WO2021255293A1 - Système de chauffage pour échangeur de gaz extracorporel - Google Patents
Système de chauffage pour échangeur de gaz extracorporel Download PDFInfo
- Publication number
- WO2021255293A1 WO2021255293A1 PCT/EP2021/066837 EP2021066837W WO2021255293A1 WO 2021255293 A1 WO2021255293 A1 WO 2021255293A1 EP 2021066837 W EP2021066837 W EP 2021066837W WO 2021255293 A1 WO2021255293 A1 WO 2021255293A1
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- WO
- WIPO (PCT)
- Prior art keywords
- heating
- water
- pump
- heating system
- water circuit
- Prior art date
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- 238000010438 heat treatment Methods 0.000 title claims abstract description 182
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 165
- 239000008280 blood Substances 0.000 claims description 40
- 210000004369 blood Anatomy 0.000 claims description 40
- 230000006698 induction Effects 0.000 claims description 21
- 230000005291 magnetic effect Effects 0.000 claims description 11
- 230000017531 blood circulation Effects 0.000 claims description 10
- 238000011144 upstream manufacturing Methods 0.000 claims description 8
- 230000033228 biological regulation Effects 0.000 claims description 6
- 230000005294 ferromagnetic effect Effects 0.000 claims description 3
- 238000002618 extracorporeal membrane oxygenation Methods 0.000 abstract description 7
- 208000015181 infectious disease Diseases 0.000 abstract description 7
- 239000007789 gas Substances 0.000 description 50
- 239000012528 membrane Substances 0.000 description 35
- 238000004140 cleaning Methods 0.000 description 8
- 230000001965 increasing effect Effects 0.000 description 8
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- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 6
- 238000005202 decontamination Methods 0.000 description 6
- 230000003588 decontaminative effect Effects 0.000 description 6
- 238000001816 cooling Methods 0.000 description 5
- 239000000203 mixture Substances 0.000 description 5
- 230000015572 biosynthetic process Effects 0.000 description 4
- 230000001939 inductive effect Effects 0.000 description 4
- 238000011282 treatment Methods 0.000 description 4
- 241000894006 Bacteria Species 0.000 description 3
- 230000008901 benefit Effects 0.000 description 3
- 229910002092 carbon dioxide Inorganic materials 0.000 description 3
- 239000001569 carbon dioxide Substances 0.000 description 3
- 238000013461 design Methods 0.000 description 3
- 210000004072 lung Anatomy 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 238000006213 oxygenation reaction Methods 0.000 description 3
- 230000010412 perfusion Effects 0.000 description 3
- 238000012546 transfer Methods 0.000 description 3
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- 241001631457 Cannula Species 0.000 description 2
- MWUXSHHQAYIFBG-UHFFFAOYSA-N Nitric oxide Chemical compound O=[N] MWUXSHHQAYIFBG-UHFFFAOYSA-N 0.000 description 2
- 239000003570 air Substances 0.000 description 2
- 239000012080 ambient air Substances 0.000 description 2
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 2
- 230000005540 biological transmission Effects 0.000 description 2
- 238000007675 cardiac surgery Methods 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 230000018109 developmental process Effects 0.000 description 2
- 238000012423 maintenance Methods 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 239000001301 oxygen Substances 0.000 description 2
- 229910052760 oxygen Inorganic materials 0.000 description 2
- 230000029058 respiratory gaseous exchange Effects 0.000 description 2
- 239000008223 sterile water Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 231100000331 toxic Toxicity 0.000 description 2
- 230000002588 toxic effect Effects 0.000 description 2
- 238000009564 veno-arterial ECMO Methods 0.000 description 2
- 238000009565 veno-venous ECMO Methods 0.000 description 2
- 238000009423 ventilation Methods 0.000 description 2
- UGFAIRIUMAVXCW-UHFFFAOYSA-N Carbon monoxide Chemical compound [O+]#[C-] UGFAIRIUMAVXCW-UHFFFAOYSA-N 0.000 description 1
- 206010020843 Hyperthermia Diseases 0.000 description 1
- 208000019693 Lung disease Diseases 0.000 description 1
- 230000006978 adaptation Effects 0.000 description 1
- 239000000443 aerosol Substances 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 241001506930 atypical mycobacterium Species 0.000 description 1
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- 229910002091 carbon monoxide Inorganic materials 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 230000004087 circulation Effects 0.000 description 1
- 239000012459 cleaning agent Substances 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 238000012937 correction Methods 0.000 description 1
- 230000003670 easy-to-clean Effects 0.000 description 1
- 230000008030 elimination Effects 0.000 description 1
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- 239000012530 fluid Substances 0.000 description 1
- 239000001307 helium Substances 0.000 description 1
- 229910052734 helium Inorganic materials 0.000 description 1
- SWQJXJOGLNCZEY-UHFFFAOYSA-N helium atom Chemical compound [He] SWQJXJOGLNCZEY-UHFFFAOYSA-N 0.000 description 1
- 230000036031 hyperthermia Effects 0.000 description 1
- 238000009413 insulation Methods 0.000 description 1
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- 230000007774 longterm Effects 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
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- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 230000006911 nucleation Effects 0.000 description 1
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- 238000003825 pressing Methods 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 238000005086 pumping Methods 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
- 239000002918 waste heat Substances 0.000 description 1
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
- A61M1/1698—Blood oxygenators with or without heat-exchangers
-
- 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
- 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
- A61M1/3666—Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3331—Pressure; Flow
- A61M2205/3334—Measuring or controlling the flow rate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3368—Temperature
-
- 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
- A61M2205/36—General characteristics of the apparatus related to 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
- A61M2205/36—General characteristics of the apparatus related to heating or cooling
- A61M2205/366—General characteristics of the apparatus related to heating or cooling by liquid heat exchangers
Definitions
- the present invention relates to heating systems for regulating the temperature of extracorporeal gas exchangers such as membrane oxygenators and ECLS systems with corresponding heating systems, in particular to prevent contamination and the spread of germs.
- Extracorporeal living systems also known as ECLS ("extracorporeal! Hfe supporf)" or extracorporeal circulatory support systems
- ECLS extracorporeal! Hfe supporf
- extracorporeal membrane oxygenation taking place .
- ECMO extracorporea / membrane oxygenation
- the patient's breathing function is taken over by an external medical device and in particular can ensure a reduction in carbon dioxide in the blood, for example if the patient's own breathing function is suppressed in the case of cardiac surgery.
- lung diseases such a procedure can also relieve the lungs so that they can heal without exogenous ventilation, depending on the treatment over days or weeks.
- ECMO systems which include a membrane oxygenator and serve as gas exchangers for the patient's blood can thus be used as extracorporeal life support systems.
- Cannulas are inserted into one or two blood vessels, depending on the cannula, and the blood is continuously pumped through a membrane oxygenator that replaces gas exchange in the lungs. In this way, carbon dioxide is removed from the blood and oxygenated blood is returned to the patient.
- the blood can for example be a venous Access can be removed and returned via a venous or arterial access. Oxygenation then takes place, for example, by means of a veno-venous ECMO (VV-ECMO) or a veno-arterial ECMO (VA-ECMO).
- VV-ECMO veno-venous ECMO
- VA-ECMO veno-arterial ECMO
- the system components which are fluidically connected to one another except for the membrane oxygenator and are used again in successive treatments, have to be decontaminated and cleaned in a laborious manner after each use.
- the choice of chemicals that can be used is limited, especially since it must be avoided that toxic residues can remain in the device.
- the materials built into the devices may not be suitable for the chemicals used, so that further damage can occur if such agents are used. Accordingly, when decontaminating the water tank, there is a risk that the cleaning and disinfection carried out by the user could possibly impair the integrity of the connected membrane oxygenator. Residual amounts of toxic cleaning agents could still get into the blood circuit in the event of a possible leak between the blood and water circuit of the membrane oxygenator.
- a system for temperature control of blood is known from document DE 102016 014200 A1
- Peltier elements are used for heating and cooling and a water circuit of a corresponding temperature control unit is controlled using temperature and flow sensors integrated in the water circuit.
- the use of Peltier elements for cooling and heating as well as control using integrated flow sensors in the water circuit lead to an increased complexity of the Systems. Consequently, there is a need to reduce cleaning and decontamination costs without endangering the safety of a patient being treated.
- a heating system for regulating the temperature of an extracorporeal gas exchanger which comprises a water circuit, which can be fluidly connected to a water side of the extracorporeal gas exchanger, and a pump which is connected to the water circuit and is set up to convey the water in the water circuit.
- the heating system further comprises at least one heating element, which is thermally coupled to the water circuit, and a control unit, which is communicatively connected to the pump and the at least one heating element and is configured to set a pump rate of the pump and an output of the at least one heating element.
- the water circuit is closed in the connected state with the extracorporeal gas exchanger.
- a closed system is thus provided so that the heating system is fluidically sealed and the water contained in the water circuit during operation of the heating system cannot be exchanged with the environment.
- the water circuit can preferably be designed as a hose system which can be connected to the water side of the extracorporeal gas exchanger by means of appropriate connectors or fluid couplings.
- the water side is to be understood as the side of a heat exchanger which is fluidically separated from a blood side or a blood circuit, but is therefore thermally coupled. In this way, the blood of a patient flowing through the heat exchanger can be heated or tempered without causing a mass transfer or exchange between the two sides of the heat exchanger.
- the gas exchanger can be designed as a membrane oxygenator.
- the closed water circuit of the heating system whereby the heating medium "water” has no contact with the circulating air, effectively prevents the formation of dangerous bacteria, which could get into the ambient air through contaminated water.
- the risk of possibly life-threatening germ formation is thus excluded before pairing already be present or presented as sterile water in the water circuit and / or in the gas exchanger.
- a compensating tank can be provided which is fluidically connected to the water circuit to compensate for pressures and / or flow fluctuations and can optionally also contain a predetermined amount of water.
- a sterile connector or access can be provided in order, for example, to fill the water circuit once with a predetermined amount of sterile “water”.
- the heating system thus forms a hyperthermia device, which can be connected to an extracorporeal gas exchanger or membrane oxygenator, with the at least one heating element and the pump pumping temperature-controlled water through the heat exchanger of the gas exchanger in order to significantly cool the patient due to the existing in the extracorporeal gas exchanger To prevent gas perfusion.
- the water forms the heating medium or temperature control medium.
- alternative temperature control media with alternative heat transfer coefficients can also be provided, preferably in the liquid phase.
- the heating system according to the invention is thus, unlike, for example, the system known from the prior art according to DE 102016 014 200 A1, designed exclusively for heating, i.e. not for cooling the water as a heating medium, so that in this way a temperature control unit with Peltier elements dispensed with and the complexity of the heating system can be significantly simplified. This also significantly reduces the weight of the system according to the invention.
- the closed system can also provide a compact design, so that the cleaning and decontamination effort can be reduced considerably.
- the reduced complexity and compact design also enable the heating system to be used in a variety of ways and to be easily coupled with different hose sets. Furthermore, due to the approach of the invention, only a small amount of water is required in the water circuit, so that a rapid adaptation of the temperature control provided is made possible.
- the heating system also comprises only a small number of components, so that it is easy to assemble and to implement in existing circulatory support systems.
- the control unit, the pump and / or the at least one heating element can be implemented in an ECMO console or can be communicatively coupled to it as a separate unit. Due to the small number of components and the elimination of wearing parts, a low-maintenance and cost-effective heating system is provided.
- the water circuit and / or the pump are preferably designed as single-use items.
- the closed system largely eliminates the risk of dangerous nucleation.
- sterile materials can be used with sufficient certainty and cleaning or decontamination after using the extracorporeal gas exchanger or membrane oxygenator can be largely dispensed with. This further reduces the risk of infection for the patient to be treated and for successive treatments.
- the disposables not only facilitate the cleaning process, but also the upgrading of the heating system or the extracorporeal circulatory support system.
- the disposable articles can be connected to one another by means of simple connectors or even provided in the connected state, so that only a fluidic coupling with the extracorporeal gas exchanger and a thermal coupling with the at least one heating element are required.
- a hose set with a connected expansion tank or filling tank can be provided as a disposable item. After use, the various components of the system, except for the heating element, can be disposed of easily and safely.
- the heating system comprises a water container which is fluidly and detachably coupled to the water circuit, the at least one heating element being arranged in the water container in such a way that the water pumped from the water circuit into the water container surrounds the at least one heating element.
- the water container or water tank can thus have a predetermined amount of water and be connected to the water circuit in order to convey the water in the circuit by means of the pump.
- the at least one heating element is preferably arranged in such a way that when the water is conveyed through the water circuit, the water comes into contact with as large an area of the heating element as possible without significantly blocking the flow.
- the water container is preferably designed in such a way that it functions as a flow heater, the water pumped through the water container by the pump washing around the at least one heating element.
- the at least one heating element is furthermore preferably arranged in such a way that the heating surface is easily accessible and easy to clean.
- a continuous channel can be provided in the water tank, which can be connected to the water circuit at respective openings by means of connectors.
- the heating element is preferably arranged at least partially on an inner circumference or an inner cross section of the channel.
- the water tank itself can also be arranged on the heating system so that it is easily accessible, for example outside the heating system, so that it can be removed in a few simple steps.
- the releasable connection enables the water tank with the inside arranged heating elements can be decoupled for further or successive applications.
- simple cleaning and decontamination can be provided.
- the other components of the heating system can be designed as single-use items, so that in this case too the cleaning and decontamination effort and the risk of infection for the patient are considerably reduced.
- the at least one heating element is preferably a PTC thermistor.
- the heating element can thus comprise at least one PTC resistor or PTC thermistor or be designed as a PTC element or as an element with a positive temperature coefficient.
- PTC elements have the advantage that they have pronounced heating dynamics, while at the same time they have an increased electrical resistance at higher temperatures. This prevents an increased flow of current due to a change in temperature. This means that PTC heating elements are particularly reliable, do not overheat and do not burn out even in an empty water tank.
- the at least one heating element surrounds at least a section of the water circuit.
- no heating element is arranged in the water circuit, so that direct contact with the water is avoided. According to this embodiment, a non-contact instantaneous water heater is thus provided.
- the section there can be a magnetic element or ferromagnetic element which is arranged in the channel of the water circuit and is preferably designed so that it offers a large surface area for the water flowing around with the lowest possible flow resistance.
- the water circuit can be designed as a hose set, for example.
- the at least one section has a heating element on the outer circumference of the water channel (for example a hose) which is designed as an induction coil and surrounds the water channel, preferably completely.
- control unit is set up to set a frequency of the current flowing through the induction coil at an output stage of the control unit.
- the coil comprising, for example, a metal sleeve incorporated in the hose system of the water circuit.
- a current frequency for example in the range from about 25 to 50 kHz, generates an alternating magnetic field in the induction coil, which induces an inductive generation in the (ferro) magnetic element Eddy currents arise and the magnetic element heats up according to the frequency.
- a specific frequency on the output stage for example an HF output stage, a fine adjustment or a fine-level regulation of the heat input can thus be provided.
- the required amount of water can thus be, for example, between approximately 1 l and 5 l, while conventional systems usually require an amount of water between approximately 25 l and 30 l.
- the heating system according to the invention can accordingly be designed to be particularly compact and weight-saving and consequently can be easily transported.
- the (preferably contactless) induction heating and the design of the heating system for exclusively heating the water also make it possible, as described above, to dispense with a temperature control unit with Peltier elements and to considerably simplify the complexity of the heating system.
- the gas exchanger or membrane oxygenator which is to be regarded as an application part, can place high demands on the maximum permissible patient leakage current due to its insulation class.
- the inductive and contactless heating or energy transfer provides a galvanic separation of the water circuit from the live parts of the heating system, which enables maximum protection of the patient from undesirably high leakage currents.
- the heating system can furthermore preferably comprise a plurality of heating elements, with each induction coil surrounding a respective section and being individually adjustable.
- the heating and the supply of energy can thus take place successively and more evenly, while at the same time a control stage is provided in order to prevent an upper and lower threshold value from being exceeded.
- the water temperature must never exceed 42 ° C and an excessively low temperature of the heating medium would possibly lead to a further increase Cause cooling of the patient's blood flowing in the gas exchanger to be heated.
- an increase to a predetermined temperature can first be achieved and then a fine adjustment of the temperature can be made available by optionally supplying additional energy.
- the heating system is not limited to the use of a specific pump
- the pump is preferably a centrifugal pump.
- Driving the water circuit by means of a centrifugal pump has the advantage that an essentially wear-free pump is used and the heating system is therefore also particularly suitable for long-term applications.
- Centrifugal pumps allow a simple, galvanically separated power transmission between the pump drive (motor) and the pump module via a magnetic coupling.
- the pump can therefore also be designed in such a way that the drive can be reused, while the pump module can be used as a cost-effective disposable product.
- the wear which can already be considerably reduced by the low flow rate of the heating medium using the heating system according to the invention, can thus be reduced even further by using a centrifugal pump. With a centrifugal pump, it is also possible to continuously adjust the pump rate, so that fine adjustment of the water flow rate is also possible.
- the functional principle of the centrifugal pump also prevents the water from developing too high, for example bursting pressure, on the gas exchanger or on the heat exchanger. This provides a low-maintenance and particularly safe heating system.
- the centrifugal pump can be coupled to a pump drive of a motor in order to enable torque transmission.
- the centrifugal pump is preferably designed as a disposable or disposable item and is fluidically separated from the respective pump drive and can be easily coupled, for example via a magnetic coupling.
- the control unit actuates the motor of the pump drive and is set up to set the speed or the pump rate of the pump.
- the pump can be arranged upstream of the at least one heating element or downstream of the at least one heating element.
- the heat medium or water can be conveyed either by suction or by pressing.
- the pump is preferably arranged downstream of the gas exchanger or heat exchanger and upstream of the at least one heating element.
- control unit can be set up to provide information on the extracorporeal gas exchanger to receive the current blood flow rate and the type of gas exchanger and to set the pump rate and / or the power of the at least one heating element based on the characteristics of the gas exchanger or membrane oxygenator and the current blood flow rate.
- the optimum water flow rate can be calculated using the two parameters and the characteristic maps of the gas exchangers or membrane oxygenators stored in the control unit and the pump rate or the speed of the pump can be set.
- the blood flow rate can for example be received by a corresponding sensor via an interface, or a system-specific sensor, for example on the blood side of the gas exchanger, can be provided which is communicatively coupled to the control unit.
- control unit can preferably be set up to determine the temperature of the exiting gas mixture at the gas exchanger or membrane oxygenator.
- different gas mixtures can be provided for the treatment of the patient, so that in addition to enrichment with oxygen, enrichment of the blood with nitrogen, nitric oxide, helium and / or carbon monoxide can also be provided.
- the temperatures of the exiting gas mixture can be different and thus require a different output of the heating system or the pump rate and / or the output of the at least one heating element.
- the temperature can be received by the control unit, for example, via an interface or a sensor provided in the gas exchanger.
- one or more patient parameters are preferably determined continuously in order to monitor the performance of the heating system.
- the control unit can preferably be set up to receive a temperature of the blood flowing through the extracorporeal gas exchanger and / or a temperature of a patient connected to a blood side of the extracorporeal gas exchanger via a coupled temperature sensor and the pump rate and / or the power of the at least one heating element based on the temperature.
- an additional external temperature sensor can be provided which is communicatively coupled to the control unit via an interface, for example in an ECMO device or ECMO module.
- a too low output of the heating system for example if a cooling of the patient temperature is determined, can be corrected.
- the pump rate can also be increased so that an improved temperature control of the blood flowing through the extracorporeal gas exchanger is provided.
- the pump rate and / or the power of the at least one heating element can already be set based on the type of gas exchanger and the blood flow rate, it can alternatively or additionally be provided that the heating system has a temperature sensor for measuring a temperature of the water circuit, which is arranged downstream of the at least one heating element and upstream of the extracorporeal gas exchanger, wherein the control unit is configured to adjust the pump rate and / or the power of the at least one heating element based on the temperature of the water circuit.
- the required energy or heat is regulated via the output power on the control unit, for example on an HF output stage in the case of inductive heating.
- the water temperature can therefore be measured after the at least one heating element and reported back to the system or the control unit. Since the water temperature must never exceed 42 degrees, the maximum permissible temperature is preferably monitored by a redundant sensor and the power is reduced if necessary. Conversely, as described above, the output can be increased accordingly if the temperature is too low. As a result, the water temperature fed into the gas exchanger is monitored. Furthermore, the power and / or the pump rate can be adjusted accordingly.
- the heating system preferably comprises a plurality of heating elements, the control unit being set up to switch the heating elements on and off individually and / or to set a power of the heating elements individually.
- the control unit being set up to switch the heating elements on and off individually and / or to set a power of the heating elements individually.
- individual heating elements can be switched on and their output can still be individually controlled so that fine-grained regulation of the heat input can be provided.
- a step-by-step heating or a targeted correction of the temperature of the heating medium that has been reached in the meantime can take place in this way.
- an ECLS system or an extracorporeal circulatory support system which the heating system according to the invention and a includes extracorporeal gas exchanger. Accordingly, the ECLS system can provide extracorporeal oxygenation and decarbolization of the patient's blood, with the blood flowing through the extracorporeal gas exchanger being appropriately efficiently and safely tempered by the water side or the water circuit of the heating system.
- FIG. 1 is a schematic representation of a heating system according to the invention in the coupled state with an extracorporeal gas exchanger
- FIG. 2 is a schematic representation of a further embodiment of the heating system according to FIG. 1;
- FIG. 3 is a schematic representation of an alternative embodiment of the heating system according to FIG. 1.
- FIG. 1 shows a schematic representation of a heating system 10 according to the invention in the coupled state with an extracorporeal gas exchanger 12 in the form of a membrane oxygenator.
- the heating system has a water circuit 14 which is fluidly connected to a water side 16 of the extracorporeal membrane oxygenator 12.
- the membrane oxygenator 12 also has a blood side 18, which can be connected to a patient's circulation, for example by means of two cannulas, the blood being taken, for example, from a venous access and returned via a venous or arterial access. Blood from a patient can thus be conveyed through the blood side 18, a gas perfusion line 20 coupled to the blood side 18 being provided to replace the gas exchange in the lung or to remove carbon dioxide from the blood and return oxygen-enriched blood to the patient.
- a pump 22 is provided which is connected to the water circuit 14 and is set up to convey the water in the water circuit 14.
- the pump 22 is one Centrifugal pump, whereby a particularly maintenance-free system and at the same time overpressures in the membrane oxygenator can be avoided.
- the pump 22 optionally has a pump drive 22a and a pump module 22b, the pump module 22b in the present case being designed as a disposable item.
- alternative pumps can optionally be provided, for example a centrifugal pump, such as a rotor pump or impeller pump, or a semi-axial pump, also known as a diagonal pump.
- the pump 22 conveys the water through a heating element 24 which is thermally coupled to the water circuit 14. An energy supply is thus provided and the water is heated before it enters the membrane oxygenator 12. In the membrane oxygenator 12, there is then an exchange of heat between the water side 16 and the blood side 18, so that the temperature of the blood flowing through the membrane oxygenator 12, which loses thermal energy due to the gas exchange, is tempered.
- the pump 22 is connected downstream of the heating element 24, but could alternatively also be arranged upstream of the heating element 24.
- the exact temperature control is determined by the power of the heating element 24 and the pump rate of the centrifugal pump. These control parameters are set accordingly by a control unit 26 of the heating system 10, which is communicatively connected to the pump 22 and the at least one heating element 24. In this way, the temperature of the extracorporeal membrane oxygenator 12 and in particular of the blood side 18 is regulated, so that a heat exchanger is formed by the water side 16 and the blood side 18.
- the water circuit 14 or the heating system 10 is a closed system, so that the water has no contact with the circulating air. In this way, the formation of dangerous bacteria, which can get into the ambient air through contaminated water, is effectively prevented. This eliminates the risk of potentially life-threatening germ formation and the risk of infection for the patient is correspondingly reduced considerably.
- the closed system has the advantage that only a small amount of water is required in the water circuit, so that a rapid adjustment of the temperature control provided is made possible. The efficiency of the temperature regulation can thus be increased at the same time.
- a heating system 10 according to FIG. 1 with an inductive heating element 24 is shown schematically in FIG.
- the heating element 24 is designed accordingly as an induction coil 28, which surrounds a section of the water circuit 14 without contact, as with the dashed lines shown.
- the water circuit 14 contains a magnetic element 30.
- the magnetic element 30 is designed as a ferromagnetic sleeve, the water being conveyed through the sleeve.
- the sleeve is arranged within the water circuit 14 or in a flow channel and is thus fluidically connected to the water circuit 14, for example a hose set.
- the sleeve can be inserted in an interior space of a hose and axially fixed therein, for example by means of a press fit, latching elements or by means of external holding elements such as clamps or clamps.
- the induction coil 28 is connected to the control unit 26 and in the present case completely surrounds the sleeve, but is radially spaced from the surface of the sleeve, so that the induction coil 28 surrounds the sleeve without contact.
- the control unit 26 is preferably set up to set a frequency of the current flowing through the induction coil 28 at an output stage of the control unit 26. In this way, contactless induction heating is provided.
- a current frequency for example in the range from about 25 to 50 kHz, generates an alternating magnetic field in the induction coil 28, which induces eddy currents in the sleeve and the sleeve heats up according to the frequency.
- the energy supplied to the water side of the heat exchanger or the membrane oxygenator can easily be optimally adapted to the membrane oxygenator used via the power control of a frequency output stage, for example an HF output stage, and the flow rate of the water or the pump rate.
- a frequency output stage for example an HF output stage
- the combination of these two control parameters makes it possible to achieve an optimal efficiency of the heating system.
- a separate water tank can be dispensed with and the required amount of water can be reduced and the dimensions of the heating system 10 can be kept compact.
- the components of the system can particularly advantageously be designed as single-use articles or disposables.
- a temperature sensor 32 for measuring a temperature of the water circuit 14 is arranged downstream of the induction coil 28 and upstream of the extracorporeal membrane oxygenator 12, the control unit 26 being set up to measure the pump rate and / or the power of the induction coil 28 based on the measured temperature of the water circuit 14 to discontinue.
- a blood flow rate and a blood temperature are determined by the control unit 10.
- the membrane oxygenator 12 has a corresponding one with the Control unit 26 coupled to sensor 34 in order to detect the current blood flow rate and the blood temperature of the blood flowing through the extracorporeal membrane oxygenator 12.
- the type of membrane oxygenator 12 is also stored in the control unit 26, so that the control unit 26 can set the pump rate and / or the power of the induction coil 28 based on the type of membrane oxygenator 12, the current blood flow rate, the water temperature and the blood temperature. This enables particularly precise temperature control.
- fewer sensors 32, 34 can be provided in the heating system 10.
- an optional compensation tank 36 is also provided. In this way, overpressures on the water side 16 of the membrane oxygenator 12 can be avoided and a predetermined amount of sterile water can be provided in the compensation tank for filling the water circuit 14 before the heating system is started up.
- FIG. 3 shows a schematic representation of an alternative embodiment of the heating system 10 according to FIG. 1 with a water container 38.
- the water tank 38 is fluidically and detachably coupled to the water circuit 14 and contains a continuous channel 40 for this purpose.
- Two heating elements 24 are also provided as PTC elements 42 on the inner wall of the channel 40, which are each coupled to the control unit 26 and provide individual control and can be regulated in order to enable fine-grained regulation of the heat input. However, only one or more heating elements 24 can alternatively be provided.
- the water tank 38 with the PTC elements 42 contained therein serves as a flow heater for the water circuit 14.
- the arrangement and number of the PTC elements 42 is not limited to the embodiment shown.
- the water required for temperature control can be present in the water tank 38 before the heating system 10 is started up, so that after the fluidic coupling with the water circuit 14, a closed heating system 10 with a closed water circuit 14 is also provided.
- the releasable connection also enables the water container 38 with the heating elements 24 arranged therein to be decoupled for further or successive applications and to be easily cleaned and decontaminated.
- the remaining components of the heating system 10 can be designed as disposable items, so that in this case too the cleaning and decontamination effort and the risk of infection for the patient are considerably reduced.
- the pump 22 is also arranged upstream of the water container 38. Alternatively, however, the pump 22 can be arranged downstream of the water container 38.
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- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Urology & Nephrology (AREA)
- Emergency Medicine (AREA)
- Pulmonology (AREA)
- External Artificial Organs (AREA)
Abstract
La présente invention concerne des systèmes de chauffage et des systèmes d'assistance respiratoire extracorporelle AREC correspondants qui réduisent le risque d'infection pour des patients dans des applications correspondantes. En conséquence, l'invention concerne un système de chauffage (10) pour réguler la température d'un échangeur de gaz extracorporel (12), ledit système comprenant un circuit d'eau (14) qui peut être relié fluidiquement à un côté d'eau (16) de l'échangeur de gaz extracorporel (12), et une pompe (22) qui est reliée au circuit d'eau (14) et est configurée pour transporter l'eau dans le circuit d'eau (14). Le système de chauffage (10) comprend en outre au moins un élément chauffant (24), qui est couplé thermiquement au circuit d'eau (14), et une unité de commande (26), qui est relié en communication à la pompe (22) et l'au moins un élément chauffant (24) et est configuré pour régler un débit de pompe de la pompe (22) et la sortie de l'au moins un élément chauffant (24). Selon l'invention, le circuit d'eau (14) est fermé lorsqu'il est raccordé à l'échangeur de gaz extracorporel (12).
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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DE102020003680.5 | 2020-06-19 | ||
DE102020003680.5A DE102020003680A1 (de) | 2020-06-19 | 2020-06-19 | Heizsystem für einen extrakorperalen Gastauscher |
Publications (1)
Publication Number | Publication Date |
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WO2021255293A1 true WO2021255293A1 (fr) | 2021-12-23 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/EP2021/066837 WO2021255293A1 (fr) | 2020-06-19 | 2021-06-21 | Système de chauffage pour échangeur de gaz extracorporel |
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DE (1) | DE102020003680A1 (fr) |
WO (1) | WO2021255293A1 (fr) |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102014116601A1 (de) * | 2014-11-13 | 2016-05-19 | Jürgen Kramer | Medizingerät für einen extrakorporalen Blutkreislauf sowie Einrichtung zur Anreicherung des Bluts einesPatienten mit Sauerstoff |
DE102016014200A1 (de) | 2016-11-29 | 2018-05-30 | Christoph Gründler | System zum Temperieren von Blut und Patientenset hierfür |
WO2019035869A1 (fr) * | 2017-08-15 | 2019-02-21 | University Of Maryland, Baltimore | Échangeur de gaz à double chambre et procédé d'utilisation pour une assistance respiratoire |
WO2020081995A2 (fr) * | 2018-10-19 | 2020-04-23 | Zoll Circulation, Inc. | Échange de chaleur dans des systèmes extracorporels |
Family Cites Families (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8803044B2 (en) | 2003-11-05 | 2014-08-12 | Baxter International Inc. | Dialysis fluid heating systems |
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2020
- 2020-06-19 DE DE102020003680.5A patent/DE102020003680A1/de active Granted
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2021
- 2021-06-21 WO PCT/EP2021/066837 patent/WO2021255293A1/fr active Application Filing
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102014116601A1 (de) * | 2014-11-13 | 2016-05-19 | Jürgen Kramer | Medizingerät für einen extrakorporalen Blutkreislauf sowie Einrichtung zur Anreicherung des Bluts einesPatienten mit Sauerstoff |
DE102016014200A1 (de) | 2016-11-29 | 2018-05-30 | Christoph Gründler | System zum Temperieren von Blut und Patientenset hierfür |
WO2019035869A1 (fr) * | 2017-08-15 | 2019-02-21 | University Of Maryland, Baltimore | Échangeur de gaz à double chambre et procédé d'utilisation pour une assistance respiratoire |
WO2020081995A2 (fr) * | 2018-10-19 | 2020-04-23 | Zoll Circulation, Inc. | Échange de chaleur dans des systèmes extracorporels |
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