Intravascular catheter with heat exchange element having inner inflation element and methods of use

• US 6,716,236 B1
• Filed: 10/19/2001
• Issued: 04/06/2004
• Est. Priority Date: 04/21/1998
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Alsius Corporation
• Inventors: Barker, Peter, Evans, Scott M., Tzeng, Elbert, Noda, Wayne A.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US10/045,936
• Time in Patent Office: 900 Days
• Field of Search: 607/96, 607/104, 607/105, 607/106, 607/113
• US Class Current: 607/105
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

An intravenous catheter system (apparatus and method) for controlling patient temperature includes a generally tubular elongate body, a heat exchange element through which a heat exchange fluid circulates, and an inflation element or irregular surface positioned within the heat exchange element for promoting mixing of the circulating heat exchange fluid. The heat exchange element and inflation element preferably include inflatable balloons. The catheter preferably has two to four balloons having a substantially straight configuration, each balloon containing an inner balloon inflation element having a substantially spiral configuration. The catheter also preferably has at least one infusion lumen for providing access to the patient'"'"'s blood and a guidewire lumen to accommodate a guidewire. The catheter is used in conjunction with a heat/cool system to cool a hyperthermic patient as quickly as possible, to warm a hypothermic patient as quickly as possible or to maintain normothermia.

Claims

1. An intra-vascular catheter adapted to exchange heat with a body fluid flowing through a body conduit of a patient, comprising:

an elongate body including an inflow lumen and an outflow lumen each extending therethrough, at least one inflow duct and at least one inflation duct each in fluid communication with the inflow lumen, and at least one outflow duct in fluid communication with the outflow lumen;

at least one heat exchange element in fluid communication with the inflow lumen through at least one of the at least one inflow duct and in fluid communication with the outflow lumen through at least one of the at least one outflow ducts; and

at least one inflation element disposed at least partially within the heat exchange element and in fluid communication with the inflow lumen through at least one of the at least one inflation duct.

2. The catheter of claim 1:

the at least one inflow duct including a first inflow duct and a second inflow duct;

the at least one outflow duct including a first outflow duct and a second outflow duct; and

the at least one inflation duct including a first inflation duct and a second inflation duct;

the at least one heat exchange element including a first heat exchange element in fluid communication with the first inflow duct and the first outflow duct, and a second heat exchange element in fluid communication with the second inflow duct and the second outflow duct;

the at least one inflation element including a first inflation element in fluid communication with the first inflation duct and a second inflation element in fluid communication with the second inflation duct.

3. The catheter of claim 1, at least one of the at least one inflation element being configured to promote mixing of the heat exchange fluid as the heat exchange fluid flows outside the inflation element.

4. The catheter of claim 3, the at least one of the at least one inflation element including a balloon having a substantially spiral configuration, and at least one of the at least one heat exchange element including a balloon having a substantially straight configuration.

5. The catheter of claim 1, at least one of the at least one inflation element having a maximum diameter that is approximately 50 percent to approximately 90 percent of a diameter of the heat exchange element.

6. An intra-vascular catheter adapted to exchange heat with a body fluid flowing through a body conduit of a patient, comprising:

an elongate body including inflow means for transporting a heat exchange fluid and outflow means for transporting the heat exchange fluid, each extending through the elongate body;

heat exchange means for exchanging heat between the heat exchange fluid and the body fluid in the patient'"'"'s body conduit, the heat exchange means being in fluid communication with the inflow means and with the outflow means; and

inflation element means for promoting mixing of the heat exchange fluid as the heat exchange fluid flows through the heat exchange means, the inflation element means being in fluid communication with the inflow means.

7. An intra-vascular catheter adapted to exchange heat with a body fluid flowing through a body conduit of a patient, comprising:

an elongate body including an inflow lumen, an outflow lumen and an inflation lumen each extending through the elongate body;

at least one inflow duct in fluid communication with the inflow lumen;

at least one outflow duct in fluid communication with the outflow lumen; and

at least one inflation duct in fluid communication with the inflation lumen;

at least one heat exchange element in fluid communication with the inflow lumen through at least one of the at least one inflow duct and in fluid communication with the outflow lumen through at least one of the at least one outflow duct; and

at least one inflation element disposed at least partially within the heat exchange element and in fluid communication with the inflation lumen through at least one of the at least one inflation duct.

8. The catheter of claim 7:

the at least one inflow duct including a first inflow duct and a second inflow duct, the at least one outflow duct including a first outflow duct and a second outflow duct; and

the at least one inflation duct including a first inflation duct and a second inflation duct;

the at least one heat exchange element including a first heat exchange element in fluid communication with the first inflow duct and the first outflow duct, and a second heat exchange element in fluid communication with the second inflow duct and the second outflow duct;

the at least one inflation element including a first inflation element in fluid communication with the first inflation duct and a second inflation element in fluid communication with the second inflation duct.

9. The catheter of claim 7, at least one of the at least one inflation element being configured to promote mixing of the heat exchange fluid as the heat exchange fluid flows outside the inflation element.

10. The catheter of claim 9, the at least one of the at least one inflation element including a balloon having a substantially spiral configuration, and at least one of the at least one heat exchange element including a balloon having a substantially straight configuration.

11. The catheter of claim 9, the at least one of the at least one inflation element including a balloon having a substantially straight configuration, and at least one of the at least one heat exchange element including a balloon having a substantially spiral configuration.

12. An intra-vascular catheter adapted to exchange heat with a body fluid flowing through a body conduit of a patient, comprising:

an elongate body including inflow means for transporting a heat exchange fluid, outflow means for transporting the heat exchange fluid, and inflation means for transporting an inflation fluid, each extending through the elongate body;

heat exchange means for exchanging heat between the heat exchange fluid and the body fluid in the patient'"'"'s body conduit, the heat exchange means being in fluid communication with the inflow means and with the outflow means; and

inflation element means for promoting mixing of the heat exchange fluid as the heat exchange fluid flows through the heat exchange means, the inflation element means being in fluid communication with the inflation means.

13. An intra-vascular catheter adapted to exchange heat with a body fluid flowing through a body conduit of a patient, comprising:

an elongate body having an inflow lumen and an outflow lumen each extending therethrough, the inflow lumen and outflow lumen for conveying a heat exchange fluid through the elongate body;

at least one heat exchange element through which the heat exchange fluid may flow, the at least one heat exchange element being in fluid communication with the inflow lumen and the outflow lumen and covering a portion of the elongate body;

wherein at least part of the portion of the elongate body covered by the at least one heat exchange element has a configuration that promotes mixing of heat exchange fluid flowing through the heat exchange element.

14. The method for controlling a temperature of a patient and accessing a body fluid flowing through a body conduit of the patient, comprising the acts of:

providing an intra-vascular catheter including an elongate body, at least one heat exchange element disposed on the elongate body, and at least one inflation element disposed within at least one of the at least one heat exchange element;

inserting the catheter into a body conduit of a patient;

inflating at least one of the at least one inflation element;

circulating a heat exchange fluid through at least one of the at least one heat exchange element to effect heat transfer with the body fluid flowing through the body conduit.

15. The method of claim 14, the inflating step including the step of conveying an inflation fluid to the at least one of the at least one inflation element, a flow of the inflation fluid being controlled independently of a flow of the heat exchange fluid.

16. The method of claim 14, the at least one of the at least one inflation element being inflated with the heat exchange fluid.