Selective organ hypothermia method and apparatus

• US 6,482,226 B1
• Filed: 08/30/2000
• Issued: 11/19/2002
• Est. Priority Date: 01/23/1998
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Innercool therapies Incorporated (Taxus Cardium Pharmaceuticals Group, Inc.)
• Inventors: Dobak, John D. III
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/650,940
• Time in Patent Office: 811 Days
• Field of Search: 607/96, 607/104, 607/112-115, 606/27-32
• US Class Current: 607/104
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/0262 using a circulating cryogenic fluid
• CPC Class Codes: A61F 2007/0056 for cooling
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities

Abstract

A method and apparatus for performing hypothermia of a selected organ without significant effect on surrounding organs or other tissues. A flexible catheter is inserted through the vascular system of a patient to place the distal tip of the catheter in an artery feeding the selected organ. A compressed refrigerant is pumped through the catheter to an expansion element near the distal tip of the catheter, where the refrigerant vaporizes and expands to cool a flexible heat transfer element in the distal tip of the catheter. The heat transfer element cools the blood flowing through the artery, to cool the selected organ, distal to the tip of the catheter.

Claims

1. An apparatus for causing hypothermia in at least a portion of a mammal, said apparatus comprising:

a source of working fluid;

a flexible elongated catheter, said catheter having a flexible tubular outer catheter body;

a flexible tubular inner working fluid supply conduit located within said outer catheter body, a proximal end of said inner working fluid supply conduit being connected in fluid flow communication with an outlet of said source of working fluid;

a working fluid return path within said outer catheter body, a proximal end of said working fluid return path being connected in fluid flow communication with an inlet of said source of working fluid;

a flexible elongated, hollow, heat transfer element mounted to said distal end of said outer catheter body, said heat transfer element having an enhanced heat transfer surface area; and

a chamber defined within said hollow heat transfer element, said chamber being connected in fluid flow communication with an outlet of said working fluid supply conduit, said chamber being connected in fluid flow communication with a distal end of said working fluid return path within said outer catheter body;

wherein;

said working fluid supply conduit is substantially coaxial with said catheter body; and

said working fluid return path surrounds said working fluid supply conduit.

2. An apparatus for causing hypothermia in at least a portion of a mammal, said apparatus comprising:

a source of working fluid;

a flexible elongated catheter, said catheter having a flexible tubular outer catheter body;

a flexible tubular inner working fluid supply conduit located within said outer catheter body, a proximal end of said inner working fluid supply conduit being connected in fluid flow communication with an outlet of said source of working fluid;

a working fluid return path within said outer catheter body, a proximal end of said working fluid return path being connected in fluid flow communication with an inlet of said source of working fluid;

a flexible elongated, hollow, heat transfer element mounted to said distal end of said outer catheter body, said heat transfer element having an enhanced heat transfer surface area; and

a chamber defined within said hollow heat transfer element, said chamber being connected in fluid flow communication with an outlet of said working fluid supply conduit, said chamber being connected in fluid flow communication with a distal end of said working fluid return path within said outer catheter body;

wherein said heat transfer element comprises a plurality of elongated elements; and

wherein said plurality of elongated elements comprise a plurality of hollow tubes leading from said working fluid supply conduit to said working fluid return path in said catheter body, said hollow tubes being outwardly expandable.

3. An apparatus for causing hypothermia in at least a portion of a mammal, said apparatus comprising:

a source of working fluid;

a flexible elongated catheter, said catheter having a flexible tubular outer catheter body;

a flexible tubular inner working fluid supply conduit located within said outer catheter body, a proximal end of said inner working fluid supply conduit being connected in fluid flow communication with an outlet of said source of working fluid;

a working fluid return path within said outer catheter body, a proximal end of said working fluid return path being connected in fluid flow communication with an inlet of said source of working fluid;

a flexible elongated, hollow, heat transfer element mounted to said distal end of said outer catheter body, said heat transfer element having an enhanced heat transfer surface area; and

a chamber defined within said hollow heat transfer element, said chamber being connected in fluid flow communication with an outlet of said working fluid supply conduit, said chamber being connected in fluid flow communication with a distal end of said working fluid return path within said outer catheter body;

wherein said heat transfer element comprises a hollow tube coiled around said working fluid supply conduit.

4. An apparatus for causing hypothermia in at least a portion of a mammal, said apparatus comprising:

a source of working fluid;

a flexible elongated catheter, said catheter having a flexible tubular outer catheter body;

a flexible tubular inner working fluid supply conduit located within said outer catheter body, a proximal end of said inner working fluid supply conduit being connected in fluid flow communication with an outlet of said source of working fluid;

a working fluid return path within said outer catheter body, a proximal end of said working fluid return path being connected in fluid flow communication with an inlet of said source of working fluid;

a flexible elongated, hollow, heat transfer element mounted to said distal end of said outer catheter body, said heat transfer element having an enhanced heat transfer surface area; and

a chamber defined within said hollow heat transfer element, said chamber being connected in fluid flow communication with an outlet of said working fluid supply conduit, said chamber being connected in fluid flow communication with a distal end of said working fluid return path within said outer catheter body;

wherein said heat transfer element comprises a double helix.

5. An apparatus for causing hypothermia in at least a portion of a mammal, said apparatus comprising:

a source of working fluid;

a flexible elongated catheter, said catheter having a flexible tubular outer catheter body;

a flexible tubular inner working fluid supply conduit located within said outer catheter body, a proximal end of said inner working fluid supply conduit being connected in fluid flow communication with an outlet of said source of working fluid;

a working fluid return path within said outer catheter body, a proximal end of said working fluid return path being connected in fluid flow communication with an inlet of said source of working fluid;

a flexible elongated, hollow, heat transfer element mounted to said distal end of said outer catheter body, said heat transfer element having an enhanced heat transfer surface area; and

a chamber defined within said hollow heat transfer element, said chamber being connected in fluid flow communication with an outlet of said working fluid supply conduit, said chamber being connected in fluid flow communication with a distal end of said working fluid return path within said outer catheter body;

wherein said heat transfer element comprises a hollow tube in the form of a loop having two sides, each side of said loop comprising a coil.

6. An apparatus for causing hypothermia through intravascular cooling, said apparatus comprising:

a compressor;

a flexible elongated catheter, said catheter having a flexible tubular catheter body;

a flexible tubular refrigerant supply conduit within said catheter body, a proximal end of said refrigerant supply conduit being connected in fluid flow communication with an outlet of said compressor;

a refrigerant return path within said catheter body, a proximal end of said refrigerant return path being connected in fluid flow communication with an inlet of said compressor;

an expansion element adjacent to a distal end of said catheter body, said expansion element having an inlet at a distal end of said refrigerant supply conduit;

a flexible heat transfer element mounted to said distal end of said catheter body; and

a refrigerant chamber within said heat transfer element, said refrigerant chamber being connected in fluid flow communication with an outlet of said expansion element, said refrigerant chamber being connected in fluid flow communication with a distal end of said refrigerant return path within said catheter body;

wherein said heat transfer element comprises a hollow coiled tube.

7. A method for causing hypothermia through intravascular cooling, said method comprising:

providing a flexible catheter, said catheter having a heat transfer element adjacent its distal tip, said heat transfer element having an enhanced heat transfer surface area;

inserting said catheter through the vascular system of a patient to place said heat transfer element in a blood vessel;

supplying a working fluid to said heat transfer element;

passing said working fluid through said heat transfer element to cool the interior of said hollow heat transfer element;

cooling blood flowing in said vessel with said heat transfer element; and

forming said heat transfer element as a hollow coiled tube.

8. A method for causing hypothermia through intravascular cooling, said method comprising:

providing a flexible catheter, said catheter having a heat transfer element adjacent its distal tip, said heat transfer element having an enhanced heat transfer surface area;

inserting said catheter through the vascular system of a patient to place said heat transfer element in a blood vessel;

supplying a working fluid to said heat transfer element;

passing said working fluid through said heat transfer element to cool the interior of said hollow heat transfer element;

cooling blood flowing in said vessel with said heat transfer element; and

forming said heat transfer element as a hollow tube coiled around said working fluid supply conduit.

9. A method for causing hypothermia through intravascular cooling, said method comprising:

providing a flexible catheter, said catheter having a heat transfer element adjacent its distal tip, said heat transfer element having an enhanced heat transfer surface area;

inserting said catheter through the vascular system of a patient to place said heat transfer element in a blood vessel;

supplying a working fluid to said heat transfer element;

passing said working fluid through said heat transfer element to cool the interior of said hollow heat transfer element;

cooling blood flowing in said vessel with said heat transfer element; and

forming said heat transfer element as multiple helices.

10. A method as recited in claim 9, further comprising forming said multiple helices as a double helix.

11. A method as recited in claim 10, further comprising forming said double helix with each said helix being disposed to coil around said working fluid supply conduit.

12. A method as recited in claim 9, further comprising forming said multiple helices with each said helix being disposed to coil around said working fluid supply conduit.

13. A method as recited in claim 12, further comprising forming said multiple helices as a triple helix.

14. A method for causing hypothermia through intravascular cooling, said method comprising:

providing a flexible catheter, said catheter having a heat transfer element adjacent its distal tip, said heat transfer element having an enhanced heat transfer surface area;

inserting said catheter through the vascular system of a patient to place said heat transfer element in a blood vessel;

supplying a working fluid to said heat transfer element;

passing said working fluid through said heat transfer element to cool the interior of said hollow heat transfer element;

cooling blood flowing in said vessel with said heat transfer element; and

forming said heat transfer element as a hollow tube in the form of a loop having two coiled sides.

15. A method for causing hypothermia through intravascular cooling, said method comprising:

providing a flexible catheter, said catheter having a heat transfer element adjacent its distal tip, said heat transfer element having an enhanced heat transfer surface area;

inserting said catheter through the vascular system of a patient to place said heat transfer element in a blood vessel;

supplying a working fluid to said heat transfer element;

passing said working fluid through said heat transfer element to cool the interior of said hollow heat transfer element; and

cooling blood flowing in said vessel with said heat transfer element;

wherein said heat transfer element comprises a plurality of hollow tubes leading from said working fluid supply conduit to a working fluid return path in said catheter, said method further comprising expanding said plurality of hollow tubes outwardly.

16. An apparatus for causing hypothermia in at least a portion of a mammal, said apparatus comprising:

a source of working fluid;

a flexible elongated catheter, said catheter having a flexible tubular outer catheter body;

a flexible elongated, hollow, heat transfer element mounted to said distal end of said outer catheter body, said heat transfer element having an enhanced heat transfer surface area;

a flexible tubular inner working fluid supply conduit located within said outer catheter body, from an outlet of said source of working fluid to said heat transfer element; and

a working fluid return path within said outer catheter body, from said heat transfer element to an inlet of said source of working fluid;

wherein;

said working fluid supply conduit is substantially coaxial with said catheter body; and

said working fluid return path surrounds said working fluid supply conduit.

17. An apparatus for causing hypothermia in at least a portion of a mammal, said apparatus comprising:

a source of working fluid;

a flexible elongated catheter, said catheter having a flexible tubular outer catheter body;

a flexible elongated, hollow, heat transfer element mounted to said distal end of said outer catheter body, said heat transfer element having an enhanced heat transfer surface area;

a flexible tubular inner working fluid supply conduit located within said outer catheter body, from an outlet of said source of working fluid to said heat transfer element; and

a working fluid return path within said outer catheter body, from said heat transfer element to an inlet of said source of working fluid;

wherein said heat transfer element comprises a plurality of elongated elements; and

wherein said plurality of elongated elements comprise a plurality of hollow tubes leading from said working fluid supply conduit to said working fluid return path in said catheter body, said hollow tubes being outwardly expandable.

18. An apparatus for causing hypothermia in at least a portion of a mammal, said apparatus comprising:

a source of working fluid;

a flexible elongated catheter, said catheter having a flexible tubular outer catheter body;

a flexible elongated, hollow, heat transfer element mounted to said distal end of said outer catheter body, said heat transfer element having an enhanced heat transfer surface area;

a flexible tubular inner working fluid supply conduit located within said outer catheter body, from an outlet of said source of working fluid to said heat transfer element; and

a working fluid return path within said outer catheter body, from said heat transfer element to an inlet of said source of working fluid;

wherein said heat transfer element comprises a hollow tube coiled around said working fluid supply conduit.

19. An apparatus for causing hypothermia in at least a portion of a mammal, said apparatus comprising:

a source of working fluid;

a flexible elongated catheter, said catheter having a flexible tubular outer catheter body;

a flexible elongated, hollow, heat transfer element mounted to said distal end of said outer catheter body, said heat transfer element having an enhanced heat transfer surface area;

a flexible tubular inner working fluid supply conduit located within said outer catheter body, from an outlet of said source of working fluid to said heat transfer element; and

a working fluid return path within said outer catheter body, from said heat transfer element to an inlet of said source of working fluid;

wherein said heat transfer element comprises a double helix.

20. An apparatus for causing hypothermia in at least a portion of a mammal, said apparatus comprising:

a source of working fluid;

a flexible elongated catheter, said catheter having a flexible tubular outer catheter body;

a flexible elongated, hollow, heat transfer element mounted to said distal end of said outer catheter body, said heat transfer element having an enhanced heat transfer surface area;

a flexible tubular inner working fluid supply conduit located within said outer catheter body, from an outlet of said source of working fluid to said heat transfer element; and

a working fluid return path within said outer catheter body, from said heat transfer element to an inlet of said source of working fluid;

wherein said heat transfer element comprises a hollow tube in the form of a loop having two sides, each side of said loop comprising a coil.