WO2019077599A1

WO2019077599A1 - Target core temperature management by administering pulmonary cold air

Info

Publication number: WO2019077599A1
Application number: PCT/IL2018/051090
Authority: WO
Inventors: Joseph Hadash
Original assignee: Coretemp Technologies Ltd.
Priority date: 2017-10-19
Filing date: 2018-10-09
Publication date: 2019-04-25
Also published as: IL255152A0

Abstract

The invention provides a body cooling system for achieving a predetermined core temperature reduction, which includes breathing cooled air and a separate coolant.

Description

TARGET CORE TEMPERATURE MANAGEMENT BY ADMINISTERING PULMONARY COLD AIR

Field of the Invention

The present invention relates to body cooling systems that deliver pulmonary cold air through a well-controlled device, aiming at achieving a predetermined core temperature reduction.

Background of the Invention

Mild therapeutic hypothermia (MTH) is a treatment that maintains a lowered temperature in the body or in a part thereof in an effort to improve health outcomes following a traumatic event. Various disorders may be treatable with MTH applied by pulmonary delivery of an inhaled cooling substance. For example, in sudden cardiac arrest, residual neurologic damage is widely common. Cardiac arrest with no blood flow for more than five minutes generates free radicals and other mediators, starting biochemical cascades that result in cerebral injury. Until recently, there was no therapy with documented efficacy in preventing brain damage after cardiac arrest. MTH is beneficial also in ischemic and hemorrhagic strokes, in traumatic head injuries, and in post-traumatic epilepsy. Strokes happen when the blood flow to the brain stops; "mini-strokes" or transient ischemic attacks occur when the blood supply to the brain is briefly interrupted. Traumatic head injuries may result in immediate seizures, or in chronic seizures which are frequently resistant to both medication and surgical intervention. Post-traumatic epilepsy is quite prevalent and often is difficult to manage. Emergency and/or maintenance respiratory delivery of a coolant into the airway immediately after the traumatic event, possibly together with a substance reducing the body metabolic activity, reduces the associated damages. WO 2015/139142 described a head cooling system employing compressed gas which served both as a coolant and as a breathable gas. WO 03/047603 described breathable gas mixtures comprising helium and fluorocarbon for reducing the body temperature. It is an object of the invention to provide a pulmonary cooling system which excludes non-air gases and which entirely separates the coolant from the breathed gas. US 5,896,856 described an emergency breathing device for protecting the firefighters from breathing hot air by cooling the air before it is inhaled; however, the device had no control over the temperature of the breathed air or the user's body. Beside the mentioned drawbacks, the prior art systems usually employ large and heavy pressurized gas cylinders, which make the whole system cumbersome and difficult to manage and transport, and which precludes providing a quick and flexible assistance to a broader group of afflicted subjects, such as a tourist group suffering from a heat stroke.

It is therefore an object of the invention to provide a pulmonary cooling system with careful control over the body temperature reduction, which is easily operable even for a larger group of afflicted subjects.

It is a further object of the invention to provide a light and easily portable device for a quick assistance to a subject in need of pulmonary cold air.

It is also an object of the invention to provide a device and method for reducing the body core temperature by delivering cooled pulmonary air, while entirely separating the coolant from the breathed gas, and carefully controlling the temperature reduction.

It is an object of the invention to provide a system for administering pulmonary cold air to reduce the body temperature of a subject suffering from a condition benefiting from the body temperature reduction, comprising a cooling means, a delivery means, at least one sensor for detecting a physical parameter of the cold air, and a processor receiving a detection signal from said sensor and sending a command signal to said cooling and/or delivery means.

Other objects and advantages of present invention will appear as the description proceeds.

Summary of the Invention

This invention provides a device for administering pulmonary cold air for reducing the body temperature of a user, comprising an oro-nasal face mask, a cooling member connected to said mask and cooling the air to be administered, the member comprising a coolant and at least one blower driving said air to said mask, at least one sensor for detecting at least one physical parameter characterizing the cooled air, and a processor, wherein said cooled air and said coolant move through separate spaces, and wherein said processor receives a detection signal from said at least one sensor and sends at least one command signal to said blower. The cooling member in a device according to the invention comprises an inlet and an outlet for the air to be cooled, at least one blower driving the air from said inlet to said outlet, a cooling space through which said air moves between said inlet and said outlet, a container filled with a coolant and provided with a coolant valve, a coolant space to which said coolant is released from said container via said coolant valve to be thermally contacted with said air, the heat from said cooled air flowing through the interface between said cooling space and said coolant space whereby forming said pulmonary cold air, and a sensor located near said outlet detecting the temperature of said pulmonary cold air to be administered. The cooling member further comprises valves for regulating the flow of the coolant out of the cooling member and the flow of the cooled air through the member. The cooling member may further comprise refilling apparatus for renewing the coolant content. The cooling member may comprise more than one coolant container. The cooling member may also comprise more types of coolants for separate or simultaneous use. The coolant may be a cool liquid or a compressed gas whose expansion consumes the heat. The coolant in a preferred embodiment comprises carbon dioxide (C02). In one embodiment, the coolant comprises barium hydroxide and ammonium nitrate. The device of the invention may further comprise a mixer unit in which the cooled air is mixed with another gas adjusting the temperature or the composition of the inhaled mixture, said gas being in one embodiment warmer air, and in another embodiment oxygen or oxygen enriched air. In a preferred embodiment, the device according to the invention comprises a processor which receives at least two detection signals characterizing the cooling process, and dispatches at least one command signal affecting the blowers or fans regulating the flow of the cooled air, or affecting the release of the coolant. The detection signals are preferably related to the temperature of the administered air and to the body temperature. The command signals preferably manage the blower or blowers. The command signals may comprise signals managing a valve regulating the flow of the cooled air, or the coolant valve.

In a preferred embodiment, the cooling member in a device according to the invention comprises a container with liquid C02, the coolant space in the cooling member comprises a conical metal horn into which the C02 is released and expanded, and in which it converts to a solid cooling the inner surface of the horn; the outer surface of the horn is conductively connected with metal heat exchanger of a large surface, the surface absorbing the heat of the pulmonary air. The horn is provided with an exhaust system for releasing the used carbon dioxide. The exhaust system comprises a regulated stopper for keeping the desired amount of carbon dioxide in the horn.

The device may comprise additional sensors for detecting air flow rates, temperatures, and pressures in the system. The device may comprise sensors for detecting vital signs of the body, including the flow rate of inhaled or exhaled air, the temperature of the exhaled air and/or its carbon dioxide content. The detection signals preferably comprise one or more signals related to said body temperature, measured by contact or non-contact thermometers and characterizing the core body temperature, or body surface temperature at different body parts. Said processor may comprise a computing device, a mobile computing device, a smartphone, a tablet computer, a notebook computer, or a portable medical device. In a preferred embodiment, said oro-nasal face mask in the device according to the invention comprises a heat-exchange member capable of marked absorption and release of heat; in one embodiment, the member comprises a textile- based material.

This invention provides a method for reducing the body temperature of a subject, comprising i) cooling air in a cooling member with a coolant moving through separate valves and separate spaces, ii) driving said cooled air by means of at least one blower to an oro-nasal face mask located on the face of said subject, iii) detecting, via sensors, at least one parameter related to the temperature of said body or said air, iv) providing a processor configured to receive detection signals from said sensors and to send command signals affecting said blower, thereby managing said body temperature, resulting in reducing said body temperature and maintaining it at a predetermined value. Importantly, the method comprises collecting detection signals characterizing the immediate system state, comparing with predetermined desired values, and generating the suitable managing signals which keep the cool air flow as needed. The command signals manage the blower(s). They may manage releasing the coolant into the coolant space. In one embodiment, active agents are injected into the cold air stream in any state of matter. For example, solid or liquid agent is dispersed into the air stream from agent containers. The agents may comprise inhibitors of sympathetic nervous system, for example agents for reducing the body metabolic activity such as •-blockers. The agents in a preferred embodiment comprise refreshers, such as natural refreshing ingredients (NRIs). In a preferred embodiment, the method of the invention comprises cleaning and drying the air before its administration. The pulmonary air may be cleaned and rid of any potentially present particles of any size. In a preferred embodiment of the invention, the pulmonary cool air is essentially dry.

This invention provides a system for Target Temperature Management (TTM), comprising administering pulmonary cold air-based gas to reduce the body temperature of a subject suffering from a condition benefiting from the temperature reduction, comprising a cooling means, a delivery means, at least one sensor for detecting a physical parameter of the cold air, and a processor receiving a detection signal from said sensor and sending a command signal to said cooling and delivery means. For example, the cold air is delivered to a user by a system in which said cooling means comprises a cooling member with a coolant for cooling the air to be administered, such as C02, and said the delivery means comprises oro-nasal face mask. In a preferred embodiment, the invention provides an integrated system comprising a cooling member with separated cooled and coolant materials, and oro-nasal face mask connected to said cooling member, a processor, and sensors for detecting physical parameters characterizing at least the temperatures in the device and in the user's body, and possibly other parameters including the flow rates and the pressures of the air, wherein said cooled air and said coolant move through separate spaces, and wherein said processor receives detection signals from said sensors and sends command signals to the blower(s), thereby attaining the TTM goals.

Brief Description of the Drawings

The above and other characteristics and advantages of the invention will be more readily apparent through the following examples, and with reference to the appended drawings, wherein: Fig. 1. is a conceptual drawing illustrating a TTM system in one embodiment of the invention, including cooling member 101, oro-facial mask 110, and processor 102;

Fig. 2. shows a cooling member in a TTM system in one embodiment of the invention, including C02 container 203 and discharge horn 206; and

Fig. 3. shows a discharge horn for expansion of C02 in a TTM system according to one embodiment of the invention, including expanding C02 gas 225, and particles of dry ice 255

Detailed Description of the Invention

It has now been found that brain damages after events comprising cardiac arrest or ischemic and hemorrhagic strokes may be efficiently reduced when pulmonary cold air is administered through a novel device which separates the cooled air from the used coolant, while managing the air flow parameters by a processor receiving a signal from a temperature sensor.

Delivering cold air, optionally with another therapeutic agent, for managing a traumatic condition may be achieved through the use of an inhaling mask device with release into the airways. Such a mask device may have similar properties as emergency escape respirator. A user, or anybody assisting the user, may operate the TTM device by placing the mask on the user's face, with or without a mouthpiece and with or without a nostrils-piece, followed by activating the trigger opening the canister containing the cooling substance. Actuation of the trigger will i) open the canister valve such that the substance is released into the cooling "heat sink", and ii) activate the airflow system that leads breathable air through a designated pathway along which the air cools. The airflow system is managed by a blower fan, preferably more smaller fans (blowers), that pushes the breathable air through the heat sink system to cool it. The use of a device according to the invention will lower the body temperature and consequently will decrease the metabolic rate of the brain. The TTM system of the invention will provide superior results in treating various disorders treatable with Mild Therapeutic Hypothermia (MTH).

The invention provides a method comprising: i) tracking, monitoring, and collecting information on the user inhalation flow rate and body core temperature within the TTM device via sensors, and sending detection signal(s) to a processor; and ii) receiving said detection signal(s), and sending command signal(s) from the processor to the blower(s) in order to control the air flow rate and the cooling rate. In one embodiment, the method of the invention further comprises iii) filling a cold air depot and monitoring its capacity via the sensors and the processor; and iv) mixing the cool air from the depot with outer non-cooled air, whereby achieving the predetermined temperature of the inhaled air. The coolant, preferably C02, is contained in a canister and is released out from the canister to the coolant space. The TTM device comprises a face mask, preferably provided with warming members precluding the tremor reaction of the cooled body. The TTM device may comprise an element configured to move within and as a function of the air flow, and wherein the movement of the element produces a detectable visual indication of the air flow within the TTM device. The processor may be configured to receive the command from a communication unit of a computing device different from the TTM device. The face mask may be removably coupled to a housing in the TTM device, wherein the face mask may comprise the portion defining at least one intake opening through which at least a portion of the air flow originates; and it may comprise the valve for the exhaust of the exhalation air and, a heat exchange unit attached to the face mask with warming elements.

Many known systems for providing cool pulmonary gases are clumsy due to complex construction, large gas cylinders, and difficult management. The TTM system of the invention comprises small devices which are easily activated, managed, transported, and maintained. In one embodiment, the TTM system of the invention employs very small C02 cylinders, in fact little cartridges, available in various sizes on the market. Expanded gas is transformed to the dry ice which is capable to reduce the temperature of the known amount of the pulmonary air. It is important also in cases when more subjects are suddenly in need of un urgent assistance. In one embodiment, a plurality of TTM devices of the invention may provide help to a group of tourists, for example a class of children, who suffer from serious heat stroke. In other embodiments, a number of TTM devices are prepared and wait to help to a unit of soldiers after a difficult exercise during hot weather or in hot climate. In one embodiment, said plurality or said number of TTM devices may be managed by a limited number of processors, for example by one processor via radio signals.

In an important embodiment, the system of the invention may provide a quick and flexible assistance to a group of afflicted subjects, children or adults, suffering from a heat stroke, via providing cool pulmonary air with careful control over the body temperature reduction, while employing portable and easily operable, and centrally manageable devices.

Some principles of the system according to the invention are shown in the figures 1 to 3. The device of the invention for administering pulmonary cold air for reducing the body temperature of a user comprises a cooling member 101 with a coolant 130 for cooling the air to be administered, oro-nasal face mask 120 connected to said cooling member, sensor 160 for detecting at least one physical parameter characterizing the cooled air, for example the temperature of the inhaled air or the exhaled air or both, and a processor 102, wherein said cooled air and said coolant move through separate separate spaces 131 and 132, and eventually through separate valves, and wherein said processor receives a detection signal from said sensor and sends at least one command signal to blower(s) 140. The cooling member comprises an inlet and an outlet for the air to be cooled, a blower 140 driving the air from said inlet to said outlet, a cooling space 132 through which said air moves from said inlet to said outlet, a container 130 filled with a coolant such as C02 and provided with a coolant valve 202, a coolant space 131 to which said coolant is released from said container via said coolant valve to be thermally contacted with said air, the heat from said cooled air flowing through the interface between said cooling space and said coolant space whereby forming said pulmonary cold air, and a sensor 160 located near said outlet detecting the parameters of said pulmonary cold air to be administered. The cooling member may further comprise valves for regulating the flow of the coolant out of the cooling member and the flow of the cooled air through the member. The cooling member may further comprise refilling apparatus for renewing the coolant content, additional coolant containers and coolants, and importantly containers with agents and medicaments to be eventually coadministered with the cold air, preferably injected to the air such as a refresher from a container 135. In a preferred embodiment, the device according to the invention comprises a processor 102 which receives at least two detection signals characterizing the TTM system, such as a temperature of the inhaled air, or a temperature on or in the body or its parts characterizing the core temperature. The processor 102 dispatches for example command signals affecting blower 140. In one embodiment, air streams of different temperatures are mixed to achieve the desired temperatures of the inhaled air; in one embodiment, the air from the cooling member or from a cool air depot is mixed with the outer non-cooled air. In one embodiment of the invention, oxygen is injected to the air before or after cooling to increase the oxygen content in the inhaled mixture.

TTM device and system may provide unique and improved cooling effects to the user. The respiratory tract and organs can be considered as a heat exchanger that removes the heat out of the user's body in the expired air. The effectiveness of this heat exchange depends on the cooling mechanism, on the breathing air temperature and humidity, and on the airflow rate of the user. These factors may determine the duration of the core temperature reduction, and the quantity of needed coolant. To achieve adequate cooling effects, a sufficient amount of coolant must be available in the refrigerating system of the TTM device. This requires a delivery device which is not user-activated, and preferably comprises fully automated system providing sufficient amounts of cold air to the lungs of the user, while maximizing the efficacy of the device. Efficiency is achieved by optimal management of the coolant dispensing and the air flow rate, in accordance with the user's exhalation and inhalation.

Generally, this disclosure describes various techniques and systems for controlling the release of the substance, a coolant and/or a chemical agent, into an inhaled stream of fresh air by a user. For example, a pulmonary device may be configured to trigger the release of at least a portion of the substance in response to detection of inhaled air flow and or core body temperature, indicative of an inhalation by a user. The device may include a sensor that generates a signal indicative of the inhaled air flow and or core body temperature, through a portion of the device (e.g., a housing and/or face mask of the device) caused by an inhaling action of the user. In response to a command based on the signal indicative of the inhaled air flow and or core body temperature, the device may control a blower. In some embodiments, the device may include processors and/or modules to generate the command such that the device is configured to operate autonomously. In other examples, a computing device (e.g., a mobile computing device such as a smartphone, tablet computer, notebook computer, or portable medical device) may generate the command for releasing or dispensing an agent or substance. The device may transmit the signal indicative of the inhaled air flow and or core body temperature to a computing device, the computing device may generate the command for controlling the cooling or delivery means.

In one example, the disclosure describes a method that includes i) generating a signal indicative of inhaled air flow and or core body temperature (CBT) within a portion of a device, ii) receiving a command based on the signal by a processor associated with a blower, configured to release at least a part of the substance via the device, and iii) controlling the canister valve, by the processor and according to the received command, configured to release at least a portion of a the substance into the air refrigeration system.

In another example, the disclosure describes a device that includes a valve configured and designed to at least partially control release of the substance (coolant and/or medication for reduction of the body metabolic activity such as · -blockers), a sensor configured to generate a signal indicative of air flow and or core body temperature, within a portion of the device, a refrigeration unit with a heat exchanger configured to reduce the air temperature of the air/substance mixture inhaled by the user; and exchange heat with the face mask frame, and a processor configured to receive a command based on the signal and associated with valves.

A large population can benefit from mild therapeutic hypothermia (MTH). The TTM system of the invention can provide an MTH treatment, in emergency assistance and maintenance therapy, for a broad range of situations under specific conditions. Referring to Fig.l, it is a conceptual drawing illustrating an example of the TTM system 100 according to the invention, including cooling member 101 (foldable in axe 109), computing device or processor 102, and mask 110 bringing the cold air to user 200. The TTM system includes a face mask 110 and housing 120. Face mask 110 may be removably attached to housing 120, permanently coupled to housing 120, or formed with housing 120. Canister 130 contains a coolant which cools the pulmonary air in the cooling member 101. Canister 130 may be replaceable or exchangeable. User 200 may place the face mask 110 onto face 210. In some examples, face mask 110 may include or define a layer or a tunnel 111 within which there is a warming element, or optionally a therapeutic agent to be injected to the inhaled air. With the TTM device 100 activated, user 200 begins to inhale air through the face mask 110, the canister 130 is activated such that the coolant is released into the device circuit of coolant space 131. In response to the inhalations of air, the air blower 140 will blow fresh air into the cooling space 132, cooled by a set of heat exchangers 134. In a preferred embodiment, the air is led to cool air depot 150. Also in response to the air inhalation, the layer or tunnel 111 (within which there is the warming element) will be activated to warm the face with a heat supply. A sensor 160 is configured to generate the signal within TTM device system 100, indicative of the air flow of the inhalation toward the user 200. Based on the generated signal, a processor 102 of TTM device may generate a command such that can control the above mechanism. The generated command, or a second command produced by the processor when the sensor 160 sensing the termination of the air flow, may indicate when the processor 102 sends command signals. The air flow may sip and atomize a small volume of a natural refreshing ingredients out of capsule 135.

Fig. 2 and Fig 3 show the cooling member in one embodiment of the TTM system of the invention. Pressurized liquid gas, such as C02, is dispensed in a predetermined amount into a cone-shaped horn where it expands and absorbs a defined amount of heat. A mixture of frozen "snow" and gas is formed, such as dry ice flakes and gas in case of C02. The horn is designed to prevent the major problems: it has to allow the gas to exit at high speed to form the solid flakes, but without blocking the system. The cooling horn consists of trigger 201, striking pin 202 (valve), tank with pressurized liquid gas 203, copper mesh pads that can exchange low temperatures with the blown air 204, valve and nipple with a screw thread to which the horn attaches 205, discharge horn made of metal that can exchange low temperatures 206, blocking piece 207, exhaust system for the gas 208, capillary holes 215, circulated gas 225, and frozen gas flakes 255. As the gas enters the horn, it swirls around in a turbulent flow forming snow and gas. The swirling turbulence stops dead air zones forming in the horn, which in turn prevents air being swept down the horn toward the blocking piece.

Various examples have been described for delivering cool air to a user in response to detecting inhalations. Any combination of the described operations or functions is contemplated. While the invention has been described using some specific examples, many modifications and variations are possible. It is therefore understood that the invention is not intended to be limited in any way, other than by the scope of the appended claims.

Claims

A device for administering pulmonary cold air for reducing the body temperature, comprising

i) an oro-nasal face mask;

ii) a cooling member connected to said mask and cooling the air to be administered, the member comprising a coolant and at least one blower driving said air to said mask;

iii) at least one sensor for detecting at least one physical parameter characterizing the cooled air; and

iv) a processor;

wherein said cooled air and said coolant move through separate spaces, and wherein said processor receives a detection signal from said sensor and sends at least one command signal to said blower.

The device of claim 1, wherein said cooling member comprises

i) an inlet and an outlet for the air to be cooled;

ii) at least one blower driving the air from said inlet to said outlet; iii) a cooling space through which said air moves from said inlet to said outlet;

iv) a container filled with a coolant and provided with a coolant valve; v) a coolant space to which said coolant is released, from said container via said coolant valve, to be thermally contacted with said air;

wherein a sensor is located near said outlet, detecting the temperature of said pulmonary cold air to be administered, and wherein the heat from said cooled air flows through the interface between said cooling space and said coolant space whereby forming said pulmonary cold air.

The device of any one of claims 1 to 2, further comprising a mixer unit in which the cooled air is mixed with another gas adjusting the temperature or the composition of the inhaled mixture.

4. The device of any one of claims 1 to 3, wherein said another gas is warmer air or oxygen.

5. The device of any one of claims 1 to 4, wherein said coolant is a cool liquid, or a compressed gas whose expansion consumes heat.

6. The device of any one of claims 1 to 5, wherein said coolant is carbon dioxide.

7. The device of any one of claims 1 to 6, wherein said coolant comprises barium hydroxide and ammonium nitrate.

8. The device of any one of claims 1 to 7, wherein said processor receives at least two detection signals characterizing the cooled air or the cooled body, and dispatches at least one command signal affecting the blower regulating the flow of the cooled air.

9. The device of any one of claims 1 to 8, wherein said detection signals are related to the temperature of said body and said air.

10. The device of any one of claims 1 to 9, wherein said command signals manage said blower(s).

11. The device of any one of claims 1 to 10, wherein said pulmonary air is essentially dry.

12. The device of any one of claims 1 to 11, comprising sensors for detecting temperatures, pressures, and gas flow rates in the system.

13. The device of any one of claims 1 to 12, wherein said detection signals are related to said body temperature measured by contact or non- contact thermometers and characterizing core body temperature or surface body temperature at different body parts.

14. The device of any one of claims 1 to 13, wherein said processor may comprise a computing device, a mobile computing device, a smartphone, a tablet computer, a notebook computer, or a portable medical device.

15. The device of any one of claims 1 to 14, further comprising in said mask a material capable of absorbing and releasing heat, preferably a textile material.

16. A method for reducing the body temperature of a subject, comprising i) cooling air in a cooling member with a coolant moving through separate spaces than said air;

ii) driving said cooled air by means of at least one blower to an oro- nasal face mask located on the face of said subject;

iii) detecting, via sensors, at least one parameter related to the temperature of said body or said air;

iv) providing a processor configured to receive detection signals from said sensors and to send command signals affecting said blower; thereby reducing said body temperature and maintaining it at a predetermined value.

17. The method of claim 16, wherein the processor collects detection signals characterizing the immediate system state, effects comparisons with predetermined desired values, and generates suitable managing signals which keep the cool air flow as needed.

18. The method of any one of claims 16 to 17, wherein the command signals manage said blower.

19. The method of any one of claims 16 to 18, further comprising releasing active agents in any state of matter into the cool air.

20. The method of any one of claims 16 to 19, wherein said agents comprise oxygen or natural refreshing ingredients.

21. The method of any one of claims 16 to 20, comprising cleaning and drying the air before its administration.