Method of manufacturing a heat transfer element for in vivo cooling

• US 7,066,947 B2
• Filed: 03/08/2004
• Issued: 06/27/2006
• Est. Priority Date: 01/23/1998
• Status: Expired due to Fees

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Innercool therapies Incorporated (Taxus Cardium Pharmaceuticals Group, Inc.)
• Inventors: Nest, Mark Van, Yon, Steven A.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US10/795,733
• Publication Number:
  US 20040172109A1
• Time in Patent Office: 841 Days
• Field of Search: 607/96, 607104-107, 607/113, 606 21- 26, 604/113
• 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: 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
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/006 having a special surface topography or special surface properties, e.g. roughened or knurled surface
• CPC Class Codes: A61M 2205/3606 cooled
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter

Abstract

An intravascular heat transfer device is provided with a mixing-inducing surface formed by an easily manufacturable process. The device can have a plurality of elongated, articulated segments, each having a mixing-inducing exterior surface. A flexible joint connects adjacent elongated, articulated segments. The device may be conveniently formed, e.g., by vapor deposition or molding, and further lacks undercuts so that the same may be conveniently removed from, e.g., a two-part mold.

Claims

1. A heat transfer device for intravascular temperature control of a patient, comprising:

a flexible layer of a material, the flexible layer having a feature to produce mixing in fluid flowing adjacent said layer, the flexible layer and feature shaped and configured such that the flexible layer may be removed from a multi-part mold in the absence of an undercut,

wherein the heat transfer device includes heat transfer segments separated by articulating joints.

2. The device of claim 1, wherein the flexible layer is formed of a metal selected from the group consisting essentially of Fe, Ti, Ta, nitinol, stainless steel, Al, Ag, Au, Cu, and Ni.

3. The device of claim 1, wherein a total outside diameter of the device is between about 9 f to 18 f.

4. The device of claim 1, wherein the articulating joints are shaped and configured as bellows.

5. The device of claim 1, wherein the articulating joints are shaped and configured as flexible tubes.

6. The device of claim 1, wherein the flexible layer has a thermal conductivity in the range of about 0.1 to 4 W/cm-K.

7. The device of claim 1, wherein each segment has at least one feature thereon, the feature including at least two helical ridges or grooves, one of said at least two helical ridges or grooves having opposite helicity from another of said helical ridges or grooves.

8. The device of claim 1, wherein each segment has a substantially cylindrical shape, said substantially cylindrical shape having a first half-cylinder and a second half-cylinder, said first and second half-cylinders joined at two sets of parting strips, each parting strip extending substantially parallel to an axis of the cylindrical shape;

and

at least two helical ridges or grooves, one of said at least two helical ridges or grooves disposed on the first half-cylinder and another disposed on the second half-cylinder.

9. The device of claim 1, wherein each segment has at least one feature thereon, the feature including a continuous corkscrew design.

10. The device of claim 1, wherein each segment has at least one dimple or knob thereon.

11. The device of claim 10, wherein each segment has at least two features thereon, the at least two features being selected from the group consisting of dimples or knobs or combinations thereof.

12. The device of claim 11, wherein the at least two features are arranged in a line substantially parallel to the axis of the segment.

13. The device of claim 11, wherein the at least two features are arranged to be not in a line substantially parallel to the axis of the segment.

16. The device of claim 1, wherein the fluid is blood.

17. The device of claim 1, wherein the fluid is a working fluid.

14. A method for performing a medical procedure while managing and controlling the temperature of the patient, comprising:

intravascularly inserting a catheter having a heat transfer element into a patient to be treated, the heat transfer element being formed of a flexible layer of a material, the flexible layer having a feature to produce mixing in fluid flowing adjacent said layer, the flexible layer and feature shaped and configured such that the flexible layer may be removed from a multi-part mold in the absence of an undercut; and

cooling or heating the heat transfer element to control the patient'"'"'s temperature.

15. The method of claim 14, wherein the medical procedure is selected from the group consisting of:

angioplasty, neurosurgery, cardiovascular surgery, stroke treatment, and combinations thereof.