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WO2018183278A1 - Dispositifs œsophagiens renforcés de transfert de chaleur - Google Patents

Dispositifs œsophagiens renforcés de transfert de chaleur Download PDF

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Publication number
WO2018183278A1
WO2018183278A1 PCT/US2018/024493 US2018024493W WO2018183278A1 WO 2018183278 A1 WO2018183278 A1 WO 2018183278A1 US 2018024493 W US2018024493 W US 2018024493W WO 2018183278 A1 WO2018183278 A1 WO 2018183278A1
Authority
WO
WIPO (PCT)
Prior art keywords
heat transfer
transfer device
reinforced
lumen
esophageal
Prior art date
Application number
PCT/US2018/024493
Other languages
English (en)
Inventor
Erik Kulstad
Frank E. GARRETT
Original Assignee
Advanced Cooling Therapy, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Advanced Cooling Therapy, Inc. filed Critical Advanced Cooling Therapy, Inc.
Priority to EP18774511.2A priority Critical patent/EP3600180A4/fr
Priority to US16/498,263 priority patent/US20200100939A1/en
Publication of WO2018183278A1 publication Critical patent/WO2018183278A1/fr
Priority to US18/462,339 priority patent/US12290470B2/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/12—Devices for heating or cooling internal body cavities
    • 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

Definitions

  • the present disclosure generally relates to heat transfer devices, more specifically, reinforced esophageal heat transfer devices; systems; and methods for managing temperature, particularly esophageal temperature and/or core body temperature, in a subject.
  • the present technology relates to a reinforced esophageal heat transfer device for managing core body temperature in a subject.
  • the present technology relates to a temperature management system including a reinforced esophageal heat transfer device for managing core body temperature in a subject.
  • the present technology relates to a method of using a reinforced esophageal heat transfer device or temperature management system for managing core body temperature in a subject.
  • Active temperature management has been shown to be important for a number of conditions. In particular, adults who remain comatose after resuscitation from cardiac arrest, neonates suffering from hypoxic ischemic encephalopathy, and patients undergoing general surgical procedures longer than one hour in duration all have strong recommendations for temperature modulation. More broadly, active temperature management has been shown to be potentially beneficial for certain subsets of traumatic brain injury, including refractory fever in acutely brain injured patients; spinal cord injury; certain subsets of stroke; acute myocardial infarction; traumatic/hemorrhagic cardiac arrest; surgical operations lasting longer than one hour; hepatic encephalopathy; sepsis/septic shock; and raised intracranial pressure.
  • temperature management in an operative setting may improve patient outcome and reduce adverse events.
  • a patient's body temperature is controlled while undergoing surgical procedures in an operating room.
  • the patient's body temperature may be controlled to avoid perioperative hypothermia during operative procedures, which potentially may otherwise increases the incidence of wound infection, prolong hospitalization, increase the incidence of morbid cardiac events and ventricular tachycardia, and/or impair coagulation.
  • surface cooling e.g., via blankets, external vests, cooling helmets, etc.
  • raised operating room temperatures, inhaled gases, balloon catheters, and/or intravenous fluids are utilized to control a patient's body temperature during surgery.
  • Circulation of heat transfer medium within an esophageal heat transfer device allows for management of core body temperature of a subject.
  • External heat exchangers are used to monitor subject temperature and adjust the temperature of circulating heat transfer medium to warm the subject, cool the subject, and/or maintain the subject at a relatively constant temperature, such as in a state of normothermia.
  • Available esophageal heat transfer devices are fabricated from relatively thin-walled silicone tubing, which has a desirable combination of heat transfer, manufacturability, and strength properties.
  • the present technology pertains to a reinforced esophageal heat transfer device.
  • An example disclosed reinforced esophageal heat transfer device includes a distal end configured for nasopharyngeal or oropharyngeal insertion into an esophagus of a subject, a proximal end including an inlet port and an outlet port, a heat transfer region between the distal end and the proximal end and configured for contacting esophageal epithelium of the subject, a flexible tube defining one or more lumens configured for providing a fluid path for flow of a heat transfer medium to and from the heat transfer region, and one or more reinforcing elements, such as a reinforcing wire (e.g., a coiled wire), configured for reinforcing the flexible tube to enable the heat transfer medium to flow through the fluid path via negative pressure.
  • a reinforcing wire e.g., a coiled wire
  • the present technology pertains to an esophageal heat transfer device comprising at least one reinforced silicone tube.
  • the reinforced silicone tube comprises at least one reinforcing element.
  • the reinforcing element is a reinforcing wire.
  • the reinforcing element is a reinforcing coil.
  • the reinforcing coil is a metal spring, such as a stainless steel spring, a nylon spring, or a plastic spring.
  • the reinforcing coil is coextruded with the silicone during the formation of the tube itself.
  • the reinforcing coil has a substantially D-shaped cross section.
  • the reinforcing coil has a circular cross section such that the coil is substantially cylindrical.
  • the reinforcing coil is a light weight, low stiffness compression spring.
  • the reinforcing coil has a diameter of about 1 mm to about 5 mm, preferably about 3 mm.
  • FIG. 1 is a cross-sectional side view an example heat transfer device in accordance with the teachings herein.
  • FIG. 2 is a cross-sectional view the example heat transfer device of FIG. 1.
  • FIG. 3A depicts another example heat transfer device in accordance with the teachings herein.
  • FIG. 3B is a cross-sectional view of the heat-transfer device of FIG. 3A.
  • FIG. 4 depicts portions of reinforcing springs extending through the heat transfer device of FIGS. 3 A and 3B.
  • FIG. 5 further depicts a portion of one of the reinforcing springs extending through the heat transfer device of FIGS. 3A and 3B.
  • a patient's body temperature is controlled while undergoing surgical procedures in an operating room.
  • the patient's body temperature may be controlled to avoid perioperative hypothermia during operative procedures, which potentially may otherwise increases the incidence of wound infection, prolong hospitalization, increase the incidence of morbid cardiac events and ventricular tachycardia, and/or impair coagulation.
  • surface cooling e.g., via blankets, external vests, cooling helmets, etc.
  • raised operating room temperatures, inhaled gases, balloon catheters, and/or intravenous fluids are utilized to control a patient's body temperature during surgery.
  • Example reinforced esophageal heat transfer devices include a heat transfer region that is configured for contacting tissue (e.g., esophageal epithelium) of a subject and transferring heat to the esophageal epithelium to heat or cool the subject.
  • the reinforced esophageal heat transfer devices include a distal end configured for nasopharyngeal or oropharyngeal insertion into an esophagus of the subject and a proximal end that includes an inlet port and an outlet port.
  • the heat transfer region is located between the distal end and the proximal end.
  • an example reinforced esophageal heat transfer device includes a plurality of lumens (e.g., a heat transfer medium supply lumen, a heat transfer medium return lumen) that are configured for providing a fluid path for flow of a heat transfer medium to and from the heat transfer region.
  • Example reinforced esophageal heat transfer devices include a reinforcing element.
  • a plurality of reinforcing wires are configured for reinforcing a flexible tube that defines the plurality of lumens to enable the heat transfer medium to flow through the fluid path via negative pressure. That is, the example reinforced esophageal heat transfer devices are reinforced with the plurality reinforcing wires to prevent the negative pressure from collapsing the flexible tube and, thus, maintain the patency of the fluid path.
  • the reinforcing element is integrated with the device and, in particular, the flexible tube(s) defining a lumen for flow of heat transfer medium.
  • the reinforcing element may be coextruded with the tubing during the formation of the tube itself.
  • the reinforcing element is a separate component from the device.
  • the reinforcing element may be disposed within the lumen.
  • a reinforced esophageal heat transfer device is intended to control a subject's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage.
  • the esophageal heat transfer device comprises a silicone tube with three lumens.
  • two parallel lumens are in fluid communication with each other and an external heat exchanger to provide a fluid path for the flow of heat transfer medium to and from the external heat exchanger.
  • a third lumen provides gastric access. The third lumen can be connected to wall suction and used for standard gastric decompression.
  • the third lumen is in a co-axial arrangement with the inflow and outflow lumens.
  • a web supports the inner gastric lumen and separates inflow and outflow lumens.
  • the present technology pertains to an esophageal heat transfer device comprising at least one reinforced silicone tube.
  • the reinforced silicone tube comprises at least one reinforcing element.
  • the reinforcing element enhances the radial stiffness of the tube sufficiently to prevent the collapsing of the tube when operating in a negative pressure environment and/or enhances longitudinal stiffness of the tube to enhance placement.
  • the reinforcing element is a light weight, low stiffness compression spring.
  • the spring is a metal spring.
  • the metal is non-ferromagnetic metal.
  • one or more such springs are disposed within at least one lumen of the esophageal heat transfer device (i.e., multiple springs may be present in each lumen). In certain embodiments, a single spring is coextruded to maintain the stiffness of the tube. In certain embodiments, an exemplary esophageal heat transfer device comprises three lumens: inflow lumen, outflow lumen, and central lumen. In some such embodiments, at least one reinforcing element is disposed within at least one of the lumens. In some such embodiments, the reinforcing element is a reinforcing wire, such as metal spring.
  • a first metal spring is disposed within the inflow lumen and a second metal spring is disposed within the outflow lumen.
  • a first set of metal springs are disposed within inflow lumen and a second set of metal springs are disposed within the outflow lumen.
  • the first set of metal springs can be arranged in parallel to each other.
  • the second set of metal springs can be arranged in parallel to each other.
  • extension tubes are provided to connect the heat transfer device to an external heat exchanger.
  • an esophageal heat transfer device comprising at least one reinforced silicone tube has an increased radio-opacity relative to existing esophageal heat transfer devices.
  • an esophageal heat transfer device comprising at least one reinforced silicone tube may be viewed using x-ray imaging.
  • the reinforcing element is integrated with the device and, in particular, the silicone tube.
  • the reinforcing element may be coextruded with the silicone during the formation of the tube itself.
  • the reinforcing element is a separate component from the device.
  • the reinforcing element may be disposed within the lumen of the silicone tube.
  • the present technology pertains to a system to manage temperature in a subject, the system including: an esophageal heat transfer device comprising at least one reinforced silicone tube and a source of a heat transfer medium.
  • the esophageal heat transfer device is capable of interconnection to the source of the heat transfer medium.
  • the source of the heat transfer medium operates to circulate the heat transfer medium through the heat transfer device.
  • the source of the heat transfer medium includes a reservoir.
  • the reservoir is capable of storing the heat transfer medium.
  • the system includes the esophageal heat transfer device comprising at least one reinforced silicone tube and a negative pressure chiller, such as the Arctic Sun Temperature Management System (Bard Medical) or equivalent unit
  • the esophageal heat transfer device comprising at least one reinforced silicone tube is used with a negative pressure chiller, such as the Arctic Sun Temperature Management System (Bard Medical) or equivalent unit.
  • a negative pressure chiller such as the Arctic Sun Temperature Management System (Bard Medical) or equivalent unit.
  • the esophageal heat transfer device comprising at least one reinforced silicone tube is used with another source of heat transfer medium such as a Medi-Therm III Conductive Hyper/Hypothermia System (Gaymar/Stryker), a Blanketrol II or Blanketrol III Hyper- Hypothermia System (Cincinnati Sub-Zero) or equivalent unit.
  • the source of the heat transfer medium supplies temperature-controlled fluid, such as water or saline, through a connector hose to the heat transfer device.
  • An accessory temperature probe may interface between the source and the subject to sense subject temperature, which may be displayed on the source's control panel.
  • the source includes a circulating pump, heater, and refrigeration system.
  • the system further comprises a subject temperature probe.
  • the source of the heat transfer medium interfaces with a subject temperature probe.
  • the subject temperature probe can be a component of the heat transfer device or a separate device that is capable of being directly or indirectly coupled to the source.
  • Subject temperature probes are commercially available from, for example, Smiths Medical. Subject temperature probes are available for rectal, oral, vaginal, esophageal, or bladder temperature measurement.
  • the system includes: (a) at least one processor; (b) at least one operator interface configured to provide input to the processor; and (c) at least one memory.
  • the system is configured to: (1) receive an operator generated temperature setting and (2) control the temperature of the heat transfer medium and/or the flow rate of heat transfer medium through the heat transfer device.
  • the system senses a temperature of the subject (e.g., core body temperature of the subject) through a temperature probe and compares it to a user- selected target temperature, adjusting the temperature and/or flow rate of the heat transfer medium appropriately.
  • a temperature probe may convert subject temperature data into electronically readable signals that are transmitted to the source of the heat transfer medium, which then, if necessary, automatically adjusts the temperature and/or flow rate of the heat transfer medium to achieve target temperature.
  • the reinforcing element enhances radial stiffness of the tube sufficiently to prevent the collapsing of the tube when operating under negative pressure.
  • the reinforcing element additionally provides longitudinal stiffness to the device. The additional longitudinal stiffness provided by the reinforcing element allows for easier placement of the device.
  • the reinforcing element provides sufficient longitudinal stiffness to facilitate insertion and placement of the device, but also includes sufficient flexibility to facilitate traversal of the subject's pharynx and esophagus from an access point, such as the subject's mouth or nostril.
  • the term “subject” includes a mammal in need of therapy for a condition, disease, or disorder or the symptoms associated therewith.
  • the term “subject” includes dogs, cats, pigs, cows, sheep, goats, horses, rats, mice and humans. The term “subject” does not exclude an individual that is normal in all respects.
  • the subject is in need of targeted temperature management.
  • the subject is febrile.
  • the subject is in an intensive care unit.
  • the subject is suffering from or is at risk of suffering an ischemia-reperfusion injury.
  • the subject presents with out-of-hospital cardiac arrest (OHCA). In certain embodiments, the subject presents with in-hospital cardiac arrest (THCA). In certain embodiments, the subject has been resuscitated following cardiac arrest.
  • the subject's core body temperature is maintained between about 33°C and about 36°C, such as about 33°C, about 34°C, about 35°C, or about 36°C, for at least 12 hours. Alternatively, the subject's core body temperature is maintained between about 33°C and about 36°C for at least 24 hours, at least 36 hours, at least 48 hours, at least 60 hours, at least 72 hours, at least 84 hours, or at least 96 hours.
  • the subject has hypoxic ischemic encephalopathy.
  • the subject's core body temperature is maintained between about 32°C and about 34°C, such as about 32°C, about 33°C, or about 34°C, for at least 24 hours.
  • the subject's core body temperature is maintained between about 32°C and about 34°C for at least 48 hours, at least 72 hours, or at least 96 hours.
  • the subject has suffered a neurological insult, such as a stroke, spinal cord injury, or traumatic brain injury.
  • a neurological insult such as a stroke, spinal cord injury, or traumatic brain injury.
  • the subject's core body temperature is maintained at normothermia for at least 24 hours.
  • the subject's core body temperature is maintained at normothermia for at least 48 hours, at least 72 hours, or at least 96 hours.
  • the subject has suffered an acute myocardial infarction.
  • the subject's core body temperature is maintained between about 33°C and about 36°C, such as about 33°C, about 34°C, about 35°C, or about 35°C, for at least 12 hours.
  • the subject's core body temperature is maintained between about 33°C and about 36°C for at least 24 hours, at least 36 hours, at least 48 hours, at least 60 hours, at least 72 hours, at least 84 hours, or at least 96 hours.
  • the subject is a burn patient.
  • the burn patient is undergoing a surgical procedure.
  • the burn patient's core body temperature is maintained at normothermia for the duration of the surgical procedure.
  • the burn patient's core body temperature is maintained within a target range for the duration of the surgical procedure.
  • the subject is a patient undergoing a surgical operation.
  • the surgical operation is scheduled to last for more than one, two, three, four, five, six, seven, or eight hours. In a particular embodiment, the surgical operation is scheduled to last for at least one hour.
  • the subject's core body temperature is maintained at normothermia for the duration of the surgical operation. In some such embodiments, the subject's core body temperature is maintained within a target range for the duration of the surgical operation.
  • FIGS. 1 and 2 depict an exemplary reinforced heat transfer device 100 in accordance with the teachings herein. More specifically, FIG. 1 is a cross- sectional side view of the reinforced heat transfer device 100, and FIG. 2 is a cross-sectional view of the heat transfer region of the reinforced heat transfer device 100.
  • the reinforced heat transfer device 100 includes a heat transfer region 102, which includes an internal cavity 104.
  • the reinforced heat transfer device 100 includes a proximal end 106 and a distal end 108.
  • the heat transfer region 102 extends between the proximal end 106 and the distal end 108.
  • the reinforced heat transfer device 100 also includes an inlet port 110 and an outlet port 112.
  • the inlet port 110 is fluidly connected to a heat transfer medium supply lumen 114 of the reinforced heat transfer device 100
  • the outlet port 112 is fluidly connected to a heat transfer medium return lumen 116 of the reinforced heat transfer device 100.
  • the reinforced heat transfer device 100 includes a wall 118 that divides the internal cavity 104 into a multi-lumen cavity including the heat transfer medium supply lumen 114 and the heat transfer medium return lumen 116.
  • the heat transfer medium supply lumen 114 and the heat transfer medium return lumen 116 are in fluid communication with each other, thereby defining a fluid path for flow of a heat transfer medium through the reinforced heat transfer device 100.
  • the wall 118 extends from the proximal end 106 and toward, but not to, the distal end 108 such that the heat transfer medium supply lumen 114 and the heat transfer medium return lumen 116 fluid connected toward the distal end 108 of the reinforced heat transfer device 100.
  • the inlet port 110 is configured to connect to an inflow tube 120
  • the outlet port 112 is configured to connect to an outflow tube 122.
  • the inflow tube 120 and the outflow tube 122 are coupled to an external source (e.g., a heat exchanger configured to heat or chill a heat transfer medium).
  • the inflow tube 120 defines an external supply lumen that provides a fluid path for flow of the heat transfer medium from the heat exchanger and to the heat transfer medium supply lumen 114 of the reinforced heat transfer device 100.
  • the outflow tube 122 defines an external return lumen that provides a fluid path for flow of the heat transfer medium from the heat transfer medium return lumen 116 of the reinforced heat transfer device 100 to the external source.
  • the heat exchanger may be any of a variety of conventionally designed heat exchangers.
  • the heat exchanger may operate to provide the heat transfer medium via negative pressure.
  • the heat transfer medium may be a gas, such as, for example, nitrous oxide, Freon, carbon dioxide, or nitrogen.
  • the heat transfer medium may be a liquid, such as, for example, water, saline, propylene glycol, ethylene glycol, or mixtures thereof.
  • the heat transfer medium may be a slurry, such as, for example, a mixture of ice and salt.
  • the heat transfer medium may be a gel, such as, for example, a refrigerant gel.
  • the heat transfer medium may be a solid, such as, for example, ice or a heat conducting metal.
  • the heat transfer medium may be formed, for example, by mixing a powder with a liquid.
  • the inflow tube 120 and the outflow tube 122 fluidly connect the heat exchanger and the reinforced heat transfer device 100 to enable the heat transfer medium to flow between the heat exchanger and the reinforced heat transfer device 100 to heat or cool the reinforced heat transfer device 100.
  • the heat transfer medium flows from the heat exchanger, through the inflow tube 120 and into the heat transfer medium supply lumen 114 to heat or cool a subject via the heat transfer medium.
  • the heat transfer medium flows from the heat transfer medium supply lumen 114, through the heat transfer medium return lumen 116, and to the outflow tube 122 to circulate the heat transfer medium back to the heat exchanger.
  • the reinforced heat transfer device 100 is configured for placement within an anatomical structure of a mammalian subject.
  • the distal end 108 of the reinforced heat transfer device 100 is configured for insertion into a body orifice.
  • the distal end 108 of the reinforced heat transfer device 100 is configured for insertion into the nostrils, mouth, anus, or urethra of a subject.
  • the distal end 108 of the reinforced heat transfer device 100 may be ultimately positioned in the esophagus, rectum, colon, bladder, or other anatomical structure.
  • a heat transfer region 102 of the reinforced heat transfer device 100 may directly contact an epithelial surface of the subject.
  • the heat transfer region 102 may comprise flexible tubing 124 and is generally located between the distal end 108 and the proximal end 106. In other examples, the heat transfer region 102 is defined by the flexible tubing 124 and the distal end 108 of the reinforced heat transfer device 100.
  • the heat transfer medium is supplied to the reinforced heat transfer device 100 (e.g., from a heat exchanger) via the inlet port 110 and the inflow tube 120 connected to the inlet port 110.
  • the heat transfer medium circulates through the reinforced heat transfer device 100 to transfer heat (e.g., to heat, to cool, or to maintain temperature) between the subject and the heat transfer region 102 that contacts and/or is positioned adjacent to an inner surface (e.g., of the esophagus) of the subject. Further, the heat transfer medium exits the reinforced heat transfer device 100 through the outlet port 112 and the outflow tube 122 connected to the outlet port 112.
  • the reinforced heat transfer device 100 also includes a gastric access tube 126 that defines a gastric access lumen 128 and extends to the distal end 108 of the reinforced heat transfer device 100. Further, the reinforced heat transfer device 100 includes one or more ports 130 along the side of the gastric access tube 126. In the illustrated example, the one or more ports 130 are located along the gastric access tube 126 at the distal end 108 of the reinforced heat transfer device 100. The one or more ports 130 may provide for communication between the space exterior to the reinforced heat transfer device 100 and the gastric access lumen 128.
  • the one or more ports 130 may act as a portal between the subject's stomach and the gastric access lumen 128 allowing the gastric contents to be suctioned from the subject's stomach out through the gastric access lumen 128.
  • the presence of one or more ports 130 provides reduced likelihood of blockage of the gastric access lumen 128 from semi-solid stomach contents.
  • multiple gastric access lumens may be employed.
  • the addition of one or more ports 130 may improve and enhance the removal of stomach contents, which, in turn, may improve contact between gastric mucosa and the heat transfer region 102 of the reinforced heat transfer device 100. Such improved contact may enhance heat transfer between the reinforced heat transfer device 100 and the gastric mucosa and, thus, enhance heating or cooling of the subject.
  • the configuration of the ports 130 shown in Figure 1 is oval. However, the ports 130 can be, for example, circular, rectangular, or any other shape that permits flow of gastric contents from the stomach to the gastric access lumen 128.
  • the reinforced heat transfer device 100 is manufactured via, for example, extrusion.
  • extrusion processes to form the reinforced heat transfer device 100 may eliminate the need to seal junctions or affix end caps and reduce the points at which leaks may occur.
  • the flexible tubing 124, the wall 118, and the gastric access tube 126 are integrally formed via extrusion.
  • the flexible tubing 124 and the wall 118 are integrally formed via extrusion, the gastric access tube 126 is formed separately via extrusion, and the gastric access tube 126 is subsequently inserted into the internal cavity 104 defined by the flexible tubing 124.
  • the flexible tubing 124, the wall 118, and the gastric access tube 126 are formed separately via extrusion, and the wall 118 and the gastric access tube 126 are inserted into the internal cavity 104 to assemble the reinforced heat transfer device 100.
  • components of the reinforced heat transfer device 100 includes or is formed of a semi-rigid material such as a semi-rigid polymer.
  • the flexible tubing 124, the wall 118, and/or the gastric access tube 126 is formed of silicone to increase a flexibility and/or a thermal conductivity of the reinforced heat transfer device 100.
  • the components of the reinforced heat transfer device 100 are formed of biomedical grade extruded silicone rubber such as Dow Corning Q7 4765 silicone.
  • the heat transfer region 102 defined by the flexible tubing 124 more efficiently transfers heat from the heat transfer medium to the esophageal epithelium to heat or cool the subject due to the increased thermal conductivity of the material forming the reinforced heat transfer device 100.
  • the components of the reinforced heat transfer device 100 are formed of other semi-rigid materials including semi-rigid plastics such as ethylene tetrafluoroethylene (ETFE), polytetrafluoroethylene (PTFE), perfluoroalkoxy (PFA), and fluorinated ethylene propylene (FEP).
  • the reinforced heat transfer device 100 of the illustrated example includes one or more reinforcing elements disposed within one or more lumens, such as an inflow lumen and/or an outflow lumen.
  • the reinforced heat transfer device 100 of the illustrated example includes one or more reinforcing elements, such as a reinforcing wire (e.g., mesh, coil), embedded into the flexible tubing 124, the wall 118, and/or the gastric access tube 126 of the reinforced heat transfer device 100.
  • a reinforcing wire may be embedded into one or more of the components of the reinforced heat transfer device 100 during the extrusion process.
  • the reinforcing wire may be a metallic wire that stiffens the reinforced heat transfer device 100.
  • the reinforcing wires form a mesh embedded in the flexible tubing 124, a mesh embedded in the wall 118, and/or a mesh embedded in the gastric access tube 126 of the to reinforce the semi-rigid material of the reinforced heat transfer device 100.
  • the reinforcing wires may be springs (e.g., helical springs such as 5- millimeter helical springs, D-shaped springs) that are embedded in the flexible tubing 124, the wall 118, and/or the gastric access tube 126 to reinforce or stiffen the reinforced heat transfer device 100.
  • the reinforced heat transfer device 100 includes a reinforcing element, such as a reinforcing wire, to prevent the fluid path from becoming blocked when a negative pressure is applied to the heat transfer medium supply lumen 114 and/or the heat transfer medium return lumen 116.
  • the heat transfer device 100 may be fluidly connected to a heat exchanger via the inlet port 110 and the outlet port 112 to enable the heat transfer device 100 to transfer heat to heat or cool the subject.
  • the heat exchanger provides the heat transfer medium to the heat transfer device 100 by creating a negative pressure.
  • the flexible tubing 124, the wall 118, and/or the gastric access tube 126 defining the heat transfer medium supply lumen 114 and/or the heat transfer medium return lumen 116 are formed of silicone rubber and/or any other semi-rigid material without a reinforcing element
  • the negative pressure generated by the heat exchanger potentially may cause the flexible tubing that defines the heat transfer medium supply lumen 114 and/or the heat transfer medium return lumen 116 to collapse.
  • the heat transfer medium is unable to flow through the fluid path defined by the heat transfer medium supply lumen 114 and the heat transfer medium return lumen 116 and, thus, is unable to cause heat to transfer to the subject via the heat transfer region 102.
  • the reinforcing element of the heat transfer device 100 serves to stiffen and/or otherwise reinforce the flexible tubing 124, the wall 118, and/or the gastric access tube 126 to prevent the heat transfer medium supply lumen 114 and the heat transfer medium return lumen 116 from collapsing when negative pressure is created by the heat exchanger fluidly connected to the heat transfer device 100. That is, the reinforcing element facilitates flow of the heat transfer medium through the fluid path of the heat transfer device 100 when utilized with an external heat exchanger that provides heat transfer medium via negative pressure, thereby enabling the heat transfer device 100 to be utilized with such heat exchangers to warm or cool a subject.
  • a reinforcing element increases radio-opacity of the heat transfer device 100.
  • the increased radio-opacity enables the heat transfer device 100 to be viewed via an x-ray when inserted into the esophagus of the subject.
  • the reinforcing element enables an operator (e.g., a technician, a nurse, a doctor) to utilize an x- ray to determine a location of and/or to navigate the heat transfer device 100 when inserted into the subject.
  • FIGS. 3 A, 3B, 4, and 5 illustrate another example heat transfer device 300 in accordance with the teachings herein. More specifically, FIG. 3 depicts the heat transfer device 300 when assembled, FIG. 4 depicts a cross-sectional top view of the heat transfer device 300, FIG. 5 depicts a portion of the heat transfer device 300 when partially disassembled, and FIG. 6 depicts a portion of the heat transfer device 300 when partially assembled.
  • the heat transfer device 300 includes the heat transfer region 102, the proximal end 106, the distal end 108, the inlet port 110, the outlet port 112, the wall 118, and the gastric access tube 126.
  • Those components of the heat transfer device 300 are identical to or substantially similar to the heat transfer region 102, the proximal end 106, the distal end 108, the inlet port 110, the outlet port 112, the wall 118, and the gastric access tube 126 as disclosed in accordance with FIGS. 1-2. Accordingly, some features of those components of the heat transfer device 300 will not be described in further detail below.
  • the heat transfer device 300 includes one or more reinforcing elements 302 that extend through the internal cavity 104 to reinforce or stiffen the heat transfer device 300.
  • the reinforcing element(s) 302 are metallic wires that stiffen the reinforced heat transfer device 300.
  • one or more of the reinforcing elements 302 extend through the inlet port 110 and/or into the inflow tube 120 to reinforce at least a portion of the inflow tube 120.
  • One or more of the reinforcing elements 302 also extend through the outlet port 112 and/or into the outflow tube 122 to reinforce at least a portion of the outflow tube 122.
  • one or more of the reinforcing elements 302 are inserted into the heat transfer medium supply lumen 114 to reinforce the heat transfer medium supply lumen 114 to prevent the heat transfer medium supply lumen 114 from collapsing when a negative pressure is applied. Further, one or more of the reinforcing elements 302 are inserted into the heat transfer medium return lumen 116 to reinforce the heat transfer medium return lumen 116 to prevent the heat transfer medium return lumen 116 from collapsing when a negative pressure is applied. In the illustrated example, two of the reinforcing elements 302 are inserted into the heat transfer medium supply lumen 114, and two of the reinforcing elements 302 are inserted into the heat transfer medium return lumen 116.
  • more or less of the reinforcing elements 302 may be inserted into the heat transfer medium supply lumen 114 and/or the heat transfer medium return lumen 116 to stiffen the heat transfer device 300. Further, in some examples, one or more of the reinforcing elements 302 are inserted into the gastric access lumen 128.
  • the reinforcing elements 302 are springs, such as helical springs (e.g., 5-millimeter helical springs) or D-shaped springs. In other examples, the reinforcing elements 302 are meshes that extend through the internal cavity 104 of the heat transfer device 300. Further, in the illustrated example, the flexible tubing 124, the wall 118, and/or the gastric access tube 126 are not embedded with reinforcing wires such that the reinforcing elements 302 inserted into the internal cavity 104 to prevent the flexible tubing 124, the wall 118, and/or the gastric access tube 126 from collapsing.
  • springs such as helical springs (e.g., 5-millimeter helical springs) or D-shaped springs.
  • the reinforcing elements 302 are meshes that extend through the internal cavity 104 of the heat transfer device 300.
  • the flexible tubing 124, the wall 118, and/or the gastric access tube 126 are not embedded with reinfor
  • reinforcing elements e.g., a reinforcing wire
  • a reinforcing wire is embedded into the flexible tubing 124, the wall 118, and/or the gastric access tube 126 such that the reinforcing element and the embedded reinforcing wires combine to reinforce the fluid path of the heat transfer device 300.
  • FIG. 4 illustrates a portion of the heat transfer device 300 when a port connector 402 of the heat transfer device 300 is decoupled from the flexible tubing 124.
  • the port connector 402 includes the inlet port 110, the outlet port 112, an aperture 404 through which the gastric access tube 126 is to extend, and an end 406 that is to couple to the flexible tubing 124.
  • two reinforcing elements 302 extend through the heat transfer medium supply lumen 114. Additionally, two reinforcing elements 302 extend through the heat transfer medium return lumen 116.
  • FIG. 5 illustrates a portion of the heat transfer device 300 when the port connector 402 is coupled to the flexible tubing 124 of the heat transfer device 300.
  • one reinforcing element 302 extends through the heat transfer medium return lumen 116, through the outlet port 112, and at least partially into the outflow tube 122.
  • the present disclosure provides an esophageal heat transfer device comprising at least one reinforced tube defining a lumen for flow of a heat transfer medium.
  • the reinforced tube is a silicone tube.
  • the present disclosure provides an esophageal heat transfer device comprising a lumen for flow of a heat transfer medium and a reinforcing element disposed within said lumen.
  • the reinforcing element is a coil, preferably a spring, and more preferably a metal spring.
  • the present disclosure provides an esophageal heat transfer device comprising a first reinforced tube defining an inflow lumen and a second reinforced tube defining an outflow lumen.
  • the first and second reinforced tubes have sufficient radial strength to prevent collapse in a negative pressure environment.
  • the present disclosure provides an esophageal heat transfer device comprising an inflow lumen in fluid communication with an outflow lumen, and at least one reinforcing element disposed within said inflow lumen or said outflow lumen. In certain embodiments, at least one reinforcing element is disposed within each of said inflow lumen and said outflow lumen.
  • the present disclosure provides a reinforced esophageal heat transfer device comprising: (a) a distal end configured for nasopharyngeal or oropharyngeal insertion into an esophagus of a subject; (b) a proximal end including an inlet port and an outlet port; (c) a heat transfer region between the distal end and the proximal end; (d) one or more lumens configured for providing a fluid path for flow of a heat transfer medium to and from the heat transfer region; and (e) one or more reinforcing elements configured for reinforcing the one or more lumens to enable the heat transfer medium to flow through the fluid path via negative pressure.
  • the use of the disjunctive is intended to include the conjunctive.
  • the use of definite or indefinite articles is not intended to indicate cardinality.
  • a reference to “the” object or “a” and “an” object is intended to denote also one of a possible plurality of such objects.
  • the conjunction “or” may be used to convey features that are simultaneously present instead of mutually exclusive alternatives. In other words, the conjunction “or” should be understood to include “and/or”.
  • the terms “includes,” “including,” and “include” are inclusive and have the same scope as “comprises,” “comprising,” and “comprise” respectively.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Thermal Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Thermotherapy And Cooling Therapy Devices (AREA)

Abstract

L'invention concerne des dispositifs œsophagiens renforcés de transfert de chaleur. À titre d'exemple, un dispositif œsophagien renforcé de transfert de chaleur comprend une extrémité distale conçue pour une insertion nasopharyngée ou oropharyngée dans l'œsophage d'un sujet, une extrémité proximale comprenant un orifice d'entrée et un orifice de sortie, une région de transfert de chaleur située entre l'extrémité distale et l'extrémité proximale, au moins une lumière conçue pour fournir un trajet de fluide destiné à l'écoulement d'un milieu de transfert de chaleur, vers et à partir de la région de transfert de chaleur, et au moins un élément de renforcement conçu pour renforcer l'au moins une lumière afin de permettre au milieu de transfert de chaleur de s'écouler à travers le trajet de fluide par l'intermédiaire d'une pression négative.
PCT/US2018/024493 2017-03-27 2018-03-27 Dispositifs œsophagiens renforcés de transfert de chaleur WO2018183278A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP18774511.2A EP3600180A4 (fr) 2017-03-27 2018-03-27 Dispositifs oesophagiens renforcés de transfert de chaleur
US16/498,263 US20200100939A1 (en) 2017-03-27 2018-03-27 Reinforced esophageal heat transfer devices
US18/462,339 US12290470B2 (en) 2023-09-06 Reinforced esophageal heat transfer devices

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US62/477,012 2017-01-17
US201762480842P 2017-04-03 2017-04-03
US62/480,842 2017-04-03

Related Child Applications (2)

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US16/498,263 A-371-Of-International US20200100939A1 (en) 2017-03-27 2018-03-27 Reinforced esophageal heat transfer devices
US18/462,339 Continuation US12290470B2 (en) 2023-09-06 Reinforced esophageal heat transfer devices

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WO2021195493A1 (fr) * 2020-03-27 2021-09-30 Advanced Cooling Therapy, Inc. Dispositifs, systèmes et méthodes de traitement d'une sepsie et/ou d'une infection virale
US12290470B2 (en) 2023-09-06 2025-05-06 Advanced Cooling Therapy, Inc. Reinforced esophageal heat transfer devices

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WO1999005996A1 (fr) * 1997-07-31 1999-02-11 Vasu M Andre Procede et appareil permettant de maintenir la temperature corporelle lors d'une intervention chirurgicale
US6694977B1 (en) * 1999-10-01 2004-02-24 Critical Care Research, Inc. Mixed-mode liquid ventilation gas and heat exchange
US20030078638A1 (en) * 2001-10-11 2003-04-24 Marc Voorhees Patient temperature control system with fluid temperature response
US20060175543A1 (en) * 2005-02-08 2006-08-10 John Elefteriades Intra-thecal catheter and method for cooling the spinal cord
US20070225781A1 (en) * 2006-03-21 2007-09-27 Nidus Medical, Llc Apparatus and methods for altering temperature in a region within the body
US20080161890A1 (en) * 2007-01-03 2008-07-03 Boston Scientific Scimed, Inc. Methods, systems, and apparatuses for protecting esophageal tissue during ablation
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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021195493A1 (fr) * 2020-03-27 2021-09-30 Advanced Cooling Therapy, Inc. Dispositifs, systèmes et méthodes de traitement d'une sepsie et/ou d'une infection virale
US12290470B2 (en) 2023-09-06 2025-05-06 Advanced Cooling Therapy, Inc. Reinforced esophageal heat transfer devices

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