IP Library Granted Patent US 12,427,056
Granted Patent B2
US 12,427,056 · App. 17/116,164 · Granted Sep 30, 2025

Devices, systems, and methods for temperature management

Inventor: Erik Kulstad (Chicago, IL)
Assignee: Advanced Cooling Therapy, Inc.
A61F7/12A61F2007/0054A61F2007/126
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Quick Facts
Patent No.
US 12,427,056
App. No.
17/116,164
Granted
Sep 30, 2025
Kind
B2
Abstract

The present technology relates to systems and methods for managing core body temperature in a subject using, for example, an esophageal heat exchange device. In one aspect, the disclosure provides a method for reducing duration of a hospital stay in a subject undergoing core body temperature management.

Claims (9)

1. A method for controlling core body temperature in a subject in which mild to moderate hypothermia is being induced, the method comprising the steps of:

providing an esophageal cooling device, the esophageal cooling device comprising a heat exchange region having at least two lumens providing a fluid path for flow of a heat exchange medium, the esophageal cooling device further including first and second external tubes for delivering the heat exchange medium to and from the lumens of the heat exchange region and from and to an external source of the heat exchange medium;

orally or nasally placing at least a portion of the heat exchange region of the esophageal cooling device in an esophagus of the subject, wherein, throughout a procedure, the first and second external tubes remain completely outside of an oral or nasal cavity of the subject, wherein the heat exchange medium passes through the first and second external tubes before passing into the heat exchange region or after passing from the heat exchange region;

securing the first external tube with an anchor pad to reduce or prevent direct contact between the outer surface of the first external tube and exposed skin of the subject, wherein the anchor pad is positioned external to the oral cavity of the subject, wherein the first external tube passes over the anchor pad without passing through the anchor pad, so that the anchor pad lies between the first external tube and the exposed skin of the subject, wherein the second external tube is not secured to the anchor pad;

initiating flow of the heat exchange medium through the fluid path to achieve or maintain hypothermia;

assessing the subject for a shivering response; and

providing at least one anti-shivering intervention if the subject demonstrates mild to severe shivering.

2. The method of claim 1 , wherein the anti-shivering intervention is a non-sedating anti-shivering intervention.

3. The method of claim 2 , wherein the non-sedating anti-shivering intervention comprises (i) administering an anti-shivering agent selected from the group consisting of acetaminophen, buspirone, magnesium sulfate, nephopam, meperidine, and combinations thereof or (ii) skin counter-warming.

Assignments (2)
MERGER Recorded Apr 1, 2024
From: AURORA MERGER SUB, INC.
To: ADVANCED COOLING THERAPY, INC.
Reel/Frame 066968/0799 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 5, 2021
From: KULSTAD, ERIK
To: ADVANCED COOLING THERAPY, INC.
Reel/Frame 055166/0329 →
Continuity (3)
Continuation 15703629 · Sep 13, 2017
Provisional Application 62393764 · Sep 13, 2016
Related Publication 20210085520A1 · Mar 25, 2021
References Cited (37)
US 9301871B2 · Kulstad et al. · 2016 [cited by applicant]
US 9326890B2 · Kulstad et al. · 2016 [cited by applicant]
US 9622909B2 · Kulstad et al. · 2017 [cited by applicant]
US 10869778B1 · Kulstad · 2020 [cited by examiner]
US 20020095118A1 · Bertoch · 2002 [cited by examiner]
US 20040167593A1 · Keller et al. · 2004 [cited by applicant]
US 20080288033A1 · Mason et al. · 2008 [cited by applicant]
US 20100087900A1 · Flint · 2010 [cited by examiner]
US 20120265172A1 · Kulstad et al. · 2012 [cited by applicant]
US 20130006336A1 · Kulstad et al. · 2013 [cited by applicant]
US 20140155965A1 · Kulstad · 2014 [cited by examiner]
US 20160106578A1 · Kulstad et al. · 2016 [cited by applicant]
US 20170100280A1 · Kulstad et al. · 2017 [cited by applicant]
US 20170100281A1 · Kulstad et al. · 2017 [cited by applicant]
Asl, et al., “Ondansetron and Meperidine Prevent Postoperative Shivering After General Anesthesia,” Middle East Journal of Anesthesiology, 21(1), 2011. [cited by applicant]
Badjatia, et al., “Novel Esophageal Cooling Device for Therapeutic Normothermia,” Abstracts from the 6 [cited by applicant]
Choi, et al., “Prevention of Shivering During Therapeutic Temprature Modulation: The Columbia Anti-Shivering Protocol,” Neurocritical Care, 14(3), 2010. [cited by applicant]
Chun, et al., “A Randomized, Clinical Trial of Frozen Versus Standard Nasogastric Tube Placement,” World Journal Surg., 33(9), 2009. [cited by applicant]
Flint, et al., Therapeutic Hypothermia after Cardiac Arrest: Performance Characteristics and Safety of Surface Cooling with or without Endovascular Cooling, Neurocritical Care, 7(2), 2007. [cited by applicant]
Hoque, et al., “A Comparison of Cooling Methods Used in Therapeutic Hypothermia for Perinatal Asphyxia,” Pediatrics, 2010. [cited by applicant]
Hung, et al., “A novel method to assist nasogastric tube insertion,” Emergency Medicine Journal, 25(1) 2008. [cited by applicant]
Jarrah, et al., “Surface Cooling after Cardiac Arrest: Effectiveness, Skin Safety, and Adverse Events in Routine Clinical Practice,” Neurocritical Care, 14, 2011. [cited by applicant]
Jurado, et. al., “Continuous Infusion versus Intermittent Bolus Dosing of Vecuronium in Patients Receiving Therapeutic Hypothermia After Sudden Cardiac Arrest,” Pharmacotherapy, 31(12), 2011. [cited by applicant]
Kirtania, et. al., “Esophageal Guidewire-Assisted Nasogastric Tube Insertion in Anesthetized and Intubated Patients: A Prospective Randomized Controlled Study,” Anesthesia Analgesia, 114(2), 2012. [cited by applicant]
Knapik, et. al., “Comparison of intravascular and conventional hypothermia after cardiac arrest,” Kardiologia Polska, 69(11), 2011. [cited by applicant]
Logan, et. al., “Optimal Management of Shivering During Therapeutic Hypothermia After Cardiac Arrest,” Critical Care Nurse, vol. 31, No. 6, Dec. 2011. [cited by applicant]
May, et. al., “Association of the Bedside Shivering Assessment Scale and derived EMG power during therapeutic hypothermia in survivors of cardiac arrest,” Resuscitation 82, 2011. [cited by applicant]
Merchant, et. al., “Therapeutic hypothermia after cardiac arrest: Unintentional overcooling is common using ice packs and conventional cooling blankets,” Critical Care Medicine, 34(12 Suppl)., 2006. [cited by applicant]
Polderman, “Application of therapeutic hypothermia in the intensive care unit,” Intensive Care Medicine, 30(5), 2004. [cited by applicant]
Presciutti, et. al., “Shivering Management During Therapeutic Temperature Modulation: Nurses' Perspective,” Critical Care Nurse, 32(1), 2012. [cited by applicant]
Scaravilli, et. al., “Fever Management in SAH,” Neurocritical Care, 15(2), 2011. [cited by applicant]
Sessler, “Complications and Treatment of Mild Hypothermia,” Anesthesiology, 95(2), 2001. [cited by applicant]
Taniguchi, et al., “The Effect of Altering Skin-Surface Cooling Speeds on Vasoconstriction and Shivering Thresholds,” Anesthesia Analgesia, vol. 113, No. 3, Sep. 2011. [cited by applicant]
Topjian, et al., “Induction and maintenance of therapeutic hypothermia after pediatric cardiac arrest: Efficacy of a surface cooling protocol,” Pediatric Critical Care Medicine, vol. 12, No. 3, 2011. [cited by applicant]
Tsai, et al., “Tying a Slipknot to an Intubation Stylet. for Facilitating Insertion of a Nasogastric Tube in Liver Transplant Recipients: A Prospective, Randomized Study,” Transplant Proceedings, 44(2), 2012. [cited by applicant]
Usta, et al., “Dexmedetomidine for the prevention of shivering during spinal anesthesia,” Clinics, 66(7), 2011. [cited by applicant]
Weant, et al., “Pharmacologic Options for Reducing the Shivering Response to Therapeutic Hypothermia,” Pharmacotherapy, 30(8), 2010. [cited by applicant]