WO2004062710A3 - Batch filtration system for preparation of sterile replacement fluid for renal therapy - Google Patents

Batch filtration system for preparation of sterile replacement fluid for renal therapy Download PDF

Info

Publication number
WO2004062710A3
WO2004062710A3 PCT/US2004/000476 US2004000476W WO2004062710A3 WO 2004062710 A3 WO2004062710 A3 WO 2004062710A3 US 2004000476 W US2004000476 W US 2004000476W WO 2004062710 A3 WO2004062710 A3 WO 2004062710A3
Authority
WO
WIPO (PCT)
Prior art keywords
fluid
replacement fluid
preparation
batch
filtration system
Prior art date
Application number
PCT/US2004/000476
Other languages
French (fr)
Other versions
WO2004062710A2 (en
Inventor
James Brugger
Jeffrey Burbank
Brian Green
Original Assignee
James Brugger
Jeffrey Burbank
Nxstage Medical Inc
Brian Green
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
Priority to AT04700648T priority Critical patent/ATE434454T1/en
Priority to EP04700648A priority patent/EP1592494B1/en
Priority to DE602004021672T priority patent/DE602004021672D1/en
Application filed by James Brugger, Jeffrey Burbank, Nxstage Medical Inc, Brian Green filed Critical James Brugger
Publication of WO2004062710A2 publication Critical patent/WO2004062710A2/en
Publication of WO2004062710A3 publication Critical patent/WO2004062710A3/en
Priority to PCT/US2005/000381 priority patent/WO2005068043A1/en
Priority to US10/585,675 priority patent/US20080210606A1/en
Priority to US11/160,764 priority patent/US7544300B2/en
Priority to US12/434,246 priority patent/US7749393B2/en
Priority to US12/786,255 priority patent/US7976711B2/en
Priority to US13/083,915 priority patent/US8679348B2/en
Priority to US13/159,045 priority patent/US8202420B2/en
Priority to US13/526,145 priority patent/US8460558B2/en
Priority to US13/603,505 priority patent/US8545428B2/en
Priority to US13/909,990 priority patent/US20130264250A1/en
Priority to US13/968,430 priority patent/US9388059B2/en
Priority to US14/269,076 priority patent/US20140238909A1/en
Priority to US15/195,801 priority patent/US10130746B2/en
Priority to US15/615,655 priority patent/US10420871B2/en
Priority to US16/164,047 priority patent/US11446417B2/en

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
    • 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
    • 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
    • A61M1/166—Heating
    • 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
    • A61M1/1668—Details of containers
    • A61M1/167—Flexible packaging for solid concentrates
    • 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
    • A61M1/1656—Apparatus for preparing dialysates
    • A61M1/1674—Apparatus for preparing dialysates using UV radiation sources 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
    • A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • A61M1/288—Priming
    • 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
    • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/342—Adding solutions to the blood, e.g. substitution solutions
    • A61M1/3455—Substitution fluids
    • A61M1/3462—Circuits for the preparation thereof
    • C—CHEMISTRY; METALLURGY
    • C02—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F1/00—Treatment of water, waste water, or sewage
    • C02F1/44—Treatment of water, waste water, or sewage by dialysis, osmosis or reverse osmosis
    • 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
    • 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
    • A61M2205/12—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit

Abstract

A method and device for blood treatment involving infusion of replacement fluid are provided. In an embodiment, fluid is passed either by pump or passively by gravity feed, through a microporous sterilization filter (11) from a fluid source to a replacement fluid container (1). The latter forms a batch that may be used during treatment. The advantage of forming the batch before treatment is that the rate of filtering need not match the rate of consumption during treatment. As a result, the sterilization filter (11) can have a small capacity. In another embodiment, a filter (11) is placed immediately prior to the point at which replacement fluid is injected into the patient's bloodstream. The latter may be used in combination with the former embodiment as a last-chance guarantee of sterility and/or that the fluid is free of air bubbles. It may also be used as the primary means of sterile-filtration.
PCT/US2004/000476 2003-01-07 2004-01-07 Batch filtration system for preparation of sterile replacement fluid for renal therapy WO2004062710A2 (en)

Priority Applications (18)

Application Number Priority Date Filing Date Title
AT04700648T ATE434454T1 (en) 2003-01-07 2004-01-07 BATCH FILTRATION SYSTEM FOR PRODUCING A STERILE REPLACEMENT LIQUID FOR KIDNEY TREATMENTS
EP04700648A EP1592494B1 (en) 2003-01-07 2004-01-07 Batch filtration system for preparation of sterile replacement fluid for renal therapy
DE602004021672T DE602004021672D1 (en) 2003-01-07 2004-01-07 CHARGE FILTRATION SYSTEM FOR PRODUCING A STERILE SPARELIFE FLUID FOR NURSING TREATMENTS
PCT/US2005/000381 WO2005068043A1 (en) 2004-01-07 2005-01-07 Filtration system for preparation of fluids for medical applications
US10/585,675 US20080210606A1 (en) 2004-01-07 2005-01-07 Filtration System Preparation of Fluids for Medical Applications
US11/160,764 US7544300B2 (en) 2003-01-07 2005-07-07 Batch filtration system for preparation of sterile fluid for renal replacement therapy
US12/434,246 US7749393B2 (en) 2003-01-07 2009-05-01 Batch filtration system for preparation of sterile fluid for renal replacement therapy
US12/786,255 US7976711B2 (en) 2003-01-07 2010-05-24 Batch filtration system for preparation of sterile fluid for renal replacement therapy
US13/083,915 US8679348B2 (en) 2003-01-07 2011-04-11 Filtration system for preparation of fluids for medical applications
US13/159,045 US8202420B2 (en) 2003-01-07 2011-06-13 Batch filtration system for preparation of sterile fluid for renal replacement therapy
US13/526,145 US8460558B2 (en) 2003-01-07 2012-06-18 Batch filtration system for preparation of sterile fluid for renal replacement therapy
US13/603,505 US8545428B2 (en) 2003-01-07 2012-09-05 Filtration system for preparation of fluids for medical applications
US13/909,990 US20130264250A1 (en) 2003-01-07 2013-06-04 Batch filtration system for preparation of sterile fluid for renal replacement therapy
US13/968,430 US9388059B2 (en) 2003-01-07 2013-08-16 Filtration system for preparation of fluids for medical applications
US14/269,076 US20140238909A1 (en) 2003-01-07 2014-05-02 Batch filtration system for preparation of sterile fluid for renal replacement therapy
US15/195,801 US10130746B2 (en) 2003-01-07 2016-06-28 Filtration system for preparation of fluids for medical applications
US15/615,655 US10420871B2 (en) 2003-01-07 2017-06-06 Filtration system for preparation of fluids for medical applications
US16/164,047 US11446417B2 (en) 2003-01-07 2018-10-18 Filtration system for preparation of fluids for medical applications

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US43856703P 2003-01-07 2003-01-07
US60/438,567 2003-01-07

Related Child Applications (3)

Application Number Title Priority Date Filing Date
US10/585,675 Continuation US20080210606A1 (en) 2003-01-07 2005-01-07 Filtration System Preparation of Fluids for Medical Applications
PCT/US2005/000381 Continuation WO2005068043A1 (en) 2003-01-07 2005-01-07 Filtration system for preparation of fluids for medical applications
US11/160,764 Continuation US7544300B2 (en) 2003-01-07 2005-07-07 Batch filtration system for preparation of sterile fluid for renal replacement therapy

Publications (2)

Publication Number Publication Date
WO2004062710A2 WO2004062710A2 (en) 2004-07-29
WO2004062710A3 true WO2004062710A3 (en) 2004-10-21

Family

ID=32736511

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2004/000476 WO2004062710A2 (en) 2003-01-07 2004-01-07 Batch filtration system for preparation of sterile replacement fluid for renal therapy

Country Status (5)

Country Link
US (11) US7544300B2 (en)
EP (1) EP1592494B1 (en)
AT (1) ATE434454T1 (en)
DE (1) DE602004021672D1 (en)
WO (1) WO2004062710A2 (en)

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US8679348B2 (en) 2003-01-07 2014-03-25 Nxstage Medical, Inc. Filtration system for preparation of fluids for medical applications

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