WO2016054165A1 - Dispositifs de refroidissement de fluide, systèmes et procédés pour refroidir des fluides - Google Patents

Dispositifs de refroidissement de fluide, systèmes et procédés pour refroidir des fluides Download PDF

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Publication number
WO2016054165A1
WO2016054165A1 PCT/US2015/053152 US2015053152W WO2016054165A1 WO 2016054165 A1 WO2016054165 A1 WO 2016054165A1 US 2015053152 W US2015053152 W US 2015053152W WO 2016054165 A1 WO2016054165 A1 WO 2016054165A1
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WIPO (PCT)
Prior art keywords
cooling device
target fluid
reactant
endothermic
inner chamber
Prior art date
Application number
PCT/US2015/053152
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English (en)
Inventor
Anthony S. Voiers
Francisco Javier DE ANA ARBELOA
Nathan Marcus COX
SR. Andrew J. DIMEO
Julianna MURPHY
William Louis ATHAS
Charles Harry BRADY
Original Assignee
Novocor Medical Systems, Inc.
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Application filed by Novocor Medical Systems, Inc. filed Critical Novocor Medical Systems, Inc.
Publication of WO2016054165A1 publication Critical patent/WO2016054165A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/44—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for cooling or heating the devices or media
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/0085—Devices for generating hot or cold treatment fluids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/10—Cooling bags, e.g. ice-bags
    • A61F7/106—Cooling bags, e.g. ice-bags self-cooling, e.g. using a chemical reaction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0054—Heating or cooling appliances for medical or therapeutic treatment of the human body with a closed fluid circuit, e.g. hot water
    • A61F2007/0056—Heating or cooling appliances for medical or therapeutic treatment of the human body with a closed fluid circuit, e.g. hot water for cooling

Definitions

  • the subject matter described herein relates to devices and procedures for cooling fluids, such as in medical applications. More particularly, the subject matter disclosed herein relates to fluid cooling devices, systems and methods for cooling fluids.
  • Some medical treatments require the cooling of the core body temperature, i.e. induced hypothermia, of a patient to be treated.
  • the administration of cooled intravascular fluid can achieve such cooling, and sometimes is necessitated where rapid cooling is required, particularly in the pre-hospital or in the field setting.
  • induced hypothermia i.e. induced hypothermia
  • Figures 1 A and 1 B are rear and front perspective views, respectively, of embodiments of a cooling device as disclosed herein,
  • Figure 2 is a rear perspective view of an embodiment of a cooling device as disclosed herein,
  • Figure 3 is a plan view of an embodiment of a cooling device as disclosed herein,
  • Figure 4 is a plan view of an embodiment of a cooling device as disclosed herein
  • Figure 5 is a rear perspective view of an embodiment of a cooling device as disclosed herein
  • Figure 6 is a rear perspective view of an embodiment of a cooling device as disclosed herein,
  • Figures 7A-7D are plan views of embodiments of a cooling device as disclosed herein,
  • FIGS. 8A and 8B are side views of an embodiment of a cooling device as disclosed herein,
  • Figure 9 is a plan view of an embodiment of a cooling device as disclosed herein.
  • Figures 1 0A-1 0C are perspective views of components of embodiments of a cooling device as disclosed herein,
  • Figures 10D and 10E are cross-sectional views of components of embodiments of a cooling device as disclosed herein,
  • Figure 1 1 is a perspective view of a component of an embodiment of a cooling device as disclosed herein,
  • Figures 12-16 are perspective views of embodiments of a cooling device as disclosed herein,
  • FIGS. 1 7A-17E are schematics of embodiments of a cooling device as disclosed herein,
  • FIGS. 18A-18D are schematics of embodiments of a cooling device as disclosed herein,
  • FIGS. 1 9A-19B are schematics of embodiments of a cooling device as disclosed herein.
  • Figures 20A-20D are schematics of embodiments of a cooling device as disclosed herein.
  • the cooling of the core body temperature is a medical treatment increasingly being used to treat patients as part of various medical-related procedures.
  • Administering cooled intravascular fluids to induce hypothermia in cardiac arrest patients, particularly in the pre-hospital setting, i.e. in the field, has been found to improve the likelihood of those patients being subsequently discharged from the hospital neurologically intact.
  • Induced hypothermia therapy has proven effective in postponing damage to tissues caused by insufficient blood flow and oxygen deprivation. The smaller the time difference between cardiac arrest and induced hypothermia the higher the likelihood of successful treatment.
  • Unfortunately, currently available products for inducing hypothermia in a hospital setting are not feasible for use in the pre-hospital or in the field setting.
  • the cooling of intravascular fluids for use in the pre-hospital setting is currently achieved through the use of conventional bulky refrigeration units or simple ice-filled containers.
  • Primary responders in the field and outside the hospital are typically unable to carry both conventional refrigerators and cardiac arrest patients simultaneously on-board a vehicle (e.g., ambulance, helicopter, etc.), or at least it is impractical to do so given the space required for refrigeration units and/or ice-filled containers.
  • a vehicle e.g., ambulance, helicopter, etc.
  • induced hypothermia as a treatment will be indicated in only a small fraction of the calls encountered by emergency medical personnel makes incorporating refrigeration units in emergency vehicles impractical. Consequently, in some situations a second emergency vehicle carrying a refrigeration unit is required to intercept the primary responder and supply the primary responder with cooled intravascular fluids to administer to the patient when such therapy is indicated.
  • cooling devices for cooling a solution, such as saline or other intravascular solution. Also provided herein are methods of cooling a solution or target fluid, and methods of treating a subject or patient using a cooled fluid.
  • Figures 1 -20 illustrate various embodiments of fluid cooling devices and related systems.
  • the various embodiments provide a highly effective, compact, transportable, and efficient solution for rapidly cooling a target fluid for use, as for example, in the pre-hospital setting for intravascularly inducing hypothermia or otherwise significantly reducing the core body temperature in patients where hypothermia is medically indicated, particularly in cardiac arrest cases, as well as for other medical uses and non-medical uses.
  • hypothermia is medically indicated, particularly in cardiac arrest cases, as well as for other medical uses and non-medical uses.
  • the less the difference in time between cardiac arrest and induced hypothermia the higher the likelihood of success in subsequently discharging cardiac arrest patients from the hospital neurologically intact.
  • these cooling methods can be used to induce normothermia, e.g. bring the core body temperature down to a normal temperature range (37 °C- 37.5*0).
  • Hypothermia is defined as a body temperature significantly below 37° Celsius (C) or about 98.6° Fahrenheit (F), and there are various levels of hypothermia.
  • mild hypothermia is defined as a body temperature of about 34° C (about 93.2° F)
  • moderate hypothermia is defined as a body temperature of about 23° C to about 32° C (about 73.4° F to about 89.6° F)
  • profound hypothermia is defined as a body temperature of about 12° C to about 20° C (about 53.6° F to about 68° F). See Stedman's Medical Dictionary, 26th Edition, 1995.
  • a fluid cooling device as disclosed herein has experimentally demonstrated superior performance in providing a cooled target fluid for use in the pre-hospital setting, as compared with existing methods of cooling fluids in the pre-hospital setting, e.g., via conventional refrigeration. See, e.g. the Examples section herein.
  • a fluid cooling device according to the present disclosure has experimentally cooled a target fluid (i.e., saline solution) from room temperature to about 4° C in about 1 .5 to 2.0 minutes, wherein ammonium nitrate and water were utilized as the endothermic reactants in the cooling device.
  • the cooling device according to the present disclosure may be sized and configured for compatibility with associated fluid delivery components.
  • the cooling device may be easily connected to standardized intravascular delivery equipment to function as an in-line, on-demand chilling device. All or part of the cooling device may be sterilizable and reusable, or alternatively may be configured as a disposable single-use device.
  • a cooling device as disclosed herein can comprise up to and including eight (8) components: 1 ) a target fluid inlet, 2) a target fluid outlet, 3) a target fluid inner conduit, 4) an inner chamber surrounding the inner conduit containing a first endothermic reactant, e.g. a solid endothermic reactant, 5) a separate inner chamber containing a second endothermic reactant, e.g. a liquid endothermic reactant, 6) an activation mechanism, 7) an outer shell encasing the inner chamber, and 8) an anchoring system to tether the device to or near the patient during use.
  • the target fluid inner conduit can connect the target fluid inlet to the target fluid outlet, providing a flow path for the target fluid to be cooled.
  • the inner chamber surrounding the inner conduit can contain the first endothermic reactant of a binary endothermic reaction.
  • the first endothermic reactant can be kept isolated from a second endothermic reactant. Addition of the second endothermic reactant to the inner chamber containing the first endothermic reactant can initiate the endothermic reaction and the target fluid contained within the inner conduit can then be cooled.
  • the inner chamber can be encased by an outer shell that encloses the entirety of the device except for the target fluid inlet and target fluid outlet. Such a cooling device is depicted for example in Figures 1 A and 2.
  • FIG. 1 A is a left rear perspective view of a cooling device 100 (shown without an upper housing component as shown in Figure 2).
  • Figure 1 B is a right front perspective view of some of the internal components of cooling device 100 as shown in Figure 1 A.
  • Cooling device 100 of Figures 1 A and 1 B comprises in some embodiments an outer shell 102 in a U-shaped, horseshoe shaped, or horseshoe crab shaped, configuration.
  • Outer shell 102 can comprise a substantially vertical wall 102a configured in a U-shape joined by a substantially vertical end plate 102b, both of which can be capped by a projection 102c that can be substantially horizontal and extend perpendicularly from an upper portion of vertical wall 102a and/or end plate 102b.
  • Outer shell 102 can comprise a curved end 102e opposite end plate 102b.
  • Outer shell 102 can comprise a floor 102d enclosing a lower portion of vertical wall 102a and/or end plate 102b, together thereby forming a shell or bowl-like structure configured to contain a liquid or fluid medium, with such interior space forming an inner chamber 104.
  • Outer shell 102 can in some embodiments comprise a central wall 106 along or approximately along the midline of outer shell 102 and extending perpendicular from end plate 102b, and in some embodiment substantially but incompletely divide inner chamber 104 into two halves.
  • the division of inner chamber 104 by central wall 106 can in some embodiments create a flow path for inner target fluid conduits 108.
  • One or more inner conduits 108 can reside in inner chamber 104, and can extend from one side of end plate 102b, follow the U-shaped curvature of outer shell 102, and continue to the opposing side of end plate 102b.
  • Inner conduits 108 can provide one or more conduits for moving a target fluid to be cooled through inner chamber 104 where an endothermic reaction can take place to thereby cool or transfer heat away from the target fluid inside inner conduits 108.
  • heat can be transferred from the target fluid inside inner conduits 108 to the reaction medium to thereby cool the target fluid.
  • Manifolds 110a and 110b can provide an interface between a target fluid source and inner conduits 108.
  • a target fluid can be provided from an incoming conduit 122, such as an intravenous (IV) line (IV tubing, PVC, stainless steel, silicone) from an IV bag, and after cooling by passing through inner conduits 108, can exit cooling device 100 by an outgoing conduit 124, such as an IV line to a patient to be treated.
  • incoming conduit 122 and outgoing conduit 124 can connect directly to manifolds 110a and 110b.
  • incoming conduit 122 and outgoing conduit 124 can further comprise connectors 122a and 122b, respectively, which can be configured to connect to other conduits, IV lines, target fluid sources and related medical devices.
  • cooling device 100 can further comprise an agitator component 116 configured to enhance and maintain the endothermic reaction within inner chamber 104.
  • Agitator component 116 can comprise a pump, shaker, off-center motor, sparger, magnetic stirrer, manual stirbar, combinations thereof and/or other mechanical devices configured to agitate, stir, mix or otherwise disturb the endothermic reaction mixture.
  • agitator component 116 can be in fluid communication with inner chamber 104, such as by being housed within inner chamber 104 or otherwise connected to outer shell 102.
  • agitator component 116 can be fluidly connected to end wall 102a/102b of outer shell 102 by one or more channels 118a/118b, thereby allowing a fluid flow path to create a current or flow of the reaction mixture within inner chamber 104.
  • an additional channel 120 can be provided as discussed below with regard to Figure 4 for example.
  • cooling device 100 can comprise a housing 112, including is some embodiments a lower housing 112a ( Figure 1 A), and an upper housing 112b ( Figure 2).
  • outer shell 102 can be configured to fit inside housing 112, and when lower housing 112a and upper housing 112b are joined together can completely, or substantially completely, encase outer shell 102 and related components (depicted in Figure 2).
  • housing 112 can be configured to contain all or substantially all of the components of cooling device 100 and can be configured to provide a protective outer structure.
  • housing 112 can be shaped to mimic or be substantially similar to the shape of outer shell 102.
  • housing 112 can comprise a thermoplastic made from an injection or thermo-forming process.
  • housing 112 including lower housing 112a and upper housing 112b, comprises one or more controls 126, 128, such as buttons, knobs or switches, for controlling the operation and functionality of cooling device 100.
  • controls 126, 128 can be electrically and/or mechanically linked to a power source, an agitator component, a conduit, a computer or other component for controlling cooling device 100.
  • control 126 can comprise a power button while control 128 can comprise a button, a knob or a handle to activate an agitation component.
  • cooling device 100 can impact the efficiency of cooling of a target fluid.
  • a horseshoe crab or U-shaped design as depicted in Figures 3 and 4 can provide a greater cooling capacity for cooling device 100, including quicker and/or more extensive cooling of a target fluid.
  • such a design can in some aspects provide for a counter-current flow with the direction 202 of the reactant mixture (or cooling fluid) flowing opposite, or substantially opposite, to the direction 204 of flow of the target fluid inside the inner conduits 108.
  • the directional flow 202 of the reactant mixture within inner chamber 104 can be created by an input flow 202a of cooling fluid on one side of end plate 102b and an output flow 202b of reactant mixture (cooling fluid) on an opposite side of end plate 102b.
  • Input flow 202a and output flow 202b can in some embodiments originate from agitator component 116 (see also Figure 1 A), and particularly in some aspects from channels 118a and 118b, respectively.
  • Curved end 102e and central wall 106 can in some embodiments facilitate this directional flow of the reactant mixture.
  • Data from experiments as described in the Examples herein, demonstrate that the design of Figure 3 (counter current flow configuration) can in some embodiments provide for improved cooling of the target fluid, particularly as compared to a thermoform rectangle cooling device.
  • the U-shaped outer shell 102 can be configured to provide a bi-directional flow 202 of reactant mixture, wherein a central tube 106a comprises an internal conduit and nozzle 106b at the end thereof.
  • central tube 106a can be housed inside central wall 106.
  • Nozzle 106b is configured to spray or otherwise direct a flow 202 of reactant mixture toward curved end 102e of inner chamber 104 of outer shell 102. By directing a flow of the reactant mixture toward curved end 102e of inner chamber 104 the flow of reactant mixture (cooling fluid) is diverted around curved end 102e thereby creating bi-directional flow 202.
  • diverter 106c can be included to assist in diverting the reactant mixture emitted from nozel 106a and creating bi-directional flow 202.
  • the direction 204 of flow of the target fluid inside the inner conduits 108 is depicted by flow 204.
  • the bi-directional flow 202 of the reactant mixture within inner chamber 104 in Figure 4 can be created by an input flow 202a of cooling fluid through central tube 106a and out nozzle 106b, and output flows 202b of reactant mixture (cooling fluid) on both sides of end plate 102b.
  • Input flow 202a and output flows 202b can in some embodiments originate from agitator component 116 (see also Figure 1 A), and particularly in some aspects from channels 118a and 118b, and channel 120.
  • channel 120 can comprise a conduit in fluid communication with central tube 106a and agitator component 116.
  • channel 120 can be connected to a water source (or other endothermic reactant source), which can be pumped or flowed into inner chamber 104 upon initiation of the dissolution or endothermic reaction.
  • a cooling device 100 as provided herein can comprise multiple target fluid inlets and target fluid outlets in end plate 102b.
  • a manifold 110 can facilitate the transfer of a target fluid to be cooled from an incoming line or source to the inner conduits 108, and then back again to an output source or line.
  • manifolds 110a and 110b are provided to connect target fluid inlets/outlets 136a and 136b to inner conduits 108.
  • Manifolds 110a and 110b can convert a single target fluid input line into a plurality, for example 4 individual lines, of inner conduits 108.
  • a target fluid to be cooled can pass through fluid inlet 136a (from a source such as an IV bag and IV line for example) and be received by manifold 110a, which can then distribute the target fluid into the one or more inner conduits 108, where it can be circulated (by gravity flow and/or mechanical pumping) through inner conduits 108 and into manifold 110b where it is then sent out via target fluid outlet 136b.
  • target fluid outlet 136b the cooled target fluid can then be routed to its intended target, e.g. a patient to be treated, by an attached conduit, tube or line, e.g. a IV line.
  • the above flow path through the manifolds and inner conduits can be reversed in some embodiments.
  • manifolds 136a and 136b can in some embodiments be oriented in a substantially horizontal plane or direction such that inner conduits 108 originate and terminate near end plate 102b in a substantially horizontal plane.
  • conduits 110c and 110d are depicted in a substantially vertical plane.
  • inner conduits 108 originate and terminate near end plate 102b in a substantially horizontal plane by virtue of their connection and fluid communication with conduits 110c and 110d.
  • conduits 110c and 110d in Figure 6 function similarly to conduits 110a and 110b in Figure 5.
  • a manifold 110 can be directly incorporated into end plate 102b of the U-shaped outer shell 102. That is, the manifold can be physically integrated into outer shell 102 where the target fluid inlets and outlets enter and leave the device, respectively.
  • the manifolds can be designed so that the inner conduits 108 (coils) enter or begin in the inner chamber in either a substantially horizontal or substantially vertical orientation ( Figure 5 and Figure 6, respectively).
  • connection points 132a and 132b are shown for connecting to channels 118a and 118b (see Figure 1 ), respectively.
  • Such connection points can in some embodiments provide an entry and/or exit to inner chamber 104 for agitating, stirring and/or creating a directional flow of the reactant mixture/cooling fluid.
  • connection points 132a and 132b are in fluid communication with agitation component 116 as depicted in Figure 1 for example.
  • inner conduits 108 can comprise medical grade tubing such as stainless steel or Polytetrafluoroethylene (PTFE) coated braided stainless steel reinforced coils.
  • the number and size of conduits 108 or coils can be altered in the design without departing from the scope of this disclosure to meet specific fluid flow requirements.
  • the number and size of inner conduits 108 can depend on, for example, the size of the target fluid inlet 136a/136b, the size and/or configuration of manifolds 110, and/or the tubing connected to that inlet.
  • the sum of the cross-sectional areas of inner conduits 108 can be equal to or greater than the cross sectional area of incoming conduit 122, such as an IV tubing connected to the inlet, to minimize flow restriction by cooling device 100.
  • the use of four inner conduits can result in no discernible decrease, or substantially no decrease, in the fluid flow rate as a result of the use of cooling device 100. (i.e. the flow rate is the same as if the device was not present in the IV flow path).
  • the Examples below provide data from experiments that demonstrate how the number of inner conduits can in some embodiments impact the flow rate, particularly as compared to the flow rate in an IV tube without a cooling device attached.
  • the number of inner conduits 108 needed or desired to achieve a sum of the cross-sectional areas of the conduits that is equal to or greater than the cross sectional area of the IV tubing connected to the inlet can be 1 , 2, 3, 4, 5, 6, 7, 8, 9, 10, 1 1 , 12, 13, 14, 1 5, 20, 25, 30 or more.
  • the target fluid inner conduit 108 is configured to efficiently and effectively accommodate the heat transfer from the target fluid to the endothermic reaction occurring inside inner chamber 104, while maintaining structural integrity for the duration of the reaction.
  • inner conduit 108 can comprise varying materials, including but not limited to stainless steel or PTFE coated stainless steel coils.
  • inner conduits 108 can follow central wall 106 from the target fluids inlets 110a around curved end 102e of U- shaped outer shell 102 of the inner chamber 104, effectively making a 180° turn, and exiting out the target fluid outlets 110b.
  • inner conduits 108 can be of equal length or varying length.
  • inner conduits 108 can comprise PTFE coated braided stainless steel reinforced coils.
  • inner conduit(s) 108 can be constructed of various materials (e.g., medical grade metals, thermally conductive plastics, and the like) and can include various shapes and cross-sectional areas so as to provide sufficient available surface area for heat transfer.
  • the first endothermic reactant such as for example ammonium nitrate or some other salt prills, can be packed around these inner conduits.
  • inner conduits 108 can have a wall thickness that is suitable for heat transfer from the target fluid to the reactant mixture (cooling fluid) to thereby facilitate the cooling of the target fluid.
  • the walls of inner conduit 108 can be relatively thin to thereby facilitate heat transfer away from the target fluid, as illustrated in Example 3.
  • the thickness of the wall of inner conduit 108 can range from about 0.001 inches thick to about 0.1 inches thick. In some embodiments, the thickness of the wall of the inner conduit can range from about 0.001 inches thick to about 0.05 inches thick. In some embodiments, the thickness of the wall of the inner conduit can be about 0.005 inches thick.
  • the target fluid inlets and target fluid outlets at the end wall, or flat portion of the U-shaped outer shell can in some embodiments be arranged in a semi-circular arc as depicted in Figure 1 .
  • the orientation of the flow pump inlets and outlets are inverted from that of the target fluid inlets and outlets, establishing a counter current to promote the cooling of the target fluid as it passes through the inner conduits. That is, the side of the end wall of the U-shaped outer shell where the target fluid inlets are located is where the single flow pump outlet will be located, and vice versa.
  • a flow pump can be located external to the device.
  • the inlet to the flow pump can be coated with or surrounded by a mesh material or netting structure to prevent or substantially reduce the intake of undissolved ammonium nitrate prills (or other first reactant within the inner chamber, such as for example ammonium nitrate, ammonium chloride, potassium chloride, or the like, in any suitable form such as powder, pellets, grains, gel, colloid, suspension, liquid, or the like).
  • Endothermic agents or endothermic dissolution chemicals can be selected from those listed in Table 1 .
  • Positive ⁇ indicates an endothermic dissolution. Since all of the compositions listed in Table 1 have positive ⁇ , they have potential as an endothermic agent in the context of the disclosed devices, systems and methods.
  • an agitator component such as agitator 116 in
  • Figure 1 for example, is configured to agitate, or otherwise mix, stir and/or circulate the endothermic reactants, namely the first and second endothermic reactants, thereby promoting and sustaining an endothermic reaction.
  • the movement of the fluid endothermic reaction, or reaction mixture, around the inner conduits facilitates the cooling of the target fluid as it passes through the inner conduits.
  • the specific reactants utilized in the disclosed cooling devices, systems and methods can depend on the particular endothermic reaction being implemented.
  • ammonium nitrate, ammonium chloride, or potassium chloride may be utilized as the first endothermic reactant, and in each case, water may be utilized as the second endothermic reactant.
  • the first endothermic reactant can comprise a combination of two or more endothermic reactants, such as for example a combination of solid reactants listed in Table 1 .
  • a combination of ammonium nitrate and urea can be utilized as the first endothermic reactant, and water as the second endothermic reactant.
  • the second endothermic reactant is a flowable reactant, e.g. water.
  • Other flowable materials and/or compositions can be suitable for serving as the second endothermic reactant.
  • the cooling devices, systems and methods disclosed herein can employ any combination of reactants that, when combined, result in an endothermic reaction suitable for rapid cooling of a selected target fluid such as, for example, saline solution.
  • the second endothermic reactant can be flowed into the inner chamber via the reactant inlet by any suitable means such as, for example, a pump.
  • the second endothermic reactant can be provided internally within the cooling device, but separated from the first endothermic reactant, and can be mixed with the first endothermic reactant by removing or alternating a barrier separating the two, as disclosed herein.
  • the first endothermic reactant may not be pre-loaded in the inner chamber of the cooling device.
  • both the first and second endothermic reactants can, in some embodiments, be supplied from external sources (e.g., pumps or loading devices into the inner chamber in any order from two separate reactant inlets) for initiating the endothermic reaction.
  • having the at least two endothermic reactants, including for example a first endothermic reactant and/or a second endothermic reactant, preloaded in the chamber may be particularly useful in implementations in which the cooling device is utilized to rapidly cool intravascular fluids in the pre-hospital setting, for example.
  • both a first and a second endothermic reactant can be supplied from external sources (e.g., pumps or loading devices into the inner chamber in any order from two separate reactant inlets) in incremental quantities so as to prolong the dissolution reaction and increase the overall cooling capacity of the device.
  • external sources e.g., pumps or loading devices into the inner chamber in any order from two separate reactant inlets
  • the second endothermic reactant can be in a separate chamber that is connected to the device, e.g. via the flow pump or agitator component, for activation.
  • the initiation of the endothermic reaction can in some embodiments occur with the addition of the second endothermic reactant to the inner chamber.
  • the addition of water, an exemplary second endothermic reactant, followed by the activation of the flow pump/agitator component can initiate the reaction by introducing the water into the inner chamber where the first endothermic reactant, e.g. ammonium nitrate prills, is housed.
  • the agitator component can mix, stir or agitate the at least two endothermic reactants to enhance and maintain the endothermic reaction and provide agitation of the cooling solution or reactant mixture (first and second endothermic reactants) for the device to properly cool the target fluid flowing through the inner conduits.
  • the agitator component can mix, stir or agitate the at least two endothermic reactants to enhance and maintain the endothermic reaction at a level greater than would be achieved in the absence of an agitator component.
  • Activation of the disclosed cooling devices initiates cooling of the target fluid.
  • Activation of the device can in some embodiments comprise the occurrence of multiple events.
  • the flow of the target fluid through the target fluid inlet and into the target fluid inner conduits is a component of activation.
  • a saline IV bag for example, can be connected to the device such that the saline flows through the target fluid inlet and into the inner conduits.
  • the endothermic reaction can initiate immediately after or soon thereafter following the mixing of the first and second endothermic reactants. In order to prevent occurrence of the endothermic reaction prior to the desired time, i.e. once the target fluid starts flowing through the inner conduits, the first and second endothermic reactants are kept separated until the device is activated.
  • the at least two endothermic reactants can be stored in separate compartments within the inner chamber. These compartments can be linked via a conduit containing a removable barrier.
  • Activation of the device can comprise the simultaneous mixing of the first and second endothermic reactants and the activation of an agitator component such as a pump to agitate the fluid endothermic reaction mixture, which in turn facilitates the cooling of the target fluid. These two events can in some embodiments be performed in a single action.
  • One approach to actuation can be through the use of a ball valve coupled with an electrical circuit.
  • an external handle of the valve As an external handle of the valve is turned 90°, for example, the separation between the two compartments of the inner chamber can be removed.
  • the handle As the valve handle is turned, the handle completes a circuit that can activate pump or other agitator component and facilitate the mixing and agitation of the fluid endothermic reaction.
  • a second option for actuation is through the use of a push button flange 280 (or push button flange valve assembly) as depicted in Figures 10A-10F and 1 1 .
  • Push button flange 280 can puncture a barrier between the at least first and second endothermic reactants which can be separated by a barrier in the inner chamber 140 of cooling device 100 (see Figure 1 for example).
  • a first endothermic reactant e.g. ammonium nitrate prills
  • a second endothermic reactant e.g.
  • Push button flange 280 can comprise a button on the exterior of the device that when depressed a sharp object within the flange can puncture the bag or membrane separating the two compartments or endothermic reactants within the inner chamber.
  • the same motion can cause the flange to close and connect a circuit. The circuit can then activate a pump or agitator component to agitate the fluid endothermic reaction, which in turn can facilitate the cooling of the target fluid.
  • push button flange 280 can comprise an upper portion 282 and lower portion 284 that can be adjoined with a membrane m sandwiched therebetween as illustrated in Figure 1 1 .
  • Sharp object 300 is configured to reside within upper portion 282.
  • Upper portion 282 comprises a flange 286, a housing 290 and depressable member 294 or push button.
  • a collar 292 can in some aspect be included to support the joinder of flange 286 and housing 290.
  • Lower portion 284 can comprise a flange 288 extending radially from a collar 296 with an opening 298.
  • Sharp object 300 can in some aspects comprise a main body 302 with an end that terminates in a point 304. When assembled as illustrated in Figure 1 1 membrane m is sandwiched between upper portion 282 and lower portion 284, and particularly between flange 286 and flange 288.
  • FIGS 10D and 10E Cross-sectional views of assembled push button flange 280 are illustrated in Figures 10D and 10E.
  • sharp object 300 is contained within housing 290 and in the un-depressed state.
  • depressable member 294 can push sharp object 300 downward such that point 304 punctures membrane m.
  • Collar 296 prevents sharp object 300 from leaving button flange 280 by acting as a stop mechanism.
  • a liquid or fluid such as a second endothermic reactant, e.g. water, can flow from one side of the membrane to the other.
  • a liquid can pass from a tubing or conduit 310, such as an IV line, that is attached to depressable member 294 that can also act as a nipple over which tubing 310 can slide.
  • the liquid can flow through opening O, through housing 290, then through the puncture in membrane m, and out exit 298.
  • push button flange 280 can be place or integrated into a membrane in inner chamber 104 of cooling device 100 that creates two separate chambers for holding an at least first and second endothermic reactants.
  • push button flange 280 can be integrated into the wall of a bag or reservoir within or proximate to inner chamber 104 of cooling device 100.
  • push button flange 280 can provide a mechanism to mix an at least first endothermic reactant with an at least second endothermic reactant upon activation, i.e. pushing the button, to thereby begin the endothermic reaction and start cooling a target fluid within inner conduits 108.
  • the inner chamber 104 of cooling device 100 can be separated into two distinct compartments.
  • the first compartment can immediately surround the target fluid inner conduits 108 and contain the first endothermic reactant, such as, for example, ammonium nitrate prills.
  • the second compartment can comprise a sealed plastic bag, for example, that can contain the second endothermic reactant, such as for example water.
  • the second compartment can be connected to the first compartment by a removable barrier, or push button flange 280.
  • the first compartment can be capped with a flexible membrane 262, as illustrated in Figure 8A,that is positioned in such a manner as to exclude all or substantially all free space, i.e. air, in the first compartment.
  • Free space can be defined as any space in the first compartment that is not filled by the first endothermic reactant or the target fluid inner conduits.
  • the second endothermic reactant can be pumped from the second compartment to the first to initiate the reaction.
  • the flexible membrane 262 can extend or expand thereby accommodating the increase in volume, as illustrated in Figure 8B.
  • Flexible membrane 262 can for example be affixed to outer shell 102.
  • the purpose for flexible membrane 282 can be at least two-fold.
  • other systems can be provided for removing, or substantially eliminating air in the inner chamber that is not filled with a reactant mixture.
  • such mechanisms as a gas permeable chamber, a vented cooling chamber, a pump to remove excess air, and/or a chemical to displace air, can act as air reducing components.
  • Such mechanisms are illustrated in Figures 7A-7D for example.
  • gas permeable membrane 252 can comprise a material that is permeable to gases 250, but not to liquids, e.g. Tyvek® (DuPont, Wilmington, Delaware, United States of America).
  • an outer shell 102 can comprise a vent 254 configured to prevent or substantially reduce air 250 from becoming trapped within the chamber, thereby reducing the amount of free space.
  • an outer shell 102 can comprise a chemical gas 256, such as ammonia, that dissolves in water, and is capable of displacing air 250 contained within the chamber and then being dissolved in and/or absorbed by the water in a reaction mixture, thereby reducing free space in the chamber that would be taken up by air.
  • outer shell 102 can comprise a pump 258 configured to remove air 250 trapped in the system upon activation of the device, and release it to the external environment by a conduit 260, as illustrated in Figure 7D.
  • cooling devicel OO can be placed sufficiently close or proximate to the patient to be treated such that target fluid cooled by cooling device 100 can be effectively delivered to the patient soon after leaving the device so as to minimize or prevent any significant increasing in the temperature, i.e. warming, of the cooled target fluid.
  • outgoing conduit 124 from Figure 1 can be connected (by connector 124a for example) to a patient intravascular access port via a short tube, e.g. IV tube, to prevent the target fluid to warm up while travelling through it.
  • cooling device 100 can in some embodiments be designed to be placed as close to this access port as reasonably and/or conveniently possible.
  • An example of the location of the intraosseous access port would be the proximal part of the tibia or femur, anterior to the patient.
  • the device can in some embodiments have an attachment option close to this access point, for example the medial part of the tibia, the thigh, or on the forearm where IV access is used. See, e.g. Figure 12, which illustrates a disclosed cooling device 100 strapped to a leg of a subject.
  • cooling device 100 in order to optimize functionality can be attached directly to a patient to be treated.
  • the cooling device can in some embodiments be attached to a structure, e.g. gurney, bed, IV pole, etc., that is located proximate to a patient to be treated.
  • the orientation of the device can be properly maintained in order to ensure proper and/or optimal functionality.
  • the proper orientation of cooling device 100 can comprise maintaining the device in a substantially level orientation or upright orientation with respect to a planar or horizontal top side.
  • cooling device 100 can comprise a substantially planar top side and substantially planer bottom side, and have a substantially U-shaped outer wall defining the substantially vertical sides when optimally oriented, as depicted in Figure 12.
  • inner conduits 108 are more likely to remain submerged in the cooling fluid or reactant mixture, i.e. first and second reactants, within the inner chamber.
  • the cooling device is oriented on one side of the U-shaped outer shell, or on the curved end of the U-shaped outer shell, or on the flat end plate of the outer shell, it is possible that some portion of the inner conduit inside the inner chamber will no longer be submerged in the cooling fluid, thereby potentially reducing the optimal cooling effect.
  • the orientation and/or placement of the inner conduits 108 within inner chamber 104, and particularly manifolds 110 can in some embodiments minimize this effect. Nevertheless, it can be desirable in some aspects to position, and/or attach cooling device 100 to a patient or object to maintain a desired position or orientation, to thereby optimize its cooling performance.
  • Cooling device 100 can be attached to the patient using one or more exemplary attachment mechanisms as disclosed herein, and particularly as depicted in Figures 12-1 6.
  • Attachment mechanisms can comprise, but are not limited to, a static friction cuff, dual ankle and foot straps, adhesive silicone tape, adhesive patches designed for use on human skin, and/or an ergonomic recess attachment.
  • Figures 1 2 and 13 illustrate an ergonomic recess attachment 130 on a cooling device 100. As illustrated in Figure 12, such an attachment 130 can be configured to attach or otherwise secure cooling device 100 to an appendage of a patient to be treated, such as an arm or leg.
  • Ergonomic recess attachment 130 can comprise an ergonomic bolster 140 affixed to the bottom of cooling device 100, as well as a strap 138 and buckle 142,which can allow for easy and stable attachment to an appendage of the patient.
  • the ergonomic structure and/or design of bolster 140 can give a wide variety of attachment points to the patient. These points can in some embodiments be both on top of and underneath a patient's appendage.
  • this attachment mechanism can provide stable anchoring to the patient, as it can allow cooling device 100 to lay on the surface next to the patient. Such a secure attachment to the patient can reduce and/or minimize the risk of the device being accidentally moved.
  • Coupling the ergonomic design of Figure 13 with one of the straps or adhesive designs disclosed herein can in some embodiments greatly increase the stability of the attachment.
  • cooling device 100 can comprise an attachment mechanism 130 that comprises adhesive patches 146.
  • adhesive patches 146 can comprise adhesive patches such as those used in adhesive bras and are designed to adhere to human skin under a variety of conditions.
  • attachment mechanism 130 can comprise an ergonomic bolster 144, in some aspects attached to the bottom of cooling device 100, to provide stability to the attachment by ergonomically resting against a body part or appendage of a patient to which cooling device 100 is affixed.
  • Adhesive patches 146 can in some embodiments be affixed to the bottom of cooling device 100 and designed to cooperate with ergonomic bolster 144 to securely attach cooling device 100 to a patient. By incorporating such patches in an attachment mechanism a cooling device could readily be affixed to an appendage of a patient and would provide a stable anchor point.
  • a cooling device can comprise an ergonomic bolster (140 in Figure 13, and 144 in Figure 14) affixed to the bottom of cooling device 100, which can provide for easy and stable attachment to an appendage of the patient.
  • a bolster 140, 144 can comprise foam or other compressible material, and can in some aspects have a V-shaped contour.
  • the ergonomic structure of bolster 140, 144 can give a wide variety of attachment points to the patient. These points can in some embodiments be both on top of and underneath a patient's appendage.
  • the V-structure of a foam ergonomic structure can allow for the device to be secured to a variety of sizes of patient limbs or appendages.
  • this attachment mechanism can provide stable anchoring to the patient, as it can allow the device to lay on the surface next to the patient. Such a secure attachment to the patient can reduce and/or minimize the risk of the device being accidentally moved.
  • cooling device 100 can comprise an attachment mechanism 130 that comprises a strap 144 or material strip comprising an elastic material or elastic property. All or a portion of strap 144 can comprise elastic or stretchable material so as to provide flexibility and adaptability to various sizes of appendage or structure to which cooling device 100 is to be secured.
  • elastic strap 144 can comprise hook and loop fasteners 146, e.g. Velcro® brand fasteners.
  • elastic strap 144 can comprise a portion, e.g.
  • hook fasteners 146 can engage or hook directly to any portion of elastic strap 144, such that when strap 144 is used to wrap around a patient appendage, for example, to secure cooling device 100 to the patient the elastic strap can loop back and fasten to itself. See, e.g., Figure 15.
  • hook fasteners 148 can be affixed to a portion of cooling device 100 such as a bottom or top side as illustrated in Figure 16.
  • hook fasteners 148 can be affixed to a portion of upper housing 112b of device 100.
  • the strap 144 can wrap around an appendage of a patient, or a structure such as a bed rail, and then fasten to cooling device 100 by using a loop structure 146 on strap 144 to engage hook fasteners 148 on cooling device 100, or by allowing elastic strap 144 to directly engage hook fasteners 148 on cooling device 100.
  • an elastic strap 144 or similar attachment mechanism can be coupled with an attachment mechanism that comprises an ergonomic bolster affixed to the bottom of the cooling device as illustrated in Figures 12, 1 3 and 14 and as discussed above.
  • delivery of the cooled target fluid to the patient needs to be performed in a sterile manner.
  • the following components of a cooling device as disclosed can be sterilized or steriliazable: incoming conduit 122, outgoing conduit 124, connection points 132a and 132b, manifolds 110 and inner conduits 108 (see Figures 1 A, 1 B, 5 and 6).
  • the integrity of the target fluid should be maintained, meaning there can be neither leaks from the fluid endothermic reaction into the target fluid nor any leaks of the target fluid into the fluid endothermic reaction.
  • the device can be packaged inside a sterile Tyvek® pouch or vacuum formed PET (or similar) blister with a Tyvek® lid.
  • the entire package can be sterilized using Ethylene Oxide (EtO), which is a gas that can easily penetrate the Tyvek® and sterilize the target fluid inner conduits where the IV fluids will be traveling.
  • EtO Ethylene Oxide
  • the inner chamber can comprise a membrane made out of a material that is permeable to gases, but not to liquids, e.g. Tyvek®.
  • the purpose of this membrane can be at least twofold. The membrane can substantially reduce the amount of free space in the inner chamber during device operation, in addition to facilitating the penetration of EtO during sterilization.
  • the target fluid inlet and target fluid outlet can each be covered with a cap designed to allow the EtO gas to enter and exit the target fluid pathway while preventing the entry of any microbes.
  • Other options for sterilization can comprise applying heat (dry heat, autoclaving), chemicals, irradiation (gamma ray or E-beam), high pressure and/or filtration.
  • a cooling device as disclosed herein can be completely sterile, or parts of the device can be sterilized.
  • the cooling device can comprise a modular configuration where the inner conduit and manifold component can be removable from the outer shell and sterilizable via gamma irradiation. The components can be separately packaged and sterilized and can be combined at the point of care.
  • Such a modular configuration is illustrated in Figure 9.
  • a modular cooling device 240 can comprise a modular outer shell 242 that is substantially similar in shape and design to outer shell 102 in Figure 1 A, for example. Unlike outer shell 102 in Figure 1 A, however, modular outer shell 242 can comprise a receiving end 248 configured to slidingly engage an insert portion 250 by sliding insert portion 250 in direction D. Modular outer shell 242 can in some embodiments comprise a first chamber 244 and a second chamber 246, with a gate 270 therebetween. First chamber 244 can comprise a first endothermic reactant, which can be mixed with a second endothermic reactant in second chamber 246 by opening gate 270 to thereby facilitate an endothermic reaction.
  • inner conduits 252 can be exposed to the reactant mixture to thereby cool a target fluid inside inner conduits 252.
  • Ports 256a, 256b can fluidly communicate with inlet/outlet 224a/254b once insert portion 250 is inserted into receiving end 248, which thereby allows the endothermic reaction mixture to pass or flow into insert portion 250 and surround inner conduits 252.
  • pump or agitator component 258 can facilitate the movement or flow of the endothermic reaction mixture into insert portion 250.
  • Central wall 262 can act as a diverter to create a flow path of the endothermic mixture from outlet 254a, around the U-shaped inner chamber, and out outlet 254b.
  • a target fluid to be cooled e.g.
  • cooling device 240 can come into the cooling device via incoming conduit 122, through manifold 260b, circulate through inner conduits 252 to be cooled, and then out manifold 260a and to the patient through outgoing conduit 124.
  • cooling device 240 one or more of the modular components can be sterilized and/or stored separately.
  • the cooling chamber or the entire cooling device can be insulated to minimize heat gain by the system when in use to cool a target fluid.
  • the insulation can reduce and/or substantially minimize cooled target fluid from gaining heat by heat transfer with the exterior of the device due to temperature differential, as well as the target fluid conduits not absorbing heat when exiting the cooling chamber. This can be achieved by surrounding the device in part or completely with an insulating material including but not limited to: closed cell foam, Styrofoam, air gap, plastic, silicone, and other thermally non-conductive materials or layers of materials.
  • FIGS 17-20 depict alternate configurations of cooling devices as disclosed herein.
  • the cooling device as described herein and as depicted in Figure 1 can have a substantially U-shape. However, in some embodiments a cooling device as disclosed herein can comprise one or more alternative shapes or configurations.
  • a cooling device 150 as disclosed in Figures 1 7A-1 7E can comprise an outer shell 152 substantially in the shape of a domed cylindrical canister.
  • outer shell 152 can be divided along the lateral midline 158 into two distinct sections.
  • the lower section 152 of the device can contain a target fluid inlet 156a on the exterior of the device, proximal to central laterally dividing line 158.
  • a target fluid outlet 156b can be provided in the same location as the inlet with respect to the laterally dividing line.
  • the interior 166 of lower section 152 of the device can contain the target fluid inner conduit 168 which can fluidly connect with fluid inlet 156a with target fluid outlet 156b.
  • the inner conduit can traverse inner chamber 166 in a serpentine manner with the undulations spanning nearly the entire vertical distance of the inner chamber.
  • the target fluid inner conduit 168 can be contained within the inner chamber as described above.
  • This inner chamber can be lined with a thin flexible bag which can contain the target fluid inner conduit 168 and the first endothermic reactant.
  • the upper section 154 of the device can house a reservoir 164 for the second endothermic reactant.
  • the two sections of the device can serve the purpose of segregating the two endothermic reactants.
  • the orientation of the two sections can be held in place by a central "pull out" tab 160.
  • tab 160 As tab 160 is removed (see Figure 17C), the two sections can rotate with respect to one another by way of a threaded member 162 (see Figure 17C)
  • the two endothermic reactants can be combined, initiating the endothermic reaction and cooling the target fluid as it passes through inner conduit 168.
  • cooling device 150 can be shaken by a user as depicted in Figure 1 7E.
  • a cooling device as disclosed herein can comprise an outer shell comprising a flexible sheet or bag as depicted in Figures 18A-18D. Due to the compliant nature of the outer shell 172, cooling device 170 can be rolled up ( Figure 18B) upon itself for storage and unrolled in order to perform the cooling task. As cooling device 170 is unrolled, the top exterior face of the device contains a target fluid inlet 174a located on one side, and a target fluid outlet 174b on the other side. Target fluid inlet 174a and target fluid outlet 174b can be connected via the target fluid inner conduit 176. The target fluid inner conduit 176 can descend vertically from the target fluid inlet 174a until the conduit approaches the bottom of the inner chamber 178.
  • Inner conduit 176 can turn 180 ° and return towards the top of inner chamber 178. This circuitous pattern can be repeated as inner conduit 176 traverses inner chamber 178 and reaches target fluid outlet 174b.
  • Inner chamber 178 can be lined with a flexible bag containing target fluid inner conduit 176, the first endothermic reactant and a segregated second endothermic reactant. The division between the first endothermic reactant and the second endothermic reactant, by for example a separate compartment 180, can be breached, allowing for the mixing of the reactants, and initiating the endothermic reaction, thereby cooling the target fluid as it passes through inner conduit 176.
  • Figure 18D illustrates an exemplary cross-sectional view of cooling device 170, including inner conduits 176 bathing in endothermic reaction mixture 184 inside inner chamber 178, all of which is surrounded by an outer layer of flexible material 182.
  • a cooling device 190 can comprise an outer shell 192 substantially in the shape of a curved "flask" container or curved canister.
  • a cooling device 190 can comprise an outer shell 192 comprising a cylindrical bottle design, as depicted in Figures 19A and 19B.
  • outer shell 192 can be a rigid material forming a cylinder which comprises the body of the device. At the top of the cylinder, the edges of the cylindrical walls can be connected to the top exterior plate via a chamfer.
  • the chamfer edge near the top of the device can contain ports 194a, 194b that breach the outer shell and allow for access to the inner chamber 212, as depicted in the cutaway view of Figure 19B These ports can in some embodiments constitute the target fluid inlet 194a and the target fluid outlet 194b.
  • the target fluid inlet and target fluid outlets can be connected via the target fluid inner conduit 198.
  • the target fluid inner conduit 198 can descend from target fluid inlet 194a at the top of the device towards the bottom of the device.
  • the target fluid inner conduit 198 turns and follows parallel to the bottom of the device, approaching the opposite wall of the device before ascending towards the top of the device and connecting to target fluid outlet 194b.
  • the target fluid inner conduit track can be contained by the inner chamber 212 of the device, as defined as the space inside outer shell 192 of the device.
  • the inner chamber can be lined with a flexible bag.
  • the flexible bag constrains the first endothermic reactant 214 and holds it near target fluid inner conduit 198.
  • the second endothermic reactant can be sequestered by a barrier 210, separating the first and second endothermic reactants.
  • activator 196 can comprise a push button flange 280 such as depicted in Figures 1 0A-10E and 1 1 .
  • the endothermic reaction can cool the target fluid as it passes through the target fluid inner conduit.
  • a cooling device 220 can comprise an outer shell 222 that is a flattened, centrally incompletely hollow disc, or torus, as depicted in Figures 20A-20D.
  • Outer shell 222 of cooling device 220 can be a rigid material with a more flexible material over central indentation 226.
  • the ports 224a, 224b can be the target fluid inlet 224a and target fluid outlet 224b and can be fluidly connected by target fluid inner conduit 234, as depicted in cross- sectional top view Figure 20B.
  • Target fluid inner conduit 234 can run around the circumference of inner chamber 236.
  • Inner chamber 236 can be filled with the first endothermic reactant.
  • the second endothermic reactant can be housed in central depression 226 of the device (see cross-sectional view of Figure 20D).
  • the second endothermic reactant can be separated from the first endothermic reactant by a barrier 230.
  • the first and second endothermic reactants can be allowed to mix and the ensuring endothermic reaction cools the target fluid as it passes through inner conduit 234.
  • a user can use hands or thumbs to depress central portion 226 and/or activation component 228 by a motion x to start the endothermic reaction.
  • a cooling device as depicted in any of Figures 1 -20 can comprise an indicator configured to signal, notify or otherwise convey information to a user of the device.
  • an indicator can comprise an indicator located on the outer enclosure of the device, or any place visible to a user.
  • An indicator can comprise a visual indicator that is activated when the target fluid temperature is within a desired range of temperatures and deactivated when the temperature falls outside said range.
  • the outer enclosure can have a visual indicator that is activated when the chemical endothermic reaction is activated, indicating that the device cooling has started.
  • the indicator can comprise a light produced by an light emitting diode (LED) or similar electronic component, a colored LED that is turned on when the endothermic reaction is started and changes color when the target fluid temperature reaches a desired range of temperatures, a temperature sensitive material that changes color when it falls within the desired range of temperatures, a color tab that is exposed when the device activation mechanism is actuated, and/or an indicator that shows the internal temperature.
  • LED light emitting diode
  • a colored LED that is turned on when the endothermic reaction is started and changes color when the target fluid temperature reaches a desired range of temperatures
  • a temperature sensitive material that changes color when it falls within the desired range of temperatures
  • a color tab that is exposed when the device activation mechanism is actuated
  • an indicator that shows the internal temperature.
  • such an indicator can comprise an LED screen that shows the real time fluid output temperature.
  • the indicator further comprises a closed feedback mechanism that adjusts the voltage to the pump based on the fluid output temperature, thus altering the rate of circulation of the cooling solution.
  • Cooling devices as disclosed herein can be used to rapidly, effectively and reliably supply cooled fluids in a manner which does not require the aid of any other device.
  • the cooling devices can be utilized to quickly supply cooled saline solution, or other target solution, medication or pharmaceutical, for intravascular administration to cardiac arrest, stroke, heat stroke, traumatic brain injury, sepsis, and spinal cord injury patients in the pre-hospital setting, so as to reduce the core body temperature of the patients.
  • the cooling devices can be completely isolated from the external environment, ensuring no contamination of the target liquid, any potential user, and any potential patient while a cooling device is in use.
  • a cooling device as disclosed herein can also be utilized in various other settings, e.g., hospital based therapy and surgery.
  • the cooling devices can be utilized in a wide variety of non-medical as well as medical applications for cooling various liquids, gases, vapors, suspensions, etc.
  • the cooling devices can be portable, easily storable and easily disposed of after use.
  • the cooling devices can be easily connected to input tubing and output tubing for use as an in-line device.
  • the cooling devices according to the present disclosure can be manufactured in varying sizes and dimensions so as to allow for various temperatures of the target fluid at the target fluid outlet of the cooling device. For example, reducing the length of the cooling device can result in a higher temperature of the target fluid at the target fluid outlet as a result of a decrease in surface area utilized for heat transfer.
  • the cooling device according to the present disclosure can be manufactured with varying amounts of the first endothermic reactant so as to allow for various temperatures of the target fluid at the target fluid outlet of the cooling device.
  • different cooling devices according to the present disclosure may be manufactured with different endothermic reactants so as to allow for various temperatures of the target fluid at the target fluid outlet of the cooling device.
  • a target fluid flowing through a cooling device as disclosed herein can be cooled from room temperature down to about 3 or 4° C upon exit from the cooling device.
  • the time required for this amount of cooling to occur from the target fluid inlet to the target fluid outlet can depend on a variety of factors, including for example the volume of the chamber and of the reactant loaded therein, the internal diameter and length of the inner conduit(s) and thus the resulting flow rate and residence time of the target fluid in the chamber, as well as the specific endothermic reactants utilized.
  • the amount/ratio of reactants used, and/or the size/dimensions of the device can be adjusted or optimized in order to effectively cool a desired amount of target fluid, such as one or more different sized bags of fluid, e.g. 250 ml_, 500 ml_ or 1 ,000ml_.
  • Methods of using a cooling device as disclosed herein can comprise advancing or flowing the target fluid through a target fluid inlet into an inner conduit or conduits of a cooling device.
  • the target fluid may include, for example, saline solution or any other fluid desired to be cooled in a particular application.
  • the cooling device of the present example may include a chamber surrounding the inner conduit and containing a first endothermic reactant (e.g., ammonium nitrate).
  • the chamber may include a reactant inlet that is selectively alterable from a closed state to an open state.
  • the reactant inlet may be internal or external to the chamber as described above. When the reactant inlet is in the closed state, the first endothermic reactant is isolated from a second endothermic reactant and no endothermic reaction occurs.
  • a next step of a method of using a cooling device can comprise altering the reactant inlet from the closed state to the open state, and/or activating the endothermic reaction. Consequently, the reactant inlet provides a flow path for enabling the second endothermic reactant (e.g., water) to come into contact with the first endothermic reactant in the chamber for initiating the endothermic reaction and cooling the target fluid in the inner conduit.
  • the target fluid may be cooled to a temperature of, for example, 3 to 4 degrees Celsius, or a variety of other temperatures, depending on the particular application of the method. In some implementations this step can be performed prior to carrying out the first step above so as to allow the reaction to begin before flowing the target fluid through the target fluid inlet.
  • Another step can comprise flowing the target fluid through a target fluid outlet of the cooling device to a selected destination for the cooled target fluid such as into a receiving tube.
  • the cooled-fluid-receiving tube may include IV tubing for use in the medical field.
  • a first step in such a method can, for example, generally include advancing or flowing a target fluid to be cooled from a reservoir.
  • the target fluid reservoir may include, for example, an IV bag containing a suitable intravascular fluid such as saline solution, and which may additionally include a therapeutically active drug if indicated for the specific situation.
  • a drug may be added to the saline solution after the saline solution has exited a cooling device.
  • a next step can for example comprise advancing or flowing the target fluid through a target fluid inlet and into an inner conduit(s) of the cooling device.
  • a next step in the method can for example include altering a reactant inlet from a closed state to an open state, or otherwise activating the endothermic reaction.
  • the activation step and/or alteration of the reactant inlet from the closed state to the open state prior to flowing the target fluid through the target fluid inlet of the cooling device so as to allow the reaction to commence prior to the target fluid entering the inner conduit(s) of the cooling device.
  • a next step can for example comprise advancing or flowing the target fluid through a target fluid outlet of the cooling device into a cooled-fluid- receiving tube, as described above. Then, a next step can for example comprise administering to the patient the target fluid in the cooled-fluid- receiving tube intravascularly until, for example, a state of hypothermia is reached in the patient. Administering the cooled target fluid to the patient may include adding therapeutically active drugs to the cooled target fluid, either prior to or after cooling.
  • the final step may include administering the cooled target fluid to the patient to begin induced hypothermia therapy in the pre-hospital setting, although a state of induced hypothermia in the patient may not be reached until the patient is, for example, in the in-hospital setting.
  • the final step may include for example intravascularly administering the cooled target fluid to the patient in order to significantly reduce the core body temperature of the patient, with or without the patient ever reaching a state of hypothermia.
  • the devices, systems and methods can be used to administer a cooled target fluid to a patient by way of intravascular administration.
  • intravascular refers to routes or modes of administration via the vascular system of a patient, i.e. within the blood vessels or lymphatics, including but not limited to intravenous and/or intraosseous routes of administration.
  • the phrase “A, B, C, and/or D” includes A, B, C, and D individually, but also includes any and all combinations and subcombinations of A, B, C, and D.
  • the phrase “consisting of” excludes any element, step, or ingredient not specified in the claim.
  • the phrase “consists of” appears in a clause of the body of a claim, rather than immediately following the preamble, it limits only the element set forth in that clause; other elements are not excluded from the claim as a whole.
  • a fluid cooling device consistent with the present disclosure experimentally demonstrated superior performance in providing a cooled target fluid for use in the pre-hospital setting, as compared with the current method of cooling fluids in the pre-hospital setting via conventional refrigeration.
  • a fluid cooling device according to the present disclosure experimentally cooled a target fluid (i.e. , saline solution) from room temperature to about 4 ° C in about 1 .5 to 2.0 minutes, wherein ammonium nitrate and water were utilized as the endothermic reactants in the cooling device.
  • the cooling device according to the present disclosure may be sized and configured for compatibility with associated fluid delivery components.
  • the cooling device may be easily connected to standardized intravascular delivery equipment to function as an in-line, on- demand chilling device. All or part of the cooling device may be sterilizable and reusable, or alternatively may be configured as a disposable single-use device.
  • the shape of the cooling device can impact the efficiency of cooling of the target fluid, and was therefore analyzed to determine optimal shape(s).
  • a horseshoe crab shaped design as depicted can provide for a counter-current flow of the cooling fluid with respect to the target fluid inside the inner conduits.
  • Data from experiments showed that a counter current flow configuration, such as that depicted in Figure 1 A and 3, can in some embodiments provide for improved cooling of the target fluid.
  • the average output fluid temperature ( °C) was compared between a counter current flow design ( Figure 3) and a bidirectional flow design ( Figure 4).
  • the current flow design had an average output fluid temperature of 7.96 °C and 7.92 °C.
  • the bi-directional flow design had an average output fluid temperature of 9.42 °C and 9.63 °C.
  • the counter current flow design can have a greater cooling capacity.
  • thermoform rectangle design contained approximately half the volume of the U-shaped design. Using these test parameters the temperature profiles differed dramatically between the two designs. Particularly, the U-shaped design caused a dramatic reduction in temperature to below 4°C in the first 1 to 2 minutes with a gradual increase in temperature over a twelve minute period. Conversely, the thermoform rectangle design causes a significantly smaller and less pronounced decrease in temperature of the target fluid.
  • the number and size of inner conduits or coils can be altered in the design without departing from the scope of this disclosure to meet specific fluid flow requirements.
  • the number and size of inner conduits can depend on, for example, the size of the target fluid inlet, the size and/or configuration of manifolds, and/or the tubing connected to that inlet.
  • the sum of the cross-sectional areas of inner conduits can be equal to or greater than the cross sectional area of incoming conduit, such as an IV tubing connected to the inlet, to minimize flow restriction by the cooling device.
  • the use of a plurality of inner conduits can result in no discernible decrease, or substantially no decrease, in the fluid flow rate as a result of the use of the cooling device (i.e. the flow rate is the same as if the device was not present in the IV flow path).
  • the inner conduits can have a wall thickness that is suitable for heat transfer from the target fluid to the cooling fluid to thereby facilitate the cooling of the target fluid.
  • the walls of the inner conduit can be relatively thin to thereby facilitate heat transfer away from the target fluid.
  • the thickness of the wall of the inner conduit can range from about 0.001 inches thick to about 0.1 inches thick. Experiments were conducted to test the impact of wall thickness on cooling capacity. Braided stainless steel conduits having a wall thickness of 0.005 inches were compared to copper tubing having a wall thickness of 0.014 inches.
  • Test parameters included the following: cooling method included use of ice water; agitation of 50 RPM on orbital shaker plate; 30 inch total tubing length in both designs; and a flow rate of 50.0 mL/min.
  • the average output temperature of the braided stainless steel conduit having a wall thickness of 0.005 inches was 5.2°C, while the average output temperature copper tubing having a wall thickness of 0.014 inches was 8.4 °C.
  • a thinner walled conduit can provide a greater heat transfer and cooling capacity.

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  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • Biomedical Technology (AREA)
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  • Engineering & Computer Science (AREA)
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  • General Chemical & Material Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Thermal Sciences (AREA)
  • Thermotherapy And Cooling Therapy Devices (AREA)

Abstract

La présente invention concerne des dispositifs, des systèmes, des procédés et des procédures pour refroidir des fluides, tels que dans des applications médicales. La présente invention concerne des dispositifs, des systèmes et des procédés pour refroidir des fluides. L'invention concerne des dispositifs de refroidissement qui peuvent comprendre une entrée de fluide cible, une sortie de fluide cible, une pluralité de conduits internes en communication fluidique avec l'entrée de fluide cible et la sortie de fluide cible, la pluralité de conduits internes constituant une pluralité de trajets d'écoulement respectifs pour un fluide cible à refroidir, et au moins un premier et un deuxième réactif endothermique pour provoquer une réaction endothermique pour refroidir le fluide cible dans les conduits internes.
PCT/US2015/053152 2014-10-01 2015-09-30 Dispositifs de refroidissement de fluide, systèmes et procédés pour refroidir des fluides WO2016054165A1 (fr)

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US11241541B2 (en) 2017-08-21 2022-02-08 Miraki Innovation Think Tank Llc Cold slurry syringe
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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3534852A4 (fr) * 2016-11-02 2020-09-30 Miraki Innovation Think Tank LLC Dispositifs et procédés de génération de suspension
US11000409B2 (en) 2016-11-02 2021-05-11 Miraki Innovation Think Tank Llc Devices and methods for slurry generation
US11890225B2 (en) 2016-11-02 2024-02-06 Miraki Innovation Think Tank Llc Devices and methods for slurry generation
US11324673B2 (en) 2016-11-18 2022-05-10 Miraki Innovation Think Tank Llc Cosmetic appearance of skin
CN106955189A (zh) * 2017-03-31 2017-07-18 常淑芳 一种冷疗袋及含有该冷疗袋的冷疗内裤
US11439532B2 (en) 2017-04-05 2022-09-13 Miraki Innovation Think Tank Llc Point of delivery cold slurry generation
US11446178B2 (en) 2017-04-05 2022-09-20 Miraki Innovation Think Tank Llc Cold slurry containment
US11241541B2 (en) 2017-08-21 2022-02-08 Miraki Innovation Think Tank Llc Cold slurry syringe

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