JP7480266B2 - 透析システムおよび方法 - Google Patents
透析システムおよび方法 Download PDFInfo
- Publication number
- JP7480266B2 JP7480266B2 JP2022195874A JP2022195874A JP7480266B2 JP 7480266 B2 JP7480266 B2 JP 7480266B2 JP 2022195874 A JP2022195874 A JP 2022195874A JP 2022195874 A JP2022195874 A JP 2022195874A JP 7480266 B2 JP7480266 B2 JP 7480266B2
- Authority
- JP
- Japan
- Prior art keywords
- blood
- dialysate
- pump
- tubing set
- dialyzer
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
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- 239000011780 sodium chloride Substances 0.000 claims description 130
- 238000011282 treatment Methods 0.000 claims description 93
- 238000000108 ultra-filtration Methods 0.000 claims description 16
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- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 140
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- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 description 20
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- QDHHCQZDFGDHMP-UHFFFAOYSA-N Chloramine Chemical class ClN QDHHCQZDFGDHMP-UHFFFAOYSA-N 0.000 description 2
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- 239000003053 toxin Substances 0.000 description 1
- 231100000765 toxin Toxicity 0.000 description 1
- 108700012359 toxins Proteins 0.000 description 1
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Classifications
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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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- 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
- A61M2205/3365—Rotational speed
-
- 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
- A61M2205/3673—General characteristics of the apparatus related to heating or cooling thermo-electric, e.g. Peltier effect, thermocouples, semi-conductors
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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
- A61M2230/00—Measuring parameters of the user
- A61M2230/30—Blood pressure
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D19/00—Degasification of liquids
- B01D19/0063—Regulation, control including valves and floats
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T137/00—Fluid handling
- Y10T137/0318—Processes
- Y10T137/0402—Cleaning, repairing, or assembling
- Y10T137/0419—Fluid cleaning or flushing
- Y10T137/0424—Liquid cleaning or flushing
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49782—Method of mechanical manufacture of a slide fastener
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
- Y10T29/49895—Associating parts by use of aligning means [e.g., use of a drift pin or a "fixture"]
- Y10T29/49897—Registering mating opposed tool parts [e.g., registering a punch and a cooperating die]
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Description
本出願は、発明の名称が「Air Removal in Modular Home Dialysis System」であり、2014年4月29日に出願された米国仮出願61/985,779号の利益を要求し、また発明の名称が「Dialysis System」であり、2015年3月2日に出願された米国仮出願62/127,155の利益を要求し、両方の仮出願は、参照により本明細書に組み入れられる。
本明細書で言及された全ての刊行物および特許出願は、個々の刊行物または特許出願が具体的かつ個別に参照により援用されるように、参照により同程度に本明細書に援用される。
本開示は、一般的に、透析システムに関する。より詳細には、本開示は、透析治療の準備および管理における専門家の関与の必要性を低減する多くの特徴を含む透析システムに関する。
フレーム内に配置され、チューブセットに接続された静脈ドリップチャンバであって、フレームが透析システム上に取り付けられたときに、透析システムの1つ以上の流体レベルセンサと音響的に結合されるように、フレーム内に配置される静脈ドリップチャンバ、を含む。
本明細書の開示内容は、以下の態様を含み得る。
(態様1)
透析システムとの動的バランスを達成する方法であって、
患者からの血液の流れを、患者のチューブセットおよびダイアライザーの血液側を通して血流を動かすために、血液ポンプを操作する工程、
前記ダイアライザーの透析液側を通る透析液の流れを動かすために、第1の透析液ポンプおよび第2の透析液ポンプを操作する工程、
前記ダイアライザーの前記透析液側を通る前記透析液の流れをバイパスする工程、および
前記ダイアライザーの前記透析液側を通る前記透析液の流れがバイパスされている間、前記第1の透析液ポンプと前記第2の透析液ポンプとの間の透析液の圧力を測定し、前記測定された透析液の圧力が安定するまで、前記第2の透析液ポンプのポンプ速度を調節する工程、を含む、透析システムとの動的バランスを達成する方法。
(態様2)
さらに、前記ダイアライザーの前記透析液側を通る透析液の流れを回復する工程を含む、態様1に記載の方法。
(態様3)
前記透析液の流れが前記ダイアライザーの前記透析液側を通って回復するときに、流体は前記ダイアライザーの前記血液側から前記ダイアライザーの前記透析液側まで通過しない、態様2に記載の方法。
(態様4)
透析システムとの動的バランスを達成する方法であって、
患者からの血液の流れを、患者のチューブセットおよびダイアライザーの血液側を通して動かすために、血液ポンプを操作する工程、
患者の静脈圧を測定する工程、
前記ダイアライザーの透析液側を通る透析液の流れを動かすために、第1の透析液ポンプおよび第2の透析液ポンプを操作する工程、
透析液の流れが前記ダイアライザーの透析液側を通ることを防止する工程、
前記ダイアライザーの前記透析液側を通る透析液の流れが防止されている間、前記第1の透析液ポンプおよび前記第2の透析液ポンプとの間の透析液の圧力を測定し、前記測定された透析液の圧力が安定するまで、前記第2の透析液ポンプのポンプ速度を調節する工程、
前記透析液の流れが前記ダイアライザーの透析液側を通ることを許可する工程、および
前記第1の透析液ポンプと前記第2の透析液ポンプとの間の流れアンバランスを引き起こすために、前記第2の透析液ポンプのポンプ速度を調節する工程であって、前記流れアンバランスは、当該流れアンバランスを均一にするために前記ダイアライザーの血液側と前記ダイアライザーの透析液側との間の流体の流れをもたらす、前記第2の透析液ポンプのポンプ速度を調節する工程、を含む、透析システムとの動的バランスを達成する方法。
(態様5)
前記流体の流れは、前記ダイアライザーの前記血液側から前記ダイアライザーの前記透析液側に進む、態様4に記載の方法。
(態様6)
前記流体の流れは、前記ダイアライザーの前記透析液側から前記ダイアライザーの前記血液側に進む、態様4に記載の方法。
(態様7)
さらに、前記ダイアライザーの前記血液側と前記ダイアライザーの前記透析液側との間の圧力損失をキャリブレートするために、前記第2の透析液ポンプのポンプ速度を調節する工程を含む、態様4に記載の方法。
(態様8)
さらに、前記測定された静脈圧が所定の閾値だけ変化した場合に、前記防止、測定および調節する工程を繰り返す工程を含む、態様4に記載の方法。
(態様9)
前記所定の閾値は、30mmHgを超える、態様8に記載の方法。
(態様10)
透析システムであって、
患者からの血液の流れを、患者のチューブセットおよびダイアライザーの血液側を通して動かすように構成された血液ポンプ、
患者の静脈圧を測定するように構成された静脈圧センサ、
前記ダイアライザーの透析液側を通る透析液の流れを制御するように構成された第1のポンプおよび第2のポンプ、
透析液の流れが前記ダイアライザーの透析液側を通ることを防止するために、前記ダイアライザーの透析液側をバイパスするように構成された1つ以上のバルブ、
前記第1のポンプと前記第2のポンプとの間に配置され、前記ダイアライザーの透析液側がバイパスされたときに、透析液の圧力を測定するように構成された透析液圧センサ、および
前記血液ポンプ、前記静脈圧センサ、前記第1および第2のポンプ、前記1つ以上のバルブ、および前記透析液圧センサと操作可能に結合された電子コントローラであって、前記電子コントローラは、前記第1のポンプと前記第2のポンプとの間の流れアンバランスを引き起こすために、前記第1および第2のポンプのポンプ速度を調節するように構成されており、前記流れアンバランスは、当該流れアンバランスを均一にするために前記ダイアライザーの前記血液側と前記ダイアライザーの前記透析液側との間の流体の流れをもたらす、電子コントローラ、を含む、透析システム。
(態様11)
透析システムであって、
血液側および透析液側を含むダイアライザー、
前記ダイアライザーの前記血液側に結合された血液回路であって、さらに、患者の静脈接続部位に接続されるように適合された静脈ラインと、患者の動脈接続部位に接続されるように適合された動脈ラインとを含む血液回路、
前記血液回路に結合され、患者からの血液を、前記動脈ラインを通り、前記ダイアライザーの前記血液側を通り、そして前記静脈ラインを通って患者に戻すように構成された血液ポンプ、
前記血液回路に結合され、患者の静脈圧を測定するように構成された静脈圧センサ、
前記ダイアライザーの前記透析液側に結合された透析液回路であって、さらに、透析液供給源に結合された透析液ラインを含む透析液回路、
前記透析液回路に結合されたアクチュエータであって、透析液が前記ダイアライザーの前記透析液側を通って移動する第1の構成と、透析液が前記ダイアライザーの前記透析液側を通って移動することを防止する第2の構成とを含むアクチュエータ、
前記透析液回路に結合された第1の透析液ポンプおよび第2の透析液ポンプであって、前記アクチュエータが前記第1の構成のときに、前記透析液供給源から、前記透析液ラインを通り、そして前記ダイアライザーの前記透析液側を通る透析液を動かすように構成された、第1の透析液ポンプおよび第2の透析液ポンプ、
前記透析液回路に結合され、前記第1の透析液ポンプと前記第2の透析液ポンプとの間の前記透析液の圧力を測定するように構成された透析液圧センサ、および
前記血液ポンプ、前記静脈圧センサ、前記透析液圧センサ、前記アクチュエータ、前記第1の透析液ポンプおよび前記第2の透析液ポンプと操作可能に連結された電子コントローラであって、
前記ダイアライザーの前記透析液側を通る透析液の流れを動かすために、前記第1の透析液ポンプのポンプ速度を調節する工程、
透析液の流れが前記ダイアライザーの前記透析液側を通過するのを防止するために前記アクチュエータを制御する工程、
測定された透析液圧を前記透析液圧センサから受信する工程と、
前記測定された透析液圧が安定するまで、前記第2の透析液ポンプのポンプ速度を調節する工程、
前記透析液の流れが前記ダイアライザーの前記透析液側を通過することを可能にするために前記アクチュエータを制御する工程、および
前記第1の透析液ポンプと前記第2の透析液ポンプとの間の流れアンバランスを引き起こすために、前記第2の透析液ポンプのポンプ速度を調節して、前記流れアンバランスは、当該流れアンバランスを均一にするために前記ダイアライザーの前記血液側と前記ダイアライザーの前記透析液側との間の流体の流れをもらす工程、
を実行することによって、透析治療中に前記ダイアライザーを横切る流体流れの動的バランスを達成するように構成された電子コントローラ、を含む、透析システム。
(態様12)
前記電子コントローラは、前記測定された静脈圧を前記静脈圧センサから受信するように構成され、かつ前記測定された静脈圧が所定の閾値だけ変化する場合に、前記制御、受信および調節する工程を繰り返すように構成される、態様11に記載のシステム。
(態様13)
透析システムに使い捨てのカートリッジおよびチューブセットを接続する方法であって、
前記透析システムのアライメント機構に隣接して、前記使い捨てのカートリッジおよびチューブセットのアライメント機構を配置する工程と、
前記使い捨てのカートリッジおよびチューブセットの静脈ドリップチャンバを前記透析システムの1つ以上の流体レベルセンサと音響的に結合させるために、前記透析システム上に前記使い捨てのカートリッジおよびチューブセットを取り付ける工程と、を含む、使い捨てカートリッジおよびチューブセットを接続する方法。
(態様14)
さらに、前記静脈ドリップチャンバ内の流体レベルを前記1つ以上の流体レベルセンサで測定する工程を含む、態様13に記載の方法。
(態様15)
透析システム上に取り付けるように適合された使い捨てカートリッジであって、
前記透析システム上の対応するアライメント機構と取り外し可能に嵌合するように構成された複数のアライメント機構を有するフレーム、
前記フレーム内に配置されたチューブセット、および
前記フレーム内に配置され、前記チューブセットに接続された静脈ドリップチャンバであって、前記フレームが前記透析システム上に取り付けられたときに、前記透析システムの1つ以上の流体レベルセンサと音響的に結合されるように、前記フレーム内に配置される静脈ドリップチャンバ、を含む、使い捨てカートリッジ。
(態様16)
チューブセットおよび透析システムのダイアライザーをプライミングする方法であって、
生理食塩水供給源からの生理食塩水を、第1の方向で、前記チューブセット内および前記ダイアライザーの血液側を通して動かして、前記チューブセットおよび前記ダイアライザーの前記血液側から空気を除去するために、第1の操作モードで前記透析システムの血液ポンプを操作する工程、および
前記生理食塩水の少なくとも一部を、前記第1の方向とは反対の第2の方向で前記ダイアライザーの前記血液側を通して動かして、前記チューブセットから出すために、第2の操作モードで前記血液ポンプを操作する工程、を含む、プライミングする方法。
(態様17)
前記チューブセットの静脈ドリップチャンバ内の前記生理食塩水の流体レベルをモニターする工程、および
前記静脈ドリップチャンバ内の流体レベルが安定したとき、または空気がもはや前記チューブセットを循環しないとき、前記第1の操作モードで前記血液ポンプの操作を停止する工程、をさらに含む、態様16に記載の方法。
(態様18)
前記第1の操作モードで前記血液ポンプを操作する工程は、前記生理食塩水を前記ダイアライザーの前記血液側を通して動かす前に、前記生理食塩水の少なくとも一部を前記チューブセットの静脈ドリップチャンバ内に動かす工程をさらに含む、態様16に記載の方法。
(態様19)
前記第2の操作モードで前記血液ポンプを操作する工程は、前記生理食塩水を前記チューブセットの静脈ドリップチャンバを通して動かす前に、前記生理食塩水の少なくとも一部を前記ダイアライザーの前記血液側を通して動かす工程をさらに含む、態様16に記載の方法。
(態様20)
前記ダイアライザーの透析液側から空気を除去するために、透析液供給源からの透析液を、第1の方向で前記ダイアライザーの前記透析液側を通して動かすように、透析液ポンプを操作する工程をさらに含む、態様16に記載の方法。
(態様21)
前記ダイアライザーの向きを物理的に操作することなく、空気が前記ダイアライザーの前記透析液側から除去される、態様20に記載の方法。
(態様22)
前記ダイアライザーの向きを反転することなく、空気が前記ダイアライザーの前記透析液側から除去される、態様20に記載の方法。
(態様23)
前記生理食塩水が前記生理食塩水供給源から前記チューブセット内に動くことを可能にするために、電子コントローラにより前記透析システムの1つ以上のバルブを開く工程をさらに含む、態様16に記載の方法。
(態様24)
前記血液ポンプを操作する工程は、前記透析システムの電子コントローラにより前記血液ポンプを操作する工程をさらに含む、態様16に記載の方法。
(態様25)
前記生理食塩水が、前記チューブセットの静脈ラインを前記チューブセットの動脈ラインに取り付けるユニオン継手を通して、前記チューブセットから出される、態様16に記載の方法。
(態様26)
透析治療が開始可能になる前に、所定量の生理食塩水は前記ユニオン継手を通して動かされる、態様25に記載の方法。
(態様27)
透析治療後に、透析送達システムの患者チューブセット内の血液を患者に戻す方法であって、
生理食塩水を前記患者チューブセット内に引き込んで、血液を患者の体内に押し戻すために、前記患者チューブセットに結合された血液ポンプを動作する工程、
前記患者チューブセット内に引き込まれた生理食塩水量を決定するために、前記血液ポンプの回転数を追跡する工程、および
所定量の生理食塩水が前記患者チューブセット内に引き込まれたときに、前記血液ポンプを停止する工程、を含む、血液を患者に戻す方法。
(態様28)
前記所定量は300~500mlを含む、態様27に記載の方法。
(態様29)
生理食塩水供給源と前記チューブセットとの間の経路を形成するために、前記透析送達システムの1つ以上のピンチバルブを開く工程をさらに含む、態様27に記載の方法。
(態様30)
前記生理食塩水供給源と、患者の動脈アクセス部位またはその近傍のチューブセットとの間の経路を形成するために、1つ以上のピンチバルブを開く工程をさらに含む、態様29に記載の方法。
(態様31)
血液が患者の静脈アクセス部位を通して患者に押し戻される、態様27に記載の方法。
(態様32)
透析治療後に透析システムのダイアライザーから流体を排出する方法であって、
前記透析システムの患者チューブセットの静脈ラインを閉鎖する工程、および
前記ダイアライザーの透析液側から前記ダイアライザーの血液側内へ、および前記ダイアライザーから出て廃液容器内へと流体を引き出すために、前記患者チューブセットに結合されたポンプを操作する工程、を含む、流体を排出する方法。
(態様33)
前記廃液容器は生理食塩水バッグを含む、態様32に記載の方法。
(態様34)
前記ダイアライザーの前記透析液側から前記ダイアライザーの前記血液側に流体を動かすために、前記流体は前記ダイアライザーのマイクロチューブ壁を通って引き出される、態様32に記載の方法。
(態様35)
前記流体は、重力に抗して前記ダイアライザーから引き出される、態様32に記載の方法。
(態様36)
治療中に透析システムの静脈ドリップチャンバ内の流体レベルを制御する方法であって、
患者チューブセットおよび前記静脈ドリップチャンバを通る血液の流れを生成する工程、
前記静脈ドリップチャンバ内の血液の流体レベルを第1および第2のセンサでモニターする工程、
前記流体レベルが前記第1のセンサより下に降下したときに、自動的に、前記静脈ドリップチャンバから外に空気をポンプ輸送または放出する工程、および
前記流体レベルが前記第2のセンサより上に上昇したときに、自動的に、前記静脈ドリップチャンバ内に空気をポンプ輸送する工程、を含む、流体レベルを制御する方法。
(態様37)
治療中に透析システムの静脈ドリップチャンバ内の流体レベルを制御する方法であって、
患者チューブセットおよび前記静脈ドリップチャンバを通る血液の流れを生成する工程、
前記静脈ドリップチャンバ内の血液の流体レベルをセンサでモニターする工程、
前記センサが、前記流体レベルがより低い流体レベル閾値を下回って低下したことを検出した場合、自動的に、前記静脈ドリップチャンバから外に空気をポンプ輸送または放出する工程、および
前記センサが、前記流体レベルがより高い流体レベル閾値を上回って上昇したことを検出した場合、自動的に、前記静脈ドリップチャンバ内に空気をポンプ輸送する工程、を含む、流体レベルを制御する方法。
(態様38)
治療中に透析システムの静脈ドリップチャンバ内の流体レベルを制御する方法であって、
患者チューブセットおよび前記静脈ドリップチャンバを通る血液の流れを生成する工程、
前記静脈ドリップチャンバ内の血液の流体レベルを第1および第2のセンサでモニターする工程、および
前記第1のセンサが、前記流体レベルがより低い閾値を下回って低下したことを検出した場合、自動的に、前記静脈ドリップチャンバから外に空気をポンプ輸送または放出し、前記第2のセンサが、前記流体レベルがより高い閾値を上回って上昇したことを検出した場合、自動的に、前記静脈ドリップチャンバ内に空気をポンプ輸送することによって、前記静脈ドリップチャンバ内の血液の前記流体レベルを自動的に維持する工程、を含む、流体レベルを制御する方法。
(態様39)
透析システムであって、
流れる血液から空気を除去するように構成された静脈ドリップチャンバ、
前記静脈ドリップチャンバ内の血液の流体レベルをモニターするように構成された少なくとも1つのセンサ、
前記静脈ドリップチャンバに結合され、前記静脈ドリップチャンバ内にまたは前記静脈ドリップチャンバから外に空気をポンプ輸送するように構成されたポンプ、および
前記少なくとも1つのセンサおよび前記ポンプと通信する電子コントローラであって、前記少なくとも1つのセンサが、前記流体レベルが第1の閾値を下回って低下したことを検出したときに、前記ポンプで前記静脈ドリップチャンバから外に空気をポンプ輸送し、前記少なくとも1つのセンサが、前記流体レベルが第2の閾値を上回って上昇したことを検出したときに、前記ポンプで前記静脈ドリップチャンバ内に空気をポンプ輸送することによって、前記静脈ドリップチャンバ内の血液の前記流体レベルを維持するために、自動的に前記ポンプを制御するように構成された電子コントローラ、を含む、透析システム。
(態様40)
透析治療で使用するために透析システムに挿入されるように適合されている使い捨てカートリッジであって、
透析送達システム上のアライメントペグと嵌合するように構成された複数の位置合わせ孔を有するオーガナイザー、
前記オーガナイザーに配置されたチューブセットであって、
患者から血液を引き込むように構成された動脈ライン部、
患者に血液を戻すように構成された静脈ライン部、
前記透析送達システムの血液ポンプと相互作用するように構成された血液ポンプ部、
前記透析送達システムのダイアライザーに血液を運ぶように構成された第1のダイアライザー部、
前記ダイアライザーから血液を戻すように構成された第2のダイアライザー部、および
生理食塩水供給源を前記チューブセットに結合するように構成された第1および第2の生理食塩水ライン、を含む、チューブセット、並びに
前記オーガナイザー内に配置され、静脈ドリップチャンバに入る血液から空気を除去するように構成された静脈ドリップチャンバであって、
前記静脈ドリップチャンバの下部に配置された第1および第2のポートであって、前記チューブセットの前記静脈ライン部に結合された前記第1のポートと、前記チューブセットの前記動脈ライン部に結合された前記第2のポートと、を含む静脈ドリップチャンバ、を含む、使い捨てカートリッジ。
(態様41)
ヘパリン供給源を前記チューブセットに結合するように構成されたヘパリンラインをさらに含む、態様40に記載の使い捨てカートリッジ。
(態様42)
前記ヘパリンラインは、前記静脈ドリップチャンバの上部に配置された第3のポートに結合される、態様41に記載の使い捨てカートリッジ。
(態様43)
治療中に前記ヘパリンライン内への血液の逆流を防止するために、前記ヘパリンラインは、非拍動位置で前記静脈ドリップチャンバに結合されている、態様42に記載の使い捨てカートリッジ。
(態様44)
前記非拍動位置は、前記静脈ドリップチャンバ内のエアギャップを含む、態様43に記載の使い捨てカートリッジ。
(態様45)
前記第1の生理食塩水ラインは、前記チューブセットの前記血液ポンプ部の近位端で前記チューブセットに取り付けられる、態様40に記載の使い捨てカートリッジ。
(態様46)
前記第2の生理食塩水ラインは、前記チューブセットの前記動脈ライン部の近位端近傍で前記チューブセットに取り付けられる、態様40に記載の使い捨てカートリッジ。
(態様47)
前記チューブセットの前記動脈ライン部に沿って配置され、前記透析送達システムの動脈圧センサと嵌合するように構成された動脈圧ポッドをさらに含む、態様40に記載の使い捨てカートリッジ。
(態様48)
前記静脈ドリップチャンバに結合され、前記透析送達システムの静脈圧センサと嵌合するように構成された静脈トランスデューサ接続部をさらに含む、態様40に記載の使い捨てカートリッジ。
(態様49)
透析システムであって、
筐体、
前記筐体内に配置され、利用可能な水供給源を用いてリアルタイムに透析治療に使用するための水を調製するように構成された浄水システム、
前記筐体内に配置され、透析治療のために透析液を調製するように構成されたた透析送達システム、
前記筐体上または前記筐体内に配置されたダイアライザー、
前記筐体上に配置された前面パネルであって、
複数のアライメント機構、
静脈レベルセンサ、
血液ポンプ、
複数のピンチバルブ、を含む、前面パネル、
前記前面パネルに取り付けられるように構成されたオーガナイザーであって、前記複数のアライメント機構と嵌合するように構成された複数の装着機構を含み、
前記オーガナイザー内に配置されたチューブセットであって、
患者から血液を引き込むように構成された動脈ライン部、
患者に血液を戻すように構成された静脈ライン部、
前記血液ポンプと相互作用するように構成された血液ポンプ部、
前記ダイアライザーに血液を運ぶように構成された第1のダイアライザー部、
前記ダイアライザーから血液を戻すように構成された第2のダイアライザー部、
生理食塩水供給源を前記チューブセットに結合するように構成された第1および第2の生理食塩水ライン、を含む、チューブセット、
前記オーガナイザー内に配置され、静脈ドリップチャンバに入る血液から空気を除去するように構成された静脈ドリップチャンバであって、
前記静脈ドリップチャンバの下部に配置された第1および第2のポートを含み、
前記第1のポートは前記チューブセットの前記静脈ライン部に結合され、
前記第2のポートは前記チューブセットの前記動脈ライン部に結合されており、
前記オーガナイザーを前記前面パネルに取り付けると、自動的に、前記チューブセットの前記血液ポンプ部が前記血液ポンプに結合され、前記静脈ドリップチャンバが前記静脈レベルセンサに結合される、静脈ドリップチャンバ、を含む、オーガナイザー、
を含む、透析システム。
Claims (3)
- 透析システムであって、
動脈ライン(230)、静脈ライン(232)、血液ポンプ部(2167)および生理食塩水ライン(233)を含む、チューブセット(122)と、
前記チューブセットの前記血液ポンプ部(2167)と相互作用して前記チューブセットを通して患者から血流が移動するように構成された、血液ポンプ(213)と、
前記生理食塩水ラインと接続された生理食塩水供給源(240)と、
前記動脈ラインが患者に接続される位置に隣接して配置された、前記チューブセットと前記生理食塩水ラインとの間の生理食塩水接続部(353b)と、
前記生理食塩水接続部と相互作用するように構成された少なくとも1つのバルブ(180b)と、
前記チューブセット、前記血液ポンプおよび前記少なくとも1つのバルブと操作可能に結合された電子コントローラであって、
患者の目標体重が達成されるように、限外濾過における流体の除去目標を計算し;
前記患者に透析治療を提供するように前記血液ポンプを作動し;
前記透析治療の完了時に前記血液ポンプを停止し、ここで透析治療の完了後も血液が前記チューブセット内に残り;且つ
返血シーケンスを開始するように構成されている電子コントローラであって、
前記少なくとも1つのバルブを開放し、
前記チューブセット内の前記血液を前記患者に押し戻すのに必要な生理食塩水の目標量を決定し、患者の前記目標体重も達成し、
前記生理食塩水供給源から前記生理食塩水接続部を通して前記チューブセットに生理食塩水を引き込み、且つ前記動脈ライン内の血液の実質的に全てを含んで、前記患者に血液を押し戻すように、前記血液ポンプを作動し、
前記チューブセットに引き込まれる生理食塩水の量が前記目標量に合うときを決定するように、前記血液ポンプの回転数を追跡し、且つ
前記目標量の生理食塩水が前記患者のチューブセットに引き込まれたとき、前記血液ポンプを停止させるように構成されている、電子コントローラと、
を含む透析システム。 - 前記所定量は300~500mlを含む、請求項1に記載のシステム。
- 血液が患者の静脈アクセス部位を通して患者に押し戻される、請求項1に記載のシステム。
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EP3137128A4 (en) | 2018-01-03 |
EP3137128A1 (en) | 2017-03-08 |
JP2023025224A (ja) | 2023-02-21 |
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JP2017514653A (ja) | 2017-06-08 |
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US20150343133A1 (en) | 2015-12-03 |
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US20150343131A1 (en) | 2015-12-03 |
JP6657186B2 (ja) | 2020-03-04 |
EP3137128B1 (en) | 2021-02-24 |
US11305040B2 (en) | 2022-04-19 |
US9402945B2 (en) | 2016-08-02 |
US9504777B2 (en) | 2016-11-29 |
US20170326285A1 (en) | 2017-11-16 |
EP3838308A1 (en) | 2021-06-23 |
US20150314055A1 (en) | 2015-11-05 |
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