WO2021156429A1 - A system and method for producing fluid for peritoneal dialysis - Google Patents

A system and method for producing fluid for peritoneal dialysis Download PDF

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Publication number
WO2021156429A1
WO2021156429A1 PCT/EP2021/052784 EP2021052784W WO2021156429A1 WO 2021156429 A1 WO2021156429 A1 WO 2021156429A1 EP 2021052784 W EP2021052784 W EP 2021052784W WO 2021156429 A1 WO2021156429 A1 WO 2021156429A1
Authority
WO
WIPO (PCT)
Prior art keywords
fluid
concentrate
effluent
diluted
pump
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.)
Ceased
Application number
PCT/EP2021/052784
Other languages
English (en)
French (fr)
Inventor
Christian Vartia
Henrik Lindgren
Per-Olof BORGQVIST
Olof Jansson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Gambro Lundia AB
Original Assignee
Gambro Lundia AB
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Gambro Lundia AB filed Critical Gambro Lundia AB
Priority to CN202180013488.XA priority Critical patent/CN115087472B/zh
Priority to JP2022548233A priority patent/JP7629932B2/ja
Priority to EP21704466.8A priority patent/EP4100076A1/en
Priority to US17/798,114 priority patent/US12440614B2/en
Publication of WO2021156429A1 publication Critical patent/WO2021156429A1/en
Anticipated expiration legal-status Critical
Priority to US19/356,412 priority patent/US20260034289A1/en
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • A61M1/1672—Apparatus for preparing dialysates using membrane filters, e.g. for sterilising the dialysate
    • 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
    • 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
    • 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
    • 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
    • A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • A61M1/282—Operational modes
    • 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
    • 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
    • A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • A61M1/282—Operational modes
    • A61M1/284—Continuous flow peritoneal dialysis [CFPD]
    • 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
    • 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
    • A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • A61M1/287—Dialysates therefor
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/002—Forward osmosis or direct osmosis

Definitions

  • the system is a continuous flow peritoneal dialysis (CFPD) system, and which includes a drain pump positioned and arranged to pump effluent from a patient to a location for delivery to the feed side of the FO-unit.
  • the control arrangement includes the first pump configured to pump diluted one or more PD concentrate fluids from the diluted PD concentrate container and a second PD concentrate pump configured to pump the one or more PD concentrate fluids into the draw side of the FO-unit.
  • the method comprises controlling a flow rate of the effluent fluid into the feed side of the FO-unit; and controlling a flow rate of the one or more PD concentrate fluids into the draw side, to a flow rate that matches a certain production rate of a final PD fluid to achieve a prescribed concentration of the one or more PD concentrate fluids in the final PD fluid.
  • the method comprises sensing the concentration of the diluted PD concentrate fluid and controlling the flow rate of the one or more PD concentrate fluids into the draw side based on the sensed concentration of the diluted PD concentrate fluid.
  • the method comprises controlling the flow rate of the one or more PD concentrate fluids into the draw side using a first pump.
  • the method comprises supplying pure water from a source of pure water located downstream the FO-osmosis unit to the diluted PD concentrate fluid to achieve a prescribed composition of the final PD fluid.
  • a second fluid line 22 is fluidly connected between an outlet of the draw side 6a and an outlet connector 11a.
  • the second fluid line 22 thus fluidly connects the draw side 6a and the outlet connector 11 a.
  • the outlet connector 11 a is configured to be connected to a corresponding connector of a fluid line 11 , which is configured to transport final PD fluid directly to a catheter of patient, to a cycler for pumping the fluid to a patient, or to a batch container.
  • a third fluid line 25 is connected between the inlet connector 5a and an inlet of the feed side 6b. The third fluid line 25 thus fluidly connects the inlet connector 5a and the feed side 6b.
  • the amount of effluent is also known from how much effluent the effluent pump 44 has been pumping into the effluent bag 15, or from weighting the effluent bag 15. For example, if 100 ml of PD concentrate is included in the batch of final PD fluid, then 100 ml will be supplied from the PD concentrate source 4a and pumped into the
  • valves described are typically on/off valves.
  • the valves may be two-way or three-way valves.
  • the method at S3 further comprises controlling a flow rate of the one or more PD concentrate fluids 4a, 4b into the draw side 6a, to achieve a flow rate that matches a certain production rate of a final PD fluid with a prescribed concentration of the one or more PD concentrate fluids.
  • a diluted PD concentrate is obtained such that when water (and sometimes osmotic agent) is thereafter added downstream to the diluted PD concentrate, a final PD fluid with a prescribed composition is obtained.
  • the controlling at S3 may include controlling the flow rate of the one or more PD concentrate fluids into the draw side 6a using a first pump 41 .
  • buffer solution as a draw solution is that is has about twice the osmolarity of the glucose concentrate and hence causes twice as high osmotic pressure during the FO session.
  • Different constitutions of buffer solutions may be used in the different versions of system 1 described herein (e.g., different nominal dilution ratios, buffer systems, etc.).
  • System 1 in Fig. 3 is explained together with a proposed sequence for producing fluid for PD, including diluted concentrate fluid and final PD fluid.
  • the system 1 in Fig. 3 has the same reference numbers for the same parts as described in connection with the system in Fig. 1 .
  • Fig. 3 further illustrates a plurality of valves.
  • the first pump 41 is used to pump buffer concentrate from the bag 4a to the container 9 via the draw side 6a of the FO-unit 6.
  • the sensed concentration with the first concentration sensor 8 is used to calculate an amount of buffer concentrate pumped to the container 9.
  • the sensed concentration may also be used for flow control with the first pump 41 .
  • the effluent pump 44 is used to pump effluent from the effluent container 15 to a drain via the feed side 6b of the
  • Control unit 40 of system 1 of Fig. 6 may alternatively or additionally be programmed to run a batch-type APD treatment.
  • system 1 may perform a dwell phase in which final PD fluid dwells within the peritoneal cavity of patient P for a specified period of time.
  • Control unit 40 at the same time may run effluent pump 44 and diluting pump 41 to perform FO and create and deliver new diluted first PD concentrate to diluted PD concentrate container 9.
  • control unit 40 may be programmed to simultaneously run an FO session and drain patient P.
  • valve 37 is open and drain pump 49 is operated to pull effluent from patient P to effluent container 15. Drain valve 55 is open to allow drain fluid to flow to drain 75.
  • the added first PD concentrate pump 57 which may be an accurate pump, e.g., membrane or piston pump, enables the FO session to run in parallel with the mixing session.
  • diluting pump 41 delivers diluted first concentrate so as to be added to glucose and possibly purified water to make a desired final PD fluid for delivery to patient P.
  • added first PD concentrate pump 57 performs FO.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Emergency Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Water Supply & Treatment (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Chemical & Material Sciences (AREA)
  • External Artificial Organs (AREA)
PCT/EP2021/052784 2020-02-06 2021-02-05 A system and method for producing fluid for peritoneal dialysis Ceased WO2021156429A1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
CN202180013488.XA CN115087472B (zh) 2020-02-06 2021-02-05 用于产生用于腹膜透析的流体的系统和方法
JP2022548233A JP7629932B2 (ja) 2020-02-06 2021-02-05 腹膜透析のための液体を生成するためのシステム
EP21704466.8A EP4100076A1 (en) 2020-02-06 2021-02-05 A system and method for producing fluid for peritoneal dialysis
US17/798,114 US12440614B2 (en) 2020-02-06 2021-02-05 System and method for producing fluid for peritoneal dialysis
US19/356,412 US20260034289A1 (en) 2020-02-06 2025-10-13 System and method for producing fluid for peritoneal dialysis

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE2050127 2020-02-06
SE2050127-6 2020-02-06

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US17/798,114 A-371-Of-International US12440614B2 (en) 2020-02-06 2021-02-05 System and method for producing fluid for peritoneal dialysis
US19/356,412 Continuation US20260034289A1 (en) 2020-02-06 2025-10-13 System and method for producing fluid for peritoneal dialysis

Publications (1)

Publication Number Publication Date
WO2021156429A1 true WO2021156429A1 (en) 2021-08-12

Family

ID=74587009

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2021/052784 Ceased WO2021156429A1 (en) 2020-02-06 2021-02-05 A system and method for producing fluid for peritoneal dialysis

Country Status (5)

Country Link
US (2) US12440614B2 (https=)
EP (1) EP4100076A1 (https=)
JP (1) JP7629932B2 (https=)
CN (1) CN115087472B (https=)
WO (1) WO2021156429A1 (https=)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023114621A1 (en) * 2021-12-17 2023-06-22 Baxter International Inc. Peritoneal dialysis system with a modular flat sheet membrane filter
WO2023129943A1 (en) * 2021-12-28 2023-07-06 Baxter International Inc. Peritoneal dialysis system having air-aided pumping sequences
WO2024115437A1 (en) * 2022-11-29 2024-06-06 Baxter International Inc. Medical fluid generation device

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4733587A1 (en) 2024-10-25 2026-04-29 Stratec SE Method and device for the dilution of liquids

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009083011A2 (en) * 2007-12-30 2009-07-09 Mohamed Fahim Khaled Mohamed T A method for dialysis fluid regeneration
US10293094B2 (en) * 2014-02-24 2019-05-21 Aquaporin A/S Systems for utilizing the water content in fluid from a renal replacement therapy process

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AU2003274901A1 (en) 2002-07-19 2004-02-09 Baxter Healthcare S.A. Systems and methods for performing peritoneal dialysis
DK177696B1 (en) 2013-02-25 2014-03-17 Aquaporin As Systems for water extraction
CN104379189B (zh) * 2013-04-25 2016-10-12 甘布罗伦迪亚股份公司 医疗流体制备系统和方法
JP6523614B2 (ja) 2014-04-22 2019-06-05 日機装株式会社 使用済み透析液用の除水器及びそれを用いた透析液再生システム
CN106535953B (zh) * 2014-05-29 2019-09-03 费森尤斯医疗保健集团 处理透析液的方法、透析系统及用其预评估透析患者的方法
JP6575249B2 (ja) 2014-09-19 2019-09-18 東洋紡株式会社 人工透析液の製造方法および人工透析液製造システム
US12491301B2 (en) 2016-04-04 2025-12-09 Mozarc Medical Us Llc Peritoneal dialysate preparation and sensor system
EP3238756B1 (en) * 2016-04-26 2019-09-04 Gambro Lundia AB Apparatus for determining a parameter indicative of the progress of an extracorporeal blood treatment
US10744253B2 (en) * 2016-08-10 2020-08-18 Medtronic, Inc. Adaptive peritoneal dialysis intra-session adjustments for overall session optimization
EP3506963B1 (en) * 2016-09-02 2024-11-27 Baxter International Inc. Apparatus for providing automated peritoneal dialysis
AU2018227226A1 (en) * 2017-10-03 2019-04-18 Medtronic, Inc. Peritoneal dialysate preparation and sensor system
CN115038473A (zh) * 2020-01-28 2022-09-09 费森尤斯医疗护理德国有限责任公司 用于制备透析液的设备和方法

Patent Citations (2)

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Publication number Priority date Publication date Assignee Title
WO2009083011A2 (en) * 2007-12-30 2009-07-09 Mohamed Fahim Khaled Mohamed T A method for dialysis fluid regeneration
US10293094B2 (en) * 2014-02-24 2019-05-21 Aquaporin A/S Systems for utilizing the water content in fluid from a renal replacement therapy process

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023114621A1 (en) * 2021-12-17 2023-06-22 Baxter International Inc. Peritoneal dialysis system with a modular flat sheet membrane filter
WO2023129943A1 (en) * 2021-12-28 2023-07-06 Baxter International Inc. Peritoneal dialysis system having air-aided pumping sequences
US12458739B2 (en) 2021-12-28 2025-11-04 Baxter International Inc. Peritoneal dialysis system having air-aided pumping sequences
WO2024115437A1 (en) * 2022-11-29 2024-06-06 Baxter International Inc. Medical fluid generation device
WO2024115436A1 (en) * 2022-11-29 2024-06-06 Baxter Healthcare Sa Medical fluid generation device

Also Published As

Publication number Publication date
EP4100076A1 (en) 2022-12-14
US12440614B2 (en) 2025-10-14
JP2023512841A (ja) 2023-03-29
US20260034289A1 (en) 2026-02-05
CN115087472A (zh) 2022-09-20
US20230069896A1 (en) 2023-03-09
CN115087472B (zh) 2025-10-17
JP7629932B2 (ja) 2025-02-14

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