Methods and devices for non-invasive cerebral and systemic cooling

• US 20060276552A1
• Filed: 05/10/2006
• Published: 12/07/2006
• Est. Priority Date: 05/13/2005
• Status: Active Grant

• Current Assignee: Braincool Ab, Temple University of The Commonwealth System of Higher Education
• Original Assignee: Benechill, Inc. (Braincool Ab)
• Inventors: Rozenberg, Allan, Barbut, Denise, Hoffman, John K.
• Granted Patent: US 7,824,436 B2
• Time in Patent Office: Days
• US Class Current: 514/743
• CPC Class Codes: A61F 2007/0065 Causing evaporation
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element
• CPC Class Codes: A61K 31/02 Halogenated hydrocarbons
• CPC Class Codes: A61M 11/02 operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised sprayers for horticulture A01G, A01H; killing insects A01M; air humidifying by nozzles F24F6/14, F24F6/18; cooling by spraying F28B, F28C
• CPC Class Codes: A61M 11/06 of the injector type
• CPC Class Codes: A61M 15/08 Inhaling devices inserted into the nose
• CPC Class Codes: A61M 15/085 Fixing means therefor
• CPC Class Codes: A61M 16/04 Tracheal tubes catheters in general A61M25/00
• CPC Class Codes: A61M 16/0409 with mean for closing the oesophagus
• CPC Class Codes: A61M 16/0438 Liquid-filled
• CPC Class Codes: A61M 16/0443 Special cuff-wall materials A61M16/0481, A61M16/0422 take precedence
• CPC Class Codes: A61M 16/0459 one cuff behind another
• CPC Class Codes: A61M 16/0461 Nasoendotracheal tubes
• CPC Class Codes: A61M 16/0479 above the cuff, e.g. giving access to the upper trachea
• CPC Class Codes: A61M 16/0486 Multi-lumen tracheal tubes
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/107 in the inspiratory path
• CPC Class Codes: A61M 16/209 Relief valves
• CPC Class Codes: A61M 19/00 Local anaesthesia syringes therefor A61M5/00; Hypothermia A61M5/42 takes precedence; cooling blood in a bypass of the arterial system A61M1/36
• CPC Class Codes: A61M 2016/0027 : pressure meter
• CPC Class Codes: A61M 2025/0034 : characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
• CPC Class Codes: A61M 2025/0036 : with more than four lumina
• CPC Class Codes: A61M 2025/0073 : Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow
• CPC Class Codes: A61M 2202/0275 : Nitric oxide [NO]
• CPC Class Codes: A61M 2205/3606 : cooled
• CPC Class Codes: A61M 25/003 : characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/0032 : characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0068 : Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 : Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 31/00 : Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

A method for cerebral and systemic cooling by providing a nebulized liquid having a boiling point of 38-300° C. The nebulized liquid is delivered as a mist or a spray via the nasal and/or oral cavities of a patient. The mist causes cooling by direct heat transfer through the nasopharynx and hematogenous cooling through the carotids and the Circle of Willis. Compositions and medical devices for cerebral and systemic cooling are also provided. Cooling assemblies, and methods of use, are also provided that include flexible balloon assemblies that are inserted to various locations in a patient'"'"'s body. The flexible balloons are then infused with a liquid having a temperature between about −20° C. and about 37° C. The flexible balloon assemblies can be inserted into the nasal cavity, oral cavity, throat, stomach, and other locations to effect cerebral cooling.

Claims

1. A method for cerebral cooling, comprising the steps of:

inserting an elongate member into a nasal cavity of a patient through a patient'"'"'s nostril, the elongate member comprising a proximal end, a distal end, a first lumen extending therebetween, and a plurality of ports in fluid communication with the first lumen; and

delivering a perfluorocarbon spray and a gas onto a surface of the patient'"'"'s nasal cavity through the plurality of ports in the elongate member,

wherein the gas enhances evaporation of the perfluorocarbon from the nasal cavity and wherein a cerebral temperature of the patient is reduced by at least 1°

C. in one hour by evaporation of the perfluorocarbon in the nasal cavity.

2. The method of claim 1, wherein the elongate member further comprises a second lumen extending between the proximal and distal ends.

3. The method of claim 1, further comprising the steps of:

infusing the perfluorocarbon into the first lumen of the elongate member;

infusing the gas into the second lumen of the elongate tubular member; and

combining the perfluorocarbon and gas at the plurality of ports to form a perfluorocarbon spray.

4. The method of claim 1, wherein the gas is oxygen.

5. The method of claim 1, wherein the perfluorocarbon has a boiling point above 37°

C.

6. The method of claim 1, wherein the perfluorocarbon has a boiling point between about 0°

C. and about 160°

C.

7. The method of claim 1, wherein the perfluorocarbon has a boiling point between about 25°

C. and about 140°

C.

8. The method of claim 1, wherein the perfluorocarbon is perfluorohexane.

9. The method of claim 1, wherein the perfluorocarbon 2-methy perfluoropentane.

10. The method of claim 1, wherein the perfluorocarbon spray is delivered at a temperature between about −

5°

C. and about 25°

C.

11. The method of claim 1, wherein the perfluorocarbon spray is delivered to the roof and the turbinates of the nasal cavity.

12. The method of claim 1, further comprising the step of delivering a drug onto the surface of the patient'"'"'s nasal cavity through the plurality of ports in the elongate member.

13. The method of claim 1, further comprising the steps of:

inserting a second elongate member into the nasal cavity of the patient through a second nostril of the patient, the second elongate member comprising a proximal end, a distal end, a first lumen extending therebetween, and a plurality of ports in fluid communication with the first lumen; and

delivering a perfluorocarbon spray and a gas onto a surface of the patient'"'"'s nasal cavity through the plurality of ports in the second elongate member,

wherein the gas delivered through the second elongate member enhances evaporation of the perfluorocarbon delivered through the second elongate member from the nasal cavity.

14. A method for cerebral cooling, comprising the steps of:

inserting a cooling assembly into a nasal cavity of a patient through a patient'"'"'s nostril, wherein the cooling assembly comprises

a flexible balloon defining a chamber,

a first elongate tubular member having a lumen in fluid communication with the chamber, and

a second elongate tubular member having a lumen in fluid communication with the chamber;

a third elongate tubular member having a lumen extending from a proximal end to a distal end, wherein the flexible balloon is mounted circumferentially about the third elongate tubular member; and

wherein the lumen is in fluid communication with at least one of a patient'"'"'s nasopharynx, pharynx, larynx, or esophagus.

infusing a liquid having a temperature between about −

20°

C. and about 37°

C. through the lumen of the first elongate tubular member into the chamber; and

withdrawing the liquid from the chamber through the lumen of the second tubular member;

wherein the chamber of the flexible balloon expands to place the flexible balloon in contact with the nasal cavity.

15-27. -27. (canceled)

28. A method for cerebral cooling, comprising the steps of:

inserting a cooling assembly into a nasal cavity of a patient through a patient'"'"'s nostril, wherein the cooling assembly comprises

a first balloon defining a chamber and having a port,

a second balloon defining a chamber inside of the chamber of the first balloon;

a first elongate tubular member having a lumen in fluid communication with the chamber of the second balloon, and

a second elongate tubular member having a lumen in fluid communication with the chamber of the second balloon;

filling the chamber of the first balloon with a first liquid through the port to place the balloon in contact with the nasal cavity; and

infusing a second liquid having a temperature between about −

20°

C. and about 37°

C. through the lumen of the first elongate tubular member into the chamber of the second balloon,

wherein the second liquid exits the chamber of the second balloon through the lumen of the second elongate tubular member, wherein the second liquid reduces a temperature of the first liquid, and wherein a cerebral temperature of the patient is reduced by at least 1°

C. in about one hour.

29-36. -36. (canceled)

37. A method for cerebral cooling, comprising the steps of:

inserting a cooling assembly into a nasal cavity of a patient through a patient'"'"'s nostril, wherein the cooling assembly comprises

a balloon defining a chamber and having a first port with a gas-venting filter and a second port,

a first elongate tubular member having a lumen in fluid communication with the chamber,

filling the chamber of the balloon with a first liquid through the second port to place the balloon in contact with the nasal cavity; and

infusing a second liquid having a temperature between about −

5°

C. and about 5°

C. through the lumen of the first elongate tubular member into the first liquid in the chamber,

wherein the second liquid undergoes a phase transition to gas, wherein the gas is then vented through the gas-venting filter, wherein the second liquid reduces a temperature of the first liquid, and wherein a cerebral temperature of the patient is reduced by at least 1°

C. in about one hour.

38-43. -43. (canceled)

44. A method for cerebral cooling, comprising the steps of:

inserting a cooling assembly into a nasal cavity of a patient through a patient'"'"'s nostril, wherein the cooling assembly comprises

a balloon defining a chamber,

a branched tubular member comprising a first tubular member that branches into a second and a third tubular member, wherein each of the first, second, and third tubular members have lumens, wherein the lumen of the first tubular member is in fluid communication with the chamber and the lumens of the second and third tubular members, and

a pump connected to the second tubular member;

a cooler connected to the pump and the third tubular member;

infusing a liquid having a temperature between about −

20°

C. and about 37°

C. through the lumens of the third and first tubular members into the chamber; and

withdrawing the liquid from the chamber through the lumens of the first and second tubular members;

wherein the chamber of the balloon expands to place the surface of the balloon in contact with the nasal cavity when the chamber is infused with liquid, and wherein a cerebral temperature of the patient is reduced by at least 1°

C. in about one hour.

45-53. -53. (canceled)

54. A method for cerebral cooling, comprising the steps of:

inserting a cooling assembly into a patient through a patient'"'"'s nostril, wherein the cooling assembly comprises;

a first elongate tubular member having a proximal end, a distal end, a lumen therebetween, and a port at the distal end in fluid communication with the lumen;

a flexible balloon mounted circumferentially about the first elongate tubular member to the distal end, and wherein the flexible balloon defines a chamber that is in fluid communication with the port and lumen of the first elongate tubular member;

a second elongate tubular member having a proximal end, a distal end, and a lumen therebetween, wherein the lumen is in fluid communication with the chamber of the flexible balloon;

advancing the first elongate tubular member down the patient'"'"'s throat, through the patient'"'"'s esophagus, and into the patient'"'"'s stomach;

infusing a liquid having a temperature between about −

20°

C. and about 37°

C. through the lumen of the first elongate tubular member into the chamber of the flexible balloon; and

withdrawing the liquid from the chamber through the lumen of the second elongate tubular member;

wherein the chamber of the flexible balloon is filled to place the flexible balloon in contact with the adjacent anatomy.

55-65. -65. (canceled)

66. A method for cerebral cooling, comprising the steps of:

inserting a cooling assembly into a patient'"'"'s throat, wherein the cooling assembly comprises;

a first elongate tubular member having a proximal end, a distal end, a lumen therebetween, and a port at the distal end in fluid communication with the lumen;

a flexible toroidal balloon mounted at the distal end of the elongate tubular member, the flexible toroidal balloon defining a chamber;

a second elongate tubular member having a proximal end, a distal end, and a lumen therebetween in fluid communication with the chamber of the flexible toroidal balloon; and

a third elongate tubular member having a proximal end, a distal end, and a lumen therebetween in fluid communication with the chamber of the flexible toroidal balloon,

wherein the cooling system is positioned such that the flexible toroidal balloon is located over the larynx;

infusing a liquid having a temperature between about −

20°

C. and about 37°

C. through the lumen of the second elongate tubular member into the chamber; and

withdrawing the liquid from the chamber through the lumen of the third elongate tubular member,

wherein the chamber of the flexible toroidal balloon is filled to place the flexible toroidal balloon in contact with the epiglotis.

67-77. -77. (canceled)

78. A method for cerebral cooling, comprising the steps of:

inserting a cooling assembly into the oral cavity of a patient through a patient'"'"'s mouth, wherein the cooling assembly comprises;

a flexible balloon defining a chamber;

a first tubular member having a proximal end, a distal end, a lumen therebetween, and a port in fluid communication with the lumen of the first tubular member and the chamber of the flexible balloon;

a second tubular member having a proximal end, a distal end, a lumen therebetween, and a port in fluid communication with the lumen of the second tubular member and the chamber of the flexible balloon;

positioning the cooling assembly such that the flexible balloon covers a patient'"'"'s retromandibular area or peritonsillar region;

infusing a liquid having a temperature between about −

20°

C. and about 37°

C. through the lumen of the first tubular member into the chamber of the flexible balloon; and

withdrawing the liquid from the chamber through the lumen of the second tubular member;

wherein the chamber of the flexible balloon is filled to place the flexible balloon in contact with the retromandibular area or peritonsillar region.

79-89. -89. (canceled)

90. A gas and liquid delivery system comprising:

a flow meter for delivering a gas;

a mixing manifold in fluid communication with the flow meter; and

a reservoir containing a liquid portion and a gas portion, wherein the gas portion is in fluid communication with the flow meter and the mixing manifold, and wherein the liquid portion independently communicates with the mixing manifold.

91-95. -95. (canceled)

96. A method for delivering a liquid and a gas comprising the steps of:

providing a delivery system comprising;

a flow meter for delivering a gas;

a mixing manifold in fluid communication with the flow meter; and

a reservoir containing a liquid portion and a gas portion, wherein the gas portion is in fluid communication with the flow meter and the mixing manifold, and wherein the liquid portion independently communicates with the mixing manifold;

delivering gas from the flow meter to the mixing manifold and to the gas portion of the reservoir; and

delivering liquid from the liquid portion of the reservoir to the mixing manifold,

wherein pressure from the gas builds within the gas portion of the reservoir, thereby displacing liquid from the liquid portion of the reservoir into the mixing manifold.

97-104. -104. (canceled)

105. A gas and liquid delivery system comprising:

a flow meter for delivering a gas;

a mixing manifold in communication with the flow meter through a lumen of a first elongate tubular member; and

a sealed reservoir containing a fluid, wherein the interior of the sealed reservoir is in communication with a lumen of a second elongate tubular member, wherein the lumen of the second elongate tubular member is also in communication with the lumen of the first elongate tubular member, and wherein the fluid is in communication with the mixing manifold through a lumen of a third elongate tubular member.

106-109. -109. (canceled)

110. A method for cerebral cooling, comprising the steps of:

inserting an elongate member into a nasal cavity of a patient through one of the patient'"'"'s nostrils, the elongate member having a proximal end, a distal end and a lumen extending therebetween and an outer wall having a plurality of ports spaced apart along the elongate tubular member, each port in fluid communication with the lumen;

positioning said elongate member in the nasal cavity;

placing the proximal end of the elongate member in fluid communication with a liquid source;

nebulizing the liquid; and

delivering a nebulized liquid spray into the patient'"'"'s nasal cavity through the plurality of ports in the elongate member.

111-157. -157. (canceled)