Selective organ cooling apparatus and method employing turbulence-inducing element with curved terminations

• US 6,238,428 B1
• Filed: 02/09/1999
• Issued: 05/29/2001
• 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: Lasheras, Juan C., Werneth, Randell L., Dobak, John D. III
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): ROLLINS, ROSILAND STACIE
• Application Number:
  US09/246,514
• Time in Patent Office: 840 Days
• Field of Search: 607/104-106, 606/20, 606/21, 606/22, 606/23, 604/52, 604/53, 604/93, 165/142, 165/179, 165/181, 165/184
• US Class Current: 607/105
• 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 2018/0281 using a tortuous path, e.g. formed by fins or ribs
• 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 selective organ heat transfer device with deep irregularities in a turbulence-inducing exterior surface. The device can have a plurality of elongated, articulated segments, each having a turbulence-inducing exterior surface. A flexible joint connects adjacent elongated, articulated segments. An inner lumen is disposed within the heat transfer segments. The inner lumen is capable of transporting a pressurized working fluid to a distal end of the heat transfer element. The irregularities may be grooves, and the grooves have a curved termination point which directs blood along a direction having a component perpendicular to the axis of the segments, thereby enhancing turbulence and heat transfer.

Claims

1. A heat transfer device, comprising:

a flexible coaxial catheter capable of insertion to a selected vessel in the vascular system of a patient;

a heat transfer element attached to a distal end of the catheter, the heat transfer element having an exterior diameter substantially less than the inner diameter of the selected vessel, the heat transfer element including at least two heat transfer segments, each heat transfer segment defining a respective major axis substantially along each'"'"'s length;

a plurality of exterior surface irregularities on the heat transfer element, the surface irregularities being shaped and arranged to create repetitively changing directions of flow in surrounding fluid; and

an inner coaxial tube disposed within the heat transfer element, the inner coaxial tube being connected in fluid flow communication with an inner coaxial tube within the catheter,

such that the surface irregularities each include a helical ridge and a helical groove formed on each heat transfer segment, the helical ridge on each heat transfer segment having an opposite helical twist to the helical ridges on adjacent heat transfer segments, and a termination of each helical groove is curved to direct blood flowing therein along a direction having a component perpendicular to the major axis of the heat transfer segment.

2. The heat transfer device of claim 1, further comprising a flexible joint connecting each of the heat transfer segments to adjacent the heat transfer segments.

3. The heat transfer device of claim 2, wherein the flexible joint includes a bellows.

4. The heat transfer device of claim 1, further comprising a plurality of interior surface irregularities in the heat transfer element, the interior surface irregularities being shaped and arranged to create repetitively changing directions of flow in a working fluid within the heat transfer element, the interior surface irregularities having a depth at least equal to the boundary layer thickness of working fluid flowing within the heat transfer element.

5. The heat transfer device of claim 4, wherein:

the interior surface irregularities include a helical ridge and a helical groove formed within each heat transfer segment; and

the helical ridge within each heat transfer segment has an opposite helical twist to the helical ridges within adjacent heat transfer segments;

such that the termination of each helical groove is curved to direct a working fluid flowing therein along a direction having a component perpendicular to the major axis of the heat transfer segment.

6. The heat transfer device of claim 1, wherein the termination is substantially spherical.

7. The heat transfer device of claim 1, wherein the termination is substantially paraboloidal.

8. The heat transfer device of claim 1, wherein the termination is substantially ellipsoidal.

9. The heat transfer device of claim 1, wherein the termination is substantially hyperboloidal.

10. A method for selectively controlling the temperature of a selected organ of a patient, including:

providing a catheter having a heat transfer element attached to a distal end thereof, the heat transfer element having a major axis and a plurality of exterior surface irregularities, the surface irregularities having a depth greater than the boundary layer thickness of blood flowing in a feeding artery of the selected organ;

inserting the catheter through the vascular system of the patient to place the heat transfer element in the feeding artery of the selected organ;

creating repetitively reversing directions of blood flow around the surface irregularities at a distance from the heat transfer element greater than the boundary layer thickness of blood flowing in the feeding artery and directing blood along a direction having a component perpendicular to the major axis of the heat transfer element, thereby creating and enhancing turbulence throughout the blood flow in the feeding artery;

circulating fluid into the heat transfer element via an internal lumen of the catheter and via an internal lumen of the heat transfer element;

circulating fluid out of the heat transfer element via an external lumen of the heat transfer element; and

transferring heat between the heat transfer element and the blood in the feeding artery to selectively control the temperature of the selected organ.

11. The method of claim 10, wherein:

the surface irregularities on the heat transfer element include a plurality of segments of helical ridges and grooves having alternating directions of helical rotation;

repetitively reversing directions of blood flow are created by establishing repetitively alternating directions of helical blood flow with the alternating helical rotations of the ridges and grooves; and

directing blood along a direction having a component perpendicular to the major axis of the heat transfer element is performed by establishing a curvature at the termination point of at least one helical groove.

12. The method of claim 11, wherein the directing blood is performed with a substantially spherical termination.

13. The method of claim 11, wherein the directing blood is performed with a substantially paraboloidal termination.

14. The method of claim 11, wherein the directing blood is performed with a substantially ellipsoidal termination.

15. The method of claim 11, wherein the directing blood is performed with a substantially hyperboloidal termination.