JP2021506372A - 正確な用量の送達のためのデバイス及び方法 - Google Patents
正確な用量の送達のためのデバイス及び方法 Download PDFInfo
- Publication number
- JP2021506372A JP2021506372A JP2020532039A JP2020532039A JP2021506372A JP 2021506372 A JP2021506372 A JP 2021506372A JP 2020532039 A JP2020532039 A JP 2020532039A JP 2020532039 A JP2020532039 A JP 2020532039A JP 2021506372 A JP2021506372 A JP 2021506372A
- Authority
- JP
- Japan
- Prior art keywords
- barrel
- plunger rod
- delivery device
- pinion
- drug delivery
- 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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Classifications
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
- A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
-
- A—HUMAN NECESSITIES
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
- A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
- A61M5/31586—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod performed by rotationally moving or pivoted actuator, e.g. an injection lever or handle
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/3159—Dose expelling manners
- A61M5/31593—Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M2005/3125—Details specific display means, e.g. to indicate dose setting
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31501—Means for blocking or restricting the movement of the rod or piston
- A61M2005/31508—Means for blocking or restricting the movement of the rod or piston provided on the piston-rod
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
- A61M2005/3152—Piston or piston-rod constructions, e.g. connection of piston with piston-rod including gearings to multiply or attenuate the piston displacing force
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
- A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
- A61M2205/585—Means for facilitating use, e.g. by people with impaired vision by visual feedback having magnification means, e.g. magnifying glasses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/3146—Priming, e.g. purging, reducing backlash or clearance
Abstract
Description
この出願は、2017年12月13日に提出された米国特許出願公開第62/598,212号;2018年5月24日に提出された米国特許出願公開第62/676,047号;及び2018年8月24日に提出された米国特許出願公開第62/722,252号の優先権を主張する。これらはすべて、参照によりその全体が本明細書に組み込まれる。
本開示の分野
本開示の態様は、正確な用量の送達を促進するために、例えばシリンジなどの用量送達デバイスをプライミングまたは他の方法で構成するためのデバイス及び方法に関する。より具体的には、本開示の実施形態は、医薬品、プラセボ製品、または流体を含む他の製品の正確な用量を装填、保管、輸送、及び/または送達するためのデバイス及び方法に関する。
液状医薬品は、注射を含む様々な方法で患者に送達可能であり得る。多くの場合、液状医薬品の体積の正確さが重要である。例えば、医療の専門家は、承認または処方された体積の医薬品が、薬物を必要とする各患者に一貫して送達されることを保証することに関心を抱く場合がある。さらに、医薬品を患者に過剰投与または過少投与すると、わずかであっても、患者に望ましくない(または負の場合さえもある)臨床的な影響を与える可能性がある。さらに、一部の医薬品は少量で処方される(例えば100μL未満)。少量の場合、注射用の医薬品の正確な用量を調製及び送達する際の人為的ミスは、患者における薬物の有効性及びその後の患者に対する臨床的な作用に影響を与える可能性がある。
アクチュエータの押し下げによりプライミング及び/または薬物分配ステップを達成するために、駆動歯車及びアクチュエータの複数の構成が可能である。例えば、図17Bは、2つではなく3つの長い歯を有する駆動歯車714bと、2つではなく3つのタブを有するアクチュエータ710bとを有する第2のシリンジ700bを示す。このような実施形態では、アクチュエータ710bを複数回(例えば、第1の深さ、第2の深さ、及び第3の深さまで)押し下げて、所望の結果(例えば、シリンジ700bのプライミング)を達成することができることが企図される。アクチュエータ710bのタブと駆動歯車714bの長い歯の間の各接触は、触覚、音声、または視覚のフィードバックを伴うことができ、またシリンジ700bの部分的または完全なプライミング、シリンジ700bからの気泡の除去、またはシリンジ700bからの所望な用量の体積の分配に相当し得る。いくつかの実施形態では、アクチュエータは、駆動歯車の1つまたは複数の長い歯と相互作用するように構成された1つのみのタブを有し得る(例えば、図17Cに示されるアクチュエータ710c及び駆動歯車714cを参照されたい)。
Claims (40)
- 薬物送達デバイスであって、
長手方向軸、近位端領域、及び遠位端領域を含むバレルであって、前記近位端領域が開口部を含み、前記バレルが内部に薬物を受け入れるように構成される、前記バレル、
少なくとも部分的に前記バレルの内側に配置され、前記開口部から突出するプランジャロッドであって、複数の歯を有するラックを含む、前記プランジャロッド、及び
前記ラックの前記複数の歯と係合するように構成された複数の歯を有するピニオンであって、前記ラックに対する前記ピニオンの回転は、前記バレルの前記長手方向軸に沿って前記プランジャロッドの少なくとも一部を移動する、前記ピニオン
を含む、
前記薬物送達デバイス。 - 前記ピニオンに固定されるシャフトであって、前記シャフトの回転により、前記ピニオンが前記ラックに対して回転する、前記シャフトをさらに含む、
請求項1に記載の薬物送達デバイス。 - 前記シャフトに固定されたノブをさらに含む、
請求項2に記載の薬物送達デバイス。 - 前記バレルの前記遠位端領域に配置された拡大鏡をさらに含む、
請求項1に記載の薬物送達デバイス。 - 前記バレル内部のストッパであって、前記プランジャロッドの遠位端に固定されている、前記ストッパをさらに含む、
請求項1に記載の薬物送達デバイス。 - 前記ピニオンと同軸に配置された円形ラチェットであって、前記円形ラチェットの直径は前記ピニオンの直径よりも小さい、前記円形ラチェット、
前記ピニオンの内周に配置されたばね式の歯止めであって、前記ラチェットと係合するように構成されている、前記歯止め、及び
前記ラチェットに固定されたシャフトであって、一方向への前記シャフトの回転が前記ピニオンの回転を引き起こし、第2の方向への前記シャフトの回転は前記ピニオンの回転を引き起こさない、前記シャフトをさらに含む、
請求項1に記載の薬物送達デバイス。 - 前記ラチェットが前記ピニオンの内側に配置されている、請求項6に記載の薬物送達デバイス。
- 前記ピニオンが、第1の高さを有する複数の歯と、前記第1の高さより高い第2の高さを有するストッパ歯とを含む、請求項1に記載の薬物送達デバイス。
- 前記ストッパ歯の前記第2の高さが、前記ピニオンが前記ラックの前記複数の歯と係合するのを防ぐ、請求項8に記載の薬物送達デバイス。
- 前記ストッパ歯の前記第2の高さが、前記プランジャロッド及び前記ラックのうちの1つと接触して前記ピニオンの回転を停止するように構成される、請求項8に記載の薬物送達デバイス。
- 前記プランジャロッドが内側カラム及び外側管腔を含み、前記ラックが前記内側カラムに配置される、請求項1に記載の薬物送達デバイス。
- 前記ラックに対する前記ピニオンの回転が、前記外側管腔とは独立して前記プランジャロッドの前記内側カラムを移動させる、請求項11に記載の薬物送達デバイス。
- 前記ピニオンに取り外し可能に固定されたシャフトをさらに備え、前記シャフトは、前記バレルに対する前記プランジャロッドの前記外側管腔の移動を防止し、前記シャフトの取り外しにより、前記バレルに対する前記プランジャロッドの前記外側管腔の移動が可能になる、請求項11に記載の薬物送達デバイス。
- 前記プランジャロッドが本体及びフランジをさらに含み、前記フランジが前記本体の長手方向の長さに沿って部分的に延在し、前記本体の幅より大きい幅を有し、
前記バレルが、プランジャロックをさらに含み、前記プランジャロックは、前記フランジが前記第2のプランジャロックを特定の向きで通ることを可能にするように構成された貫通穴を含む、請求項1に記載の薬物送達デバイス。 - 薬物送達デバイスであって、
長手方向軸、近位端領域、遠位端領域、及び内部を含むバレルであって、前記近位端領域が前記開口部を含み、前記内部がねじ部分を含む、前記バレル、及び
少なくとも部分的に前記バレルの内側に配置され、前記開口部から突出するプランジャロッドであって、前記バレル内部の前記ねじ領域に係合するように構成されたねじ領域を含む、前記プランジャロッド
を含み、
前記薬物送達デバイスの前記長手方向軸の周りの前記プランジャロッドの回転は、前記長手方向軸に沿って前記プランジャロッドを移動する、
前記薬物送達デバイス。 - 前記プランジャロッドが、前記プランジャロッドから第1の方向に突出し、前記プランジャロッドの前記ねじ領域から近位に位置するタブをさらに含み、前記バレルの前記内部の前記ねじ領域がさらに、前記タブが前記バレルの前記内部の前記ねじ領域を通過できるように寸法決め及び構成されたスロットを含む、請求項15に記載の薬物送達デバイス。
- 前記スロットが、前記薬物送達デバイスの前記長手方向軸に平行な第1のセグメント、及び前記薬物送達デバイスの前記長手方向軸に垂直な第2のセグメントを含む、請求項16に記載の薬物送達デバイス。
- 前記スロットが前記薬物送達デバイスの前記長手方向軸に平行な第3のセグメントを含み、前記第2のセグメントが前記第1のセグメントと前記第3のセグメントとの間にある、請求項17に記載の薬物送達デバイス。
- 前記タブが第1のタブであり、前記プランジャロッドが、前記第1の方向と反対の第2の方向に前記プランジャロッドから突出する第2のタブをさらに含み、前記バレルの前記内部にある前記ねじ領域は、前記第2のタブが前記バレルの前記内部の前記ねじ領域を通ることを可能にする寸法及び構成の第2のスロットをさらに含む、請求項16に記載の薬物送達デバイス。
- 薬物送達デバイスであって、
近位端領域、遠位端領域、前記近位端領域の開口部、内部、及び前記内部のねじ領域を有するバレル、
前記バレルの内部に部分的に配置され、前記バレルの前記近位端領域の前記開口部から突出するスリーブであって、前記バレル内部の前記ねじ領域と係合するねじ領域を含む、前記スリーブ、
前記スリーブの内側に少なくとも部分的に配置されたプランジャロッド、及び
前記バレルの内側にあり、前記スリーブから遠位に配置されたストッパであって、前記プランジャロッドの遠位端に接続されている、前記ストッパ
を含み、
前記薬物送達デバイスの長手方向軸の周りの第1の方向への前記スリーブの回転は、前記スリーブを前記バレルの前記遠位端領域に向かって移動させる、
前記薬物送達デバイス。 - 前記第1の方向への前記スリーブの回転は、前記ストッパを前記バレルの前記遠位端領域に向かって移動させる、請求項20に記載の薬物送達デバイス。
- 前記スリーブが内部通路を含み、前記ストッパが前記内部通路の直径よりも長い直径を有する、請求項20に記載の薬物送達デバイス。
- 前記スリーブが前記スリーブの外側に配置されたタブを含み、前記タブが前記バレル内部の前記ねじ領域から近位に配置され、前記タブが前記スリーブの前記バレルの前記遠位端領域への移動を停止する、請求項20に記載の薬物送達デバイス。
- 前記タブは、前記薬物送達デバイスがプライミングされた後、前記バレルの前記遠位端領域に向かう前記スリーブの移動を停止するように構成される、請求項23に記載の薬物送達デバイス。
- 前記タブが第1のタブであり、前記スリーブがさらに、前記スリーブの外側に配置された第2のタブを含み、前記第2のタブが、前記バレル内部の前記ねじ領域から遠位に配置され、前記第2のタブは、前記バレルの近前記位端領域に向かう前記スリーブの移動を止める、請求項23に記載の薬物送達デバイス。
- 薬物送達デバイスであって、
近位端領域及び遠位端領域を含むバレルであって、前記近位端領域が開口部を含む、前記バレル、
本体とフランジを含むプランジャロッドであって、前記フランジが前記本体の長手方向の長さに沿って部分的に延在し、前記本体の幅より大きい幅を有し、少なくとも部分的に前記バレルの内側に配置され、前記開口部から突出する、前記プランジャロッド、
前記バレル上に配置される第1のプランジャロックであって、前記フランジが前記バレルに入ることを阻止するように構成されている、前記第1のプランジャロック、及び
前記バレルに配置される第2のプランジャロックであって、前記フランジが前記第2のプランジャロックを特定の向きで通ることを可能にするように構成された貫通穴を含む、前記第2のプランジャロックを含む、
薬物送達デバイス。 - 前記第1のプランジャロックが取り外し可能である、請求項26に記載の薬物送達デバイス。
- 前記第1のプランジャロックが脆い、請求項26に記載の薬物送達デバイス。
- 前記第1のプランジャロックと前記第2のプランジャロックとの間の距離は、前記薬物送達デバイスをプライミングするために前記ストッパが移動しなければならない距離に等しい、請求項26に記載の薬物送達デバイス。
- 前記プランジャロッドが前記薬物送達デバイスの長手方向軸の周りを回転可能である、請求項26に記載の薬物送達デバイス。
- プランジャロッド及びバレルを有する薬物送達デバイスから物質を分配する方法であって、
前記プランジャロッドの前進がストップによって阻止されるまで、前記プランジャロッドを前記バレル内に所定の距離だけ前進させること、
前記ストップを無効にすること、及び
前記プランジャロッドを作動させて前記物質を送達することを含む、
前記方法。 - 前記プランジャロッドを前進させることが、前記プランジャロッドに配置されたラックに対してピニオンを回転させることを含む、請求項31に記載の方法。
- 前記ストップは、前記ピニオンに取り外し可能に固定されたシャフトを含み、前記ストップを無効にすることは、前記ピニオンから前記シャフトを取り外すことを含む、請求項32に記載の方法。
- 前記ストップを無効にすることが、前記プランジャロッドを回転させることを含む、請求項31に記載の方法。
- 前記プランジャロッドがフランジを含み、前記ストップが、前記フランジが前記バレルに入ることを防ぐロックを含む、請求項31に記載の方法。
- 前記ストップを無効にすることは、前記ロックを取り外すことを含む、請求項35に記載の方法。
- 前記ストップを無効にすることが、前記ロックを破断することを含む、請求項35に記載の方法。
- 薬物送達デバイスであって、
長手方向軸、近位端領域、及び遠位端領域を含むバレルであって、前記近位端領域が開口部及び前記バレルの前記内部に配置されるラックを含み、前記ラックは複数の歯を有し、前記バレルは内部に薬物を受け入れるよう構成される、前記バレル、
少なくとも部分的に前記バレルの内側に配置され、前記開口部から突出するプランジャロッドであって、複数の歯を有するラックを含む、前記プランジャロッド、
前記プランジャロッドラックの前記複数の歯と係合するように構成された複数の歯を有するピニオン、及び
ロッドによって前記ピニオンに連結された内側プランジャであって、前記プランジャロッドラックに対する前記ピニオンの回転により、前記バレルの前記長手方向軸に沿って前記内側プランジャが移動する、前記内側プランジャを含む、
前記薬物送達デバイス。 - 前記ピニオンの前記歯が、前記バレルに配置された前記ラックの前記複数の歯と係合するようにさらに構成されている、請求項38に記載の薬物送達デバイス。
- 前記ピニオンが第1のピニオンであり、
前記第1のピニオンと同軸に配置される第2のピニオンであって、前記第1のピニオンの直径よりも小さい直径と、前記バレルに配置された前記ラックの複数の歯と係合するように構成された前記複数の前記歯とを有する、前記第2のピニオンをさらに含み、
前記第1のピニオンの回転により、前記バレルに配置された前記ラックに対する前記第2のピニオンの回転、及び前記バレルの前記長手方向軸に沿って前記内側プランジャの移動がもたらされる、
請求項38に記載の薬物送達デバイス。
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