JP6355169B2 - 薬剤送達ポンプ用制御送達駆動機構 - Google Patents
薬剤送達ポンプ用制御送達駆動機構 Download PDFInfo
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Description
本出願は、2012年8月29日に出願された米国特許仮出願第61/694,534号、2012年11月30日に出願された米国特許仮出願第61/731,744号、並びに2013年1月3日に出願された米国特許仮出願第61/748,667号の優先権を主張するものであり、これらは、あらゆる目的のために参照により全体が本明細書に含まれている。
電源/制御系
本発明の実施形態においては、幾つかの流体経路接続部が利用されてよい。一般に、適切な流体経路接続部は、無菌流体導管と、穴あけ部材と、薬剤容器又は薬剤容器に組み込まれた穴あけ可能な摺動封止材に取り付けられた無菌スリーブと、を含む。流体経路接続部は更に、1つ以上の流量制限器を含んでよい。本装置10が適正に起動されると、ただちに、流体経路接続部300は、無菌流体導管30を駆動機構100の薬剤容器に接続することが可能になる。そのような接続は、駆動機構100の薬剤容器の穴あけ可能な封止材に穴をあける、針などの穴あけ部材によって促進されてよい。この接続の無菌状態は、フレキシブル無菌スリーブ内で接続を行うことによって維持可能である。挿入機構が実質的に同時に起動されると、薬剤容器と挿入機構との間の流体経路が完結して、ユーザの体内への薬剤送達が可能になる。
本発明の薬剤ポンプ内で、幾つかの挿入機構が利用されてよい。本発明のポンプ式送達装置は、流体流連通によって患者又はユーザとつながってよく、これは、例えば、任意の好適な中空チューブを介して行われてよい。患者の皮膚に穴をあけ、しかるべき送達位置に中空カニューレを配置する為に、非中空ボア針が使用されてよく、この非中空ボア針は、患者への薬剤送達の前に取り外されるか引き込まれる。上述のように、流体を体内に投入することは、様々な手段によって可能であり、そのような手段として、例えば、自動的に挿入される針、カニューレ、顕微針アレイ、又は輸液セットのチューブなどがあり、これらに限定されない。患者への針装入を起動する為に、幾つかの機構が使用されてもよい。例えば、患者の皮膚に穴をあけるのに十分な力を針及びカニューレに与える為に、ばねなどの付勢部材が使用されてよい。針を患者から引き込む為には、同じばね、又は追加のばね、又は別の同様な機構が利用されてよい。好ましい一実施形態では、挿入機構は、おおむね、あらゆる目的のために参照により全体が本明細書に含まれている、国際特許出願第PCT/US2012/53174号に記載されているとおりであってよい。そのような構成は、患者の痛みを最小限に抑えるように、薬剤送達経路を患者の皮膚(又は筋肉)の中又は下に挿入する為に利用されてよい。流体経路を挿入する為の、他の知られた方法も利用されてよく、それらも本発明の範囲内で考えられる。
図2及び図3に示される実施形態を参照すると、駆動機構100は、駆動ハウジング130と、キャップ52、穴あけ可能封止材(見えない)、バレル58、及びプランジャ封止材60を有する薬剤容器50と、を含む。バレル58内の、穴あけ可能封止材とプランジャ封止材60との間に位置する薬剤チャンバ21が、挿入機構及び薬剤ポンプを介してユーザの体内に送達される薬剤流体を収容してよい。本明細書に記載の封止材は、幾つかの材料からなるものであってよいが、好ましい一実施形態では、1つ以上のエラストマ又はゴムからなる。駆動機構は更に、流体経路接続部の穴あけ部材の挿入を薬剤容器50のバレル58内へガイドする接続マウント54を含んでよい。駆動機構100は更に、1つ以上の駆動付勢部材、1つ以上の解放機構、及び1つ以上のガイドを収容してよく、これらについては、本明細書において詳述される。駆動機構の各構成要素は、流体を、流体経路接続部、無菌流体導管、及び挿入機構を介してユーザの体内へ送達すべく、薬剤容器から、穴あけ可能封止材を通して、又は好ましくは流体経路接続部の穴あけ部材を通して押し出すように機能する。
Claims (22)
- バレル(58)内を平行移動するように構成されたプランジャ封止材(60)を有する薬剤容器(50)のための制御送達駆動機構(100)であって、
駆動ハウジング(130)と、ピストン(110A、110B)であって、前記プランジャ封止材(60)に当たるように構成されており、最初は前記プランジャ封止材(60)に対して、隣接して設けられ、間隔があけられ、及び機械的に分離されている前記ピストン(110A、110B)と、付勢部材(122)であって、最初はエネルギ蓄積状態で保持され、前記ピストン(110)の接合面(110C)に当たるように構成された前記付勢部材(122)と、一端が前記ピストン(110A、110B)と接続され、他端が送達制御機構(500)のウインチドラム(520)と接続されたテザー(512)であって、前記付勢部材(122)の、最初のエネルギ蓄積状態からの自由伸張と、前記付勢部材(122)が当たるように構成された前記ピストン(110A、110B)の自由軸方向平行移動と、を抑制するための張力がかけられる前記テザー(512)と、前記テザー(512)に隣接するように配置された状態読み取り器(544)であって、前記テザー(512)がたるんだ際に信号を与えるように構成された前記状態読み取り器(544)と、を備え、前記状態読み取り器(544)が、前記テザー(512)上にインクリメンタルに間隔を置いて配置された、対応する1つ以上の状態トリガ(512A)を読み取るか認識するように構成され、前記駆動機構(100)の動作中に、前記状態読み取り器(544)と前記状態トリガ(512A)との間の相互作用によって、ユーザにフィードバックを与える為の信号が電源/制御系(400)に送信される、制御送達駆動機構(100)。 - 前記状態読み取り器(544)は、前記テザー(512)に張力をかける、請求項1に記載の駆動機構(100)。
- 前記状態読み取り器(544)は、前記テザー(512)がたるんだ際に支点の周りを回転する、請求項1又は2に記載の駆動機構(100)。
- 前記状態読み取り器(544)は、スイッチを備える、請求項1から3のいずれか一項に記載の駆動機構(100)。
- 前記薬剤容器(50)は、薬剤チャンバ(21)内に薬剤流体を収容する、請求項1から4のいずれか一項に記載の駆動機構(100)。
- 前記付勢部材(122)と前記ピストン(110A、110B)の前記接合面(110C)との間でカバースリーブ(140)を更に備える、請求項1から5のいずれか一項に記載の駆動機構(100)。
- 前記テザー(512)は、前記送達制御機構(500)のウインチドラム(520)から緩められて、前記付勢部材(122)の、最初のエネルギ蓄積状態からの自由伸張と、前記付勢部材(122)が当たる前記ピストン(110A、110B)の自由軸方向平行移動と、を計量調節するように構成されている、請求項1から6のいずれか一項に記載の駆動機構(100)。
- 複数のギヤ(528)を有するギヤアセンブリを備え、前記ギヤ(528)の少なくとも1つがエンコーダーとして動作する、請求項1から7のいずれか一項に記載の駆動機構(100)。
- 前記テザー(512)が弛緩可能に巻き付けられてよいウインチドラム(520)に接続されたドラムギヤ(522)を有するギヤアセンブリと、前記ドラムギヤ(522)と係合可能に接続されたウォームギヤ(524)と、前記ウォームギヤ(524)と係合可能に接続された複合ギヤ(526)と、前記複合ギヤ(526)と係合可能に接続されたピニオン(530A)を有するモータ(530)であって、前記テザー(512)を前記ウインチドラム(520)から緩めて、前記付勢部材(122)の、最初のエネルギ蓄積状態からの自由伸張と、前記付勢部材(122)が当たる前記ピストン(110A、110B)の自由軸方向平行移動と、を計量調節するように、前記ギヤアセンブリを駆動するように構成された前記モータ(530)と、を更に備える、請求項1から8のいずれか一項に記載の駆動機構(100)。
- モータ(530)による前記テザー(512)の前記緩めによって、ユーザへの薬剤送達の流量又は特性が制御される、請求項7に記載の駆動機構(100)。
- 前記ピストン(110A、110B)は、1つ以上の部品から構成され、前記テザー(512)の遠位端に接続される、請求項1から10のいずれか一項に記載の駆動機構(100)。
- 前記状態読み取り器(544)は光学式状態読み取り器であり、前記対応する状態トリガ(512A)は光学式状態トリガである、請求項1から11の何れか一項に記載の駆動機構(100)。
- 前記状態読み取り器(544)は電気機械式状態読み取り器であり、前記対応する状態トリガ(512A)は電気機械式状態トリガである、請求項1から11の何れか一項に記載の駆動機構(100)。
- 前記状態読み取り器(544)は機械式状態読み取り器であり、前記対応する状態トリガ(512A)は機械式状態トリガである、請求項1から11の何れか一項に記載の駆動機構(100)。
- ハウジング(12)及びアセンブリプラットフォーム(20)を備え、薬剤送達が制御される薬剤送達ポンプ(10)であって、前記アセンブリプラットフォーム(20)上には、起動機構(14)、挿入機構(200)、流体経路接続部(300)、電源/制御系(400)、及び請求項1から14のいずれか一項に記載の制御送達駆動機構(100)を備えている、薬剤送達ポンプ(10)。
- 前記電源/制御系(400)は、1つ以上の入力を受け取って、前記ウインチドラム(520)が前記テザー(512)を緩める度合いを計量調節することにより、前記付勢部材(122)が前記ピストン(110)を軸方向平行移動させてプランジャ封止材(60をバレル(58)内で平行移動させることを可能にするように構成されている、請求項15に記載の薬剤送達ポンプ(10)。
- 前記1つ以上の入力は、前記ユーザが前記起動機構(14)を操作することによって与えられる、請求項15又は16に記載の薬剤送達ポンプ(10)。
- 前記1つ以上の入力は、前記ユーザが制御インタフェースを操作することによって与えられる、請求項15又は16に記載の薬剤送達ポンプ(10)。
- 前記1つ以上の入力は、前記ユーザが遠隔制御機構を操作することによって与えられる、請求項15又は16に記載の薬剤送達ポンプ(10)。
- 前記電源/制御系(400)は、1つ以上の入力を受け取って、前記付勢部材(122)が当たる前記ピストン(110A、110B)の自由軸方向平行移動に対して前記テザー(512)及び前記ウインチドラム(520)によって与えられる抵抗を、薬剤送達の所望の流量又は特性を満たすべく調節するように構成されている、請求項15から19のいずれか一項に記載の薬剤送達ポンプ(10)。
- 前記電源/制御系(400)は、1つ以上の入力を受け取って、前記付勢部材(122)が当たる前記ピストン(110A、110B)の自由軸方向平行移動に対して前記テザー(512)及び前記ウインチドラム(520)によって与えられる抵抗を、前記ユーザに送達される薬剤の体積を変更すべく調節するように構成されている、請求項15から19のいずれか一項に記載の薬剤送達ポンプ(10)。
- 前記電源/制御系(400)は、1つ以上の入力を受け取って、前記付勢部材(122)が当たる前記ピストン(110A、110B)の自由軸方向平行移動に対して前記テザー(512)及び前記ウインチドラム(520)によって与えられる抵抗を、前記駆動機構(100)の動作を開始、停止、又は一時停止する為に調節するように構成されている、請求項15から19のいずれか一項に記載の薬剤送達ポンプ(10)。
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