JP2018519001A - 調合デバイス、システム、キット、ソフトウエア、および方法 - Google Patents
調合デバイス、システム、キット、ソフトウエア、および方法 Download PDFInfo
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- JP2018519001A JP2018519001A JP2017556220A JP2017556220A JP2018519001A JP 2018519001 A JP2018519001 A JP 2018519001A JP 2017556220 A JP2017556220 A JP 2017556220A JP 2017556220 A JP2017556220 A JP 2017556220A JP 2018519001 A JP2018519001 A JP 2018519001A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/002—Compounding apparatus specially for enteral or parenteral nutritive solutions
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- A—HUMAN NECESSITIES
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- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/22—Valves or arrangement of valves
- A61M39/223—Multiway valves
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2048—Connecting means
- A61J1/2058—Connecting means having multiple connecting ports
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- A—HUMAN NECESSITIES
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- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
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- A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
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- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
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Abstract
Description
2 移送セット
3 成分フレーム
4a マイクロ容器、マイクロ貯蔵容器、ソース容器
4b マクロ容器、マクロ貯蔵容器、マクロ・ソース容器
10 ハウジング、メイン・ハウジング
10c 凹み、浅いトレイ、トレイの凹み、プラットフォーム
10d 第2の浅いポンプ・トレイの凹み、プラットフォーム
10e センサ・ブリッジ
10f センサ・ブリッジ・カバー
10g ポンプ・カバー
18 アウトプット・ガイド、ノッチ
20 多岐管、多岐管アッセンブリ
20a マイクロ・インプット・ライン・ポート、マイクロ・ポート
20ah マイクロ・バルブ・ハウジング
20b マクロ・インプット・ライン・ポート、マクロ・ポート
20bf フレックス・ポート
20bfh バルブ・ハウジング
20bh バルブ・ハウジング、マクロ・バルブ・ハウジング
21a バルブ、マイクロ・バルブ
21b バルブ、マクロ・バルブ
21bf バルブ
21bh バルブ・ハウジング
24a 第1のチャンネル、チャンネル
24b 第2のチャンネル
25a マイクロ吐出口、マイクロ吐出口
25b マクロ吐出口
26 ソケット
27a クリップ
27b クリップ
29 センサ構造
29h ハウジング
29m 磁石
33 張力解放クリップ、クリップ
33a 上側部分
33b バブル・センサ、下側部分
33c 通過路
33d カラー
33g シャント
33h ガイド・スリーブ
33i クリップ
33o 閉塞センサ
33r リッジ
33s リッジ
40 ポンプ
41 ポンプ、ロータ
41s ステッパ・モータ
42 ポンプ、ロータ
42s ステッパ・モータ
43a 第1のプラテン、プラテン
43b 第2のプラテン、プラテン
44a プラテン・ロック、ロック・アーム
44b プラテン・ロック
60 ユニオン・ジャンクション、ジャンクション
60a マイクロ・インプット・ライン取り入れポート
60b マクロ・インプット・ライン取り入れポート
60c マクロ・インプット・ライン・タイダウン
60e ハンドル
60f クリップ・ロック、可撓性ばねロック
61 ユニオン・ジャンクション・ライン、ジャンクション・ライン
62 孤立リブ
63 吐出ポート
65 ピン・ボス
70 排出トレイ、バッグ・トレイ
71 ロード・セル
80 経静脈流体バッグ、IV流体バッグ、収容バッグ、流体バッグ
90 コントローラ接続
102a ステッパ・モータ
102a' バルブ・アクチュエータ
102b ステッパ・モータ
102b' バルブ・アクチュエータ、突出部
200 フィラー
201 ロッド、フィラー・ロッド
202 スペーサ、ベーン
203 クリップ・ロック
203a 可撓性タブ
203b 開口
204 シール部材、Oリング
204a 受け溝
21b1 取り入れ口
21b2 壁
21b3 吐出口
21b4 アクチュエータ接続スロット、スロット
441 延長部、上側延長部
442 延長部、下側延長部
442m 第2の磁石
443 ばね
444 カム
445 止めねじ構造
445s 止めねじ
446 磁石
449 回転ポスト、ポスト
449m ロック構造、第1の磁石
801 タグ
802 識別タグ
1330 バッグ・トレイ・ピン
1340 バッグ・トレイ・クリップ
1350 バッグ受け入れセクション、ツイスト・ロック
1360 ポート
1380 開口
1390 マニュアル・ポート
2011 マイクロ・ライン、マイクロ・インプット・ライン、取り入れ口ライン
2021 マクロ・ライン、取り入れ口ライン
2031 アウトプット・ライン、吐出口ライン、混合流体ライン
2071 ジャンクション
2900 コントローラ
2901 センサ
2902 センサ
2904a センサ
2910 センサ
Claims (28)
- 医薬調合デバイスに用いられるジャンクション構造であって、
前記調合デバイスは、ポンプシステムおよびバルブ機構を支持するためのハウジングを有し、
前記ジャンクション構造は、
ジャンクション本体と、
前記ジャンクション本体の第1の部分に位置する第1の取り入れポートと、
前記ジャンクション本体の第2の部分に位置する第2の取り入れポートと、
前記ジャンクション本体の第3の部分に位置する吐出ポートと、
前記吐出ポートと前記第1および第2の取り入れポートとの間に位置する混合チャンバーであって、前記第1および第2の取り入れポートの両方から受け入れた流体を混合し、当該流体を前記吐出ポートに移送する混合チャンバーと、
前記ジャンクション本体上に位置し、前記ジャンクション構造を前記調合デバイスの前記ハウジングに取り付けるべく構成された取り付け構造と、を備えるジャンクション構造。 - 前記第1の取り入れポートは流体用の第1の流路を規定し、前記第2の取り入れポートは流体用の第2の流路を規定し、
前記第1の取り入れポートにより規定された前記第1の流路は、当該第1の流路に対し直角に取られたマイクロ断面域を有し、
前記第2の取り入れポートにより規定された前記第2の流路は、当該第2の流路に対し直角に取られたマクロ断面域を有し、
前記マイクロ断面域は、前記マクロ断面域よりも小さい、請求項1に記載のジャンクション構造。 - 前記吐出ポートにより規定された吐出流路は、当該吐出流路に対し直角に取られ、前記マクロ断面域と同じかこれより大きい吐出断面域を有する、請求項2に記載のジャンクション構造。
- 前記取り付け構造は、前記ジャンクション本体の低い側の表面から延び、かつ、前記調合デバイスの前記ハウジングにある対応ロック構造に嵌合するように構成された少なくとも1つのクリップを有する、請求項1に記載のジャンクション構造。
- 前記少なくとも1つのクリップが、第1のクリップおよび第2のクリップを有し、
前記取り付け構造が、前記ジャンクション本体の上面から離れる方向に、かつ、前記第1のクリップから離れる方向に延びる第1のハンドルと、前記ジャンクション本体の上面から離れる方向に、かつ、前記第2のクリップから離れる方向に延びる第2のハンドルとを有する、請求項4に記載の取り付け構造。 - 前記ジャンクション本体が、ジャンクションプレートとして構成され、
前記第1の取り入れポート、前記第2の取り入れポート、前記吐出ポートおよび前記混合チャンバーが、ジャンクションラインとして構成され、
前記ジャンクションプレートが、前記ジャンクションラインを受け入れるように構成された凹部を有する、請求項1に記載のジャンクション構造。 - 前記ジャンクションプレートは、単一部品の集積構造であり、
前記ジャンクションラインは、前記ジャンクションプレートに取り付けられるよう構成された単一部品の集積構造である、請求項6に記載のジャンクション構造。 - 前記ジャンクションプレートが、前記ジャンクションプレートの前記凹部に前記ジャンクションラインを固定するよう構成されたロック構造を有する、請求項6に記載のジャンクション構造。
- 前記ジャンクション本体の低い側の表面から延び、当該ジャンクション本体が取り付けられる前記調合デバイスの表面に対し前記ジャンクション本体が間隔をあけるよう構成された孤立構造を備える、請求項1に記載のジャンクション構造。
- 前記混合デバイスの前記バルブ機構に取り付けられるよう構成された多岐管と、
前記多岐管から前記ポンプシステムおよび前記ジャンクション本体に延びるマクロラインと、
前記多岐管から前記ポンプシステムおよび前記ジャンクション本体に延びるマイクロラインと、をさらに備え、
前記ジャンクション本体、前記第1の取り入れポート、前記第2の取り入れポート、および前記混合チャンバーは、前記ポンプシステムに対し下流側に位置し、かつ、前記マイクロラインおよび前記マクロラインからの流体が前記ポンプシステムを通過した後、前記混合チャンバーで混合されるよう構成された、請求項1に記載のジャンクション構造。 - 前記マクロラインおよび前記マイクロラインは、前記ジャンクション本体の上流側で互いに流体隔離されている、請求項10に記載のジャンクション構造。
- 前記多岐管は、マイクロチャンネルおよびマクロチャンネルを有し、
前記マイクロチャンネルの長さ方向の軸に対し直角に取った断面積が、是木マクロチャンネルの長さ方向の軸に対し直角に取った断面積よりも小さい、請求項11に記載のジャンクション構造。 - 医薬混合デバイスであって、
第1のバルブに接続された第1の流体ソースと、
第2のバルブに接続された第2の流体ソースと、
第3のバルブに接続された第3の流体ソースと、
前記第1のバルブのアウトプットと流体連通し、マイクロポンプ機構に延びる第1のラインと、
前記第2のバルブのアウトプットおよび前記第3のバルブのアウトプットと流体連通し、マクロポンプ機構に延びる第2のラインと、
前記マイクロポンプ機構および前記マクロポンプ機構の両方の下流側に位置し、前記第2の流体ソースからの流体および前記第3の流体ソースからの流体が前記マイクロポンプ機構および前記マクロポンプ機構を過ぎた後に前記第1の流体ソースからの流体とが結合されるように前記第1のラインと前記第2のラインとを接合するべく構成したジャンクション構造と、を備える医薬調合デバイス。 - 前記第1のラインは、前記第2のラインの長さ方向の軸に対して直角に取った当該第2のラインの断面積よりも小さい、当該第1のラインの長さ方向の軸に対して直角に取った断面積を有する、請求項13に記載の医薬混合デバイス。
- 前記第1のラインと前記第2のラインとは、前記ジャンクション構造までこれらが流体的に完全に分かれているよう、互いに隔離されている、請求項13に記載の医薬混合デバイス。
- 前記第1のラインに接続されるよう構成されたマイクロチャンネルと、前記第2のラインに接続されるよう構成されたマクロチャンネルとを有する多岐管をさらに備え、
前記マイクロチャンネルの長さ方向の軸に対し直角に取った断面積は、前記マクロチャンネルの長さ方向の軸に対して直角に取った断面積よりも小さく、
前記多岐管は、流体が当該多岐管を通過し、その後前記マイクロポンプ機構および前記マクロポンプ機構を通過するように、前記マイクロポンプ機構および前記マクロポンプ機構の上流側に位置する、請求項13に記載の医薬混合デバイス。 - 前記第1のバルブは、前記多岐管の前記マイクロチャンネルの近傍に、かつ流体連通するように位置にしており、
前記第2のバルブおよび前記第3のバルブは、前記多岐管の前記マクロチャンネルの近傍に、かつ流体連通するように位置する、請求項16に記載の医薬混合デバイス。 - 前記マイクロチャンネルの内径は、前記マクロチャンネルの内径と等しい、請求項17に記載の医薬混合デバイス。
- 前記マクロポンプ機構および前記マイクロポンプ機構を支持するハウジングをさらに備え、
前記ジャンクション構造は、各々が前記第1のラインおよび前記第2のラインの1つを取り付けるよう構成された2つの取り入れポートと、当該ジャンクション構造を前記ハウジングに取り付けるよう構成された取り付け構造と、を有する、請求項13に記載の医薬混合デバイス。 - 前記ジャンクション構造が、混合チャンバーおよび吐出ポートを有する、請求項13に記載の医薬混合デバイス。
- 前記マクロポンプ機構および前記マイクロポンプ機構を支持するハウジングをさらに備え、
前記ジャンクション構造は、当該ジャンクション構造の低い側の表面から延び、当該ジャンクション構造が取り付けられる前記ハウジングの表面から前記ジャンクション構造が間隔をあけるよう構成された孤立構造を有する、請求項13に記載の医薬混合デバイス。 - 医薬混合デバイスとともに用いられる移送セットキットであって、
複数のマイクロインプットラインであり、それぞれの前記複数のマイクロインプットラインの長さ方向の軸に対し直角に取った断面積を有する複数のマイクロインプットラインと、
複数のマクロインプットラインであり、それぞれの前記複数のマクロインプットラインの長さ方向の軸に対し直角に取った断面積を有し、各々の前記マイクロインプットライン内の流体が各々の前記マクロインプットライン内の流体と隔離されるよう前記マクロインプットラインの各々が前記マイクロインプットラインの各々と分離され区別された複数のマクロインプットラインと、
マイクロチャンネルおよび当該マイクロチャンネルから分離され流体隔離されたマクロチャンネルを有する多岐管であって、当該多岐管は、各々が前記複数のマイクロインプットラインのそれぞれの1つと接続されるよう構成された複数のマイクロポートと、各々が前記複数のマクロインプットラインのそれぞれの1つと接続されるよう構成された複数のマクロポートとを有し、前記マイクロインプットラインの各々の断面積が前記マクロインプットラインの各々の断面積よりも小さい多岐管と、
前記マイクロチャンネルのマイクロアウトプットポートに接続されるように構成されたアウトプットマイクロインプットラインと、
前記マクロチャンネルのマクロアウトプットポートに接続されるように構成されたアウトプットマクロインプットラインと、
前記アウトプットマイクロインプットラインと前記アウトプットマクロインプットラインとを接合するよう構成されたジャンクション構造と、を備えた移送セットキット。 - 前記ジャンクション構造を前記調合デバイスのハウジングに接続するよう構成された少なくともジャ1つのンクション構造クリップをさらに備えた、請求項22に記載の移送セットキット。
- 前記ジャンクション構造が、最終容器との流体接続のための取り付け構造を有する、請求項22に記載の移送セットキット。
- 前記ジャンクション構造が、混合チャンバーおよび吐出ポートを有する、請求項22に記載の移送セットキット。
- 前記ジャンクション構造が、前記ジャンクション構造の低い側の表面から延び、当該ジャンクション構造が取り付けられる前記調合デバイスの表面に対し前記ジャンクション構造が間隔をあけるよう構成された孤立構造を備える、請求項22に記載の移送セットキット。
- 前記ジャンクション構造のアウトプットポートから延びるジャンクションアウトプットラインをさらに備え、
前記孤立構造は、前記アウトプットマイクロインプットラインおよび前記アウトプットマクロインプットラインの各々が共通面内にほぼ含まれるよう、かつ、前記ジャンクションアウトプットラインが前記共通面内で前記ジャンクション構造から離れる方向に延びるよう構成された、請求項26に記載の移送セットキット。 - 前記第1のハンドルは、利用者により当該第1のハンドルに所定の力が加えられたときに前記ジャンクション本体の前記低い側の表面に対し前記第1のクリップを動かすよう構成され、
前記第2のハンドルは、利用者により当該第2のハンドルに所定の力が加えられたときに前記ジャンクション本体の前記低い側の表面に対し前記第2のクリップを動かすよう構成された、請求項5に記載の取り付け構造。
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