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WO2015074999A1 - Dispositif de réchauffement et procédé de réchauffement - Google Patents

Dispositif de réchauffement et procédé de réchauffement Download PDF

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Publication number
WO2015074999A1
WO2015074999A1 PCT/EP2014/074785 EP2014074785W WO2015074999A1 WO 2015074999 A1 WO2015074999 A1 WO 2015074999A1 EP 2014074785 W EP2014074785 W EP 2014074785W WO 2015074999 A1 WO2015074999 A1 WO 2015074999A1
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WO
WIPO (PCT)
Prior art keywords
fluid
blood
heating element
effluent
treatment
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/EP2014/074785
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English (en)
Inventor
Jan Sternby
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
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Gambro Lundia AB
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Filing date
Publication date
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Publication of WO2015074999A1 publication Critical patent/WO2015074999A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61M1/166—Heating
    • A61M1/1662—Heating with heat exchange between fresh and used 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
    • 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
    • A61M1/36—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
    • A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
    • 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
    • A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
    • A61M1/36223—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit the cassette being adapted for heating or cooling the blood
    • 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
    • A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
    • A61M1/36225—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit with blood pumping means or components thereof
    • 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
    • A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
    • A61M1/36226—Constructional details of cassettes, e.g. specific details on material or shape
    • 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
    • A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
    • A61M1/36226—Constructional details of cassettes, e.g. specific details on material or shape
    • A61M1/362266—Means for adding solutions or substances to the blood
    • 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
    • A61M1/3623—Means for actively controlling temperature of blood
    • 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
    • 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
    • A61M2205/127—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with provisions for heating or cooling
    • 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
    • A61M2205/3368—Temperature

Definitions

  • the present invention relates generally to extracorporeal blood treatment. More particularly the invention relates to a warming arrangement, a system, a disposable kit and a method for warming an effluent fluid.
  • the extracorporeal circuit comprises a bloodline and a blood treatment unit in which the blood is treated. Heat loss from the blood in the extracorporeal circuit, in time, results in cooling of the patient's body when the blood is returned to the patient. Different kinds of blood warmers exist, but they are often difficult to get efficient enough since it is important not to expose the extracorporeally circulated blood to any excess temperatures.
  • the temperature of the extracorporeally circulated blood should not exceed 41° as the blood might be severely affected, and/or gas bubbles might be introduced into the blood.
  • Effluent fluid is constituted by the dialysis fluid used in a treatment in hemodialysis (HD) mode as well as the fluid extracted in hemodiafiltration (HDF) or hemofiltration (HF) mode. Effluent fluid is sent to a drain whereby the heat diffused from the blood to the effluent fluid is lost.
  • Treatment fluids required in treatment of a patient by continuous renal replacement therapy, hereinafter referred to as CRRT, must often be stored in a temperature which is relatively cold with respect to the patient's body
  • the continuous nature of CRRT increases the potential of heat loss from the blood circulating in the extracorporeal circuit and the patient may under certain circumstances experience a depression of body temperature. This is especially significant when the treatment fluid has a temperature lower than the extracorporeally circulated blood. For this reason it is often desirable to heat the treatment fluid to an appropriate temperature before introducing it into the patient's body to prevent any rapid decrease of the patient's body temperature.
  • the treatment fluid may be any fluid used in the CRRT treatment, i.e. a fluid intended for dialysis, infusion, replacement or anticoagulation.
  • a heat exchanger as disclosed in WO 2010/040819 has been developed.
  • the heat exchanger exchanges heat from the effluent fluid to one or several treatment fluids, or to the cleaned extracorporeally circulated blood.
  • JP2004313303 discloses an arrangement for discontinuous CRRT treatment working in two cycles, in which, during the first cycle, no pumping of blood or treatment fluids take place in the blood treatment unit while fresh treatment fluids are transported to balancing chambers enclosed in a casing. During the second cycle these fresh treatment fluids are passed through the fluid compartment of the blood treatment unit and the blood pump is running. During the second cycle the
  • a system comprising the warming arrangement, a disposable kit adapted to cooperate with the warming
  • the object is at least partly achieved with a warming arrangement for a CRRT system.
  • the system comprises a blood treatment unit connecting a blood line for extracorporeally circulating blood and a fluid distribution circuitry comprising at least one treatment fluid line for passing treatment fluid, and an effluent fluid line for passing effluent fluid.
  • the warming arrangement further comprises a heat exchanger configured to be fluidly coupled to the effluent fluid line and disposed in thermal relationship with the at least one treatment fluid line so as to provide for transfer of heat from the continuously pumped effluent fluid to the at least one continuously pumped treatment fluid, and/or disposed in thermal relationship with the blood line so as to provide for transfer of heat from the continuously pumped effluent fluid to the continuously pumped blood during therapy.
  • the warming arrangement further comprises a heating element configured to transfer heat to the effluent fluid, wherein the heating element is located downstream the blood treatment unit and upstream the heat exchanger.
  • the effluent fluid may reach a higher temperature compared to warming by means of a heat exchanger only, and the treatment fluids and/or blood may then be warmed to a higher temperature.
  • the warming of the treatment fluids and/or blood is made by indirect warming, the risk for introducing unwanted bubbles due to rapid heat changes is very low.
  • the intermediate heating media, thus the effluent fluid will level out any rapid temperature changes of the heating element, before the heat reaches the fluids and/or blood.
  • indirect warming is meant warming via an intermediate heating media, here the effluent fluid.
  • the effluent fluid is first warmed, whereafter the warmed effluent fluid warms one or several treatment fluids and/or blood.
  • the warming arrangement comprises a control unit configured to control the temperature of the heating element based on a control parameter.
  • control unit is
  • control parameter is either of a parameter which makes the heating element generate an effect, or a temperature value T he of the heating element, needed to warm the at least one of the treatment fluids to a desired temperature T se t and/or blood to a desired temperature T S etB.
  • control unit is configured to calculate the control parameter based on a model of the heat exchanger.
  • the warming arrangement is configured to warm the at least one treatment fluid to a desired temperature T se t in an interval between 35° and 45° C, preferably between 37° and 43° C. This may be accomplished by warming the effluent fluid to a temperature between 37° and 55° C, preferably 40° to 50° C before the effluent fluid enters the heat exchanger.
  • the heating element comprises at least one heating plate configured to warm the effluent fluid in the effluent fluid line. The heating element may then be an electrical heater. Other applicable kinds of heating elements may be an infrared heater or an induction heater.
  • the object is at least partly achieved by a system for continuous renal replacement therapy.
  • the system comprises a continuous renal replacement monitor with at least one blood pump for continuous pumping of blood, at least one treatment fluid pump for continuous pumping of treatment fluid, and optionally an effluent pump for
  • the system further comprises a blood line associated with the monitor for
  • the fluid distribution circuitry further comprises the warming arrangement according to any of the embodiments described herein.
  • the effluent fluid line of the system has a portion that is designed to mate with the heating element in order to increase the heat exchange between the heating element and the effluent fluid, wherein the portion is located upstream the heat exchanger.
  • the object is at least partly achieved with a disposable kit.
  • the disposable kit comprises a support structure, a blood line and a fluid distribution circuitry.
  • the fluid distribution circuitry comprises an effluent fluid line and at least one treatment fluid line where all the lines are associated to the support structure and the at least one treatment fluid line has a U-shaped portion designed to cooperate with a respective pump.
  • the fluid distribution circuitry further comprises a heat
  • the effluent fluid line further has a portion that is designed to mate with a heating element configured to transfer heat to the effluent fluid in the effluent fluid line, wherein the portion is located upstream the heat exchanger.
  • the portion has a flattened, bulging shape in order to increase the heat exchange between the heating element and the effluent fluid.
  • the portion has a shape of a spiral and is designed to encircle the heating element.
  • the portion comprises a material
  • the object is at least partly achieved with a method for warming an effluent fluid in an effluent fluid line in a continuous renal replacement therapy system with a warming arrangement as disclosed herein, comprising a control unit configured to control the
  • the method comprises:
  • At least one measurement signal indicating a temperature and/or a flow rate of at least one of the effluent fluid, the at least one treatment fluid and the blood in the blood line; determining a control parameter based on the indicated temperature and/or flow rate; and controlling the temperature of, or the power delivered to, the heating element based on the control parameter.
  • the method comprises calculating the control parameter based on a model of the heat exchanger.
  • the method comprises warming the at least one treatment fluid to a desired temperature T se t in an interval between 35° and 45° C, preferably between 37° and 43° C.
  • the object is at least partly achieved with a computer program at a system, wherein the computer program comprises computer instructions to cause a control unit to perform the method according to any of the steps or embodiments as disclosed herein.
  • the object is at least partly achieved with a computer program product comprising computer instructions stored on a computer readable medium for
  • a continuous flow of both effluent fluid and fresh treatment fluid or fluids and/or blood through the heat exchanger is provided by the disclosure.
  • the heat exchanger may be arranged to work in counter current mode, that is, the heat exchanger is arranged such that the flow of effluent fluid is flowing in the opposite direction to at least one of the flows of treatment fluid or blood during heat exchange.
  • the heating element is further arranged to warm the effluent fluid continuously, which is more efficient than prior art solutions. Further, as the fluid flows are continuous the temperature control may become more accurate.
  • Fig. 1 schematically illustrates a CRRT flow diagram
  • Figs. 2A-2D illustrate different embodiments of the heating element and a mating portion of the effluent fluid line.
  • Fig. 3 schematically illustrates a CRRT flow diagram
  • Fig. 4 schematically illustrates an embodiment of a disposable kit for a CRRT monitor comprising a heat exchanger and an effluent fluid line configured to be warmed by a heating element .
  • Fig. 5 schematically illustrates a kit according to Fig. 4 arranged on the CRRT monitor.
  • Fig. 6 illustrates a flow diagram of a method according to one embodiment.
  • Fig. 1 shows a schematic system for continuous renal
  • the system comprises a blood circuit or blood line la for extracorporeally circulating blood from a patient P through a first compartment 2a of a blood treatment unit 2 by means of at least one blood pump lb (by way of example only one blood pump is shown) .
  • the arrangement further comprises an effluent fluid line 3a for transferring effluent fluid from a second compartment 2b of the blood treatment unit 2 to an effluent fluid container 4 by means of an effluent fluid pump 3b.
  • the first compartment 2a and the second compartment 2b are separated by a semipermeable membrane 2c e.g. of hollow fibre typ.
  • the arrangement comprises a blood circuit or blood line la for extracorporeally circulating blood from a patient P through a first compartment 2a of a blood treatment unit 2 by means of at least one blood pump lb (by way of example only one blood pump is shown) .
  • the arrangement further comprises an effluent fluid line 3a for transferring effluent fluid from a second compartment 2b of the
  • the CRRT therapy is monitored and controlled by means of a CRRT monitor (not shown) .
  • the monitor may be microprocessor-based.
  • the monitor may contain all logic and receive and process commands by controlling valves (not shown) and pumps, interpret sensors (not shown) , activate alarms and direct the operation of all aspects of the therapy system.
  • CRRT may be carried out in three different modes depending on the principle for solute removal: hemodialysis (HD) mode, hemofiltration (HF) mode and hemodiafiltration (HDF) mode.
  • HD hemodialysis
  • HF hemofiltration
  • HDF hemodiafiltration
  • the continuous treatment also includes one or several continuously pumped treatment fluids and a continuously pumped flow of effluent fluid during therapy without any intentional interruptions. Thereby a continuous transfer of heat from the effluent fluid to the at least one treatment fluid during therapy and/or a continuous transfer of heat from the effluent fluid to the blood may be achieved during therapy.
  • the continuous treatment however does not exclude that the treatment is stopped e.g. for periods of alarm situations or for exchange of bags with fluid solution.
  • HD mode where the solute removal in the blood treatment unit 2 is based on diffusion, fresh dialysis fluid is
  • the dialysis fluid used in the blood treatment unit 2 is
  • the filtrate i.e. the liquid that has been filtered from the patients blood through the semipermeable membrane, is transferred from the second
  • replacement fluid from a replacement fluid source 7 is infused into the blood line la at an infusion point lc arranged upstream the blood treatment unit 2.
  • the replacement fluid is transferred to the infusion point lc in the blood line la via a replacement fluid line 8a by means of a replacement fluid pump 8b.
  • replacement fluid source 7 is infused at an infusion point Id downstream the blood treatment unit 2.
  • the replacement fluid is then transferred to the infusion point Id via the
  • replacement fluid lines 8a, 8e by means of the replacement fluid pump 8b.
  • the volume of replacement fluid is controlled by means of the CRRT monitor such that it is less than the volume of filtrate.
  • the replacement fluid is constituted by dialysis fluid in the dialysis fluid source 5 and transferred to the infusion point Id in the blood line la via the dialysis fluid lines 6a, 6e by means of the dialysis fluid pump 6b.
  • both fresh dialysis fluid and replacement fluid is made use of according to the principles described above in connection with HD and HF mode.
  • an anticoagulant fluid from an anticoagulation fluid source 9 is infused into the blood line la at an infusion point le arranged upstream the blood pump lb.
  • the anticoagulant fluid is passed to the infusion point le via an anticoagulation line 10a by means of an anticoagulation fluid pump 10b.
  • the respective sources for dialysis fluid 5, replacement fluid 7 and anticoagulant fluid 9 may all be in the form of
  • the fluids 5, 7, 9 are all referred to as treatment fluids to be used for treatment in the CRRT system.
  • Each container may contain a volume of treatment fluid in the range of 1-10 litres.
  • the container may be flexible, rigid or semi rigid.
  • the treatment fluids in the containers may all be cold fluids relatively to the effluent fluid. As will be explained in the following, the temperature difference is used to warm the colder treatment fluids. Thus, the warmer effluent fluid is used to warm one or more of the colder fluids, e.g. the dialysis fluid, replacement fluid, anticoagulant fluid and/or blood.
  • the warming takes place in a heat exchanger 12 arranged in thermal relationship with the effluent fluid so as to provide for transfer of heat from the effluent fluid to the colder treatment fluid or fluids, or blood, to be warmed.
  • a warming arrangement 11 for the CRRT system is illustrated in Fig. 1.
  • the warming arrangement 11 comprises the heat
  • the warming arrangement 11 further comprises a heating element 13 configured to transfer heat to the effluent fluid, wherein the heating element 13 is located downstream the blood treatment unit 2 and upstream the heat exchanger 12.
  • the heating element 13 may be located upstream or downstream the effluent pump 3b, if present .
  • the warming arrangement 11 comprises a control unit 14 configured to control the
  • the control unit 14 may be part of the CRRT monitor of the system.
  • the heating element 13 is configured to be connected to the control unit 14 for power supply and/or data transfer.
  • the control unit 14 comprises a computer readable memory 31 and a processor or processing unit 32 configured to execute computer instructions stored on the control unit 14.
  • the heating element 13 may provide a continuous warming of the effluent fluid.
  • the heating element 13 is controlled in an appropriate way by the control unit 14 in order to cause a continuous warming of the effluent fluid.
  • This appropriate control of the heating element 13 may include standard on-off control, where the heat transfer from the heating element 13 may fluctuate slightly.
  • the heat exchanger 12 is suitable for continuously warming at least one fluid by means of the effluent fluid, and may be configured to warm two, three, four or more fluids.
  • the heat exchanger 12 is illustrated when heating two fluids, i.e. fresh dialysis fluid in a dialysis fluid line 6b, and replacement fluid in a replacement fluid line 8a.
  • the heat exchanger 12 may heat a third fluid, a replacement fluid in an anticoagulation fluid line 10a, as illustrated by the dotted line of the anticoagulation fluid line 10a.
  • the heat exchanger 12 may be of plate type or hollow fiber type where the hollow fibers may be of semi-permeable or non- permeable type.
  • One example of a suitable heat exchanger is disclosed in WO2010/040819A1.
  • the heat exchanger 12 may operate in a counter current mode. Counter current mode means that the warmed effluent fluid is arranged to flow in an opposite direction to at least one of the fluids that it exchanges heat with in the heat exchanger 12 during heat exchange .
  • the heating element 13 has according to one embodiment a design to provide for an efficient heat transfer between the heating element 13 and the effluent fluid line 3a. In Figs.
  • the heating element 13 may e.g. be an electrical heater, an infrared heater, an induction heater or another kind of heat source.
  • the effluent fluid line 3a may be provided with a portion 20 upstream the heat exchanger 12 that is designed to provide efficient heat transfer between the heating element 13 and the effluent fluid.
  • the portion 20 may be designed to mate with the heating element 13, and/or be made of a material configured to increase the heat exchange between the heating element 13 and the effluent fluid.
  • Fig. 2A an embodiment is shown where the heating element 13 comprises two heating plates 23a, 23b.
  • Fig. 2A illustrates an expanded view of the heating element 13 and portion 20. In operation, the heating element 13 is placed in tight
  • the mating portion 20 here has a shape of a bag, e.g. a flattened, bulging shape, with an upper and a lower opposite flattened side 26a, 26b.
  • the mating portion 20 here has a cross-section that is greater than the cross-section of the remaining effluent fluid line 3a.
  • Each heating plate 23a, 23b is located such that the side 25 of the heating plate 23a, 23b intended to face the mating portion 20, faces the upper or lower flattened side 26 of the mating portion 20. If only one heating plate 23a, 23b, then the heating plate 23a, 23b is located to face the upper or lower flattened side 26a, 26b of the mating portion 20.
  • the portion 20 may also have inner channels 24 in the portion 20 for transport of the effluent fluid. The effluent fluid is then forced to flow a longer way than if the effluent fluid had flowed straight through the portion 20, and the heat transfer between the heating element 13 and the effluent fluid in the portion 20 may be increased.
  • the direction of the flow of the effluent fluid through the channels 24 is indicated with hatched arrows.
  • the mating portion 20 may instead comprise only one large channel with a flattened bulging shape (not shown) . Inside the large channel, the effluent fluid is spread out when flowing through the portion 20 in order to increase the heat transfer between the effluent fluid and the side or sides 25 of the heating element or elements 23a, 23b.
  • the control unit 14 is shown connected to the heating element 13, i.e. the heating plates 23a, 23b.
  • the heating element 13 comprises at least one infraread heater 27a, 27b.
  • the shape of the portion 20 may be the same as any of the embodiments described with reference to Fig. 2A.
  • the infrared heater or heaters 27a, 27b are configured to face the upper and/or lower opposite flattened sides 26a, 26b of the mating portion 20.
  • the control unit 14 is shown connected to the heating element 13, i.e. infrared heaters 27a, 27b.
  • the mating portion 20 has a shape of a spiral and is designed to encircle the heating element 13.
  • the heating element 13 may then have a shape of a rod, e.g. with a corresponding mating recess 28 or trace for the spiral-shaped mating portion 20.
  • the spiral- shaped mating portion 20 may partly or completely be
  • the spiral-shaped mating portion 20 is accomodated in the rod such that half the circumference of the spiral- shaped mating portion 20 is in contact with a surface of the recess 28 or trace of the rod.
  • the direction of the flow of the effluent fluid through the mating portion 20 is indicated by the arrows.
  • the control unit 14 is shown connected to the heating element 13, i.e. the rod.
  • the heating element 13 has the shape of an outer casing 29 configured to enclose the mating portion 20.
  • the outer casing 29 may have an opening 34 such that the outer casing can be dressed over the mating portion 20.
  • the outer casing 29 comprises a heating conductor, e.g. a heating thread 30.
  • the heating thread 30 is arranged to the outer casing 29 such that the effluent fluid in the mating portion 20 can be efficiently warmed from the heat of the heating thread 30.
  • the heating thread 30 may be arranged in a regular or unregular pattern to the outer casing 29. According to one embodiment, the heating thread 30 is at least partly arranged inbetween linings of the outer casing 29.
  • the heating thread 30 is at least partly arranged on a surface of the outer casing 29, e.g. on the surface facing the mating portion 20 when dressed over the mating portion 20.
  • the heating thread 30 may be arranged to have an extension going back and forth from one side of the outer casing 29 to an opposite side of the outer casing 29 in order to efficiently and uniformly provide heat to the mating portion.
  • the direction of the flow of the effluent fluid through the mating portion 20 is indicated by the arrows.
  • the control unit 14 is shown connected to the heating element 13, i.e. the outer casing 29 and the heating thread 30. Many other alternatives of heating elements 13 and mating portions 20 may however be considered to provide for an efficient heat transfer.
  • Fig. 3 shows a schematic view of a CRRT system, initially described in connection with Fig. 1, comprising a warming arrangement 11 suitable for warming blood by means of the effluent fluid extracted from the blood treatment unit 2.
  • the heat exchanger 12 is configured to be fluidly coupled to the effluent fluid line 3a and disposed in thermal relationship with the blood line la so as to provide for continuous transfer of heat from the effluent fluid to the blood.
  • the blood may indirectly be warmed continuously in a safe way via the effluent fluid.
  • the heating element 13 may have a constant temperature between 40° to 55° C, preferably between 45° to 50° C to warm the effluent fluid before the effluent fluid enters the heat exchanger 12, in order to warm the blood and/or one or more of the treatment fluids.
  • the heating element 13 may then be simultaneously activated when the CRRT system is activated, e.g. by being power supplied by the CRRT system.
  • the parameter which makes the heating element 13 generate an effect needed to warm the at least one of the fluids to a desired temperature T se t and/or blood to a desired temperature T S etB-
  • the parameter may thus be a power value Qh , current value I , voltage value 3 ⁇ 4, duty cycle value or any other
  • control unit 14 is then configured to control transfer of the power Q h , current I h , voltage 3 ⁇ 4, etc to the heating element 13, or control the heating element 13 according to the duty cycle value etc.
  • control parameter is a temperature value T he of the heating element 13 needed to warm the at least one of the treatment fluids to a desired temperature T se t and/or blood to a desired temperature T se tB-
  • the control unit 14 is then configured to control the temperature of the heating element 13 to the temperature T he ⁇ This may be done by e.g.
  • the desired temperature T se t of the one or several treatment fluids, or desired temperature T se tB of the blood may be set from a user interface of the CRRT system.
  • the temperature T se t or temperature T se tB is a predefined value and known to the control unit.
  • the temperature T se t is in an interval between 35° and 45° C, preferably between 37° and 43° C.
  • the temperature T se tB should be set to a temperature close to a normal body temperature, and is typically set to around 37° C.
  • control unit 14 In order to determine a suitable control parameter, such as a power value Q h or temperature value T hei based on the desired temperature of the one or several treatment fluids or blood, the control unit 14 is configured to receive at least one measurement signal indicating a temperature and/or flow rate of at least one of the effluent fluid, the at least one treatment fluid and the blood in the blood line la. The control unit 14 is then configured to determine the control parameter based on the temperature and/or flow rate.
  • a suitable control parameter such as a power value Q h or temperature value T hei based on the desired temperature of the one or several treatment fluids or blood
  • the control unit 14 is configured to receive at least one measurement signal indicating a temperature and/or flow rate of at least one of the effluent fluid, the at least one treatment fluid and the blood in the blood line la. The control unit 14 is then configured to determine the control parameter based on the temperature and/or flow rate.
  • the measured temperature of the blood may be transmitted to the control unit 14 as a measurement signal indicating the measured blood temperature.
  • the measurement signal may be transferred to the control unit 14 via a wire 33, via wireless transmission or exchanged via an internal data network.
  • the control unit 14 is then configured to determine a control parameter based on the measured
  • the control parameter may here be determined by using ordinary control algorithms known to the skilled person, such as feedback control. Feedback control here works to minimize the error between the desired temperature T se tB and the measured blood temperature.
  • the temperature sensor on the blood line la the temperature is measured somewhere in or on the dialysis fluid path.
  • the temperature of the effluent fluid may be measured downstream the heating element 13 but upstream the heat exchanger 12.
  • the temperature of the effluent fluid is then measured after the effluent fluid leaves the heating element 13 but before it enters the heat exchanger 12. In other words, the temperature of the effluent fluid is measured downstream the heating element 13, but upstream the heat exchanger 12.
  • the temperature of one or several of the treatment fluids may be measured.
  • the CRRT system is then provided with one or several appropriate temperature sensors.
  • the control unit 14 is then configured to determine a control parameter based on the measured temperature, such that a desired temperature T se t of the one or several treatment fluids may be achieved, and regulate the heating element 13 accordingly.
  • the control parameter may be determined by using ordinary control algorithms known to the skilled person, such as feedback control. Feedback control here works to minimize the error between the desired temperature T se t and the measured
  • control parameter may be any parameter
  • control parameter is for simplicity calculated as a desired power value Q h , but may be converted to a desired voltage U h , current I h etc. to the heating element 13.
  • the efficiency of the heating element 13 is usually close to 100%, but may for greater accuracy be measured (e.g. in advance), and the measured efficiency 3 ⁇ 4 may be included in the calculations below. Only a fraction ⁇ ⁇ of the heat transferred to the effluent fluid will be transmitted to the treatment fluids in the heat exchanger 14. This
  • fraction ⁇ ⁇ will depend on the flow rates of the fluids, and may be determined in advance as a model of the heat exchanger 12 for different flow rates.
  • the system may be provided with appropriate flow rate sensors.
  • the flow rate may also be calculated by using e.g. a rotational speed of the pumps and their known stroke volume.
  • the control unit 14 may be configured to calculate the control parameter based on a model of the heat exchanger 12.
  • Both the blood and the treatment fluids will lose some heat Q a to ambient air. This loss will also depend on the flow rates, which may be used to estimate the loss. The calculation may be done separately for each treatment fluid and for the blood using their individual flow rates, and the results summed to give Q a . Q a thus depict the total amount of heat lost to the ambient air.
  • the treatment fluids should be warmed to a desired temperature T Set from their initial temperature T 0 , e.g. the temperature of the treatment fluids in their bags.
  • C p , T set and T 0 are assumed to be equal for the different treatment fluids, and the calculation may then be done with F as the sum of the flow rates for the treatment fluids. Otherwise the equation for Q f is used on each treatment fluid separately and the results are then summed to give a total Q f .
  • This heat Q x may be calculated from the temperature
  • the amount of power Q h that needs to be provided to the heating element 13 may now be calculated, taking into account the efficiencies and the losses, according to:
  • Treatment fluids are used in room temperature, and are
  • T 0 a room temperature of 25°C will therefore overestimate the true temperature and will then prevent overheating of the fluids by overestimating Q f .
  • the effluent fluid is filtered from the blood, and will experience some temperature loss, but T e may be assumed to be close to 36°C. Since the losses have already been included in the calculations T se t is not set higher than wanted, e.g. 37°C.
  • Another way to calculate the required power Q h is to determine which temperature T h i gh the effluent fluid should have upstream the heat exchanger 12 in order to transfer the required power in the heat exchanger 12. The heat Q transferred by the heat exchanger 12 will then be
  • the power Q h required to heating element 13 may then be
  • a model or a table may be used by the control unit 14 in order to control the heating element 13 to warm the blood to a desired temperature.
  • the temperature of the effluent fluid may be measured as explained above downstream the heating element 13, but upstream the heat exchanger 12. This temperature of the warmed effluent may be used as a control parameter.
  • the flow of the effluent is known, e.g. measured by a flow meter or known from the effluent pump rate, and from knowledge about which power that is needed to the heating element 13 to reach a certain temperature of the effluent fluid, the temperature of the effluent fluid upstream the heating element 13 may be calculated.
  • the blood flow rate and fluid flow rates e.g. from the rate of the pumps pumping the different fluids, knowing which type of blood treatment device that is used for the treatment, and using the data calculated and measured above, the
  • effectiveness of the heat transfer in the blood treatment device may be derived from a table or calculation model, and therefrom the energy loss from the blood.
  • the energy loss from the blood may be calculated to which desired temperature the effluent fluid should be controlled in order for the blood to reach or regain a desired temperature.
  • FIG. 4 is shown a principal sketch of a disposable kit in the form of an integrated fluid treatment module comprising a blood line la, and a fluid distribution circuitry comprising an effluent fluid line 3a, multiple treatment fluid lines 6a, 8a, 10a and a heat exchanger 12 that is fluidly coupled to the effluent fluid line 3a and disposed in thermal relationship with the treatment fluid lines 6a, 8a, 10a so as to provide for transfer of heat from the effluent fluid to the treatment fluid.
  • the heat exchanger 12 may be disposed in thermal relationship with the blood line la, so as to provide for transfer of heat from the effluent fluid to the blood.
  • the lines all have at least a portion forming a U-shaped line length 15, 16, 17, 18, 19 to cooperate with the respective pump, i.e. with the blood pump lb, the effluent fluid pump 3b, the dialysis fluid pump 6b, the replacement fluid pump 8b and the anticoagulation fluid pump 10b.
  • the disposable kit also comprises a blood treatment unit 2 associated with the blood line la and the fluid distribution circuitry.
  • the lines la, 3a, 6a, 8a, 10a, the blood treatment unit 2 and the heat exchanger 12 are arranged on a support structure 22 indicated with dashed lines for facilitated connection of the lines to the pumps la, 3b, 6b, 8b, 10b.
  • the effluent fluid line 3a further comprises the portion 20 that is designed to mate with a heating element 13 configured to transfer heat to the effluent fluid in the effluent fluid line 3a.
  • the heating element 13 may be one of the herein disclosed embodiments.
  • the portion 20 is located upstream the heat exchanger 12, and downstream the blood treatment unit 2. In the Fig. 4, the portion 20 is located outside the support structure 22, but may instead be arranged on the support structure 22.
  • the portion 20 may be formed to facilitate the heat exchange between the heating element 13 and the effluent fluid flowing in the portion 20.
  • a plurality of different embodiments of the portion 20 have been explained in connection with the Figs. 2A-2D.
  • a wall segment of the mating portion 20 may also be made thinner than other wall segments of the effluent fluid line 3a, in order to increase the heat transfer.
  • the portion 20 comprises a material configured to increase the heat exchange between the heating element 13 and the effluent fluid.
  • the material may be a metal, e.g.
  • the remaining effluent fluid line 3a may e.g. be made of a plastic material.
  • the disposable kit is designed to be used together with a CRRT monitor 21 of the type shown in Figure 4.
  • the disposable kit is in use arranged on a front side of the monitor 21.
  • the disposable kit has a blood line la, an effluent fluid line 3a and a multiple of treatment fluid lines 6a, 8a, 10a. All the lines are associated to the support structure 22 and each line has a U-shaped portion 15, 16, 17, 18, 19 (Fig. 4) designed to cooperate with a respective pump 3b, 6b, 8b, 10b (Fig. 4).
  • a blood treatment unit 2 is also arranged on the support
  • the heat exchanger 12 is connected to the support structure 22 and fluidly coupled to the effluent fluid line 3a and disposed in thermal
  • the heat exchanger 12 will be vertically arranged. Vertical arrangement of the heat exchanger 12 will facilitate air bubble dissipation.
  • Fig. 5 is further indicated bags for containing effluent fluid 4, dialysis fluid 5, replacement fluid 7 and anticoagulant fluid 9.
  • the disclosure also relates to a system for CRRT.
  • the system comprises the continuous renal replacement monitor 21 (Fig. 5) with any of the previously presented at least one blood pump lb, at least one treatment fluid pump 6b, 8b, 10b, and
  • the system further comprises the blood line la associated with the monitor 21 for extracorporeally circulating blood by means of the blood pump lb, and a fluid distribution circuitry associated with the monitor 21 comprising the at least one treatment fluid line 6a, 8a, 10a for passing treatment fluid by means of the treatment fluid pump 6b, 8b, 10b and the effluent fluid line 3a for passing effluent fluid.
  • the system also includes the blood treatment unit 2 arranged between the blood line la and the fluid distribution circuitry.
  • the fluid distribution circuitry comprises a warming arrangement 11 according to any of the embodiments as has been previously described.
  • the effluent fluid line 3a may comprise a portion 20 (Fig. 4) according to any of the embodiments as described herein.
  • the computer instructions stored on the control unit 14 may be in the form of a computer program P c .
  • the computer instructions are according to one embodiment configured to cause the control unit 14 to perform a method for warming the effluent fluid in the effluent fluid line 3a in the CRRT system, with the warming arrangement 11 comprising the control unit 14 configured to control the temperature of the heating element 13, according to any of the described embodiments.
  • the method will now be described with reference to the flow chart in Fig. 6.
  • the method comprises receiving at least one measurement signal indicating a temperature and/or a flow rate of at least one of the effluent fluid, the at least one treatment fluid and the blood in the blood line la (Al) . Thereafter the control parameter is determined based on the indicated
  • control parameter Based on the control parameter the temperature of, or the power delivered to, the heating element 13 is controlled.
  • the control parameter has previously been described, and the various alternatives of different kinds of control parameters and calculations of the same are here referred to and may be determined and/or
  • the disclosure also relates to a computer program product comprising computer instructions stored on a computer readable medium for performing the method as previously described.
  • any of the embodiments where a temperature of the blood and/or any of the fluids is measured be combined with any of the embodiments where temperature measurements are not needed to, if possible, achieve a further verified control parameter.

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Abstract

La présente invention concerne un dispositif de réchauffement et un procédé destiné à un système de thérapie de substitution rénale continue. Le système comporte une unité de traitement du sang et un échangeur de chaleur conçu pour être relié de façon fluidique à une ligne de fluide effluent pour transférer de la chaleur à au moins un fluide de traitement et/ou au sang de traitement. Le dispositif de réchauffement comporte également un élément chauffant conçu pour transférer de la chaleur au fluide effluent, l'élément chauffant étant situé en aval de l'unité de traitement du sang et en amont de l'échangeur de chaleur. Le procédé comprend la définition d'un paramètre de régulation en fonction d'une température indiquée et/ou le taux d'écoulement et pour réguler la température de l'élément chauffant ou l'énergie fournie à ce dernier en fonction du paramètre de régulation.
PCT/EP2014/074785 2013-11-22 2014-11-17 Dispositif de réchauffement et procédé de réchauffement Ceased WO2015074999A1 (fr)

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WO2017084757A1 (fr) * 2015-11-17 2017-05-26 Fresenius Medical Care Deutschland Gmbh Appareil de dialyse présentant un mécanisme de chauffage et de refroidissement
US20230355855A1 (en) * 2019-12-06 2023-11-09 Fresenius Medical Care Holdings, Inc. Syringe Warmer
CN117919529A (zh) * 2024-02-26 2024-04-26 南京汉科明德医疗科技有限公司 一种血液净化用液体加热装置和加热方法

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DE102015012604B4 (de) * 2015-09-28 2025-05-08 Fresenius Medical Care Deutschland Gmbh Dialysegerät
DE102016010722A1 (de) 2016-09-05 2018-03-08 Fresenius Medical Care Deutschland Gmbh Verfahren und Vorrichtung zur Bestimmung der Körpertemperatur eines Patienten
CN108042864A (zh) * 2017-12-23 2018-05-18 玉林市玉州区万通华信科技服务部 一种便于安装和温控的血液透析液制造用改性树脂吸附器
CN109125830B (zh) * 2018-07-23 2021-05-11 南京医科大学 一种适用于血液净化的智能辅助温控装置的控制方法

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WO1996009080A1 (fr) * 1994-09-23 1996-03-28 Gambro Ab Agencement de desinfection pour machines de dialyse
JP2004313303A (ja) * 2003-04-14 2004-11-11 Nipro Corp 持続的血液浄化装置
WO2010040819A1 (fr) * 2008-10-10 2010-04-15 Gambro Lundia Ab Échangeur de chaleur et procédé d’échange de chaleur

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WO1996009080A1 (fr) * 1994-09-23 1996-03-28 Gambro Ab Agencement de desinfection pour machines de dialyse
JP2004313303A (ja) * 2003-04-14 2004-11-11 Nipro Corp 持続的血液浄化装置
WO2010040819A1 (fr) * 2008-10-10 2010-04-15 Gambro Lundia Ab Échangeur de chaleur et procédé d’échange de chaleur

Cited By (5)

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Publication number Priority date Publication date Assignee Title
WO2017084757A1 (fr) * 2015-11-17 2017-05-26 Fresenius Medical Care Deutschland Gmbh Appareil de dialyse présentant un mécanisme de chauffage et de refroidissement
US20180369471A1 (en) * 2015-11-17 2018-12-27 Fresenius Medical Care Deutschland Gmbh Dialysis device
US20230355855A1 (en) * 2019-12-06 2023-11-09 Fresenius Medical Care Holdings, Inc. Syringe Warmer
US12465673B2 (en) * 2019-12-06 2025-11-11 Fresenius Medical Care Holdings, Inc. Syringe warmer
CN117919529A (zh) * 2024-02-26 2024-04-26 南京汉科明德医疗科技有限公司 一种血液净化用液体加热装置和加热方法

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