JP4308524B2 - 注入装置のための駆動機構 - Google Patents
注入装置のための駆動機構 Download PDFInfo
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- JP4308524B2 JP4308524B2 JP2002552613A JP2002552613A JP4308524B2 JP 4308524 B2 JP4308524 B2 JP 4308524B2 JP 2002552613 A JP2002552613 A JP 2002552613A JP 2002552613 A JP2002552613 A JP 2002552613A JP 4308524 B2 JP4308524 B2 JP 4308524B2
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- 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
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
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- 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
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
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- 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
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
- A61M5/14566—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir for receiving a piston rod of the pump
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- A—HUMAN NECESSITIES
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- 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
- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
- G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
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- 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
- A61M2005/31588—Constructional features or modes of drive mechanisms for piston rods electrically driven
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- 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
- A61M2205/21—General characteristics of the apparatus insensitive to tilting or inclination, e.g. spill-over prevention
- A61M2205/215—Tilt detection, e.g. for warning or shut-off
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61M2205/00—General characteristics of the apparatus
- A61M2205/50—General characteristics of the apparatus with microprocessors or computers
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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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/60—General characteristics of the apparatus with identification means
- A61M2205/6018—General characteristics of the apparatus with identification means providing set-up signals for the apparatus configuration
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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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/82—Internal energy supply devices
- A61M2205/8206—Internal energy supply devices battery-operated
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
- A61M5/31525—Dosing
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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
- 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
- A61M5/31533—Dosing mechanisms, i.e. setting a dose
- A61M5/31545—Setting modes for dosing
- A61M5/31546—Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons
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- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S128/00—Surgery
- Y10S128/01—Motorized syringe
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Description
本発明は、注入装置の改良に関し、具体的には薬剤の量を制御して投与するための携帯用注入装置の改良に関する。
【0002】
典型的には、このような注入装置は糖尿病患者がインスリンまたはインスリンタイプの薬剤の自分自身への投与量を管理するために使用される。このような注入装置が他の薬剤の注入にも好適であることは言うまでもない。
【0003】
このような投与は、かつては使い捨て注射器を使って管理されていた。すなわち、まず、投与量が別のバイアルまたは別の容器から注射器に充填され、それからその注射器を使って注射された。しかし、このような装置にはいくつかの難点があった。具体的には、衰弱者にとってこのような装置は適さなかった。そうでない者にとっては、このような注射器は社会的に不評を買っているため、それを一般に使用することには問題があった。
【0004】
こうした問題を克服するため、いくつかの、いわゆるペン型注入装置が開発されてきた。これらの装置は小型であるため、上着のポケットなどに入れて運ぶことができ、その上、注入装置に装着されたカートリッジまたはアンプルから投与を繰返し行うことができる。本発明は、特にこのようなペン型注入装置に適用されるものである。
【0005】
このようなペン型注入装置は、使い捨て皮下用注射器に対してかなりの改善をもたらしているが、依然として残された問題がある。
【0006】
特に、ペン型注入装置用の駆動系の設計を考える場合、時にはいくつかの相反する技術的な要求が出てくる。駆動系は正確で信頼性が高くなければならないことは当然であるが、それと同時にコンパクトで効率が良いことも要求される。駆動系は信頼性が高く、かつ頑丈でなければならず、製品の寿命が尽きるまで機能することができなければならない。さらに加えて、駆動系は本質的に危険防止措置(フェイルセーフ)が講じられていなければならない。
【0007】
本発明の利点は、このような問題を解消するか、少なくとも大幅に減らすところにある。さらに、本発明は、使い勝手が改善され、使用者にとって扱いやすくなっている注入装置を提供するものである。
【0008】
以下では、実施例のみに基づいて、添付の図面を参照しながら本発明を説明する。
図1は、本発明によるペン型注入装置の平面図である。
図2は、図1において注入装置のエンド・キャップを外した平面図である。
図3は、図1および図2の注入装置の断面図である。
図4は、本発明に従う注入装置に使用される別の駆動機構の概略図である。
【0009】
まず図1ないし図3において、本発明によるペン型注入装置2が示されている。注入装置2は、本体ハウジング4を備え、そのハウジングにはエンド・キャップすなわちカバー6が着脱可能なように装着されている。
【0010】
本体ハウジング4の第一の端部には、コントロールパネル領域8が確保されている。この領域には、典型的にはLCDパネルである表示パネル10と、第一投与量制御ボタン12および第二投与量制御ボタン14が配置され、第一および第二投与量制御ボタンは、注入薬剤の投与量の増減を調節するための操作ボタンである。図示する実施例のコントロールパネル領域10には、アームボタン16も配置されている。
【0011】
本体ハウジングの第一の端部には、投与(dispense)ボタン18も配置されている。この投与ボタン18は、押されていない状態では本体ハウジング4と同一面にあることが好ましい。
【0012】
注入装置2の縦軸に沿い、コントロールパネル領域10の両側には、複数の溝または窪み20が設けられている。これらの溝または窪みは、使用者が注入装置2を持ちやすいようにするために設けられるものである。
【0013】
本体ハウジング4の第二の端部には、針ユニット22が本体ハウジングに着脱可能なように装着されている。本体ハウジング4の第二の端部には、さらに、型形成部分24が設けられている。
【0014】
使用時には、薬剤のカートリッジ40またはアンプルは、型形成部分24の下の本体ハウジング4内に収納されている。この型形成部分は、カートリッジ40が使用者に見えるように透明であることが好ましい。
【0015】
開始ボタン26も本体ハウジング4の第二の端部に配置される。エンド・キャップ6がハウジングの第二の端に装着されていれば、誤って開始ボタン26を押し下げたり、針ユニット22が刺さったりする恐れはないことが理解できるであろう。本体ハウジング4の第二の端部には、エンド・キャップすなわちカバー6が正しく装着されているか否かを検知するためのカバー検知スイッチ28も配置されている。
【0016】
図3には、それぞれのボタンに対応する開始接点30、アーム接点32、第一投与量制御接点34および第二投与量制御接点36が示されている。投与ボタン18に対応する投与接点19も示されている。
【0017】
図3においては、電源38として、例えば一個以上の電池を収納するための場所が設けてあることが理解できるであろう。同じく、薬剤カートリッジ40またはアンプルを装着すべき好適な領域も配置されている。この領域に本体ハウジング4の脱着可能な型形成部分24からアクセスすることで、使用者は必要に応じてカートリッジ40またはアンプルを交換することができる。カートリッジにアクセスする別の手段は、図16ないし図23に関連して開示されている。
【0018】
本体ハウジング4の第三の領域には駆動機構42が配置されていて、電源38からの電力によって駆動され、薬剤カートリッジ40またはアンプルに対して作動する。
【0019】
薬剤カートリッジ40またはアンプルは、容器44またはスリーブを備えており、その一方の端である頭部端はカバー46によって閉鎖され、他方の端は、可動栓48またはストッパによって密閉されている。所定の位置で、針ユニット22はカバー46を貫通し、栓48がカバー46の方向に運動すると、薬剤カートリッジ40またはアンプル内に充填されている薬剤が排出される。カートリッジは、ISO/FDIS 11608 Part3による3mlカートリッジでもよいし、注入装置に適合するものであればいかなるカートリッジであってもよい。
【0020】
栓48またはストッパの運動は、駆動機構42の一部を成すピストンまたはプランジャ50の運動によって行われる。ピストンまたはプランジャ50は、薬剤カートリッジ40またはアンプルの交換が可能な第一の完全に後ろに引いた位置(図示せず)と、薬剤カートリッジ40またはアンプルから薬剤が最大限に排出される第二の完全に繰り出された位置の間を運動することができる。ピストン50が完全に後ろに引いた位置にあるときに、そのことを検知するエンド・ストップ・スイッチ52を本体ハウジング4に配置することができる。エンド・ストップ・スイッチ52が作動すると、止め金またはその他の止め装置が解除されて、本体ハウジング4に装着したカートリッジ40を交換するためのアクセスが可能となる。
【0021】
駆動機構42は、電子制御ユニット(図示せず)で制御されるモータ54によって駆動される。ピストン50が第一の位置と第二の位置の間で運動できるためには、モータ54は逆回転可能でなければならない。図3において、モータ54が歯車列42を通じてピストン50を動かすことが分かり、第三の回転子58が回転すると、ピストン50が第三の回転子58に対して運動する。
【0022】
使用者がモータ54およびそれと連動する駆動機構42の振動を感じ、またはそれらが作動中であることを音で聞けるようにすることが好ましい。このようにすれば、注入装置2が作動していることに対する使用者の信頼感は、さらに高まる。
【0023】
以下では、特に図1、2および3を参照しながら、本発明に係るペン型注入装置の機能について説明する。
【0024】
注入装置2には、電子制御ユニットが装備されている。電子制御ユニットは、駆動装置およびユーザ・インターフェースの両方と連結されている。ユーザ・インターフェースは、表示パネル10と使用者が操作できるボタン(およびそれと連携する接点)とを備えている。電子制御ユニットはマイクロプロセッサを中心として構成されている。「投与履歴」および患者に関する情報の保存には、揮発性または非揮発性メモリを使うことができる。
【0025】
電子制御ユニットの電源は、注入装置の電源38から供給されることが好ましい。
【0026】
注入装置2は、電子制御ユニットと、パーソナルコンピュータのような外部装置とを接続するための通信用ポートをも備えていることが好ましい。
【0027】
また、注入装置2は、注入装置2が逆さまにされたときにそれを検知するための開始検知機構(傾斜スイッチまたは加速計)も装備している。逆さ位置(針を上向きにする)を検知すると、注入装置2は自動的に開始準備が完了した状態に変わる。開始ボタン26を押し下げると開始動作が始まり、一定の小さい投与動作が引き起こされる。開始ボタン26を押し下げたとき、電子制御ユニットによりスピーカから音を発生させることもできる。
【0028】
それ以外のときは、開始ボタン26は作動しない。開始ボタン26が作動可能なときは、制御パネル領域に配置されているすべての他のボタン、すなわち投与量を設定または投与するために使用されることになっているボタンは作動しない。
【0029】
アームボタン16を十分な時間押し下げると、可聴音として使用者にフィードバックを行うために電子制御ユニットはスピーカから音を発生させることができる。
【0030】
アームボタン16の機能は投与ボタン18を作動可能にすることである。注入装置2が準備完了状態になるまでのあらかじめ決められた時間の間、アームボタンを押し下げた状態で保持することが好ましい。準備完了状態は表示パネル10に表示することもできる。アームボタンの機能とカバー検知スイッチ28とを連結させて、カバー6がないときのみ、アームボタン16の機能が注入装置2を作動できる状態にすることが好ましい。
【0031】
さらに、好ましい実施態様によれば、電子制御ユニットに組み込まれた計時手段が、注入装置2が準備完了後、指定された時間間隔内に投与ボタン18が押されているか否かを検知する。投与ボタン18が指定された時間間隔内に押し下げられなかった場合は、電子制御ユニットが注入装置2を準備態勢から解除する。また、使用者があらかじめ決められた時間内にアームボタンを二度目に押し下げると、注入装置が動作を停止するようにしてもよい。
【0032】
さらに別の実施態様によれば、投与ボタン18が開始ボタンと投与ボタンの両方の機能を果たすようにしてもよい。注入装置2の針を上に向けて開始検知器を作動させると、投与ボタン18は、その機能を上記実施態様の開始ボタンの機能に変えることになる。
【0033】
注入装置2のボタンは、操作結果が触感で使用者に分かるようにすることが好ましい。
【0034】
図4は、出力軸172を具備する回転ソレノイド170の形をした駆動機構を示す。回転ソレノイドは、典型的には、直線的なプッシュプル運動をソレノイド内の螺旋ボールレースによって数度の角度(約15°)の回転運動に変換する。出力軸172は第一ラチェット部材178と係合する。そして第一ラチェット部材178は、送りねじの軸180に取り付けられた第二ラチェット部材174を駆動する。ここに記述する説明の文脈によれば、送りねじが、栓48を薬剤カートリッジ40の内部で前進させるためのピストン手段を包含することは理解されるであろう。第一および第二ラチェット部材178,174は、ハウジング176の中に配置される。第二ラチェット部材174は、第一ラチェット部材178に向かって付勢される(ここでは、コイルばね182によって)。
【0035】
ソレノイドが第一行程に入ると、第一ラチェット部材178は回転される。図4から分かるように、第一ラチェット部材178の図面上最も手前側にある歯が上に向かって動くと、その結果、第二ラチェット部材174の対応する歯は遠ざかる方向、つまり付勢手段に対する方向に押される。第一および第二ラチェット部材178,174に配置される歯は、回転ソレノイド170の出力軸の角変位よりわずかに小さい角変位に相当する角度で配置される。行程の終わりでは、第一ラチェット部材178の歯は、割り出しによって第二ラチェット部材174の次の組の歯とかみ合っている。ソレノイド170が戻り行程に入ると、第一ラチェット部材178は反対方向に回転して第二ラチェット部材174および連動する送りねじの軸180とを駆動する。
【図面の簡単な説明】
【図1】 図1は、本発明によるペン型注入装置の平面図である。
【図2】 図2は、図1において注入装置のエンド・キャップを外した平面図である。
【図3】 図3は、図1および図2の注入装置の断面図である。
【図4】 図4は、本発明に従う注入装置に使用される別の駆動機構の概略図である。
Claims (5)
- ピストン手段が選択的に駆動されて薬剤カートリッジから薬剤を排出する注入装置のための駆動機構であって、前記駆動機構は、第一ラチェット手段と連動する駆動手段と、前記ピストン手段と連動する第二ラチェット手段と、ハウジングとを具備し、前記第一ラチェット手段と前記第二ラチェット手段は前記ハウジングの中に配置され、前記第二ラチェット手段は付勢手段によって前記第一ラチェット手段に向かって押され、そして前記駆動手段は、正逆方向に作動可能であり、前記第一ラチェット手段を第一回転方向に駆動することによって、前記第一ラチェット手段は、その運動の少なくとも一部分で前記付勢手段に抗しながら、前記第二ラチェット手段を縦軸方向に動かし、それから、前記第一ラチェット手段と前記第二ラチェット手段とを一緒に前記第一回転方向とは逆方向である第二回転方向に駆動することによって、前記ピストン手段を作動させるようになされている注入装置のための駆動機構。
- 前記第一及び第二ラチェット手段は歯を有し、前記第1ラチェット手段は前記第2ラチェット手段のかみ合っている歯を押すことによって付勢手段に対向して前記第二ラチェット手段を軸方向に離れる方向に駆動することを特徴とする請求項1に記載の駆動機構。
- 前記駆動手段は、回転ソレノイドを具備することを特徴とする請求項1または2に記載の駆動機構。
- 前記送りねじは、前記ピストン手段を含むことを特徴とする請求項1〜3の何れか1項に記載の駆動機構。
- 前記第二ラチェット手段は、前記送りネジの軸に取り付けられていることを特徴とする請求項1〜4の何れか1項に記載の駆動機構。
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GBGB0031466.6A GB0031466D0 (en) | 2000-12-22 | 2000-12-22 | Improvements in and relating to an injection device |
PCT/GB2001/005705 WO2002051472A1 (en) | 2000-12-22 | 2001-12-21 | Drive mechanism for an injection device |
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