JP2013512060A - 二つ又はそれ以上の薬剤の送達のためのデバイス及び方法 - Google Patents
二つ又はそれ以上の薬剤の送達のためのデバイス及び方法 Download PDFInfo
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Abstract
【選択図】図1B
Description
2.両端が相似したニードルアセンブリのような用量ディスペンサを、投与インターフェースの遠位端に取り付ける。このようにして、ニードルアセンブリの近位端が一次的な化合物及び二次的な化合物の両方と流体連通している。
3.例えば、グラフィカルユーザーインターフェース(GUI)を介して、注射デバイスから一次的な化合物の望みの用量をダイアルして増し/設定する。
4.一次的な化合物の用量を使用者が設定した後、マイクロプロセッサに制御される制御ユニットによって二次的な化合物の用量が決定され又は計算され、そして、好ましくは、前に保存された治療用量プロファイルに基づいて、この第二の用量が決定され又は計算される。薬物送達デバイスが第三の薬剤を含む場合、マイクロプロセッサに制御される制御ユニットによって、同じ又は異なる治療用量プロファイルに基づいて、第三の薬剤の用量が計算される。次いで使用者によって注射されるであろうものは、この計算された薬剤の組合せである。
5.場合により、二次的な用量が計算された後、デバイスは装着された状態に置かれ得る。そのような場合による装着された状態において、これは制御パネル上の「OK」ボタンを押す及び/又は掴むことによって達成され得る。この状態は、組み合わされた用量を投与するためにデバイスが使用され得る前に、事前に定義された期間より長く供され得る。
6.次いで、使用者は用量ディスペンサ(例えば、両端が相似したニードルアセンブリ)の遠位端を望みの注射部位に挿入または適用するであろう。一次的な化合物及び二次的な化合物及び潜在的には第三の化合物)の組合せの用量は、注射使用者インターフェース(例えば、注射ボタン)を作動させることによって投入される。
を更に含む。
第一の用量設定ボタン62、
第二の用量設定ボタン64、及び
OK又はENTERボタン66。
a、主外部本体210、
b、第一の内部ボディ220、
c、第二の内部ボディ230、
d、第一の穿孔針240、
e、第二の穿孔針250、
f、バルブシール260、及び
g、セプタム270。
a、投与インターフェース200が薬物送達デバイス10に適切に取り付けられたか否か;
b、取り外し可能なキャップ18が薬物送達デバイス10の本体20に適切に取り付けられたか否か;
c、第一のカートリッジ90に対してカートリッジホルダ40の第一のカートリッジ保持器50が適切に閉じられたか否か;
d、第二のカートリッジ100に対してカートリッジホルダ40の−−52が適切に閉じられたか否か;
e、第一のカートリッジ90の存在を検出すること;
f、第二のカートリッジ100の存在を検出すること;
g、第一のカートリッジ90中のストッパ94の位置を決定すること;及び
h、第二のカートリッジ100中のストッパ104の位置を決定すること;
a、用量ダイアル増加;
b、用量ダイアル減少;
c、音レベル;
d、用量;
e、排出;
f、プライミング;
g、用量設定;及び
h、OK。
a、最後の用量以来の時間;
b、最後の用量のサイズ;
c、現在の用量のサイズ;
d、現在の血糖レベル;
e、血糖履歴;
f、最大及び/又は最小の許容用量サイズ;
g、時刻;
h、患者の健康状態;
i、実行された運動;及び
j、食物摂取。
h、両端が相似した針を投与インターフェース200から取り除く;
i、投与インターフェース200をデバイス10のカートリッジホルダ40から取り除く;
j、デジタル表示部80上のメニュー選択肢によって第一のカートリッジ90及び/又は第二のカートリッジ100を変えることができるようにする;
k、第一及び/又は第二のピストンロッド514、516を巻き戻す;
l、第一及び/又は第二のカートリッジ保持器ドアがポンと開くであろう;
m、使用者が使用済みカートリッジを取り除き、そしてこの使用済みカートリッジを新しいカートリッジで交換する;
n、リザーバドアが手動で閉じられ得る;
o、一旦、ドアが閉じられると、各ロッドの最遠位部分が各リザーバのストッパと合うであろうように、そしてマイクロプロセッサに連結された栓検出機構が作動されるとき、前進を停止するであろうように、第一及び/又は第二のピストンロッド514、516を前進させる;
p、使用者はカートリッジホルダ40上で一方向に投与インターフェース200を交換する;
q、使用者は、所望ならば、新しい両端が相似した針を投与インターフェース200に連結できる;
r、使用者は、所望ならば、デバイス10を用いて試験注射又はプライミング工程に実行できる;及び
s、使用者は、次いで、引き続く用量投与工程のために次の用量を設定できる。
a、モータ636;
b、第二の歯車配置646;及び
c、伸縮自在ピストンロッド616。
た、複数レベル固定用量−可変用量治療を定義するためのプロファイル1100の配置を図示する。図示された通り、この特別な事前に定義された複数レベル、固定用量−可変用量治療プロファイルは迅速なランプアップを含む。この好ましいプロファイル1100において、薬物B1108の複数レベル、固定用量及び薬物A1104の可変用量プロファイルが示される。この場合、プロファイル1100は、一旦、薬物Aの対応する閾値用量が超えられたら、薬物Bの段階的な固定用量が送達されることを述べている。
Claims (16)
- 一次的な薬剤の用量に関する情報を受け取るように構成された制御ユニット(300)を含んでなる、デバイス(10)であって:
該制御ユニット(300)が更に、少なくとも部分的に、該一次的な薬剤の該用量及び治療用量プロファイルに基づいて、流体剤の用量の少なくとも一つの値を決定するように構成され、
治療用量プロファイルが、一次的な薬剤及び流体剤の非線形プロファイル(820、860、880、900、920)である、上記デバイス。 - 制御ユニット(300)が、治療用量プロファイルを記憶するように構成されたマイクロコントラーラ(302)及びメモリー(304)を含む、請求項1に記載のデバイス。
- 流体剤が二次的な薬剤である、請求項1又は2に記載のデバイス。
- 前記制御ユニット(300)と通信可能なオペレータインターフェース(60)を更に含んでなる、請求項1〜3の何れかに記載のデバイスであって、ここで一次的な薬剤の用量に関する前記情報が、該オペレータインターフェース(60)から制御ユニット(300)に受信される、上記デバイス。
- 請求項1〜4の何れかに記載のデバイスであって、制御ユニットが流体剤の用量の一つの値を決定するように構成される、上記デバイス。
- 流体剤の用量の少なくとも一つの値が、一定の範囲の値である、請求項1〜4の何れかに記載のデバイス。
- オペレータインターフェース(60)が、表示部(80)上に流体剤の用量の値の範囲を表示するように構成され、そして制御ユニット(300)が、使用者が流体剤の用量の範囲内でオペレータインターフェース(60)から選択した用量値を受け取るように構成される、請求項6に記載のデバイス。
- 前記制御ユニット(300)が更に、少なくとも部分的に、前記一次的な薬剤の前記用量及び前記治療用量プロファイルに基づいて、別の流体剤の用量の少なくとも一つの値を決定するように構成される、請求項1〜7の何れかに記載のデバイス。
- 前記一次的な薬剤が、インスリン及びインスリン類似体の少なくとも一つを含む、請求項1〜8の何れかに記載のデバイス。
- 前記流体剤が、GLP−1及びGLP−1類似体の少なくとも一つを含む、請求項1〜9の何れかに記載のデバイス。
- 前記制御ユニット(300)に操作可能に連結された電気機械駆動ユニット(500、600)(ここで、該電気機械駆動ユニット(500、600)も、前記一次的な薬剤を含有する一次的なリザーバ(90)及び前記流体剤を含有する二次的なリザーバ(100)に連結される);及び
該一次的な及び該二次的なリザーバ(90、100)と流体連通するように構成された単回投与アセンブリ(200);
を更に含んでなる、請求項1〜10の何れかに記載のデバイス。 - 注射ボタン(74)の作動によって、前記電気機械駆動ユニット(500、600)が、前記一次的な薬剤の前記用量及び前記流体剤の前記用量を、前記単回投与アセンブリ(200)を通して投与する、請求項11に記載のデバイス。
- 前記単回投与アセンブリ(200)が第一の内部ボディ(220)を含み、ここで、該第一の内部ボディ(220)が、前記一次的なリザーバ(90)と流体連通している第一の穿孔針(240)、及び前記二次的なリザーバ(100)と流体連通している第二の穿孔針(250)を含み;そしてここで該単回投与アセンブリ(200)が両端が相似したニードルアセンブリ(400)を含む、請求項11又は12に記載のデバイス。
- 前記一次的な及び前記二次的なリザーバ(90、100)が、ストッパ(94、104)及び穿孔可能なセプタムを含んでなる少なくとも一つの反復用量カートリッジ中に含有される、請求項11〜13の何れかに記載のデバイス。
- 治療用量プロファイルに関する情報を制御ユニットで受け取る工程;
一次的な薬剤の用量に関する情報を制御ユニットで受け取る工程;
少なくとも部分的に、該一次的な薬剤の該用量及び治療用量プロファイルに関する情報に基づいて、流体剤の用量の少なくとも一つの値を制御ユニットで決定する工程;及び
治療用量プロファイルに従って該一次的な薬剤の該用量及び流体剤の該用量の投与を開始する工程;
を含み、
ここで、治療用量プロファイルが、一次的な薬剤及び流体剤の非線形プロファイル(820、860、880、900、920)である、
方法。 - 治療用量プロファイルに関する情報を制御ユニットで受け取るためのコード;
一次的な薬剤の用量に関する情報を制御ユニットで受け取るためのコード;
少なくとも部分的に、該一次的な薬剤の該用量及び治療用量プロファイルに基づいて、流体剤の用量の少なくとも一つの値を制御ユニットで決定するためのコード; そして
該一次的な薬剤の該用量及び流体剤の該用量の投与を治療用量プロファイルに従って開始するためのコード、
を含み、
ここで、治療用量プロファイルが、一次的な薬剤及び流体剤の非線形プロファイル(820、860、880、900、920)である、
コンピュータプログラム。
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PCT/EP2010/068358 WO2011067187A1 (en) | 2009-12-01 | 2010-11-29 | Device and method for delivery of two or more drug agents |
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