WO2016024217A1 - Système de circuit extracorporel utilisable en vue du traitement de déséquilibres hydroélectrolytiques et acido-basiques au niveau du sang - Google Patents

Système de circuit extracorporel utilisable en vue du traitement de déséquilibres hydroélectrolytiques et acido-basiques au niveau du sang Download PDF

Info

Publication number
WO2016024217A1
WO2016024217A1 PCT/IB2015/056103 IB2015056103W WO2016024217A1 WO 2016024217 A1 WO2016024217 A1 WO 2016024217A1 IB 2015056103 W IB2015056103 W IB 2015056103W WO 2016024217 A1 WO2016024217 A1 WO 2016024217A1
Authority
WO
WIPO (PCT)
Prior art keywords
acid
treatment
hydroelectrolyte
extracorporeal circuit
blood
Prior art date
Application number
PCT/IB2015/056103
Other languages
English (en)
Inventor
Antonio Maria Pesenti
Alberto ZANELLA
Domenico Salerno
Nicolò Antonino Patroniti
Francesco Mantegazza
Luciano Gattinoni
Pietro CAIRONI
Original Assignee
Universita' Degli Studi Di Milano - Bicocca
Universita' Degli Studi Di Milano
Fondazione Irccs "Ca' Granda - Ospedale Maggiore Policlinico"
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 Universita' Degli Studi Di Milano - Bicocca, Universita' Degli Studi Di Milano, Fondazione Irccs "Ca' Granda - Ospedale Maggiore Policlinico" filed Critical Universita' Degli Studi Di Milano - Bicocca
Publication of WO2016024217A1 publication Critical patent/WO2016024217A1/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
    • A61M1/34—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
    • 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
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1694—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes with recirculating dialysing liquid
    • A61M1/1696—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes with recirculating dialysing liquid with dialysate regeneration
    • 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
    • A61M1/3458—Substitution fluids having electrolytes not present in 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
    • A61M1/34—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
    • 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
    • A61M1/3479—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration with treatment of the filtrate by dialysing the 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
    • A61M1/3472—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration with treatment of the filtrate
    • A61M1/3486—Biological, chemical treatment, e.g. chemical precipitation; treatment by absorbents

Definitions

  • the present invention relates to an extracorporeal circuit system for the treatment of hydroelectrolyte and acid-base blood imbalances.
  • disorders of acid-base and electrolyte balance are extremely common in medicine and especially in critically ill patients. Said disorders are found in nine out of ten patients in intensive care, which means that the disorders of the acid- base and electrolyte balance can be considered some of the clinical problems most commonly found in intensive care. It has been estimated that the incidence of this type of disorder is more than 95% among the patients admitted in emergency rooms.
  • the mixed acid-base balance disorders are the most common disorders and, among these, metabolic acidosis combined with respiratory alkalosis is the most common disorder.
  • Simple acid-base disorders despite having a lower incidence than the mixed ones, may be an urgent clinical condition and without simple treatment. Among them, respiratory acidosis, both acute and chronic, is a clinical condition common in critically ill patients which necessarily requires the use of a support respiratory treatment (such as mechanical ventilation) not free from side effects .
  • the ventilation by means of the lungs, is a fast response, but not so effective, and often is not a usable therapy due to serious complications (for example, the ventilator can cause pulmonary damage) ; the urinary excretion of chlorine, by way of the kidneys, is more effective but requires a preserved renal function and an extended period of time (several days) before being effective.
  • the need was therefore felt to find a treatment for acidosis states which is free of the disadvantages of known therapies.
  • the purpose of the present invention is therefore to provide an alternative treatment allowing efficient and fast selective removal of chlorine.
  • This new technology exploits the electrodialysis technique for selectively removing chlorine from the dialysate or from the ultrafiltrate . Therefore in case of metabolic or respiratory acidosis it is suitable for selectively removing the chlorine ions to restore the acid-base systemic balance.
  • FIG. 2 illustrates a detail of the electrodialyzer of the extracorporeal circulation system of figure 1 ;
  • FIG. 3 illustrates a second embodiment of the invention
  • FIG. 4 illustrates a third embodiment of the invention.
  • the circuit 300 comprises a blood withdrawal line from the patient 2, on which a peristaltic pump 3 acts, a first filter unit 6 and a blood reinsertion line 5 in the patient which define a main circuit 12.
  • the first filter unit 6 can be chosen from the group consisting of a hemodiafilter, a hemofilter and a dialyzer.
  • the circuit 300 also comprises an electrolytic restoration group 4 which in turn comprises an electrodialyzer 10.
  • the first filter unit 6, in Figure 1 a hemodiafilter is connected to a recirculation circuit 7 of the plasmatic water which acts on a peristaltic pump 8 to push the plasmatic water towards the electrodialyzer 10 placed on the circuit 7.
  • the electrodialyzer 10 is provided with a first electrodialysis chamber 21 and a second electrodialysis chamber 22 separated by an anionic membrane 23.
  • Each chamber is separated from the corresponding electrode 24,25 by means of a bipolar membrane 26,27.
  • the positive electrode 24, or anode is placed in a chamber 28 immersed in an anolyte solution, for example sodium sulphate or sodium phosphate, and the negative electrode 25, or cathode, is placed in a chamber 29 immersed in a catholyte solution, for example, sodium chloride.
  • anolyte solution for example sodium sulphate or sodium phosphate
  • a catholyte solution for example, sodium chloride.
  • the electrodialysis chamber 21 associated with the anode 24 is suitable for generating a chlorine-rich solution 30a; the electrodialysis chamber 22 associated with the cathode 25 is suitable instead for generating a chlorine- poor solution 30b.
  • a bipolar membrane 26 and 27 prevents the passage of ions contained in the chambers 21 and 22 towards the chambers 28 and 29 and vice versa.
  • the chlorine-rich solution 30a and the chlorine- poor solution 30b are prevented from being contaminated by the catholyte or by the anolyte.
  • the anolyte solution and the catholyte solution are recirculated respectively within the chambers 28 and 29 by means of the circuits 17 and 18 by means of the pumps 40 and 41.
  • degasifiers 42 and 43 are provided which eliminate the gases developed during the electrodialysis, typically oxygen and hydrogen gases.
  • the blood withdrawn from the patient through the withdrawal line 2, is pushed by the peristaltic pump 3 towards the hemodiafilter 6.
  • the hemodiafilter 6, separates the ultrafiltrate or plasmatic water which, pushed by the pump 8, reaches the electrodialyzer 10 where it enters the second electrodialysis chamber 22 where the transfer of chlorine in favour of the hydroxyl ion takes place.
  • a chlorine-poor and basic solution 30b is therefore formed.
  • the first electrodialysis chamber 21 instead receives a replacement solution, for example physiological saline solution, contained in a container 31, through the line 32.
  • a replacement solution for example physiological saline solution
  • This solution receives the chlorine from the chamber 22 and the H+ ions generated within the bipolar membrane 26. Therefore inside the first electrodialysis chamber 21 a chlorine-rich and acid solution 30a is formed.
  • the plasmatic water that enters the second chamber 22, provides anions to the substitutive solution in the first chamber 21. Since the main anion in the plasmatic water is Cl ⁇ , the solution flowing in the first chamber 21 is enriched in Cl ⁇ ions, generating, in a manner proportional to the electric current applied, a chlorine-rich solution 30a. In the chamber 22, the plasmatic water deprived of the Cl ⁇ ions instead gives rise to a chlorine-poor solution 30b.
  • the system according to the present invention does not modify the tonicity of the chlorine-poor solution 30b exiting the electrodialyzer 10 with respect to that of plasmatic water entering the electrodialyzer 10.
  • This allows the reinfusion of the chlorine-poor solution 30b directly to the patient by means of the line 16 without changing the tonicity of the blood on the return line 5 to the patient and thus prevent possible local and systemic complications such as the hemolysis of red blood cells.
  • the chlorine-rich solution 30a exiting the first chamber 21 is removed by means of the line 15.
  • the solution 30b generated from the second chamber 22 is in part transported by means of the line 11 to a C0 2 exchanger 9, and in part is recirculated by means of the line 13 to the electrodialyzer 10.
  • Said recirculation along the line 13 has the further advantage of allowing the precipitation of calcium before the plasmatic water enters in the electrodialyzer 10.
  • the treatment of plasmatic water, rich in calcium and carbon dioxide, with the electrodialysis to generate a chlorine-poor and basic solution 30b causes the precipitation of salts of calcium and magnesium, mainly calcium carbonate, inside of the electrodialyzer 10 thus reducing the efficiency.
  • the presence of calcium crystals in the chlorine-poor solution 30b might cause embolization of said crystals if they were to be returned to the patient.
  • a precipitate removal unit 14 can be provided, for example a filter or a tangential filter or a centrifugal separator, to remove the precipitate, in particular calcium carbonate.
  • the calcium crystals can subsequently be re-dissolved by acidification and optionally the recuperated calcium may be reinfused into the patient.
  • the solution 30b is loaded with C0 2 , to obtain a physiological pH before returning to the extracorporeal blood flux downstream from the filter unit 6.
  • the administration of C0 2 prevents the pH increase and the reduction of the C0 2 in the extracorporeal blood after the reinfusion of the solution 30b which has a basic pH, thus minimizing the strain of red blood cells and preventing a possible reduction of the patient ventilation.
  • the C0 2 exchanger 9 can be removed from the electrolyte restoration group 4.
  • the solution 30b Downstream from the C0 2 exchanger 9, the solution 30b is fed back to the main circuit 12 downstream from the filter unit 6 by means of the line 16.
  • a filter 19 On said line 16 a filter 19 is provided for retaining particles or particulates that may possibly be harmful if reinfused into the patient.
  • the system of Figure 1 was tested in a porcine model.
  • the blood flow was set to 150 ml/min and the flow in the recirculation ultrafiltrate to 30 ml/min.
  • An electric current of 4 amperes was applied to the electrodialyzer thus allowing to obtain a removal of chlorine ions of 1-2 mEq/min, using then a C0 2 flow in the gas exchanger to compensate for the removal of chlorine.
  • the calcium loss was corrected by an infusion of a calcium-rich solution.
  • the extracorporeal circuit system 400 comprises, as first filter unit 6, a dialyzer.
  • a dialyzer allows the use of a dialysate flow higher with respect to that of the ultrafiltrate possible with the use of a hemodiafilter as in the circuit of Figure 1 and therefore allows to remove a greater amount of chlorine in the same haematic flow.
  • This configuration can therefore also be used with very low blood flows, without necessarily requiring high gauge cannulas (requests for higher extracorporeal blood flows), making the use of the device easier.
  • the line 16 exiting the C0 2 exchanger 9 takes the plasmatic water back to the dialyzer 6.
  • the removal of calcium can be made by replacing the precipitate removal unit 14 with a cartridge 114 containing a cationic ion exchange resin, for example loaded with a solution containing 145 mEq/1 of sodium and 4 mEq/L of potassium.
  • a solution containing 145 mEq/1 of sodium and 4 mEq/L of potassium As shown in Figure 4 in relation to the embodiment of Figure 1, in this case, it will no longer be necessary to recirculate along the line 13 the solution 30b to basify the plasmatic water and facilitate the calcium precipitation.
  • the system in this embodiment must be provided, upstream from the pump 8, with a system to remove part of the plasmatic water, and, along the blood reinsertion line 5 in the patient, with a system for infusing a replacement liquid poor in sodium and rich in calcium, suitable for maintaining the sodium balance.

Abstract

La présente invention concerne un circuit extracorporel (300, 400) utilisable en vue du traitement de déséquilibres hydroélectrolytiques et acido-basiques au niveau du sang et comprenant un cathéter de prélèvement de sang (2) chez le patient, une première unité de filtration (6) et un cathéter de réintroduction du sang chez le patient (5) formant un circuit principal (12). Le circuit extracorporel (1, 100, 200, 300, 400) comprend, en outre, un groupe de régénération électrolytique (4) adapté à l'alimentation en une solution pauvre en chlore (30b) et un moyen (16) d'injection de la solution pauvre en chlore (30b) dans le circuit principal (12). Le groupe de régénération électrolytique (4) comprend un électrodialyseur (10) comprenant des première (21) et seconde (22) chambres d'électrodialyse, séparées par une membrane anionique (23), et séparées de leur électrode respective (24,25) par une membrane bipolaire (26, 27).
PCT/IB2015/056103 2014-08-11 2015-08-11 Système de circuit extracorporel utilisable en vue du traitement de déséquilibres hydroélectrolytiques et acido-basiques au niveau du sang WO2016024217A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITTO20140655 2014-08-11
ITTO2014A000655 2014-08-11

Publications (1)

Publication Number Publication Date
WO2016024217A1 true WO2016024217A1 (fr) 2016-02-18

Family

ID=51753393

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2015/056103 WO2016024217A1 (fr) 2014-08-11 2015-08-11 Système de circuit extracorporel utilisable en vue du traitement de déséquilibres hydroélectrolytiques et acido-basiques au niveau du sang

Country Status (1)

Country Link
WO (1) WO2016024217A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3617545A (en) * 1969-03-13 1971-11-02 Thomson Csf Removing urea from saline water solutions particularly in an artificial kidney
WO1982002841A1 (fr) * 1981-02-18 1982-09-02 University Patents Inc Precipitation de proteines
US20120273354A1 (en) * 2011-04-29 2012-11-01 Medtronic, Inc. Multimodal dialysis system
US20140158588A1 (en) * 2012-12-10 2014-06-12 Medtronic, Inc. pH AND BUFFER MANAGEMENT SYSTEM FOR HEMODIALYSIS SYSTEMS

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3617545A (en) * 1969-03-13 1971-11-02 Thomson Csf Removing urea from saline water solutions particularly in an artificial kidney
WO1982002841A1 (fr) * 1981-02-18 1982-09-02 University Patents Inc Precipitation de proteines
US20120273354A1 (en) * 2011-04-29 2012-11-01 Medtronic, Inc. Multimodal dialysis system
US20140158588A1 (en) * 2012-12-10 2014-06-12 Medtronic, Inc. pH AND BUFFER MANAGEMENT SYSTEM FOR HEMODIALYSIS SYSTEMS

Similar Documents

Publication Publication Date Title
EP3174572B1 (fr) Circuit extracorporel destiné à éliminer le co2 présent dans le sang
JP5634520B2 (ja) 尿素を除去するための透析処理デバイス
US9308308B2 (en) Methods of performing dialysis using an electrodeionization system
US10709833B2 (en) Multipart fluid system and a system for regional citrate anticoagulation in an extracorporeal blood circuit
US10518017B2 (en) Regional ant-coagulation system for an extracorporeal circulation circuit
EP2238995A1 (fr) Système pour le traitement sanguin
EP2900296B1 (fr) Systèmes d'hémodialyse et de dialyse péritonéale à capacités d'électrodialyse et d'électrodésionisation
EP3796956B1 (fr) Circuit extracorporel pour l'élimination du co2 présent dans le sang
WO2016024217A1 (fr) Système de circuit extracorporel utilisable en vue du traitement de déséquilibres hydroélectrolytiques et acido-basiques au niveau du sang
Bazaev et al. Design Concepts for Wearable Artificial Kidney
KR102400189B1 (ko) 정삼투 기반 투석액 재생 장치 및 착용 형 인공 신장 장치
CN209864801U (zh) 一种新型血液透析器
CN220158875U (zh) 连续性血液净化管路
Pesenti et al. Extracorporeal Circuit for CO2 Removal from Blood
CN217548657U (zh) 一种血液净化设备浓缩液除气系统
JP2007144228A (ja) 血漿交換廃液浄化循環透析方法
CN111265732A (zh) 腹膜透析液、连续肾脏替代治疗用置换液连续制备设备
CN113368328A (zh) 一种内置智能枸橼酸抗凝技术的血液净化设备
CN103751868A (zh) 一种治疗重金属中毒的电极分离式透析装置
Baldwin et al. Terminology and nomenclature
Kawanishi Clinical results of daily hemofiltration

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 15766634

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 15766634

Country of ref document: EP

Kind code of ref document: A1