WO1999066938A1 - Composition containing sulfur hexafluoride and oxygen, for increasing or decreasing the body temperature of a patient - Google Patents

Composition containing sulfur hexafluoride and oxygen, for increasing or decreasing the body temperature of a patient Download PDF

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Publication number
WO1999066938A1
WO1999066938A1 PCT/US1999/013878 US9913878W WO9966938A1 WO 1999066938 A1 WO1999066938 A1 WO 1999066938A1 US 9913878 W US9913878 W US 9913878W WO 9966938 A1 WO9966938 A1 WO 9966938A1
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WIPO (PCT)
Prior art keywords
patient
composition
body temperature
sulfur hexafluoride
gas mixture
Prior art date
Application number
PCT/US1999/013878
Other languages
French (fr)
Inventor
Massimo Ferrigno
Original Assignee
The Brigham And Women's Hospital, 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 The Brigham And Women's Hospital, Inc. filed Critical The Brigham And Women's Hospital, Inc.
Priority to EP99928807A priority Critical patent/EP1089743A1/en
Priority to CA002335939A priority patent/CA2335939A1/en
Priority to JP2000555624A priority patent/JP2002518453A/en
Publication of WO1999066938A1 publication Critical patent/WO1999066938A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/16—Fluorine compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/04—Sulfur, selenium or tellurium; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • A61M2205/362—General characteristics of the apparatus related to heating or cooling by gas flow

Definitions

  • the present invention is directed to noninvasive methods for rapidly changing the body temperature of a patient. This is accomplished by having the patient hyperventilate a gaseous mixture containing sulfur hexafluoride and oxygen.
  • the invention also includes the compositions used in these methods.
  • hypothermia has been induced in patients undergoing cardiac surgery and operations for cerebral aneurysms. More recently, the lowering of body temperature has been used as a technique for protecting the brain in head trauma patients and there are indications that this procedure may be useful in treating patients for hemorrhagic shock.
  • the present invention addresses this problem and discloses a method that can be used for rapidly inducing hypothermia or, alternatively, for rapidly warming a hypothermic patient.
  • the present invention is based upon the concept that respiratory heat exchange can be used to rapidly change a patient's body temperature.
  • the method requires nothing more than standard hospital equipment such as a ventilator and a means for heating or cooling gases prior to administration to a patient.
  • the invention is directed to a method for reducing the body temperature of a patient by administering a gas mixture comprising a combination of sulfur hexafluoride and oxygen.
  • a gas mixture comprising a combination of sulfur hexafluoride and oxygen.
  • the gas mixture is administered while the patient hyperventilates, either spontaneously or as the result of mechanical ventilation.
  • the mixture being administered must be below the body temperature of the patient and administration is continued until the patient's temperature is reduced to the desired level.
  • the sulfur hexafluoride will be present at a concentration of between 20 and 80%, with about an 80/20 ratio of sulfur hexafluoride to oxygen being preferred.
  • the pressure of carbon dioxide in the patient's arterial blood be maintained within the normal range during gas adrninistration.
  • a reduction in body temperature may be facilitated by mamtaining the water vapor content of the gas mixture at low levels, preferably below 10%.
  • the method discussed above can, alternatively, be used for increasing the body temperature of a patient.
  • the same mixture of sulfur hexafluoride and oxygen is administered but, rather than being cooled prior to administration, it is heated to a temperature above that of the patient. Again, administration of the mixture is maintained until the desired body temperature of the patient is achieved.
  • sodium hexafluoride should be maintained at a concentration of between 20 and 80%, with an 80/20 ratio of sodium hexafluoride to oxygen being preferred.
  • a patient's arterial blood carbon dioxide pressure may be maintained within the normal range during this procedure.
  • the water vapor content of the gas mixture administered to a patient may be maintained at levels of greater than 20 or 40%.
  • the invention also encompasses the compositions for rapidly changing a patient's body temperature used in the methods described above.
  • the invention includes mixtures of sulfur hexafluoride and oxygen, typically with the sulfur hexafluoride present at a concentration of 20-80%.
  • the composition should have about 80% sulfur hexafluoride.
  • the most desirable concentration of water vapor will depend upon the intended use of the composition. In cases where the composition will be used for lowering the body temperature of a patient, water vapor should, preferably, be present at a concentration of less than 10%.
  • Compositions that will be used to warm a patient should have a concentration of water vapor of greater than 20% and, more preferably, of greater than 40%.
  • the purpose of the present invention is to provide a simple, noninvasive method for rapidly changing the body temperature of a patient. This is accomplished by the patient hyperventilating a breathing mixture containing sulfur hexafluoride and oxygen.
  • the method is based upon the fact that the convective component of respiratory heat exchange is directly proportional to the minute ventilation, the density of the breathing mixture (gas) and its specific heat, and the difference in temperature between exhaled and inhaled gas.
  • respiratory heat exchange is maximized by:
  • Increasing minute ventilation This can be achieved by asking the patient to increase his/her tidal volumes and respiratory rate and/or by using a standard operating room or ICU ventilator in an intubated patient. The patient may be asked to hyperventilate spontaneously prior to being sedated and intubated to achieve faster rates of cooling or rewarming. If eucapnia (also known as isocapnia) is desired, carbon dioxide can be added to the breathing mixture as guided by either end-tidal or arterial pressures of carbon dioxide in the patient.
  • eucapnia also known as isocapnia
  • the content of water vapor in the breathing mixture to be inhaled can be changed to improve the efficiency of the method.
  • the content of water vapor can be decreased (e.g., down to zero) if the patient needs to be cooled; the drier the breathing mixture, the higher the evaporative heat loss.
  • the content of water vapor can be increased (up to saturation) if the patient needs to be rewarmed. This will have the effect of minimizing evaporative heat loss.
  • patients are heated or warmed using eucapnic hyperventilation with about an 80/20 sulfur hexafluoride-oxygen mixture.
  • hyperventilation is performed with a gas mixture to which CO 2 is added to maintain isocapnia.
  • the gas mixture is delivered dry and at subfreezing temperature through an endotracheal tube of the type routinely used in operations.
  • hyperventilation is performed with a humidified and warmed gas mixture.
  • the gas mixtures aclministered to patients may be mixed in a reservoir and then delivered to patients by means of a ventilator of the sort commonly available in hospitals.
  • the gas mixture may be forced through a desiccator to remove water vapor and through a heat exchanger to lower its temperature (see e.g., Beran, et al, J. App. Physiol 59:337-340 (1975)).
  • gases from a mixing reservoir may be delivered using a ventilator, humidified, and warmed by a standard electrically operated heater/humidifier system. As with cooling, rewarming will be accomplished using a gas mixture of sulfur hexafluoride and oxygen.
  • hyperventilation will be by means of the voluntary cooperation of a patient immediately prior to their being anesthetized. In patients who are unconscious or anesthetized, hyperventilation may be induced using a standard operating room or ICU ventilator. The monitoring of a patient's temperature and arterial blood gas values may be accomplished using procedures that are routine in the art.
  • the present methods will typically be used for cooling patients prior to cardiac or neurosurgery. They may also be used to rapidly lower the body temperature of patients suffering from hemorrhagic shock or in an emergency room setting for rapidly rewarming hypothermic patients. In general, the procedures may be performed on all patients in whom core temperature changes are desired, with the possible exception of those with asthma. In these patients, there is a risk of inducing bronchospasm and the risk/benefit ratio of using the techniques will need to be considered on a case by case basis.

Abstract

The present invention is directed to a method for changing the body temperature of a patient by having them hyperventilate a gas mixture containing sulfur hexafluoride and oxygen. The method may be applied to cool patients in any clinical situation where induced hypothermia is desirable or to rapidly rewarm hypothermic patients. The invention also includes the gas mixtures used in the method.

Description

COMPOSITION CONTAINING SULFUR HEXAFLUORIDE AND OXYGEN, FOR INCREASING OR DECREASING THE BODY TEMPERATURE OF A PATIENT
Field of the Invention
The present invention is directed to noninvasive methods for rapidly changing the body temperature of a patient. This is accomplished by having the patient hyperventilate a gaseous mixture containing sulfur hexafluoride and oxygen. The invention also includes the compositions used in these methods.
Background of the Invention
Patients undergoing operations that require low blood flow or circulatory arrest often must have their body temperature lowered prior to surgery in order to help protect the heart and brain. In particular, hypothermia has been induced in patients undergoing cardiac surgery and operations for cerebral aneurysms. More recently, the lowering of body temperature has been used as a technique for protecting the brain in head trauma patients and there are indications that this procedure may be useful in treating patients for hemorrhagic shock. Unfortunately, there is, at present, no reliable noninvasive method for rapidly lowering a patient's body temperature. The present invention addresses this problem and discloses a method that can be used for rapidly inducing hypothermia or, alternatively, for rapidly warming a hypothermic patient.
Summary of the Invention The present invention is based upon the concept that respiratory heat exchange can be used to rapidly change a patient's body temperature. The method requires nothing more than standard hospital equipment such as a ventilator and a means for heating or cooling gases prior to administration to a patient.
In its first aspect, the invention is directed to a method for reducing the body temperature of a patient by administering a gas mixture comprising a combination of sulfur hexafluoride and oxygen. In order to increase the rate of heat exchange, the gas mixture is administered while the patient hyperventilates, either spontaneously or as the result of mechanical ventilation. The mixture being administered must be below the body temperature of the patient and administration is continued until the patient's temperature is reduced to the desired level. Typically, the sulfur hexafluoride will be present at a concentration of between 20 and 80%, with about an 80/20 ratio of sulfur hexafluoride to oxygen being preferred. It is also generally preferred that the pressure of carbon dioxide in the patient's arterial blood be maintained within the normal range during gas adrninistration. A reduction in body temperature may be facilitated by mamtaining the water vapor content of the gas mixture at low levels, preferably below 10%.
The method discussed above can, alternatively, be used for increasing the body temperature of a patient. The same mixture of sulfur hexafluoride and oxygen is administered but, rather than being cooled prior to administration, it is heated to a temperature above that of the patient. Again, administration of the mixture is maintained until the desired body temperature of the patient is achieved. As with the procedure described above, sodium hexafluoride should be maintained at a concentration of between 20 and 80%, with an 80/20 ratio of sodium hexafluoride to oxygen being preferred. A patient's arterial blood carbon dioxide pressure may be maintained within the normal range during this procedure. In order to further promote an increase in body temperature, the water vapor content of the gas mixture administered to a patient may be maintained at levels of greater than 20 or 40%.
The invention also encompasses the compositions for rapidly changing a patient's body temperature used in the methods described above. Thus, the invention includes mixtures of sulfur hexafluoride and oxygen, typically with the sulfur hexafluoride present at a concentration of 20-80%. Preferably, the composition should have about 80% sulfur hexafluoride. The most desirable concentration of water vapor will depend upon the intended use of the composition. In cases where the composition will be used for lowering the body temperature of a patient, water vapor should, preferably, be present at a concentration of less than 10%. Compositions that will be used to warm a patient should have a concentration of water vapor of greater than 20% and, more preferably, of greater than 40%.
Detailed Description of the Invention
The purpose of the present invention is to provide a simple, noninvasive method for rapidly changing the body temperature of a patient. This is accomplished by the patient hyperventilating a breathing mixture containing sulfur hexafluoride and oxygen. The method is based upon the fact that the convective component of respiratory heat exchange is directly proportional to the minute ventilation, the density of the breathing mixture (gas) and its specific heat, and the difference in temperature between exhaled and inhaled gas. Thus, respiratory heat exchange is maximized by:
1) Increasing minute ventilation: This can be achieved by asking the patient to increase his/her tidal volumes and respiratory rate and/or by using a standard operating room or ICU ventilator in an intubated patient. The patient may be asked to hyperventilate spontaneously prior to being sedated and intubated to achieve faster rates of cooling or rewarming. If eucapnia (also known as isocapnia) is desired, carbon dioxide can be added to the breathing mixture as guided by either end-tidal or arterial pressures of carbon dioxide in the patient.
2) Increasing the density of the gas (breathing mixture): The higher the concentration of sulfur hexafluoride in the mixture, the higher the resulting gas density.
3) Increasing the specific heat of the breathing mixture: This may be accomplished by adding another gas which has a high specific heat to the mixture.
4) Increasing the difference in temperature between exhaled and inhaled gas: In order to cool a patient, the breathing mixture to be inhaled must be cooled below the patient's body temperature; the colder the inhaled breathing gas, the higher the resulting respiratory heat loss. In order to warm a patient, the breathing mixture to be inhaled will be warmed; the warmer the inhaled breathing gas, the higher the resulting respiratory heat gain.
In addition, the content of water vapor in the breathing mixture to be inhaled can be changed to improve the efficiency of the method. For example, the content of water vapor can be decreased (e.g., down to zero) if the patient needs to be cooled; the drier the breathing mixture, the higher the evaporative heat loss. Alternatively, the content of water vapor can be increased (up to saturation) if the patient needs to be rewarmed. This will have the effect of minimizing evaporative heat loss.
In a preferred method, patients are heated or warmed using eucapnic hyperventilation with about an 80/20 sulfur hexafluoride-oxygen mixture. To cool a patient, hyperventilation is performed with a gas mixture to which CO2 is added to maintain isocapnia. The gas mixture is delivered dry and at subfreezing temperature through an endotracheal tube of the type routinely used in operations. To rewarm a patient, hyperventilation is performed with a humidified and warmed gas mixture.
The gas mixtures aclministered to patients may be mixed in a reservoir and then delivered to patients by means of a ventilator of the sort commonly available in hospitals. In procedures designed to lower body temperature, the gas mixture may be forced through a desiccator to remove water vapor and through a heat exchanger to lower its temperature (see e.g., Beran, et al, J. App. Physiol 59:337-340 (1975)). In procedures designed to increase body temperature, gases from a mixing reservoir may be delivered using a ventilator, humidified, and warmed by a standard electrically operated heater/humidifier system. As with cooling, rewarming will be accomplished using a gas mixture of sulfur hexafluoride and oxygen. These procedures are merely illustrative and the invention is compatible with any other method for heating or cooling gas mixtures and for effectively delivering them to a patient.
The simplest way for achieving hyperventilation will be by means of the voluntary cooperation of a patient immediately prior to their being anesthetized. In patients who are unconscious or anesthetized, hyperventilation may be induced using a standard operating room or ICU ventilator. The monitoring of a patient's temperature and arterial blood gas values may be accomplished using procedures that are routine in the art.
The present methods will typically be used for cooling patients prior to cardiac or neurosurgery. They may also be used to rapidly lower the body temperature of patients suffering from hemorrhagic shock or in an emergency room setting for rapidly rewarming hypothermic patients. In general, the procedures may be performed on all patients in whom core temperature changes are desired, with the possible exception of those with asthma. In these patients, there is a risk of inducing bronchospasm and the risk/benefit ratio of using the techniques will need to be considered on a case by case basis.

Claims

What is Claimed is:
1. A method of reducing the body temperature of a patient for any clinical condition in which such a change is desirable, comprising: a) administering a gas mixture to said patient by hyperventilation, wherein: i) said gas mixture comprises a combination of sulfur hexafluoride and oxygen; ii) said gas mixture is administered at a temperature below the body temperature of said patient; and b) maintaining the administration of the gas mixture of step a) until said patient's body temperature is reduced.
2. The method of claim 1, wherein said sulfur hexafluoride is present at a concentration of 20-80%.
3. The method of claim 1, wherein said sulfur hexafluoride is present at a concentration of about 80%.
4. The method of claim 1, wherein the concentration of carbon dioxide in said patient's blood is maintained in the normal range.
5. The method of claim 1 , wherein the water vapor content of said gas mixture is less than 10%.
6. The method of claim 1, wherein said patient is cooled in preparation for or during surgery.
7. The method of claim 6, wherein said surgery is cardiac or neurosurgery.
8. The method of claim 1, wherein said patient is cooled as a treatment for hemorrhagic shock.
9. A method of increasing the body temperature of a patient for any clinical condition in which such a change is desirable, comprising: a) administering a gas mixture to said patient by hyperventilation, wherein: i) said gas mixture comprises a combination of sulfur hexafluoride and oxygen; ii) said gas mixture is administered at a temperature above the body temperature of said patient; and b) maintaining the administration of the gas mixture of step a) until said patient's body temperature is increased.
10. The method of claim 9, wherein said sulfur hexafluoride is present at a concentration of 20-80%.
11. The method of claim 9, wherein said sulfur hexafluoride is present at a concentration of about 80%.
12. The method of claim 9, wherein the pressure of carbon dioxide in said patient's arterial blood is maintained in the normal range.
13. The method of claim 9, wherein the water vapor content of said gas mixture is greater than 20%.
14. The method of claim 9, wherein the water vapor content of said gas mixture is greater than 40%.
15. The method of claim 9, wherein the body temperature of said patient is increased as a treatment for hypothermia.
16. A composition for rapidly changing the body temperature of a patient, comprising sulfur hexafluoride and oxygen.
17. The composition of claim 16, wherein said sulfur hexafluoride is present at a concentration of 20-80%.
18. The composition of claim 16, wherein said sulfur hexafluoride is present at a concentration of about 80%.
19. The composition of claim 16, wherein the water vapor content of said composition is less than 10%.
20. The composition of claim 17, wherein the water vapor content of said composition is less than 10%.
21. The composition of claim 16, wherein the water vapor content of said composition is greater than 20%.
22. The composition of claim 17, wherein the water vapor content of said composition is greater than 20%.
23. The composition of claim 16, wherein the water vapor content of said composition is greater than 40%.
24. The composition of claim 17, wherein the water vapor content of said composition is greater than 40%.
PCT/US1999/013878 1998-06-24 1999-06-22 Composition containing sulfur hexafluoride and oxygen, for increasing or decreasing the body temperature of a patient WO1999066938A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP99928807A EP1089743A1 (en) 1998-06-24 1999-06-22 Composition containing sulfur hexafluoride and oxygen, for increasing or decreasing the body temperature of a patient
CA002335939A CA2335939A1 (en) 1998-06-24 1999-06-22 Composition containing sulfur hexafluoride and oxygen, for increasing or decreasing the body temperature of a patient
JP2000555624A JP2002518453A (en) 1998-06-24 1999-06-22 Composition comprising sulfur hexafluoride and oxygen for increasing or decreasing the temperature of a patient

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US9052198P 1998-06-24 1998-06-24
US60/090,521 1998-06-24

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US (1) US6303156B1 (en)
EP (1) EP1089743A1 (en)
JP (1) JP2002518453A (en)
CA (1) CA2335939A1 (en)
WO (1) WO1999066938A1 (en)

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WO2003047603A2 (en) * 2001-12-04 2003-06-12 Minnesota High-Tech Resources, Llc Breathable gas mixtures to change body temperature
US7201163B2 (en) * 2002-01-09 2007-04-10 The Brigham And Women's Hospital, Inc. Method for altering the body temperature of a patient using a nebulized mist
US8100123B2 (en) 2004-01-22 2012-01-24 Thermocure, Inc. Respiratory system for inducing therapeutic hypothermia
WO2013036540A1 (en) 2011-09-05 2013-03-14 Thermocure, Inc. Gastric, cutaneous, or peritoneal delivery of frozen mist to induce therapeutic hyperthermia
US10238831B2 (en) 2013-09-08 2019-03-26 Qool Therapeutics, Inc. Temperature measurement and feedback for therapeutic hypothermia
US11020269B2 (en) 2015-02-23 2021-06-01 Qool Therapeutics, Inc. Systems and methods for endotracheal delivery of frozen particles

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Cited By (16)

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Publication number Priority date Publication date Assignee Title
WO2003047603A2 (en) * 2001-12-04 2003-06-12 Minnesota High-Tech Resources, Llc Breathable gas mixtures to change body temperature
WO2003047603A3 (en) * 2001-12-04 2003-10-30 Minnesota High Tech Resources Breathable gas mixtures to change body temperature
US6983749B2 (en) 2001-12-04 2006-01-10 Minnesota High-Tech Resources, Llc Inducing hypothermia and rewarming using a helium-oxygen mixture
US7201163B2 (en) * 2002-01-09 2007-04-10 The Brigham And Women's Hospital, Inc. Method for altering the body temperature of a patient using a nebulized mist
US9004066B2 (en) 2004-01-22 2015-04-14 Qool Therapeutics, Inc. Respiratory system for inducing therapeutic hypothermia
US8281786B2 (en) 2004-01-22 2012-10-09 Thermocure, Inc. Respiratory system for inducing therapeutic hypothermia
US8402968B2 (en) 2004-01-22 2013-03-26 Thermocure, Inc. Respiratory system for inducing therapeutic hypothermia
US8100123B2 (en) 2004-01-22 2012-01-24 Thermocure, Inc. Respiratory system for inducing therapeutic hypothermia
US9757272B2 (en) 2004-01-22 2017-09-12 Qool Therapeutics, Inc. Respiratory system for inducing therapeutic hypothermia
US10893976B2 (en) 2004-01-22 2021-01-19 Qool Therapeutics, Inc. Respiratory system for inducing therapeutic hypothermia
WO2013036540A1 (en) 2011-09-05 2013-03-14 Thermocure, Inc. Gastric, cutaneous, or peritoneal delivery of frozen mist to induce therapeutic hyperthermia
US9414959B2 (en) 2011-09-05 2016-08-16 Qool Therapeutics, Inc. Gastric, cutaneous, or peritoneal delivery of frozen mist to induce therapeutic hyperthermia
US10238533B2 (en) 2011-09-05 2019-03-26 Qool Therapeutics, Inc. Gastric, cutaneous, or peritoneal delivery of frozen mist to induce therapeutic hyperthermia
US10238831B2 (en) 2013-09-08 2019-03-26 Qool Therapeutics, Inc. Temperature measurement and feedback for therapeutic hypothermia
US11357949B2 (en) 2013-09-08 2022-06-14 Pagonia Medical, Inc. Temperature measurement and feedback for therapeutic hypothermia
US11020269B2 (en) 2015-02-23 2021-06-01 Qool Therapeutics, Inc. Systems and methods for endotracheal delivery of frozen particles

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CA2335939A1 (en) 1999-12-29
US6303156B1 (en) 2001-10-16
JP2002518453A (en) 2002-06-25

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