JP2017531459A - 薬剤送達デバイス用センサシステム - Google Patents
薬剤送達デバイス用センサシステム Download PDFInfo
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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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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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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
- A61M5/44—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 having means for cooling or heating the devices or media
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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
- A61M5/44—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 having means for cooling or heating the devices or media
- A61M5/445—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 having means for cooling or heating the devices or media the media being heated in the reservoir, e.g. warming bloodbags
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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
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- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3368—Temperature
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- A61M2205/00—General characteristics of the apparatus
- A61M2205/36—General characteristics of the apparatus related to heating or cooling
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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
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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
- A61M2205/6027—Electric-conductive bridges closing detection circuits, with or without identifying elements, e.g. resistances, zener-diodes
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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
- A61M2205/6054—Magnetic identification systems
Abstract
Description
本特許出願は:2014年11月17日出願の米国仮特許出願第62/080,603号;2014年8月28日出願の米国仮特許出願第62/043,217号;及び2014年8月28日出願の米国仮特許出願第62/043,239号の利益を主張するものであり、上記仮特許出願はそれぞれ、あらゆる目的のためにその全体が参照によって本出願に援用される。
52 ハウジング
52A 内部ハウジング表面
54 カートリッジ、薬剤カートリッジ
56 バレル
60 剛性針シールド
62 プランジャロッド
64 プランジャシール
68 プランジャヘッド
70 拡張フィンガフランジ
72 カートリッジカバー
74 窓
76 遠位デテント
78 噛合突出部
80 ケーシング本体
86 ラッチ
88 突出部
90 凹部
92 ラッチリリース
96 ユーザインタフェース
98 ライト
102 細長フレーム
104 駆動制御機構
106 モータ
108 エネルギ源
110 伝動組立体
114 駆動ねじ
126 カートリッジキャリア
138 プランジャキャリア
182 カートリッジイジェクタ組立体
501 起動ボタン
520 温度センサ
530 キャリッジベッド
535 可撓性クリップ
537 凹部
540 ライナー
550 可撓性ケーブルコネクタ
600 自動注射器制御システム
605 主要制御ユニット
610 電気駆動ユニット、駆動ユニット
615 カートリッジカバーセンサ
620 エネルギ源センサ、バッテリセンサ
625 針シールドセンサ
630 タイマーユニット
635 表示ユニット
640 オンボードメモリストレージ、メモリストレージ、メモリ記憶ユニット、記憶ユニット
645 カートリッジセンサ
650 温度制御要素、ヒータ
655 温度センサ‐A、ヒータセンサ、ヒータ温度センサ
660 温度センサ‐B、薬剤又は薬剤カートリッジ温度センサ
680 通信ユニット
810 センサ、RFIDタグセンサ、タグセンサ、データタグセンサ、カートリッジIDセンサ
810A センサアンテナトレース
810B 接続点
810C 供給ライン
820 機械可読タグ、タグ、シリンジ又はカートリッジタグ、パッシブタグ、RFIDタグ、インレイ
820A アンテナコンダクタトレース
820B 集積回路、IC
830 トランシーバ
850 センサキャリッジ
850A スナッププロング、点
850B スナッププロング、点
850C 点
Claims (30)
- 薬剤を内包するカートリッジの温度を感知及び制御するよう構成された、薬剤送達デバイスのための温度制御システムであって、
前記温度制御システムは:
前記カートリッジに近接するよう構成され、かつ前記薬剤を温めるよう構成された、ヒータ;
前記ヒータに近接して位置決めされ、前記ヒータの第1の温度値を検出するよう構成された、第1の温度センサ;
前記カートリッジに近接して位置決めされ、前記薬剤の第2の温度値を検出するよう構成された、第2の温度センサ;並びに
前記ヒータ、前記第1の温度センサ及び前記第2の温度センサに電気的に接続された、第1の制御ユニット
を備え、
前記第1の制御ユニットは:
前記ヒータの検出された前記第1の温度値が、第1の警告設定点温度値未満であるかどうか、及び前記薬剤の検出された前記第2の温度値が薬剤作用温度値の範囲内であるかどうかを決定するよう;並びに
前記検出された第1の温度値が前記第1の警告設定点温度値未満であること、及び前記検出された第2の温度値が薬剤作用温度値の範囲内ではないことの決定に基づいて、前記薬剤の検出された前記第2の温度値を、薬剤作用温度値の範囲内である前記薬剤の作用温度値へと調整するよう、構成される、温度制御システム。 - 前記第1の制御ユニットは、前記検出された第1及び第2の温度値をそれぞれ前記第1及び第2の温度センサから受信する、フィードバック制御ユニットである、請求項1に記載の温度制御システム。
- 前記第1の制御ユニットは、前記ヒータの前記検出された第1の温度値、及び前記薬剤の前記検出された第2の温度値が、前記第1の警告設定点温度値超又は第2の警告設定点温度値未満であることを決定するとすぐに、エラー信号を送信する、請求項1又は2に記載の温度制御システム。
- 前記第1の警告設定点温度値及び前記第2の警告設定点温度値は、前記第1及び第2の温度センサそれぞれの記憶ユニットにプログラムされた、所定値である、請求項1〜3のいずれか1項に記載の温度制御システム。
- 前記検出された第2の温度値の調整は更に、前記ヒータの前記第1の温度値を監視しながら前記薬剤を所定の時間内で温めるための、前記第1の制御ユニットによる、前記ヒータへの命令信号の送信を含む、請求項1〜4のいずれか1項に記載の温度制御システム。
- 前記第1の制御ユニットは、前記ヒータによって前記薬剤を前記所定の時間内で温めるための、前記送信された命令信号を、前記薬剤の熱プロファイルに基づいて制御する、請求項5に記載の温度制御システム。
- 前記第1の制御ユニットは、前記第2の温度値が前記所定の時間内に前記作用温度へと調整されなかったことを決定するとすぐに、前記第1の制御ユニットに連結された表示ユニットに別のエラー信号を送信する、請求項1〜6のいずれか1項に記載の温度制御システム。
- 前記第1の制御ユニットは、前記検出された第2の温度を前記作用温度へと調整するとすぐに、前記カートリッジからの薬剤送達に関連する1つ又は複数の動作を起動することをユーザに要求する、請求項1〜7のいずれか1項に記載の温度制御システム。
- 前記第1の制御ユニットは更に、前記薬剤の前記検出された第2の温度の調整後に、前記第1の制御ユニットに連結された記憶ユニットに、前記作用温度値を記憶する、請求項1〜8のいずれか1項に記載の温度制御システム。
- 前記作用温度値の範囲は、前記作用温度値のパーセンテージとなるようにプログラムされた上限値及び下限値を有する、請求項1〜9のいずれか1項に記載の温度制御システム。
- 前記第1の制御ユニットは、ユーザから起動信号を受信するとすぐに、前記薬剤を内包する前記カートリッジの温めの開始を指示する命令信号を前記ヒータに送信する、請求項1〜10のいずれか1項に記載の温度制御システム。
- 薬剤を内包するカートリッジを識別するよう構成された、薬剤送達デバイス用の識別システム又は識別センサシステムであって、
前記識別システムは:
制御ユニット;及び
前記制御ユニットに電気的に接続されたタグセンサ
を備え、
前記制御ユニットは、前記カートリッジの存在を検出するとすぐに、前記タグセンサを起動させて、前記カートリッジとの非接触通信を開始する、識別システム。 - 前記カートリッジの存在を示すステータス信号を前記制御ユニットに送信するよう構成された、カートリッジセンサを更に含む、請求項12に記載の識別システム。
- 前記タグセンサは、前記非接触通信を開始するために、前記カートリッジに対して質問信号を発する、請求項12又は13に記載の識別システム。
- 前記タグセンサは弓形であり、
前記タグセンサは、前記カートリッジの表面に添付されたカートリッジタグと略弓状に整列する、請求項12〜14のいずれか1項に記載の識別システム。 - 前記非接触通信は無線通信であり、
前記タグセンサは、前記カートリッジタグと略整列されるとすぐに、前記質問信号によって前記カートリッジタグを電磁的に刺激する、請求項15に記載の識別システム。 - 前記タグセンサは、前記質問信号が前記カートリッジタグを刺激した場合に、前記カートリッジから応答信号を受信し、
前記応答信号は、前記カートリッジが内包する前記薬剤に関連する情報を含む、請求項15又は16に記載の識別システム。 - 前記制御ユニットは、前記カートリッジタグが、前記タグセンサが受信する情報に基づいて可読であるかどうかを決定する、請求項15〜17のいずれか1項に記載の識別システム。
- 前記制御ユニットは更に、前記カートリッジタグが可読である場合に、前記カートリッジの識別を決定する、請求項15〜17のいずれか1項に記載の識別システム。
- 通信ユニットを更に含み、
前記通信ユニットは、前記カートリッジの前記識別に基づいて、前記通信ユニットを介して遠隔コンピュータデバイスと情報交換することによって、前記カートリッジタグからの前記情報が有効であるかどうかを更に決定する、請求項19に記載の識別システム。 - 前記情報は:
前記薬剤の使用期限;
製造識別情報(ID);及び
前記薬剤の薬剤ID
からなる群から選択されるパラメータを含み、
前記制御ユニットは、前記パラメータのうちの少なくとも1つ又は組み合わせに基づいて、前記薬剤が使用のために許容可能であるか、又はリコールされているかを決定する、請求項17〜20のいずれか1項に記載の識別システム。 - 前記制御ユニットは、前記カートリッジタグから前記情報を受信するとすぐに、薬剤送達プロセスに関連する1つ又は複数のパラメータを構成する、請求項17〜21のいずれか1項に記載の識別システム。
- 薬剤を内包するカートリッジを受承するよう適合された、自動注射器(automatic injector:AI)デバイスであって、
前記AIデバイスは、バレルと、針と、プランジャシールを含むプランジャ組立体とを含み、
前記カートリッジは長手方向軸を画定し、
前記AIデバイスは:
ハウジング;
前記カートリッジの少なくとも一部分を受承するよう適合されたカートリッジキャリアであって、前記カートリッジキャリアは、前記ハウジングに対して、前記カートリッジの前記長手方向軸に平行な方向に移動するよう配置される、カートリッジキャリア;
前記カートリッジキャリアに対して移動するよう配置されたプランジャキャリア;
前記プランジャキャリアに連結された細長駆動デバイスであって、前記細長駆動デバイスは、前記カートリッジの前記長手方向軸に平行な方向の前記プランジャキャリアの移動を提供するよう配置される、プランジャキャリア;
モータ;
前記モータを前記細長駆動デバイスに連結する伝動組立体;
請求項1〜11のいずれか1項に記載の温度制御システム;
請求項12〜22のいずれか1項に記載の識別システム;並びに
第2の制御ユニットであって:
前記識別システムのタグセンサから受信した前記薬剤の情報を処理し;
処理された前記情報の少なくとも一部分に基づいて、前記温度制御システムのヒータの検出された第1の温度値が、第1の警告設定点温度値未満であるかどうか、及び前記薬剤の検出された第2の温度値が、薬剤作用温度値の範囲内であるかどうかを決定し;
更に、前記処理された情報に基づいて、前記モータを制御する
よう構成された、第2の制御ユニット
を備える、AIデバイス。 - 前記第2の制御ユニットは、前記タグセンサが起動されており、かつ前記薬剤情報を無線で受信したことを示す起動信号を前記タグセンサから受信するとすぐに、命令信号を前記ヒータに送信する、請求項23に記載のAIデバイス。
- 前記検出された第2の温度値の調整は、前記カートリッジタグから受信された温め期間情報に基づいて、所定の時間内に前記薬剤を温めるための、前記ヒータへの命令信号の送信を更に含む、請求項23又は24に記載のAIデバイス。
- 前記第2の制御ユニットは、前記薬剤の前記検出された第2の温度の調整後の作用温度値、及び取得された前記薬剤データを、前記通信ユニットを介して、遠隔記憶ユニットに記憶する、請求項23〜25のいずれか1項に記載のAIデバイス。
- 前記第2の制御ユニットは、前記温度制御センサ及び前記識別システムのうちの少なくとも1つから受信した情報に基づいて、前記針が前記ハウジング内にある第1の位置から、前記針が前記ハウジングから遠位に延伸する第2の位置へと、前記カートリッジを移動させるように、前記カートリッジキャリアを制御する、請求項23〜26のいずれか1項に記載のAIデバイス。
- 前記第2の制御ユニットは、前記温度制御システムの前記第1の制御ユニット、及び前記識別システムの前記制御ユニットと同一である、請求項23〜27のいずれか1項に記載のAIデバイス。
- 前記タグセンサを受承するよう構成されるセンサキャリッジを更に備え、
前記制御ユニットは、前記センサキャリッジ内の前記カートリッジの存在を検出するとすぐに、前記タグセンサを起動して、前記カートリッジとの非接触通信を開始する、請求項23〜28のいずれか1項に記載のAIデバイス。 - 前記プランジャキャリアの運動は、前記タグセンサが前記カートリッジタグから受信した情報に基づいて、前記制御ユニットによって制御され、これによって薬剤送達の速度を制御できる、請求項23〜29のいずれか1項に記載のAIデバイス。
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AU2015308670B2 (en) | 2020-04-30 |
IL250659A0 (en) | 2017-04-30 |
US20180236181A1 (en) | 2018-08-23 |
MX2017002428A (es) | 2017-05-15 |
US10799649B2 (en) | 2020-10-13 |
CA2959162A1 (en) | 2016-03-03 |
CA2959162C (en) | 2023-02-28 |
WO2016033507A2 (en) | 2016-03-03 |
EP3733228A1 (en) | 2020-11-04 |
AU2015308670A1 (en) | 2017-03-09 |
EP3185933B1 (en) | 2020-08-19 |
BR112017002848A2 (pt) | 2018-01-30 |
EP3733228B1 (en) | 2024-03-06 |
WO2016033507A3 (en) | 2016-04-21 |
CN107073216A (zh) | 2017-08-18 |
ES2834023T3 (es) | 2021-06-16 |
JP6752777B2 (ja) | 2020-09-09 |
EP3185933A2 (en) | 2017-07-05 |
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