Devices, systems, and methods for selectively cooling the brain of living humans and certain living animals

Abstract

Brain-temperature-control (BTC) systems for controlling brain temperature via one or more neck arteries, and neck wraps therefore. In some embodiments, the neck wrap includes one or more thermal islands each having one or more fluid-flow-based thermal elements that carry a circulated fluid coolant during brain-cooling operations. In some embodiments, the neck wrap includes one or more sensor islands that each contain one or more sensors that provide one or more feedback signals that a controller of the BTC system uses to control one or more operating parameters of the BTC system. In some embodiments, the BTC system includes one or more sensors external to the neck wrap that provide such feedback signals. In some embodiments, the BTC system provides both brain cooling and brain warming functionalities. Methods, algorithms, and other features of BTC systems are also disclosed.

Description

DEVICES, SYSTEMS, AND METHODS FOR SELECTIVELY COOLING THE BRAIN OF LIVING HUMANS AND CERTAIN LIVING ANIMALSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority of U.S. Provisional Patent Application Serial No. 63 / 552,868, filed February 13, 2024, and titled “DEVICES, SYSTEMS, AND METHODS FOR SELECTIVELY COOLING THE BRAIN OF LIVING HUMANS AND CERTAIN LIVING ANIMALS”, which is incorporated herein by reference in its entirety for all purposes.FIELD

[0002] The present disclosure generally relates to the field of brain cooling. In particular, the present disclosure is directed to devices, systems, and methods for selectively cooling the brain of living humans and certain living animals.BACKGROUND

[0003] Some current brain-cooling technologies cool the entire body and require sedation to be tolerated, thereby limiting their use to intensive care settings and creating a delay between stroke onset and initiation of cooling. Whole-body cooling is also associated with negative iatrogenic effects, including increased blood pressure, altered coagulation, and increased risk of pneumonia and sepsis.

[0004] Other current brain-cooling technologies attempt to cool the brain using thermoelectric coolers located proximate to carotid and vertebral arteries in the patient’s neck. However, such thermoelectric-cooler based brain-cooling systems have drawbacks that can impact their efficiency and effectiveness.SUMMARY

[0005] In an implementation, the present disclosure is directed to a brain-cooling system for cooling a brain of a living subject having a neck having a plurality of arteries that supply blood to the brain. The brain-cooling system includes a neck wrap designed and configured to wrappingly engage the neck of the living subject, the neck wrap including a plurality of fluid-cooling islands located on the neck wrap so that, when the neck wrap is engaged around the neck of the subject, the plurality of fluid-cooling islands overlie corresponding ones of the plurality of arteries, wherein each fluid-cooling island includes a dermal-interface layer that confronts the neck of the subject duringusing the neck wrap; one or more fluid passageways that, during operation, carries a flowing fluid coolant that draws heat directly from an underlying one of the plurality of arteries via the dermal- interface layer; and an adhesive that, when the neck wrap is engaged with the neck for use, adheres the dermal-interface layer to the neck.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] For the purpose of illustrating aspects of the disclosure, the drawings illustrate features and / or characteristics of one or more embodiments of the disclosure. However, it should be understood that the present disclosure is not limited to the precise arrangements and instrumentalities shown in the drawings, wherein:

[0007] FIG. 1 A is a diagrammatic view of a person, illustrating the neck and right-side carotid artery of the person;

[0008] FIG. IB is diagrammatic view of a person wearing a neck wrap of the present disclosure and showing the person’s neck arteries and portions of the brain;

[0009] FIG. 2 is a high-level partial block diagram / partial schematic view of an example braintemperature-changing (BTC) system made in accordance with aspects of the present disclosure;

[0010] FIG. 3 is a side diagrammatic view of a portion of an example neck wrap of the present disclosure, showing an example thermal element of an example thermal island onboard the neck wrap;

[0011] FIG. 4 is a cross-sectional view of an example neck wrap of the present disclosure, showing the construction of the neck wrap;

[0012] FIG. 5 is a cross-sectional view of a composite tether that can be used to fluidly and optionally electrically connect a neck wrap of the present disclosure to a fluid cooling / heating system;

[0013] FIG. 6 is a panoramic view of an example neck wrap of the present disclosure showing an example configuration of thermal islands and other components onboard the neck wrap;

[0014] FIG. 7A is an isometric elevational view of a portion of a subject, showing a pair of thermal islands in the form of flowthrough heat exchangers engaging the neck of the subject;

[0015] FIG. 7B is an enlarged isometric view of one of the thermal islands of FIG. 7A

[0016] FIG. 8A is a partial cutaway / partial facial view of another example neck wrap of the present disclosure;

[0017] FIG. 8B is an enlarged isometric view of the quick-connect connector of the neck wrap of FIG. 8 A; and

[0018] FIG. 8C is an enlarged isometric view of a composite tether that can be used with the quick-connect connector of FIG. 8B.DETAILED DESCRIPTION

[0019] OVERVIEW

[0020] At a high level, the present disclosure is directed to methods and devices to non- invasively and selectively change the temperature of the brain of a living human or living animal (hereinafter and in the appended claims, “subject”) via that subject’s neck without the need for sedation and in an efficient and effective manner. For example, a brain-temperature-changing (BTC) system of the present disclosure may be deployed to cool the brain to provide neuroprotection after a stroke, after a traumatic brain injury, during heat exhaustion, during a fever, and / or during and / or after another neurological condition. In other examples, a BTC system of the present disclosure may be used to study the influence of brain-temperature control on a subject’s sleep stages and / or to control brain temperature during one or more sleep stages to enhance the quality of sleep of a subject. In some embodiments, a BTC system of the present disclosure may be deployed to warm the brain to a normal temperature, for example, to assist a subject with recovering from hypothermia or assist in warming the brain after cooling the brain in one of the above-mentioned scenarios, among other things.

[0021] In the context of cooling, BTC methods and systems of the present disclosure solve at least three key problems that currently limit the use of brain-cooling technology, namely, the constraints for implementing total-body cooling and the producing of negative iatrogenic effects, as mentioned in the Background Section above. BTC devices of the present disclosure cool the brain selectively (i.e., potentially without meaningfully affecting the temperature of the rest of the body), do not require sedation to be tolerated, can be taken to the patient, thereby eliminating / reducing the gap in time that currently exists between a neurologic injury and the activation of conventional whole-body cooling brain cooling procedures, and can be operated at temperatures lower than current neck-based brain-cooling technologies to more quickly lower brain temperature when fast action is critical to a subject (e.g., patient experiencing stroke). These and other aspects of BTCsystems of the present disclosure greatly expand the number of medical indications for which brain cooling can be applied.

[0022] BTC methods and systems of the present disclosure make at least three key advancements. First, they shift much of the brain-cooling field from whole-body cooling to selective-brain cooling. Second, they eliminate / reduce the delay in initiation of brain cooling by taking cooling to the patient rather than the patient to the cooling. This greatly expands the number of indications in which brain cooling can be applied. For example, with a BTC system of the present disclosure, brain cooling could be initiated by emergency personnel in the ambulance after stroke, by medical personnel attending to a person with heat exhaustion / heat stroke, by athletic trainers on the sports field after concussion, by a person experiencing migraine or a professional attending to a person experiencing migraine, by a person desiring to improve sleep or a professional researching brain cooling in the context of sleep, among other situations. Third, BTC systems of the present disclosure can operate at temperatures meaningfully lower than current neck-based brain-cooling technology, which not only can save time in lowering brain temperature in crucial medical situations, such as strokes, when every moment counts but also cool the brain to a lower temperature than can typically be achieved conventionally, thereby improving patient outcome.

[0023] As another example, BTC methods and systems of the present disclosure may warm the brain of the target human or animal. Such warming can be useful, for example, in cases of hypothermia or to reverse prior brain cooling. Embodiments for BTC systems of the present disclosure that provide selective brain cooling and / or warming are described below.

[0024] At a high level, the targeted cooling and / or warming that a BTC system of the present disclosure can provide focuses the cooling and / or warming on one or more of the arteries within the neck of the human or animal that supply blood to the brain, namely, the carotid and vertebral arteries. Regarding animals, BTC systems can be configured and used on any animal, such as a horse, having one or more brain-blood-supplying arteries in the animal’s neck relatively near the surface of neck skin of the animal. Those skilled in the art will readily understand which animals fit this criteria.

[0025] GENERAL

[0026] In some embodiments, a BTC system of the present disclosure is provided as a flexible neck wrap, rigid or semirigid collar, or similar neck-engaging form for changing brain temperature. For convenience, the term “neck wrap” is used herein and in the appended claims as a generic termto cover a neck-engaging BTC device of the present disclosure, including neck-engaging BTC devices that do not actually wrap around the neck. For example, the BTC system could cool (e.g., for stroke, concussion, heat exhaustion, sleep enhancement, etc.) or warm (e.g., for hypothermia, post-cooling rewarming, etc.) the brain. For cooling, a BTC system of this disclosure utilizes a chilled flowing fluid (i.e., a “fluid coolant”) that is typically, but not necessarily, a non-toxic liquid, such as a water-based liquid containing one or more freeze-point lowering additives, such as a glycol, salt, etc. For warming, when this feature is provided, a BTC system of this disclosure may use, for example, a warmed flowing fluid, that may be the same as or different from the fluid coolant that is provided for cooling or electrically resistive heating elements, among other things.

[0027] It is noted that a neck wrap of the present disclosure is engaged with a subject by an “operator”, which can be any person, including, but not limited to, a physician, a physician’s assistant, a nurse, an emergency medical technician, a paramedic, and the subject himself or herself. Regarding the subject being the operator, an example of this is for home use, such as sleep therapy and / or sleep enhancement, among other non-critical uses. For the sake of convenience, the term “operator” is also used to denote a person that operates the corresponding BTC system outside of engaging the neck wrap with the subject. It is recognized that the operator that engaged the neck wrap with the subject and the operator that otherwise operates the BTC system may be two different people. However, for the sake of simplicity, both of such people are collectively denoted as “an operator” or “the operator”.

[0028] As exemplified below in conjunction with some of the attendant figures, a neck wrap of the present disclosure includes one or more cooling islands each of which is a region of the neck wrap wherein the cooling ability of the neck wrap is concentrated so that, when the neck wrap is engaged with the neck of the subject, the cooling island lies directly over one of the neck arteries or, in some cases wherein a cooling island is designed, configured and located to applying cooling to, for example, a carotid artery and one or both vertebral arteries or just both vertebral arteries, over two or more neck arteries. In some embodiments, cooling / warming is directed at both (left and right) carotid arteries, since these arteries carry about 90% of the blood flow to the brain. In some embodiments, cooling is concentrated in a cooling island by increasing the areal density of a cooling fluid flowing through the cooling island, such as by providing the cooling island with a single fluid passageway having a tortuous path within the cooling island, providing a plurality of fluid passageways (each tortuous or not) within the cooling island, or providing one or more heat-transferchambers (i.e., each generally a locally expanded flow passageway) within the cooling island, or any combination thereof, among others.

[0029] In embodiments having one or more warming functionalities, a neck wrap of the present disclosure has one or more warming islands located based on the functionality(ies) provided. For example, when the functionality of the warming island(s) is brain warming, a warming island may coincide with one or more of the cooling islands. In this example, when the fluid coolant flowed through the cooling island during brain cooling is also used as a warming fluid for brain warming, the warming island may be considered to be of the same size and shape as the cooling island, since the heating element(s) associated with that cooling / warming island carry the same fluid along the same path. In another embodiment, a separate warming source, such as one or more electrically resistive heating elements or a warming-fluid circuit separate and apart from the fluid-coolant circuit, may be provided to the cooling island to create the warming island, which may or may not be of the same size and shape as the cooling island. As another example, when the functionality of the warming island(s) is to warm one or more regions of the subject’s neck at locations away from any neck artery, such as for tricking the subject’s brain into allowing the subject to tolerate colder temperatures at the cooling islands, a warming island may be spaced from any generally proximate cooling island. In some embodiments, a neck wrap of the present disclosure includes at least one warming island for each of the two types of functionalities just noted.

[0030] Hereinafter, the notation “and / or” is simply represented by a “ / ” located immediately between two elements, two components, two features, two effects, two method steps, etc., to replace “and / or”; e.g., “cooling / warming” is the same as “cooling and / or warming”, which itself means “cooling or warming, or cooling and warming” for the sake of clarity.

[0031] In some embodiments, a neck wrap of the present disclosure has one or more “sensing islands” in each of which a thermometer is embedded to monitor skin temperature and that provides feedback to BTC-system software for controlling a BTC system of the present disclosure. In some embodiments, a neck wrap of the present disclosure has one or more sensing islands that are located over one or more of the neck arteries when the neck wrap is engaged with a subject’s neck. In some embodiments, one or more sensing islands are located over one or more regions of the neck that do not overlie any of the neck arteries when the neck wrap is engaged with a subject’s neck. In some embodiments, a neck wrap of the present disclosure has, when the neck wrap is engaged with asubject’s neck, at least one sensing island located over a neck artery and at least one sensing island not located over a neck artery.

[0032] In some embodiments, BTC-system software made in accordance with the present disclosure can, among other things, adjust cooling / warming parameters of the BTC system (e.g., flow rate, temperature, voltage, number and / or location of cooling / warming islands used, etc.) to achieve a target temperature, for example, set prior to BTC system initiation or during treatment with the BTC system. The neck wrap can, in some embodiments, cool at the target areas (i.e., over one or more of the carotid arteries and / or over one or more of the vertebral arteries) while concurrently warming other neck regions not anticipated to meaningfully affect brain temperature (e.g., the back of the neck). This may permit lower tolerated temperatures in the target regions.

[0033] Nonlimiting examples of thoughtful control of cooling / warming that may be implemented in a BTC system of the present disclosure, for example, using BTC software and / or operator-selected or adjusted control(s), include, but are not limited to:• selective cooling by targeting only a subset of the relevant arteries, e.g., only left-side carotid for left-side brain cooling (e.g., via manual or software-controlled valving onboard or offboard the neck wrap);• provide specific cooling temperature that is as low as possible without damaging soft tissue;• selective cooling and warming to “trick” the brain;• temperature control with temperature feedback from one or more thermal islands;• temperature control system with temperature feedback from a working fluid that supplies one or more thermal islands;• temperature control with brain-temperature feedback (e.g., direct brain-temperature readings or indirect brain-temperature readings (e.g., from jugular veins, ear (tympanic), etc.);• temperature control based on electroencephalogram (EEG) data;• temperature control based on sleep cycle data;• temperature control based on electrocardiogram (EKG) data; and• temperature control based on automated calculations and relevant parameters (e.g., can control time of cooling application and temperature of cooling islands; parameters may be, for example, initial brain temperature, brain volume, and ambient temperature, among others).

[0034] As mentioned above, most current brain-cooling schemes cool a subject’s entire body. This is typically done in an intensive care unit (ICU). Cooling the entire body induces shivering. To address shivering, patients are sedated. In the context of a medical stroke, the mean delay from stroke to initiation of total body cooling in the ICU is greater than 2.5 hours, which misses an early critical window during which brain cooling should be initiated. Early cooling has been shown to be superior to late cooling in both animals and humans.

[0035] As indicated above, some embodiments of BTC systems of the present disclosure are intended to selectively cool the brain without meaningfully affecting the temperature of the rest of the body without inducing shivering, without the need for sedation (which requires ICU admission), and as efficiently (e.g., quickly) as practicable. In some embodiments, a BTC system of the present disclosure can be taken to the patient rather than the patient to the BTC system, thereby closing the gap between neurologic insult and the initiation of cooling. Being able to take the BTC system to the patient expands the potential indications in which brain cooling may be applied.

[0036] In some cases, such as strokes and brain trauma, among others, the subject often must be evaluated using one, the other, or both of computed tomography (CT) scanning and magnetic- resonance imaging (MRI) scanning. In urgent situations, it would be highly desirable to not have to remove the neck wrap nor stop using the BTC system to apply cooling and / or warming while the subject is getting a CT scan or an MRI scan. To accommodate CT scanning, in some embodiments all of the materials used in the neck wrap and in any tether needed to support the neck wrap are materials that minimize imaging artifacts in the resulting scan image(s). Such materials include materials that have relatively low physical densities, such as certain polymers for tubing, valving, and any other plumbing, non-metal fabrics and / or films for other components of the neck wrap, among others. For MRI scanning, it is also desirable to use the same materials just noted for CT scanning. In a particular example, CT and / or MRI scanning compatibility can be a benefit to a subject that experienced a stroke for whom it is desired to continue therapeutic brain cooling while continuing to assess damage from the stroke using a CT or an MRI scanner. Research into brain cooling and / or brain warming may also benefit from CT / MRI-compatible BTC systems.

[0037] In some embodiments, the cooling / warming is applied to both the carotid and vertebral arteries. The carotid arteries supply anterior brain regions. The vertebral arteries supply posterior brain regions, as well as portions of the cerebellum, brainstem, and upper spinal cord. Mathematicalmodeling data has indicated the ability to cool the tissues around both the carotid and vertebral arteries with a BTC system of the present disclosure.

[0038] In some embodiments, data from one or more skin-temperature sensors feeds into BTC- system software, which, in response thereto, issues control signals that cause adjustments in cooling / warming parameters, for example, in a continuous, intermittent, or continual manner. This allows a BTC system of the present disclosure to achieve and maintain a preset target skin temperature. Some embodiments include other features, such as one or more built-in alerts. For example, the BTC system could alert the wearer and / or another (e.g., healthcare professional) if skin temperature drops below target or if poor contact exists between the sensor and the skin, or both. Regarding poor contact, each cooling / warming island of the BTC system may include one or more skin-contact sensors for sensing skin contact and lack thereof, such as one or more pressure sensors, one or more galvanic skin-response sensors, or one or more other type of suitable sensors. In some embodiments, a BTC system that utilizes one or more skin-contact sensors to ensure contact between the neck wrap and the subject’s skin can include an alert system that alerts an operator to a problem with skin contact. For example, the alert system may include software and / or hardware that alerts an operator to each cooling / warming island that is not in proper thermal contact with the skin adjacent to that cooling / warming island, either visually (e.g., via a display, such as a video display, via notification LED lights on the neck wrap over each affected cooling / warming island) or aurally (e.g., spoken location of improper contact), or any combination thereof, among others.

[0039] In terms of cooling / warming parameters, as those skilled in the art will appreciate, parameters that can be varied will be dictated by the heat-exchange system(s) implemented in the cooling / warming islands present in any particular instantiation. For example, if cooling / warming is achieved with a working-fluid chiller / heater (e.g., vapor compression system type chiller) and a working-fluid circulator (e.g., one or more pumps (suction or positive pressure)), parameters that could be varied include, but are not necessarily limited to, flow rate, working-fluid temperature, and number of working-fluid passageways open to flow, among others. As another example, if one or more warming islands each have one or more electrically resistive heating elements, then the parameters may include the magnitude of the electrical energy (i.e., electrical power per unit of time) provided to the corresponding heating element(s) and / or the number of electrically resistive heating elements energized, and any combination thereof, among others. Those skilled in the art will understand the parameter(s) that can be varied to control the amount of cooling / warming that a BTC system of the present disclosure provides for any cooling / warming means implemented.

[0040] The above description mentions “external inputs” because some embodiments of BTC systems made in accordance with the present disclosure can be configured to allow one or more separate systems to plug into them. Examples of such separate systems include, but are not limited to, tympanic membrane temperature thermometers, and polysomnogram systems, EEG systems, and multi-sensor systems, among others, and combinations thereof. In such embodiments, signals / data from the external input(s) can trigger the BTC-system software to cause the BTC system to change one or more of the cooling / warming parameters and / or to alert an operator to make one or more changes manually.

[0041] For example, sleep is closely linked with temperature. Consequently, some embodiments of a BTC system of the present disclosure can be configured to connect to a polysomnography system to obtain data on a wearer’s sleep state that the BTC-system software can use to control cooling / warming that the BTC system provides to the wearer.

[0042] In some embodiments, various other information could be incorporated into BTC-system software. For example, correlations between skin temperature, or tympanic membrane temperature, for example, and core brain temperature may exist. BTC-system software of the present disclosure can be configured to leverage such information in its parameter-control scheme.

[0043] Other sensors that can be supported by a BTC system of the present disclosure include, but are not limited to, an EEG sensor, a heart-rate sensor, a respiratory-rate sensor, a tissue-oxygen- saturation sensor, and an EKG sensor. In some embodiments, data from any one or more of such or other sensors could be used to support BTC-system safety and / or to trigger alterations in cooling / warming parameters. In some embodiments, a BTC system of the present disclosure may include one or more multi-sensor systems that each include a set of some or all of temperature, heart rate, respiratory-rate, tissue-oxygen-saturation, and EKG sensors, among others, integrated therein. Such multi-sensor systems are known, for example, in the context of an Apple Watch Series 9, among other wearable systems.

[0044] In the context of the carotid arteries, one location for a multi-sensor system is touching the skin overlying the left or right carotid artery, near that artery’s bifurcation, at the carotid sinus. However, if that location were to interfere with brain cooling / warming, an alternative location, such as located between a carotid artery and the most proximate vertebral artery, can be used. In some embodiments having two or more multi-sensor systems, such as one for each of the two carotid arteries, may be desirable, for example, to allow averaging of data collected by the two or moremulti-sensor systems. External inputs / outputs (e.g., for tympanic-membrane temperature, polysomnogram, and / or EEG data) could be plugged in to the neck wrap in any convenient location (e.g., at the back of the neck and / or front of the neck) and / or transmitted to the BTC system wirelessly. In some embodiments, external inputs / outputs can interface with the cooling / heating system, with any signals from and / or to the neck wrap being carried wiredly and / or wirelessly as suits a particular design.

[0045] In terms of cooling phases and as an example, say that a BTC system of the present disclosure is used in an ICU, wherein brain cooling is commonly employed for 24 hours or more. Rather than just turning the BTC system off, it may be desirable to have a controlled rewarming phase. For example, the BTC system may enter a warming mode so as to increase skin temperature, which correlates with brain temperature, by +0.25 to 0.50°C / hour until normothermic. As another example, some embodiments may benefit from providing intermittent cooling and / or intermittent wanning or alternating cooling and warming. For example, the BTC-system software may be configured to provide cooling repeatedly for 2 hours, with a 10-minute break of no cooling between adjacent cooling periods. As another example, the 10-minute break may be filled or at least partially filled with a warming phase. In some embodiments, the cooling / warming that a BTC system provides may be controlled in a ramp-up or ramp-down manner until the temperature is increased to a desired temperature or is decreased to a desired temperature, respectively. For example, a ramping-down of temperature may include applying a constant coolness in increasingly longer time periods and / or applying increasing levels of coolness, among other possibilities. Those skilled in the art will readily appreciate the variety of control schemes that BTC-system software of the present disclosure may implement.

[0046] Some embodiments of a BTC system of the present disclosure may benefit from one or more features for enhancing the exchange of heat between the artery(ies) at issue. Such features may include, but not be limited to, a feature that provides percussion and / or vibration and a feature that provides ultrasound, among others. It is noted that the carotid sinuses may be located in the thermal treatment region of the wearer’s neck. It is known that massaging the carotid sinuses can lead to changes in heart rate, heart rhythm, and blood pressure, and this knowledge may be leveraged to design a BTC system of the present disclosure. For example, if a percussion feature is used, it may be desirable to avoid applying the percussive forces to the carotid sinuses. On the other hand, a massaging feature may be desirable to achieve any one or more of the desired effects, such as a change in one or more of heart rate, heart rhythm, and blood pressure.

[0047] Some embodiments of a BTC system of the present disclosure may include one or more wireless transceivers, such as a BLUETOOTH® transceiver and / or a WI-FI® transceiver, among others, to communicate with one or more offboard devices, such as a WI-FI® router, smartphone, laptop computer, etc., to provide data to each such device and / or receive data and / or control commands from each such device. For example, for a home-use BTC system, it may be desirable to “remote into” the BTC system, for example, to check usage and settings, among many other examples.

[0048] DETAILED EXAMPLES

[0049] The following descriptions and the figures accompanying these descriptions are not independent of the details discussed above in the OVERVIEW section and the GENERAL section. On the contrary, the following descriptions and accompanying figures augment, exemplify, and / or complement the above details. Furthermore, those skilled in the art will readily be able to modify any aspect of the detailed examples described below and / or illustrated in the accompanying figures using only ordinary skill in the art and without undue experimentation using only common knowledge in the art and informed on the inventive features by the present disclosure.

[0050] Turning now to the drawings, for the sake of general information and context relative to features and aspects described above in the OVERVIEW and GENERAL sections above and described in this current section, FIG. 1 A illustrates a typical location and anatomy of the right lateral carotid artery 100R of a subject 104, with parts of the carotid artery labeled for information. Also shown are two possible locations 108(1) and 108(2) for one or two multi-sensor devices (not shown) of the type described above in the GENERAL section.

[0051] FIG. IB illustrates a neck wrap 112 of the present disclosure engaged with the neck 116 of the subject 104. In this example, the neck wrap includes a first thermal island 120(1) corresponding to and overlying the left lateral carotid artery 100L of the subject 104 and a second thermal island 120(2) corresponding to and overlying a left lateral vertebral artery 124L of the subject. In this connection, it is noted that the term “thermal island” is used in this section to denote any one of a cooling island, and warming island, or an island that functions as both a cooling island and a warming island, as such islands are described above in the GENERAL section.

[0052] At a gross level, FIG. IB also illustrates the fact that differing neck arteries, such as the left lateral carotid artery 100L and the left lateral vertebral artery 124L, provide blood flow to differing regions of the brain 128, here, regions 128(1) through 128(3). Those skilled in the art ofhuman anatomy know this fact, and it is mentioned herein for completeness. Of course, the right lateral carotid artery 100R (FIG. 1A) and the right lateral vertebral artery (not shown) similarly provide blood flow to other regions (not shown) of the brain 128 according to normal human anatomy.

[0053] FIG. 2 illustrates, at a high level, an example BTC system 200 of the present disclosure. In this example, the BTC system includes a neck wrap 204 designed and configured to engage the neck of a subject (not shown, but see the subject 104 of FIGS. 1A and IB) as needed to provide the requisite cooling and / or warming. The neck wrap 204 may take any of a variety of forms, including, but not limited to, any one of the forms shown in FIGS. 5-10 of U.S. Provisional Patent Application Serial No. 63 / 552,868, filed February 13, 2024, and titled “DEVICES, SYSTEMS, AND METHODS FOR SELECTIVELY COOLING THE BRAIN OF LIVING HUMANS AND CERTAIN LIVING ANIMALS” in the name of Sprouse-Blum (“the ’868 provisional application”), which is incorporated herein by reference above, a form that is the same as or similar to the form of the neck wrap 112 of FIG. IB of this disclosure, or a form that is the same as or similar to the neck wrap 300 shown in FIG. 3 of this disclosure, or any combination thereof, among others.

[0054] Briefly, and referring to figures of the’ 868 provisional application for example differing forms that a neck wrap of the present disclosure can take, such as the neck wrap 204 of FIG. 2 and the neck wrap 300 of FIG. 3: FIG. 5 shows a helical-wrap form that is pliable so that it can be engaged with a wearer’s neck; FIG. 6 shows a pliable drawstring-type-collar form that uses drawstrings (here, on the anterior of the collar) to draw the pliable collar into proper engagement with a wearer’s neck; FIG. 7 shows a stretchable-collar form that uses one or more elastic panels that allow the collar to stretch circumferentially to allow it to be engaged with the neck by pulling the collar over the wearer’s head; FIG. 8 shows a minimalistic rigid form having thermal islands on both sides of the neck wrap for providing cooling / warming to carotid arteries on both sides of a neck and another thermal island for providing warming to the back of the neck; FIG. 9 shows a rigid form configured like a conventional neck brace; and FIG. 10 shows a wrapped-blanket form for a large animal, such as the horse shown there. As those skilled in the art will readily appreciate, the forms of FIGS. 5-10 of the’868 provisional application are merely exemplary and nonlimiting, as a neck wrap of the present disclosure may be provided in any other suitable form that allows the neck wrap to perform the requested function(s).

[0055] Referring again to appended FIG. 2, the neck wrap 204 includes one or more thermal islands (singly and collectively represented at 208), though the typical instantiation will have multiple thermal islands. As discussed above in the OVERVIEW and GENERAL sections, in some embodiments a plurality of cooling-type thermal islands 208 are present to provide cooling, respectively, to a plurality of neck arteries (not shown, but see, for example, FIGS. 1A and IB) and are located on the neck wrap 204 to overlie corresponding ones of the neck arteries. In some embodiments, a plurality of warming-type thermal islands 208 are optionally provided to provide one or more functionalities as discussed above in the OVERVIEW and GENERAL sections. These functionalities include providing warming to one or more of the neck arteries to warm or rewarm the brain and providing warming to one or more regions of the neck away from (e.g., adjacent to) the neck arteries. In the former, the warming-type thermal islands are located so as to overlie corresponding ones of the neck arteries and may optionally be integrated into the cooling-type thermal islands provided over the neck arteries. In the latter, the warming-type thermal islands are located so as to not overlie any of the neck arteries.

[0056] Each thermal island 208 includes one or more thermal elements (singly and collectively represented at 212). For cooling, the thermal element 212 can be, for example, one or more fluid passageway, concentrated within the thermal island, that each carry the working fluid, or one or more relatively large chambers through which the working fluid flows during cooling operations.

[0057] For each thermal island 208 targeting one or more neck arteries, the thermal island can be sized and / or shaped to generally match the size and / or shape of the corresponding artery or pair of arteries. For example, for a thermal island 208 targeting a carotid artery, the thermal island may be limited in width facing the carotid artery largely to the diameter of the carotid artery. Similarly, for a thermal island 208 targeting a vertebral artery, the thermal island may be limited in width facing the vertebral artery largely to the diameter of the vertebral artery. The length of each such thermal island 208 in a direction parallel to the flow axis of the corresponding artery can be any suitable length, such as the maximum length that the dimensions of the neck wrap 204 at issue will allow or any length less than that maximum length. In some embodiments, a single thermal island 208 may target both the carotid and vertebral arteries on the same side of the neck and extend circumferentially on the neck wrap 204 just enough to lay over the two arteries. In some embodiments, one or more of the thermal islands 208 can be locationally adjusted at least in a circumferential direction so as to accommodate differing neck sizes and differing artery locations. Such adjustability can be provided in any suitable manner, such as, among others, sliding thecorresponding thermal element(s) 212 relative to an underlying support structure of the neck wrap 204, or moving the corresponding thermal element(s) from one detent location to another detent location. Those skilled in the art will readily appreciate the variety of ways by which thermal elements 212 and corresponding thermal islands 208 can be made movable. In some embodiments, two or more thermal islands 208 can be provided per artery.

[0058] As alluded to above, two or more thermal islands 208 are typically provided to the neck wrap 204. For example, two thermal islands 208 may be provided for cooling / warming the two carotid arteries or four thermal islands may be provided for cooling / warming the two carotid arteries and the two vertebral arteries (one each) or eight may be provided for cooling / warming the two carotid arteries and the two vertebral arteries (two each), among other possibilities. In addition, one or more additional thermal islands 208 may be provided in addition to the arterial thermal islands that overlie the relevant arteries when the BTC device is engaged with a wearer. For example, if the artery-overlying thermal islands 208 are provided for cooling, one or more additional thermal islands for warming may be provided adjacent to the cooling thermal islands as discussed above. In some embodiments, thermal insulation 244 may be provided between any two adjacent thermal islands 208. In some embodiments, the thermal insulation 244 can be provided separately from all of the components of the neck wrap 204, while in other embodiments, the thermal insulation may be integrated with another component of the neck wrap, such as in a soft and / or pliable liner that engages the wearing subject’s neck. Those skilled in the art will readily understand where and how to provide thermal isolation 244 aboard the neck wrap 204 to achieve any one or more desired purposes, such as to locationally constrain the cooling / warming provided by each thermal island 208, for example, to avoid unwanted heat flow through the neck wrap between adjacent thermal islands and / or to more precisely control the cooling / warming provided to the subject, among others.

[0059] FIG. 3 illustrates an example of a thermal island 300 that can be used as any thermal island 208 of FIG. 2. Referring to FIG. 3, in this example, the thermal island 300 has a thermal element 304 defined by a plurality of fluid passageways 308 (only some labeled to avoid cluttering the figure) that carry the working fluid (represented by arrows) from a header passageway 312 to a plenum passageway 316 that extend within the neck wrap 320. In the example of FIG. 3, regions outside of the thermal island 300, such as regions 324 may include thermal insulation. In this example, the thermal island 300 is relatively long (from side to side in FIG. 3) and can function as a cooling island, and optionally a warming island, for two or more neck arteries, such as, for example,a carotid artery and one or both vertebral arteries or just both vertebral arteries or just both carotid arteries. Other thermal islands can be constructed similarly and can be provided for cooling and / or warming as needed to suit a particular instantiation. In other embodiments, the multiple passageways 308 can be replaced, for example, by a single fluid passageway (not shown) having a circuitous pathway or one or more relatively large chambers, among other things. Referring again to FIG. 2, when a thermal island 208 is a warming island, each thermal element 212 of that thermal island may be an electrically resistive heating element, which are commonly known in many fields.

[0060] FIG. 4 is an example of another thermal island 400 that can be used as any thermal island 208 of the neck wrap 204 of FIG. 2. Referring to FIG. 4, in this example, the thermal island 400 has a thermal element 404 defined by a plurality of flexible tube segments 408 (only some labeled to avoid cluttering the figure) that define corresponding lumens (not labeled) that carry the working fluid (not shown). The tube segments 408 may be segments of a single circuitous tube (e.g., extending back and forth into and out of the page of FIG. 4) that provides a single fluid passageway or segments of individual tubes that define multiple fluid passageways, for example, in the manner of the passageways 308 shown in FIG. 3.

[0061] In this example, the instantiation of the neck wrap 204 of FIG. 4 has a multilayer construction at the thermal island 400 that includes a liner layer 412, an adhesive layer 416 applied to the liner layer, a thermally conductive layer 420, an insulating layer 424, and a backing layer 428, all of which in the example are flexible to allow the neck wrap to be engaged conformally with the neck of a subject. The liner layer 412 may be made of any suitable material, such as a woven or nonwoven fiber material, a film, or a combination of any two or more of these and / or other materials. Each material used to make the liner layer 412 should have thermal-transfer properties that no more than minimally interfere with the transfer of heat between the tube segments 408 and the skin of the wearing subject. As those skilled in the art will readily appreciate, the adhesive layer 416 must be made of a non-toxic medical -grade adhesive that does not excessively interfere with heat transfer between the liner layer and the skin (not shown) of the neck of a subject wearing the neck wrap 204. The thermally conductive layer 420 is made of any suitable thermally conductive material, such as a thermally conductive gel or semi-gel that maximizes the surface area of the tube segments 408 that participate in the thermal transfer.

[0062] In some embodiments, the thermally conductive layer 420 can be eliminated or combined with the liner layer 412. The insulating layer 424 may be made of any suitable thermallyinsulating material that minimizes negative influence of temperature differences between the working fluid that the tube segments 408 carry and the ambient environment on the backside of the neck wrap 204 during use of the neck wrap. The backing layer 428 may be made of any suitable material, such as a woven or nonwoven fiber material, a film, or a combination of any two or more of these and / or other materials. In some embodiments, the insulating layer 424 and the backing layer 428 may be integrated into the same layer. It is noted that, in some embodiments, the thermally conductive layer 420 and the insulating layer 424 may only be present at a thermal island, here, thermal island 400, while the liner layer 412 and / or the backing layer 428 may be continuous along the entire length of the neck wrap 204. Of course, those skilled in the art will readily appreciate that the instantiation shown in FIG. 4 is only illustrative and that many designs can be implemented. Those skilled in the art will also readily appreciate that the thermal island 400 of FIG. 4 can be enhanced with any one or more of the enhancements described above, including, but not limited to, adding one or more electrically resistive heating elements, adding one or more sensor islands, and adding one or more thermal-transfer-enhancing transducers, among others.

[0063] In some embodiments, the BTC system 200 of FIG. 2 includes a fluid cooling / heating system 216 that cools and / or heats the working fluid (not shown) provided to one or more of the thermal element(s) of one or more thermal islands 208 aboard the neck wrap 204 and is located remotely from the neck wrap. In some embodiments, the fluid cooling / heating system 216 includes a vapor-compression system 216VC that chills or heats the working fluid provided to the neck wrap 204 based on any suitable thermal cycle, such as a refrigeration cycle, and one or more circulators (singly and collectively represented at 216C) for circulating the working fluid to and from relevant ones of the thermal elements 212. Vapor-compression systems suitable for use in the fluid cooling / heating system 216 are well known in the relevant art and, so, do not need to be described herein in any further detail. In some embodiments, one or more thermoelectric devices (e.g., Peltier device(s); not shown, but well known in the art) are used in place of the vapor-compression system 216VC. Another type of cooling / heating means can be used in other embodiments of the fluid cooling / heating system 216. When the fluid cooling / heating system 216 provides chilling to the working fluid of the neck wrap 204, it can be referred to as a “chiller” according to convention.

[0064] In embodiments in which the neck wrap 204 needs to be fluidly connected to the fluid cooling / heating system 216, the fluid connections can be made using any suitable fluid carrying conduits that circulate the working fluid through the neck wrap and the fluid cooling / heating system. Such fluid conduits are collectively represented at 220 in FIG. 2. FIG. 5 shows an examplecomposite tether 500 that can be used in the BTC system 200 of FIG. 2 to provide the fluid conduits 220. As seen in FIG. 5, the composite tether 500 includes a supply lumen 504 and a return lumen 508, one or both of which may or may not be provided by tubing separate and distinct from other structures of the composite tether. In this example, the lumens 504 and 508 are present within insulation 512, which may be, for example, a flexible polymer foam. Having the lumens 504 and 508 completely surrounded by insulation 512 can be ideal. However, other embodiments may have insulation 512 only between the supply and return lumens 504 and 508, as that is generally the location of the greatest thermal transfer and the greatest losses.

[0065] Referring again to FIG. 2, and also to FIG. 5, the fluid conduits 220 (e.g., in the composite tether 500) are typically flexible and can be provided in any length suitable for the use at issue. For example, when used in an ambulance-to-treatm ent-room scenario, the length of the fluid conduits 220 / composite tether 500 may be on the order of about 6 feet to about 12 feet so as to allow operators and / or others to locate the conduits / tether so as to not interfere with any other procedure that they must perform on a subject wearing the neck wrap 204. However, in other scenarios, such as in CT or MRI scanning, the length of the conduits 220 / tether 500 may be, for example about 15 feet to about 30 feet, depending on the location of the fluid cooling / heating system 216 relative to where the neck wrap 204 will be located when the subject (not shown) is being scanned.

[0066] In this connection, some embodiments may include one or more quick-connect connectors (singly and collectively represented at 224 in FIG. 2) that provide one or more benefits. For example, when all or a portion of the neck wrap 204 is disposable, one part of each quickconnect connector 224 can be provided as part of the disposable neck wrap or disposable portion of the neck wrap. This allows the conduits 220 / tether 500 to be reused. As another example, providing the quick-connect connector(s) 224 and locating each close to the neck wrap 204 allows the subject to be moved between scenarios wherein the lengths of the conduits 220 / tether 500 are different from another without needing to remove the neck wrap from the subject and to maintain continuity of the brain-cooling or brain-warming therapy as much as possible, which can be critical to the health outcome for the subject. For example, a subject may have to be moved quickly from an ambulance having conduits 220 / tether 500 of an 8-foot length to a MRI-scanning room having conduits / tether of a 25-foot length, wherein the cooling / heating system 216, which may be portable, used aboard the ambulance cannot be located within 15 feet of the MRI scanner. Instead of removing the neck wrap 204 from the subject, an operator simply disconnects the neck wrap fromthe 8-foot conduits 220 / tether 500 via the quick-connect connector(s) 224 and connects the neck wrap to the 25-foot conduits / tether that may further be connected to another iteration, relative to the iteration used on the ambulance, of the cooling / heating system 216, which may be permanently associated with the MRI-scanning room.

[0067] In some embodiments, each of one or more of the thermal islands 208 are optionally provided with one or more sensor islands (singly and collectively represented at 228) that each contain one or more sensors of any suitable type, such as a temperature sensor, a skin-contact sensor, or a multi-sensor, among others, and any combination thereof. Example sensors and uses thereof are described above in the GENERAL section. If a sensor island 228 is a temperature sensor (e.g., a negative temperature coefficient thermistor, a resistance temperature detector, a thermocouple, a semiconductor-based sensor, etc.), it may be provided for measuring temperature of the underlying skin and / or measuring the temperature of the thermal island itself. In some embodiments, one or more of the temperature sensors may be a fiber optic thermometer that uses any one or more well- known physical principles of operation, such as, but not limited to, fluorescence spectroscopy, bandgap shift (e.g., using a gallium arsenide (GaAs) crystal), Raman scattering use the ratio of Stokes to anti-Stokes signals, Brillouin scattering, interferometry, blackbody radiation, and refractive-index changes.

[0068] As discussed above in the OVERVIEW and GENERAL sections, temperature data / signals from such temperature sensor(s) can be used to control cooling / warming functionality(ies) of the neck wrap 204. It is noted that in lieu of or in addition to the sensor island(s) 228, the neck wrap may be provided with one or more sensor islands (singly and collectively represented at 232) outside of the thermal island(s) 208, and each of the sensor islands 232 can be the same as or similar to each or any sensor island 228. Any one or more types of sensors aboard either or both of the sensor islands 228 and 232 may be part of one or more sensor systems (singly and collectively represented at 234) that provide any support hardware and / or software needed to operate such sensors, including, but not limited to, a power source, amplifiers, A / D converters, D / A converters, signal conditioners, and connectivity to the controller 240 (see below). Those skilled in the art will readily appreciate how to embody each sensor system 234 as needed to suit a particular design.

[0069] In some embodiments, each of one or more of the thermal islands 208 are optionally provided with one or more thermal-transfer-enhancement transducers (singly and collectively represented at 236) of any suitable type(s), such as the percussive, vibratory, and ultrasonic typesmentioned above in the GENERAL section. If provided, the thermal-transfer-enhancement transducer(s) 236 may be part of one or more thermal -transfer-enhancement system(s) (singly and collectively represented at 238 that each provide any support hardware and / or software needed to operate such thermal-transfer-enhancement transducer(s), including, but not limited to, a power source, amplifiers, A / D converters, D / A converters, signal conditioners, and connectivity to the controller 240 (see below). Those skilled in the art will readily appreciate how to embody thermaltransfer-enhancement system(s) 238 as needed to suit a particular design.

[0070] A BTC system of the present disclosure, such as the BTC system 200 of FIG. 2, may be completely self-contained, i.e., the neck wrap 204 itself contains all components illustrated in FIG. 2, or it may have one or more components offboard of the neck wrap, depending on the design. An example of a self-contained version of the BTC system is one that includes a miniaturized fluid cooling / heating system 216 located onboard the neck wrap 204 and that circulates the working fluid and operates on a power source (not shown) provided onboard the neck wrap, among others. Examples of the BTC system 200 in which the neck wrap 204 requires one or more external support systems include, but are not limited to, versions of the BTC system that circulate a working fluid from an offboard version of the fluid cooler / heater 216, versions of the BTC system that have an offboard controller, such as the controller 240, and versions of the BTC system that require any combination of such offboard components, among others. Those skilled in the art know that there are other embodiments of BTC systems of the present disclosure that fall between the extremes of having all neck-wrap support systems onboard the neck wrap and having all neck-wrap support systems offboard the neck wrap.

[0071] In some embodiments, the controller 240 of the BTC system of FIG. 2 includes one or more processors (singly and collectively represented at 248) for executing software 252 containing algorithms (not illustrated) for causing the BTC system 200 to perform any one or more operations, including operations for automating one or more tasks that the BTC system can perform. Each processor 240 can be of any suitable form, such as, but not limited to, a general processing unit, and application-specific integrated circuit, or a field-programmable gate array, among others.Software 252 / algorithms for executing any needed functionality(ies) of the BTC system 200 are stored in machine memory 256, which singly and collectively represents any one or more hardware memories known and ubiquitous in the computing arts, including any one or more long-term memories and / or short-term memories, such as, for example, RAM, cache, solid-state memory, magnetic memory, and ROM, among many others, as is well known in the art. According to U.S.patent convention, the machine memory 256 can be singly and collectively referred to as a “machine-readable storage medium”, which explicitly excludes information present on a carrier wave (e.g., a digital signal encoded into a carrier wave) or in a series of pulses (e.g., light pulses carrying digital data).

[0072] The functionalities that the controller 240 may control include, but are not limited to, controlling thermal elements 212 and / or their thermal-support system(s), such as the cooling / warming system 216 and, for example, as also discussed above in the “GENERAL” section, controlling any thermal -transfer-enhancement system(s) 238, collecting, storing, and / or disseminating data, such as from one or more sensor systems and / or external devices, controlling any wireless communications, and providing alerts, among many others, and any relevant combination thereof. Those skilled in the art will readily understand how to configure a controller for a BTC system of the present disclosure, such as the controller 240 of the BTC system 200 of FIG. 2, according to the functionality(ies) provided to the BTC system at hand and using this disclosure as a guide.

[0073] The one or more sensor systems 234 of the BTC system 200 of FIG. 2 may include a temperature-sensor system for sensing any one or more of a variety of temperatures, such as temperature of one or more of the thermal elements 212 / thermal islands 208, skin temperature at one or more locations on the neck of the wearer, and one or more temperatures more closely correlated to brain temperature, such as tympanic temperature, among others. As discussed above, the one or more sensor systems 234 may include any one or more of a variety of other sensors, including multi-sensors for sensing a host of differing parameters and contact sensors for ensuring that the thermal islands 208 / thermal elements 212 are in proper operational position relative to a wearer’s neck, such as in direct thermal contact with the neck.

[0074] The one or more power sources 242 of the BTC system 200 of FIG. 2 may be of any suitable types. Most typically, each such power source 242 will be some sort of electrochemical storage cell, such as, for example, a lithium-ion secondary battery or a lithium-metal secondary battery, among many other types. Those skilled in the art will readily appreciate the various types of power sources 242 that can be used. In some embodiments, at least one power source 242 may be a power supply that connects on one side to a main power supply and on the other to the neck wrap 204 and / or to another component, such as an external thermal-support system, such as the fluidcooling / heating system 216. In some embodiments, differing components of the BTC system may have differing power sources.

[0075] In some embodiments, one or more wireless communications devices 260 and / or one or more wired communications ports 264 provided can be used for any one or more of a variety of purposes, including, but not limited to, acquiring data and / or operating instruction(s) from one or more external devices 268 (e.g., remote sensors, external controller (e.g., smartphone, laptop, etc.), providing data to one or more external devices (e.g., an external computing device (e.g., smartphone, laptop, router, etc.)), and providing inter-component communications, among other things.

[0076] If provided, the one or more thermal-transfer-enhancement systems 238 may implement any one or more of the thermal-transfer-enhancement schemes noted above, namely percussion, vibration, and / or ultrasound, or other enhancement feature.

[0077] In some embodiments, one or more physiological -control systems 272 may implement one or more of any relevant physiological-control scheme, such as, for example, a scheme for altering sleep state, a scheme for altering heart rate, a scheme for altering blood pressure, and a scheme for relaxing muscle tissue, among others. In some embodiments, data from one or more external inputs may be used to alter cooling / warming paradigms to achieve a desired physiologic state. For example, say a polysomnography external input is indicating that the patient is awake and it is desired to facilitate sleep onset. In this example, the polysomnography date can be used to control a BTC device to lower brain temperature. For seizures, say an EEG external input is indicating that a patient is experiencing seizure activity. In this example, the EEG data can be used to turn a BTC device on to initiate brain cooling (or cool deeper if it is already in a cooling mode).

[0078] Referring again to FIG. 5, it is noted that any tether to the neck wrap 204 (FIG. 2) that may be provided to the BTC system 200, such as the composite tether 500 of FIG. 5, may optionally further include one or more electrical wires / cables 516 (two shown for the sake of illustration) for one or more purposes. For example, one or more electrical wires / cables 516 may be provided to power any electrically resistive heating element that may be present as a thermal element 212 aboard the neck wrap 204 (FIG. 2), conduct signals from / to and / or provide electrical power to any ancillary device(s) aboard the neck wrap, such as, but not limited to, one or more temperature sensors, one or more multi-sensors, or one or more thermal enhancement devices, among others, and any combination thereof.

[0079] FIG. 6 is a panoramic view, as would be viewed looking outward from a central longitudinal neck axis (not shown, but parallel to each of the neck posterior and anterior centerlines shown in FIG. 4), of the internal face of an example neck wrap 600 of a BTC system of the present disclosure, such as the BTC system 200 of FIG. 2 as an example. In this example, the neck wrap 600 includes arterial thermal islands (corresponding thermal elements not shown) for both of the carotid arteries (carotid thermal islands 604) and both of the vertebral arteries (vertebral thermal islands 608), as well as thermal islands (corresponding thermal elements not shown) between immediately adjacent ones of the four arterial thermal islands, namely a pair of lateral thermal islands 612 and a posterior thermal island 616. When the example neck wrap 600 of FIG. 6 is used for brain cooling, the four arterial thermal islands 604, 608 primarily provide targeted cooling, but if the particular therapy regime includes having these arterial thermal islands, then these thermal islands can also provide warming under command of a particular control scheme. Also when the example neck wrap 600 of FIG. 6 is used for brain cooling, the two lateral thermal islands 612 and the posterior thermal island 616 can be primarily used to provide warming, either simultaneously with the four arterial thermal islands performing their cooling functions or between periods in which the four arterial thermal islands are performing their cooling functions, or both. In this example, the neck wrap 600 of FIG. 6 includes thermal insulation 620 located between immediately adjacent ones of the thermal islands 604, 608, 612, 616 to minimize the extent to which one thermal island thermally influences an immediately adjacent thermal island and to keep the thermal effect of each thermal island contained to the corresponding desired discrete region of the wearer’s neck.

[0080] The embodiment of FIG. 6 is a wrap form in which the neck wrap 600 is engaged with a target neck (not shown) by wrapping the neck wrap around the neck and overlapping the lapping region 624 shown in FIG. 6 on the outside face (not seen) of the neck wrap on the opposite end 628 of the neck wrap. Although not shown, the lapping region 624 and the region with which the lapping region engages at the opposite end 628 when the neck wrap 600 is engaged on the neck includes securement means 632 for securely holding the two regions together. Examples of such securement means include, but are not limited to, hook-and-catch fastener(s), magnets, and malefemale-engagement mechanisms, among many others. Those skilled in the art will readily appreciate that the example neck wrap 600 of FIG. 6 is merely illustrative and not limiting. Rather, a neck wrap of the present disclosure can be configured in many other ways as described above and illustrated below.

[0081] All of the thermal islands 604, 608, 612, 616 and regions of insulation 620 of the example neck wrap 600 of FIG. 6 are supported by a support structure 636, which may be in any suitable form, here a wrap form made of one or more suitable materials that provide the neck wrap 600 with flexibility and corresponding wrapability. It is noted that while the thermal islands 604, 608, 612, 616 are depicted in a way that makes it appear that they are visible on the neck-facing surface of the neck wrap 600, this is not necessarily the case. While the thermal islands may be visibly discernible in some embodiments, in other embodiments one or more of the thermal islands 604, 608, 612, 616 may not be visible on the neck-facing surface. In such cases, the corresponding thermal element(s) may be located beneath a covering that obscures it / them. See, for example, accompanying FIG. 4.

[0082] FIG. 7A shows a subject 700 having a pair of thermal islands 704 engaging the subject’s neck 700N over the subject’s carotid arteries (not seen). In this example and as more particularly seen in FIG. 7B, each thermal island 704 is in the form of a rigid heat exchanger 708, such as may be made of a rigid material, such as a rigid thermoplastic or rigid thermoset plastic, among others. A working fluid (not shown) is supplied to each of the heat exchangers 708 from a fluid cooling / heating system (not shown, but see the cooling / heating system 216 of FIG. 2) via a supply port 712, and the working fluid that has passed through the heat exchanger is returned to the cooling / heating system via a corresponding return port 716. During use, the supply and return ports 712, 716 may be fluidly connected to the fluid cooling / heating system via individual fluid conduits (not shown, but see the fluid conduits 220 of FIG. 2) or a composite tether (not shown, but see the composite tether 500 of FIG. 5), for example using one or more quick-connect connectors (not shown, but see the quick-connect connector 224 of FIG. 2).

[0083] Referring still to FIG. 7B, in the example shown, the surface of the heat exchanger 708 that engages the neck 700N of the subject 700 during use includes an adhesive layer 720 that, as discussed above relative to other embodiments, aids in the transfer of heat between the neck and the heat exchanger to maximize cooling / warming. FIG. 7B also shows the heat exchanger 708 as having slots 724, each for receiving a support structure (not shown), such as a flexible and / or longitudinally elastic strap that helps support the two heat exchangers 708 (FIG. 7A) during use of the resulting neck wrap (not shown, but includes such support structures and the two heat exchangers).

[0084] In some embodiments, one or all of the support structures can be of adjustable length so as to allow an operator (not shown) to properly position the heat exchangers 708 / thermal islands 704 over the respective ones of the carotid arteries. In this connection, although not seen in either of FIGS. 7A and 7B, each heat exchanger 708, and, therefore, each thermal island 704, includes at least one heat-pulse sensor that can assist the operator in properly positioning each thermal island over the corresponding carotid artery. For example, each thermal island 704 may have a single pulse sensor at the optimal location of the carotid artery, and the pulse sensor may control an LED indicator that emits a green light when the pulse sensor is properly over the carotid artery. In another example, each thermal island 704 may have an odd number of multiple pulse sensors spaced apart from one another circumferentially around the neck 700N that control one or more indicators (e.g., LED indicator(s)) that allows the operator to visualize where the carotid artery is currently located and how the thermal island needs to be moved for proper positioning over the carotid artery.

[0085] FIG. 8A illustrates a further example of a neck wrap 800 made in accordance with aspects of the present disclosure and can be used as the neck wrap 204 of the BTC system 200 of FIG. 2. Referring to FIG. 8A, in this example, the neck wrap includes a pair of thermal islands 804(1) and 804(2), with the thermal element 808 being shown for the thermal island 804(1) and the unseen thermal island for the other thermal island 804(2) being substantially the same but a mirror image of the thermal element 808 shown. In this example, the thermal element 808 is essentially a circuitous fluid conduit 812 that carries a working fluid (represented by arrows in FIG. 8A). As part of the fluid system of the neck wrap 800, the neck wrap includes a quick-connect connector 816 (see also FIG. 8B) that removably receives a composite tether 820 (FIG. 8C). As seen in FIG. 8B, the quick-connect connector 816 has a fluid inlet 8161 and a fluid outlet 8160 that, when the composite tether 820 (FIG. 8C) is engaged with the quick-connect connector, fluidly communicate with corresponding respective supply and return tubes 820S and 820R of the composite tether.

[0086] In the embodiment of FIG. 8 A, the neck wrap 800 includes a pair of identical fiber-optic multi-sensors 824 that can be used for a variety of purposes, such as determining temperature and determining carotid pulse strengths, among other things. As seen in FIGS. 8B and 8C, respectively, each of the quick-connector connector 816 and the composite tether 820 includes one or more optical fibers 816F and 820F for carrying the necessary signals from the multi-sensors 824. Especially when it is desired to use the neck wrap 800 in CT and / or MRI scanning scenarios, suchfiber-optic-based communication is preferred over electrical-wire-based communication because of the artifacts that electrically conductive metal wires can create in such scenarios. It is noted that other embodiments, such as embodiments described above, can substitute fiber-optic-based communication for electrical-wire-based communication. In this example, the neck wrap 800 includes a notch 828 at its centerline, which an operator is to align medially with the anterior of a subject’s neck (not shown) during use.

[0087] EXPERIMENTAL DATA

[0088] In experimentation using a simplistic brain-cooling device of the present disclosure fashioned by modifying a conventional neck wrap, brain temperature was decreased by -0.23°C overall, but -0.5°C or more in 4 of 15 subjects by the end of the experiment, including one who experienced a drop greater than -0.8°C. There were two key issues with the crude experimental brain-cooling device that, when avoided, would permit achieving lower brain temperatures.

[0089] First, the neck wrap used was a pediatric torso wrap modified to apply it to the neck. A custom neck wrap design to fit the contours of the neck so as to maximize targeted coverage of the neck arteries, i.e., the carotid and vertebral arteries, will induce larger drops in core brain temperature. Second, all 15 test subjects tolerated maximum cold without shivering or discontinuing the intervention. This suggests that lowering the temperature of the circulating water further, such as by adding salt to the cooling liquid, may be beneficial. While making these modifications are anticipated to permit lowering of brain temperature further, it may not be necessary, as the braincooling field is moving toward more mild levels of brain cooling and actively maintaining normothermia, preventing fever. A brain-cooling device of the present disclosure may be perfectly suited for these goals, even without modification.

[0090] In the experiments, cold water circulating at 4°C (which was as low as the device permitted) led to a mean skin / wrap interface temperature of 12°C. All 15 test subjects tolerated the maximum coldness achievable with the experimental device without shivering or discontinuing the intervention, indicating that the circulating water could be colder. This can be achieved, for example, by adding a chemical (e.g., salt, anti-freeze, etc.) to the water, which would prevent the water from freezing and chilling the mixture to a temperature lower than 4°C.

[0091] Various modifications and additions can be made without departing from the spirit and scope of this disclosure. Features of each of the various embodiments described above may be combined with features of other described embodiments as appropriate in order to provide amultiplicity of feature combinations in associated new embodiments. Furthermore, while the foregoing describes a number of separate embodiments, what has been described herein is merely illustrative of the application of the principles of the present invention. Additionally, although particular methods herein may be illustrated and / or described as being performed in a specific order, the ordering is highly variable within ordinary skill to achieve aspects of the present disclosure. Accordingly, this description is meant to be taken only by way of example, and not to otherwise limit the scope of the present invention(s). The appended claims are incorporated by reference into this section.

[0092] Exemplary embodiments have been disclosed above and illustrated in the accompanying drawings. It will be understood by those skilled in the art that various changes, omissions and additions may be made to that which is specifically disclosed herein without departing from the spirit and scope of the present invention(s).

Claims

What is claimed is:

1. A brain-cooling system for cooling a brain of a living subject having a neck having a plurality of arteries that supply blood to the brain, the brain-cooling system comprising: a neck wrap designed and configured to wrappingly engage the neck of the living subject, the neck wrap including: a plurality of fluid-cooling islands located on the neck wrap so that, when the neck wrap is engaged around the neck of the subject, the plurality of fluid-cooling islands overlie corresponding ones of the plurality of arteries, wherein each fluid-cooling island includes: a dermal-interface layer that confronts the neck of the subject during using the neck wrap; one or more fluid passageways that, during operation, carries a flowing fluid coolant that draws heat directly from an underlying one of the plurality of arteries via the dermal-interface layer; and an adhesive that, when the neck wrap is engaged with the neck for use, adheres the dermal-interface layer to the neck.

2. The brain-cooling system of claim 1, wherein the neck wrap consists of only materials that are compatible with computed-tomography scanning.

3. The brain-cooling system of claim 1, wherein the neck wrap consists of only materials that are compatible with magnetic-resonance imaging.

4. The brain-cooling system of any of claims 1-3, wherein the neck wrap further comprises at least one quick-connect fluid connector that allows an operator to connect and disconnect coolant supply and return lines to the neck wrap.

5. The brain-cooling system of claim 1, wherein the neck wrap further includes warming islands located between adjacent ones of the cooling islands, the warming islands provided so that, during use, the warming islands are selectively activatable to provide heat to portions of the neck adjacent to one or more of the plurality of arteries.

6. The brain-cooling system of claim 5, wherein each warming island includes at least one thermoelectric heater.

7. The brain-cooling system of claim 5, wherein each warming island includes an electricalresistance heating element.

8. The brain-cooling system of claim 5, wherein each warming island includes one or more fluid passageways that, during use of the neck wrap, carries a flowing warming fluid.

9. The brain-cooling system of claim 8, wherein the neck wrap further comprises at least one quickconnect fluid connector that allows an operator to connect and disconnect heating-fluid supply and return lines to the neck wrap.

10. The brain-cooling system of claim 5, wherein the neck wrap further comprises one or more temperature sensors located so as to, when the neck wrap is in use, sense temperature of the neck at one or more corresponding desired locations.

11. The brain-cooling system of claim 10, further comprising a controller that, when the braincooling system is in use, uses temperature feedback from the one or more temperature sensors to control warming that the warming islands provide.

12. The brain-cooling system of claim 11, wherein, when the brain-cooling system is in use, the controller uses the temperature feedback from the one or more temperature sensors to control cooling that the cooling islands provide.

13. The brain-cooling system of any one of the foregoing claims, wherein the neck wrap is disposable.

14. The brain-cooling system of any one of the claims 1-12, wherein: the neck wrap includes a flexible disposable portion that provides the dermal-interface layer and the adhesive; and each of the one or more fluid passageways of the cooling islands is part of a multiuse portion that removably receives the disposable portion.

15. The brain-cooling system of claim 1, further comprising a controller that includes a braintemperature-signal input for receiving a brain-temperature signal, wherein the controller is designed and configured to control cooling provided by the brain-cooling system via the plurality of cooling islands based on brain-temperature signal.

16. The brain-cooling system of claim 15, further comprising a tympanic-membrane temperature sensor that, when operating, provides a surrogate for the brain-temperature signal.

17. The brain-cooling system of claim 15, wherein the neck wrap further includes a plurality of heating elements located on the neck wrap so that, when the neck wrap is engaged around the neck of the subject, the plurality of heating elements overlie corresponding ones of the plurality of arteries, and the controller is designed and configured to control warming provided by the brain-cooling system via the plurality of heating elements.

18. The brain-cooling system of claim 17, wherein the controller is designed and configured to provide an operator-selectable rewarming mode that, when selected during use of the braincooling system, controls, as a function of the brain-temperature signal, the plurality of heating elements to warm the plurality of arteries according to a predetermined brain-rewarming plan after a brain-cooling operation performed by the brain-cooling system.

19. The brain-cooling system of claim 17, wherein the controller is designed and configured to provide an operator-selectable hypothermia mode that, when selected during use of the braincooling system, controls, as a function of the brain-temperature signal, the plurality of heating elements to warm the plurality of arteries according to a predetermined hypothermia brainwarming plan.

20. The brain-cooling system of claim 1, further comprising: a chiller that, during operation of the brain-cooling system, has an operator-selected chilling temperature and chills the fluid coolant; a circulator that, during operation of the brain-cooling system, has a flow rate and circulates the fluid coolant through the one or more fluid passageways of the cooling islands; and a controller in operative communication with at least one of the chiller and the circulator, wherein the controller is configured to vary an amount of cooling that the cooling islands provide during operation of the brain-cooling system by varying either the chilling temperature of the chiller, or the flow rate of the circulator, or both the chilling temperature of the chiller and the flow rate of the circulator.

21. The brain-cooling system of claim 20, wherein: the chiller is designed and configured to chill the fluid coolant to a temperature of about 12°C or less; andthe controller is designed and configured to control the chiller so as to chill the fluid coolant to the temperature of about 12°C or less.

22. The brain-cooling system of claim 20, wherein: the chiller is designed and configured to chill the fluid coolant to a temperature of about 5°C or less; and the controller is designed and configured to control the chiller so as to chill the fluid coolant to the temperature of about 5°C or less.

23. The brain-cooling system of claim 20, wherein: the chiller is designed and configured to chill the fluid coolant to a temperature of about 0°C or less; and the controller is designed and configured to control the chiller so as to chill the fluid coolant to the temperature of about 0°C or less.

24. The brain-cooling system of claim 20, wherein the circulator comprises a suction device that pulls the fluid coolant through the at least one fluid passageway.

25. The brain-cooling system of claim 20, further comprising at least one temperature sensor for, during use of the brain-cooling system, sensing a temperature proximate the neck of the subject at at least one of the cooling islands, wherein the controller is designed and configured to vary the amount of cooling that the at least one of the cooling islands provides as a function of the temperature of the neck as sensed by the at least one temperature sensor.

26. The brain-cooling system of claim 20, wherein the controller is configured to receive an input setting such as a body -mass index (BMI) value for the subject and to use the BMI value to vary the amount of cooling that the cooling islands provide during use of the brain-cooling system.

27. The brain-cooling system of claim 20, wherein the controller includes a brain-temperature-signal input for receiving a brain-temperature signal, and the controller is designed and configured to vary an amount of cooling that the cooling islands provide as a function of the brain-temperature signal.

28. The brain-cooling system of claim 27, further comprising a tympanic-membrane temperature sensor that, when operating, provides the brain-temperature signal.

29. The brain-cooling system of claim 20, wherein the controller includes a polysomnogram-data input for receiving polysomnogram data, and the controller is designed and configured to vary an amount of cooling that the cooling islands provide as a function of the polysomnogram data.

30. The brain-cooling system of claim 29, further comprising a polysomnogram system that provides the polysomnogram data during use of the brain-cooling system.

31. The brain-cooling system of claim 20, wherein the controller includes an electroencephalogram (EEG) data input for receiving EEG data, and the controller is designed and configured to vary an amount of cooling that the cooling islands provide as a function of the EEG data.

32. The brain-cooling system of claim 31, further comprising an EEG system that provides the EEG data during use of the brain-cooling system.

33. The brain-cooling system of claim 20, wherein the chiller is located remotely from the neck wrap, and the brain-cooling system further comprises unitary fluid supply-return tubing having a supply lumen and a return lumen separated from one another by thermal insulation.

34. The brain-cooling system of claim 20, wherein the brain-cooling system is designed and configured to allow an operator to cause the brain-cooling system to selectively cool a first subregion of the brain more than one or more other subregions of the brain.

35. The brain-cooling system of claim 34, further comprising valving that allows the operator to control flows of the fluid coolant to the plurality of cooling islands.

36. The brain-cooling system of claim 34, wherein the neck wrap includes the valving.

37. The brain-cooling system of claim 34, wherein the brain has left and right cerebral hemispheres, and the valving is arranged so that the operator can selectively control cooling of the left and right cerebral hemispheres independently of one another.

38. The brain-cooling system of claim 37, wherein the controller is designed and configured to allow the operator to select a desired brain-region cooling mode from among a plurality of differing brain-region cooling modes and to control the valving based on the desired brain-region cooling mode.

39. The brain-cooling system of claim 20, wherein the controller is designed and configured to allow an operator to select a desired brain-region cooling mode from among a plurality of differing brain-region cooling modes and to control the valving based on the desired brain-region cooling mode.

40. The brain-cooling system of claim 20, wherein the controller is designed and configured to allow an operator to select a desired use mode from among a plurality of differing use modes and to control the chiller or the circulator, or both of the chiller and the circulator, based on the desired use mode.

41. The brain-cooling system of claim 40, further comprising valving that allows the operator to control flows of the fluid coolant to the plurality of cooling islands, wherein the controller is further designed and configured to control the valving based on the desired use mode.

42. The brain-cooling system of either of claims 40 and 41, wherein the plurality of use modes includes at least two use modes selected from the group consisting of a stroke mode, a hypothermia mode, a hyperthermia mode, a sleep-stage-enhancement mode, a seizure prevention mode, and a plurality of targeted-brain-region modes.

43. The brain-cooling system of claim 20, wherein the controller is designed and configured to allow an operator to select a desired use mode from among a plurality of differing use modes and to control the chiller or the circulator, or both of the chiller and the circulator, based on the desired use mode.

44. The brain-cooling system of claim 1, wherein the neck wrap further includes a skin-contact sensor provided to determine whether or not a corresponding portion of the neck wrap is properly engaged with the neck of the subject.

45. The brain-cooling system of claim 44, wherein the skin-contact sensor comprises a galvanic sensor.

46. The brain-cooling system of claim 44, further comprising a controller designed and configured to, when the skin-contact sensor is not properly engaged with the neck, issue an alarm notifying an operator of improper skin contact.

47. The brain-cooling system of claim 1, wherein the neck wrap further includes at least one multisensor that includes two or more sensors selected from the group consisting of a temperature sensor, an oxygen sensor, a heart-rate sensor, a respiratory -rate sensor, and an electrocardiogram sensor.

48. The brain-cooling system of claim 47, further comprising a controller designed and configured to, when the brain-cooling system is in use, receive a plurality of signals from the multi-sensor and control operation of the brain-cooling system based on the plurality of signals from the multi-sensor.

49. The brain-cooling system of claim 1, wherein the neck wrap further includes a thermal -transferenhancement transducer that, when activated during use of the brain-cooling system, increases transfer of heat from at least one of the arteries to at least one of the cooling islands.

50. The brain-cooling system of claim 49, wherein the thermal-transfer-enhancement transducer is selected from the group consisting of a percussive transducer, a vibratory transducer, and an ultrasound transducer.

51. The brain-cooling system of claim 49, further comprising a controller designed and configured to, when the brain-cooling system is in use, control operation of the thermal-transferenhancement transducer.

52. The brain-cooling system of any one of the foregoing claims, wherein the fluid coolant is a liquid coolant.

53. The brain-cooling system of any one of the foregoing claims, wherein the living subject is a human.

54. The brain-cooling system of any one of claims 1-52, wherein the living subject is a warmblooded animal.

55. The brain-cooling system of claim 54, wherein the warm-blooded animal is a horse.

Images