JP6159771B2 - 血液浄化装置 - Google Patents
血液浄化装置 Download PDFInfo
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- JP6159771B2 JP6159771B2 JP2015201891A JP2015201891A JP6159771B2 JP 6159771 B2 JP6159771 B2 JP 6159771B2 JP 2015201891 A JP2015201891 A JP 2015201891A JP 2015201891 A JP2015201891 A JP 2015201891A JP 6159771 B2 JP6159771 B2 JP 6159771B2
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- 239000008280 blood Substances 0.000 title claims description 88
- 210000004369 blood Anatomy 0.000 title claims description 88
- 238000000746 purification Methods 0.000 title claims description 55
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 145
- 238000004659 sterilization and disinfection Methods 0.000 claims description 111
- 230000004087 circulation Effects 0.000 claims description 63
- 238000010438 heat treatment Methods 0.000 claims description 58
- 230000007613 environmental effect Effects 0.000 claims description 57
- 239000007788 liquid Substances 0.000 claims description 32
- 238000000034 method Methods 0.000 claims description 26
- 238000009529 body temperature measurement Methods 0.000 claims description 16
- 238000001514 detection method Methods 0.000 claims description 15
- 238000011144 upstream manufacturing Methods 0.000 claims description 15
- 238000000502 dialysis Methods 0.000 claims description 13
- 238000005259 measurement Methods 0.000 claims description 11
- 238000007599 discharging Methods 0.000 claims description 4
- 238000004140 cleaning Methods 0.000 description 8
- 238000010586 diagram Methods 0.000 description 8
- 230000000249 desinfective effect Effects 0.000 description 7
- 230000009977 dual effect Effects 0.000 description 6
- 239000012510 hollow fiber Substances 0.000 description 5
- 230000001954 sterilising effect Effects 0.000 description 5
- 230000000694 effects Effects 0.000 description 4
- 238000001631 haemodialysis Methods 0.000 description 4
- 230000000322 hemodialysis Effects 0.000 description 4
- 230000002093 peripheral effect Effects 0.000 description 4
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 239000000385 dialysis solution Substances 0.000 description 3
- 239000000047 product Substances 0.000 description 3
- 239000002699 waste material Substances 0.000 description 3
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 238000001914 filtration Methods 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- 238000005406 washing Methods 0.000 description 2
- 230000005856 abnormality Effects 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 230000008878 coupling Effects 0.000 description 1
- 238000010168 coupling process Methods 0.000 description 1
- 238000005859 coupling reaction Methods 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
- 229910052742 iron Inorganic materials 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 238000005457 optimization Methods 0.000 description 1
- 230000000149 penetrating effect Effects 0.000 description 1
- 239000012466 permeate Substances 0.000 description 1
- 239000011148 porous material Substances 0.000 description 1
- 238000004092 self-diagnosis Methods 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 239000011550 stock solution Substances 0.000 description 1
- 230000008646 thermal stress Effects 0.000 description 1
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- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
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- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
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- A61M1/1688—Sterilisation or cleaning before or after use with recirculation of the sterilising fluid
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- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
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- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
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- 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
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- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1621—Constructional aspects thereof
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- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1621—Constructional aspects thereof
- A61M1/165—Constructional aspects thereof with a dialyser bypass on the dialysis fluid line
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- A—HUMAN NECESSITIES
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- 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1654—Dialysates therefor
- A61M1/1656—Apparatus for preparing dialysates
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- A—HUMAN NECESSITIES
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- 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
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- A61M2202/00—Special media to be introduced, removed or treated
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- A—HUMAN NECESSITIES
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- 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
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- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3327—Measuring
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- A—HUMAN NECESSITIES
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- 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
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- A61M2205/3331—Pressure; Flow
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- A—HUMAN NECESSITIES
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- A61M2205/00—General characteristics of the apparatus
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- A61M2205/3368—Temperature
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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
- A61M2205/36—General characteristics of the apparatus related to heating or cooling
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- 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
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- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Urology & Nephrology (AREA)
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- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Vascular Medicine (AREA)
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- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- External Artificial Organs (AREA)
Description
配管の熱湯消毒は、その熱湯消毒工程時の環境条件に依存することが大きく、当該環境条件が最悪の条件下でも一定の消毒効果が得られるように熱湯消毒時間等が設定されている。すなわち、ヒータの加熱機能(電源電圧)、給水温度及び雰囲気温度等の環境条件が熱湯消毒のための熱湯を得る上で最悪である場合を想定し、一定の熱湯消毒効果を担保するべく、最悪条件に合わせた長時間の熱湯消毒時間が設定されているのである。
また、熱湯消毒工程時、液体を循環させ得る循環流路を形成するための循環用配管と、循環流路を循環する液体を加熱して熱湯消毒に必要な温度の熱湯を生成し得る加熱手段と、該加熱手段で加熱された液体の温度を計測し得る温度計測手段とを具備するとともに、検出手段は、温度計測手段から成り、当該温度計測手段による計測値が環境条件に関わるパラメータとされたので、血液浄化治療時に配管の温度を計測するための温度計測手段を流用して必要とされる熱湯消毒時間を推定することができる。
さらに、加熱手段及び温度計測手段は、循環流路に配設されたので、加熱手段及び温度計測手段を流用して必要とされる熱湯消毒時間を推定することができる。
またさらに、推定手段は、熱湯消毒工程時の任意の環境条件における、温度計測手段の計測値と、循環流路における加熱手段の加熱によって温度上昇が遅い部位の温度との相関に基づき予め作成され、当該温度計測手段の計測値から熱湯消毒時間を求めるためのテーブルを有するので、より正確且つ円滑に必要とされる熱湯消毒時間を推定することができる。
本実施形態に係る血液浄化装置は、患者の血液を体外循環させつつ浄化するためのもので、血液透析治療で使用される血液透析装置に適用されたものである。かかる血液透析装置は、図1に示すように、血液回路1(動脈側血液回路1a及び静脈側血液回路1b)と、血液浄化手段としてのダイアライザ2と、ダイアライザ2に対して接続可能とされ、当該ダイアライザ2に透析液を導入し得る透析液導入ラインL1と、ダイアライザ2に対して接続可能とされ、当該ダイアライザ2からの排液を排出し得る透析液排出ラインL2と、接続具C1、C2(所謂「カップリング」と称される接続具)と、制御手段10と、推定手段11と、算出手段12とを主に有して構成されている。
2 ダイアライザ(血液浄化手段)
3 血液ポンプ
4 エアトラップチャンバ
5 複式ポンプ
6 除水ポンプ
7 濾過フィルタ
8 ヒータ(加熱手段)
9 サーミスタ(温度計測手段)
10 制御手段
11 推定手段
12 算出手段
13 電圧計
L1 透析液導入ライン(配管)
L2 透析液排出ライン(配管)
L5 バイパスライン(循環用配管)
Claims (7)
- 患者に透析治療を施すための血液浄化手段が取り付けられるとともに、当該血液浄化手段に透析液を導入又は当該血液浄化手段からの排液を排出するための配管が配設された血液浄化装置において、
熱湯消毒工程時、液体を循環させ得る循環流路を形成するための循環用配管と、
前記循環流路に配設され、当該循環流路を循環する液体を加熱して熱湯消毒に必要な温度の熱湯を生成し得る加熱手段と、
前記循環流路に配設され、前記加熱手段で加熱された液体の温度を計測し得る温度計測手段から成る検出手段と、
該検出手段で計測された温度に基づいて前記配管の熱湯消毒に必要な熱湯消毒時間を推定する推定手段と、
を備え、前記推定手段は、前記熱湯消毒工程時の任意の環境条件における、前記温度計測手段の計測値と、前記循環流路における前記加熱手段の加熱によって温度上昇が遅い部位の温度との相関に基づき予め作成され、当該温度計測手段の計測値から前記熱湯消毒時間を求めるためのテーブルを有することを特徴とする血液浄化装置。 - 前記推定手段で推定された前記熱湯消毒時間に基づいて熱湯消毒の終了時刻又は終了までの残り時間を算出する算出手段を具備したことを特徴とする請求項1記載の血液浄化装置。
- 前記温度計測手段は、前記加熱手段の下流側に配設されたことを特徴とする請求項1又は請求項2記載の血液浄化装置。
- 前記温度計測手段は、前記加熱手段の下流側近傍に配設されたことを特徴とする請求項3記載の血液浄化装置。
- 前記テーブルは、任意の前記環境条件における、前記温度計測手段の計測値と、前記循環流路における前記温度計測手段の下流側で、且つ前記加熱手段の上流側の部位の温度との相関に基づき予め作成されることを特徴とする請求項1〜4の何れか1つに記載の血液浄化装置。
- 前記テーブルは、任意の前記環境条件における、前記温度計測手段の計測値と、前記循環流路における前記温度計測手段の下流側で、且つ前記加熱手段の上流側近傍の部位の温度との相関に基づき予め作成されることを特徴とする請求項1〜4の何れか1つに記載の血液浄化装置。
- 前記温度計測手段の計測値に基づいて前記テーブルの環境条件の少なくとも一つを特定し得ることを特徴とする請求項1〜6の何れか1つに記載の血液浄化装置。
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JP2015201891A JP6159771B2 (ja) | 2015-10-13 | 2015-10-13 | 血液浄化装置 |
CN201680059660.4A CN108136094B (zh) | 2015-10-13 | 2016-10-12 | 血液净化装置 |
EP16855406.1A EP3351275B1 (en) | 2015-10-13 | 2016-10-12 | Blood purification apparatus |
PCT/JP2016/080187 WO2017065152A1 (ja) | 2015-10-13 | 2016-10-12 | 血液浄化装置 |
US15/946,856 US10729838B2 (en) | 2015-10-13 | 2018-04-06 | Blood purification apparatus |
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EP (1) | EP3351275B1 (ja) |
JP (1) | JP6159771B2 (ja) |
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US10441702B2 (en) | 2016-10-04 | 2019-10-15 | Fresenius Medical Care Holdings, Inc. | Medical fluid temperature control |
JP6873838B2 (ja) * | 2017-06-20 | 2021-05-19 | 日機装株式会社 | 血液浄化装置 |
JP7280749B2 (ja) * | 2019-05-23 | 2023-05-24 | 日機装株式会社 | 薬液供給装置及び血液浄化システム |
JP2023006644A (ja) | 2021-06-30 | 2023-01-18 | 日機装株式会社 | 血液浄化装置 |
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US6153102A (en) * | 1995-02-13 | 2000-11-28 | Aksys, Ltd. | Disinfection of dead-ended lines in medical instruments |
JP2006255153A (ja) * | 2005-03-17 | 2006-09-28 | Toray Medical Co Ltd | 透析液供給装置の消毒方法および装置 |
CN101844851A (zh) * | 2010-05-17 | 2010-09-29 | 盛建华 | 可对血液净化用制水设备进行消毒的高温消毒设备 |
CN202154894U (zh) * | 2011-07-29 | 2012-03-07 | 广州市暨华医疗器械有限公司 | 血液透析机中消毒液双吸的双循环消毒*** |
JP5748280B2 (ja) * | 2011-09-09 | 2015-07-15 | 日機装株式会社 | 透析液取出装置 |
JP5734262B2 (ja) | 2012-11-14 | 2015-06-17 | 日機装株式会社 | 血液浄化システム |
AU2013201567B2 (en) * | 2012-11-28 | 2015-12-17 | Gambro Lundia Ab | Systems, apparatus, equipment with thermal disinfection and thermal disinfection methods |
DE102013107672A1 (de) * | 2013-07-18 | 2015-01-22 | B. Braun Avitum Ag | Extrakorporale Blutbehandlungsanlage mit Wärmerückgewinnung |
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EP3351275B1 (en) | 2020-06-24 |
US20180221556A1 (en) | 2018-08-09 |
CN108136094A (zh) | 2018-06-08 |
JP2017074086A (ja) | 2017-04-20 |
EP3351275A4 (en) | 2019-05-01 |
US10729838B2 (en) | 2020-08-04 |
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WO2017065152A1 (ja) | 2017-04-20 |
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