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    • 专利摘要:
    A medical cooling device and a method for operating the same are provided.Figured to be published with Abstract: Fig. 1
    公开号:SE1451236A1
    申请号:SE1451236
    申请日:2014-10-15
    公开日:2016-04-16
    发明作者:Jon Berg；Martin Waleij；Christian Strand
    申请人:Braincool Ab；
    IPC主号:
    专利说明:

    DEVICE AND METHOD FOR MEDICAL COOLING OF A BODY PART OF APATIENT TECHNICAL FIELDThe present invention pertains to a medical Cooling device and method for medical Cooling of a body part of a patient, and in particular the brain of the patient.
    BACKGROUND Medical cooling of parts of the human body is a useful tool to reduce adverseimpacts on the same under certain conditions. For example, medical cooling may beused for cooling the brain of patient suffering from a stroke. By reducing thetemperature of the brain the risk of tissue damage is reduced for those parts of the brainlacking an adequate oxygen supply during the stroke. Another application of medicalcooling is to cool the scalp for patients going through chemo therapy, to avoidundesirable hair loss.
    In animal models of stroke, target temperatures of between 24° C and 34°C aremost efficacious for reducing infarct size. However, even a brain temperature of 35° Creduces the infarct volume by 30%. Cooling to levels of 32° to 34° C generally requiressedation, mechanical ventilation and admission to an intensive care unit. OWing to thelimited availability of intensive care beds in most countries, treatment of even aminority of acute stroke patients to those levels is therefore precluded by substantialpractical and logistical problems. Temperature reductions to 35.5°C or 35.0°C havebeen shown to be feasible and safe in aWake patients With acute ischemic stroke bysurface cooling, in combination With for example pethidine to prevent shivering. Somestudies of patients With severe traumatic brain injuries indicate that temperatures of 35to 35.5°C seem to be the optimal temperature at Which to treat patients With severetraumatic brain injuries.
    A more versatile medical cooling device and method further improving the medical cooling process Would be advantageous.
    SUMMARYAn object of the present invention is to eliminate or alleviate at least one of thedraWbacks mentioned above, Which is achieved by assigning to the device the characteristics according to claim l.
    According to a first aspect, a medical cooling device for conducting a medicalcooling process for cooling at least two body parts of a patient is provided. The medicalcooling device comprises a cooling fluid supply source. Moreover, the medical coolingdevice comprises at least two inlet/outlet pairs, each inlet/outlet pair comprising anoutlet being connected to the cooling fluid supply source and arranged for connection toone individual supply line for supplying a flow of cooling fluid from the cooling fluidsupply source to a patient, and an inlet for connection to an individual return line beingoperatively coupled with the individual supply line and to the cooling fluid supplysource thereby forrning a continuous loop cooling circuit in use. The medical coolingdevice further comprises a flow pump connected to each inlet/outlet pair for pumpingcooling liquid from the cooling fluid supply source to each of the outlets and receivingretuming cooling fluid via each of the inlets. Furthermore, the medical cooling devicecomprises means for distributing different cooling power to each cooling circuit byadapting at least one control process parameter for each cooling circuit and re-startingthe medical cooling process according to said adapted control process parameter.
    In a second aspect a means is provided for distributing different cooling powerto at least two body parts of a patient by adapting at least one control process parameterof a medical cooling process, wherein each body part is cooled individually by means ofone cooling circuit being operatively connected to a medical cooling device. The at leastone control process parameter relates to: the operation of at least one flow control valve arranged in each coolingcircuit, whereby the means is conf1gured to adapt the flow in each cooling circuit bycontrolling said operation; the operation of at least one flow pump operatively coupled to eachcooling circuit, whereby the means is configured to adapt the flow in each coolingcircuit by controlling said operation; or the energy consumption of the medical cooling device, wherein theenergy consumption in each cooling circuit is calculated using the following forrnularelating to the first law of therrnodynamics: Q(energy) =rñ *CP(T2-TI), wherein Q is the energy, rñ is the mass flow of the cooling fluid in thesupply line, CP represents a constant for the cooling fluid related to the specific heat atconstant pressure, Tl being the temperature of the cooling fluid exiting the medicalcooling device towards the patient, and T2 being the temperature of the retuming cooling fluid from the patient, whereby the means is conf1gured to adapt the temperature Tl according to a target energy consumption Value in each cooling circuit. The means isfurther configured to re-start the medical cooling process according to the adaptedcontrol process parameter.According to an aspect, a method for distributing different cooling power to at least two body parts of a patient by adapting at least one control process parameter of amedical cooling process is provided. Each body part is cooled individually by means ofone cooling circuit being operatively connected to a medical cooling device. The at leastone control process parameter relates to: the operation of at least one flow control valve arranged in each coolingcircuit, whereby the method comprises the step of adapting (2la) the flow in eachcooling circuit by controlling said operation; the operation of at least one flow pump operatively coupled to eachcooling circuit, whereby the method comprises the step of adapting (21b) the flow ineach cooling circuit by controlling said operation; or the energy consumption of the medical cooling device, wherein theenergy consumption in each cooling circuit is calculated using the following forrnularelating to the first law of therrnodynamics: Q(energy) =1ñ *CP(T2-TI), wherein Q is the energy, rñ is the mass flow of the cooling fluid in thesupply line, CP represents a constant for the cooling fluid related to the specific heat atconstant pressure, Tl being the temperature of the cooling fluid exiting the medicalcooling device towards the patient, and T2 being the temperature of the retumingcooling fluid from the patient, wherein the method comprises the step of adapting (2lc)the temperature Tl according to a target energy consumption in each cooling circuit.Moreover, the method comprises the step of re-starting (22) the medical cooling process according to the adapted control process parameter.
    BRIEF DESCRIPTION OF DRAWINGS In order to explain the invention, a number of embodiments of the inventionwill be described below with reference to the drawings, in which: Fig 1 is a schematic view of a medical cooling device according to oneembodiment; and Fig. 2 illustrates a method according to an embodiment.
    DESCRIPTION OF EMBODIMENTS An idea of the present invention is to provide a medical cooling process forcooling several body parts of patient using a single medical cooling device. Morespecifically, an idea is to provide simultaneous independent cooling to each body part ofthe patient using the single medical cooling device. In this way some body parts may becooled to a further extent and in a different than others such as to optimize the coolingfor the given patient condition. Not only will the independent cooling of body partsallow for improved cooling efficiency, but also the power consumption of the medicalcooling device will be managed in the most efficient manner, e.g. by focusing moreenergy to the body parts requiring more cooling and vice versa.
    In an embodiment, according to Fig. 1, a medical cooling device 10 isprovided. The medical cooling device 10 comprises a cooling fluid supply source 11(schematically shown in Fig. 1 with dotted lines). The medical cooling device 10comprises a first outlet 12 for connection to a first supply line 121 for supplying a flowof cooling fluid from the cooling fluid supply source to a patient. The medical coolingdevice further comprises a first inlet 14 for connection to a first retum line 141 beingoperatively connected to the first supply line 121 retuming the cooling fluid from thepatient to the cooling fluid supply source 11. The first supply line 121 and the firstretum line 141 together form part of a first cooling circuit and may comprise tubes forthe transfer of cooling fluid. A second outlet 22 of the medical cooling device isarranged to connect to a second supply line 221 and a second inlet 24 of the medicalcooling device is arranged to connect to a second retum line 241. The second supplyline 221 and the second retum line 241 together form part of a second cooling circuit and may similarly to the first cooling circuit comprise tubes for the transfer of coolingfluid.
    Between the first supply line 121 and the first return line 141 a first coolingfluid distribution device 131, e.g. a wearable garrnent, which distributes the suppliedcooling fluid around the body part of the body to be cooled is used.
    In use, a second cooling fluid distribution device 231 is provided between thesecond supply line 221 and the second return line 241.
    In an embodiment, at least a third outlet 32 of the medical cooling device isarranged for connection to a third supply line 321 and a third inlet 34 of the medicalcooling device is arranged to connect to a third return line 341. The third supply line321 and the third return line 341 together forrn part of a third cooling circuit and maysimilarly to the first or second cooling circuit comprise tubes for the transfer of coolingfluid. In use, a third cooling fluid distribution device 331 is provided between the thirdsupply line 321 and the third return line 341.
    Generally, each cooling fluid distribution device 131, 231, 331 may contain achannel pattern for improving the cooling efficiency of the body part to which it isconnected in use. Preferably, each cooling fluid distribution device has a shape beingconfigured to encompass and tightly fit the body part of the patient to be cooled. Thecooling of the body part of the patient is thus govemed by means of conductive heattransfer between the cooling fluid in the corresponding distribution device and the bodypart of the patient to the cooled. Hence, the cooling of the body part of the patient ispreferably made ex vivo whereby there is no direct contact between the cooling fluidand the body part of the patient to be cooled.
    Ideally, the liquid cooling distribution device is preferably made of a materialshowing good heat conductive properties and comfortable fit in use. While metals havevery good heat conductive properties, they are less suitable too allow for a comfortablefit on the body part. According to one embodiment, the at least one fluid distributiondevice is made of a silicon material which allows for a very comfortable fit however,having less heat conductive properties than a metal.
    Depending on the type of material the temperature of the cooling fluid coolingsupply source may be altered. For example, the temperature of the cooling fluid in thesupply source when the distribution device is made of a silicon material may bebetween -9 °C and -6°C, such as -7 °C. For a distribution device material having better(compared to silicon) heat conductive properties the temperature of the cooling fluid inthe supply source may be higher than -6 °C, such as -2°C, or even higher such as 4 till5°C. Depending on the type of condition the patient is in, more than one distribution device may be connected to the medical cooling device. Each distribution device is supplied using a separate Cooling Circuit, i.e. a separate supply line and a separate returnline.
    In an embodiment, the first Cooling fluid distribution deviCe 131 is arranged tobe ConneCted to the sCalp of the patient. The seCond Cooling fluid distribution deviCe231 is arranged to be ConneCted to the neCk region of the patient, e.g. for Cooling of theCarotid artery. The third Cooling fluid distribution deviCe 331 is arranged to beConneCted to the groin part of the patient.
    In an embodiment, the mediCal Cooling deviCe is semiportable and Contains abattery in order to allow the Cooling system to run for 2-3 hours without aCCess to asoCket. This makes it possible to start the Cooling treatment in the emergenCy room (oralready in the ambulanCe) and Continuing the Cooling treatment during a Couple of hourswhen a patient with for example stroke is moved around in the hospital before beingplaCed in a bed in a hospital Ward with aCCess to a power socket.
    The Cooling fluid supply sourCe 11 may be integral with or ConneCted to arefrigerator unit (not shown) for Cooling the Cooling fluid to a Certain presettemperature.
    The Cooling fluid in the patient Cooling CirCuit, i.e. flowing from the mediCalCooling deviCe through eaCh supply line, distribution deviCe, retum line and then baCk tothe mediCal Cooling deviCe may be a Conventional refrigerator liquid, suCh as a glyColbased solution or optionally water. In the event the refrigerator unit utilizes aCompressor for Cooling the Cooling fluid in the supply sourCe, the Compressor CoolingCirCuit being separate from the patient Cooling CirCuit may be using a ConventionalCompressor refrigerant.
    The mediCal Cooling deviCe 10 may further Comprise a flow pump forproviding flow rate of the Cooling fluid in the Cooling CirCuit aCCording to the demand.
    Each outlet 12, 22, 32 may be operatively Coupled to the flow pump by meansof intemal tubes (not shown) inside the mediCal Cooling deviCe.
    Two main faCtors affeCting the Cooling eff1CienCy of the body part of thepatient are the fluid flow rate and the temperature of the Cooling fluid leaving themediCal Cooling deviCe via the supply line 12. InCreased flow for any Cooling fluidtemperature being below the temperature of the body part of the patient results in ahigher rate of Cooling. Similarly, for a Constant flow rate any reduCtion in the Coolingfluid temperature leaving the mediCal Cooling deviCe will result in a higher rate of Cooling of the body part.
    In an embodiment, the medical cooling device 10 further comprises means forsimultaneously adapting at least one control process parameter for each cooling circuitand re-starting the medical cooling process according to said adapted control processparameter.
    The means may comprise a control unit for controlling the operation of devicesof the medical cooling device, in order to adapt the flow and/or temperature of coolingfluid in each cooling circuit. The control unit comprises a processor and a memory and is thus capable of computer processing capabilities.
    Flow control valves In an embodiment, the control process parameter relates to the operation of atleast one flow control valve arranged in each cooling circuit, whereby the control unit isconf1gured to adapt the flow in each cooling circuit by controlling said operation.
    In one embodiment the flow control valve is of an ON/ OFF type, e.g. solenoidbeing provided downstream the flow pump. In an ON position the flow of the coolingcircuit allows for the rated flow of the flow pump is supplied to the supply line. In anOFF position no flow is supplied to the supply line whereby, the cooling fluid betweenthe supply line and the retum line is stationary. A mean flow is attained by using aprecise timing schedule for each cooling circuit being stored in the control unit.
    The control unit may be conf1gured to allow for a precise flow in each supplyline by means of controlling the associated flow control valves. For example, if the flowpump provides a rated flow of 6000ml-8000/min, and the control unit is conf1gured toprovide a flow in the first supply line of 2000ml/min flow, the flow control valve needsto be in the OFF position during 20 seconds each minute. For example, the timingschedule may define the flow control valve to be OFF in 10 times /minute with durationof 2 seconds each time. Altematively, the flow control valve may be OFF 5 times/minwith duration of 4 seconds each time in the OFF position. Altematively, the controlvalve may be set to OFF once during 20 seconds per minute.
    In an embodiment, the timing schedule of the ON/ OFF valve(s) may bechanged throughout the cooling treatment. For example, the ON/ OFF valve(s) may beopen until the cooling fluid is reduced to the demanded cooling fluid temperature, e.g. -7°C and for a predeterrnined time after reaching the demanded cooling temperature,after which the flow is reduced by closing the ON/ OFF valve(s) according a frequency/duration govemed by the timing schedule for each cooling circuit. After another predeterrnined time period the closing frequency/ duration may be altered furtherif desired.
    In an embodiment, the flow control valves may be proportional valves, whichmay be set to more than two positions for allowing different flow rates to passdepending on the position of the valve.
    By operating the flow control valves the control unit may provide forindependent flow rates in each of the cooling circuits, thereby allowing for thepossibility of simultaneously cooling individual body parts to different extents.
    For example, in the case of cooling treatment of a stroke patient, a higher flowrate may be provided to the third distribution device at the groin, than to the first andsecond distribution devices. This since the cooled blood in the groin cooled blood willcirculate back to the heart before it reaches the brain during the next blood circulationcycle, thereby increasing its temperature during the transport. Hence, by cooling thegroin body part to a higher extent, e. g. by a higher flow rate, the temperature of theblood reaching the brain during the next blood circulation cycle will be advantageouslycooler.
    The flow control valve(s) may be arranged intemally or extemally of themedical cooling device. In an embodiment, each cooling circuit has at least one flowcontrol valve arranged within the medical cooling device. Altematively, or in addition, aflow control valve may be extemally arranged, e. g. in the supply line(s), distribution device(s), or retum line(s).
    Flow pumpIn an embodiment, the control process parameter relates to the operation of the at least one flow pump (not shown), whereby the control unit is configured to adapt theflow in each cooling circuit by controlling said operation.
    In an embodiment, the control unit is configured to control the output flow rateof the pump by the transmission of a control signal to the pump to thereby maintain,increasing or decreasing the flow rate.
    In an embodiment, the flow pump is a constant flow pump. Here the flow maybe controlled using one or several flow control valves (not shown) provided in eachcooling circuit.
    In an embodiment, wherein the operation of the at least one flow pump iscontrolled by means of an ON/OFF state and flow control valves arranged to distribute output flow of the flow pump evenly between each cooling circuit.
    Energy consumptionAccording to an embodiment, the control process parameter relates to the energy consumption of the medical cooling device. The energy consumption in eachcooling circuit may be calculated using the following forrnula relating to the first law oftherrno dynamics :Q(energy) =rñ *CP*(T2-TI),wherein Q is the energy, rñ is the mass flow of the cooling fluid in the supply line, CP represents a constant for the cooling fluid related to the specific heat atconstant pressure, Tl being the temperature of the cooling fluid exiting the medicalcooling device via an outlet towards the patient, and T2 being the temperature of theretuming cooling fluid from the patient via an inlet. In this embodiment the control unitis configured to adapt the temperature Tl according to a target energy consumptionvalue in each cooling circuit. In combination with the operation of the flow controlvalves it is possible to simultaneously direct independent energy power to each of thecooling circuits.
    In an embodiment, the temperature Tl may be adapted by setting an adaptedtarget temperature TX of the cooling fluid of the cooling fluid supply source, therebyresulting in an adapted power being transferred to a refrigerator unit of the cooling fluidsupply source to cool/heat the cooling fluid in the cooling fluid supply source to theadapted target temperature. If the new target temperature TX of the cooling fluid supplysource is set higher then the refrigerator unit of the supply source then heats (or avoidscooling) the cooling fluid therein such as to attain the new target temperature TX. TXmay be set identical to Tl provided there are no heat loss between the cooling fluidsupply source and the supply line. In practice, TX may be set slightly lower than thetarget Tl since the cooling fluid may absorb some heat between the supply source andthe supply line, due to warrn components within the medical cooling device casing.
    As an example, if the power consumption of the refrigerator unit is 700W, it ispossible to direct 300W to the first distribution device, l50W to the second distributiondevice and 25 0W to the third distribution device, by controlling the flow in each coolingcircuit and/or supply temperature.
    The control unit may also be configured to limit the energy consumptionproportionally to each cooling circuit upon receipt of input that the body part(s) havereached their target temperature. By proportionally is here meant proportionally to the previous power ratio or proportion. With reference to the example above, with a new target energy consumption of 500W, the first distribution device would receive ~214 W(300W/700W*500W), the second distribution device would receive ~l07W(l50W/700W*500W), and the third distribution device would receive ~l79W (25 0W/ 700W*500W) using such a proportionally regulation made by the control unit.
    The referred input could be a temperature signal from a temperature sensorbeing connected to the body part of interest, or the input could be user input to themedical cooling device by the treatment staff, e. g. by using a screen thereof to inputrelevant data to the control unit.
    It should be appreciated that by adapting the flow in each cooling circuit, byoperating the control flow valve(s) in each cooling circuit the power transferred to eachcooling circuit may adapted as desired. Hence, for the above example where the firstdistribution device in the first cooling circuit is set to receive 300W, the seconddistribution device in the second cooling circuit is set to receive 150W, and the thirddistribution device in the third cooling circuit is set to receive 25 0W to the thirddistribution device, the control flow valve(s) in the first cooling circuit is set more openthat that of the second and third cooling circuit, and the control flow valves of thesecond cooling circuit is set less open than that of the first and third cooling circuit. Bymore open for an ON/ OFF valve would mean that the control flow valve during a giventime period is set in the ON position for an extended period as compared to situationbefore the new "more open" setting was made. By "less open" for an ON/OFF valvewould mean that the control flow valve during a given time period is set in the OFFposition for an extended period as compared to situation before the new "more open"setting was made. For a proportional control valve the meaning of "more open" and "less open" follows naturally.
    Monitoring of the process parameters In order to improve the adaption of the control process parameter(s), thecontrol unit is configured to monitor at least one process parameter relating to the flowrate of the pump, flow rate in each cooling circuit, temperature of the cooling fluidsupply source ll, supply line temp in each cooling circuit, retum line temperature ineach cooling circuit, and/or energy consumption of each cooling circuit.
    In order to calculate the energy consumption of the refrigerator unit of themedical cooling device, each cooling circuit may be provided with a first temperature sensor for sensing the supply temperature T1 and a second temperature sensor for ll sensing return temperature T2. The first and second sensor of each cooling circuit isoperatively coupled to the control unit 15.
    In an embodiment, at least one temperature sensor is operatively connected tothe control unit are provided in the cooling fluid supply source ll.
    A flow meter general to all cooling circuits may be used to measure the coolingfluid flow rate downstream of the supply line. Optionally, each cooling circuit may beprovided with a flow sensor, e.g. either intemally arranged, i.e. within the medicalcooling device, or extemally arranged, e. g. in the supply line or retum lines of eachcooling circuit.
    It should be appreciated that when on/off valves and a constant flow pump areused, a mean flow may be calculated by the control unit based on the rated flow (e.g.21/min) of the flow pump and the time period during which the valve is in the on and offstate, respectively. When the ON/ OFF flow control valves using are set to OFF thecooling fluid may be stationary in the cooling circuit. This will mean that thetemperature between the supply line and the retum line will be heated by thedistribution device by the body heat. Hence, in this case the control unit is conf1gured todisregard temperature indications from the supply line temperature and retum linetemperature indicating an increase in retum line temperature until the volume of coolingfluid being stationary in the supply line, distribution device, and the retum line has beenflushed out setting the ON/ OFF valve to ON again.
    Instead of calculating the energy consumption using the above forrnula, theenergy consumption may be measured e. g. by any conventional power consumption measuring device etc, such as an ammeter connected in series with the refrigerator unit.
    Decision processThe control unit is conf1gured to make a decision relating as to when to adapt a control process parameter.
    In an embodiment, this decision is triggered when the total powerconsumption, which corresponds to the total cooling effect in the cooling circuits beforelosses withdrawn, of the medical cooling device increases beyond a predeterrninedthreshold.
    In an embodiment, this decision is triggered when the total cooling effect in thecooling circuits, of the medical cooling device increases beyond a predeterrninedthreshold. 12 In one embodiment, this decision may be triggered by detecting a state ofinvoluntary shivering in the patient. At the onset of involuntary shivering the body ofpatient starts attempts to increase the body temperature. This results in increased returnline temperature, thereby increasing the power consumption, i.e. the cooling powereffect, of the medical cooling device for any constant flow rate.
    The table below illustrates an example of the power transferred to each coolingcircuit in a medical cooling device throughout a treatment duration of 240 minutes for apatient suffering from a stroke. In this example, three cooling circuits are shown. In thefirst cooling circuit a cap shaped distribution device is provided for cooling the scalp ofthe patient. In the second cooling circuit a neck shaped distribution device is providedfor cooling at least the carotid artery of the patient. In the third cooling circuit a bodyshaped distribution device is provided for cooling another part of the body, such as the stomache and/or groin parts of the patient.
    Time Total Power to Power to the Power to the Core Brain[minutes] cooling the CAP NECK COLLAR BODY PAD Temp. Temp.effect [W] [W] [W] [°C] [°C][W] 0 101 25 15 61 37 3720 108 30 15 63 36,7 36,740 107 28 17 62 36,4 36,460 115 27 18 70 36,1 36,180 99 26 16 57 35,8 35,8100 97 27 17 53 35,5 35,5120 259 120 75 64 35,5 35140 268 115 80 73 35,5 35160 220 117 75 28 35 34,5180 210 118 68 24 35 34200 215 120 72 23 35 33,5220 210 122 65 23 35 33,5240 221 123 69 29 35 33,5 As may be observed from the above table, after 120 minutes from the start ofthe cooling treatment the total cooling effect is drastically increased to 259 W from 97W at l00 minutes. This indicates the onset of shivering. The shivering state remains atthe l40 minutes mark. At the onset of shivering the control unit is configured to adaptthe flow rate in each cooling circuit. As may be observed at the 120 minutes mark thecooling power supplied to the first distribution device (cap) is increased from 27 W atthe l00 minute mark to l20W at the 120 minute mark, by increasing the flow in the first 13 Cooling Circuit. Also the flow rate in the seCond Cooling CirCuit (neCk) is increased at the120 minute mark thereby generating a Cooling power of 75W, whiCh is an inCrease from17W at the 100 minute mark. The Cooling power supplied to the third Cooling CirCuit(body) remains essentially Constant at the onset of shivering at the 120 minute mark.The Changed power Cooling effect supplied to eaCh Cooling CirCuit at the onset ofshivering results in that the brain and the neCk portion of the patient is Cooled loCally toa higher extent than the body portion, whiCh thereby reduCes the overall shivering stateof the patient. As may be noted from the 160 minute mark the Core body temperatureremains at 35 °C, whereas the brain temperature is Continuously reduCed to about 33,5 °C at the 240 minutes mark. This allows for keeping the shivering state to aConstant low level or even reduCes the shivering state even if the brain temperature ofthe is Continuously lowered throughout the Cooling treatment process.
    ACCordingly, when a state of shivering is taken into aCCount by the Control unit,in an embodiment and depending on the main target tissue to be Cooled, e.g. the brain ina stroke Condition, the Cooling effect or power submitted to the distribution deviCe(s)provided Close to the target area are inCreased in relation Compared to the fluiddistribution deviCe(s) ConneCted further away from the main target area, suCh as thegroin area in a stroke Condition. In this way the total shivering effeCt of the patient maybe reduCed.
    The table below illustrates an example of the power transferred to eaCh CoolingCirCuit in a mediCal Cooling deviCe throughout a treatment duration of 240 minutes for apatient suffering from CardiaC arrest. In this example, three Cooling CirCuits are shown.In the first Cooling CirCuit a Cap shaped distribution deviCe is provided for Cooling thesCalp of the patient. In the seCond Cooling CirCuit a neCk shaped distribution deviCe isprovided for Cooling at least the Carotid artery of the patient. In the third Cooling CirCuita body shaped distribution deviCe is provided for Cooling another part of the body, suCh as the stomaChe and/or groin parts of the patient. 14 Time Total Power to Power to the Power to the Core Brain[minutes] cooling the CAP NECK COLLAR BODY PAD Temp. Temp.effect [W] [W] [W] [°C] [°C][W] 0 101 25 15 61 37 3720 108 30 15 63 36,7 36,740 107 28 17 62 36,4 36,460 115 27 18 70 36,1 36,180 99 26 16 57 35,8 35,8100 97 27 17 53 35,5 35,5120 259 62 45 152 35,5 35,5140 268 68 43 157 35,5 35,5160 105 30 15 60 35,5 35,5180 100 28 17 55 35,5 35,5200 92 27 18 47 35,5 35,5220 109 26 16 67 35,5 35,5240 92 27 17 48 35,5 35,5 As may be observed from the table, after 120 minutes from the start of thecooling treatment the total cooling effect is drastically increased to 259 W from 97 W at100 minutes. This indicates the onset of shiVering. The shivering state remains at the140 minutes mark. Here, the control unit may reduce the flow (not shown in the tableabove) in each cooling circuit such as to produce a total cooling effect of around l00W,which corresponds to the total cooling effect before the onset of shivering. As may benoted in the table, the cooling effect or power in the first, second, and third cooling circuits are different throughout the cooling treatment.
    A licabili In the normal case the medical cooling treatment may be started with atemperature of the cooling fluid in the cooling fluid supply source corresponding to theambient temperature, e.g. being around 20°C. Hence, initially the supply sourceincluding the refrigerator unit, will require maximum power to cool the cooling fluiddown to the set demand temperature of -9 °C to -6°C. During this time, the energyconsumption will thus be high. Accordingly, the control unit may be configured tomonitor the energy consumption of the refrigerator unit once the temperature of the cooling fluid supply source has reached the set demand temperature.
    One body part of particular interest is the scalp of the patient, and here thedistribution device may be shaped like a cap or helmet. Scalp cooling particularlyadvantageous for lowering the brain temperature in patients suffering of acute stroke aswell as patients undergoing chemo therapy to reduce hair loss.
    However, cooling of the brain may also be advantageous after cardiac arrest, inneonatal hypoxia ischemia or insomnia.
    It should be appreciated that the medical cooling device, control unit, andmethod according to the embodiments presented herein may be used in combinationwith other methods for brain cooling such as infusion of cold saline or pharrnacologicalcooling with antipyretics such as paracetamol. In the case of ischemic stroke, themedical cooling device, control unit, and method according to the embodimentspresented herein may also be used in conjunction with reestablishment of cerebralperfusion.
    Hypotherrnia with lowered brain temperature has been shown to be a robustneuroprotectant against a variety of brain injuries. Recently, a randomized crossoverstudy showed that cooling of the frontal lobes with a scalp cooling device significantlyreduced insomnia.
    In usual care, the optimal target brain temperature seems to be 35.0° - 35.5° C.Such low temperatures in the deep brain tissue cannot be reached with scalp coolingonly. However, by adding cooling of the neck over the carotid arteries it is possible toreach the optimal brain temperature.
    In an embodiment, in addition to the scalp silicon cap constituting a firstdistribution device, a separate neck band with temperature sensors is provided. The neckband is cooled by cooling fluid from the same cooling fluid supply source as the cap.
    Brain cooling has been shown to be safe at least as long as the braintemperature stays at 34° C or above.
    The duration of brain cooling treatment may be anything from 30 minutes up to24 hours or more. For stroke applications, treatment duration of up to at least 72 hoursappears provide advantageous results. However, some suggestions have been made toprovide cooling treatment for up to ll to 14 days or more depending on the type ofcondition of the patient.
    Although some of the embodiments above have been described in relation to astroke application, in which cooling of the brain is advantageous. It should be noted thatthe embodiments of the present invention is equally useful in the case of cardiac arrest.
    For patient suffering from a sudden cardiac arrest, body temperature control and cooling 16 treatment to cause hypotherrnia can be a life saving intervention. This means that thebody temperature of the patient is lowered to reduce the tissue damage due to lack ofoxygen. Patients suffering from a cardiac arrest Who receive a cooling treatment have agreater rate of survival and also have less risk of permanent injury, e.g. brain damage.Cooling treatment at cardiac arrest also protects all of the body organs, Which each hasdifferent sensitivity for ischemia. For example, muscle tissue may cope With ichemia forhours Whereas the brain may suffer great damage Within only a couple of minutes.During cooling treatment of patients suffering from cardiac arrest it may beadvantageous to reduce the body temperature to lower temperatures. According to anembodiment, the distribution device(s) may be provided one or more garrnents, eachconnected to one or more cooling circuits. In the case of cardiac arrest a larger part ofthe body, may be cooled down, and hence the distribution devices may cover a largerportion of the body, such as the legs, stomache area, arms, scalp and neck. In anembodiment, such a garrnent may be provided With a opening at the position of the heart such as to facilitate optional heart surgery, While keeping the garrnent on.
    权利要求:
    Claims (14)
    [1] 1. A medical cooling device (10) for conducting a medical cooling process forcooling at least two body parts of a patient, comprisinga cooling fluid supply source (1 1),at least two inlet/outlet pairs, each inlet/outlet pair comprisingan outlet (12, 22, 32) being connected to the cooling fluid supply source(11) and arranged for connection to one individual supply line (121, 221, 321) forsupplying a flow of cooling fluid from the cooling fluid supply source (11) to a patient,andan inlet (14, 24, 34) for connection to an individual retum line (141, 241,341) being operatively coupled with the individual supply line (121, 221, 321) and tothe cooling fluid supply source (1 1) thereby forrning a continuous loop cooling circuitin use,a flow pump connected to each inlet/outlet pair for pumping cooling liquidfrom the cooling fluid supply source (1 1) to each of the outlets (12, 22, 32), andmeans (15) for distributing different cooling power to each cooling circuit byadapting at least one control process parameter for each cooling circuit and re-starting the medical cooling process according to said adapted control process parameter.
    [2] 2. The medical cooling device (10) according to claim 1, wherein the meanscomprises a control unit (15) and one of the at least one control process parametersrelates to the operation of at least one flow control valve arranged in each cooling circuit.
    [3] 3. The medical cooling device (10) according to claim 2, wherein the at leastone flow control valve of a cooling circuit is arranged within the medical cooling device.
    [4] 4. The medical cooling device (10) according to claim 2, wherein the at leastone flow control valve of a cooling circuit is arranged adj acent to the inlet or outlet of said cooling circuit.
    [5] 5. The medical cooling device (10) according to claim 2, further comprising the individual supply lines (121 , 221 , 321) and the corresponding individual retum lines 18 (141, 241, 341), wherein at least one flow control Valve is arranged in at least one of theindividual supply lines (121, 221, 321) or individual return lines (141, 241, 341).
    [6] 6. The medical cooling device (10) according to claim 1, wherein the meanscomprises a control unit (15) and the control process parameter relates to the operationof the at least one flow pump for providing a flow of cooling fluid in each of the cooling circuits.
    [7] 7. The medical cooling device (10) according to claim 6, wherein the operationof the at least one flow pump is controlled by means of an ON/OFF state and flowcontrol valves arranged to distribute output flow of the flow pump evenly between each cooling circuit.
    [8] 8. The medical cooling device (10) according to claim 6, wherein the operationof the at least one flow pump is controlled by means of an ON/OFF state and flowcontrol valves arranged to distribute output flow of the flow pump proportionally between each cooling circuit.
    [9] 9. The medical cooling device (10) according to any one of the claims 2 to 8,wherein at least one flow control valves is an ON/ OFF valve, and wherein the controlunit is arranged to continuously or interrnittently setting the ON/OFF valve to the OFFposition for a first time period and ON/ OFF valve to the ON position for a second time period, thereby controlling the mean flow the corresponding cooling circuit.
    [10] 10. The medical cooling device (10) according to any of the previous claims,wherein the means comprises a control unit (15) and one of the at least one controlprocess parameters relates to the energy consumption of the medical cooling device,wherein the energy consumption in each cooling circuit is calculated using thefollowing forrnula relating to the first law of therrnodynamics: Q(energy) =1ñ *CP*(T2-TI), wherein Q is the energy, rñ is the mass flow of the cooling fluid in the supplyline, CP represents a constant for the cooling fluid related to the specific heat at constantpressure, T1 being the temperature of the cooling fluid exiting the medical coolingdevice through the outlet of each cooling circuit, and T2 being the temperature of the retuming cooling fluid through inlet the corresponding cooling circuit, wherein the 19 control unit is further arranged to adapt the temperature T1 of each cooling circuit according to a target energy consumption in each cooling circuit.
    [11] 11. The medical cooling device (10) according to claim 10, further comprisinga first temperature sensor for sensing the temperature T1 and a second temperaturesensor for sensing temperature T2, said first and second temperature sensors being operatively coupled to the control unit (15).
    [12] 12. The medical cooling device according to claim 10, wherein the control unit(15) is configured to adapt the temperature T1 by setting an adapted target temperatureof the cooling fluid of the cooling fluid supply source, thereby resulting in an adaptedpower being transferred to a refrigerator unit of the cooling fluid supply source tocool/heat the cooling fluid in the cooling fluid supply source to the adapted target temperature.
    [13] 13. A means (15) for distributing different cooling power to at least two bodyparts of a patient by adapting at least one control process parameter of a medical coolingprocess, wherein each body part is cooled individually by means of one cooling circuitbeing operatively connected to a medical cooling device, wherein the at least one control process parameter relates to: the operation of at least one flow control valve arranged in each coolingcircuit, whereby the means is configured to adapt the flow in each cooling circuit bycontrolling said operation; the operation of at least one flow pump operatively coupled to eachcooling circuit, whereby the means is configured to adapt the flow in each coolingcircuit by controlling said operation; or the energy consumption of the medical cooling device, wherein theenergy consumption in each cooling circuit is calculated using the following forrnularelating to the first law of therrnodynamics: Q(energy) =1ñ *CP(T2-TI), wherein Q is the energy, ih is the mass flow of the cooling fluid in thesupply line, CP represents a constant for the cooling fluid related to the specific heat atconstant pressure, T1 being the temperature of the cooling fluid exiting the medicalcooling device towards the patient, and T2 being the temperature of the retuming cooling fluid from the patient, whereby the means (15) is configured to adapt the temperature T1 according to a target energy consumption value in each cooling circuit, and wherein the means (15) is further configured to re-start the medical cooling process according to the adapted control processparameter.
    [14] 14. A method (20) for distributing different cooling power to at least two bodyparts of a patient by adapting at least one control process parameter of a medical coolingprocess, wherein each body part is cooled individually by means of one cooling circuitbeing operatively connected to a medical cooling device, wherein the at least one control process parameter relates to: the operation of at least one flow control valve arranged in each coolingcircuit, whereby the method comprises the step of adapting (21a) the flow in eachcooling circuit by controlling said operation; the operation of at least one flow pump operatively coupled to eachcooling circuit, whereby the method comprises the step of adapting (2lb) the flow ineach cooling circuit by controlling said operation; or the energy consumption of the medical cooling device, wherein theenergy consumption in each cooling circuit is calculated using the following forrnularelating to the first law of therrnodynamics: Q(energy) =1ñ *CP(T2-TI), wherein Q is the energy, rñ is the mass flow of the cooling fluid in thesupply line, CP represents a constant for the cooling fluid related to the specific heat atconstant pressure, T1 being the temperature of the cooling fluid exiting the medicalcooling device towards the patient, and T2 being the temperature of the retumingcooling fluid from the patient, wherein the method comprises the step of adapting (21c)the temperature T1 according to a target energy consumption in each cooling circuit,and wherein the method further comprises the step of re-starting (22) the medical cooling process according to the adapted control process parameter.
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    同族专利:
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    SE540877C2|2018-12-11|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    法律状态:
    优先权:
    申请号 | 申请日 | 专利标题
    SE1451236A|SE540877C2|2014-10-15|2014-10-15|Device and method for medical cooling of a body part of a patient|SE1451236A| SE540877C2|2014-10-15|2014-10-15|Device and method for medical cooling of a body part of a patient|
    EP15781113.4A| EP3206639A1|2014-10-15|2015-10-15|Device and method for reducing the body core temperature of a patient for hypothermia treatment by cooling at least two body parts of the patient|
    US15/519,406| US10959877B2|2014-10-15|2015-10-15|Device and method for reducing the body core temperature of a patient for hypothermia treatment by cooling at least two body parts of the patient|
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    PCT/EP2015/073910| WO2016059167A1|2014-10-15|2015-10-15|Device and method for reducing the body core temperature of a patient for hypothermia treatment by cooling at least two body parts of the patient|
    KR1020177013112A| KR20170092539A|2014-10-15|2015-10-15|Device and method for reducing the body core temperature of a patient for hypothermia treatment|
    PCT/EP2015/073918| WO2016059173A1|2014-10-15|2015-10-15|Device and method for reducing the body core temperature of a patient for hypothermia treatment|
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    JP2017540311A| JP6923443B2|2014-10-15|2015-10-15|Devices and methods for lowering a patient's core body temperature for hypothermia treatment by cooling at least two body parts of the patient|
    EP15781115.9A| EP3206640A1|2014-10-15|2015-10-15|Device and method for reducing the body core temperature of a patient for hypothermia treatment|
    US15/519,051| US20170224528A1|2014-10-15|2015-10-15|Device and method for reducing the body core temperature of a patient for hypothermia treatment|
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