、ブロック515(スリープにおけるカセット)で同じ状態に留まり続ける。
有効なカセット200が自動注入機300に挿入されており、カセットキャップ240が取り外されており、自動注入機システム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)に自動注入機300を配置できる。前述のように、自動注入機300の様々な実施形態は、自動注入機システム100に注入場所への近接を検出させることができる皮膚センサを備え得る。そのため、自動注入機システム100は、使用者に、注入場所が検出されたときだけ注入過程へと進ませることができる。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でプログラムされ得る。これは、使用者が過程に委ねられており、ブロック528(注入準備)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240の様々な実施形態は、ひとたび取り外されるとカセット200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240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。
注入過程が完了し、自動注入機システム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200を取り外しおよび廃棄し、矢印550で自動注入機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、自動注入機システム100は、ブロック548の状態で、使用者がカセット200のある自動注入機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、自動注入機システム100は、カセット200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、自動注入機システム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機300を保管するために、使用者にカセット200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行為を実施しないことを選択する場合、自動注入機システム100は、ブロック556(扉開スリープB)で同じ状態に留まり続け得る。
TO 1275);抗IL13 mAb(CAT-354);抗IL2Ra mAb(HuMax-TAC);抗IL5受容体mAb;抗インテグリン受容体mAb(MDX-018、CNTO 95);抗IP 10潰瘍性大腸炎mAb(MDX- 1100);抗LLY抗体;BMS-66513;抗マンノース受容体/hCGβ mAb(MDX-1307);抗メソテリンdsFv-PE38共役(CAT-5001);抗PD1mAb(MDX-1106 (ONO-4538));抗PDGFRα抗体(IMC-3G3);抗TGFβ mAb(GC-1008);抗TRAIL受容体-2ヒトmAb(HGS-ETR2);抗TWEAK mAb;抗VEGFR/Flt-1 mAb;抗ZP3 mAb(HuMax-ZP3);NVS抗体#1;およびNVS抗体#2;限定されることなく、ロモソズマブ(romosozumab)、ブロソズマブ(blosozumab)、またはBPS 804(Novartis)などのスクレロスチン抗体である。同じく含まれ得るのは、リロツムマブ、ビキサロマ、トレバナニブ、ガニツマブ、コナツムマブ、モテサニブ二リン酸塩、ブロダルマブ、ビヅピプラント、パニツムマブ、デノスマブ、ロモソヅマブ、NPLATE、PROLIA、VECTIBIX、またはXGEVAなどの治療物質であり得る。また、AIに含まれ得るのは、例えば、米国特許第8,030,547号、米国特許出願第13/469,032号、WO2008/057457、WO2008/057458、WO2008/057459、WO2008/063382、WO2008/133647、WO2009/100297、WO2009/100318、WO2011/037791、WO2011/053759、WO2011/053783、WO2008/125623、WO2011/072263、WO2009/055783、WO2012/0544438、WO2010/029513、WO2011/111007、WO2010/077854、WO2012/088313、WO2012/101251、WO2012/101252,WO2012/101253、WO2012/109530、およびWO2001/031007といった、ヒトプロタンパク質転換酵素ズブチリシン/Kexin Type 9(PCSK9)を結合する
モノクローナル抗体(IgG)であり得る。
A1.注入機であって、
前記注入機の運転パラメータを制御するためのプロセッサと、
カセット識別構成(カセットID)を有するカセットを支持するための表面であって、前記カセットIDが前記カセットについての情報を含むコードを定める、表面と、
前記カセットIDで定められた前記コードを解読するように、前記カセットIDを検出して前記マイクロプロセッサへと通信するための、前記プロセッサと通信可能に連結される検出器と
を備える注入機。
A2.前記検出器が、前記カセットIDと前記検出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と前記検出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、条項A1に記載の注入機。
A3.前記接触システムが、1つまたは複数のスイッチ、2つ以上のポゴピン接続部、または、それらの任意の組み合わせを備える、条項A2に記載の注入機。
A4.前記1つまたは複数のスイッチがオフ状態およびオン状態へと切り替えられ得る、条項A3に記載の注入機。
A5.前記1つまたは複数のスイッチがオフ状態、第1のオン状態、および、少なくとも第2のオン状態へと切り替えられ得る、条項A3に記載の注入機。
A6.前記2つ以上のポゴピン接続部のうちの少なくとも2つの同時の作動が回路を閉じる、条項A3に記載の注入機。
A7.前記非接触システムが、無線周波数(RF)電磁場(EMF)を受信するためのデバイス、磁場(MF)を受信するためのデバイス、データの光学表現を読み取るためのデバイス、または、それらの任意の組み合わせを備える、条項A2に記載の注入機。
A8.注入機であって、
前記注入機の運転パラメータを制御するためのプロセッサと、
カセット識別構成(カセットID)を有するカセットを支持するための表面であって、前記カセットIDが前記カセットについての情報を含むコードを定める、表面と、
カセットとの組み合わせで、前記カセットIDで定められた前記コードを解読するように、前記カセットIDを検出して前記マイクロプロセッサへと通信するための、前記プロセッサと通信可能に連結される検出器と
を備える注入機。
B1.注入機のためのカセットであって、
筐体と、
薬物容器を直接的または間接的に保持するための、前記筐体内に移動可能に配置されるスリーブと、
前記筐体と前記スリーブとの一方と関連付けられるバネ付勢部材と、前記筐体と前記スリーブとの他方と関連付けられる、バネ付勢部材と連動するための固定部材とを備える、前記スリーブを前記筐体と連動させるための係止構成と
を備えるカセット。
B2.前記係止構成は、前記バネ付勢部材および前記固定部材を係止解除するためのカムをさらに備える、条項B1に記載のカセット。
B3.前記カムが前記バネ付勢部材と関連付けられる、条項B2に記載のカセット。
B4.前記バネ付勢部材が少なくとも1つの係止足を備え、前記固定部材が少なくとも1つの長穴を備え、前記少なくとも1つの係止足が、前記スリーブを前記筐体と連動させるために、係止位置において前記少なくとも1つの長穴と係合する、条項B1に記載のカセット。
B5.前記少なくとも1つの係止足が手部材に配置される、条項B4に記載のカセット。
B6.前記手部材が、前記手部材を付勢する少なくとも1つの可撓性のアーム部材によって、前記筐体と前記スリーブとの前記一方と連結される、条項B5に記載のカセット。
B7.前記少なくとも1つのアーム部材が、前記少なくとも1つの係止足が前記少なくとも1つの長穴から係合解除される非係止位置において、前記手部材を付勢する、条項B6に記載のカセット。
B8.前記少なくとも1つのアーム部材が、前記少なくとも1つの係止足が前記少なくとも1つの長穴と係合される前記係止位置において、前記手部材を付勢する、条項B6に記載のカセット。
B9.前記カムが前記手部材に配置される、条項B6に記載のカセット。
B10.前記カムが、前記注入機の針挿入サイクルの間に、前記注入機によって作動される、条項B2に記載のカセット。
B11.前記少なくとも1つの係止足と前記少なくとも1つの長穴とが、前記少なくとも1つの係止足が前記少なくとも1つの長穴と係合される場合に互いと係合する角度の付けられた表面を有して、前記表面の角度に依存して、その自己係止または自己係止解除を容易にする、条項B2に記載のカセット。
B12.前記係止構成が、前記バネ付勢部材が前記筐体への前記スリーブの組立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、条項B1に記載のカセット。
B13.前記第2のカムが前記手部材に配置される、条項B12に記載のカセット。
B14.前記第2のカムが前記手部材の先端の前方へと延びる、条項B13に記載のカセット。
B15.前記筐体と関連付けられる第1の部材と、前記スリーブ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、条項B1に記載のカセット。
B16.前記スリーブに配置され、注入針、および、前記注入針を覆って配置される針遮蔽体を有する薬物容器と、
概して円筒形の本体部分および前記円筒形本体部分に隣接して配置されるキー部分を備える、前記針遮蔽体を取り外すためのカセットキャップであって、前記円筒形本体部分が前記針遮蔽体と係合し、前記円筒形本体部分が、前記筐体にある開口を通じて延び、前記カセットキャップを前記筐体から引き抜いて前記針遮蔽体を取り外すために掴まれ得る部分を有する、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、前記キー部分と関連付けられる第1の部材を少なくとも有し、前記筐体が、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、条項B1からB3のいずれか一項に記載のカセット。
C1.注入機のためのカセットであって、
開口を有する筐体と、
前記筐体に配置され、注入針、および、前記注入針を覆って配置される針遮蔽体を有する薬物容器と、
概して円筒形の本体部分および前記円筒形本体部分に隣接して配置されるキー部分を備える、前記針遮蔽体を取り外すためのカセットキャップであって、前記円筒形本体部分が前記針遮蔽体と係合し、前記円筒形本体部分が、前記筐体にある開口を通じて延び、前記カセットキャップを前記筐体から引き抜いて前記針遮蔽体を取り外すために掴まれ得る部分を有する、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、前記キー部分と関連付けられる第1の部材を少なくとも有し、前記筐体が、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
を備えるカセット。
C2.前記第1の部材が第1の対のタブを備える、条項C1に記載のカセット。
C3,前記第1の対のタブが前記キー部分の側壁に配置される、条項C2に記載のカセット。
C4.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、条項C2に記載のカセット。
C5.前記第2の対のタブが前記キー部分の側壁に配置される、条項C4に記載のカセット。
C6.前記タブが前記側壁の外面から延びる、条項C5に記載のカセット。
C7.前記第1の対のタブが前記キー部分の第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部分の第2の端に隣接して配置される、条項C4に記載のカセット。
C8.前記第2の部材が一対のリブを備える、条項C1に記載のカセット。
C9.前記リブが前記筐体の側壁に配置される、条項C8に記載のカセット。
C10.前記タブの表面が前記リブの表面と係合する、条項C9に記載のカセット。
C11.前記リブが前記側壁の内面から延びる、条項C9に記載のカセット。
C12.前記筐体にある前記開口を通じて延びる前記円筒本体の前記部分が把持フランジを備える、条項C1に記載のカセット。
200 カセット
210 カセット外側筐体
210a 係止開口
210b 下壁、カセット外側筐体壁
210de 遠位端
210is 内側壁面
210pe 近位端壁
210s 側壁
210t 上壁
212 窓、開口
214 開口
214s 長穴
214sx 長穴拡張部
215 ピン
220 内側スリーブ
220b 下部分
222 近位端
222a
224 遠位端
230 係止キャップ
240 カセットキャップ
240de 遠位端
240pe 近位端
241 本体
241c 円筒形本体部分
241cf 可撓性部材
241i 内面
241k キー部分、キー
241kb 下壁
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 金属管状挿入体
247 片持ち梁バネ部材
248 突起、係止タブ
250 カバー
260 薬物容器
261 胴部
262 流体室
263 フランジ
264 押子ストッパ
265 注入針
266 針遮蔽体
267 薬物
268 駆動柱
270 アーム、タブ、キータブ
272 アーム、タブ、キータブ
274 リブ
280 ラッチ機構
280a ラッチアーム
292 片持ち梁係止アーム
292a アーム部材
292ac 組立カム
292f 係止足
292fp 近位面
292fd 遠位面
292h 手部材
292oc 開カム
292pe 先端縁、近位縁
294 係止足受け長穴
296n 鼻面
296r 遠位斜面
298n 鼻面
298r 近位斜面
300 自動注入機、注入機
301 シャーシ
301s 支持面
302 筐体
304 把手区域
305 把手部
305S 把持領域
306 カセット受入れ区域
307 開始ボタン
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 取り出しボタン
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 押子棒
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 ポゴピン接続部
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
L 長さ
P ピンスイッチ
Claims (11)
- 注入機のためのカセットであって、
筐体と、
前記カセットについての情報を含むコードを定めるカセット識別構成(カセットID)であって、前記コードが、前記注入機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、前記筐体に配置されるか、前記筐体内に埋め込まれるか、前記筐体内に収容される別体の構造体の表面もしくは内部に設けられるか、または、それらの任意の組み合わせである、カセット識別構成(カセットID)と、を備え、
前記カセットIDは、前記カセットが前記注入機内あるいは前記注入機上に置かれたとき、前記注入機の検出器の少なくとも1つの感知要素に接触するための接触システムを備え、
前記接触システムは、前記コードを提供する複数の位置を備え、前記複数の位置のそれぞれは、構造体を有するか、あるいは構造体を有しておらず、前記構造体は、2つ以上の異なる長さから選択される長さを有するタブ、2つ以上の異なる深さから選択される深さを有する窪み、あるいはその組み合わせを備え、
前記コードは、少なくとも1つの前記タブの前記長さ、あるいは少なくとも1つの前記窪みの前記深さを含む、前記構造体によって、あるいは前記構造体の欠如によって少なくとも部分的に決定される、カセット。 - 前記カセットIDが、前記カセットIDと前記注入機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1に記載のカセット。
- 前記接触システムはさらに、前記複数の位置と組み合わされた少なくとも1つの導電性ストリップを備え、かつ、
任意選択で、
(a)前記コードは、前記少なくとも1つの導電性ストリップの筐***置によって少なくとも部分的に決定され、あるいは
(b)前記複数の位置と組み合わされた前記少なくとも1つの導電性ストリップの数が、少なくとも部分的に前記コードを決定する、請求項1に記載のカセット。 - 前記構造体が、複数のタブ、複数の窪み、または、それらの組み合わせを備える、請求項3に記載のカセット。
- 前記少なくとも1つの導電性ストリップが、真っ直ぐな経路または曲がった経路を形成し、前記コードが、前記少なくとも1つ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3に記載のカセット。
- 前記非接触システムが、無線周波数(RF)を放つためのデバイス、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機の内部または表面に置かれるとき、前記注入機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2に記載のカセット。
- 薬物で治療のために充填されるか、または、あらかじめ充填される容器をさらに備える、請求項1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み、前記カセットの内容物を識別する前記情報が、容器内の薬物の量および/または薬物特性を含み、かつ、前記情報は、前記注入機が、その運転パラメータを調節もしくは選択すること、あるいは、1つまたは複数の運転プログラムを選択することを可能にする、請求項1に記載のカセット。
- 前記薬物が治療薬を含み、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)、Prolia(登録商標)、IL-17受容体Aに対する抗体、アンジオポエチン2の拮抗薬、TNF遮断薬およびTNF阻害剤から成る群から選択される一つを含む、請求項7に記載のカセット。
- 前記薬物が治療薬を含み、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7に記載のカセット。
- 前記薬物が治療薬を含み、前記治療薬が、室温において、約1センチポアズと約320センチポアズとの間の範囲である粘度を有する、請求項7に記載のカセット。
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EP2968775A4 (en) | 2017-02-08 |
TW201716095A (zh) | 2017-05-16 |
US10492990B2 (en) | 2019-12-03 |
TWI614041B (zh) | 2018-02-11 |
JP2019069165A (ja) | 2019-05-09 |
WO2014143815A2 (en) | 2014-09-18 |
US20180098914A1 (en) | 2018-04-12 |
US20210393888A1 (en) | 2021-12-23 |
CA2904661C (en) | 2022-03-15 |
TW201509462A (zh) | 2015-03-16 |
WO2014143815A3 (en) | 2015-01-15 |
TWI639449B (zh) | 2018-11-01 |
EP2968775B1 (en) | 2019-12-18 |
EP2968775A2 (en) | 2016-01-20 |
US20160120751A1 (en) | 2016-05-05 |
WO2014143815A9 (en) | 2014-11-27 |
TW201815431A (zh) | 2018-05-01 |
TW201811383A (zh) | 2018-04-01 |
EP3593839A1 (en) | 2020-01-15 |
CA2904661A1 (en) | 2014-09-18 |
TWI580452B (zh) | 2017-05-01 |
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