EP2763718A1 - Dispositif de dialyse et procédé pour le faire fonctionner - Google Patents

Dispositif de dialyse et procédé pour le faire fonctionner

Info

Publication number
EP2763718A1
EP2763718A1 EP12741329.2A EP12741329A EP2763718A1 EP 2763718 A1 EP2763718 A1 EP 2763718A1 EP 12741329 A EP12741329 A EP 12741329A EP 2763718 A1 EP2763718 A1 EP 2763718A1
Authority
EP
European Patent Office
Prior art keywords
plasma
patient
dialysis
bloodstream
blood
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.)
Withdrawn
Application number
EP12741329.2A
Other languages
German (de)
English (en)
Inventor
Werner Kleophas
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of EP2763718A1 publication Critical patent/EP2763718A1/fr
Withdrawn legal-status Critical Current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
    • A61M1/34—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
    • 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
    • A61M1/34—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
    • A61M1/3424—Substitution fluid path
    • A61M1/3437—Substitution fluid path downstream of the filter, e.g. post-dilution with filtrate
    • 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
    • A61M1/3441—Substitution rate control as a function of the ultrafiltration rate
    • 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
    • A61M1/3468—Substitution fluids using treated filtrate as substitution fluid
    • 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
    • A61M1/3472—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration with treatment of the filtrate
    • A61M1/3482—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration with treatment of the filtrate by filtrating the filtrate using another cross-flow filter, e.g. a membrane filter
    • 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
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3639—Blood pressure control, pressure transducers specially adapted 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
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0413—Blood
    • A61M2202/0415—Plasma
    • 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
    • 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

Definitions

  • the invention relates to a dialysis apparatus and a method for operating a dialysis apparatus.
  • JP 2004358269 A a dialysis apparatus is known in which the blood pressure is to be kept under control by adjusting the sodium dosage. It has been found in practice that known therapeutic approaches, especially the treatment under certain volume or sodium profiles, often have only insufficient effectiveness, sometimes only the time of a critical drop in blood pressure is postponed or advanced.
  • a dialysis apparatus comprises: a hemodialyzer connectable to the bloodstream of a patient;
  • a plasma storage device for temporarily storing blood plasma of the patient; and a delivery device for delivering blood plasma stored in the plasma storage device into the bloodstream of the patient.
  • the dialysis apparatus further comprises a plasma separator for separating blood plasma from blood of the patient, the plasma separator being connected to the plasma storage device.
  • the supply device has a valve device 25, via which the plasma separator can be selectively connected to the bloodstream of the patient.
  • the delivery device includes a plasma pump for delivering blood plasma stored in the plasma storage device to the patient's bloodstream.
  • the invention further relates to a method for operating a dialysis machine, the dialysis machine comprising: a hemodialyzer connectable to the bloodstream of a patient; a plasma storage device for temporarily storing blood plasma of the patient; and delivery means for delivering blood plasma stored in the plasma storage device into the bloodstream of the patient; wherein the feeder is driven based on the current value of the intradiolytic fluid volume.
  • the supply device is actuated in such a way that the supply of blood plasma stored in the plasma storage device into the bloodstream of the patient preferably takes place at a point in time during which the intradialytic liquid volume reaches a volume value V2 during hemodialysis which corresponds to a physiological hydration state.
  • the so-called dry weight is set at the end of a dialysis treatment in which the liquid volume must be low in order to provide sufficient latitude for the expected fluid increase. From this volume value (hereinafter referred to as V1), an increase of the volume to a value V2, which corresponds to a physiological state of hydration, takes place up to the day following the dialysis treatment as a result of the intake of liquid.
  • V3 The day before The next dialysis treatment to be achieved is a nonphysiologically high volume, hereinafter referred to as V3, which corresponds to hyperhydratation.
  • This volume V3 corresponding to the hyperhydratation in turn results in a greatly increased hydrostatic pressure difference, especially since there is virtually no vasoconstriction or dilatation due to the given neuropathy.
  • this volume V3 comprises both an intravascular portion and an intracellular portion.
  • this post-flow process is commonly referred to as "refilling"
  • the course of this refilling process depends not only on the hydrostatic pressure difference but also on the colloid osmotic pressure difference (also referred to as the oncotic pressure difference), which in turn is significantly influenced by the protein components of the plasma.
  • the osmotic pressure difference caused by sodium ions or the like plays a rather subordinate role for refilling.
  • Circulatory collapse typically occurs when a drop in volume 25 from value V3 above value V2 to value VI corresponding to hypovolaemia occurs.
  • the invention is now based on the concept of performing a substitution with previously separated self-plasma of the patient, preferably at the time at which the volume value V2 is reached during hemodialysis or ultrafiltration. As a result, a circulation stabilization can be achieved and a circulation collapse can be prevented.
  • the approach according to the invention is based on the knowledge that it can be assumed that a decrease in the colloid osmotic pressure taking place at the beginning of the dialysis treatment is tolerable red or has no circulatory destabilizing effect, which results in particular from the decrease of the volume 5 from the value V3 to the value V2 occurring at the beginning of the dialysis treatment. Refilling "promotional and thus has a circulatory stabilizing effect.
  • the refilling process is promoted in particular by the increase in the colloid-osmotic pressure difference, which is accompanied by the reinfusion of the intrinsic plasma i o.
  • This effect shows a more direct effect for refilling compared to influencing the osmotic pressure differences, as attempted in the prior art by adjusting the sodium dosage - without any truly resounding success.
  • FIGURE 1 is a schematic diagram for explaining the structure and operation of a dialysis apparatus according to an embodiment of the invention.
  • a dialysis apparatus initially has, in a known manner, a hemodialyzer 10 arranged in a dialysis line 15, in which the blood is subjected to dialysis
  • a blood pump 20 is in operation between an arterial blood line.
  • a plasma separator 30 is now connected to the dialysis device according to the invention. From this plasma Rator 30 leads a plasma line 35 via a plasma storage device 40 and a plasma pump 50 to the venous blood line 26. Upstream and downstream of the plasma separator 30 is provided in each case a (two-way) valve 31 or 32, via which the pumped by the blood pump 20 Blood flow can be selectively guided via the plasma separator 30 and the plasma storage device 40.
  • the valve means formed of the valves 31, 32, the plasma pump 50 and the plasma pipe 35 together form a supply means for supplying blood plasma stored in the plasma storage means 40 into the blood circulation of the patient.
  • connection of the plasma separator 30 may also be in the area of the arterial blood line 26, i. so be done before the hemodialyzer 10.
  • a temporary storage of blood plasma can take place, which is separated off at the beginning of the dialysis treatment, wherein this blood plasma is then preferably supplied during the dialysis treatment at the time at which the volume value V2 is reached during hemodialysis or ultrafiltration, which corresponds to the physiological state of hydration.
  • the supply device is thus activated based on the current value of the intradialytic liquid volume.
  • the blood stream is passed via the plasma separator 30, the blood plasma separated there being stored in the plasma storage device 40 and the plasma-poor blood remaining after separation being supplied via the valve 32 to the venous blood line 26.
  • the plasma-poor blood remaining after separation can also be supplied to the hemodialyzer 10.
  • the Abseparationsvorgang is preferably start with the beginning of the dialysis process or shortly thereafter, ie at a time at which there is a hydrate hydration with a corresponding volume V3.
  • the Abseparationsvorgang preferably in one - in relation to the total duration of the dialysis procedure - relatively short period of time, for example within the first half hour with a total of four hours of dialysis, ie preferably within the first eighth of the available dialysis time, possibly also within the first third of the available dialysis time.
  • the refilling process supported by the self-plasma reinfusion should be able to run for as long a period as possible, if possible before the non-physiological hydration state V1 is reached.
  • the amount of self-plasma to be separated is i.a. limited in that the physiological hydration state V2 should not already be exceeded by the initial Abseparationsvorgang.
  • reinfusion can be used at any time for circulatory stabilization and promotion of the refilling process.
  • the reinfusion may preferably be started at a time in the last third of the dialysis process.
  • the reinfusion rate may be relatively high to achieve a rapid therapeutic effect.
  • the re-infusion rate can be chosen to be relatively low and, for example, adjusted so that the reinfusion is completed approximately in conjunction with the dialysis session.
  • blood plasma stored in the plasma storage device 40 is supplied to the venous blood line 26 by reopening the valve 31 so as to be initially diverted blood plasma to the patient's bloodstream and to compensate for the further decrease in fluid volume.
  • the supply of the colloid osmotic effective self-plasma promotes Refilling, ie the Nachströmem extravasal fluid into the intravascular space, whereby a circulation-stabilizing effect is achieved.
  • the determination of the appropriate time of the start of the supply of the stored blood plasma is preferably based on the fluid balance of the patient taking into account u.a. the current ultrafiltration rate as well as the current circulatory status.
  • sequence control of the device according to the invention is preferably carried out by means of an automated, microcomputer-supported sequence control which, by monitoring the monitor values of the patient (eg blood pressure) possibly also prematurely reinfuses the stored one Can initiate blood plasma.
  • monitor values of the patient eg blood pressure

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (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)
  • Emergency Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Cardiology (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne un dispositif de dialyse ainsi qu'un procédé pour le faire fonctionner. Le dispositif de dialyse comporte un hémodialyseur (10) pouvant être relié au système vasculaire sanguin d'un patient, un dispositif de stockage de plasma (40) pour stocker temporairement du plasma sanguin du patient et un dispositif d'introduction (31, 32, 35, 50) pour introduire du plasma sanguin stocké dans le dispositif de stockage de plasma (40) dans le système vasculaire sanguin du patient.
EP12741329.2A 2011-07-28 2012-07-30 Dispositif de dialyse et procédé pour le faire fonctionner Withdrawn EP2763718A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102011052264A DE102011052264A1 (de) 2011-07-28 2011-07-28 Dialysevorrichtung sowie Verfahren zum Betreiben derselben
PCT/EP2012/064868 WO2013014297A1 (fr) 2011-07-28 2012-07-30 Dispositif de dialyse et procédé pour le faire fonctionner

Publications (1)

Publication Number Publication Date
EP2763718A1 true EP2763718A1 (fr) 2014-08-13

Family

ID=46601814

Family Applications (1)

Application Number Title Priority Date Filing Date
EP12741329.2A Withdrawn EP2763718A1 (fr) 2011-07-28 2012-07-30 Dispositif de dialyse et procédé pour le faire fonctionner

Country Status (4)

Country Link
US (1) US20140323943A1 (fr)
EP (1) EP2763718A1 (fr)
DE (2) DE102011052264A1 (fr)
WO (1) WO2013014297A1 (fr)

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3374660D1 (en) * 1982-03-10 1988-01-07 Toyoda Chuo Kenkyusho Kk Blood purification apparatus
US5252213A (en) * 1989-06-20 1993-10-12 University Of Washington Dry dialysate composition
US5346472A (en) 1993-06-02 1994-09-13 Baxter International Inc. Apparatus and method for preventing hypotension in a dialysis patient
CA2214754A1 (fr) * 1996-09-09 1998-03-09 Masataka Narisada Methode et appareil pour traiter le sang
AU2003261571A1 (en) * 2002-09-12 2004-04-30 Asahi Medical Co., Ltd. Plasma purification membrane and plasma purification system
US7169303B2 (en) * 2003-05-28 2007-01-30 Hemocleanse Technologies, Llc Sorbent reactor for extracorporeal blood treatment systems, peritoneal dialysis systems, and other body fluid treatment systems
DE102004026561B4 (de) 2004-05-27 2007-02-22 Fresenius Medical Care Deutschland Gmbh Hämodialysegerät mit Notfallaktivierungsmittel
US7785463B2 (en) * 2006-03-17 2010-08-31 Children's Hospital Medical Center Extracorporeal renal replacement modeling system
CA2678394C (fr) * 2007-02-15 2012-08-07 Atsushi Karakama Systeme de purification du sang
IT1391086B1 (it) 2008-07-09 2011-11-18 Gambro Lundia Ab Apparato trattamento extracorporeo sangue

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
None *
See also references of WO2013014297A1 *

Also Published As

Publication number Publication date
DE112012003147A5 (de) 2014-04-10
WO2013014297A1 (fr) 2013-01-31
US20140323943A1 (en) 2014-10-30
DE102011052264A1 (de) 2013-01-31

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