WO2000007644A1 - Procede et dispositif pour maintenir l'utilite d'un dispositif servant a l'hemotherapie - Google Patents

Procede et dispositif pour maintenir l'utilite d'un dispositif servant a l'hemotherapie Download PDF

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Publication number
WO2000007644A1
WO2000007644A1 PCT/DE1999/002325 DE9902325W WO0007644A1 WO 2000007644 A1 WO2000007644 A1 WO 2000007644A1 DE 9902325 W DE9902325 W DE 9902325W WO 0007644 A1 WO0007644 A1 WO 0007644A1
Authority
WO
WIPO (PCT)
Prior art keywords
blood
chamber
hemotherapy
rinsing liquid
extracorporeal
Prior art date
Application number
PCT/DE1999/002325
Other languages
German (de)
English (en)
Inventor
Bernd Tersteegen
Original Assignee
Imt Innovative Medizintechnik Gmbh
TERSTEEGEN, Johanne
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 Imt Innovative Medizintechnik Gmbh, TERSTEEGEN, Johanne filed Critical Imt Innovative Medizintechnik Gmbh
Priority to AU63240/99A priority Critical patent/AU6324099A/en
Priority to EP99950449A priority patent/EP1102605A1/fr
Publication of WO2000007644A1 publication Critical patent/WO2000007644A1/fr

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
    • A61M1/168—Sterilisation or cleaning before or after use
    • 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
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/168—Sterilisation or cleaning before or after use
    • A61M1/1682—Sterilisation or cleaning before or after use both machine and membrane module, i.e. also the module blood side
    • 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
    • A61M1/168—Sterilisation or cleaning before or after use
    • A61M1/1688—Sterilisation or cleaning before or after use with recirculation of the sterilising 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
    • A61M1/36—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
    • A61M1/3643—Priming, rinsing before or after use
    • 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
    • A61M1/3643—Priming, rinsing before or after use
    • A61M1/3644—Mode of operation
    • 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
    • A61M1/3643—Priming, rinsing before or after use
    • A61M1/3644—Mode of operation
    • A61M1/3646—Expelling the residual body fluid after use, e.g. back to the body
    • 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
    • A61M1/3643—Priming, rinsing before or after use
    • A61M1/3644—Mode of operation
    • A61M1/365—Mode of operation through membranes, e.g. by inverted trans-membrane pressure [TMP]
    • 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
    • A61M1/168—Sterilisation or cleaning before or after use
    • A61M1/169—Sterilisation or cleaning before or after use using chemical substances
    • 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
    • A61M2205/75—General characteristics of the apparatus with filters
    • A61M2205/7554—General characteristics of the apparatus with filters with means for unclogging or regenerating filters

Definitions

  • the invention relates to a method for maintaining the usability of an already used device for extracorporeal hemotherapy, in which used dialysis fluid or filtrate has been obtained and in which the device has at least one blood-side and one non-blood-side chamber and in which after completion of the therapy process by at least one Chamber a rinsing liquid is passed, and a device for performing the method.
  • a dialysis apparatus having a blood side chamber as a component of an extracorporeal blood circuit and a non-blood-side chamber ⁇ , is passed through a dialysis solution. Both chambers are separated from each other by a semipermeable membrane.
  • a semipermeable membrane is known from DE 31 15 665 C2, the content of which is expressly included.
  • the dialysis liquid is stored in a storage container and is fed back into the container after passing through the dialyzer.
  • Methods for reusing dialyzers are known in which a cleaning liquid is passed through the dialyzers and these are then filled and stored with a preservation liquid.
  • the desired patient-specific protein layers are at least partially removed or chemically / biologically changed. These changes can in turn trigger immunological reactions.
  • a protein layer can also reduce the risk of an immunological reaction in the tubes used.
  • common hoses e.g. made of PVC
  • plasticizer additives Small amounts of these plasticizers can enter the patient's bloodstream during dialysis treatment. By maintaining a patient-specific protein layer, the plasticizer migration from the tubes can be reduced for the benefit of the patient.
  • the present invention strives to ensure hygienically safe multiple use or long-term use of facilities for extracorporeal hemotherapy (including the tubing) with reasonable effort, whereby removal and / or modification of the patient-specific protein deposits should be avoided.
  • Claim 9 describes an apparatus for performing this method.
  • the used dialysis liquid or the used filtrate which has already arisen during use, is used as the rinsing liquid, the desired patient-specific protein deposits remain largely unchanged and constituents which clog the dialyzer membrane are also flushed out.
  • the dialysis fluid is largely germ-free is and will remain as long as it is extremely low in germs and pyrogenic and afterwards no germs or pyrogens could get into the system from outside.
  • the urea which has passed from the blood into the dialysis fluid has an additional bacteriostatic effect.
  • the entire device is kept virtually sterile during the method. Germs can result in the formation of endotoxins and other substances which can trigger a fever even without the presence of a bacterial germ and are known collectively as "pyrogens". If it is not possible to suppress the nucleation in the entire system, safe multiple use or continuous use of the device for extracorporeal hemotherapy and also the tubing is not possible, since pyrogens have the negative property of attaching to the membranes used in the devices.
  • the method according to the invention and the device according to the invention ensure virtually sterility, since contact with the ambient air during the treatment and cleaning processes is negligible and the system is easy to clean.
  • the invention is explained in more detail below using the drawing as an example.
  • the single figure shows a schematic representation of a hemodialysis machine with a device for extracorporeal hemotherapy and associated tubes which, after minor modifications, is suitable for carrying out the method according to the invention or represents a possible device according to the invention after these modifications.
  • the arterial blood is supplied through a line 1 during the dialysis process, conveyed by a peristaltic pump 2 through a first flow path 3a of a dialyzer and returned to the patient via a line 4, as indicated by the arrows in the drawing.
  • a dialysis liquid flows in a second flow path 3b of the dialyzer. This is removed through a line 5 with a connection 5a opening into a container 6, a container 6, passed through the flow path 3b of the dialyzer and by means of a hose pump 7 arranged behind the flow path 3b via a line 8 and a tube opening at 9a in the lower region of the container 9 returned to the container.
  • the container is double-walled and has an inner container 6a with an additional casing 6b.
  • the inner container 6a and the sleeve 6b are preferably as made of transparent materials, such as the inner container made of glass and the shell made of a transparent polymer, so that a visual inspection is possible.
  • the line 5 for removing the dialysis fluid begins at 5a in the upper container area.
  • the return line 8 opens into the tube 9 arranged in the center of the container.
  • the used dialysis liquid is supplied to the interior of the container filled with liquid near the bottom of the container through the open end 9a of the tube 9.
  • the container is designed to accommodate an ultraviolet emitter 11 in order to ensure low germ and pyrogen levels.
  • the following steps are carried out before uncoupling the patient in order to clean and preserve the dialyzer while maintaining the deposited protein layers, so that multiple use or continuous use is possible, preferably when the patient concerned is re-treated:
  • a bag with preferably physiological saline solution is connected at 1.
  • the peristaltic pump 2 is operated until the blood in the flow path 3a and in the feeds 1 and 4 is returned to the patient's bloodstream and only small amounts of residual blood are left in the system.
  • the venous connection is also disconnected from the patient and line 4 is also connected to the at least partially empty saline solution bag. This then serves as a collecting reservoir for the backwashed liquid.
  • the hose 1 is removed from the pump 2.
  • the hose 5 is still completely closed by means of a clamp 14a and the end is removed from the connection 5a of the container 6, so that air can flow into the container 6 as pressure compensation for the backwashing liquid removed through the open connection piece at 5a.
  • the overflow line 12 is also closed.
  • the direction of delivery of the pump 7 is reversed by reversing the direction of rotation of the pump motor or by inserting the hose 8 into the pump 7 in the opposite direction.
  • dialysis fluid is now removed from the lower part of the container 6. Air can flow into the container 6 through the open connection 5a. A pressure drop is built up in chamber 3b with respect to chamber 3a, as a result of which dialysis fluid is flushed back into chamber 3a. During this backwashing process, the corpuscular components present in the device for extracorporeal hemotherapy are loosened and rinsed into the reservoir container via lines 1 and 4, whereby existing and desired, patient-specific protein deposits in the device for extracorporeal hemotherapy and in the tubes 1 and 4 remain. This process is carried out until further usability is ensured.
  • the reservoir bag is removed, the hose 8 is removed from the pump 7 and the clamp 14a in the line 5 is opened so that the end of the hose 5 is open. Since the device for extracorporeal hemotherapy is arranged higher than the container 6, the chamber 3b, which is still filled with backwash dialysis liquid, is emptied into the container 6 by the action of gravity, which prevents unnecessary dilution of the disinfectant or corrosion agent to be supplied.
  • both chambers of the device for extracorporeal hemotherapy and the tubes are filled with a disinfectant or preservative solution so that all critical areas of the system come into contact with disinfectant or preservative.
  • concentration of the disinfectant or preservative with 0.01 to 0.02% per-acetic acid is chosen to be significantly (approximately by a factor of four to twenty) lower than is customary for disinfectant solutions for comparable applications. Since no or only a very small number of germs are generally introduced into the system during the entire dialysis and preparation process due to the closed system, a weakly concentrated disinfectant solution is completely sufficient to kill these germs. This spares the desired protein deposits, ie avoids undesired oxidation reactions, which increases patient tolerance. In addition, the risk that disinfectant residues accidentally get into the patient's bloodstream is lower, the lower the concentration of the disinfectant is chosen. The use of a lower disinfectant concentration has also resulting in lower physical impairments.
  • the device for extra-corporal hemotherapy filled with disinfectant, as well as the hoses remaining connected to it, are stored until the next use, preferably with the same patient, for whom the therapy was previously carried out with the same device.
  • the hose ends are disinfected and sealed with adapters, whereby the use of cooling devices is not required for storage.
  • the disinfectant or preservative is removed.
  • a three-stage process is preferably used for this: First, the disinfection or Preservative rinsed out with pure water or a saline solution. Then a vitamin C solution is added. Vitamin C reacts with any remaining disinfectant residues to form physiological substances (provitamin C and acetic acid).
  • the blood side is then dialyzed again against fresh dialysis fluid before the start of the therapy. A new dialysis can then be carried out on the patient concerned. In a procedure other than hemodialysis, the third step must be replaced by an adequate procedure.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Emergency Medicine (AREA)
  • Cardiology (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne un procédé permettant de maintenir l'utilité pratique d'un dispositif servant déjà à l'hémothérapie extracorporelle (par ex. dialyse, filtration, hémodiafiltration), selon lequel le liquide de dialyse utilisé ou le filtrat est accumulé. Il est prévu au moins une chambre (3a) située côté sang et une chambre (3b) non située côté sang. Une fois le processus thérapeutique accompli, un liquide de rinçage est introduit à travers au moins une chambre, à des fins de nettoyage. Le liquide de rinçage utilisé est le liquide de dialyse employé résultant de l'utilisation déjà effectuée ou le filtrat accumulé, de préférence dans le cadre d'un procédé de rétrolavage. Le dispositif est ensuite soumis à un traitement de conservation avec une concentration infime d'agent désinfectant, ce qui permet d'éviter de rincer par un courant d'eau ou de dénaturer les couches de protéines déposées et réduit par ailleurs le risque de réactions immunologiques.
PCT/DE1999/002325 1998-08-05 1999-07-30 Procede et dispositif pour maintenir l'utilite d'un dispositif servant a l'hemotherapie WO2000007644A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU63240/99A AU6324099A (en) 1998-08-05 1999-07-30 Method and device for maintaining the usability of a device for haemotherapy
EP99950449A EP1102605A1 (fr) 1998-08-05 1999-07-30 Procede et dispositif pour maintenir l'utilite d'un dispositif servant a l'hemotherapie

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19835294.8 1998-08-05
DE19835294A DE19835294C1 (de) 1998-08-05 1998-08-05 Verfahren zur Aufrechterhaltung der Verwendbarkeit einer bereits verwendeten Einrichtung zur extrakorporalen Hämotherapie

Publications (1)

Publication Number Publication Date
WO2000007644A1 true WO2000007644A1 (fr) 2000-02-17

Family

ID=7876490

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/DE1999/002325 WO2000007644A1 (fr) 1998-08-05 1999-07-30 Procede et dispositif pour maintenir l'utilite d'un dispositif servant a l'hemotherapie

Country Status (4)

Country Link
EP (1) EP1102605A1 (fr)
AU (1) AU6324099A (fr)
DE (1) DE19835294C1 (fr)
WO (1) WO2000007644A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3115665A1 (de) * 1981-04-18 1982-11-04 Günter van Dr.med. 4000 Düsseldorf Endert Haemodialysegeraet und arbeitsverfahren zur ultrafiltrationssteuerung mit diesem geraet
US5252213A (en) * 1989-06-20 1993-10-12 University Of Washington Dry dialysate composition
EP0720856A2 (fr) * 1992-03-13 1996-07-10 Medical Support Gmbh Dispositif de nettoyage et remplissage en ligne d'un circuit extracorporel sanguin d'une machine de dialyse
US5762782A (en) * 1995-02-13 1998-06-09 Aksys, Ltd. Water treatment for dialysate preparation

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3115665A1 (de) * 1981-04-18 1982-11-04 Günter van Dr.med. 4000 Düsseldorf Endert Haemodialysegeraet und arbeitsverfahren zur ultrafiltrationssteuerung mit diesem geraet
DE3115665C2 (de) 1981-04-18 1985-02-07 Günter van Dr.med. 4000 Düsseldorf Endert Hämodialysegerät und Einrichtung zur Ultrafiltrationssteuerung mit diesem Gerät
US5252213A (en) * 1989-06-20 1993-10-12 University Of Washington Dry dialysate composition
EP0720856A2 (fr) * 1992-03-13 1996-07-10 Medical Support Gmbh Dispositif de nettoyage et remplissage en ligne d'un circuit extracorporel sanguin d'une machine de dialyse
US5762782A (en) * 1995-02-13 1998-06-09 Aksys, Ltd. Water treatment for dialysate preparation

Also Published As

Publication number Publication date
AU6324099A (en) 2000-02-28
EP1102605A1 (fr) 2001-05-30
DE19835294C1 (de) 2000-01-27

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