WO2005117546A2 - Appareil et procede pour induire une hypothermie therapeutique extracorporelle rapide - Google Patents

Appareil et procede pour induire une hypothermie therapeutique extracorporelle rapide Download PDF

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Publication number
WO2005117546A2
WO2005117546A2 PCT/US2005/018524 US2005018524W WO2005117546A2 WO 2005117546 A2 WO2005117546 A2 WO 2005117546A2 US 2005018524 W US2005018524 W US 2005018524W WO 2005117546 A2 WO2005117546 A2 WO 2005117546A2
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WO
WIPO (PCT)
Prior art keywords
blood
patient
hypothermia
extracorporeal
temperature
Prior art date
Application number
PCT/US2005/018524
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English (en)
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WO2005117546A3 (fr
Inventor
Ralph E. Gill
William Sylvester Novak
Michael Nicholas Pitsakis
Vladimir Zhuze
Original Assignee
Ardiem Medical, Inc.
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Application filed by Ardiem Medical, Inc. filed Critical Ardiem Medical, Inc.
Publication of WO2005117546A2 publication Critical patent/WO2005117546A2/fr
Publication of WO2005117546A3 publication Critical patent/WO2005117546A3/fr

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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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/44—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for cooling or heating the devices or media
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/12—Devices for heating or cooling internal body cavities
    • A61F2007/126—Devices for heating or cooling internal body cavities for invasive application, e.g. for introducing into blood vessels
    • 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
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • A61M2205/3606—General characteristics of the apparatus related to heating or cooling cooled
    • 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
    • A61M2205/362—General characteristics of the apparatus related to heating or cooling by gas flow

Definitions

  • the invention relates to the use of emergency therapeutic hypothermia.
  • the present invention relates to providing transportable, emergency, cooling capabilities to rapidly induce mild-to-moderate therapeutic hypothermia using extracorporeal circulation to lower and maintain the core body temperature of a patient.
  • hypothermia Interest in therapeutic hypothermia intervention continues to increase as a result of hypothermia's protective impact during ischemic events.
  • Clinical evidence demonstrates that patients suffering severe brain trauma or ischemia from myocardial infarction or stroke have improved medical outcomes if core temperature is lowered below normal body temperature (37°C).
  • Hypothermia was employed during the 1980s and 1990s in a range of surgical procedures to protect the brain, heart and other vital organs from ischemia, but did not gain broad acceptance as a standard of care for specific applications. Only recently has therapeutic hypothermia generated increased interest based on several significant clinical studies. Therapeutic hypothermia may ultimately become an important therapeutic adjunct in acute stroke, acute myocardial infarction, cardiac arrest, head trauma, and specific surgical procedures requiring neuroprotection.
  • Rapid emergency cooling could ultimately benefit the following conditions: acute myocardial infarction, stroke, traumatic hemorrhagic shock, traumatic brain injury, spinal cord injury, septic shock, neuroprotection, fever control and status epilepticus.
  • a variety of methods to induce hypothermia in a patient are known and have been used in the past.
  • One of the earliest methods was to pack the patient in ice to lower the body's core temperature externally.
  • To return the patient to normothermia, hot packs, hot water bottles, etc. are applied externally to the patient or the patient is allowed to warm normally.
  • Using ice for external cooling is too slow to be effective, is cumbersome in application, and may cause frostbite.
  • the most serious problem is the difficulty in controlling the body's core temperature such that hypothermia is induced and maintained, but the core temperature does not drop to dangerously low levels.
  • Extracorporeal cooling has been shown to be an effective and efficient method to rapidly induce mild-to-moderate hypothermia.
  • the generally accepted range of mild-to- moderate hypothermia is 30°C to 34°C.
  • the extracorporeal process of internal heat exchange consists of cooling and rewarming infused blood with a heat exchanger during an extracorporeal process.
  • Extracorporeal therapy in which a human patient's circulating blood is detoured outside of the body, treated, and then returned to the patient, is well known in the art.
  • U.S. Patent No. 3,064,649 which shows an apparatus for controlling blood temperature during intracardiac surgery.
  • the apparatus is inserted in the extracorporeal circulation path provided by a blood oxygenator.
  • the apparatus receives circulating blood from a patient through a conventional oxygenator and routes it to a reusable tubular heat exchanger. From the heat exchanger, the circulating blood is routed to a reusable bubble filter and then back to the patient.
  • the apparatus extracorporeally pumps blood from a patient through a heat exchanger, with pre- and post- blood conditioners, and then back to the patient.
  • Control of blood temperature includes feedback from sensors coupled to the patient to provide automated monitoring and control of the patient temperature, the cooling/heating system, and the treatment protocol.
  • the system uses a separate heater and cooler to condition water from a reservoir, circulating through the heat exchanger.
  • the present invention is directed to an apparatus and method to induce rapid hypothermia and subsequent return to normothermia through heat exchange in the blood during extracorporeal circulation.
  • the present invention is an apparatus that can rapidly induce mild-to-moderate hypothermia, a core body temperature range of 30°C to 34°C, in approximately ten minutes and can indefinitely maintain the core body temperature within plus or minus 0.5°C.
  • the present invention provides a transportable, emergency, cooling apparatus, along with cooling methodologies and clinical applications, to rapidly induce whole body or regional, mild-to- moderate therapeutic hypothermia using extracorporeal blood circulation to lower and maintain the core body temperature of a patient in the range of 30°C to 34°C.
  • the apparatus and procedure are performed on a patient in a hospital emergency room or clinic, but it can be configured for use in an ambulance for induction of hypothermia at the point of injury.
  • the apparatus induces therapeutic levels of mild-to-moderate hypothermia through extracorporeal circulation of the patient's blood through a cassette located within the heat exchanger.
  • the heat exchanger cools the patient's blood and lowers the body's core temperature to the selectable hypothermic level under spontaneous blood circulation (shunt blood flow) via venous or arterial shunts.
  • the apparatus maintains mild-to-moderate hypothermia for a selectable period of time as necessary and then, through the same process, heats the blood to return the patient's core temperature to normothermia. It can also induce hyperthermia at a selectable rate by raising the core body temperature to a desired level by blood circulation through the heat exchanger and maintaining that temperature for a selectable period of time as required.
  • the apparatus is used as therapy in a variety of emergency medical situations such as cardiac arrest, traumatic brain injury, acute stroke, spinal cord injury, during surgical procedures, etc.
  • One embodiment of the invention includes a cooling unit; a heating unit; a heat exchanger; a system controller and operator interface with software; a fluid pump; sensors for measuring temperature, flow, and pressure; safety components; and a disposable set.
  • hypothermia is induced in a patient through several access techniques, dependent on the specific situation. The variations in access techniques do not materially affect the device design or configuration.
  • the induction of mild-to-moderate hypothermia using an extracorporeal heat exchanger circuit requires blood to be shunted from the patient through a disposable heat exchange cassette located within the heat exchanger and back into the patient, generally via contralateral vascular outflow and inflow connections.
  • a standard venous or arterial outflow catheter, placed in a large peripheral vessel, is connected to the disposable cassette through appropriate medical grade disposable tubing. One end is securely connected to the intravascular catheter while the other end is securely connected to the disposable cassette.
  • the tubing for the return flow from the disposable cassette is securely connected to the contralateral peripheral venous or arterial catheter placed in the patient.
  • the vascular access approaches for the induction of mild-to-moderate hypothermia require connection to the contralateral peripheral outflow and inflow vascular access catheters.
  • Placement of catheters for vascular access include: [0015] 1. Femoral veins and/or arteries; [0016] 2. Jugular veins and/or carotid arteries; [0017] 3. Sub-clavian veins and arteries; [0018] 4. Brachial/auxiliary veins and arteries; or
  • Vascular access catheters are not part of the disposable set, but the disposable set does include the connectors for attachment to the catheters.
  • the complete disposable set consists of the heat exchanger cassette, appropriately sized medical grade tubing, connector fittings, bubble trap, blood filter, temperature sensors, and flow sensors.
  • the disposable set is sterilized and heparin-bonded.
  • the fluid pump circulates the blood through the heat exchanger at a selectable flow rate while the heat exchanger cools the blood and lowers core body temperature very rapidly to a selectable level to induce therapeutic hypothermia for a short or prolonged period of time.
  • the pump circulates the blood at a selectable flow rate through the heat exchanger, warming the blood and raising the core body temperature to normothermia or to induce hyperthermia for a short or prolonged period of time.
  • the apparatus uses integrated electronic controls to automatically monitor, control, and maintain the induction of mild-to-moderate hypothermia and the patient's core temperature.
  • the combination of elements provided in the described embodiment of the present invention results in an efficient hypothermia induction apparatus using extracorporeal blood circulation to rapidly induce and maintain mild-to- moderate, whole-body or regional, hypothermia in a human patient.
  • the apparatus may also be used when transporting patients between medical facilities, such as from a clinic to a hospital or from one hospital to another, to continue induction of hypothermia or to maintain a hypothermic state.
  • the set point for instance 32°C
  • the apparatus can lower core body temperature to 34°C in less than ten minutes.
  • FIGS. 1a and 1b are the front and side views, respectively, of a mild-to- moderate hypothermia apparatus of the present invention
  • FIG. 2 is a layout of the disposable set of the present invention
  • FIG. 3 is a system control block diagram of the present invention
  • FIG. 4 is a schematic of an indirect hot-gas bypass control system of the present invention.
  • FIG. 5 is an exploded front view of the heat exchanger of the present invention.
  • DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0037] Referring to FIGS. 1-5, a preferred embodiment of the apparatus is disclosed.
  • the apparatus consists of the extracorporeal hypothermia apparatus and a disposable infusion set.
  • the best mode of the invention involves rapidly inducing therapeutic mild-to-moderate hypothermia by lowering the core body temperature from 37°C to a range of 34°C to 30°C in ten minutes or less via extracorporeal blood circulation at a flow rate of 0.2 to 1.0 liters/minute.
  • the selected core body temperature in the range of 34°C to 30°C, can be maintained for an extended period of time as desired.
  • the apparatus returns the patient's core temperature to normothermia at a selectable rate by raising the core body temperature under shunt blood circulation through the heat exchanger.
  • the apparatus is also capable of inducing hyperthermia by raising core body temperature from 37°C up to 42°C at a selectable rate of 0.1 to 1°C/hour via blood circulation at a flow rate of 0.2 to 1.0 liters/minute.
  • FIG. 1a and 1b show the front and side views, respectively, of the extracorporeal hypothermia device.
  • a fluid pump assembly 71 circulates the patient's blood received through silicon tubing 76 connected to a venous or arterial catheter with a connector 74, through a thin heat exchange cassette 79 (secondary heat exchanger) inserted in a primary heat exchanger 14 (evaporator) where heat exchange takes place by conduction.
  • a thin heat exchange cassette 79 secondary heat exchanger
  • a primary heat exchanger 14 evaporator
  • a vapor- compression refrigeration unit 15 with a compressor 16 and a condenser 17 cools or heats the primary heat exchanger 14 and thereby conditions the circulating blood.
  • the circulating blood exits the heat exchange cassette 79, through a silicon tube 76 and a fitting 78, into a bubble trap/filter 10 to remove air bubbles, and a pressure isolator 11 used to isolate the blood from the pressure sensor.
  • the circulating blood exits the pressure isolator 11 into a bubble detector 12 and a tubing occluder 13, back to the patient through a connector 75 connecting a venous or arterial catheter to the silicon tubing 76.
  • FIG. 2 shows the disposable infusion set which is sterilized, heparin bonded, and consists of a length of medical grade silicon standard tubing 76, connectors 74 and 75 for connecting to standard venous or arterial catheters, myocardial temperature probes (not shown) for monitoring inflow and outflow blood temperatures, injection ports 77 for inserting myocardial temperature probes, connection fittings 78 for connecting to a heat exchange cassette 79, a bubble trap/filter 10 to remove air bubbles from the circulating blood, and a pressure isolator 11 used to isolate the blood from a pressure sensor.
  • FIG. 3 shows the system block diagram with a power inlet 59 where a detachable 20 amp hospital grade power cord connects the extracorporeal hypothermia device to an electrical outlet, a 20 amp two-pole circuit breaker 60 that also serves as a power switch, and a standard serial COM connector 58 for providing communication means and data upload to a computer, all accessible on the rear panel of the apparatus. Also mounted on the rear panel is an AC fan 64 providing forced ambient air to cool the interior of the apparatus.
  • a toroidal isolation power transformer 61 provides 120 volts AC to the compressor and heaters, and a medical grade switching power supply 62 provides 12 volts DC to the 12V/5V DC/DC converter and a regulator 63 which supplies 5 volts DC and 3.3 volts DC to the electronics, to the pump motor, to the occluder solenoid, and to a 12V/24V DC/DC converter 55, which supplies 24 volts DC to a stepper motor current monitor 34.
  • the operator interface on the front panel of the apparatus contains multiple connectors 73 for connecting to multiple temperature probes (not shown), with at least two (2) temperature probes used for sensing patient temperatures, at least one (1) for sensing blood inflow temperature (to the patient), and at least one (1) for sensing blood outflow temperature (from the patient).
  • a pressure isolator port 80 for connecting the pressure isolator 11 to a pressure sensor 46; the ultrasonic bubble detector 12; a red push-button emergency switch 35; access to a pump head 39; access to the primary heat exchanger 14; a graphics LCD touch-screen 72 for graphical user interface; a red LED power-on indicator 36; a green LED ready indicator 37 that indicates the device is ready for a procedure; and a yellow LED alert indicator 38 that is illuminated whenever a fault or alert is detected and a message is displayed.
  • the compressor 16 of the refrigeration unit 15 is turned on and off by a compressor solid-state relay (SSR) 27 under control of a system controller/ processor 57.
  • SSR compressor solid-state relay
  • the bypass valve of the refrigeration system is opened from 0- 100% by a bypass valve stepper motor driver 33, also under control of the system controller/processor 57.
  • Heaters 24 are controlled by a heater SSR 25, a solid-state relay driven by a pulse-width modulation (PWM) circuit 26, to provide 0-100% of heating power under control of the system controller/processor 57.
  • a thermistor, an evaporator temperature sensor 29, is embedded in a top inner heat exchanger plate 66, and, after amplification by an evaporator thermistor amplifier 30, is routed to an analog-to-digital converter (ADC), multiplexed input ADC 2 53, for the purpose of monitoring the temperature of the primary heat exchanger 14.
  • ADC analog-to-digital converter
  • thermistor internal temperature sensor 31
  • ADC 2 53 a multiplexed input ADC 2 53 for monitoring temperature inside the apparatus.
  • the pump motor/pump head 39 is driven by a pump motor driver 40 under control of the system controller/processor 57 using pulse-width modulation to set the speed of the motor and the flow rate from 0-100%, if an emergency electronics circuit 45 has not been activated.
  • Measurement of blood flow is accomplished by a pump speed encoder 47, an encoder wheel and an opto-isolator attached to the back shaft of the pump motor. The combination generates pulses of frequency proportional to pump speed and, by extension, to the blood flow rate.
  • the output of the encoder is fed into flow electronics 48 for conditioning and shaping, and then to the system controller/processor 57 for measurement.
  • the tubing occluder 13 is driven by an occluder driver 42 under control of the emergency electronics circuit 45 and is commanded primarily by the bubble detector 12, or the emergency switch 35, or the blood inflow temperature out-of-range signal, IF OR, from optical isolation 51 , and secondarily by the system controller/processor 57 (only during testing).
  • the emergency electronics circuit 45 reacts directly to a signal from the bubble detector 12, or the emergency switch 35, or the IF OR signal from optical isolation 51 while the system controller/processor 57 is flagged.
  • the system controller/processor 57 has the means to disable the bubble detector 12 during priming of the tubing and to enable it for a therapeutic procedure, and also has the means to reset the emergency electronics circuit 45 after a stop event generated by a bubble detection or a closure of the stop switch.
  • the pressure sensor and electronics 46 provide an analog signal, proportional to pressure detected on the output side of the pump 71, that is fed to multiplexed ADC 2 53.
  • a patient temperature electronics 49 contain four thermistor amplifiers.
  • the four temperature signals plus two internal voltages (for diagnostics) are fed to multiplexed input ADC 1 50 for monitoring. Electrical isolation is required for this section and is accomplished by the optical isolators in optical isolation 51 and by a DC/DC converter/regulator 44.
  • the DC currents of the occluder solenoid, pump motor, and bypass valve stepper motor are monitored for diagnostics by an occluder current monitor 43, a pump current monitor 41 , and stepper motor current monitor 34.
  • Multiplexed input ADC 3 54 reads the current-related voltages of these three elements for monitoring and fault detection. These three elements also provide individual circuit fusing.
  • a coil in the magnetic AC current pick-up 28 reads the combined AC current drawn by the compressor and the heaters and sends a DC equivalent to multiplexed input ADC 3 54.
  • Scaled down versions of the supply voltages 24 VDC, 12 VDC, and 5 VDC are routed by a voltage divider 56 to multiplexed ADC 2 53 for diagnostic monitoring.
  • the system controller/processor 57 executes a digital PID algorithm contained in the embedded software for controlling the temperature. For initial cooling, a bypass valve 18 is fully closed to allow the fastest rate of cooling.
  • the PID algorithm controls are initially based on the temperature of the blood delivered to the patient (patient inflow), provided from the patient temperature electronics 49, stabilizing it to a preselected temperature.
  • the PID algorithm switches to using the core body temperature as a basis for controls, stabilizing it to the hypothermia set point.
  • the bypass valve 18 opens up a fixed amount, dependent on the patient's hypothermic temperature set point, to reduce the heating power required of the heaters 24 for maintaining a stable core body temperature.
  • the bypass valve 18 When warming the patient, the bypass valve 18 is 80% open to provide a small measure of cooling for maintaining a tight tolerance of the targeted temperature.
  • the PID algorithm controls are initially based on the temperature of the blood delivered to the patient (patient inflow), provided from the patient temperature electronics 49, stabilizing it to a preselected temperature.
  • the PID algorithm switches to using the core body temperature as a basis for controls, stabilizing it to the normothermic or hyperthermic set point.
  • FIG. 4 shows the indirect hot-gas bypass control system that controls the temperature of the circulating blood. Cooling and warming of the extracorporeally circulating blood is accomplished by heat exchange in the heat exchanger (evaporator) between the patient's blood inside the heat exchange cassette 79 and the plates of the heat exchanger 14.
  • a mechanical vapor-compression refrigeration unit 15 provides cooling to the plates of the heat exchanger 14.
  • An indirect hot-gas bypass system is used to raise the temperature of the heat exchanger. This method uses a controllable valve on the high-pressure side of the refrigeration unit to bypass the condenser to an injection point between a thermal expansion valve 22 and the heat exchanger 14. In the high demand mode, the hot-gas discharge bypass valve 18 remains closed and the refrigeration system supplies full cooling output to the heat exchanger 14. If less cooling is required, the system controller continuously opens the bypass valve 18, allowing hot gas to flow through the bypass valve to the heat exchanger 14 where it mixes with the cooled liquid refrigerant.
  • the vaporization temperature rises, thus reducing the amount of cooling delivered to the heat exchanger 14.
  • the pumping action of the compressor 16 draws vapor from the heat exchanger 14, reducing the pressure in the heat exchanger 14, and causing the liquid particles to evaporate.
  • the heat exchanger 14 is cooled. Both the liquid and vapor refrigerant tend to extract heat from warmer objects.
  • the ability of the liquid to absorb heat as it vaporizes is very high in comparison to that of the vapor and the evaporation of the liquid refrigerant would soon remove the entire refrigerant from the heat exchanger if it were not replaced.
  • the replacement of the liquid refrigerant is controlled by the thermal expansion valve 22 which acts as a restrictor to the flow of the liquid refrigerant in the liquid line. Its function is to change the high-pressure, sub-cooled liquid refrigerant to low-pressure, low-temperature liquid particles, which will continue the cycle by absorbing heat.
  • the refrigerant low-pressure vapor drawn from the heat exchanger 14 by the compressor 16, in turn is compressed to a high- pressure vapor, which is forced into the condenser 17. In the condenser 17, the high-pressure vapor condenses to a liquid under high pressure and gives up heat to the ambient atmosphere.
  • the drier 20 is located in the liquid line between the condenser 17 and thermal expansion valve 22, where velocities are generally low.
  • a sight glass 21, located in the liquid line downstream of the drier 20, provides a visual indication of the state of refrigerant before entering the thermal expansion valve 22.
  • the sight glass 21 may contain a moisture indicator for visually determining when the refrigerant's water content is excessive. A few small bubbles appearing in the sight glass window is considered normal; however, excess bubbles indicate the presence of refrigerant vapor due to an excessive pressure drop across the drier 20, little or no sub- cooling, or insufficient quantity of refrigerant.
  • the indirect bypass control system is simple and reliable.
  • FIG. 5 shows an exploded front view of the primary heat exchanger of the hypothermia apparatus, corresponding to the evaporator of a typical refrigeration unit.
  • the refrigeration unit's evaporator cooling coils are serpentinely embedded directly between heat exchanger inner plates 66 and the heat exchanger outer plates 65 of the heat exchanger 14.
  • the circulating blood flows through the heat exchange cassette 79 fully inserted in the heat exchanger 14 so it is closely sandwiched between two insertion plates 68.
  • heat exchange occurs between the heat exchanger 14 and the blood.
  • a means to precisely control the temperature of the heat exchanger, and hence the blood, requires the capacity to both cool and heat.
  • the hot-gas discharge bypass valve 18 can provide heat and raise the temperature of heat exchanger 14, but rapid response to temperature fluctuations and precise control of the core body temperature requires an additional heat source.
  • the additional heating capacity supplied to the heat exchanger 14 is accomplished by AC resistive foil heating elements 67 sandwiched between the inner plates 66 and the insertion plates 68.
  • the heat exchanger inner plates 66 and insertion plates 68 are constructed of aluminum while the outer plates 65 are constructed of polypropylene to reduce the evaporator mass of the heat exchanger 14 for a faster thermal response and to provide insulation.
  • the heating elements 67 and the refrigeration unit 15 may operate simultaneously, heating and cooling the heat exchanger at the same time. Due to the requirements for precise temperature control, the heat exchanger 14 must respond in a very short time.
  • Simultaneous heating and cooling of the heat exchanger 14 is more responsive for adjusting small temperature fluctuations in the core body temperature than just using the hot-gas discharge bypass valve 18, which opens and closes by means of a stepper motor and is slower effecting a temperature increase in the heat exchanger 14.

Abstract

L'invention concerne un appareil d'hypothermie extracorporelle et un ensemble jetable pour induire rapidement et maintenir pendant une période indéterminée chez un patient un état d'hypothermie légère à modérée généralisée ou régionale par réduction de la température interne du corps dans une plage comprise entre 30 °C et 34 °C à travers un refroidissement et/ou un réchauffement continu par l'intermédiaire d'une circulation sanguine extracorporelle au moyen d'une cassette (79) située à l'intérieur d'un échangeur de chaleur (14). Cet appareil peut réduire la température interne du corps à 34 °C en dix minutes au maximum. Son échangeur de chaleur (14) refroidit le sang du patient et réduit la température interne du corps jusqu'au niveau hypothermique sélectionnable avec une circulation sanguine spontanée (flux sanguin shunté) par l'intermédiaire de shunts veineux ou artériels. Cet appareil et cette procédure sont utilisés sur un patient dans une salle d'urgence hospitalière ou une clinique, mais ils peuvent être conçus pour être utilisés dans une ambulance afin d'induire une hypothermie au moment de la blessure. L'appareil selon l'invention maintient une hypothermie légère à modérée pendant une durée sélectionnable nécessaire, puis il réchauffe le sang pour faire revenir la température interne du patient à la normothermie. Cet appareil peut également induire une hyperthermie à une vitesse sélectionnable par augmentation de la température interne du corps à un niveau voulu par circulation du sang à travers l'échangeur de chaleur (14) et maintien de cette température pendant une durée sélectionnable requise.
PCT/US2005/018524 2004-05-26 2005-05-26 Appareil et procede pour induire une hypothermie therapeutique extracorporelle rapide WO2005117546A2 (fr)

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US57460904P 2004-05-26 2004-05-26
US60/574,609 2004-05-26

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EP2134304A2 (fr) * 2007-03-23 2009-12-23 Thermal Therapeutic Systems, Inc. Dispositif d'hyperthermie portable
WO2010111778A1 (fr) * 2009-03-30 2010-10-07 Steve Andre Beaudin Appareil, système et procédés de traitement sanguin extracorporel pour refroidir de manière sélective le cerveau par rapport au corps pendant un traitement hyperthermique ou pour induire une hypothermie du cerveau
DE102010049477A1 (de) * 2010-10-27 2012-05-03 Ingrid Barbknecht Vorrichtung zur selektiven Kühlung physiologischen Gewebes
CN106102668A (zh) * 2014-02-14 2016-11-09 佐尔循环公司 具有且仅有两个流体回路的患者换热系统
CN107096118A (zh) * 2017-06-29 2017-08-29 许祖闪 脑动脉闭塞循环再通装置及再通方法
CN109674575A (zh) * 2018-12-23 2019-04-26 庄育田 一种重症医学科用血管内亚低温治疗仪
CN109966050A (zh) * 2019-04-25 2019-07-05 温建娟 一种颅脑灌注降温便携箱
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US11033424B2 (en) 2014-02-14 2021-06-15 Zoll Circulation, Inc. Fluid cassette with tensioned polymeric membranes for patient heat exchange system
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US11571332B2 (en) 2012-09-28 2023-02-07 Zoll Circulation, Inc. Intravascular heat exchange catheter and system with RFID coupling
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US11033424B2 (en) 2014-02-14 2021-06-15 Zoll Circulation, Inc. Fluid cassette with tensioned polymeric membranes for patient heat exchange system
JP2022002714A (ja) * 2014-02-14 2022-01-11 ゾール サーキュレイション インコーポレイテッドZOLL Circulation, Inc. 熱交換システム、システムおよびカセット
EP3094288A4 (fr) * 2014-02-14 2017-10-04 ZOLL Circulation, Inc. Système d'échange thermique pour patient pourvu de seulement deux boucles de fluide
US11752251B2 (en) 2014-08-14 2023-09-12 Medivance Incorporated System and method for extracorporeal temperature control
US11865034B2 (en) 2015-01-27 2024-01-09 Medivance Incorporated Medical pad and system for thermotherapy
US11234859B2 (en) 2015-01-27 2022-02-01 Medivance Incorporated Medical pad and system for thermotherapy
US10537465B2 (en) 2015-03-31 2020-01-21 Zoll Circulation, Inc. Cold plate design in heat exchanger for intravascular temperature management catheter and/or heat exchange pad
US11058572B2 (en) 2016-10-11 2021-07-13 Stryker Corporation Thermal control system
US11185440B2 (en) 2017-02-02 2021-11-30 Zoll Circulation, Inc. Devices, systems and methods for endovascular temperature control
US11883323B2 (en) 2017-02-02 2024-01-30 Zoll Circulation, Inc. Devices, systems and methods for endovascular temperature control
US11951035B2 (en) 2017-02-02 2024-04-09 Zoll Circulation, Inc. Devices, systems and methods for endovascular temperature control
CN107096118A (zh) * 2017-06-29 2017-08-29 许祖闪 脑动脉闭塞循环再通装置及再通方法
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