JP5269268B2 - フィードバック信号伝達手段を備えた薬剤送達装置 - Google Patents
フィードバック信号伝達手段を備えた薬剤送達装置 Download PDFInfo
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- 238000012377 drug delivery Methods 0.000 title claims description 84
- 230000008054 signal transmission Effects 0.000 title 1
- 230000004913 activation Effects 0.000 claims description 57
- 239000003814 drug Substances 0.000 claims description 41
- 229940079593 drug Drugs 0.000 claims description 35
- 230000003993 interaction Effects 0.000 claims description 25
- 238000003825 pressing Methods 0.000 claims description 4
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 238000002347 injection Methods 0.000 description 25
- 239000007924 injection Substances 0.000 description 25
- 238000012790 confirmation Methods 0.000 description 7
- 238000000034 method Methods 0.000 description 7
- 238000003780 insertion Methods 0.000 description 3
- 230000037431 insertion Effects 0.000 description 3
- 210000001217 buttock Anatomy 0.000 description 2
- 230000007274 generation of a signal involved in cell-cell signaling Effects 0.000 description 2
- 230000000007 visual effect Effects 0.000 description 2
- 239000000463 material Substances 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
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- 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
- A61M5/31566—Means improving security or handling thereof
- A61M5/3157—Means providing feedback signals when administration is completed
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- A61M5/31578—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod
- A61M5/3158—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod performed by axially moving actuator operated by user, e.g. an injection button
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- 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
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- 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
- A61M5/31585—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 axially moving actuator, e.g. an injection button
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- A61M5/3202—Devices for protection of the needle before use, e.g. caps
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Description
自己投与のため、すなわちユーザ自身によって薬剤を送達するための薬剤送達装置が多数開発されている。そのためには、薬剤送達装置が、できる限り安全に使用できかつ取扱が容易なものでなければならない。これら条件を満たすためには、人的過誤の危険性を最小にしなければならず、一回分の投与量を受けるために行なわねばならない操作の数を少なくする必要があり、装置が直感的にかつ人間工学に基づいて使用されるものでなければならない。したがって、人的過誤の危険性を最小にするためには、薬剤送達装置をできる限り予め組立てておくことが望ましい。
本発明の目的は、取扱および起動時に信頼性が高く使用し易い薬剤送達装置を提供することである。この目的は、以下の薬剤送達装置によって達成される。この装置は、薬剤容器に対して作用して薬剤を放出させるように構成された駆動手段と、駆動手段を予め張力が加えられた状態で保持するように構成された保持手段と、保持手段と協働して駆動手段を予め張力が加えられた状態から解放するように構成された起動手段とを備え、この装置は、保持手段および駆動手段双方と協働して薬剤が完全に放出されたことを示す可聴および/または触知可能なおよび/または可視信号を発生するように構成されたフィードバック手段をさらに備える。
本願において、「遠位部分/端」という用語を使用するとき、この用語は、患者の薬剤送達部位から最も離れた場所に位置する、送達装置の部分/端部、または送達装置の部材の部分/端部を意味する。これに対し、「近位部分/端」という用語を使用するとき、この用語は、患者の薬剤送達部位に最も近い場所に位置する、送達装置の部分/端部、または送達装置の部材の部分/端部を意味する。
に、筒状伸長部22の近位端上の環状面の上に位置するようにされている。
Claims (10)
- 薬剤送達装置(1)であって、
近位端(11)とその反対側の遠位端(12)とを有する筒状ハウジング(20)と、
薬剤容器に対して作用して薬剤を放出させるように構成された駆動手段と、
前記駆動手段を予め張力が加えられた状態で保持するように構成された保持手段と、
前記保持手段と協働して前記駆動手段を前記予め張力が加えられた状態から解放するように構成された起動手段とを備え、前記起動手段は、前記筒状ハウジング(20)に対してスライド可能な状態で同軸で配置された筒状起動部材(30)であり、
前記筒状起動部材(30)内に同軸で配置され前記筒状ハウジング(20)に対して固定される状態で装着された容器ホルダ(50)を備え、前記薬剤容器(80)は前記容器ホルダ(50)内に配置され、前記薬剤容器は、予め定められた量の薬剤、スライド可能なストッパ(83)、および送達部材(61)を含み、
前記駆動手段は、プランジャロッド(90)と、予め張力が加えられた状態で前記プランジャロッド内に配置された第1の弾性部材(91)とを含み、前記プランジャロッドは、前記薬剤容器内で前記スライド可能なストッパと接触するように配置され、
前記保持手段は、前記筒状ハウジング(20)の遠位端に固定される状態で接続された筒状伸長部(22)と、前記筒状伸長部および前記筒状起動部材双方と協働するように接続された筒状操作部材(100)とであり、前記筒状起動部材が送達部位に対して押されると、前記筒状操作部材が前記筒状伸長部に対して回転することにより、前記駆動手段が、前記予め張力が加えられた状態から解放され、前記スライド可能なストッパ(83)に圧力が加わることによって薬剤が放出され、
前記装置は、前記保持手段および前記駆動手段双方と協働して前記薬剤が完全に放出されたことを示す可聴および/または触知可能なおよび/または可視信号を発生するように構成されたフィードバック手段をさらに備え、
前記フィードバック手段は、前記筒状伸長部および前記駆動手段と協働するように接続された、長手方向に延在する信号発生部材(110)であり、前記プランジャロッドが前記筒状伸長部および前記長手方向に延在する信号発生部材から完全に解放されると、前記長手方向に延在する信号発生部材は、前記筒状伸長部から解放されるとともに、前記第1の弾性部材の残りの力によって遠位方向に移動させられ、前記薬剤が完全に放出されたことを示す可聴および/または触知可能なおよび/または可視信号を発生する、薬剤送達装置。 - 前記筒状操作部材(100)は、前記筒状起動部材(30)の対応する第1の相互作用手段(35)と協働するように接続された第1の相互作用手段(101,102)と、前記筒状伸長部(22)の対応する第2の相互作用手段(121)と協働するように接続された第2の相互作用手段(105)とを含み、
前記プランジャロッド(90)は、前記筒状伸長部(22)の前記対応する第2の相互
作用手段(121)と協働するように接続された解放可能な係合手段(94)と、前記スライド可能なストッパ(83)と接触する近位端壁(122)とを含み、
前記長手方向に延在する信号発生部材(110)は、前記筒状伸長部(22)の内面上に解放可能な状態で配置され、
前記第1の弾性部材(91)は、前記プランジャロッド(90)の近位端壁と接する第1の端部(92)と、前記信号発生部材(110)の横断壁(112)と接する第2の端部(93)とを有する、請求項1に記載の薬剤送達装置(1)。 - 前記第2の相互作用手段(105)は、前記筒状操作部材(100)の内面の溝を含み、前記筒状伸長部(22)の前記対応する第2の相互作用手段(121)は、径方向内向きの突起を有する弾性の突起部分を含む、請求項2に記載の薬剤送達装置(1)。
- 前記解放可能な係合手段(94)は、前記予め張力が加えられた状態で前記駆動手段を保持するようにされた前記弾性の突起部分(121)の前記径方向内向きの突起と解放可能な状態で係合する前記プランジャロッド(90)の外面の溝を含む、請求項3に記載の薬剤送達装置(1)。
- 前記第1の相互作用手段(101,102)は、前記筒状操作部材(100)の外面の溝を含み、前記対応する第1の相互作用手段(35)は、前記筒状起動部材(30)の内面の遠位端上の径方向内向きに延びる突起を含み、前記径方向内向きに延びる突起(35)は、前記筒状操作部材(100)の外面の溝(101,102)内で案内され、前記筒状操作部材(100)を、前記筒状起動部材(30)が遠位方向に移動したときに、回転させるようにされ、これにより、前記弾性の突起部分(121)は、前記筒状操作部材(100)の内面の溝(105)内に径方向外側に撓み、前記径方向内向きに延びる突起(35)と前記プランジャロッド(90)の外面の溝(94)との係合が解除されて、前記駆動手段が前記予め張力が加えられた状態から解放される、請求項4に記載の薬剤送達装置(1)。
- 前記信号発生部材(110)は、横断壁(112)と、径方向外向きに延びる角度を付けて曲げられた支持部材(113)を有し長手方向に延在する2つの可撓性アーム(111)とを含む、細長いU字型ブラケットであり、前記支持部材(113)は、前記駆動手段が前記予め張力が加えられた状態のとき前記筒状伸長部(22)の環状の近位端の上に載るようにされている、請求項2〜5のいずれか1項に記載の薬剤送達装置(1)。
- 前記U字型ブラケット(110)の前記横断壁(112)は、前記駆動手段が前記予め張力が加えられた状態のとき前記筒状伸長部(22)の内側の遠位面から予め定められた距離Dの場所に配置されている、請求項6に記載の薬剤送達装置(1)。
- 前記プランジャロッド(90)の遠位端が前記支持部材(113)を通過したときに薬剤送達が実施されたことの確認のための可聴信号が生成され、前記長手方向に延在する可撓性アーム(111)が前記支持部材(113)とともに解放されて径方向内向きに移動することにより、前記U字型ブラケット(110)は、前記第1の弾性部材(91)によって加えられる残りの力によって遠位方向に予め定められた距離Dだけ移動することができ、これにより、前記ブラケットの横断壁(112)が前記筒状伸長部(22)の前記内側の遠位面に当たる、請求項7に記載の薬剤送達装置(1)。
- 前記U字型ブラケット(110)の前記横断壁(112)は遠位方向に延びる突起を含み、前記筒状伸長部(22)の遠位面は貫通孔を含み、前記U字型ブラケット(110)の前記横断壁(112)が前記筒状伸長部(22)の内側の遠位面に当たると、前記遠位方向に延びる突起が、前記貫通孔を通過し遠位方向に予め定められた距離だけ前記筒状伸
長部(22)の前記外面の上で延びて触知可能な信号を発生する、請求項7または8に記載の薬剤送達装置(1)。 - 前記遠位方向に延びる突起は、前記装置の残りの部分と比較して明るいおよび/または異なる色を有することによって可視信号を発生する、請求項9に記載の薬剤送達装置(1)。
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