JP4681666B2 - 薬剤分配装置における気泡確認方法 - Google Patents
薬剤分配装置における気泡確認方法 Download PDFInfo
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- JP4681666B2 JP4681666B2 JP2009506040A JP2009506040A JP4681666B2 JP 4681666 B2 JP4681666 B2 JP 4681666B2 JP 2009506040 A JP2009506040 A JP 2009506040A JP 2009506040 A JP2009506040 A JP 2009506040A JP 4681666 B2 JP4681666 B2 JP 4681666B2
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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
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
-
- 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
- A61M5/36—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 with means for eliminating or preventing injection or infusion of air into body
- A61M5/365—Air detectors
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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
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
-
- 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
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/141—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor with capillaries for restricting fluid flow
-
- 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
- A61M5/14—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
- A61M5/1454—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons spring-actuated, e.g. by a clockwork
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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
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
- A61M5/16854—Monitoring, detecting, signalling or eliminating infusion flow anomalies by monitoring line pressure
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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
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
- A61M5/16854—Monitoring, detecting, signalling or eliminating infusion flow anomalies by monitoring line pressure
- A61M5/16859—Evaluation of pressure response, e.g. to an applied pulse
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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
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/16877—Adjusting flow; Devices for setting a flow rate
- A61M5/16881—Regulating valves
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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
- A61M2205/13—General characteristics of the apparatus with means for the detection of operative contact with patient, e.g. lip sensor
-
- 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
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3331—Pressure; Flow
- A61M2205/3355—Controlling downstream pump pressure
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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
- A61M2205/50—General characteristics of the apparatus with microprocessors or computers
-
- 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
- A61M5/14—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
-
- 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
- A61M5/14—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
- A61M5/1456—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 comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
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- Health & Medical Sciences (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Heart & Thoracic Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Physics & Mathematics (AREA)
- Fluid Mechanics (AREA)
- Emergency Medicine (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Description
果、定常流れ装置の欠点を解決する為に、投薬量の極めて大きな自由度を得るために、種々の「移植可能でプログラム可能な」ポンプが開発されてきた。このような移植可能でプログラム可能なポンプを取り扱うシステム要求の定義によれば、広いダイナミックレンジに渡ってプログラム可能な追加分泌流量と基礎分泌流量とを供給する装置が、普遍的なシステムの要件である。この要件は、実際には糖尿病の治療に対する指示書で主に述べられる。一定の時間毎に注入されるべき医薬(例、インシュリン)の量は、ある時間間隔で調整しなければならない。患者の要求は、所定の既知の割合で変動することがある。食品の摂取や他の一時的な状態によっては、不規則に変動することがある。これらの状態は、注入剤の投薬量の追加的投与を必要とする。しかし、日々のインシュリン投与において、患者は、例えば食事の時間などには、追加的分泌投薬に代えて、基礎分泌投薬を必要とする。基礎分泌投薬と追加分泌投薬の間の流量の差は、極めて大きく数倍になりうる。かくして、所望の流速で適切な流量を実現する装置は、極めて低い流量で連続的に注入でき、周期的に十分に増大した流量を供給できなければならない。このように、この種の薬剤投与装置の設計基準は、最初の段階では流量の選択を変更することが調整可能であるよう基礎分泌投薬を連続して分配する能力と、比較的高い流量で追加分泌投薬を分配する能力とを有さなければならない。
即ち、大気圧よりも約3気圧高い圧力)を超える動作圧が特に好ましい。その理由は、障害物の背後の圧力上昇により、流路全域で障害物を除去できるからである。流出口の圧力は、大気圧より若干高いので、圧力差ΔPの値は、大気圧と比較した貯蔵室の圧力の直接測定値として、使用される。
12 ばねで加圧された貯蔵室
14 流出口
16 第1バルブ
18 流れ規制部
20 第2バルブ
22 圧力センサー
28 制御部
30 温度センサー
130 一方向バルブ
図2、19
32 第2バルブを開ける
34 圧力読取値ΔPを得る
36 液体残量を計算する
38 液体残量を表示し低下したときはユーザーに警告する、
40 閉塞をチェックする
42 ユーザーに警告する
44 カテーテルの外れをチェックする、
46 ユーザーに警告する
48 両方のバルブを開いている時間を計算する、
50 第1バルブを開く
52 所定時間後に第2バルブを閉じる
54 僅かな所定時間後に第1バルブを閉じる
56 圧力読取値ΔP1を得る
58 所定時間後に圧力読取値ΔP2を得る
60 ΔP1とΔP2を比較する
62 第1バルブの漏れをユーザーに警告する
64 第2バルブの漏れをユーザーに警告する
66 サイクルを終了する
200 気泡の存在を確認するためにΔP1を予想値と比較する
202 気泡存在警告を発する
図3A: 貯蔵庫 流出口 通常の流れ 開
図3B: 閉塞 開
図3C: バルブ試験状態 定数 閉
図3D: 貯蔵庫内容量テスト 貯蔵庫は満杯 V1閉 V2開
図3E: 貯蔵庫内容量テスト 貯蔵庫は空 V1閉 V2開
図3F: 離脱 Pが増加している V1閉 V2開
図6: 時計回りに、PZT保持機構 第1バルブ、フィルタ 毛細管 入り口バルブ
スプリング スプリングガイド スプリングカバー 流体出口
図7 ピエゾ結合機構の断面 スプリング スプリング保持用ネジ部材 バルブ
図12: エラストマ ポンプ本体 針 膜 カートリッジ本体
図11: 第2ポート用針 差圧センサ 第1ポート用針
図13: フィルタ エラストマ カートリッジ本体 シール用リング ピストン
図14D: 3.毛細管の流路流体がボートと第2バルブ入口に行った後
4.第2バルブからカートリッジ出口に
図14F: 2.第1バルブから通路に
1.カートリッジ内の高圧が第1バルブ入口から第1ポートへ
図15: 第1バルブ−可変流れ規制部
図16: ソレノイドが針をエラストマ・シール部材内に押し込む
図20A、B: 貯蔵庫 出口
70 本体
72 カートリッジ
90 アクチュエータ組立
92 圧電層
94 圧電増幅器
100 カム
102 シャフト
104 ノブ
106 ボール
169 ピストン
Claims (3)
- 圧力源から流路を経て流出口へ液状薬剤を分配する液状薬剤の前記圧力源を有する薬剤分配装置であって、前記流路は第1バルブと第2バルブとを有し、前記第2バルブは、前記第1バルブよりも前記流出口の近くに配置されており、さらに、前記流路は前記第一バルブと前記第二バルブとの間に配置された流れ規制部を備えた、前記薬剤分配装置における、前記流路中の気泡の存在を確認する方法において、
(a)前記第1バルブと前記第2バルブとの間の圧力が、前記圧力源の圧力より低くなるよう、前記第1バルブと前記第2バルブとを操作するステップと、
(b)圧力蓄積期間のあいだ、前記第1バルブを開に、前記第2バルブを閉に維持するステップと、
(c)前記圧力蓄積期間の最後に、流路中の気泡の存在又は不存在を、前記第1バルブと前記第2バルブとの間の圧力測定に基いて、確認するステップと、
を有することを特徴とする気泡確認方法。 - 前記第1バルブと前記第2バルブとの間の圧力の測定が、前記圧力源と前記第1、第2バルブ間の流路中の流体との間の、差圧測定によって行われることを特徴とする請求項1に記載の方法。
- 前記第1バルブが前記圧力蓄積期間の終わりに閉じられることを特徴とする請求項1または請求項2に記載の方法。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/379,791 US7311693B2 (en) | 2001-11-26 | 2006-04-23 | Drug delivery device and method |
PCT/IL2007/000505 WO2007122621A2 (en) | 2006-04-23 | 2007-04-23 | Drug delivery device and method |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
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JP2011022823A Division JP5097831B2 (ja) | 2006-04-23 | 2011-02-04 | 薬剤分配装置における気泡確認方法 |
Publications (2)
Publication Number | Publication Date |
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JP2009538640A JP2009538640A (ja) | 2009-11-12 |
JP4681666B2 true JP4681666B2 (ja) | 2011-05-11 |
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Application Number | Title | Priority Date | Filing Date |
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JP2009506040A Expired - Fee Related JP4681666B2 (ja) | 2006-04-23 | 2007-04-23 | 薬剤分配装置における気泡確認方法 |
JP2011022823A Expired - Fee Related JP5097831B2 (ja) | 2006-04-23 | 2011-02-04 | 薬剤分配装置における気泡確認方法 |
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JP2011022823A Expired - Fee Related JP5097831B2 (ja) | 2006-04-23 | 2011-02-04 | 薬剤分配装置における気泡確認方法 |
Country Status (7)
Country | Link |
---|---|
US (1) | US7311693B2 (ja) |
EP (1) | EP2010246A4 (ja) |
JP (2) | JP4681666B2 (ja) |
KR (1) | KR20080113250A (ja) |
CN (1) | CN101511402B (ja) |
CA (1) | CA2640881C (ja) |
WO (1) | WO2007122621A2 (ja) |
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EP2010246A2 (en) | 2009-01-07 |
CA2640881C (en) | 2009-09-08 |
JP2009538640A (ja) | 2009-11-12 |
WO2007122621A2 (en) | 2007-11-01 |
CN101511402A (zh) | 2009-08-19 |
CN101511402B (zh) | 2012-06-06 |
US7311693B2 (en) | 2007-12-25 |
JP5097831B2 (ja) | 2012-12-12 |
CA2640881A1 (en) | 2007-11-01 |
JP2011131070A (ja) | 2011-07-07 |
US20060206054A1 (en) | 2006-09-14 |
EP2010246A4 (en) | 2013-06-05 |
WO2007122621A3 (en) | 2009-04-09 |
KR20080113250A (ko) | 2008-12-29 |
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